National Academies Press: OpenBook

Ethical Conduct of Clinical Research Involving Children (2004)

Chapter: Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis

« Previous: Appendix A: Study Origins and Activities
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

B
State Regulation of Medical Research with Children and Adolescents: An Overview and Analysis

Amy T. Campbell, J.D., M.Bioethics

Researchwithchildrenand adolescents isincreasingly recognized as vital to promote the health of our youth, both current and future. The conduct of such research requires access to children and adolescents both to enhance the scientific validity of research with relevance to these populations and, as a matter of justice, to ensure that children and adolescents enjoy the benefits of research.

Children and adolescents are considered—both in law and in ethics—“vulnerable” populations deserving special protections. These protections enable society to reach a reasonable balance between protecting the safety of children and adolescents from research risks and promoting their inclusion in studies to benefit them and future generations.

Special federal regulations provide guidance to child and adolescent heath care researchers. One section of these regulations (Subpart A of 45 CFR Part 46 for the U.S. Department of Health and Human Services) provides for basic human subject protections and is known as the “Common Rule” for its application to most research conducted, supported, or

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

otherwise regulated by 17 federal agencies [1]. Additional protections (Subpart D of 45 CFR 46), which apply specifically to children, have been adopted by the U.S. Department of Health and Human Services [2], the Food and Drug Administration (FDA) (except for Section 46.408(c), which pertains to the waiver of parental permission), the U.S. Department of Education, the Central Intelligence Agency, and the Social Security Administration. Additional regulations issued by the U.S. Department of Education under the Protection of Pupil Rights Amendment govern social research conducted in school settings or otherwise related to education matters [3] (Table B.1; all tables are located in Addendum B1). The language of the federal regulations is frequently adopted as institutional review board (IRB) policy [4], with a likely result that most research, irrespective of the funding source, is reviewed—at least as an initial matter—according to the parameters of the federal guidelines.

Notably, with respect to several issues, the federal research regulations rely on state laws to provide relevant definitions or other elements essential to interpretation and application of the regulations. For example, the regulations define “children” as those persons who have “not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted” (emphasis added) [5]. Similarly, “guardian” means “an individual who is authorized under applicable state or local law to consent on behalf of a child to general medical care” [6].

Thus, it is critical that researchers, IRB members, and others engaged in or affected by the research process understand how state laws might affect research with children and adolescents. Relevant inquiries include the following issues: age of majority, emancipation status, the “mature minor” rule and other specific provisions related to age of consent for general medical care, and/or specific conditions (e.g., substance abuse disorders or emotional disturbances).

An overview of state laws related to these issues follows. Also addressed are state laws, regulations, or policies specific to children in state custody (e.g., children in foster care or detention facilities), when such laws, regulations, or policies are available.1 These guidelines are of particular importance in that they apply to those children who likely have unique medical or psychosocial issues distinct from those of the general population

1  

A separate project conducted under the auspices of the University of Rochester Medical Center is also pending. That project will survey IRBs at major academic medical centers in each state for further input as to state and local policies, guidance, etc., related to research with children and adolescents. Results from that study will be analyzed and published at a later date in a separate report.

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

of children.2 In light of these particular issues, targeted research is needed to focus on these specific concerns; however, special protections are justifiably attached to vulnerable (“at-risk”) children.3 A brief analysis incorporating relevant case law follows the overview to highlight the ways in which states do—or do not—regulate research with these specific populations. Directions for state guidance are also provided.

SUMMARY OF STATE LAWS RELEVANT TO MEDICAL AND BEHAVIORAL RESEARCH WITH CHILDREN AND ADOLESCENTS

Age of Majority

As a first issue, the age of majority in each state is important, as it sets forth the age above which Subpart D of the federal regulations, in addition to any special state protections, do not apply. That is, it is important to know what each state defines as the age of majority, since those who are above the age of majority should not be subject to Subpart D. Most states set the age of majority at 18 years, meaning that—for legal purposes—children are those individuals who have not yet reached the age of 18 (Table B.2).4 This is a fairly easy “bright-line” standard of which to be aware. However, for purposes of determining the ability of children—most likely adolescents—to assent, and even consent, to research participation, it is important to go beyond these “majority” statutes to focus on other consent-related provisions.

It is also worth noting that this is a legal definition and, hence, is not necessarily indicative of the maturity level, decisional capacity, or cognitive abilities of youth. In fact, several commentators call for greater attention to this matter and clarity in the law to accord adolescents greater respect vis-

2  

In fact, statistics indicate that children in foster care often end up in out-of-home placements because of parental neglect and/or abuse, substance abuse, the disproportionate impact of poverty, human immunodeficiency virus infection/AIDS, and similar problems [7].

3  

These protections are typically state specific and are often not formalized in policy but, rather, are handled on a case-by-case basis and are dependent on a variety of factors, such as the risks-benefits of the study, the age ranges of the children, the presence or availability of parents, and treatment alternatives outside of research.

4  

State statutes, administrative regulations, case law, and other written policies were identified through searches of Lexis/Nexis (a legal database) and were affirmed through reference to ClinLaw (a Thompson Publishing Group-sponsored database containing information on clinical laws) and the advice of other experts. As this is a complicated area of the law, a great deal of it exists at an “informal” (less “explicit”) level, and as adolescent maturity is an everchanging concept, this review and the accompanying tables are not meant to be relied upon as exhaustive studies of the law; rather, they offer insights into the myriad of ways in which states may approach—or choose not to approach—these issues.

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

à-vis their decisional capacities and need for confidentiality in medical care and research [8]. Furthermore, it is important to recognize that while this sets out a bright-line distinction between legal attainment of “competence” in medical decision making (as an adult), who is or is not a “child” for purposes of federal research regulation references state laws (but not specifically the age of majority) on this matter. The latter, in turn, set forth conditions under which certain “minors” might be able to make medical decisions on their own on the basis of certain life events or in certain medical scenarios. Hence, they might be “minors” according to a brightline test but are not subject to federal research regulations as “children” when state law is applied.

In the sections that follow, which discuss emancipation, the mature minor rule, and minor consent to treatment provisions, it should be emphasized that state laws have relevance in two different ways: the application of the definition of “children” and the waiver of parental permission to medical treatment and in other contexts. That is, certain state laws place a minor outside the definition of children (which would seemingly make Subpart D of the federal regulations inapplicable); other state law provisions support the waiver of parental permission (which would be much more context sensitive and which may or may not reasonably extend to research-related decisions).

Emancipated Minors

As noted earlier, certain life events remove minors from the purview of child or adolescent medical regulation. That is, the age of majority may not be met, but emancipation frees the former “child” from parental custody and control. Typical conditions that states use to establish emancipation are marriage [9], military service [10], or court order [11] (Table B.3).

The concept of emancipation arose in common law (court-developed law) and has only more recently been explicitly addressed in statutes.5 The “classical” definition of emancipation under the common law could be summarized thusly: emancipation occurs when a minor voluntarily lives independently of his or her parents (whether by marriage, military service, or the establishment of financial independence), the latter who, in turn, make no attempt at ongoing control or care of their child. In turn, it does not seem to make sense to treat “children” who meet the common-law definition of emancipated minors as being under parental authority [12].

5  

Of note, this early impetus to define emancipation was driven by the desire to allow minors to enter contracts and own property and to relieve emancipated minors from the duty to turn over their wages to their parents.

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

More recently, states have begun to supplant the common law with statutory refinements on the concept, including a focus on a broadened range of emancipation effects, including, for example, an ability to consent to medical treatment [13]. However, not every state has an emancipation statute; moreover, some that do continue to apply the concept rather narrowly, for example, to allow certain contract rights [14]. Additionally, many statutes list only certain emancipation effects. For example, some statutes establishing criteria and procedures for emancipation explicitly allow for consent to medical care; others do not [15].6

Furthermore, despite early developments in common law from which “emancipation” emerged (i.e., a focus on rights to contract, own property, and retain wages), few state courts have recently addressed the issue with respect to an “expanded” view of the effects of emancipation [16]. Thus, unfortunately for the researcher searching for uniformity, the picture is far from clear. For the purposes of this review, however, emancipation, whatever the causal event, is taken to mean that the child becomes an adult in the eyes of the state; that is, all rules governing parental custody or control are severed, which could include parental permission for research participation, to the extent that states follow a broader range of emancipation effects. Moreover, in this appendix, only those individuals considered adults for all purposes under state law are included in the category “emancipated minors.”

Mature Minors

Although emancipation in effect turns the “child” into an “adult” for the purposes of state law, other events may occur as a result of which the child or adolescent may be seen as sufficiently mature to make (certain) health care decisions [17]. In turn, the latter falls into two distinct categories: the “mature minor” rule (which is derived from common law and which has specific meaning and scope) and law that allows exceptions to the requirements of parental permission because of the types of services sought or the status of the minor. Moreover, it should be noted that the distinction between emancipation and mature minor status is unfortunately far from clear or uniform, especially as time has progressed and the two concepts have become more intertwined and complex.7

General lay audiences often confuse the concepts of emancipation and

6  

This does not imply that consent to other issues is barred; rather, it simply means that legislative action has only explicitly addressed certain situations that it finds imperative.

7  

Compare Tables B.3 and B.4 for areas of overlap.

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

maturity; for legal purposes, however, they are not the same. For the purposes of this appendix, and in accord with the general sentiments from common law, “mature minors” are typically defined as children who are seen as “sufficiently” mature (a subjective decision, made on a case-by-case basis) with the capacity to understand the risks and consequences of certain decisions and, hence, who have the ability to make those decisions, including, at times, decisions relating to medical treatment (Table B.4).8 The historical development of the “mature minor” doctrine in common law supports a distinction from emancipation, inasmuch as the former doctrine is of more recent vintage conferring more context-sensitive consent rights in children, for example, to consent to certain medical treatments.9

Age of Consent for Medical Care

Some youth, who are still technically “minors” under state law, are allowed to consent to general medical treatment under specific state statutory provisions [19]. For example, several states allow minors to make medical decisions when they hold sufficient capacity to understand the nature of the treatment [20]. A few states have set age limits younger than 18 years at which they allow minors to provide general consent for health care, such as 14 years (Alabama) [21], 15 years (California, Oregon) [22], and 16 years (South Carolina) [23]. Other states (e.g., Colorado, Indiana, and Maine) allow earlier consent to health care or treatment on the basis of certain events that indicate that the minor has sufficient decisional capacity, such as living separately and apart from the parents [24]. It is worth noting again, however, that statutes delineating conditions of sufficient decisional capacity should be distinguished from “emancipation” status. Emancipation represents a “legal” transition to adulthood in the eyes of the state, whereas decisional maturity represents a context-specific ability to consent in certain instances.10

8  

As commented upon by the American Law Institute, a prominent legal authority, in its Restatement (Second) of Torts, a minor’s consent should be effective if he or she is “capable of appreciating the nature, extent and probable consequences of the conduct consented to [e.g., medical treatment],” even if parental consent is “not obtained or is expressly refused” [18].

9  

This distinction (i.e., event versus context-sensitive maturity and the setting in which the decision is made) is followed in this paper.

10  

Again, however, it should be emphasized that the concept of “emancipation” in states is far from clear. For the purposes of this appendix, emancipation is seen as a transition to adulthood in state law, but researchers would need to consult experts in their own states for guidance on the bounds of emancipation in the respective states.

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Age of Consent Under Certain Circumstances

In addition, all states explicitly authorize minors to provide consent to health care when the decisions are related to certain disorders or types of care. That is, for purposes of consenting to specific health care services, these minors may be explicitly allowed—by statute—consent authority [25]. It is important to note, however, that this does not mean that such minors cannot consent in other situations; rather, for public policy reasons, states have, at times, chosen to specifically address minors’ decisional capacity in certain situations to promote health-seeking behavior [26].11 Examples include consent for mental health treatment, substance abuse treatment, treatment for human immunodeficiency virus (HIV) infection or acquired immune deficiency sydrome (AIDS), testing or treatment for sexually transmitted diseases (STDs), and family planning services (Table B.5).

These conditions, in essence, allow individuals who are technically minors to make their own health care decisions under specific conditions. At issue, however, is the extent to which treatment-related consent, whether in general medical settings or for specific conditions, translates to the research setting.

Research-Specific Legislation

Few states have any regulations that apply specifically to research with children and adolescents [27]. Moreover, those statutes that address research with youth do so only under confined circumstances [28]. Thus, although federal regulations reference state law, state law—as specifically applied in the research setting—is a relative vacuum in terms of the regulation of research with children and adolescents.

This uncertainty and frequent silence on the matter leaves researchers and IRBs in a position to make a best guess as to whether state laws related to treatment also apply to research, although there are good reasons to believe that they do apply, at least in certain situations [29]. Arguments have been put forward that such laws should apply, at least to the extent that research relates to specific conditions for which consent to treatment laws apply, for example, mental health and STDs [30]. For example, if a study sought to investigate the behavioral mechanisms at play in adolescents’ decisions to seek out treatment for an STD, a state that allows adolescents to consent to treatment for an STD should also allow for consent to research in connection with that STD. The argument might proceed

11  

Again, this does not mean that other areas of consent are prohibited; instead, they exist in the “gray zone” of prudent (“reasonable”) responses to the facts of a given case.

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

that the legislative intent behind consent to treatment—to promote individual and public health while preserving confidentiality—should similarly apply to research.

Moreover, it is important to note that where the law is silent on the issue (e.g., the applicability of treatment consent by minors to research consent), silence does not imply impermissibility. In fact, it could be argued that actions are permissible unless they are specifically restricted by the courts or legislative actions [31].

As a general principle, however, judicial development of the common law is not arrested by piece-meal legislative adoption of specific statutory exceptions to a general common law rule…. One of the great attributes of Anglo-American common law has been the flexibility demonstrated by the case by case judicial development of the principles and rules of the common law to adapt to the emerging conditions of society; this flexibility permits the law to remain relevant and reasonable, preventing “mindless obedience to [a] precept [that] can confound the search for truth and foster an attitude of contempt” [32].

Alternatively, of course, it should be noted that there is an important distinction between research and treatment. The former seeks to build generalizable knowledge without a focus on individual benefit, whereas the latter focuses on individual well-being. Accordingly, inasmuch as their intents vary, so too might the legal protections for children and adolescents attached to research versus treatment justifiably vary. Federal regulations also note that “assent,” the child’s “affirmative agreement to participate in research,” is required when IRBs determine that children are capable of such, thus leaving much to the IRB’s discretion [33]. This imprecision in federal regulations has not been addressed by the states [34].

Finally, it is also worth clarifying the distinction between emancipation and mature minor status, a distinction not always clearly made in state law.12 In general, emancipation (in this appendix) confers broader “adult” status to youth in all aspects of their lives, whereas the attainment of “mature minor” status is more narrowly construed in terms of the sort of health care consent authority that it confers. These differences might similarly affect the reach of regulations on research with minors, or at least the requirements to consent to research. “Emancipated minors,” to whose lives events have conferred—in the eyes of the state—legal adulthood, should be able to consent to research as adults.13 “Mature minors,” on the other

12  

See discussion infra, pp. 323–325.

13  

This still leaves the question, however, of how a researcher or IRB should reach the conclusion that a minor is emancipated. Arguably, at a minimum, minors who satisfy the common law criteria for emancipation or who have been emancipated by a court should be considered emancipated.

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

hand, are likely more limited in what they can and cannot consent to in treatment and in research.

Unfortunately, there is thus a great deal of uncertainty as to the extent of state regulations and the applicability of existing state regulations with respect to medical research with children and adolescents. Perhaps this should be unsurprising given the particularly recent nature of calls to enhance the base of research with populations of this age [35]. Whatever the case, states have for the most part seen fit to follow federal regulations in this area to date [36]. Whether the increasing demands for research with children and adolescents, coupled with advances in understanding of child and especially adolescent capacity and maturity, will affect states’ perceived need for further regulation remains to be seen. However, it would not be surprising if the conduct of more research in the absence of clear authority led to litigation, not unlike that witnessed in Maryland [37]. Before the discussion turns to case law, however, it is also important to touch upon a certain subset of the child and adolescent population: children in state custody.

Research-Specific Regulations: Children Under State Custody

Of special concern to researchers and policy makers are regulations pertaining to children in state custody, for example, children in foster care, juvenile delinquents, and wards of the state. These children fall under state control under the doctrine of parens patriae, the concept that the states assume a “parental” role to protect children when biological parents are not able to do so, such as in instances of child neglect or abuse or when children enter the juvenile detention system.

As the primary “authority” figure for these children, the state therefore typically assumes a custodial role for children that may extend to health care decision-making. The federal child-specific regulations contain a section explicitly addressing research with “wards of the state” [38]. Research with such children is permissible only if it relates to their status as wards or if it is conducted in settings in which a majority of the children involved as subjects are not wards [39]. Examples of the former might include research specifically related to issues facing children in foster care subsequent to child abuse; the latter might pertain to school-based research in which wards of the state are in a minority.

The federal regulations further require that special advocates—not state-appointed guardians—be appointed for each child [40]. These regulations are in addition to the more general federal regulations, which require IRBs to weigh the risks and benefits of any studies with any child populations, to ensure that IRBs do not allow high-risk (greater than a “minor increase over minimal risk”) studies unless they have a prospect of directly

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

benefiting the participants. Of interest is the extent to which states expand on federal guidance, inasmuch as they are the custodians primarily concerned with the welfare of children.

A further distinction is whether parental ties have been terminated, that is, if the child is simply in temporary custody of the state (state as custodian) or if the child is in a permanent out-of-home placement (state as legal guardian) because parental rights were terminated. If ties are not terminated, states likely defer to the authority of the parents over their child’s medical care, especially if the treatment is considered optional. If the state deems treatment to be necessary, however, and the parent refuses permission, the state could override the decision and provide its own authorization for treatment pursuant to parental neglect or abuse laws [41]. (This appendix refers generally to parental permission according to federal regulatory language, but some of the statutes and court decisions refer to parental consent, and that language is retained when individual statutes or court decisions are cited.)

The general tendency, however, is to defer to parental rights and, to the extent possible, involve parents in decision making when it is feasible and in the best interest of the child, as well as in keeping with constitutional law around parental rights [42]. It is likely that research participation decisions would follow a similar process, although deference to parental authority is even more likely unless the research is deemed of direct benefit and minimal risk.

A review of state law, regulation, and case law related to this research suggests that little formal guidance is available. To clarify this, commissioners of each state’s child welfare or social services department were recently contacted for further information on state and local policies or other guidance related to research with children under state custody. On the basis of the feedback received, it appears that there is little guidance in this area beyond federal research regulations or state consent to treatment laws that generally apply to children and adolescents (Table B.6). In fact, there seems to be a general lack of familiarity with and training in research issues generally, and research ethics specifically, among state agency personnel.

Applicable policies, when such policies exist, tend to track federal regulations on research with children generally. They also typically apply different standards to research with various levels of risk and to research conducted by agency employees (e.g., state or local department of social services case workers) compared with the standards that they apply to research conducted by external researchers [43]. Other states choose not to apply special rules, relying on federal regulations and IRB review by relevant institutions (presumably, the home institutions of external researchers) [44].

Moreover, when policies do exist, they often restrict the research methods used with these populations—such as research with pharmaceuticals or

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

the use of placebos—inasmuch as the “in-custody” child and adolescent population is seen as particularly vulnerable [45]. The extent to which these policies—or the general lack thereof—affect research with children under state custody is an important empirical question deserving further study. (See Addendum B2 for a discussion of two hypothetical studies proposing to perform research with children in state custody and how states might approach such proposals.)

CASE LAW

Case Example

Researchers at a prominent institute affiliated with an academic medical center propose to study the effects of various types of lead abatement on a group of already affected and at-risk children from an urban inner-city environment. The rental properties in the community at issue will be classified into five groups: the members of the first three groups live in homes experiencing various levels of lead abatement (“intervention” groups), and the members of the last two groups are the controls (the members of one control group live in homes that were previously fully abated and the members of the other control group live in homes built without lead paint). Landlords will be recruited, and those who agree to offer their properties for participation in the research will be encouraged, if not required, to rent to tenants with young children. Research investigators will also assist landlords to take advantage of loan programs supporting abatement.

The study would last 2 years, over which time the researchers would measure and compare the short- and long-term effects of the various abatement methods to reduce lead levels in dust and children’s blood. The stated purpose is to see if the less expensive means of lead abatement adequately protect the children’s health. That is, the hope is that children’s health is safeguarded, while the availability of low-rent housing in inner cities is maintained.

Parents who permit their child’s participation would be informed immediately if their child’s blood level was elevated; lead levels in the dust would also be provided periodically. Lead Registry Surveillance statistics released in 1999 show that although the number of children with elevated blood lead levels (EBLs) and lead poisoning declined during the latter part of the 1990s, the levels were disproportionately concentrated in the study site (urban region). Significantly, although 6.3 percent of children tested statewide had EBLs and 0.9 percent had lead poisoning, the proportions at the study site (urban area) were 16.7 and 2.6 percent, respectively [46]. Furthermore, the researchers estimated that the chosen study site targeted children in the highest risk communities for EBLs and lead poisoning [47].

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

Additionally, an annual state report supports claims that during the years leading up to the study (when the study was designed), up to 95 percent of the homes in the study site had lead hazards [48].

The academic medical center’s IRB approves the study, and with funding from the Environmental Protection Agency and state agencies, the research proceeds. After the study ends, two families sue the research institute for negligence, alleging untimely notice of EBLs, placing their children at unnecessary risk, in addition to a failure to meet standards of adequate parental informed permission.

The case proceeds to trial, with the lower court agreeing with the defendant that no legal duty exists between the researcher and the subject (summary judgment). The case is appealed and is taken to before the state’s highest (appellate) court. How might it respond to the facts of this case?

Illustrative States
Maryland

Few cases directly address state treatment of research with children and adolescents. Perhaps the most compelling and recent case is that described in the “case example” above, which highlights the facts of a recent Maryland case, Grimes v. Kennedy Krieger Institute, Inc. [49]. In its decision on this case, the Court of Appeals of Maryland (the state’s highest court) decided that a “legal duty normally exists between researcher and subject,” by virtue of the “special relationship” between them and arising out of contract law (the “contract” being the informed consent and permission form signed by the parents, who received compensation for their child’s participation) [50]. Finding that a duty could exist, the case was remanded to the trial court for a factual determination whether a duty did in fact exist in this case, whether that duty was breached, and if such breach was the proximate cause of damages (standard requirements of action in negligence) [51].

Of particular note was the court’s decision to go beyond the issue of negligence to find that, under state law, parental authority to permit their children to participate in research does not extend to nontherapeutic research that carries with it the risk of harm to the health of the child [52].14 In so deciding, the court referenced the history of abuse in research: from Nazi experiments (e.g., typhus experiments with concentration camp inmates) to the Tuskegee study (syphilis studies) and the Jewish Chronic

14  

Instead of referring to nontherapeutic research, many refer to research that does not present the prospect of direct benefit, as explained in Chapter 1.

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

Disease Hospital Study (cancer study without consent) [53]. The court was particularly troubled by the economically disadvantaged condition of the children and families in this case [54]. As the court stated:

The determination of whether a duty exists under Maryland law is the ultimate function of various policy considerations as adopted by the Legislature, or, if it has not spoken, as it has not in respect to this situation, by Maryland courts…. We do not feel that it serves proper public policy concerns to permit children to be placed in situations of potential harm, during nontherapeutic procedures, even if parents, or other surrogates, consent [55].

That is, the court interpreted Maryland law as not allowing parental consent (permission) for greater than minimal risk, “nontherapeutic” research in the first instance (e.g., when a “reasonable parent” would not allow such) [56]. Similarly, research was found to be impermissible without valid informed consent [57].

The merits of this decision are beyond the scope of this paper. However, its ramifications are important for future researchers in Maryland and to the extent that it has received national scrutiny across the country. The case has received much press, especially in research, research subject advocate, and legal circles, which quite likely will translate to related case and state law developments [58]. It will be interesting to see if other courts, in Maryland and beyond, follow the appellate court’s lead and further delineate those conditions under which research with children, including at-risk, sick, or healthy children, is permissible [59]. It will also be interesting to see how states respond to challenges to define “risk,” ”therapeutic,” and “nontherapeutic,” as well as the limits of “assent” and parental “permission” in relation to research with youth.

As noted in the preceding sections, state legislatures and executive agencies have, to date, had little to say about research in general and even less about research with children and adolescents. This case might serve to create ferment in state legislative bodies and within child-serving agencies to craft policies, guidelines, and even statutes to address research issues. Of note, however, is the fact that as of this writing (August 2003), the Maryland legislature has not passed legislation specifically responding to concerns raised by the Grimes decision. After the initial Court of Appeals decision, many believed that Johns Hopkins University and the University of Maryland would push for legislation to address the extent or limits of parental authority to permit research with their children, and a legislative committee hearing was scheduled to talk about what was seen as the crippling effect of the decision on research involving children.

However, after a subsequent clarification by the court in its denial of the Kennedy Krieger Institute’s motion for reconsideration (in which it

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

clarified its intent as to the meaning of “any risk” as per the bounds of parental authority), the universities backed off, deciding that the ruling would not dramatically alter their respective research portfolios [60]. The legislative committee hearing was conducted in October 2001, but its focus shifted from the Grimes case to the “regulatory gap” created by the limits of federal regulation and the unregulated status of non-federally funded, non-FDA research. To address this, a bill was enacted in 2002 [61]. Interestingly, however, no further legislative attention has been paid to the issues in the Grimes case itself [62].

On the basis of case-specific inactivity in the state legislature to date, how might Maryland trial courts respond? The Court of Appeals remanded the Grimes case back to the trial court for a decision as to the factual merits of claims of liability (by the researchers) and damages. In addition, the court also stated that a determination of “therapeutic” versus “nontherapeutic” research was for factual development on remand.

By “any risk,” we meant [in original decision] any articulable risk beyond the minimal kind of risk that is inherent in any endeavor. The context of the statement was a non-therapeutic study that promises no medical benefit to the child whatever, so that any balance between risk and benefit is necessarily negative. As we indicated, the determination of whether the study in question offered some benefit, and therefore could be regarded as therapeutic in nature, or involved more than minimal risk is open for further factual development on remand [63].

The lower court’s decision is still pending. What is less an issue for the specific parties, but a big issue for future researchers, is the appellate court’s decision to extend its holding to the bounds of the consent (permission) authority of parents on behalf of their children. This legal holding is not before the trial court. Thus, the lower court is left to decide if—in this instance—the research was therapeutic or not, was minimal or not, or was conducted with “at-risk” or healthy children.

Although it is likely that the case will be settled, if it proceeds to trial, the lower court could conclude that the research in this matter is “nontherapeutic” (i.e., there is insufficient evidence in the record that the researchers contemplated medically benefiting the “healthy” child subjects). Given the strong language of the high court’s decision, such an approach would not be out of the question. Inasmuch as the appellate court’s decision provided a litany of reasons—in quite dramatic language—for protecting children from overzealousness in research, researchers might now be a bit more hesitant when proposing studies with children in Maryland, especially when the children come from disadvantaged backgrounds, the risks are uncertain, and the notion of “benefits” is a stretch.

The relative silence thus far should not be seen as a defeat for those

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

who would seize upon the arguments used by the Maryland Court of Appeals; rather, it might well be the quiet before the storm. The case continues to be discussed in research meetings and is still cited by research subject advocates [64]. Thus, the issues raised by the court are still “in the air” and might very well surface in other decisions and on the agendas of other states’ legislatures. What might such cases look like in other states, based on their statutory and case law climates to date?

New York

Apply the same facts in the case example cited above to New York: where might its courts fall? New York is generally a conservative state with respect to research with “vulnerable subjects,” especially with persons with mental impairments.15 New York law generally designates parents or guardians as “legally authorized representatives” able to consent to (provide permission for) research with their minor children [66]; however, for persons residing in mental health treatment facilities, agencies take over decision-making authority. Furthermore, New York has in place an active mental health legal advocate structure that affects treatment decisions with mentally and developmentally challenged individuals, which also likely translates to research settings.

New York is also the only other known state, beyond Maryland, to address nontherapeutic research with vulnerable populations. In T.D. v. New York State Office of Mental Health [67], New York’s trial court ruled that the state’s Office of Mental Health (OMH) overstepped its bounds by issuing regulations pertinent to research with persons incapable of giving consent, including children. On appeal, the Appellate Division, First Department, affirmed this decision, but also went on to discuss constitutional and common law defects in the OMH regulations [68]. Of specific concern were regulations for consent to greater-than-minimal-risk nontherapeutic (or only possibly therapeutic) research with children and adults unable to give or withhold consent. Of note, the appellate level court went beyond the scope of the earlier ruling to condemn this research, much like the Grimes court did.

Although the court focused on non-federally funded research with children and adults residing in state-run mental health facilities, the court’s language appears to go far beyond this specific population to include all

15  

Query whether this stems from a prime example of research abuse within its own borders: the Willowbrook scandal [65]. It stands to reason that states which have experienced the ill effects, including bad press, of research cases are more likely to respond with protective statutory and common law approaches.

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

human subjects of questionable capacity, whose interests should be protected even at the expense of some research [69]. With respect to children, the court took issue with the fact that persons other than parents or guardians could provide consent (permission) for participation of children in “greater than minimal risk nontherapeutic research” [70]. Furthermore, the court did not simply condemn allowing nonparents to make decisions; the court also addressed the limits of parental authority, in ways similar to the Grimes decision.

We are not dealing here with parental choice among reasonable treatment alternatives, but with a decision to subject the child to nontherapeutic treatments and procedures that may cause harmful permanent or fatal side effects. It follows therefore that a parent or guardian, let alone another adult who may be a member of the child’s family, may not consent to have a child submit to painful and/or potentially life-threatening research procedures that hold no prospect of benefit for the child and that may have the same result as a denial of necessary medical treatment [71].

The court was not moved by federal regulations that might allow such research, instead setting forth a standard for New York’s approach to research with minors of certain categories of risk and benefit. And, as in Grimes, the court was critical of the IRB’s discretion in applying research protection [72].

Finally, of import for research with children under state custody, the court also critiqued the IRB’s discretion in allowing waiver of parental consent (permission) when the latter is not a “reasonable requirement to protect the patients (for example, abused and neglected children)” [73]. The court’s argument clarifies that consent (permission) authority for these subjects lies with the local commissioner of health (as in the treatment context) [74]. Moreover, it is also noteworthy for specifically referencing treatment-related law in a research case. That is, pursuant to the court’s reasoning, this decision might provide support for an argument that treatment statutes, at least insofar as they address who can consent (provide permission) on behalf of minors, could also apply in research milieus [75].

Taken together with the Grimes case, these arguments point toward a highly “restrictive” environment on the continuum of permissibility of research with children and adolescents as regulated by the states, at least insofar as research exceeds minimal-risk standards without the prospect for direct benefit. Each court interpreted state law as restricting the ability to do nontherapeutic, greater-than-minimal-risk research with children. Furthermore, each did so by explicitly acknowledging the need for state protection, notwithstanding federal regulations or cases in which such regulations do not apply (non-federally funded research), especially when such research is tied to commercial interests [76].

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

Each decision also provides convenient language to support claims that research with a child that is not clearly minimal risk or therapeutic is best avoided—ethically and legally. In addition, each decision inserts the necessity for judicial review into the research process. “Science cannot be permitted to be the sole judge of the appropriateness of such research methods on human subjects, especially in respect to children” [77]. States with particularly activist courts might also subject researchers to judicial interpretations of permissible research and the limits thereof.

However, what about states without similar case laws dealing with research with vulnerable subjects? It is worth noting that most states do not have a body of state law on this issue, especially in relation to children and adolescents. Therefore, the general trend among state court decisions vis-à-vis medical treatment for children and adolescents might have some bearing on the issue, at least to the extent that they provide useful arguments—and possible comfort levels—for researchers.

Massachusetts

Consider, for example, Massachusetts, a state with recent case law addressing minors’ ability to consent to or refuse medical treatment. In a noteworthy case, the Appeals Court of Massachusetts held that a 17-year-old female patient should have been able to voice her own interests in deciding against a blood transfusion, “where she apparently had the testimonial capacity to answer questions…. Only after evaluating this evidence in light of her maturity could the judge properly determine her best interests” [78].

The court so held the decision on the basis of “well-settled” state law that would apply a three-part balancing test for treatment decisions with unemancipated minors: the child’s best interests, the parents’ interests, and the state’s interests [79]. Moreover, the best interests criteria parallel those used in substituted judgment cases, which would include the “patient’s expressed preferences, if any” [80]. The court also noted that the state’s legislature affirmed considering a minor’s “maturity” in relation to enunciating her own interests by enacting law to allow an abortion without parental consent (permission) if the judge deems the minor “mature enough to make an informed decision” [81]. The court indicates that, at least in certain situations and with “minors” of a certain age or maturity level, the typical “best-interests” standard applied to treatment decisions should also include reference to what the minor him- or herself thinks.

Tennessee

The Tennessee Supreme Court has also recognized the common law “mature minor exception” by adopting the “Rule of Sevens” [82]. This

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

common law rule of capacity holds that (1) a minor under the age of 7 years lacks capacity; (2) a minor between 7 and 14 years of age is presumed not to have capacity, but that assumption can be rebutted (the burden is on the minor arguing that he or she has capacity); and (3) a minor aged 14 years and over is presumed to have capacity (the burden is on the one arguing against capacity) [83]. It further held that the mature minor exception is part of Tennessee’s common law to be applied on a case-by-case basis (i.e., not a bright-line test) and that such consent by a minor, when validly given (as it was in this case), freed the physician complying with such consent (again, in this case) from battery charges [84].16

Summary

Of course, there is no explicit reason to believe that reasoning similar to that described above would apply to a decision whether or not to allow a minor to consent to participation in a research protocol. In fact, it should be noted that many cases upholding a minor’s consent based on “maturity” did so when the minor was near 18 years of age. Thus, for younger children, for decisions related to riskier research, and with stronger parental disagreement, there may be a less permissive attitude toward minor consent [85]. Nor is there reason to believe that nontherapeutic research would not fall to a similar fate as in New York and Maryland, wherein no matter the willingness to agree to research participation—by the parent or the minor—some research might be invalid per se. Yet, for states where there is greater silence or “leniency” as to research in state courts or legislatures and where strong case law exists to promote mature minor treatment decision making, the same principles could arguably extend to research decisions, at least inasmuch as research specifically relates to areas in which minor consent is allowed, for example, for STD treatment [86].

FUTURE DIRECTIONS: UNIFORM STATE GUIDELINES AND NATIONAL DISCUSSION

In sum, where do the review and analysis presented above leave the research community? On the basis of a review of state law—statutory and case law—on this point (research with children and adolescents), there is little to go by in terms of the permissibility of and limits of such research. Moreover, even where case law does exist, arguments exist to preclude research with certain minors in certain situations, particularly if such children are deemed to be especially vulnerable (e.g., impoverished or suffering from emotional disturbances).

16  

See further discussion of the “mature minor” doctrine infra, pp. 324–326.

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

This is not to say that research will not or may not proceed. Rather, researchers are wise to review state law in the myriad of places where it might be found (e.g., health, public welfare, education, corrections, and social services codes). They should also judge the climates of their local and state courts and legislatures to determine the legal stance likely to be adopted in relation to research with children that goes beyond minimal risk and that is quite likely of no direct benefit. Researchers might also be well advised to seek agency approval for research with children in or at risk of being under state custody and also to develop research protocols with greater community input, particularly those members of the community from which subjects or families are likely to be drawn [87].

States, too, could respond to this uncertain climate by clarifying the bounds of what is and is not permissible in research with children and adolescents, while doing so in accord with laws that increasingly recognize “mature” status for certain medical decisions. States might be wise to do so proactively rather than wait for the “hard case” that could lead to “bad law.”

A possible and advisable approach would be for a national body representing state governments, for example, the National Governors Association or the National Conference of State Legislatures, to convene a national group of key stakeholders and experts to develop state guidelines for research with children and adolescents. As state-based guidelines and not national law, the purpose would not be to mandate compliance by states or researchers within those states. Given the nascent nature of state regulation in this area in general, it seems premature to develop a model law.

However, the process of developing national guidelines might serve to foster a broader dialogue about the limits that society accepts for research with children and adolescents. In this fashion, guidelines could be used to develop a consensus on “best practices” in research with children and adolescents. In addition, their development might influence the research agenda itself, to promote additional studies that would support the empirical basis behind the guidelines, as well as an empirical base that could influence later revisions to the guidelines [88]. So, too, would it invite greater stakeholder input into the process of setting limits, inclusive of not only researchers and state officials but also potential subjects, families, advocacy groups, and representatives of groups or institutions affected by the variety of situations or locations in which such research might take place (e.g., schools). Although states have generally chosen, when they do address the issue, to track federal regulations, especially when describing the risk-benefit calculations for IRB reviews, federal regulations only extend to federally funded research; furthermore, they leave much to IRB discretion. These are areas where state-level dialogue could be especially beneficial.

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

Perhaps nothing will come of the recent court actions in New York and Maryland; in fact, as of this writing, the Maryland legislature declined to specifically address the facts of the Grimes case. Yet, as the impetus behind research with children and adolescents builds [89] and an increasingly vigilant and media-savvy subject advocate network grows [90], it seems likely that litigation could ensue. So, too, might litigation be prompted by new privacy regulations as applied in research settings [91]. In consideration of such regulations, might it be wise for states to address this issue proactively to clarify the landscape out of an ethical sense of obligation, a legal sense of duty, and a pragmatic response to the growing media “buzz”? Additionally, might it also be wise for states to set forth guidance more uniformly and to learn from each other’s experiences, in recognition of the growing “multistate” nature of research? Such guidance could, for example, address more precisely what is meant by “emancipated minor” and “mature minor” on the one hand and “greater than minimal risk” and “nontherapeutic research” on the other [92].

It is likely that separate guidance would be needed for research with children and adolescents generally and research with children under state custody specifically, as the latter sit in unique circumstances in relation to the state’s protection and oversight of their care. Yet, whether the guidelines address one, two, or even three situations (e.g., a third situation applying to “sensitive” research, such as studies related to sexual promiscuity among adolescents), it is arguably better to provide clarifying guidance before the research endeavor with children develops a force of its own or breaks down in the face of a few unfortunate research endeavors or before research guidelines split between guidelines for government-funded research and guidelines for industry-funded research. The future of the state response is unclear. The future, however, likely includes more, not less, research with children and adolescents and, hence, will raise more research-related issues, concerns that states could begin to address now in a systematic and empirically testable fashion.

ACKNOWLEDGMENTS

This review and analysis was funded by the Institute of Medicine. I wish to acknowledge the assistance of the Family Violence Clinic at the State University of New York at Buffalo School of Law, in particular, Shannon O’Keefe, clinic student, and Catherine Cerulli, faculty member. Thanks also to Abigail English and numerous child welfare representatives for sharing their ideas and resources. Finally, I owe a special thanks to Angela Roddey Holder for reviewing this paper and, most importantly, for her ongoing support and mentorship.

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

TABLE B.1 State Education-Related Provisions for Research with Children and Adolescents (in School Settings) a

State

Provision

Statute

Alabama

None identified

 

Alaska

None identified

 

Arizona

None identified

 

Arkansas

None identified

 

California

School records may be released with written parental consent

Calif. Educ. Code § 49075

Colorado

None identified

 

Connecticut

None identified

 

Delaware

None identified

 

District of Columbia

None identified

 

Florida

School records may be released with written parental consent

Fla. Stat. Ann. § 228.093

Georgia

None identified

 

Hawaii

None identified

 

Idaho

None identified

 

Illinois

School records may be released with dated, written parental consent § 10/6

105 Ill. Comp. Stat. Ann.

Indiana

Student may not be required to participate without prior consent of student or prior written consent of parent

Ind. Code Ann. § 20-10.1-4-15

Iowa

None identified

 

Kansas

School records may not be released without parental consent

Kans. Stat. Ann. § 72-6214

Kentucky

School records may be released with parental consent or eligible student consent

Ky. Rev. Stat. Ann. § 160.720

Louisiana

None identified

 

Maine

None identified

 

Maryland

None identified

 

Massachusetts

None identified

 

Michigan

School records cannot be revealed by witness in court without parental consent

Mich. Comp. Laws Ann. § 600.2165

Minnesota

None identified

 

Mississippi

None identified

 

Missouri

School records cannot be released without written parental consent

Mo. Rev. Stat. § 167.020

Montana

School officials will notify sender that records cannot be released without written parental consent

Mont. Rev. Code § 20-1-213

Nebraska

None identified

 

Nevada

School records will not be released without written parental consent

Nev. Rev. Stat. Ann. § 392.029

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

State

Provision

Statute

New Hampshire

None identified

 

New Jersey

None identified

 

New Mexico

None identified

 

New York

None identified

 

North Carolina

None identified

 

North Dakota

None identified

 

Ohio

Information other than directory information is not released without written parental consent

Ohio Rev. Code Ann. § 3319.321(B)

Oklahoma

None identified

 

Oregon

None identified

 

Pennsylvania

None identified

 

Rhode Island

None identified

 

South Carolina

None identified

 

South Dakota

None identified

 

Tennessee

Student records are not available without parental consent

Tenn. Code Ann. § 10-7-504(4)

Texas

None identified

 

Utah

Parental consent required

Utah Code Ann. § 53A-13-302(1)(a)-(h)

Vermont

None identified

 

Virginia

Records may be released to student or student’s parent before obtaining consent

Va. Code Ann. § 22.1287(A)(1)

Washington

None identified

 

West Virginia

None identified

 

Wisconsin

Student or student’s parent may be shown records upon request

Wis. Stat. Ann. § 118.125(2)

Wyoming

None identified

 

aThe U.S. Department of Education also regulates the release of certain of information from student records (34 CFR Part 99).

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

TABLE B.2 Age of Majority

State

Age of Majority

Statute

Alabama

19

Code of Ala. § 26-1-1

Alaska

18

Alaska Stat. § 25.20.010

Arizona

18

Ariz. Rev. Stat. § 14-1201

Arkansas

18

Ark. Code Ann. § 20-13-104

California

18

Cal. Probate Code § 3901

Colorado

18

Colo. Rev. Stat. § 13-22-103

Connecticut

18

Conn. Gen. Stat. Ann. § 19a-575a

Delaware

18

1 Del. Code § 701

District of Columbia

18

Code of D.C. Regs. §§ 22-6-600, 22-6-699

Florida

18

Fla. Stat. Ann. § 743.01

Georgia

18

O.C.G.A. §§ 31-9-2, 31-9-7

Hawaii

18

Haw. Rev. Stat. Ann. § 577-1

Idaho

18

Idaho Code § 32-101

Illinois

18

410 Illinois Comp. Stat. 210/1

Indiana

18

Ind. Code Ann. § 16-8-2-5

Iowa

18

Iowa Code § 234.1

Kansas

18

Kans. Admin. Regs. § 30-6-52

Kentucky

18

Ky. Rev. Stat. Ann. § 2.015

Louisiana

18

La. Rev. Stat. § 40:1299.56

Maine

18

1 Maine Rev. Stat. Ann. §§ 72,73; 22 Maine Rev. Stat. Ann. § 1501

Maryland

18

Md. Code Ann. Art. 1, § 24

Massachusetts

18

112 Mass. Gen. Laws Ann. § 12F

Michigan

18

M.S.A. §§ 25.244 (52), 14.15 (1105)

Minnesota

18

Minn. Code §§ 144.341-144.347

Mississippi

21

Miss. Code Ann. § 1-3-27a

Missouri

18

Mo. Rev. Stat. § 431.061

Montana

18

Mont. Rev. Code Ann. § 41-1-101

Nebraska

19

Nebr. Rev. Stat. Ann. § 43-2101

Nevada

18

Nev. Rev. Stat. Ann. § 129.030

New Hampshire

18

N.H. Rev. Stat. Ann. §§ 21:44, 21-B:1

New Jersey

18

N.J. Stat. § 9:17B-4

New Mexico

18

N.M. Stat. Ann. § 28-6-1

New York

18

N.Y. Dom. Rel. Law § 2

North Carolina

18

N.C. Gen. Stat. §§ 58-3-215, 48A-1, 48A-2

North Dakota

18

N.D. Cent. Code §§ 14-10-01, 14-10-17.1

Ohio

18

Ohio Rev. Code Ann. § 3109.01

Oklahoma

18

10 Okla. Stat. § 91

Oregon

18

Oreg. Rev. Stat. § 109.510

Pennsylvania

18

35 Pa. Stat. § 10101

Rhode Island

18

R.I. Gen. Laws § 23-4.6-1

South Carolina

18

S.C. Code Ann. § 15-1-320; S.C. Code of Laws § 20-7-30

South Dakota

18

S.D. Codified Laws §§ 26-1-1-1, 29A-5-102

Tennessee

18

Tenn. Code Ann. § 1-3-113

Texas

18

Tex. Rev. Civ. Stat. § 313.004

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

State

Age of Majority

Statute

Utah

18

Utah Code Ann. § 78-14-5

Vermont

18

1 Vt. Stat. Ann. § 173

Virginia

18

Va. Code Ann. § 1-13.42

Washington

18

Rev. Code Wash. § 26.28.010

West Virginia

18

W.V. Code §§ 2-2-10, 2-3-1

Wisconsin

18

Wis. Stat. § 115.807

Wyoming

18

Wyo. Stat. § 14-1-101

aMiss. Code Ann. § 41-41-3 states that “adult” means anyone 18+ for the purposes of consent to surgical or medical treatment procedures.

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

TABLE B.3 Emancipation Conditions

State

Conditions

Statute

Alabama

Married or divorced

Code of Ala. § 22-17A-1

 

Court order

Code of Ala. § 22-17A-1

Alaska

Court order

Alaska Stat. § 09.55.590

Arizona

Veteran

Ariz. Rev. Stat. Ann. § 44-131

 

Married

Op. Atty. Gen. No. 69-27

 

Military service

Op. Atty. Gen. No. 69-27

Arkansas

Court order

Ark. Code Ann. § 9-26-104

California

Married

Calif. Fam. Code § 7002

 

Active duty in armed forces

Calif. Fam. Code § 7002

 

Court order

Calif. Fam. Code § 7002

Colorado

Over age 15 and has demonstrated independence from parents

Colo. Rev. Stat. § 19-1-103

Connecticut

Married

Conn. Gen. Stat. Ann. § 46b-150b

 

Active duty in armed forces

Conn. Gen. Stat. Ann. § 46b-150b

 

Living separate and apart from parents

Conn. Gen. Stat. Ann. § 46b-150b

 

Court order

Conn. Gen. Stat. Ann. § 46b-150b

 

Veteran

Conn. Gen. Stat. Ann. § 369-759

Delaware

Court order

1 Del. Code Ann. § 701

District of Columbia

a

 

Florida

Married

Fla. Stat. Ann. § 743.01

 

Court order

Fla. Stat. Ann. § 743.015

Georgia

Married

O.C.G.A. § 19-3-30

Hawaii

Married

Hawaii Rev. Stat. Ann. § 577-25

 

Veteran or veteran’s spouse

Hawaii Rev. Stat. Ann. § 577-2

Idaho

Married

Idaho Code § 32-101

Illinois

Court order

750 Ill. Comp. Stat. Ann. 30/1

Indiana

a

 

Iowa

Veteran

Iowa Code § 599.5

Kansas

Court order

Kans. Stat. Ann. § 38-109

Kentucky

a

 

Louisiana

Married

La. Civil Code Art. § 379-384

 

Court order

La. Civil Code Art. § 385

Maine

a

 

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

State

Conditions

Statute

Maryland

Married: individual may buy or sell property if spouse is of age

Md. Code Ann., Est. & Tr. Art. 13 §503 (a)

 

Age 15 can contract regarding insurance

Md. Code Ann., Est. & Tr. Art. 13 §503 (c)

 

Individuals in the military can enter into real estate transactions

Md. Code Ann., Est. & Tr. Art. 13 §503 (b)

Massachusetts

Married

201 Mass. Gen. Laws Ann. § 5

Michigan

Married

Mich. Comp. Laws § 551.251

 

Court order

Mich. Comp. Laws § 722.4

Minnesota

a

 

Mississippi

Married for divorce and custody claims

Miss. Code Ann. § 93-19-11

Missouri

Married for real estate if spouse of age

Mo. Rev. Stat. § 442.040

Montana

Married

Mont. Rev. Code Ann. § 40-6-234

Nebraska

Married

Nebr. Rev. Stat. Ann. § 43-2101

 

Self-supporting and apart from parents

Accent Serv. v. Ebsen, 306 N.W.2d 575 (1981)

Nevada

Court order

Nev. Rev. Stat. Ann. § 129.080

 

Veteran or spouse

Nev. Rev. Stat. Ann. § 129.020

New Hampshire

Emancipated in another state

R.S.A. 21-B:2

New Jersey

Married

N.J. Stat. § 2C:25-19

 

Military service

N.J. Stat. § 2C:25-19

 

Has child or is pregnant

N.J. Stat. § 2C:25-19

 

Court order

N.J. Stat. § 2C:25-19

New Mexico

Marriage, death, adoption as well as death, resignation or removal of guardian

N.M. Stat. Ann. § 45-5-210

 

Court order

N.M. Stat. Ann. § 24-7A-6.1

 

In military

N.M. Stat. Ann. § 32A-21-5

New York

a

 

North Carolina

Court order

N.C. Gen. Stat. § 7B-3500

North Dakota

Married

N.D. Cent. Code § 14-09-20

Ohio

Court order

Ohio Rev. Code Ann. § 2111.18.1

Oklahoma

Court order

Okla. Stat. Ann. Tit.10, 10

 

Married

Okla. Stat. Ann. Tit. 10, 91

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

State

Conditions

Statute

Oregon

Married

Oreg. Rev. Stat. § 109.555

 

Parental decree

Oreg. Rev. Stat. § 109.510

 

Court order

Oreg. Rev. Stat. § 109.510

Pennsylvania

Married

55 Pa. Code 145.62

 

Age 16+, living independently

55 Pa. Code 145.62

 

Age 16+, orphan

55 Pa. Code 145.62

Rhode Island

a

 

South Carolina

a

 

South Dakota

Married

S.D. Codified Laws § 25-5-24

 

Age 16+; no longer dependent and with parents’ consent/ acquiescence; managing own financial affairs

S.D. Codified Laws § 25-5-26

 

Military

S.D. Codified Laws § 25-5-24

 

Court order (age 16+)

S.D. Codified Laws § 25-5-19, 25-5-26

Tennessee

a

 

Texas

Age 16 or 17 and living apart from parent and self-supporting

Tex. Fam. Code Ann. § 31.01

Utah

Married

Utah Code Ann. § 15-2-1

Vermont

Married

12 V.S.A. § 7151

 

On active military duty

12 V.S.A. § 7151

 

Court order

12 V.S.A. § 7155

Virginia

Court order

Va. Code Ann. § 16.1-331

Washington

Court order

Rev. Code Wash. § 13.64

West Virginia

Married

W.Va. Code § 49-7-27

 

Court order

W.Va. Code § 49-7-27

Wisconsin

Married

Wis. Stat. § 48.375

 

Previously given birth

Wis. Stat. § 48.375

 

Freed from care, custody, and control of parents

Wis. Stat. § 48.375

Wyoming

Married

Wyo. Stat. § 14-1-201

 

In military

Wyo. Stat. § 14-1-201

 

Court order

Wyo. Stat. § 14-1-203

aNo applicable law identified through search strategy performed for the overview purposes of this appendix as explained in footnote 4 to the text.

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

TABLE B.4 Mature Minor Provisions

State

Mature Minor Status Events for Consenting to Health Care

Statute

Alabama

Pregnant

Code of Ala. § 22-8-4

 

Married

Code of Ala. § 22-8-4

 

Minor parent (may consent to child’s and own medical treatment)

Code of Ala. § 22-8-5

 

High school graduate

Code of Ala. § 22-8-4

 

Age 14+

Code of Ala. § 22-8-4

Alaska

Minor parent (may consent to child’s medical treatment)

Alaska Stat. § 25.20.025

 

Living apart from parents and managing own financial affairs

Alaska Stat. § 25.20.025

 

If parent cannot be contacted or withholds consent

Alaska Stat. § 25.20.025

Arizona

Married or divorced

Ariz. Rev. Stat. § 44-132

 

Emancipated

Ariz. Rev. Stat. § 44-132

 

Living apart from parents/homeless

Ariz. Rev. Stat. § 44-132

Arkansas

Married

Ark. Code Ann. § 20-9-602

 

Unemancipated if of sufficient intelligence to appreciate consequences of medical treatment

Ark. Code Ann. § 20-9-602

 

Pregnant

Ark. Code Ann. § 20-9-602

 

Minor parent (may consent to child’s medical treatment)

Ark. Code Ann. § 20-9-602

 

Incarcerated

Ark. Code Ann. § 20-9-602

California

Pregnant

Calif. Fam. Code § 6925

 

Age 15 years old and living apart from parents and managing own financial affairs

Calif. Fam. Code § 6922

Colorado

Married

Colo. Rev. Stat. § 13-22-103

 

Minor parent (may consent to child’s medical treatment)

Colo. Rev. Stat. § 13-22-103

 

Living apart from parents and managing own financial affairs

Colo. Rev. Stat. § 13-22-103

Connecticut

Minor parent (may consent to child’s medical treatment)

Conn. Gen. Stat. Ann. § 19a-285

Delaware

Married

13 Del. Code § 707

 

Pregnant (related to pregnancy)

13 Del. Code § 708

 

Minor parent (may consent to child’s medical treatment)

13 Del. Code § 707

District of Columbia

Minor parent (may consent to child’s medical treatment)

D.C.C. § 16-4901

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

State

Mature Minor Status Events for Consenting to Health Care

Statute

Florida

Age 16+ with court order

Fla. Stat. Ann. § 743.065

 

Pregnant (if related to pregnancy)

Fla. Stat. Ann. § 743.065

 

Minor parent (may consent to child’s medical treatment)

Fla. Stat. Ann. § 743.065

Georgia

Married

O.C.G.A. § 31-9-2

 

Pregnant (if related to pregnancy, pregnancy prevention, or childbirth)

O.C.G.A. § 31-9-2

 

Minor parent (may consent to child’s medical treatment)

O.C.G.A. § 31-9-2

Hawaii

Pregnant

Hawaii Rev. Stat. Ann.§ 577A-2

Idaho

Minor parent (may consent to child’s medical treatment)

Idaho Code § 39-4303

 

Minor of ordinary intelligence and awareness to comprehend need for, nature of, and risks in medical care

Idaho Code § 39-4302

Illinois

Married

410 Ill. Comp. Stat. Ann. 210/1

 

Pregnant

410 Ill. Comp. Stat. Ann. 210/1

 

Minor parent (may consent to child’s and own medical treatment)

410 Ill. Comp. Stat. Ann. 210/1

and

410 Ill. Comp. Stat. Ann. 210/2

Indiana

Married

Ind. Code Ann. § 16-36-1-3

 

Emancipated

Ind. Code Ann. § 16-36-1-3

 

Age 14+ and independent/living apart from parents and managing own affairs

Ind. Code Ann. § 16-36-1-3

 

Military service

Ind. Code Ann. § 16-36-1-3

Iowa

Married

Iowa Code § 234.1

 

Juvenile if tried and convicted as adult

Iowa Code § 599.1

Kansas

Married and age 16+

Kans. Stat. Ann. § 38-101

 

Pregnant

Kans. Stat. Ann. § 38-123

 

Minor parent (may consent to child’s medical treatment)

Kans. Stat. Ann. § 38-122

 

Emancipated minor through court order

Kans. Admin. Regs. § 30-6-52

 

Age 16+ and no parent immediately available

Kans. Stat. Ann. § 38-123b

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

State

Mature Minor Status Events for Consenting to Health Care

Statute

Kentucky

Married

Ky. Rev. Stat. Ann. § 214.185

 

Emancipated minor

Ky. Rev. Stat. Ann. § 214.185

 

Pregnant

Ky. Rev. Stat. Ann. § 214.185

 

Minor parent (may consent to child’s and own medical treatment)

Ky. Rev. Stat. Ann. § 214.185

 

Children with disabilities, age 21+

Ky. Rev. Stat. Ann. § 2.015

Louisiana

Minor parent (may consent to child’s medical treatment and for pain or distress during labor)

La. Rev. Stat. § 40:1299.53

 

Emancipation with court approval

La. Civil Code Art. 305

Maine

Married

22 Maine Rev. Stat. Ann. § 1503

 

Living apart from parents and independent of support for at least 60 days

22 Maine Rev. Stat. Ann. § 1503

 

Military service

22 Maine Rev. Stat. Ann. § 1503

 

Emancipated by court order

15 Maine Rev. Stat. Ann. § 3506-A

Maryland

Married

Md. Code Ann. Health-Gen. I § 20-102

 

Pregnant

Md. Code Ann. Health-Gen. I § 20-102

 

Minor parent

Md. Code Ann. Health-Gen. I § 20-102

Massachusetts

Married

112 Mass. Gen. Laws Ann. § 12F

 

Pregnant

112 Mass. Gen. Laws Ann. § 12F

 

Minor parent (may consent for child’s and own medical treatment)

112 Mass. Gen. Laws Ann. § 12F

 

Living apart from parents

112 Mass. Gen. Laws Ann. § 12F

 

Military service

112 Mass. Gen. Laws Ann. § 12F

Michigan

Pregnant (for prenatal and pregnancy related services)

M.S.A. § 333.9132

 

Minor parent (may consent for child’s medical treatment)

M.S.A. § 333.9132

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

State

Mature Minor Status Events for Consenting to Health Care

Statute

Minnesota

Married

Minn. Code § 144.342

 

Borne a child

Minn. Code § 144.343

 

Minor parent (may consent for child’s and own medical treatment)

Minn. Code § 144.342

 

Living apart from parents and maintains personal financial affairs

Minn. Code § 144.341

Mississippi

Married

Miss. Code Ann. § 41-41-3

 

Pregnant (in connection with pregnancy)

Miss. Code Ann. § 41-41-3

 

Minor parent (may consent for child’s medical treatment)

Miss. Code Ann. § 41-41-3

Missouri

Married

Mo. Rev. Stat. § 431.061

 

Pregnant (for self)

Mo. Rev. Stat. § 431.061

 

Minor parent (may consent for child’s and own medical treatment)

Mo. Rev. Stat. § 431.061

Montana

Married

Mont. Rev. Code Ann. § 41-1-404(1)(a)

 

Emancipated

Mont. Rev. Code Ann. § 41-1-404(1)

 

Pregnant

Mont. Rev. Code Ann. § 41-1-404(1)(c)

 

Minor parent (may consent to child’s and own medical treatment)

Mont. Rev. Code Ann. § 41-1-402

 

Living apart from parents and self-supporting

Mont. Rev. Code Ann. § 41-1-402(1)(b)

 

High school graduate

Mont. Rev. Code Ann. § 41-1-404(1)(a)

Nebraska

Emancipated if self-supporting and apart from parents

Accent Serv. v. Ebsen, 306 N.W.2d 575 (1981)

Nevada

Married

Nev. Rev. Stat. Ann. § 129.030

 

Emancipated

Nev. Rev. Stat. Ann. § 129.010

 

Living apart from parents for at least 4 months

Nev. Rev. Stat. Ann. § 129.030

 

Borne a child

Nev. Rev. Stat. Ann. § 129.030

New Hampshire

a

 

New

Married

N.J. Stat. § 9:17A-1

Jersey

Pregnant (on own behalf or for child)

N.J. Stat. § 9:17A-1

 

Minor parent (may consent for child’s medical treatment)

N.J. Stat. § 9:17A-1

 

Military service

N.J. Stat. § 55:14L-2

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

State

Mature Minor Status Events for Consenting to Health Care

Statute

New

Married

N.M. Stat. Ann. § 32A-21

Mexico

Emancipated if age 16+ and married, by court order or in military

N.M. Stat. Ann. §§ 24-7A-1, 24-7A-6.1, 32A-21-5

 

Living apart from parents

N.M. Stat. Ann. § 32A-21

New York

Married

N.Y. Pub. Health Law § 2504(1)

 

Pregnant (related to prenatal care)

N.Y. Pub. Health Law § 2504(3)

 

Minor parent (may consent for child’s and own medical treatment)

N.Y. Pub. Health Law § 2504

North

Married

N.C. Gen. Stat. § 7A-726

Carolina

Emancipated

N.C. Gen. Stat. § 32A-29

 

Pregnant (for self or child)

N.C. Gen. Stat. § 90-21.5

North Dakota

a

 

Ohio

a

 

Oklahoma

Married

63 Okla. Stat. Ann. § 2602(A)(1)

 

Emancipated

63 Okla. Stat. Ann. § 2602(A)

 

Pregnant

63 Okla. Stat. Ann. § 2602(A)(3)

 

Minor parent (may consent for child’s and own medical care)

63 Okla. Stat. Ann. § 2602

 

Living apart from parents and not supported by them

63 Okla. Stat. Ann. § 2602(A)(2)

 

Military service

63 Okla. Stat. Ann. § 2601

Oregon

Married

Oreg. Rev. Stat. § 109.520

 

Age 15+

Oreg. Rev. Stat. § 109.640

 

Living apart from parents

Oreg. Rev. Stat. § 109.627

Pennsylvania

Married

35 Pa. Stat. Ann. § 10101

 

Pregnant (or has been pregnant)

35 Pa. Stat. Ann. § 10103

 

Minor parent (may consent for child’s and own medical care)

35 Pa. Stat. Ann. § 10102

 

High school graduate

35 Pa. Stat. Ann. § 10101

Rhode

Married

R.I. Gen. Laws § 23-4.6-1

Island

Age 16+ if a “routine emergency”

R.I. Gen. Laws § 23-4.6-1

 

Minor parent (may consent for child’s medical care)

R.I. Gen. Laws § 23-4.6-1

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

State

Mature Minor Status Events for Consenting to Health Care

Statute

South Carolina

Married or spouse of married minor

S.C. Code Ann. § 20-7-270

 

Minor parent (may consent for child’s medical care)

S.C. Code Ann. § 20-7-300

 

Age 16+ (other than for operations, unless necessary for the health or life of the minor)

S.C. Code Ann. § 20-7-280

South Dakota

Legally emancipated (age 16+)

S.D. Codified Laws §§ 25-5-25, 25-5-26

Tennessee

Pregnant

Tenn. Code Ann. § 63-6-223

 

Minor parent (may consent for child’s medical care)

Tenn. Code Ann. § 63-6-229

Texas

Pregnant (related to pregnancy)

Tex. Fam. Code Ann. § 32.003(a)(4)

 

Minor parent (may consent for child’s medical care)

Tex. Fam. Code Ann. § 32.003(a)(6)

 

Living apart from parents and managing own affairs and age 16+

Tex. Fam. Code Ann. § 32.003(a)(2)

 

Military service

Tex. Fam. Code Ann. § 32.003(a)(1)

Utah

Married

Utah Code Ann. § 78-14-5(4)(b)

 

Pregnant

Utah Code Ann. § 78-14-5(4)(f)

 

Minor parent (may consent for child’s medical care)

Utah Code Ann. § 78-14-5(4)

Vermont

a

 

Virginia

Married

Va. Code Ann. § 16.1-333(I)

 

Emancipated (active military duty or separate from parents)

Va. Code Ann. § 16.1-333

 

Pregnant (for self/child related to delivery and minor parent for child)

Va. Code Ann. § 54.1-2969(D)(2)

Washington

Married

Rev. Code Wash. § 26.28.020

 

Minor parent (may consent for child’s medical care)

Rev. Code Wash. § 26.28.015(5)

West Virginia

Mature minor, emancipated minor

W.Va. Code §§ 16-30-3, 16-30-6, 49-7-27

 

Pregnant

W.Va. Code § 16-29-1(b)

Wisconsin

Minor parent (may consent for child’s and own medical care)

Wis. Stat. § 48.375(2)(e)

 

Living apart from parents

Wis. Stat. § 48.375(2)(e)

Wyoming

a

 

aNo applicable law identified through search strategy performed for the overview purposes of this appendix as explained in footnote 4 to the text.

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

TABLE B.5 FOLLOWS

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

TABLE B.5 Minor Consent for Certain Conditions/Disorders

State

Condition or Disorder

Age

Statute

Alabama

STD testing/treatment

12+

Code of Ala. § 22-8-6, 22-11A-19

 

Alcohol or drug abuse treatment

Any minor

Code of Ala. § 22-8-6

 

Emergency care when delay would result in increased risk to life

Any minor

Code of Ala. § 22-8-3

Alaska

STD testing/treatment

Any minor

Alaska Stat. § 25.20.025

 

Family planning

Any minor

Alaska Stat. § 25.20.025

Arizona

Alcohol or drug abuse treatment

12+

Ariz. Rev. Stat. § 44-133.01

Arkansas

STD testing/treatment

Any minor

Ark. Code Ann. § 20-16-508

 

Family planning

Any minor

Ark. Code Ann. § 20-16-304

 

Blood donation

17+

Ark. Code Ann. § 20-27-301

 

Medical treatment in prison

Any minor

Ark. Code Ann. § 20-9-602

California

STD testing/treatment, infectious diseases

12+

Calif. Fam. Code § 6926

 

HIV testing/treatment

12+

Calif. Health & Safety Code § 121020

 

Family planning

Any minor

Calif. Fam. Code § 6925

 

Alcohol or drug abuse treatment

12+

Calif. Fam. Code § 6929

 

Mental health care

12+

Calif. Fam. Code § 6924

Colorado

HIV or STD testing/treatment

Any minor (if less than 16, parent may be informed)

Colo. Rev. Stat. § 25-4-402

 

Family planning

Any minor

Colo. Rev. Stat. § 13-22-105

 

Alcohol or drug abuse treatment

Any minor

Colo. Rev. Stat. § 13-22-105

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

Connecticut

STD testing/treatment

Any minor

Conn. Gen. Stat. Ann. § 19a-216

 

HIV testing/treatment

Any minor (parental consent for treatment unless notice adversely affects treatment)

Conn. Gen. Stat. Ann. §§ 19a-582, 19a-598

 

Alcohol or drug abuse treatment

Any minor

Conn. Gen. Stat. Ann. § 17a-688

 

Blood donation

17+

Conn. Gen. Stat. Ann. § 19a-285a

 

Mental health care

14+ (parental notice within 5 days)

Conn. Gen. Stat. Ann. § 17a-79

Delaware

STD testing/treatment

12+

13 Del. Code Ann. § 708

 

HIV testing

12+

13 Del. Code Ann. § 708

 

Family planning

12+

13 Del. Code Ann. § 708

 

Alcohol or drug abuse treatment

12+

13 Del. Code Ann. § 707

 

Blood donation

17+

13 Del. Code Ann. § 709

Florida

STD testing/treatment

Any minor

Fla. Stat. Ann. § 384.30

 

Family planning

Any minor

Fla. Stat. Ann. § 381.0051

 

Medical treatment in prison

Any minor

Fla. Stat. Ann. § 743.066

Georgia

STD testing/treatment

Any minor (physician’s discretion whether or not to provide information to parents)

O.C.G.A. § 31-17-7

 

Family planning

Any minor

O.C.G.A. § 31-9-2

 

Alcohol or drug abuse treatment

Any minor

O.C.G.A. § 37-7-8

Hawaii

STD testing/treatment

Any minor

Hawaii Rev. Stat. Ann. § 577A-2

 

Family planning

Any minor

Hawaii Rev. Stat. Ann. § 577A-2

 

Alcohol or drug abuse treatment

Any minor

Hawaii Rev. Stat. Ann. § 577-26

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

State

Condition or Disorder

Age

Statute

Idaho

STD and reportable diseases testing/treatment

14+

Idaho Code § 39-3801

 

HIV testing/treatment

14+

Idaho Code § 39-609

 

Family planning

Any minor

Idaho Code § 18-603

 

Alcohol or drug abuse treatment

16+

Idaho Code § 37-3102

Illinois

STD testing/treatment

12+

410 Ill. Comp. Stat. Ann. 210/4

 

HIV testing/treatment

12+

410 Ill. Comp. Stat. Ann. 210/4

 

Family planning

Any minor

325 Ill. Comp. Stat. Ann. 10/1

 

Alcohol or drug abuse treatment

12+

410 Ill. Comp. Stat. Ann. 210/4

Indiana

STD testing/treatment (if the individual has been or is suspected of having been exposed)

Any minor

Ind. Code Ann. § 16-36-1-3

 

Alcohol or drug abuse treatment

Any minor

Ind. Code Ann. § 12-23-12-1

 

Blood donation

17+

Ind. Code Ann. § 16-36-1-3

Iowa

STD testing/treatment

Any minor

Iowa Code § 141.22

 

HIV testing/treatment

Any minor

Iowa Code § 141.22

 

Family planning

Any minor

Iowa Code § 141.22

 

Alcohol or drug abuse treatment

Any minor

Iowa Code § 125.33

 

Medical treatment in prison

Any minor

Iowa Code § 599.1

Kansas

STD testing/treatment

Any minor (physicians may inform parent/ guardian if it is most beneficial to minor)

Kans. Stat. Ann. § 65-2892

Kentucky

STD testing/treatment

Any minor

Ky. Rev. Stat. Ann. § 214.185

 

HIV testing/treatment

Any minor

Ky. Rev. Stat. Ann. § 214.185

 

Family planning

Any minor

Ky. Rev. Stat. Ann. § 214.185

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

 

Alcohol or drug abuse treatment

Any minor

Ky. Rev. Stat. Ann. § 222.441

 

Mental health treatment

16+

Ky. Rev. Stat. Ann. §§ 214.185, 645.030

Louisiana

STD testing/treatment (if minor believes he or she is infected with illness)

Any minor (may inform parent/guardian over minor’s objection)

La. Rev. Stat. §§ 40:1065.1, 40:1095

 

Alcohol or drug abuse treatment

Any minor

La. Rev. Stat. § 40:1096

 

Blood donation

17+

La. Rev. Stat. § 40:1097

Maine

STD testing/treatment

Any minor

22 Maine Rev. Stat. Ann. § 1823

 

Family planning

Minor parent, married, or physician’s judgment of harm without services

22 Maine Rev. Stat. Ann. § 1908

Alcohol or drug abuse treatment

Any minor

22 Maine Rev. Stat. Ann. § 1823

Maryland

STD testing/treatment

Any minor

Md. Code Ann., Health-Gen I, 20-102

 

Family planning

Any minor

Md. Code Ann., Health-Gen I, 20-102

 

Alcohol or drug abuse treatment

Any minor

Md. Code Ann., Health-Gen I, 20-102

 

Mental health treatment

16+

Md. Code Ann., Health-Gen I, 20-104

Massachusetts

Testing/treatment for STDs or other“dangerous diseases”

Any minor

112 Mass. Gen. Laws Ann.§ 12F

Michigan

STD testing/treatment

Any minor

M.S.A. § 333.5127

 

HIV testing/treatment

Any minor

M.S.A. § 333.5127

 

Alcohol or drug abuse treatment

Any minor

M.S.A. § 333.6121

 

Medical treatment in prison

Any minor

M.S.A. § 722.4

 

Mental health treatment (excluding use of psychotropic drugs)

14+

M.S.A. § 14.800 (707)

Minnesota

STD testing/treatment

Any minor

Minn. Code § 144.343

 

Alcohol or drug abuse treatment

Any minor (may inform parents if failure would “jeopardize minor’s health”)

Minn. Code § 144.343

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

State

Condition or Disorder

Age

Statute

Mississippi

STD testing/treatment

Any minor

Miss. Code Ann. § 41-41-13

 

Family planning

Any minor

Miss. Code Ann. § 41-42-7

 

Alcohol or drug abuse treatment

15+

Miss. Code Ann. § 41-41-14

 

Blood donation

17+

Miss. Code Ann. § 41-41-15

Missouri

STD testing/treatment

Any minor

Mo. Rev. Stat. § 431.061

 

Alcohol or drug abuse treatment

Any minor

Mo. Rev. Stat. § 431.061

Montana

STD testing/treatment

Any minor

Mont. Rev. Code Ann. § 41-1-402(1)(c)

 

HIV testing/treatment

Any minor

Mont. Rev. Code Ann. § 50-16-1007(8)

 

Alcohol or drug abuse treatment (limited to treatment of those conditions)

Any minor

Mont. Rev. Code Ann. § 41-1-402(1)(c)

Nebraska

STD testing/treatment

Any minor

Nebr. Rev. Stat. Ann. § 71-504

 

Alcohol or drug abuse treatment

Any minor

Nebr. Rev. Stat. Ann. § 71-5041

Nevada

STD testing/treatment

Any minor

Nev. Rev. Stat. Ann. § 129.060

 

Family planning

Any minor

Nev. Rev. Stat. Ann. § 430A.180

 

Alcohol or drug abuse treatment

Any minor

Nev. Rev. Stat. Ann. § 129.050

New Hampshire

STD testing/treatment

14+

N.H. Rev. Stat. Ann. § 141-C:18(II)

 

HIV testing/treatment (physician may inform parent/guardian)

Any minor

N.H. Rev. Stat. Ann. § 141-F:5

 

Alcohol or drug abuse treatment

14+

N.H. Rev. Stat. Ann. § 318-B:12-a

 

Blood donation

17+

N.H. Rev. Stat. Ann. § 571-C:1

 

Medical treatment in prison

Any minor

N.H. Rev. Stat. Ann. § 141-F:5(IV)

New Jersey

STD testing/treatment (parents may be informed without minor consent)

Any minor

N.J. Stat. § 9:17A-4

 

Alcohol or drug abuse treatment

Any minor

N.J. Stat. § 9:17A-4

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

 

Emergency care when minor has been sexually assaulted (must notifyparent/guardian unless not in“bestinterest”)

Any minor

N.J. Stat. § 9:17A-4

 

Blood donation

18+

N.J. Stat. § 9:17A-6

New Mexico

STD testing/treatment

Any minor

N.M. Stat. Ann. § 24-1-9

 

HIV testing/treatment

Any minor

N.M. Stat. Ann. § 24-2B-3

 

Family planning

Any minor

N.M. Stat. Ann. § 24-8-5

New York

STD testing/treatment

Any minor

N.Y. Pub. Health Law § 2305(2)

 

HIV testing/treatment

Any minor

N.Y. Pub. Health Law § 2782

 

Family planning

Any minor

N.Y. Soc. Serv. Law § 465(3)

 

Alcohol or drug abuse treatment

Any minor

N.Y. Mental Hyg. Law § 21.11(a)

 

Mental health care

18+, emancipated, has child, or 16+ and parents not available

N.Y. Mental Hyg. Law § 22.11, 33.21

North Carolina

STD testing/treatment

Any minor

N.C. Gen. Stat. § 90-21.5(a)(I)

 

HIV testing/treatment

Any minor

N.C. Gen. Stat. §§ 90-21.5(a)(I), 130A-148

 

Family planning

Any minor

N.C. Gen. Stat. § 90-21.5(a)

 

Alcohol or drug abuse treatment

Any minor

N.C. Gen. Stat. §§ 122C-221(a), 90-21.5(a) (iii)

 

Emotional disturbance

Any minor

N.C. Gen. Stat. § 90-21.5(a)(iv)

North Dakota

STD testing/treatment

14+

N.D. Cent. Code § 14-10-17

 

HIV testing/treatment

Any minor

N.D. Cent. Code § 23-07.5-05

 

Alcohol or drug abuse treatment

14+

N.D. Cent. Code § 14-10-17

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

State

Condition or Disorder

Age

Statute

Ohio

STD testing/treatment

Any minor

Ohio Rev. Code Ann. § 3709.241

 

HIV testing

Any minor

Ohio Rev. Code Ann. § 3701.242(B)

 

Alcohol or drug abuse treatment

Any minor

Ohio Rev. Code Ann. § 3719.012(A),(C)

 

Blood donation

17+

Ohio Rev. Code Ann. § 2108.21

 

Medical treatment in prison

Any minor

Ohio Rev. Code Ann. § 5120.172

 

Health care subject to Department of Mental Health

18+

Ohio Admin. Code § 5122-28-05(A)(4)

 

Mental health services (for limited time, except for use of medications)

14+

Ohio Admin. Code § 5122-27-05(B),

Ohio Rev. Code Ann. § 5122.04

Oklahoma

STD testing/treatment

Any minor

63 Okla. Stat. Ann. § 2602(3)

 

HIV testing

Any minor

63 Okla. Stat. Ann. §§ 2602(3),1-532.1

 

Alcohol or drug abuse treatment

Any minor

63 Okla. Stat. Ann. § 2602(A)(3)

Oregon

STD testing/treatment

Any minor

Oreg. Rev. Stat. § 109.610(1)

 

HIV testing/treatment

Any minor

Oreg. Rev. Stat. § 433.04(5)

 

Family planning

Any minor

Oreg. Rev. Stat. § 109.640

 

Alcohol or drug abuse treatment

14+

Oreg. Rev. Stat. § 109.675

 

Blood donation

16+

Oreg. Rev. Stat. § 109.670

 

Mental health care

14+

Oreg. Rev. Stat. § 109.675

Pennsylvania

STD testing/treatment

Any minor

35 Pa. Stat. Ann. § 10103; 35 Pa. Stat. Ann. § 521.14a

 

HIV testing/treatment

Any minor

35 Pa. Stat. Ann. § 10103

 

Alcohol or drug abuse treatment

Any minor

71 Pa. Stat. Ann. § 1690.112

 

Blood donation

Any minor

35 Pa. Stat. Ann. § 10001

Rhode Island

STD testing/treatment

Any minor

R.I. Gen. Laws § 23-11-11

 

HIV testing/treatment

Any minor

R.I. Gen. Laws §§ 23-6-17, 23-8-1.1

 

Alcohol or drug abuse treatment

Any minor

R.I. Gen. Laws § 14-5-4

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

 

Blood donation

17+

R.I. Gen. Laws § 23-4.5-1

 

Medical treatment in prison

Any minor

R.I. Gen. Laws § 11-37-17

South Carolina

Alcohol or drug abuse treatment

16+

S.C. Code Ann. § 44-52-20

South Dakota

STD testing/treatment

Any minor

S.D. Codified Laws § 34-23-16

 

Alcohol or drug abuse treatment

Any minor

S.D. Codified Laws § 34-20A-50

 

Mental health treatment

18+, married or emancipated

S.D. Codified Laws § 27A-15-1

Tennessee

STD testing/treatment

Any minor

Tenn. Code Ann. § 68-10-104(c)

 

HIV testing/treatment

Any minor

Tenn. Code Ann. § 49-6-1008(a)

 

Family planning

Any minor

Tenn. Code Ann. § 68-4-107

 

Alcohol or drug abuse treatment

Any minor

Tenn. Code Ann. § 63-6-220

Texas

STD testing/treatment

Any minor

Tex. Fam. Code Ann. § 32.003

 

Alcohol or drug abuse treatment

Any minor

Tex. Fam. Code Ann. § 32.003

Utah

STD testing/treatment

Any minor

Utah Code Ann. § 26-6-18(1)

 

Blood donation

18+

Utah Code Ann. § 15-2-5

Vermont

STD testing/treatment

12+

18 Vt. Stat. Ann. § 4226

 

Alcohol or drug abuse treatment

12+

18 Vt. Stat. Ann. § 4226

Virginia

STD testing/treatment

Any minor

Va. Code Ann. § 54.1-2969(D)(1)

 

HIV testing/treatment

Any minor

Va. Code Ann. § 32.1-36(C)

 

Family planning (not sterilization)

Any minor

Va. Code Ann. § 54.1-2969(D)(2)

 

Alcohol or drug abuse

Any minor

Va. Code Ann. § 54.1-2969(D)(3)

 

Blood donation

17+

Va. Code Ann. § 54.1-2969(F)

 

Mental illness

Any minor

Va. Code Ann. § 54.1-2969

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

State

Condition or Disorder

Age

Statute

Washington

STD testing/treatment

14+

Rev. Code Wash. § 70.24.110

 

HIV testing/treatment

14+

Rev. Code Wash. § 70.24.017

 

Family planning

Any minor

Rev. Code Wash. § 9.02.100(1)

 

Alcohol or drug abuse treatment

13+

Rev. Code Wash. § 70.96A.095(1)

 

Mental health treatment

13+ if inpatient or outpatient, or 12+ if treatment by Department of Social Services

Rev. Code Wash. §§ 71.34.030, 71.34.042

West Virginia

STD testing/treatment

Any minor

W.V. Code § 16-29-1(b)

 

HIV testing/treatment

Any minor

W.V. Code § 16-3C-2(a)(3)

 

Family planning

Any minor

W.V. Code § 16-29-1(b)

 

Alcohol or drug abuse treatment

Any minor

W.V. Code § 60A-5-504

Wisconsin

STD testing/treatment

Any minor

Wis. Stat. §§ 252.11, 48.023

 

Alcohol or drug abuse treatment

12+

Wis. Stat. § 252.10

 

Mental health care

14+

Wis. Stat. § 51.14

Wyoming

STD testing/treatment

Any minor

Wyo. Stat. § 35-4-131

 

HIV testing/treatment

Any minor

Wyo. Stat. § 35-4-130

 

Family planning

Any minor

Wyo. Stat. § 42-5-101

 

Blood donation

18+

Wyo. Stat. § 12-1-101(e)

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

TABLE B.6 FOLLOWS

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

TABLE B.6 Regulation of Research with Children and Adolescents in State Custody: Responses from Child Welfare or Social Services Personnel

State

Contact

Alabama

Dr. Page Walley, Commissioner, Department of Children’s Affairs

Delaware

Peter S. Feliceangeli, Deputy Attorney General

 

Patricia M. Hearn, Office of the Secretary, Department of Services for Children, Youth and their Families (DSCYF)

Florida

Gladys E. Cherry, Director, Family Safety, Department of Children & Families

 

Sue Ross, Chief, Children’s Mental Health, Department of Children & Families (DCFS)

Illinois

Mark Testa, Director, Children and Family Resource Center

Louisiana

Eileen Fourroux, Program Specialist, Office of Community Services

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

Findings

No state regulations; follow federal government.

No statutes or policies relating to health care research involving children in state custody.

DSCYF provides services to children who experience abandonment, abuse, adjudication, mental illness, neglect, or substance abuse; does not permit involvement of children in their care in medical research.

Statutes address confidentiality of records and requirements for researcher access for abuse/neglect studies; must sign privacy agreement; requires approval of Department of Health’s IRB, the Review Council for Human Subjects (RCHS) (Florida Statutes, Ch. 39.202), which tracks federal regulations.

RCHS’s review procedures are available at http://www.doh.state.fl.us/execstaff/rchs/index.html.

Florida’s DCFS has its own IRB (with Federalwide Assurance (FWA)) to review applicable protocols; follows Belmont Report and federal regulations (according to its FWA application), approved May 2003.

All research involving wards of the state and former or current recipients of services from the Department of Children and Family Services (DCFS) must be approved through the DCFS IRB; additionally, a state-appointed guardian must approve research involving any ward of the state.

Non-personally identifying information may be released to a professional, university professor, or graduate student for “bona fide professional, academic, or scholarly research in the field of child welfare services” (La. R.S. 46:56F(5)(a)); identifying information (except identifying information in abuse & neglect cases) may be released with written approval of the Department, and the child’s representative, and if the research has been approved by IRB (46:56F(5)(b)). Contact with client/former client is permissible, if it “will not have a detrimental effect on the client,” if the client or his or her legal guardian consents in writing, and if the research is of value to the Department (46:56F(6)).

Office of Community Services (OCS) policy: Except for identifying information, the OCS State Office must preapprove access to foster care records, records of abuse/ neglect investigations, and child welfare services records by external investigators (the latter cannot be undergraduate students) –(Policy 1-550). If investigators desire access to identifying information/clients, they must submit a written request to OCS State Office. Financial incentives cannot be used to recruit participants; written certification from researcher’s IRB is needed. The following are also required: the research must have no detrimental effect on client, written consent of client/legal guardian, and the research must be of value to department (Policy 1-550).

The agency’s procedure for research proposal requests: Requests are reviewed on the basis of potential benefits to knowledge development in child welfare field, relevance

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

State

Contact

Louisiana (continued)

 

Maine

Michael Norton, Director, Division of Public Affairs/Quality Assurance, Bureau of Child and Family Services (BCFS), Department of Human Services (DHS)

New Hampshire

Philip F. Nadeau, Department of Health and Human Services (DHHS)

 

Bernie Bluhm, DHHS, Division of Children, Youth, and Families (DCYF)

New Jersey

Sudha Tiwari Kantor, Esq., Director, Office of Legal, Policy, and Legislative Affairs, Department of Human Services (DHS)

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

Findings

to OCS priorities, demands placed on OCS resources, potential for adverse impact on subjects/families, and the soundness of research design and procedures. If the researcher seeks direct contact with clients, full committee (of OCS) review is required.

Identifying data are released only if it is absolutely necessary for advancing knowledge development and OCS programs, the IRB had provided written approval, and the IRB has a written plan for long-term protection of identifying information released in connection with research. Identifying information is given only to the principal investigator (PI) and co-PIs to the extent necessary and not to research assistants or others involved in the research; they must also sign confidential agreement that carries with it criminal penalties if that information is released (agency procedures were provided in an e-mail from Ms. Fourroux).

No policies specifically address medical research, but there are policies on confidentiality and medical treatment orders; allows optional disclosure of nonidentifying information for “bona fide” research and identifying information with commissioner’s prior approval; cannot contact subject directly without subject’s consent through DHS before such contact (MRSA Title 22, sec. 4008.2.f).

BCFS policy: BCFS given legal mandate to make informed decisions regarding care and treatment for children in DHS custody (Child and Family Services Manual, Policy V.I-5) for treatment for “immediate risk of injury.” When a child is in DHS custody, DHS gives consent; if a child is in voluntary care of DHS, consent is given when the child receives “generally accepted treatment” and there is “reasonable cause to believe that parents or custodians would object” and parents/custodians are not available to consent (Child and Family Services Manual, Policy X.A.).

Research requires approval by/must be conducted under auspices of an IRB.

N.H. statute prohibits release of confidential files or other identifying information to researcher, except when DCYF contracts with researcher to evaluate its programs/ impact on families (then it reports only non-identifying outcomes) (see RSA Sec. 170-G:8-a).

No state laws/regulations/general policies. DHS has specific policy for “social welfare research.” Child abuse/neglect research must be “bona fide research” by “bona fide researcher” to seek information “absolutely essential to purpose of research,” must include individual or parent/legal guardian consent (Policy 604.1), must follow Program Evaluation Unit protocols, and obtain written consent of Division of Youth and Family Services (DYFS) director.

If DYFS believes that the research is useful, the researcher can avoid consent requirements by entering “consultant employee” arrangement (Policy 604.3). The researcher cannot use DYFS to contact former clients or use DYFS as intermediary to get children enrolled in research unrelated to DYFS (state custody) involvement, e.g., for market research (Policy 604.4).

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

State

Contact

New Mexico

Linda Carlisle, Juvenile Justice Division (JJD) Data Analysis Unit, Children, Youth & Families Department (CYFD)

North Dakota

Krista Andrews, Esq., Department of Human Services

Oklahoma

Linda Smith, Director, Division of Children and Family Services

Rhode Island

Kevin Aucoin, Administrator, Department of Children, Youth and Families (DCYF)

South Carolina

Mary C. Williams, Director, Division of Human Services, Department of Social Services

South Dakota

Virginia Wieseler, Office of Child Protection, Department of Social Services

Tennessee

Mary Jane Davis, Assistant General Counsel, Department of Children’s Services (DCS)

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

Findings

JJD policy prohibits medical, pharmaceutical, or cosmetic experiments with clients in CYFD custody or under juvenile probation supervision; however, superintendent or chief Juvenile Justice Probation and Parole Officer (JPPO) may apply for access to a “special medical procedure” (including research or experimental procedure) for client on the basis of appropriate medical personnel/supervising physician referral; must meet ethical, legal, and medical treatment standards and submit written consent between client and client’s parent/guardian/custodian and treating physician.

Director of JJD, with approval of medical director, Office of General Counsel, and secretary of CYFD may allow data collection from clients and analysis of data as part of research study if benefits CYFD clients, prevents client identification, and a confidentiality agreement restricting use of data by third parties is signed (JJD General Procedures, PR 11 Medical Research on Clients; note that scope is limited to JJD).

No state laws/regulations addressing research with children in state custody. Department policy requires IRBs (in general) to review research and to track federal regulations (policy emphasizes that federal regulatory protections apply to all children, including those in state custody).

Generally, research with children is not done; evaluations are done. However, the University of Oklahoma, which does most of the evaluations, follows the recommendations of its IRB.

No state laws or agency regulations specific to children’s consent and research (particularly if a child is in state custody).

DCYF practice is to require written parental or legal guardian consent before dissemination of personally identifiable information; does not require parental consent for non-personally identifying data (e.g., demographics of children in care).

Proposals should be reviewed by staff development and legal counsel, identifying any DCYF resources affected; ultimately up to director or his/her designee to approve request to share information

Person engaged in bona fide research may have access to records on child abuse and neglect, subject to director’s permission and with limits as director may impose (S.C. Code of Laws sec. 20-7-690(B)(17)).

Does not allow medical research with children in custody. Not aware of cases/statutes that address this issue. In general, both parental and state consent (since child in state custody) required for medical treatment.

Has in place a research review committee (RRC), under DCS’s director of policy, planning, and research, to decide on appropriateness of all research requests; applies to research involving use of human subjects or access to confidential records/data. Director of policy, planning, and research appoints RRC if researcher seeks access to

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

State

Contact

Tennessee (continued)

 

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

Findings

department records/reports/data, confidential records normally requiring informed consent (e.g., medical records), or human subjects directly.

Director of policy, planning, and research reviews requests for information/data not in public domain but not involving access to departmental records (less stringent review). RRC bases review on factors typical of federal IRB reviews, and IRB review/approval is required when federal law requires such (e.g., greater than minimal risk to children); researcher must agree to give DCS research results for review/comment before publication or dissemination.

Prohibited from approval is research “that uses juveniles for medical, pharmaceutical, or cosmetic experiments, or use of medications such as stimulants, tranquilizers, or psychotropic drugs administered for purposes of … experimentation and research” (DCS Policy 6.1, B.8). However, this policy does not apply if the medications prescribed as clinically indicated are used as part of therapy, or if medical procedure is medically necessary even though it is not part of general program of medical experimentation (DCS Policy 6.1, B.8).

Informed-consent policy is being updated. The draft version gives parents the legal right to consent to medical treatment for their child, unless parental rights are terminated; DCS is authorized to consent to ordinary medical treatment by virtue of court order granting it legal custody, but “best practice is to involve the parent(s) in the child’s treatment and to facilitate the parental role in giving informed consent” (draft DCS Policy 20.24); presumes that children ages 14+ have the maturity to consent to medical treatment but is determined on a case-by-case basis; youth ages 16+ with serious emotional disturbances have the same legal rights as adults in outpatient and inpatient mental health treatment decisions, i.e., they can consent to treatment mental health conditions (draft DCS Policy 20.24, B.7); parental consent is not required for drug abuse, prenatal care, STD care, or contraceptive use.

Health administrator of youth development center or community residential facility may grant use of health records for research if precautions are taken to disguise identities of subjects and the researcher agrees not to disclose identity of youth subjects or material that might have direct adverse effect on youth (DCS Policy 20.25, C.2.c).

Important distinctions are based on what type of “guardian” is acting on behalf of child: that is, is state officially the legal guardian or guardian just in sense of being “legal custodian” (meaning no termination of parental rights); this would affect who may speak on behalf of the child/consent to research and treatment (see TCA 37-5-103, which defines “legal custodian” as person/agency given legal custody by court order, whose physical custody includes right to make ordinary medical treatment decisions [subject to limits of order granting custody and remaining rights/ duties of parents]). As matter of agency policy, DCS tries to get parental consent when feasible and in child’s best interests.

Privacy Memorandum (from M. J. Davis to DCS Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Workgroup, April 16 2003) specifies that the parent is not the minor’s personal representative with regard to health

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

State

Contact

Tennessee (continued)

 

Utah

Navina Forsythe, Supervisor, Data Research Reporting Unit, Division of Child and Family Services (DCFS)

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

Findings

information when state law does not require consent before minor can obtain health care services and minor consents (e.g., STD care, physician finds minor “sufficiently mature” to make health care decisions and minor consents); furthermore, Tennessee common law (judge-made law) presumes all minors ages 14+ have the capacity to make informed health care decisions (“Rule of Sevens”), referred to as “mature minor exception” (see Cardwell v. Bechtol, 724 S.W.2d 739, 1987).

DCFS research representative to Department of Human Services (DHS) IRB and DCFS director must review and approve research; generally, review tracks federal regulations, but also requires research to be in the best interests of DCFS and DCFS clients and the results to be of potential benefit to DCFS and DHS (Procedure on Foster Children in DCFS Custody Involvement in Research, Dec. 2002). DHS IRB reviews are pursuant to federal regulations and state laws on family educational rights and privacy act (UCA sec. 63-2-101-909), reporting abuse/neglect/exploitation (UCA sec. 62A4a-403), and HIPAA.

Informed consent for children in DCFS custody procedures: DCFS caseworker for child consults with foster parents (adoptive parents if the research involves adoptive children) and may contact therapists, school personnel, and others who work with the child to see if the child may participate; if participation is approved, caseworker signs informed consent; if the child is under 18 and the goal is to return the child home or to place the child in the custody of a relative or if parental rights are not terminated, parents/relatives must be consulted and give permission. If they give permission, they sign a consent form; if they object, the child cannot participate. If the child has the “maturity to understand the implications of participating in research,” the child is consulted. If the child agrees, the child signs an assent form unless he or she is 18+, in which case he or she signs the consent form; if the child does not agree, the child does not participate and the researcher must contact the Office of Guardian ad litem (if one is appointed) and give the guardian ad litem (GAL) a description of the research project; if GAL expresses concerns, the child cannot participate (Procedure on Foster Children in DCFS Custody Involvement in Research, Dec. 2002).

More thorough procedures contained in DHS’s Policy and Resource Manual: Institutional Review Board, Policies and Procedures, Policy 01-10 (effective Feb. 24, 2003), which explains that an appropriate authority within DHS reviews the procedures; depending on the nature and source of proposed research, the authority could be (1) an appropriate division director (e.g., director of DCFS) or (2) an appropriate division director and DHS IRB. If the research involves pharmaceuticals or biomedical devices, another layer of review applies. Any research by an external researcher would require DHS IRB review.

No children under guardianship or custody of DCFS, Division of Substance Abuse and Mental Health, Division of Youth Corrections, or Division of Services for People with Disabilities may participate in study involving use of placebo (DHS Policy and Resource Manual, Policy 01-10).

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

State

Contact

Washington

Michael Garrick, Ph.D., Executive Secretary, Washington State IRB

Wisconsin

Kitty Kocol, Administrator, Division of Children and Family Services, Department of Health and Family Services

 

SOURCES: The information presented in the table is drawn from inquiry (by mail, e-mail, and follow-up calls) of state child welfare and related departments. The initial query letter was sent in June 2003, and the responses are those received as of October 23, 2003.

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

Findings

No state law or policies pertain directly to research involving children and adolescents.

The IRB follows advice of local assistant attorney general, based on state laws related to consent.

No specific state policies on research other than statutes/regulations related to confidentiality and, if applicable, any federal guidelines/regulations under which it is funded.

Depending on nature of research request and “type” of children involved, will negotiate with researcher on individual basis for each study: might allow direct access to children or data systems or, alternatively, might permit indirect access through Department.

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

NOTES

1.  

U.S. Department of Health and Human Services. Protection of Human Subjects in Research. Washington, D.C.: U.S. Government Printing Office, 1991 (codified at 45 CFR Part 46). The regulations and a list of all agencies adopting the Subpart A (the Common Rule) may be found at http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm (accessed May 6, 2004).

2.  

45 CFR 46, Subpart D.

3.  

34 CFR Part 97 (Protection of Human Subjects) and Part 98 (Student Rights in Research, Experimental Programs, and Testing). The Protection of Pupil Rights Amendment (PPRA), codified at 34 CFR Part 98, requires schools and contractors that receive funding from the U.S. Department of Education to obtain written parental consent before minor students are required to participate in any U.S. Department of Education-funded survey, analysis, or evaluation that reveals certain information, including mental and psychological problems potentially embarrassing to the student and his or her family; sexual behavior and attitudes; and illegal, antisocial, self-incriminating, and demeaning behavior. PPRA also seeks to ensure that parents can review such surveys, analyses, or evaluations before their minor child’s participation. Subsequent legislation (No Child Left Behind Act) required that schools must provide directory information to military recruiters upon request and allowed parents to refuse their child’s participation in certain additional information collection activities. More information is available on the U.S. Department of Education’s website. Available at: http://www.ed.gov/offices/OII/fpco/ppra/index.html (accessed August 28, 2003) and http://www.ed.gov/policy/gen/guid/fpco/ppra/parents.html (accessed May 6, 2004).

4.  

See, e.g., Standard Operating Procedures. Guidance on the Inclusion of Children in Research, Johns Hopkins University Committee on Human Research (which explains four categories of risk under “additional protections” for child subjects with reference to federal regulations). Available at: http://www.jhsph.edu/chr/Childrens_guidelines.pdf (accessed June 24, 2003); Informed Consent Guide for the Institutional Review Board of the University of Southern California Health Sciences Campus, November 2, 1999 (which provides informed-consent requirements based on DHHS and FDA regulations, including the consent and assent procedures for research with children). Available at: http://ccnt.hsc.usc.edu/irb/irb.html (accessed June 23, 2003).

5.  

45 CFR 46.402(a) (emphasis added).

6.  

45 CFR 46.402(e).

7.  

Taussig HN. 2002. Risk behaviors in maltreated youth placed in foster care: a longitudinal study of protective and vulnerability factors. Child Abuse & Neglect 26:1179–1199 (study examining protective and vulnerability factors in foster care youth); Child Welfare League of America. National Fact Sheet 2003: Making Children a National Priority. Available at: http://www.cwla.org/advocacy/nationalfactsheet03.htm (accessed October 23, 2003) (citing evidence that children whose families do not receive appropriate treatment for alcohol and other drug abuse are more likely to end up in foster care, remain in foster care longer, and reenter foster care once they have returned home than are children whose families do receive treatment).

8.  

English A. 1995. Guidelines for adolescent health research: legal perspectives. Journal of Adolescent Health 17:277–286; Santelli J, et al. 2003. Guidelines for adolescent health research. A position paper for the Society of Adolescent Medicine. Journal of Adolescent Health 33(5):396–409; Hartman RG. 2002. Coming of age: devising legislation for adolescent medical decision-making. American Journal of Law and Medicine 28:409–453; Broome ME, Stieglitz KA. 1992. The consent process and children. Research in Nursing & Health 15:147–152.

9.  

See, e.g., Ariz. Rev. Stat. Ann. 44-132.

10.  

See, e.g., Ind. Code Ann. 16-36-1-3; Maine Rev. Stat. Ann. Tit. 15, 3506A.

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

11.  

See, e.g., Calif. Fam. Code 7002(c), 7120-7122; N.C. Gen. Stat. 7B-3500.

12.  

See, e.g., Connecticut Office of Legislative Research (OLR) Research Report 2002-R-0008 (emancipation of minors under common law). Note also that emancipation likely also released parents from debts arising from their children’s decisions. See, e.g., Support of Minors and Emancipation, State of Michigan, 37th Circuit Court, Family Division Justice Center, April 2000; Conn. Gen. Stat. Sec. 46b-150(d)(a) (emancipation order allows minor to “consent to mental, dental, or psychiatric care, without parental consent, knowledge, or liability” (emphasis added); W.Va. Code 49-7-27 (parents or custodians of emancipated minor not obligated to provide care of financial support); Wy. Stat. 14-1-202(a)(iii) (emancipation terminates parental tort liability for minor).

13.  

Conn. Gen. Stat. Sec. 46b-150(d)(a).

14.  

Md. Code Ann., Est. & Tr. Art. 13, sec. 503(c) (a minor 15 or older may contract for annuities or life insurance for self).

15.  

For explicitly including right to make health care decisions among legal effects of emancipation, see Calif. Family Code sec. 7050(e)(1) (effects of emancipation include minor’s capacity to “consent to medical, dental, or psychiatric care, without parental consent, knowledge, or liability”); Conn. Title 46B, Ch. 815t sec. 46b-150d(a) (emancipated minor may “consent to medical, dental, or psychiatric care, without parental consent, knowledge, or liability”). But see, e.g., Md. Code Ann., Est. & Tr. Art. 13 sec. 503(a) (a married minor may buy/sell property if spouse of age); Md. Code Ann., Est. & Tr. Art. 13 sec. 503(c) (at age 15 an individual may contract for insurance); Md. Code Ann., Est. & Tr. Art. 13 sec. 503(b) (a minor in the military can enter real estate transactions); N.C. Gen. Stat. 7B-3507 (final decree of emancipation gives the minor or petitioner the “same right to make contracts and conveyances, to sue and to be sued, and to transact business as if the petitioner were an adult”).

16.  

A. Campbell, personal communication (with Abigail English, JD, Director, Center for Adolescent Health & The Law), August 5, 2003.

17.  

See, e.g., W.Va. Code 16-30-3(o) (which defines a “mature minor” as “a person less than eighteen years of age who has been determined by a qualified physician, a qualified psychologist or an advanced nurse practitioner to have the capacity to make health care decisions).

18.  

Restatement (Second) of Torts, sec. 892A, cmt.b (1979).

19.  

But cf. Novak v. Cobb County-Kennestone Hospital Authority, 849 F.Supp 1559 (N.D. Ga. 1994), aff’d 74 F.3d 1173 (11th Cir. 1996) (which declined to recognize mature minor exception pursuant to O.C.G.A. sec. 31-9-7).

20.  

See, e.g., Id. Code 39-4302; Ark. Stat. Ann. 20-13-104, 20-9-106, 20-9-60; Miss. Code Ann. 41-41-3.

21.  

Ala. Code 22-8-4.

22.  

Calif. Family Code 6922 (applies only to minors age 15 years or older who are living apart from their parents and managing their own affairs); Oregon Rev. Stat. 109.640.

23.  

S.C.C.A. 20-7-280 (for health services other than operations, unless the operation is deemed essential to the health and the life of child).

24.  

See, e.g., Colo. Rev. Stat. 13-22-103; Ind. Code Ann. 16-36-1-3; 22 Maine Rev. Stat. 1503.

25.  

See, e.g., Va. Code Ann. 54-2969.

26.  

For further discussion of the extent and limits of minor medical decision-making, see Stenger RL. 1999/2000. Exclusive or concurrent competence to make medical decisions for adolescents in the United States and United Kingdom. Journal of Law and Health 14(209):208–241.

27.  

Santelli J, et al. 2003. Guidelines for adolescent health research: a position paper for the Society of Adolescent Medicine. Journal of Adolescent Health 33(5):396–409.

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

28.  

See, e.g., 25 Tex. Admin. Code 405.409 (which requires minor’s assent for research of mental health patients); 25 Tex. Admin. Code 414.758 (special conditions for greater-than-minimal-risk research and research with minors); 25 Tex. Admin. Code 414.754 (which provides special rules for research with persons involuntarily committed to Texas Department of Mental Health and Mental Retardation facilities); Va. Code Ann. 32.1-162.16, 32.1-162.18, 32.1-162.19, 12 Va. Admin. Code 5-20-10, 5-20-100, 35-180-10 (research connected with Department of Health and Department of Mental Health facilities must adhere to special requirements for nontherapeutic, greater-than-minimal-risk research); V.C.A. 32.1-16.16 (in which nontherapeutic research is defined as having no reasonable expectation of direct benefit to the physical or mental condition of the subject); Calif. H&S Code 24178 (A.B. 2328, signed September 11, 2002, as Chap. 477, which allows for surrogate consent to research in certain situations); Calif. H&S Code 111530 (which requires parental/guardian consent and minor assent if the child is age 7 years or older for experimental use of drugs with minors); 15 Calif. Code Regs. 1454 (which provides specific rules for clinical research with juveniles in the state corrections system); Del. HSS Policy Memo No. 55 (July 1992) (clients served by Delaware Health & Social Services may not be research subjects unless the Human Subjects Review Board approves the research and the research is compatible with DHHS [federal] regulations); D.C.C. 21-2047 (the guardian of an incapacitated person may not consent to experimental treatment or research); D.C. Code 6-1969 (a parent or guardian may act as a legally appointed representative (LAR) for experimental research with mentally retarded individuals); Ohio Admin. Code 5122-28-05 (which considers a parent or guardian of a minor to be the LAR for research subject to the authority of the Department of Mental Health); Ohio Admin. Code 5122-28-05(A)(4) (consent age of 18 for research subject to Department of Mental Health regulation); Code of Maine Regs. 14-193-001(XI); 14-142-001(XI) (for children receiving services from Bureau of Children with Special Needs, clinical research laws require full written informed consent, assent by minors over age 12, approval of clinical director for off-label use of FDA-approved drug, Research and Experimental Review Board review, and compliance with federal DHHS regulations; a special review process is required if research with minors presents greater than minimal risk).

29.  

This link was made in a prominent report issued by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which recommended allowing minor consent to research when the research is conducted in or relates to the types of care to which minors can consent in the treatment context. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 1977. Report and Recommendations: Research Involving Children. DHEW publication (OS) 77-0004. Washington, D.C.: U.S. Government Printing Office.

30.  

See, e.g., English A. 1995. Guidelines for adolescent health research: legal perspectives. Journal of Adolescent Health 17:277–286; Nelson RM. 2001. Nontherapeutic research minimal risk, and the Kennedy Krieger Lead Abatement Study. IRB: Ethics & Human Research 23(6):7–11.

31.  

See, e.g., Cohen v. Bolduc, No. SJC-08544 (Mass. 01/11/2002) (“We conclude that, absent an express limitation by the principal in the health care proxy itself, the proxy statute does not prevent an agent from making that treatment decision, provided the principal does not object.”). Available at: http://caselaw.lp.findlaw.com/scripts/getcase.pl?court=ma&vol=sjcslip/8554&invol=1.

32.  

Cardwell v. Bechtol, 724 S.W. 2d 739, 743-4 (Tenn. 1987) (citations omitted). The Cardwell case is preeminent among recent cases in its clear enunciation of the origins of and reasoning behind the “mature minor” exception, as well as its explanation, cited here, of the flexibility of the law in adapting to changing conditions and the openness to a context-sensitive interpretation of actions in the absence of specific relevant legislative enactments. For a further discussion of Cardwell, see text accompanying notes 82–84, infra. Complicating

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

   

matters, however, states may choose to remove this flexibility in interpretation in the face of silence by explicitly superseding common law through statutory means. See, e.g., N.C. Gen. Stat. 7B-3509 (which supersedes the common law of emancipation, other than by marriage).

33.  

45 CFR 46.402(b).

34,  

For useful suggestions for developing guidance to clarify “assent” and “consent” in research with children, see Broome ME, Stieglitz KA. 1992. The consent process and children. Research in Nursing & Health 15:147–152. See also American Academy of Pediatrics. 1995. Informed consent, parental permission, and assent in pediatric patients. Pediatrics 95:314–317; Wendler D, Shah S. 2003. Should children decide whether they are enrolled in nonbeneficial research? American Journal of Bioethics 3(4):1–7 (which argues that the “assent” threshold should be set at age 14 and that a “dissent” requirement should also be adopted for nonbeneficial research).

35.  

See, e.g., National Institutes of Health (NIH) Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects, released March 6, 1998. Available at: http://grants1.nih.gov/grants/guide/notice-files/not98-024.html (accessed June 23, 2003) (for grant proposals received by NIH after October 1, 1998, the website sets forth policy and guidelines for inclusion of children (defined as youth up to age 21) to encourage NIH-supported research with children); Best Pharmaceuticals for Children Act, January 4, 2002 (P.L. 107-109) (which extends the pediatric exclusivity provision of the Food and Drug Administration Modernization Act of 1997 (P.L. 105-115), which sunset on January 1, 2002, through 2007; note that the exclusivity provision provides marketing incentives to manufacturers that conduct drug studies with children by extending patent protection for 6 months in return for such studies); Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients (FDA Pediatric Rule), 21 CFR sec. 201, 312, 314, 601, 63 FR 66632, December 2, 1998 (which requires manufacturers of certain products to provide sufficient data and information to support directions for pediatric use for the claimed indications). Note that the Pediatric Rule was struck down in October 2002 by a federal court as exceeding FDA’s statutory authority (Association of American Physicians and Surgeons, Inc. v. United States Food and Drug Administration, Civil Action No. 02-02898 (Dist. Ct. D.C., October 17, 2002); however, DHHS worked with Congress to pass similar federal legislation requiring pharmaceutical companies to conduct clinical drug trials with children (see Bush Administration will Seek New Legislation for Mandatory Pediatric Drug Testing, DHHS Press Release, December 16, 2002. Available at: http://www.hhs.gov/news/press/2002pres/20021216c.html (accessed June 23, 2003)). The Pediatric Research Equity Act of 2003 was signed into law on December 5, 2003.

36.  

See, e.g., Md. Health-General Article Cod. Ann. Sec. 13-2001 et seq. (2002).

37.  

Grimes v. Kennedy Krieger Institute, Inc., 366 Md. 29, 782 A.2d 807 (2001) (hereinafter Grimes); see also Mastroianni A, Kahn JP. 2002. Risk and responsibility: ethics, Grimes v. Kennedy Krieger, and public health research involving children. American Journal of Public Health.92(7):1073–1076.

38.  

45 CFR 46.409.

39.  

45 CFR 46.409(a).

40.  

45 CFR 46.409(b).

41.  

A. Campbell, personal communication (with Mary Jane Davis, Asst. General Counsel, Tennessee Department of Children’s Services), July 21, 2003. Tennessee’s Department of Children’s Services is currently revising its informed-consent policy to clarify this presumption of parental consent authority. TN DCS Policy 20.24, eff. 02/01/00, rev’d. 05/09/03 (draft copy on file with author).

42.  

Pierce v. Society of Sisters, 268 U.S. 510 (1925) (which upholds the liberty interest of parents to direct upbringing and education of children); Parham v. J.R., 442 U.S. 584 (1979) (which states that parents’ liberty interests in raising children extends to decisions over whether

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

   

to institutionalize children with mental illness, although parental discretion is not absolute). It is also worth noting that in the Parham decision, the U.S. Supreme Court determined that there did not need to be a separate process for initial admission decisions for inpatient commitment of children for children who were wards of the state (versus children whose natural parents sought admission). In so holding, the Court stated that, “Since the state agency having custody and control of the child in loco parentis has a duty to consider the best interests of the child with respect to a decision on commitment to a mental hospital, the State may constitutionally allow that custodial agency to speak for the child, subject, of course, to the restrictions governing natural parents” (Parham, 442 U.S. 584, 619).

43.  

See, e.g., Utah Department of Human Services IRB. Procedures & Instructions for Researchers. Department of Human Services Resource Manual, eff. February 24, 2003 (copy on file with author).

44.  

A. Campbell, personal communication (with Dr. Page B. Walley, Commissioner, Alabama Department of Children’s Affairs), June 16, 2003.

45.  

See, e.g., Utah Department of Human Services IRB. Procedures & Instructions for Researchers. Department of Human Services Resource Manual, eff. February 24, 2003; State of Tennessee Department of Children’s Services. Research Proposals. Administrative Policies & Procedures: 6.1, eff. February 1, 2000, rev’d. November 1, 2001 (copy on file with author).

46.  

Maryland Department of the Environment. Lead Poisoning Prevention Program. Childhood Blood Lead Surveillance in Maryland. 1999 Annual Report. Released February, 2001. Available at: http://www.mde.state.md.us/assets/document/LeadCoordination/leadreport99.pdf (accessed August 11 2003.

47.  

Maryland Department of Health and Mental Hygiene. Community and Public Health Administration. Center for Maternal and Child Health. Childhood Lead Screening Program. Targeting Plan for Areas at Risk for Childhood Lead Poisoning. May 2000. Available at: http://www.fha.state.md.us/och/html/stp.html (accessed August 11, 2003).

48.  

Maryland Department of the Environment. Annual Report 2000, p. 53. Available at: http://www.mde.state.md.us/assets/document/AboutMDE/annualreport.pdf (accessed August 11, 2003).

49.  

Grimes at 807.

50.  

Grimes at 818, 819, 842.

51.  

Id. at 819.

52.  

For interesting discussions of the merits and the ramifications of the decision, see Kopelman LM. 2002. Pediatric research regulations under legal scrutiny: Grimes narrows their interpretation. Journal of Law, Medicine & Ethics;30:38–49; Glantz LH. 2002. Nontherapeutic research with children: Grimes v. Kennedy Krieger Institute. American Journal of Public Health 92(7):1070–1073.

53.  

Grimes at 816–817.

54.  

Id. at note 6.

55.  

Id. at 850.

56.  

Nelson RM. 2001. Nontherapeutic research minimal risk, and the Kennedy Krieger Lead Abatement Study. IRB: Ethics & Human Research23(6):7–11, 8–9.

57.  

Grimes at 853 (“not in best interest of any healthy child to be intentionally put in a nontherapeutic situation where his or her health may be impaired, in order to test methods that may ultimately benefit all children”).

58.  

See, e.g. Alliance for Human Protection. A landmark decision by Maryland’s highest court … Infomail. August, 20, 2001. Available at: http://www.researchprotection.org/infomail/0801/20.html (accessed June 20, 2003).

59.  

Kopelman LM. 2002. Pediatric research regulations under legal scrutiny: Grimes narrows their interpretation. Journal of Law, Medicine & Ethics,30:38–49; Nelson RM. 2001.

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

   

Nontherapeutic research minimal risk, and the Kennedy Krieger Lead Abatement Study. IRB: Ethics & Human Research 23(6):7–11.

60.  

See, e.g., University of Maryland Baltimore County IRB. Requirements for Research Involving Children. Updated March 11, 2002. Available at: http://www.umbc.edu/irb/Children.htm (accessed June 21, 2003).

61.  

Md. Health-General Code Ann. Sec. 13-2001 et seq. (2002).

62.  

A. Campbell, personal communication (with Jack Schwartz, Assistant Attorney General, State of Maryland), June 20, 2003.

63.  

Grimes at 862.

64.  

See, e.g., Sharav VH. 2003. Children in clinical research: a conflict of moral values. The American Journal of Bioethics 3(1):1–81. Available at: http://www.bioethics.net/journal/infocus/pdf/sharav.pdf (accessed February 25, 2004).

65.  

For more information on the Willowbrook scandal, see Bonita L. Weddle, Mental Health in New York State, 1945–1998: An Historical Overview. New York State Archives: New York. Available at: http://www.archives.nysed.gov/includes/g/researchroom/c_rr_health_mh_hist.html (accessed June 23, 2003).

66.  

NY Cons. Law Services Pub Health sec. 2442.

67.  

T.D. v. N.Y. State Office of Mental Health, 165 Misc. 2d 62, 626 N.Y.S.2d 1015 (1995).

68.  

T.D. v. N.Y. State Office of Mental Health, 228 A.D.2d 95 (1996) (hereinafter T.D.).

69.  

Id. at 100.

70.  

Id. at 123.

71.  

Id. at 124.

72.  

Id. at 120; see also Grimes at 817.

73.  

T.D. at 124-5, citing NYCRR 527.10(e)(3)(iii).

74.  

See, however, 45 CFR 46.408(c) (which allows the waiver of parental permission if it is not a reasonable requirement for the subjects involved, e.g., abused and neglected children). This federal regulation allows for protection of minors by waiving parental consent, so long as another mechanism is in place for their protection and it is in accord with state and local law. The New York court suggests—at least for studies with abused or neglected children that are not federally funded and that are nontherapeutic and present greater than minimal risk—local commissioners of health are the appropriate, and necessary, consenting authorities; surrogate consent or a waiver of “guardian” consent is not appropriate. T.D. at 124–125.

75.  

The court argues that the OMH regulations’ surrogate consent provisions are unacceptable for greater-than-minimal-risk nontherapeutic research in light of earlier treatment-related holdings and the state’s interest in child health and welfare as parens patriae, suggesting such research may lead to the same result at “denial of necessary medical treatment” (Id. at 124).

76.  

See, e.g., Grimes at 840 and T.D. at 127.

77.  

Grimes at 855; see also T.D. at 122–123 (need for notice and judicial review).

78.  

In re the Matter of Rena, 705 N.E.2d 1155, 1157 (Mass. App. Ct. 1999). See also In re E.G., 549 N.E.2d 322 (Ill. 1989) (Jehovah’s Witness case in which the Illinois Supreme Court applied substituted judgment standard to see whether a minor was sufficiently mature to make informed decision); In re Swan, 569 A.2d 1202 (Maine 1990) (the state’s highest court holds that evidence of the wishes of a minor with the capacity to weigh risks and benefits in refusing life-sustaining treatment is an important factor). But c.f. In re Application of Long Island Jewish Medical Ctr., 557 N.Y.S.2d 239 (Sup. Ct. 1990) (the court orders a transfusion for a 17-year old over his objection under the parens patriae doctrine, without consideration of “mature minor” framework, another example of New York’s conservative approach).

79.  

In re Rena at 1156–1157.

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

80.  

Id. at 1157.

81.  

Id. at note 2, citing Mass. G.L. c. 112, sec. 12S.

82.  

Cardwell v. Bechtol, 724 S.W. 2d 739 (Tenn. 1987).

83.  

Id. at 745.

84.  

Id. at 749 (“for the jury to determine whether the minor has the capacity to consent to and appreciate the nature, the risks, and the consequences of the medical treatment involved”). In this case, the court ruled that the minor, a female 5 months shy of 18 years of age, had the capacity and maturity to consent to treatment for a herniated disk.

85.  

See Stenger RL. 1999/2000. Exclusive or concurrent competence to make medical decisions for adolescents in the United States and United Kingdom. Journal of Law and Health 14(209):208–241.

86.  

National Commission for the Protection of Human Subjects of Biomedical Research. 1977. Research Involving Children: Report and Recommendations. DHEW publication (OS) 77-0044. Washington, D.C.: U.S. Government Printing Office, (which suggests that adolescents’ legal ability under state law to consent to certain medical treatments without need for parental permission, indicative of adolescent capacity, should extend to research context for same conditions). See also, Santelli J, et al. 2003. Guidelines for adolescent health research: a position paper for the Society of Adolescent Medicine. Journal of Adolescent Health 33(5): 396–409.

87.  

Mastroianni A, Kahn JP. 2002. Risk and responsibility: ethics, Grimes v. Kennedy Krieger, and public health research involving children. American Journal of Public Health 92(7):1073–1076; Rogers AS, D’Angelo L, Futterman D. 1994. Guidelines for adolescent participation in research: current realities and possible resolutions. IRB: Ethics & Human Research 16(4):1–6, 3–4; Santelli J, et al. 2003. Guidelines for adolescent health research: a position paper for the Society of Adolescent Medicine. Journal of Adolescent Health 33(5): 396–409.

88.  

See Hartman RG. 2002. Coming of age: devising legislation for adolescent medical decision-making. American Journal of Law and Medicine 28:409–453. For examples of studies that might benefit the policy-making community, see Bernhardt BA, et al. 2003. Parents’ and children’s attitudes toward the enrollment of minors in genetic susceptibility research: implications for informed consent. American Journal of Medical Genetics 116A:315–323 (which assesses parents’ and children’s reactions to disease susceptibility research and perceptions of risks and benefits of participating); Oleschnowicz JQ, et al. 2002. Assent observed: children’s involvement in leukemia treatment and research discussions. Pediatrics 109:806–814 (which examines the role of older children in discussing recent diagnosis of leukemia and treatment options including enrollment in a randomized, clinical trial); Rogers AS, Schwartz DF, Weissman G, English A. 1999. A case study in adolescent participation in clinical research: eleven clinical sites, one common protocol, and eleven IRBs. IRB: Ethics & Human Research 21(1):6–10 (which investigates decision-making by IRBs with respect to one common study protocol recruiting minor adolescents for HIV/STD study).

89.  

See, e.g., Brown K.2003. The medication merry-go-round. Science 299:1646–1649; Meadows M. 2003. Drug research and children. FDA Consumer Magazine January–February. Available at: http://www.fda.gov/fdac/features/2003/103_drugs.html (accessed March 24, 2003).

90.  

See, e.g., The Alliance for Human Research Protection (AHRP). Its listserv and website increasingly draw attention to research with children, especially pharmaceutical research; for example, see the recent alert to recent developments in the United Kingdom where the British government disapproved a license for Seroxat (Paxil) for use by children and adolescents based on adverse events in recent clinical trials. GlascoSmithKline [sic] PAXIL Warning Letter to Health Care Professionals. AHRP News Alert, June 19, 2003. Available at: http://www.ahrp.org/infomail/0603/19.html (accessed June 23, 2003).

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

91.  

45 CFR Parts 160 and 164 (Standards for Privacy of Individually Identifiable Health Information, implementing requirements set forth in the Health Insurance Portability and Accountability Act of 1996).

92.  

For a state example of the latter, see Va. Code Ann. 32.1-162.16 (which defines “nontherapeutic research” as that which holds “no reasonable prospect of direct benefit to the physical or mental condition of the human subject.”). A point to illuminate: Does “direct benefit” mean benefit to the subject’s well-being generally or only specifically to that condition or disorder under investigation?

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

ADDENDUM B1

Hypothetical Research Studies with Children in State Custody: How Might States Respond?

The following hypothetical research protocols, followed by hypothetical state responses to the regulation of such (based on inquiries made of researchers and regulators in a number of states), may serve to highlight the myriad of approaches applied to research studies involving youth in state custody. They were developed in consultation with researchers focused on the foster care population and were circulated to researchers whose work touches upon these issues in numerous states, as well as representatives of state child welfare departments (or the relevant agencies who regulate such research) for feedback. The comments below are not those of a single respondent; rather, they illustrate the collective wisdom of the respondents; that is, researchers and regulators.

Scenario 1: Behavioral Study

Faculty at a state university’s Center for Research in Child and Adolescent Health (the Center) wish to add to their colleagues’ work in documenting risk factors for adolescents in foster care. An earlier study from the Center found that adolescents in foster care often have multiple psychosocial and mental health problems that place them at risk for early sexual experiences and HIV infection. The researchers wish to identify such risk factors at early stages to better prevent such later effects. Thus, they propose to target preteens (children ages 9 to 12) in foster care and collect information about substance abuse, sexual activity, maltreatment, and suicidal intent to identify discernible interrelationships among factors that might contribute to early sexual experiences and other HIV-related behaviors (e.g., use of needles to inject illegal drugs). This prospective study will involve 400 youth ages 9 to 12 in foster care. At the onset of the project, children will be given a battery of psychiatric, social, and adaptive functioning measures to gauge mental health risk and protective factors. They will then be monitored for 5 years to identify patterns of behavior. Children will be drawn from multiple sites in four different states.

Was your (foster care/child welfare) office confronted with this situation, or if a similar proposal was brought before it, did it/might it permit these children to participate in the study? Please explain.

More regulatory or restrictive state Obviously, the most restrictive stance would be to bar such research with children in state custody outright. Beyond that, however, there could likely be “exceptions” to the ban (e.g.,

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

for “special cause”) or a slightly more permissive stance with tight control via departmental regulation.

For example, State A (say) has its own Research Review Board that reviews all requests for conducting research with its client population (by providing access to confidential records or data or direct access to the clients). Its review criteria track those provided for in federal regulations; however, special attention is paid to the “vulnerability” of its subject population, and more invasive research methods (including surveys with highly sensitive information) are scrutinized closely. Informed consent is required: the presumption is in favor of seeking parental consent for children, unless parental rights have been terminated, even though the Department has legal authority for approving “ordinary medical care” for children in its custody. If parental rights are not terminated and if parents are not causing harm to their children, their objection to research will bar their child’s participation. Additional review and reconsent are required if there are any changes in the protocol; similarly, reconsent is required if the custodial status of the child changes (e.g., the child is placed with a new foster parent).

Or consider State B, in which requests for direct access to child clients is subject to court approval. It is further stipulated that the caseworker for each child must consent on the child’s behalf, as well as obtain the child’s assent.

Less regulatory or restrictive state Falling closer to the less restrictive end of the continuum, State C allows research, including access to confidential data and direct client access, if the research protocol is approved by the researcher’s own IRB. The researcher must sign a confidentiality agreement and agree not to include personally identifying information in subsequent research reports. Consent for client participation is generally given by the Department of Children & Families (DCF) acting as the custodian for the children. Although the Department’s regulations focus on confidentiality, it is expected that research that targets the needs of children in state custody and the needs of the DCF and also that DCF’s resources (e.g., staff) will not be stretched in complying with research.

Scenario 2: Research Tied to Clinical Needs

In the early years of HIV infection, there was no treatment for the disease. Many babies who were born infected were placed in foster care because their mothers were too sick to care for them, and most mothers died before the babies’ first birthday. When zidovudine (AZT) began to be tested in studies with adults, many pediatric HIV physicians wanted to do clinical trials with HIV-infected children, including these babies, since nothing else was available to save their lives.

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

Was your (foster care/child welfare) office confronted with this situation, or if a similar proposal was brought before it, did it/might it permit these children to participate in the study? Please explain.

More regulatory or restrictive state States A and B, which were slightly more permissive of noninvasive research, prohibit medical or pharmaceutical experimentation and thus choose to bar this research. As this is far beyond what they consider “ordinary care and treatment” for pediatric populations, they are that much more cautious about enrolling children under their custody, who face their own host of vulnerabilities.

Less regulatory or restrictive state State C is also highly concerned by this hypothetical research and would require ample showing of cause or medical justification for the treatment methods contained within the protocol; that is, there must be some physician documentation that the testing is being conducted with all pediatric populations, not simply those in foster care, and that it is medically warranted and not purely an experiment without some data backing AZT’s use. Furthermore, the children’s prognoses must be sufficiently poor as to balance the risks of the research. Close monitoring by the host institution’s IRB is also expected. Consent will be required by each caseworker, who will act somewhat like an ombudsperson for his or her clients.

Overall Comments: Conducting Research in a State of Flux

Based on a query of noted researchers in the field, as well as a sampling of the opinions of regulators from select (larger) states, it seems that the more likely approach to the inclusion of wards of the state in research cannot be depicted as either black or white (i.e., as routinely permissive or routinely negative), but rather resembles shades of gray. That is, researchers likely face a continuum of permissibility, based on the county or local atmosphere, the population involved (including age), the risks inherent in the study, whether the study has a medically indicated or therapeutic” connection (e.g., treatment, say, with a new anti-HIV medication for youth is available only within the context of research protocol) or seems more purely research based or experimental, etc. As the research risks increase (e.g., in the AZT study described above), it is more likely that the research will be prohibited or at the very least subjected to much greater regulatory scrutiny and monitoring, whereas survey research and the like might be approached more favorably, with fewer restrictions. Children who are wards of the state (e.g., in juvenile detention facilities or psychiatric institutions) are more likely to be excluded from participation than children in physical custody of the state (e.g., foster care).

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×

The lack of black-and-white approaches is not necessarily a problem; in fact, it likely represents the best course given the need for individualization of studies to match individual or local community needs. Such flexibility is also in keeping with the federal government’s emphasis on local review, notably, through the IRB structure. However, this results in a situation of uncertainty for researchers, who are advised to build rapport with local regulators and routinely confer with these regulators—as well as ethics and legal counsel—to ensure that a proper balance is maintained between research needs and the protection of vulnerable children and adolescents.

Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 320
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 321
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 322
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 323
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 324
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 325
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 326
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 327
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 328
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 329
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 330
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 331
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 332
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 333
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 334
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 335
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 336
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 337
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 338
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 339
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 340
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 341
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 342
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 343
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 344
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 345
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 346
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 347
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 348
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 349
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 350
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 351
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 352
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 353
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 354
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 355
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 356
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 357
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 358
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 359
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 360
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 361
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 362
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 363
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 364
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 365
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 366
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 367
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 368
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 369
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 370
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 371
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 372
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 373
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 374
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 375
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 376
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 377
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 378
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 379
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 380
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 381
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 382
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 383
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 384
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 385
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 386
Suggested Citation:"Appendix B: State Regulation of Medical Research with Children Adolescents: An Overview and Analysis." Institute of Medicine. 2004. Ethical Conduct of Clinical Research Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/10958.
×
Page 387
Next: Appendix C: Health Care Privacy and Conflict-of-Interest Regulations Relevant to Protection of Human Participants in Research »
Ethical Conduct of Clinical Research Involving Children Get This Book
×
Buy Hardback | $68.00 Buy Ebook | $54.99
MyNAP members save 10% online.
Login or Register to save!
Download Free PDF

In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies.

Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.

  1. ×

    Welcome to OpenBook!

    You're looking at OpenBook, NAP.edu's online reading room since 1999. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.

    Do you want to take a quick tour of the OpenBook's features?

    No Thanks Take a Tour »
  2. ×

    Show this book's table of contents, where you can jump to any chapter by name.

    « Back Next »
  3. ×

    ...or use these buttons to go back to the previous chapter or skip to the next one.

    « Back Next »
  4. ×

    Jump up to the previous page or down to the next one. Also, you can type in a page number and press Enter to go directly to that page in the book.

    « Back Next »
  5. ×

    Switch between the Original Pages, where you can read the report as it appeared in print, and Text Pages for the web version, where you can highlight and search the text.

    « Back Next »
  6. ×

    To search the entire text of this book, type in your search term here and press Enter.

    « Back Next »
  7. ×

    Share a link to this book page on your preferred social network or via email.

    « Back Next »
  8. ×

    View our suggested citation for this chapter.

    « Back Next »
  9. ×

    Ready to take your reading offline? Click here to buy this book in print or download it as a free PDF, if available.

    « Back Next »
Stay Connected!