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11 Ethical and Policy Issues in Research on Elder Abuse and Neglect Rebecca Dresser* R esearch on elder abuse and neglect poses a mul- titude of challenges. Besides presenting methodological and practical diffi- culties, studying maltreatment of older people raises formidable ethical and policy problems. Two general features of the research account for these problems. First, the study population includes older persons with various mental, physical, and social vulnerabilities. Second, the research involves collecting information that could have negative legal, financial, and social consequences for the older persons and caregivers being studied. The ethical and policy analysis is further complicated by an absence of regulatory guidance and ethical consensus regarding the appropriate proce- dures to govern research involving persons who lack the ability to decide about research participation. A similar lack of guidance exists regarding the conduct of research in nursing homes and other residential facilities. Finally, current policy and ethics fail to resolve many questions about the appropriate approach to research seeking legally and socially sensitive in- formation. In this paper, I address ethical and policy issues raised by research on elder abuse and neglect. I use as a framework for ethical analysis the Belmont Report, a document that identifies ethical principles and guidelines *Rebecca Dresser, J.D., M.S., is the Daniel Noyes Kirby Professor of Law, Washington University School of Law, and Professor of Ethics in Medicine, Washington Univesity School of Medicine. 303
304 ELDER MISTREATMENT for research involving human participants1 (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979). I use as a framework for policy analysis the Federal Policy for the Protection of Human Subjects (U.S. Department of Health and Human Services, 1991), also known as the Common Rule. My analysis reviews general issues relevant to research on elder abuse and neglect. Because states vary in their approaches to regulating disclosures of private informa- tion, professional reporting duties, nursing home operations, and other relevant topics, issues raised by individual research projects must be sepa- rately evaluated by local institutional review boards (IRBs) and attorneys. The Belmont Report describes the characteristic features of research involving human participants and articulates three ethical principles that apply to such research. These principles are (1) respect for persons, (2) beneficence, and (3) justice. The principle of respect for persons underlies the requirement for informed consent to study participation. The principle of beneficence underlies the requirement to evaluate and balance risks and expected benefits in human studies. The principle of justice addresses fairness in selection of research participants. Provisions in the Common Rule incorporate these Belmont Report principles and requirements. Institutional review boards rely heavily on the Belmont Report and Common Rule when they evaluate research proposals. Thus, studies on elder abuse and neglect must take into account the concepts and consider- ations in these documents. Although the Department of Health and Hu- man Services has adopted additional regulations to cover certain popula- tions deemed especially vulnerable in research, it has no special regulations governing research involving older persons, persons with impaired decision making capacity, or residents of nursing homes and other institutions. Various individuals and groups have, however, made recommendations addressing ethical issues with particular relevance to these populations. In addition, the Common Rule contains a few provisions that specifi- cally bear on vulnerable populations in research. The Rule directs IRBs to âbe particularly cognizant of the special problems of research involving vulnerable populationsâ and to ensure that â[w]hen some or all of the subjects are likely to be vulnerable to coercion or undue influence, . . . additional safeguards have been included in the study to protect the rights and welfare of these subjectsâ (1991:28,016). The Common Rule advises IRBs that regularly review research involving a vulnerable subject popula- tion to consider including âone or more individuals who are knowledgeable about and experienced in working with these subjectsâ (1991:28,015). 1In this paper, I use both the newer term âresearch participantâ and the traditional term âresearch subjectâ to refer to persons from whom research data are collected.
ETHICAL AND POLICY ISSUES IN RESEARCH 305 In considering the issues raised by research involving elder abuse and neglect, one should keep in mind certain characteristics of U.S. policy gov- erning research involving human subjects. Ethical principles and federal regulations establish a general framework for analyzing research proposals. In the current system, local IRBs, as well as funding agencies, interpret and apply the general principles and regulations to specific studies. The over- sight system is based on the judgment that studies are sufficiently different and complex that it would be difficult (and probably futile) to set rules for every possible situation. Moreover, the current system reflects the governmentâs desire to avoid a centralized approach in which federal offi- cials are responsible for reviewing study proposals. Instead, the system is designed to allow staff at the local institution and people from the local community to decide how the general principles should apply to individual studies. One inevitable consequence of this system is variation in IRB decisions addressing matters not definitively resolved by the federal regula- tions. WHICH PROJECTS ARE GOVERNED BY RESEARCH ETHICS PRINCIPLES AND FEDERAL POLICY? An initial task is to determine which projects qualify as research and which research projects are covered by the Common Rule. Not all informa- tion gathering and interventions related to elder abuse and neglect involve research. Moreover, some research is exempt from federal oversight. The Belmont Report and the Common Rule address, but do not fully resolve, these classification issues. Distinguishing Research from Other Information Gathering Activities Underlying the research oversight system is the judgment that research presents particular ethical concerns. Past incidents illustrate that the rights and interests of participants may be compromised in research. As a result, individuals are owed certain special protections in research that may not be required in other data-collection contexts. The Common Rule and its underlying principles are intended to cover the process of producing gener- alizable knowledge, an activity that society labels desirable but not so important that people should be compelled to participate (Pritchard, 2000). A projectâs classification as research determines the nature of ethical and policy scrutiny it receives. Data collection can occur in numerous contexts, including patient care, social services, public health, and program evaluation contexts. These activities fall under the general heading of practice and are not covered by the research oversight system. At the same time, these activities may be
306 ELDER MISTREATMENT combined with research. When they are, they should undergo the same ethical and policy assessment as other research projects. The Belmont Report relies primarily on the different goals of research and practice to distinguish the two activities. Medical and behavioral clinicians gather information or perform interventions to advance the inter- ests of individual patients or clients. Researchers, on the other hand, collect data and perform interventions âto test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowl- edgeâ (National Commission for the Protection of Human Subjects of Bio- medical and Behavioral Research, 1979:3). Like the Belmont Report, the Common Ruleâs definition of research looks primarily to the intended aim of the activity. According to the Common Rule, â[r]esearch means a sys- tematic investigation, including research development, testing, and evalua- tion, designed to develop or contribute to generalized knowledgeâ (U.S. Department of Health and Human Services, 1991:28,013). The National Bioethics Advisory Commission (NBAC) recently called attention to flaws in the Common Rule definition. The NBAC observed that the definition omits the additional important point that research is done primarily to benefit society, while practice activities primarily aim to benefit patients, clients, or specific populations. In this respect, the NBAC noted, the Common Rule definition fails to recognize the possible conflict of interest that âalways exists between investigatorsâ desires to pursue knowledge and their obligation to protect the rights and welfare of research participantsâ (2001:35). Moreover, the NBAC noted that the Common Rule definition provides little assistance to those seeking to distinguish research from activities such as public health and quality improvement projects. As a result of these regulatory shortcomings, it can be difficult to determine when various data-gathering activities should be considered re- search. Three authors addressing this problem suggested that as a general rule, â[r]esearch projects are done to change the way the [health or social services] community thinks about a specific issue,â while â[n]onresearch investigations are done to give a specific group the information they need to make a specific decisionâ (Amdur et al., 2000). Consistent with this approach, the Centers for Disease Control and Prevention Guidelines for Defining Public Health Research and Public Health Non-Research (1999) provide as follows: The major difference between research and nonresearch lies in the prima- ry intent of the activity. The primary intent of research is to generate or contribute to generalizable knowledge. The primary intent of nonresearch in public health is to prevent or control disease or injury and improve health, or to improve a public health program or service. Knowledge may be gained in any public health endeavor designed to prevent disease or
ETHICAL AND POLICY ISSUES IN RESEARCH 307 injury or improve a program or service. In some cases, that knowledge may be generalizable, but the primary intention of the endeavor is to benefit clients participating in a public health program or a population by controlling a health problem in the population from which the informa- tion is gathered (1999). Similarly, a health care organizationâs quality improvement efforts typi- cally combine review of patient care data with a commitment to take cor- rective action if the findings warrant. When this commitment is absent, the organizationâs information gathering is conducted primarily to benefit oth- ers and ought to receive the ethical scrutiny appropriate to a research project (Bellin and Dubler, 2001). When public-health, quality-improvement, and other data-gathering projects have both research and practice objectives, they should be classi- fied as research. Although individual participants or populations may di- rectly benefit from their involvement in such projects, they also are sub- jected to such measures as structured interviews, intrusions on privacy, and potentially distressing questions to advance the aim of collecting gen- eralizable data. When the aim of collecting generalizable data exposes individuals to risks or burdens not present in standard practice, an activity should be evaluated in the research oversight system (Cassarett et al., 2000). Because participants in such activities fail to receive services tai- lored to their individual needs and interests, and because the dominant goal is to produce knowledge for the benefit of others, these activities present risks and inconveniences to participants that are not typically present in the practice setting. Determining Which Research Projects Are Subject to Federal Oversight Determining whether a project involves research is just the first step in evaluating the projectâs ethical and policy status. Not all activities that qualify as research are regulated by the federal government. The Common Rule explicitly applies only to research performed or funded by federal agencies that have adopted the Rule (U.S. Department of Health and Hu- man Services, 1991:28,012). One of the Ruleâs provisions seeks to extend this coverage, however, by requiring all institutions receiving federal re- search support to âprotect the rights and welfare of human subjects of research conducted at or sponsored by the institution, regardless of whether the research is subject to federal regulationâ (U.S. Department of Health and Human Services, 1991:28,014). In addition, some research conducted in the private sector is subject to explicit federal oversight. In separate regulations, the U.S. Food and Drug Administration (1999) requires manu- facturers seeking agency approval for their products to conform their stud-
308 ELDER MISTREATMENT ies to provisions similar to those in the Common Rule. Certain states also have laws regulating the conduct of human studies (Glantz, 1992). The Common Rule itself excludes certain research activities from its coverage. The Rule applies only to âresearch involving human subjectsâ (U.S. Department of Health and Human Services, 1991:28,012). Accord- ing to the Rule, âhuman subjectâ is âa living individual about whom an investigator . . . conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private informationâ (U.S. Department of Health and Human Services, 1991:28,013). Accord- ing to the Rule, information is private if it concerns âbehavior that occurs in a context in which an individual can reasonably expect that no observa- tion or recording is taking placeâ (U.S. Department of Health and Human Services, 1991:28,013). The Rule also classifies as private personal infor- mation that is collected for a particular purpose and that the individual reasonably believes will not be publicly disclosed, such as a medical record. When access to medical records or other private information would enable an investigator to readily determine the identity of a person, obtaining such information qualifies as research involving human subjects. The Common Ruleâs definition of research involving human subjects incorporates certain ethical judgments. First, if data are publicly available, researchers may use them without securing the permission of the individu- als being studied (U.S. Department of Health and Human Services, 1991:28,012). For example, elder abuse and neglect research that involves the examination of public records, such as court or police records, is ex- empt from the Common Rule provisions. Second, if the information is not publicly available, researchers may gain access without a personâs permis- sion as long as that person cannot be individually identified (U.S. Depart- ment of Health and Human Services, 1991:28,012).2 For example, elder abuse and neglect studies involving the examination of medical records lacking individual identifiers would be exempt from the Common Ruleâs coverage. Another provision of the Common Rule exempts from its cover- age surveys and interviews in which no identifying information is recorded (U.S. Department of Health and Human Services, 1991:28,012). In adopting these provisions, federal officials determined that a personâs privacy interests do not extend to certain kinds of information (King, 1995). The Common Rule makes investigators and IRBs responsible for deciding whether people have reasonable expectations that personal information is 2Also exempt is research âin established or commonly accepted educational settings involv- ing normal educational practices,â research evaluating or examining public benefit or service programs, and research on food quality (1991:28,012).
ETHICAL AND POLICY ISSUES IN RESEARCH 309 private and when access to private information would enable investigators to identify individuals. RESPECT FOR PERSONS IN RESEARCH ON ELDER ABUSE AND NEGLECT The Belmont Reportâs principle of respect for persons expresses the moral judgment that no one should be used in research purely as a means to benefit others. In essence, the principle gives protection of individual rights and welfare priority over any medical or social benefits research might generate. The Belmont Report describes two elements of the principle of respect for persons. The first element is that individuals capable of autonomous decision making should be permitted to make their own choices about whether to participate in research. To enable individuals to make autono- mous choices, investigators must disclose important facts about a study, ensure that prospective participants understand that information, and en- sure that decisions to enroll are not a response to undue pressures or incentives. The second element of the principle is that individuals with impaired decision making capacities should be protected from harm in the research process. This dimension of the principle is reflected in legal requirements preventing investigators from enrolling decisionally incapable individuals in research without the informed consent of a family member or other appropriate person. Adequate protection may also require investigators to exclude decisionally incapable individuals from certain risky or burden- some studies that are permissible when conducted with capable, consenting individuals. Standards and Procedures for Evaluating Decisional Capacity Central to applying the principle of respect for persons is the determi- nation of whether a prospective research participant can make autonomous decisions about study participation. Because capacity determinations have significant moral implications, evaluators must strive to avoid erroneous classifications. Treating a decisionally capable person as incapable leads to a demeaning and unjustified deprivation of that personâs right to decide whether research participation would be consistent with his or her particu- lar values and preferences. Treating a decisionally incapable person as capable exposes that person to exploitation to advance the interests of those who benefit from the research enterprise. In research on elder abuse and neglect, both types of errors can have serious consequences. Delegating research decision-making authority to
310 ELDER MISTREATMENT another individual can be especially problematic in this context, in light of the difficulties that may arise in selecting an appropriate research represen- tative. Moreover, research on abuse and neglect can expose vulnerable individuals to physical, psychological, social, and other risks that ought not be assumed by someone who is unable to comprehend them or is acting in response to perceived pressure from others. Although no single definition is enshrined in research ethics and policy, agreement exists on the basic features of decisional capacity. According to Paul Appelbaum and Thomas Grisso (1988), four abilities are relevant to decision-making capacity: (1) ability to communicate a choice, (2) ability to understand relevant information, (3) ability to appreciate how this infor- mation applies to oneâs current and future situation, and (4) ability to give comprehensible reasons for a decision. Similarly, a Hastings Center group considering capacity to decide about life-sustaining treatment declared that a âpatient has the capacity to make the treatment decision when he or she can understand the relevant information, reflect on it in accordance with his or her values, and communicate with caregiversâ (1987:23). The presence or absence of a dementia diagnosis fails to indicate whether someone has the necessary abilities to make choices about study participation. Similarly, although they may furnish preliminary guidance, simple mental status assessments are insufficient to determine whether some- one is able to make autonomous research decisions. Instead, investigators should evaluate decisional capacity in the context of the specific study being proposed. In the research setting, decision-making capacity should be assessed through a discussion of the facts relevant to the particular choice facing a prospective participant. At minimum, a prospective participant should demonstrate the ability to âunderstand the purpose, procedures, risks, ben- efits, and alternatives to participation in the study (including nonparticipa- tion), express a choice about participation; and understand that refusal to participate involves no penalty or loss of benefits to which the person should otherwise be entitledâ (Advisory Work Group on Human Subject Research, 1998:23). In this respect, assessing a personâs decision-making capacity goes hand in hand with assessing that personâs understanding of the important study information: The concepts of capacity and adequate information are intertwined. To be informed, a subject must be cognitively capable of understanding the relevant facts about the decision at hand. To determine whether a subject has the requisite cognitive capacity, the examiner must disclose these facts and then ascertain the subjectâs level of comprehension (Dresser, 1996:68). As the NBAC pointed out, âour society has not decided what degree of impairment counts as a lack of decision making capacityâ (1998:10). Many
ETHICAL AND POLICY ISSUES IN RESEARCH 311 groups support a sliding-scale approach to evaluating a personâs capacity to decide about research. According to this approach, capacity standards may be lower in research presenting comparatively low risk, while a higher level of decisional ability should be required for research that presents compara- tively high risks, particularly when the research fails to offer participants the prospect of direct benefit (NBAC, 1998:24). The assessment process itself can be conducted using a variety of meth- ods. The simplest method is to ask prospective participants to describe briefly and in their own words the basic study information noted above (Wendler and Prasad, 2001). Richard Bonnie has suggested as options âspecially tailored follow-up questions to assess subject understanding, vid- eotaping or audiotaping of consent interviews, second opinions, use of consent specialists, or concurrent consent by a family memberâ (1997:110). The device of concurrent consent is often adopted in dementia research when prospective participants have uncertain or fluctuating decisional ca- pacity (High et al., 1994). This will not always be an option in studies on elder abuse and neglect, but it could be feasible in some such studies. Another suggestion is to adopt a two-part consent process, in which rel- evant study information is presented and the prospective participant is then asked questions about the study. If the individual exhibits a lack of ad- equate comprehension, the information is presented again, and the indi- vidual is reexamined (Ratzan, 1985). Such a process can detect individuals with problematic memory or other incapacitating cognitive deficits. The capacity examination should enable researchers to ascertain when someone lacks the requisite abilities to make an autonomous choice about study participation. For people who appear to have adequate decision- making capacity, the next step is to ensure that they actually understand the significant information relevant to becoming a study participant. Informed Choices About Research People deciding to enter a study should understand certain facts. The Belmont Report lists the following general items essential for investigators to describe: âthe research procedure[s], their purposes, risks, and antici- pated benefits, alternative procedures (where therapy is involved), and a statement offering the subject the opportunity to ask questions and to withdraw at any time from the researchâ (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979:5). The Report describes the following risks, each of which is specifi- cally relevant to elder abuse and neglect research: âpsychological harm, physical harm, legal harm, social harm, and economic harmâ (National Commission for the Protection of Human Subjects of Biomedical and Be- havioral Research, 1979:7).
312 ELDER MISTREATMENT The Common Rule includes a more detailed list of the information that prospective participants should understand. Two items are particularly relevant to research on elder abuse and neglect. First, researchers must describe âthe extent, if any, to which confidentiality of records identifying the subject will be maintainedâ (U.S. Department of Health and Human Services, 1991:28,016). Second, if the research presents more than minimal risk, prospective subjects must be told whether compensation or treatment, or both, will be available if injury occurs (U.S. Department of Health and Human Services, 1991:28,016). Helping prospective participants to achieve adequate understanding is no small task. Surveys and interviews indicate that an appreciable number of people fail to understand important information about the studies in which they participate. A major problem is that participants often mistak- enly think that studies are done primarily for their individual benefit, rather than to advance knowledge (Kass and Sugarman, 1996). The challenges may be especially great in research on elder abuse and neglect, given the educational levels and health problems of many prospective participants. Researchers could also encounter difficulties in ensuring that participants understand when elder abuse and neglect studies offer them no direct per- sonal benefit. Besides the methods described previously in the discussion of capacity assessment, investigators may enhance participantsâ comprehension by us- ing graphics, videotapes, and other creative approaches to information disclosure (Sachs and Cassel, 1990). The NBAC suggested additional mea- sures to enhance prospective participantsâ understanding. These include the use of translators when investigators and participants speak different languages, seeking advice from representatives of study populations regard- ing the appropriate content and presentation of information to prospective participants, and focusing less on the consent form and more on ensuring an effective disclosure and decision-making process (2001:88, 100). Voluntary Choices About Research According to the Belmont Report, decisions to enroll in research are voluntary if they occur in the absence of coercion or undue influence. Coercion exists âwhen an overt threat of harm is intentionally presented by one person to another in order to obtain compliance.â Undue influence exists when there is âan offer of an excessive, unwarranted, inappropriate, or improper reward or other overture in order to obtain complianceâ (Na- tional Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979:6). A variety of factors may compromise the voluntariness of decisions to participate in elder abuse and neglect research. Older people who depend
ETHICAL AND POLICY ISSUES IN RESEARCH 313 on health and social services professionals for assistance may agree to participate out of a desire to preserve good relationships. Older people may fear they will lose needed services if they refuse to participate. Residents of nursing homes may be especially vulnerable to these pressures. Offers of monetary or other incentives for study participation may also be unduly tempting to economically disadvantaged people. The NBAC suggested ways to address some of these problems. This groupâs suggestions were to discuss possible research participation out of the presence of those to whom the prospective participant usually defers and to design studies so that staff in residential facilities are unaware which individuals are participating (2001:89). Others suggest that research dis- cussions with nursing home residents be conducted in private and that the residentsâ own physician and nurses not be involved in conducting the research (Sachs et al., 1993). If a physician is conducting research, the Helsinki Declaration urges particular caution and advises that in such a case, âthe informed consent should be obtained by a well-informed physi- cian who is not engaged in the investigation and who is completely indepen- dent of this relationshipâ (World Medical Association, 2000:3044). Procedures for Assessing the Quality of Research Decisions Investigators must adopt procedures for determining whether research choices are sufficiently capable, informed, and voluntary. At minimum, investigators should develop an assessment plan and the IRB should review that plan. Some individuals and advisory groups believe the assessment should be performed by a qualified professional not otherwise involved in the research. This proposal responds to the concern that researchers eager to enlist participants may be insufficiently demanding about the level of capacity, understanding, and voluntariness necessary to consent. Some groups say that IRBs should be authorized to decide when inde- pendent evaluations are needed in specific studies. The NBAC declared that when research proposals present greater than minimal risk, IRBs ordi- narily âshould require that an independent, qualified professional assess the potential subjectâs capacity to consentâ (1998:58). In such cases, the pro- posal âshould describe who will conduct the assessment and the nature of the assessmentâ (1998:58). Although the use of independent evaluators will add to the costs of a study, supporters contend that the costs are justified by the need to protect individual rights and welfare. This is particularly true, they say, when individuals are asked to join studies that will expose them to significant risk (Dresser, 2001a).
314 ELDER MISTREATMENT Decisionally Incapable Persons The screening process may identify individuals lacking decisional ca- pacity. According to the principle of respect for persons, individuals inca- pable of autonomous choice should be protected from harm in the research process. Conferring such protection may require excluding them from research altogether, or excluding them from studies that present relatively high risk, approaches that are discussed below. If decisionally incapable individuals are considered for research participation, special protective measures are warranted. The most common protective safeguards are (1) to designate as a research decision maker someone âlikely to understand the incompetent subjectâs situation and to act in that personâs best interestâ (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979), and (2) to require the decisionally inca- pable personâs assent or lack of objection to study participation. Selection of a Research Representative The Common Rule allows a decisionally incapable personâs âlegally authorized representativeâ to consent to that individualâs research partici- pation, as long as the representativeâs consent is adequately informed and voluntary. The Rule fails to specify who may assume the position of representative; instead, it refers generally to âan individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subjectâs participation in the procedure[s] in- volved in the researchâ (U.S. Department of Health and Human Services, 1991:28,013). State laws provide for the appointment of legal guardians to make personal and financial decisions for individuals a court has declared legally incompetent. Some states also have laws explicitly authorizing courts, guardians, or family members to act as research decision makers, but many states lack clear rules in this area (Hoffman and Schwartz, 1998). In states without clear rules, possible decision makers include a court-appointed guardian, an individual the currently incapable person previously chose as a research or health care decision maker (also known as a research or health care proxy decision maker), or a relative or close friend of the decisionally incapable person (also known as a surrogate decision maker).3 In practice, people from all three of these groups make research choices 3Although research advance directives and proxies are sometimes discussed as possible mechanisms for authorizing research involving decisionally incapable individuals, it seems highly unlikely that competent persons will complete directives that authorize participation in research on elder abuse and neglect.
ETHICAL AND POLICY ISSUES IN RESEARCH 315 for decisionally incapable individuals. Indeed, relatives acting as informal surrogates are probably the most common research decision makers for older people unable to make their own choices. Limiting research decision making to court-appointed guardians is generally seen as burdensome, expensive, and unnecessary to supply adequate protection. Because guard- ianship proceedings typically fail to examine a prospective guardianâs quali- fications to act as a research decision maker, such proceedings are an ineffective research safeguard. Moreover, court-appointed guardians may be strangers lacking knowledge of an incapable personâs current situation and former values and preferences. At the same time, the practice of relying on informal surrogates for research decision making raises its own concerns. The primary worry is that such surrogates may have personal interests that conflict with those of the prospective research subject (Dresser, 1996). Conflicts of interest are an obvious possibility in research on elder abuse and neglect, particularly when an abusive or neglectful relative acts as the surrogate decision maker for an older incapable participant. Investigators should make every effort to select research representatives genuinely concerned with the decisionally incapable individualâs welfare. One way to do this is to conduct screening and education of potential representatives, with the aim of detecting inappropriate decision makers and increasing the odds that those chosen will adequately protect research participantsâ interests. Another is to ensure that the incapable personâs research representative will not be the person asked to supply information relevant to abuse and neglect. The U.S. Department of Health and Human Services regulations on research involving children suggest a third possible response to the conflict of interest problem. The regulations provide as follows: if the IRB determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglect- ed or abused children), it may waive the [usual parental] consent require- ments . . . provided an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and . . . that the waiver is not inconsistent with federal, state, or local law (1999, Â§46.408(c)). The regulations also state that the âchoice of an appropriate mecha- nism would depend upon the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and their age, maturity, status, and conditionâ (1999, Â§46.408(c)). In discussing this research situation, the National Commission for the
316 ELDER MISTREATMENT Protection of Human Subjects of Biomedical and Behavioral Research sug- gested the following option: to appoint a social worker, pediatric nurse, or physician to act as surro- gate parent when the research is designed, for example, to study neglected or battered children. Such surrogate parents would be expected to partic- ipate not only in the process of soliciting the childrenâs cooperation but also in the conduct of the research, in order to provide reassurance for the subject and to intervene or support their desire to withdraw if participa- tion becomes too stressful (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1975:19). An analogous approach might be adopted in studies of elder abuse and neglect involving decisionally incapable adults. Major considerations would be whether it would be justifiable or practical to withhold information about the appointment of such a designated surrogate from a close family member suspected of abuse. As two authors addressing the child abuse research regulation noted, âremoving the parentâs decision-making author- ity will not assuage a childâs concerns about the consequences of disclosure, or prevent a parent from vigorously asking a child about what was dis- cussed in interviews . . .â (King and Churchill, 2000:722). Similar concerns could arise in research involving older adults with impaired decisional ca- pacity. Other important considerations would be the studyâs potential risks and direct benefits, variables that are addressed in the section on benefi- cence in research on elder abuse and neglect.4 Assent and Absence of Objection Decisionally incapable persons ought not be completely excluded from research decision making. According to the Belmont Report, the principle of respect for persons ârequires giving [such persons] the opportunity to choose to the extent they are able, whether or not to participate in re- 4It appears that the regulatory provision has rarely, if ever, been applied. My review of the literature failed to yield any discussion of the use of a surrogate parent or other alternative to parental or guardian consent in child abuse and neglect research. Moreover, neither an inquiry to the Department of Health and Human Services Office of Human Research Protec- tions nor a request to subscribers to the major IRB listserv produced any reports of studies in which these alternatives were adopted. One individual did report that his IRB had appointed an independent advocate for child research participants in foster care and other out-of-home placements, based on another provision of the pediatric research regulations that deals with children who are wards of the state or other institutions. The appointments had to be approved by the childâs legal guard- ian. He noted that they had encountered several problems in determining the appropriate role for the advocate, as well as how to cover the costs of this mechanism.
ETHICAL AND POLICY ISSUES IN RESEARCH 317 searchâ (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979:6). This requirement has two components. One is to supply information and help decisionally incapable persons understand as much as they can about the proposed study experi- ence. The other is to respect their verbal or physical opposition to partici- pation. The assent requirement is met when a decisionally incapable person verbally agrees to cooperate with study procedures. The lack of objection requirement is met when a decisionally incapable person fails to indicate verbal or physical opposition to study participation. Assent or lack of objection alone is insufficient to authorize an incapable personâs research participation; the informed and voluntary permission of the legally autho- rized representative is required as well. The presence of the decisionally incapable personâs assent or lack of objection is an additional precondition to proceeding with research. The demand for assent or lack of objection rests on the moral judgment that vulnerable incapable individuals ought not be forced to contribute to the generation of knowledge for the benefit of others. Instead, imposed interventions are warranted solely when they are absolutely necessary to protect the objecting individualâs personal welfare. These moral judgments account for the current view that assent or lack of objection are mandatory in nearly all studies seeking the involvement of decisionally incapable persons. The one possible exception arises when research offers participants a direct health or behavioral benefit unavailable outside the research context. The rationale is that in this situation, âthe decision is more akin to a treatment decision, and thus incompetent refusals may be overridden in some casesâ (Berg, 1996:24). Although some indi- viduals and groups support such an exception, others question its justifica- tion. As one group noted, âit is difficult to equate an intervention which is investigative in natureâwith an intervention âwhich would be ordered in a purely therapeutic contextââ (Keyserlingk et al., 1995:342). Compelling direct benefit would be necessary to justify including actively resisting inca- pable individuals in research on elder abuse and neglect. Exceptions to the Requirement for Informed Consent to Research The Belmont Report acknowledges that imposing the customary in- formed consent requirements could eliminate or seriously impede some research projects. The Report suggests that incomplete information disclo- sure could be acceptable under certain circumstances. This view is incorpo- rated in a Common Rule provision permitting exceptions to the general requirements for informed consent. An investigator seeking IRB approval to omit or alter information that must ordinarily be disclosed, or to waive
318 ELDER MISTREATMENT the informed consent requirement altogether, must establish that (1) par- ticipants will be exposed to no more than minimal risk, (2) waiving or altering informed consent âwill not adversely affect the rights and welfare of the subjects,â (3) the study would be impracticable if the information had to be disclosed, and (4) in appropriate cases, the withheld information will be disclosed at the end of the study (U.S. Department of Health and Human Services, 1991:28,016). According to the Belmont Report, withholding information is never justified simply to make it easier to enroll participants. Instead, withhold- ing should be permitted only if full disclosure would âdestroy or invalidate the researchâ (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979:6). This suggests that IRBs should be rigorous in demanding investigators show that their studies would be impracticable if the usual informed consent requirements were applied. An investigator proposing a study on elder abuse and neglect might seek to withhold information about the study, such as its purpose or risks, from prospective participants or research representatives. For example, an investigator might propose to omit from the consent discussion and form a statement that evidence of possible abuse or neglect will trigger a referral to the appropriate adult protective services agency. The investigator might argue that disclosure of this information would generate too many refusals to participate or distort the responses of those who agree to participate. Another example would be an investigator who sought to modify the study description so that prospective participants would be unaware that its focus was elder abuse or neglect. Withholding study information from prospective participants compro- mises their right to make informed research decisions. Thus, it should be done only for compelling reasons. One relevant IRB consideration in the above examples would be the degree of risk that the proposed study would create for participants. If study procedures would expose participants to more than minimal risk, the IRB ought not approve the information with- holding. (This topic is discussed in greater detail in the section on balancing harms and benefits in research, below.) The IRB would also need to evalu- ate the investigatorâs claim that full disclosure would make the research impracticable. Surprisingly, data from a study of parentsâ and teenagersâ preferences suggest that disclosure of reporting plans might actually be a positive factor in participant recruitment. OâSullivan and Fisher found that parents and adolescents would be more willing to enroll in studies on abuse and related behaviors if the investigator planned to notify the parents or help the child obtain independent assistance for any problems discovered in the course of the study (OâSullivan and Fisher, 1997). These data suggest that IRBs should require persuasive evidence that research will be unduly compro-
ETHICAL AND POLICY ISSUES IN RESEARCH 319 mised before granting requests to withhold information from prospective participants in elder abuse and neglect studies. Conclusion Choices to participate in research on elder abuse and neglect should be capable, informed, and voluntary. When someone is unable to make valid decisions to participate, researchers should obtain the capable, informed, and voluntary permission of a relative or other individual concerned with protecting the incapable personâs well-being. Researchers should also seek the willing cooperation of the decisionally incapable person. Departures from these rules require compelling justification, including a showing that research interventions will not expose participants to significant risk. BENEFICENCE IN RESEARCH ON ELDER ABUSE AND NEGLECT The Belmont Report describes two dimensions of the beneficence prin- ciple in research. One is to avoid harm to study participants, and the other is to maximize possible benefits and minimize possible harms. Risks to research participants cannot be completely avoided. Instead, those evaluat- ing the ethics of proposed studies must âdecide when it is justifiable to seek certain benefits despite the risks involved, and when the benefits should be forgone because of the risksâ (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979:4) Two Common Rule provisions incorporate the beneficence principle. The first provision directs researchers to minimize risks to participants through the use of procedures that are âconsistent with sound research design,â do not impose âunnecessary risks,â and, when possible, are âal- ready being performed on the subject for diagnostic or treatment purposesâ (1991:28,015). The second provision requires researchers to justify any unavoidable risks by discussing the benefits a study is expected to produce. According to the Common Rule, risks must be âreasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowl- edge that may reasonably be expected to resultâ (U.S. Department of Health and Human Services, 1991:28,015). To apply the beneficence principle in research, investigators and IRBs must first determine the risks and potential benefits presented by specific studies. The Belmont Report directs study reviewers to be systematic in evaluating potential harms and benefits: The method of ascertaining risks should be explicit, especially where there is no alternative to the use of such vague categories as small or slight risk. It should also be determined whether an investigatorâs estimates of the probability of harm or benefits are reasonable, as judged by known facts
320 ELDER MISTREATMENT or other available studies (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979:7). The material below describes types of harms and benefits possible in elder abuse and neglect research. Potential Benefits Offered by Research Research benefits are available primarily to two groups. First, people enrolled in elder abuse and neglect studies might receive personal benefits due to their study participation. Second, as noted earlier, research is con- ducted primarily to generate knowledge that could contribute to improved medical and social interventions for others. Benefits to research participants are generally classified as direct or indirect. Biomedical and behavioral studies may offer a variety of direct benefits to participants. As the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research noted, â[t]o be considered âdirect,â the possibility of benefit to the subject must be fairly immediate [and t]he expectation of success should be well-founded scien- tificallyâ (1978:13). Examples of research offering potential direct benefit are studies de- signed to enhance current biomedical or behavioral therapies or to create new training or educational materials (National Commission for the Pro- tection of Human Subjects of Biomedical and Behavioral Research, 1978:13). Direct benefits in research on elder abuse and neglect could be available in studies comparing different interventions to reduce the occur- rence of elder abuse and neglect or studies to determine the best methods of assistance to provide once maltreatment has occurred. To be considered direct, potential benefits should be provided by the intervention(s) under study. In contrast, indirect benefits may be received independently of the primary study interventions (King, 2000). Such ben- efits may include added contact with health or social services professionals, opportunities to engage in social activities outside of oneâs usual routine, and a sense of satisfaction in contributing to a valuable social endeavor. Indirect benefits can be difficult to predict due to variations in individual responses. For example, although some older people may value the above elements of the research experience, others may be distressed by having their routines disrupted or receiving additional attention from health or social services professionals. For this reason, although indirect benefits may âcountâ as possible benefits to study participants, they ought not be assigned the same significance as potential direct benefits when studies are discussed with prospective participants or reviewed by IRBs (Keyserlingk et al., 1995). The NBAC asserted that indirect benefits should be recognized,
ETHICAL AND POLICY ISSUES IN RESEARCH 321 but âshould not weigh in the judgment of IRBs regarding the balance of risks and potential benefits to the participantsâ (2001:74). A similar ap- proach should be taken regarding benefits studies offer to participantsâ relatives or other caregivers. It is generally agreed that items such as financial incentives and reim- bursement for transportation and other costs associated with research par- ticipation should not be considered benefits to participants. If payments were allowed to count as benefits, then a high payment could offset serious and otherwise unacceptable risks to participants (NBAC, 2001:74). The evaluation of a studyâs potential benefits should also consider its possible benefits to society. Evaluating possible societal benefits involves scrutinizing study design, personnel, and other factors affecting the quality of information collected. Because poorly designed or conducted studies will not yield valid and reliable data, they fail to offer benefits to others. Involving people in low-quality studies imposes burdens and risks on them without an adequate social justification. Thus, investigators must propose, and IRBs must demand, studies that meet the relevant scientific standards. When studies are not expected to undergo rigorous peer review as part of the funding process, investigators and IRBs have a responsibility to obtain such a review (Office of Protection from Research Risks, 1993:4â11). Another dimension of research benefit to others concerns the impor- tance of the research aim. This dimension of research value has received relatively little attention in research ethics analysis, but it deserves more serious consideration. In elder abuse and neglect studies, as in all human research, there must be a good reason for exposing research participants to inconveniences, burdens, and possible harms. Investigators should be able to show why the specific study problem is socially significant and how information gained from the study will help address the problem (NBAC, 2001:73). For example, studies proposing to test minor variations in exist- ing health or social service interventions might hold little prospect of mate- rial benefit to others.5 Potential Harms in Research As noted above, the Belmont Report lists the following as risks to research participants: âpsychological harm, physical harm, legal harm, so- cial harm, and economic harmâ (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979:7). More recently, the NBAC elaborated on these concepts. Included as physical 5An analogy would be clinical trials on so-called âme-tooâ drugs (Angell, 2000).
322 ELDER MISTREATMENT harms are âinjury, illness, pain, suffering, or discomfort.â Types of psycho- logical harm are ânegative perceptions of self, emotional suffering (e.g., anxiety or shame), or aberrations in thoughts or behavior.â The Commis- sion defined social harms as ânegative effects on oneâs interactions or rela- tionships with others.â Participants experience economic harm when they incur expenses as a direct or indirect result of research participation. Legal harms arise when research participation exposes people to actions such as âarrest, conviction, incarceration, or lawsuitsâ (NBAC, 2001:71â72). These categories of research risk could exist in studies of elder abuse and neglect. Older participants in such studies could suffer physical harm from family or professional caregivers due to the participantâs negative statements about these individuals. Older participants could also experi- ence anxiety or other emotional distress at being asked about a difficult living situation. Relationships with relatives could be damaged as a result of information provided to researchers. Older participants could incur financial costs if the research triggers removal of an unpaid family caregiver or another change in living situation. Information disclosures to research- ers could also lead to guardianship or other legal actions, which could be perceived as detrimental by older participants. Family and professional caregivers participating in elder abuse and neglect studies could face an array of research harms as well. Although they would be unlikely to experience physical harm as a result of research, shame and other psychological harm from being asked to discuss poten- tially problematic behavior could be a common risk in such studies. In addition, family relationships could suffer if research triggers questions about a caregiverâs conduct or abilities. Family caregivers could be de- prived of financial benefits if research leads to removal of relatives from an older personâs home. Professional caregivers could experience economic harm if their research participation leads to employment termination. Per- sons reported for abuse and neglect based on information elicited in re- search could also be subjected to legal harm. Of course, older persons and their caregivers face risks of this sort in their customary interactions with health care and social services personnel. In evaluating potential research harms, the emphasis should be on any additional risks that will arise due to the data gathering associated with a research project. If research participation will entail interviews, examina- tions, or other interventions that participants would not encounter in their usual contacts with health care and social services personnel, the risks accompanying these interventions are properly classified as research risks that should be minimized, justified, and, in many cases, disclosed to poten- tial participants.
ETHICAL AND POLICY ISSUES IN RESEARCH 323 Minimizing Risk in Research Minimizing physical and other research-related risks to participants in elder abuse and neglect studies can raise complex issues. The Common Rule directs researchers to minimize risks âby using procedures already being performed on the subjects for diagnostic or treatment purposesâ (U.S. Department of Health and Human Services, 1991:28,015). Investigators may also reduce risks by ensuring that (1) the research team is properly qualified and trained, (2) a system is in place to address harm arising in the research process, (3) confidentiality measures are appropriate, (4) partici- pants are adequately monitored during the study, and (5) individuals are excluded or withdrawn from studies presenting unacceptable risk (NBAC, 2001:73). Two general features of elder abuse and neglect research pose risks to participants. First, investigators often seek information that could produce harmful consequences if it were released to protective services or other authorities. A variety of methods allow investigators to obtain needed data while minimizing this risk. Sometimes data can be obtained from public records or other public sources. Sometimes data can be collected through the use of interviews or other procedures conducted in routine health care and social services activities; in such cases, data collection will not expose individuals to reporting risks beyond those they would encounter in clinical and social services settings. Sometimes data can be recorded without iden- tifying participants. Sometimes identifying information can be destroyed shortly after it is collected. Strict security measures can also be adopted, including identifying participants by code and severely restricting access to documents linking codes with individual participants (Office of Protection from Research Risks, 1993:3â33). The Common Rule permits IRBs to waive the usual requirement for a signed consent form if such forms would be the sole record tying an individual participant to research and a breach of confidentiality constitutes the principal study risk (U.S. Department of Health and Human Services, 1991:28,017). When investigators studying elder abuse and neglect seek information about a participantâs mental health, illegal conduct, drug or alcohol use, or other conduct with potential negative financial or employment conse- quences, they may obtain special confidentiality protections from federal officials. Federal law authorizes the Secretary of the Department of Health and Human Services to issue certificates of confidentiality to protect par- ticipantsâ privacy in both government and privately funded projects (Public Health Service Act Â§310(d), U.S. Code 42 Â§241(d), 1994). The certificates allow investigators to withhold âfrom all persons not connected with the conduct of such research the names or other identifying characteristics of such individuals.â Investigators with certificates âmay not be compelled in
324 ELDER MISTREATMENT any federal, state or local civil, criminal, administrative, legislative, or other proceedings to identifyâ research participants (Public Health Service Act, 1994). Certificates are granted only when officials deem them necessary to achieve the project aims. Certificates of confidentiality may prevent researchers from being forced by government authorities to disclose private information about partici- pants suspected to be victims or perpetrators of elder abuse and neglect. Yet some investigators and commentators question whether certificates legally exempt researchers from reporting requirements, and no definitive court ruling exists to resolve this question (Amaya-Jackson et al., 2000). Some federal agencies reportedly refuse funding for studies in which inves- tigators with confidentiality certificates plan to refrain from reporting child abuse and neglect (Runyan, 2000). Moreover, confidentiality certificates do not prohibit investigators from voluntarily disclosing information about suspected abuse and neglect. Thus, researchers must address the ethical issues that arise when withholding information could leave older persons in serious jeopardy. This point is related to the second risk-producing feature of elder abuse and neglect research. Older persons who participate and those whose relatives or professional caregivers participate may face physical and other serious risks. To minimize such risks to older persons, researchers should take measures to address suspected abuse and neglect. But such measures may cause harm to relatives or professional caregivers. Moreover, such measures may be opposed by older participants who prefer their risky situations to the available alternatives. Finally, social services interventions may do more harm than good for an older individual. As this discussion reveals, the ethical and policy directive to minimize risks can present difficult trade-offs in elder abuse and neglect research. Measures to minimize harm to older participants, such as reporting sus- pected abuse and neglect to authorities and the protective interventions that follow, can increase psychological, social, financial, and legal risks to rela- tives and caregivers. Similarly, measures to safeguard private information about families and caregivers can leave older persons vulnerable to harm. And measures to minimize certain kinds of harm to older persons may increase their exposure to other kinds of harm. The conflicts that may arise in attempts to protect older persons and caregivers from research harms are addressed in further detail in the section on confronting major ethical con- flicts. Balancing Potential Harms and Benefits in Research After investigators have reduced study risks as much as possible, some risks will almost always remain. The IRB must then determine that these remaining risks are justified by the benefits the study is expected to yield.
ETHICAL AND POLICY ISSUES IN RESEARCH 325 As noted above, the Common Rule requires that a studyâs risks are âreasonable in relation to anticipated benefits.â âReasonableâ is a term subject to varied interpretation. In directing IRBs to decide whether a proposed study presents a reasonable balance of risks and anticipated ben- efits, federal officials delegated to IRB members the authority to interpret what risks are reasonable. The Common Rule requires that IRBs include as members nonscientists and persons not affiliated with the research institu- tion (U.S. Department of Health and Human Services, 1991:28,015). By requiring such members, officials sought to ensure that reasonableness will be evaluated not just by researchers and their colleagues, but by persons who might have a different perspective on research harms and benefits. Reform proposals to increase the number of nonscientist and unaffiliated members are intended to increase the chance that a diversity of perspectives will be represented when research harms and benefits are balanced (NBAC, 2001:63). Besides requiring IRBs to decide whether research risks are reasonable, the Common Rule and the federal regulations addressing research involving vulnerable populations direct IRBs to determine when research risks are minimal. According to the Common Rule, study interventions present minimal risk if âthe probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or testsâ (U.S. Department of Health and Human Services, 1991:28,013â28,014). As observed in the section on respect for persons in research, the Com- mon Rule permits investigators to withhold certain information from pro- spective participants, or to forgo consent altogether, only if research inter- ventions present no more than minimal risk. In addition, the NBAC proposed that research interventions presenting greater than minimal risk and no prospect of direct benefit should be allowed only with an incapable individualâs prior competent consent or after review and approval by a special standing panel of diverse experts and community representatives convened by the Secretary of the Department of Health and Human Ser- vices (NBAC, 1998:54, 61). The above approaches require IRBs and other reviewers to apply the Common Ruleâs minimal risk definition. Not everyone is satisfied with the regulatory definition, however. Some argue that its reference to the risks of everyday life is problematic. These critics say that IRB members are unlikely to know enough about the nature, probability, and degree of ev- eryday risks to make comparisons with research risks (Kopelman, 1995). Furthermore, empirical studies have shown variations in the research inter- ventions clinicians and others classify as minimal risk (Dresser, 1999:22). Another problem is that the Common Ruleâs definition of minimal risk fails to clarify whether research risks should be compared to everyday risks
326 ELDER MISTREATMENT faced by people in the general population or by subjects individually. Fed- eral regulations issued in 1981 were accompanied by a preamble stating that âthe risks of harm ordinarily encountered in daily life means those risks encountered in the daily lives of the subjects of the researchâ (U.S. Department of Health and Human Services, 1981:8373). But this interpre- tation is contested by the NBAC (2001:83) and other advisory groups (National Human Research Protections Advisory Committee, 2001), which take the position that minimal risk should be tied to daily risks faced by members of the general population. If everyday risks were individualized, higher research risks could be labeled minimal risk for participants facing higher-than-average daily risks due to illness or poor living situations. As a result, less ethical scrutiny could be devoted to studies involving people already at relative disadvantage. For example, a waiver of informed con- sent might be obtained in a study presenting higher risk because it involved participants living in high-crime areas. And as the NBAC noted, the indi- vidualized standard for minimal risk âwould impose disproportionate bur- dens of research on the ill and provide weaker protections for them than for healthy individualsâ (2001:83). Such an approach would thus disregard the ethical principle of justice, discussed below. In applying the Common Ruleâs minimal risk and consent waiver pro- visions, the focus should be on whether research participation exposes older persons and caregivers to risks greater than those present in ordinary life and routine medical and social services encounters. For example, con- sider an interview study of family members caring for older individuals. If the study would expose participants to more detailed scrutiny than they would encounter in their usual interactions with the health care and social services systems, and if investigators planned to report suspected maltreat- ment to protective services authorities, the study would present more than minimal risk to study participants. The higher risk would exist because study participation would expose family members to reporting risks greater than those present in routine clinical and social services activities. If, how- ever, data would be collected in interviews conducted as part of the ordi- nary activities of a social services agency, and the agencyâs ordinary report- ing practices would be followed, the research risks would appear not to exceed the minimal risk threshold. In the first situation, the Common Rule would appear to rule out a consent waiver; in the second, the minimal risk requirement for a waiver would be satisfied. An appropriate balance of risks and expected benefits is central to the ethical conduct of research on elder abuse and neglect. Specific challenges in determining what constitutes such a balance are discussed below in the section on confronting major ethical conflicts.
ETHICAL AND POLICY ISSUES IN RESEARCH 327 JUSTICE IN RESEARCH ON ELDER ABUSE AND NEGLECT The Belmont Reportâs final ethical principle is justice. Justice in re- search involves the fair distribution of risks and benefits associated with research. The principle advises against relying too heavily on disadvan- taged individuals or groups to bear the burdens of acting as research par- ticipants. On the other hand, the justice principle holds that individuals and groups should receive a fair share of the benefits available through study participation and the improved health and social interventions re- search makes possible. The justice principle has several applications to research on elder abuse and neglect. One is that investigators observing the principle will not seek study participants solely from economically and socially disadvantaged populations simply because of âtheir easy availability, their compromised positions, or their manipulabilityâ (National Commission for the Protec- tion of Human Subjects of Biomedical and Behavioral Research, 1979:5). Similarly, vulnerable populations such as decisionally incapable adults should not be involved in research if adequate data can be obtained by studying adults able to make their own choices about participation. In- stead, there must be sound scientific and policy justifications for targeting disadvantaged or vulnerable populations in research. Three additional applications of the justice principle pertain to the distribution of benefits available through research on elder abuse and ne- glect. One such application is to give individuals and groups fair access to studies that offer potential direct benefit to participants. Thus, investiga- tors ought not exclude certain people from studies simply because it is more inconvenient or costly to recruit them (Institute of Medicine, 1994:82). Another application of the justice principle involves ensuring that the improved interventions publicly funded research makes possible are reason- ably available to research participants and to those in the general popula- tion who would benefit from them (National Commission for the Protec- tion of Human Subjects of Biomedical and Behavioral Research, 1979:5). Thus, when elder abuse and neglect studies yield health and social benefits, those benefits should be available to groups that participated in the studies and to others based on need rather than ability to pay. Finally, the failure to implement a robust research program to study elder abuse and neglect can be seen as unjust, because it denies vulnerable older persons and their families the benefits that could flow from such a program. A fair system of research funding will allocate funds to studies of serious public health needs, including elder abuse and neglect (Dresser, 2001b).
328 ELDER MISTREATMENT CONFRONTING THE MAJOR ETHICAL CONFLICTS IN RESEARCH ON ELDER ABUSE AND NEGLECT The societal importance of advancing knowledge and developing im- proved health and social programs addressing elder abuse and neglect is undeniable. At the same time, other important interests must be respected in the research process. Research ethics and policy recognize the interests of individuals (or their authorized representatives) in being informed about the studies they are asked to join. Research ethics and policy also deem important the protection of research participants from unnecessary and unreasonable risks. These ethical and policy considerations support certain restrictions on the conduct of research. Such restrictions reflect the judg- ment that advances in knowledge fail to justify compromising significant interests of the individual. In research on elder abuse and neglect, the most serious ethical conflicts involve societal interests in gaining knowledge about elder abuse and ne- glect, participantsâ interests in being informed of research risks, and the interests of both participants and nonparticipants in being protected from harm. Below, I discuss the major conflicts that can arise and offer guidance on how to resolve them. Conflicts Regarding Responses to Suspected Abuse and Neglect The first set of conflicts concerns researchersâ responses to suspected elder abuse and neglect. Here, a variety of interests may be at odds. Societal interests in advancing knowledge might be best served if research- ers take no action in response to suspected harmful conduct. Relatives, professional caregivers, and older persons who prefer their current living situations might be more likely to enroll and supply accurate information if the information will be used purely for research purposes. Though this approach promotes societal interests in generating high- quality research data, it gives little regard to older personsâ interests in protection from harm. From a broader perspective, the approach over- looks the societal interest in preventing elder abuse and neglect, an interest explicitly recognized in laws requiring reporting of suspected maltreatment. A researcherâs complete failure to respond to suspected abuse and ne- glect is questionable on both legal and ethical grounds. Although state reporting laws vary, some have language that could apply to researchers (Garfield, 1991). As noted above, a federal certificate of confidentiality does not necessarily exempt researchers from state reporting requirements. Apart from statutory reporting mandates, some writers suggest that courts could hold investigators legally responsible for acting to minimize harm they discover in the course of research. The basis of this duty would be the
ETHICAL AND POLICY ISSUES IN RESEARCH 329 decision in Tarasoff v Board of Regents of the University of California (529 P2d 334, 1976) and subsequent court decisions holding that professionals have duties to take reasonable measures to protect potential victims of their patientsâ or clientsâ violence. Paul Appelbaum and Alan Rosenbaum note that courts might deem certificates of confidentiality irrelevant to the inves- tigatorsâ duty to take some action on behalf of potential victims (1989). Besides their possible legal obligations, researchers may have ethical responsibilities to respond to suspected neglect and abuse. Appelbaum and Rosenbaum suggest that â[o]n ethical grounds alone, . . . it may be reason- able for investigators to consider building provisions for the protection of potential victims into their protocolsâ (1989:889). Investigators in a con- sortium of longitudinal studies of child abuse and neglect known as LONGSCAN, as well as those conducting the MacArthur Risk Assessment Study of community violence in former mental patients, recognized an ethical responsibility to prevent harm to both study participants and third parties, although their exact responses varied due to the specific study circumstances and different philosophies of study teams and their reviewing IRBs (Knight et al., 2000; Monahan et al., 1993).6 The ethical and legal duties to report suspected abuse and neglect are strongest when researchers conclude that an older person is at risk of serious, imminent harm. If an older person appears to be in imminent danger, a report to protective services workers may be justified even if the older person refuses assistance (Garfield, 1991:870). Similarly, when inves- tigators believe a decisionally impaired older adult is at risk of grave and immediate harm, they may have both legal and ethical responsibilities to report, despite a caregiverâs refusal of assistance. As the probability, mag- nitude, and imminence of harm decrease, however, so does the justification 6Celia Fisher proposed that the views of the population of prospective research partici- pants should be considered in formulating investigator responses to potential risky situations. In a study of high school students, Fisher and her colleagues elicited participantsâ opinions about what investigators should do if adolescents promised confidentiality in a study indi- cated they were in danger or engaged in high-risk conduct. Students were asked whether investigators should keep the information confidential, âtalk to you first and let you get help,â or notify a âparent or other concerned adult.â According to Fisher and her colleagues, their most important finding was âthat urban youth do not view the maintenance of confi- dentiality favorably in situations in which an investigator learns that a research participant is a victim of or engaged in behaviors adolescents perceive to be serious problems.â Fisher and her colleagues also believe their findings suggest adolescent research participants promised confidentiality still expect assistance if they disclose abuse or involvement in high-risk con- duct, including conduct presenting a serious risk to others (Fisher et al., 1996). Similar studies of older persons would indicate whether or not they hold beliefs resembling those of the adolescents Fisherâs team studied.
330 ELDER MISTREATMENT for reporting. In the absence of a clear and serious threat, investigators may adopt alternative responses to the living situations of older persons and their caregivers. One option is to furnish research participants with information on available community resources for individuals and families with various living difficulties. Investigators can also express any concerns they may have about a participantâs living situation and urge the at-risk individual to obtain help. In planning their studies, investigators can identify an appro- priate services agency and establish a referral process for participants ex- pressing a wish for assistance (Appelbaum and Rosenbaum, 1989:892). Investigators in the LONGSCAN studies adopted a variety of responses to participants in research on child abuse and neglect. In these studies, research team members are most likely to learn of possible maltreatment through interviews with 12-year-olds. Before their study participation, parents and children are told that children will be asked about abuse, neglect, or exposure to violence and that investigators will report children deemed to be at risk of serious harm. Children participate in a computer- administered interview that includes questions about various forms of abuse. A human interviewer is present but is unable to see the childâs answers. The children are told that they may skip questions and stop the session at any time. The LONGSCAN interviewers are trained to recognize and comfort children in distress, and interviewers may terminate the session when a child exhibits persistent distress. Interviews end with âa debriefing with each child that acknowledges that some of the questions may have been difficult, and all study participants are provided with a list of local family services agencies and how and why to contact these resourcesâ (Knight et al., 2000:769). In two LONGSCAN studies, interviewers consult clinical staff if children appear distressed. In another study, interviews are con- ducted in schools and distressed children are asked to identify a counselor or teacher with whom they can discuss their problems. Each LONGSCAN study has identified interview responses that could indicate abuse or neglect. Two LONGSCAN study teams report cases in which children give responses deemed to indicate they are at significant risk. Most interesting and controversial is the approach of two other LONGSCAN studies to a childâs indications of possible maltreatment. When a child responds in this way, the computer asks whether the child wishes to discuss possible abuse with the interviewer or another person. If the child answers no, the interview ends without further inquiry into the threat. The interviewer is unaware of the childâs responses, and the data are recorded in a manner that prevents other researchers from identifying the child (Kotch, 2000). Thus, the research team never obtains the information necessary to evaluate whether the situation should be reported. If the child
ETHICAL AND POLICY ISSUES IN RESEARCH 331 answers yes, the interviewer or an adult the child designates asks follow-up questions to determine whether reportable abuse has occurred. If it has, the child is told how and why a report will be made. If the problem does not appear to be reportable abuse, the child meets with an appropriate adult to discuss personal problems and receives information on local resources and how to obtain future assistance (Kotch, 2000). In commenting on this approach, ethicist N. King described its benefits and risks to children and their families. The approach protects children and families from the harm that could come from a more liberal reporting approach, including unjustified disruptions in home life and an inadequate or damaging social services intervention. At the same time, the two LONGSCAN studiesâ reporting model âprivileges research over interven- tion,â on the assumption that better data will produce better interventions in the future. Yet researchers may be biased in making this determination, she noted. Furthermore, King questioned whether 12-year-olds should be put in the position of deciding whether to discuss their situations with researchers. She asked, âis this a means for adolescents to adopt or respect the values and priorities within their families, or is it a way for LONGSCAN researchers to pass the buck to their adolescent subjects?â (1999:184). The above LONGSCAN approach could be adapted to elder abuse and neglect studies involving older adults with full or mildly compromised deci- sional abilities. Investigators could devise measures that enabled them to avoid learning about indications of possible abuse or neglect when study participants refused to discuss these matters. Investigators proposing such a strategy could face opposition from IRBs and others evaluating the ethics of the research, however. Related issues are presented when elder abuse and neglect research involves surveys or other methods in which participants remain anonymous or research team members are blinded to participantsâ responses. These approaches may be attractive because they allow investigators to guarantee confidentiality and avoid the need to devise measures to address suspected abuse and neglect. At the same time, such approaches have been challenged on ethical grounds. For example, the NBAC criticized the Common Ruleâs failure to cover anonymous surveys that ask sensitive questions (2001:37). Similarly, ethicists N. King and Larry Churchill raised the following ques- tions about the use of investigator blinding in interview studies of child abuse and neglect: âMight such a research design increase the risk of wrongs or harms to the child subjects who expect to develop some relationship with the researcher who asks such intimate questions? Will anonymity obviate researchersâ feelings of relationship with and obligations toward child sub- jects or just leave them with information on which they are powerless to act?â (2000:722). The beneficence principle would support offering assistance to partici-
332 ELDER MISTREATMENT pants in research incorporating participant anonymity or investigator blind- ing. At minimum, investigators could supply to all prospective participants information on available health and social services for families and older persons. Research findings on the risk and prevalence of elder abuse and neglect in particular areas could also be shared with local protective ser- vices agencies and government officials, with the aim of increasing aware- ness of and services for at-risk individuals. Moreover, researchers should consider whether ethical principles would in some cases support alterna- tives to anonymity and blinding, alternatives such as âa thorough, thought- ful, nondeceptive, informed consent process in an ongoing research rela- tionship, and a commitment to honor confidentiality unless grave harm appears imminent.â (King and Churchill, 2000:722). Conflicts Regarding Information Disclosure The second major conflict pits the interests of participants in being informed of research risks against societal interests in advancing knowl- edge. Sometimes withholding information from prospective participants would allow investigators to collect the most accurate data. Two such situations may arise. One occurs when investigators studying relatives or professional caregivers plan to report or take other actions if a research team member comes to suspect elder abuse or neglect. In this case, the concern is that prospective participants aware of the investigatorsâ plans will either refuse to enroll or if they do enroll, will provide inaccurate information. The other situation occurs when investigators are studying older persons. Here, the fear is that if investigators tell prospective partici- pants (or their representatives) about plans to address suspected abuse or neglect, individuals opposed to protective interventions will refuse to enroll or, if they do enroll, will provide inaccurate information. As indicated above, disclosure in both situations will often be required. The Common Rule permits exceptions to disclosure only when research presents no more than minimal risk to participants and when disclosure would make research impracticable. Underlying the narrowness of the exception is the ethical judgment that potential knowledge gains fail to justify depriving individuals of the freedom to refuse participation in re- search that exposes them to risks greater than those encountered in every- day life and routine health and social services practice (Beauchamp, 1996). Although failure to disclose reporting plans may be justified in clinical and social services programs designed to assist specific older persons, current policy deems such concealment unacceptable when data are collected for the purpose of advancing knowledge. Current policy also recognizes that an investigatorâs failure to disclose plans for addressing suspicions of neglect and abuse could have negative
ETHICAL AND POLICY ISSUES IN RESEARCH 333 long-term consequences for research, as well as the health care and social services systems. This is because research participants and community members who learn of the failure to disclose could lose trust in researchers, clinicians, and social workers (Bok, 1992). At the same time, it should be recognized that the current policy re- quirements for disclosure could have negative consequences. The price of disclosure is a possible loss of societal benefits. This loss could occur if the disclosure requirements limit researchersâ abilities to assess and understand the problem of elder abuse and neglect. Whether this occurs will depend in part on whether researchers are able to devise methods that avoid or com- pensate for possible underreporting and other problems related to the dis- closure requirements. The research ethics literature fails to address information disclosure in the specific context of research on elder abuse and neglect. This topic has been covered, however, in articles examining research on other forms of harmful behavior. Discussions of the ethics of research on child abuse and neglect generally support disclosure of investigatorsâ plans to address sus- pected misconduct. For example, psychologist Celia Fisher argues for dis- closure of all risks that could affect a childâs and parentâs willingness to enroll, including the possibility that suspected abuse will be reported (Fisher, 1999). In the LONGSCAN studies of child abuse and neglect, investigators and reviewing IRBs favored disclosure as well. In these studies, parents, as well as children aged eight and older, are told that investigators will take various measures in response to suspected maltreatment, including report- ing potentially serious harm to authorities. Parents also are given the option to review the questions their children will be asked. This represents a decision to give children and parents control over the information they provide, even though this may bias study results (Runyan, 1999). Study teams and IRBs in different LONGSCAN projects adopted different lan- guage to disclose reporting plans, however, with some disclosures more explicit than others. The language differences reflected differences in study responses to suspected abuse and neglect, which were discussed above. A similar approach was adopted in the MacArthur Risk Assessment study of risk factors for community violence in former mental patients. In study consent forms, prospective participants were told that confidentiality would be preserved unless researchers believed the lives of participants or third parties were in danger or child abuse was discovered (Monahan et al., 1993). Thus, individuals had the option to refuse participation or to modify their response to investigators based on their awareness that reporting was possible. In sum, if research participation will expose older persons or caregivers to risks greater than those present in ordinary encounters with health and
334 ELDER MISTREATMENT social services personnel, both research policy and ethics support disclosure of such risks. Balancing the goals of advancing knowledge, respecting informed decision making, and protecting research participants from harm will never be easy. The investigatorâs overriding ethical obligation is to detect and evaluate potential conflicts in the initial phase of study planning. The appropriate ways to address conflicts will vary depending on the spe- cific characteristics of the study. Often, there will be more than one ethi- cally defensible option. What is most important is to develop approaches that are supported by a reasonable ethical analysis. CONCLUSION: EXPANDING THE DELIBERATIONS The Belmont Report principles and Common Rule requirements supply guidance on the appropriate conduct of research on elder abuse and ne- glect. Yet these principles and regulations are by necessity somewhat gen- eral. Every human research proposal presents its own issues; thus, careful deliberation by research teams, IRBs, and funding agency officials will always be essential. These deliberations could be enriched by the views of people familiar with the actual situations of older persons, their families, and their caregivers. Since the Belmont Report and Common Rule were written, community consultation and representation have emerged as methods for making research more ethical. Indeed, the NBAC specifically advised that representatives of prospective research participants, including those from vulnerable populations, âshould be encouraged to participate in the study design and oversight processesâ (2001:91). By seeking information from members of the population of prospective research participants, investiga- tors may learn of better ways to balance competing interests in their studies. As Celia Fisher and her colleagues have shown, people affected by research may have unexpected beliefs and attitudes about researchersâ responsibili- ties to participants. Elder abuse and neglect research seems especially suited to this ap- proach. Several writers have endorsed the involvement of a panel of resi- dents and others who will be affected by research to review proposals to conduct research in nursing homes (Sachs et al., 1993). This concept could be extended to support other forms of community involvement in research on elder abuse and neglect. Members of the relevant communities could help investigators determine the facts that should be disclosed to prospec- tive research participants and create effective methods for conveying the information. They could help researchers discern the appropriate balance between protecting participantsâ privacy and preventing harm to vulnerable older persons. They could join researchers and social services workers in
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