Proposed Revisions to the Common Rule for the Protection of Human Subjects in the Behavioral and Social Sciences (2014) / Chapter Skim
Currently Skimming:
4 Informed Consent
4 Informed Consent
Pages 89-108
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 89... ...
44,512-44,531) contains an extensive list of suggested changes to these requirements for informed consent, many of which respond to prior criticisms regarding the length, legibility, and content relevance of consent forms; the time institutional review boards (IRBs)
|
From page 90... ...
The 2003 National Research Council (NRC) report, Protecting Participants and Facilitating Social and Behavioral Sciences Research, provided an expansive review of issues in the informed consent process for IRBs reviewing social and behavioral research proposals and provided yet-to-be adopted guidance for helping IRBs and researchers apply the Common Rule provisions in the process of obtaining informed consent.
|
From page 91... ...
While the committee agrees that both aims are important, we believe that changes to the regulations and accompanying guidance should more explicitly target the flexibility afforded to IRBs, while still maintaining appropriate subject protections and accountability in the informed consent process. In developing flexible consent procedures fitted to the consent needs of the participant population, the U.S.
|
From page 92... ...
Flexibility in Timing of Approval of Informed Consent Processes Many IRBs require social and behavioral researchers to finalize their informed consent process before they start research, as is the norm with biomedical research. Before the research can commence, the IRB requires approval of an informed consent form.
|
From page 93... ...
Similar problems may arise in asking investigators and IRBs to actively demonstrate that waiver of specific elements of consent "will not adversely affect rights and welfare of the participant," as well as to document that the research could not "practicably" be done without the waiver, a word that is confusing and variously interpreted by IRBs (Secretary's Advisory Committee on Human Research Protections, 2011)
|
From page 94... ...
, the required element to discuss alternative procedures with a prospective participant is typically not applicable in nonclinical studies and should not be an element that needs active defense to remove it from the consent process or form. Fitting the consent disclosures to the specific research procedures, population, and context should not cause IRBs any hand wringing but rather should simply be one of an equally valid set of alternatives in the informed consent process.
|
From page 95... ...
For example, a survey study on cigarette smoking behaviors and attitudes involving a community sample of healthy and cognitively competent adults may only require a few sentences describing the purpose and nature of the study, confidentiality protections, and investigator contact information. If the study involves no or low risk, a superficial statement regarding research risks and benefits would not be required.
|
From page 96... ...
. One option would be to extend the oral plus brief written statement recommended by the Office for Human Research Protections (OHRP)
|
From page 97... ...
Recommendation 4.2: HHS should eliminate language in the regula tions suggesting that written informed consent disclosures and writ ten documentation that consent has been obtained are the preferred norm and include language permitting informed consent by nonwritten means when appropriate, without requiring action by the IRB to grant a waiver of documentation. Distinguishing Participant Risk from the Risk of Institutional Liability The ANPRM includes changes to the Common Rule intended to separate a research institution's concerns for limiting institutional liabilities unrelated to human-subjects research protections from informed consent
|
From page 98... ...
9-10) In support of this position, the committee makes the following recommendation in favor of removing institutional liability statements from informed consent forms and presenting them to prospective participants (or their guardians)
|
From page 99... ...
Description of potential research risks and ben efits should be limited to those that might reasonably occur and those risks that would cause substantive harm if they occurred. Waivers and Research Involving Adolescents Any proposed changes to the Common Rule sections on informed consent have particular relevance to research involving children and adolescents because Subpart D (Additional Protections for Children Involved as
|
From page 100... ...
Of particular concern for pediatric and developmental scientists conducting social and behavioral research are the significant barriers to the waiver of guardian permission that permeate IRB evaluations of requests for waiver of guardian permission for adolescent health research. For research involving no more than minimal risk, guardian permission can be waived under the current regulations (45 C.F.R.
|
From page 101... ...
Informed Consent to Research and Treatment Involving Adults with Impaired Decisional Capacity The ANRPM proposes that less oversight is needed when "competent adults" are asked to participate in research, with the exception of when "emotionally charged" research is being conducted. The committee is concerned that these terms have implications for the informed consent process and might lead to both underprotection and overprotection of subjects in terms of having a valid and respectful consent process.
|
From page 102... ...
. For these adults, the committee recommends that guidance be modeled on the American Psychological Association Ethics Code Standard 3.10b, which requires that psychologists obtain the appropriate permission from a legally authorized person and provide an appropriate explanation to the prospective client, patient, or research participant, consider that person's preferences and best interests, and seek the individual's assent (American Psychological Association, 2010; Fisher, 2013)
|
From page 103... ...
12; adapted by the committee as shown by editorial insertions) To act on these suggestions, which the committee supports, the revised Common Rule will need to clarify and emphasize that, when investigators' new research entails linking extant data to the collection of new data from human subjects, the need for informed consent applies only to the new data collection and linking to the archival dataset; the need for informed consent does not extend to access to the contact information of individuals who participated in the original study.
|
From page 104... ...
. Parents' perspec tives on the consent approach for minimal-risk research involving children.
|
From page 105... ...
. Preserving and enhancing the responsible conduct of research involving children and youth: A response to proposed changes in federal regula tions.
|
From page 106... ...
. National Human Research Protections Advisory Committee.
|
From page 107... ...
:396-409. Secretary's Advisory Committee on Human Research Protections.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.