"Preparing Successful Proposals for
Institutional Review Boards"
This article previously appeared in Psychological Science Agenda, 2000, Vol. 13, 2, 12-13, Science Directorate of the American Psychological Association.
By Celia B. Fisher, Ph.D.
Director, Fordham University Center for Ethics Education
Unparalleled growth in empirically based knowledge about psychological processes and mental health interventions has heightened public and institutional commitment to helping scientists carry out research that protects the rights and welfare of participants while advancing knowledge acquisition. The formidable task of insuring ethical competence in psychological research depends upon sensitive and informed planning by responsible scientists and careful review by federally mandated Institutional Review Boards (IRBs). However, the diversity of expertise and wide latitude in decision-making given to individual IRBs can be intimidating to research psychologists who must gain IRB approval before conducting their research. This column highlights ways in which ethically informed and detailed research protocols can make the IRB submission process less daunting and increase the probability of successful review.
Document the Scientific Validity of the Research
One common error in IRB submissions is omission of detailed theoretical and methodological rationales for the study. Failure to provide sufficient scientific background is based upon the erroneous assumption that IRBs are not responsible for evaluating scientific merit. What such a presumption fails to recognize is that IRB risk-benefit assessment is inextricably linked to the scientific value and validity of the study. Since a study that lacks methodological validity can not provide scientific or social benefits, a research protocol, which poses even slight probability of risk, is not worth approving if an IRB has no evidence that the design has scientific merit.
Justify the Selection of Intervention and Control Group Conditions
According to the Office for Protection from Research Risks, it is unethical to assign persons to either a treatment or control condition if one of those conditions is known to be inferior. IRBs thus expect investigators to provide evidence that extant research has (1) not yet confirmed that participants placed in a control group will be deprived of an intervention with empirically validated effectiveness; and that (2) individuals assigned to the experimental intervention will not be exposed to greater risk than if they had been assigned to the standard treatment condition.
Successful IRB proposals for treatment research will also include procedures for monitoring participant welfare during and following experimental trials as well as examples of informed consent protocols that adequately describe the experimental nature of the treatments, the role of the clinical researcher versus the treating clinician, procedures for condition assignment (e.g., randomization), and availability of other mental health services for those who decline participation.
Develop Adequate Consent Procedures for Adults with Questionable Capacity to Consent
At present, no specific federal regulations govern research with adults with permanent or transient cognitive impairments. To address this vacuum, NIH has developed an interim list of points to consider that can guide investigators in developing ethical procedures that will assist IRB review. For example, psychologists should show evidence that their consent procedures are sensitive to differing and fluctuating levels of capacity by using consent assessment methods tailored to the specific research context, that are timed to avoid periods of heightened vulnerability, and are ongoing during the course of research. Psychologists should also provide the IRB with legal, psychological, and ethical criteria for decisions regarding when a surrogate decision-maker should be sought and who that surrogate should be. If surrogate consent is justified, IRB proposals should include procedures to insure that participant assent will be obtained whenever possible and how decisions to withdraw from the study will be honored.
Provide Legal and Ethical Rationales when Requesting Waiver of Guardian Consent
As of October, 1998, it is the policy of NIH that children (individuals under the age of 21) must be included in all federally sponsored human subjects research, unless there are scientific and ethical reasons not to include them. The anticipated increase in the number of psychological investigations involving adolescents in research previously designed for adults raises questions regarding when guardian permission is or is not justified.
Exceptions to federal regulations requiring guardian permission for research with minors include adolescents who as legally recognized emancipated or mature minors, have assumed adult responsibilities such as self-support, marriage, or procreation, or who according to state law may be treated as an adult for certain purposes (e.g., treatment for venereal disease, drug abuse, emotional disorders). Guardian permission may also be waived when there is serious doubt as to whether the parents' interests adequately reflect the teenager's interests (e.g., research on child abuse or neglect, genetic testing of the healthy sibling of a child with a mental disorder) or when parental consent cannot reasonably be obtained (e.g., research on runaways). Requests to IRBs to waive guardian permission should thus include information about relevant state laws and detailed evidence on why guardian consent will not be in the adolescent's best interest or is unavailable.
Appointment of a participant advocate with no investment in the research project or role in subject recruitment is also recommended. To assist IRB review, psychologists should provide a detailed plan for how the advocate will verify the prospective participant's understanding of procedures, support his or her preferences regarding voluntary participation, and assess reactions to planned procedures.
Participant Perspectives: Sound Evidence for Ethical Practices
The success of an IRB proposal rests on its ability to convey sensitivity to the rights and welfare of research participants. Such sensitivity can be enhanced through careful consideration of the expectations, fears, and hopes that individuals bring to the research setting achieved through informal dialogue with participant representatives or through formal examination of prospective participant views. Pilot studies, a staple of good methodological design, when extended to preliminary exploration of participant reactions to planned ethical practices, can produce sound evidence for the selection of specific ethical practices and enhance the potential for positive IRB review.