Institutional Review Board (IRB) Shopping- Accessible for Public Comment
1Professor, Department of Mental Health Nursing, Dhanvantri College of Nursing, Pallakkapalayam, Namakkal.
2Assistant Professor, Department of Obstetrics and Gynecological Nursing, Dhanvantri College of Nursing, Pallakkapalayam, Namakkal.
*Corresponding Author E-mail: sampoornamwebster@yahoo.in
Context: IRB Forum Shopping is an under-researched yet highly-relevant ethical issue in the context of clinical research. IRB members review the proposed research methods to ensure the ethical principles. The IRB has the authority to approve or disapprove the research proposals that fall within the institutional policy and adheres to SOP (Standard Operating Procedures). When the research project has obtained an unfavorable or conditional IRB review, the researcher bypass the process of addressing the IRB’s decision by deserting the IRB and selecting another forum that will provide favorable review. Currently, proposed regulations to prohibit IRB shopping are available for public comment. The FDA report made clear that no empirical evidence exists to support the widespread of IRB shopping.
KEYWORDS: IRB Shopping, Expedited review, FDA report.
Institutional Review Board (IRB) protects the rights of human research subjects, recruited to participate in research activities conducted under the affiliated institution. Institutional Review Board (IRB) is also known as Independent Ethics Committee (IEC) or Ethical Review Board (ERB) or Research Ethics Board (REB). The purpose of IRB review is to assure periodic review and to protect the rights and welfare of the human subjects. To attain the purpose, IRBs adopts group process to review research protocols and related materials i.e. informed consent documents and investigator brochures to ensure protection of the rights and welfare of human subjects for research.
The IRB shall have at least five members, for complete and adequate review of human research projects. The Board includes one member who is not affiliated with the institution and one non scientist member. The IRB has several consultants who advise the Board and are periodically involved in protocol review.
Expedited review is a procedure in which certain kinds of research are reviewed and approved without conducting IRB meeting. The IRB may use the expedited review procedure to review minor changes in previously approved research, in course of the original approval. Under expedited review procedure, review of research may be carried out by the IRB chairperson or by one experienced member of the IRB, authorized by the chairperson. The reviewer may exercise all the authorities of the IRB, except disapproval. Research may be disapproved only by the review of full committee. The IRB is required to adopt a method of keeping all members advised of research studies that have been approved by expedited review.
Those who are in favor of such rules believe that IRB shopping is common. Those who do not support the proposed rule, point out the lack of data that IRB shopping is certainly a problem. In the absence of substantive evidence that current safeguards are inadequate, individuals believe that no new rulemaking is necessary with regard to disclosure of prior IRB decisions.
There is a potential and real problem of IRB shopping with the distinct benefit that sponsors can conduct clinical trials without modification. However, prohibiting IRB shopping alone will not resolve the current problems involving the clinical trials industry that lead to conducting trials (Barbara G and Timothy D, 2002).
Already, few research programs and IRBs have been focusing on streamlining their human-subjects research programs in an attempt to respond to investigator’s concerns, in order to provide greater flexibility and streamlining of the review process (Bechert, 2011, Cola et al., 2013 and IRB Advisor, 2013).
The FDA is looking at the issue of IRB shopping because of the report issued by the Office of the Inspector General in 1998, which cited the anecdotal evidence. The existing practice could result in a circumvention of the guidelines established to protect the human subjects. Concerned about such possibility, the FDA decided to take a closer look at the issue with an eye toward establishing regulatory guidelines if necessary.
Some investigators engage in the practice of IRB shopping a term used to describe submitting a research proposal disapproved by one IRB to a second IRB to see if the outcome is more favorable. In response to this problem, the FDA has requested comments on a proposed rule that would require investigators to disclose to IRBs whether their protocol has previously been reviewed by an IRB at different institutions. While adopting such a rule might diminish IRB shopping, it would not change the underlying variation in IRBs’ standards that led to the problem of IRB shopping in the first place (David G. Foster, 2002).
Surveys of clinical researchers indicate common deception ranging from omitting information to outright lying, and controversy surrounding the FDA's decision not to ban "IRB shopping" (the practice of submitting protocols to multiple IRBs until one is found that will approve the protocol) has raised legitimate concerns about the integrity of the IRB process (Ryan Spellecy and Thomas May, 2012).
The major milestone in the history of Ethical Committee (ECs) in India was the requirement of registration with Central Drugs Standard Control Organization (CDSCO). Maharashtra has the highest number of ECs registered (259/1083, 23.9%), followed by Gujarat (125/1083, 11.5%) and Karnataka and Tamil Nadu (112/841, 10.3%). The Indian Council of Medical Research (ICMR) has published detailed guidelines on the composition and responsibilities of IRBs for biomedical research on human subjects. Establishment of Ethical Committee consortia or state level Ethical Committee to address multicenter studies and minimize “EC shopping” were other suggestions (Kadam R and Karandikar S, 2012).
CONCLUSION:
IRB Shopping is essentially the practice of choosing an IRB, based on the relative ease of the review and the perception that the review will result in favorable decision (approval). Most researchers are probably not aware of how prejudicial this practice is to rights and wellbeing of their research participants and the integrity of the research as a whole.
1. Barbara G and Timothy D, 2002. What About the Role of the US Food and Drug Administration? Communications to the Editor. Volume 122, Issue 5, P1869-1870.
2. Bechert, T, 2011. Streamlining the IRB process: Avoiding unnecessary deliberation and effort. Journal of Clinical Research Best Practices. 7(6):1-9.
3. Cola, P.A., Reider, C., and Strasser, J.E, 2013. Ohio CTSAs implement a reliant IRB model for investigator-initiated multicenter clinical trials. Clinical and Translational Science. 6(3):176-178.
4. IRB Advisor, 2013. Experts: Saving time while improving review quality is top priority. IRB Advisor, 13(8):85-88.
5. Ryan Spellecy and Thomas May, 2012. More than cheating: deception, IRB shopping, and the normative legitimacy of IRBs. J Law Med Ethics. 40(4):990-6.
6. D.R. Waring and T. Lemmens, 2006. Law and Ethics in Biomedical Research: Regulation, Conflict of Interest and Liability. University of Toronto Press, p. 149
7. David G. Foster, 2002. Independent Institutional Review Boards, 32 Seton Hall L. Rev. 513, 521
8. Kadam R, Karandikar S, 2012. Ethics committees in India: Facing the challenges! Perspect Clin Res. 3:50–6.
Received on 12.04.2021 Modified on 21.06.2021
Accepted on 10.07.2021 © AandV Publications all right reserved
Int. J. Nur. Edu. and Research. 2021; 9(4):473-474.
DOI: 10.52711/2454-2660.2021.00109