A Systematic Review: The Role of the Institutional Review Board in Managing Conflict of Interest
Ethical integrity in the conduct of healthcare research is essential for maintaining the public trust and support of such activities. Institutional Review Boards (IRB) play a critical role in maintaining the ethical integrity of research by reviewing research protocols to ensure safe and ethical treatment of participants, the provision of informed consent, and minimizing of conflicts of interest.
Investigators with the VA Evidence-based Synthesis Program at the West Los Angeles VA Medical Center conducted a review of the literature from January 1, 2000 to February 11, 2011, in order to describe the evidence regarding areas of interest in the ethical conduct of research. Specifically, the purpose of this review was to: catalog the literature on issues pertaining to IRBs; identify the issue with the greatest number of published studies -- conflict of interest policies -- which might inform VA policy; and assess the evidence regarding that issue. After reviewing more than 4,000 titles and abstracts, 116 references were determined to be appropriate for addressing the following key questions.
What has been published regarding the IRB and each of the following issues: 1) quality improvement initiatives as research, 2) conflict of interest (COI), 3) studies requiring approval of multiple IRBs, and 4) genetic issues?
- Accounting for 60% of identified articles, the two topic areas for which the largest number of studies have been published are: 1) the challenges of getting multiple IRB approvals for multi-site research studies, and 2) defining when quality improvement initiatives are considered research. VA has recently implemented national policies designed to reduce complexity and uncertainty for researchers in these two areas, while maintaining appropriate safeguards for patients.
- Of the remaining studies, the next most common topic of study was COI, which the ESP investigators designated as the focus of key question #2 for an in-depth review.
- A modest body of research has been devoted to studies of payments to providers or patients for participating in research; these studies indicate wide variability and little relationship between the time expected for participant involvement and the payment.
- Investigators also identified a modest number of published studies about the ethics of genetic studies, a surprising finding given the high degree of interest in the topic from both professional and lay audiences.
What has been published regarding Conflict of Interest?
- A modest number of published studies, almost all of them descriptive and some with substantial limitations (i.e., low survey response rates or restriction of the sample to a small number of sites), were identified.
- More studies have examined COI among research investigators than among IRB members reviewing proposed research. Nevertheless, the available evidence indicates potentially worrisome variation in practice across sites. Variation was identified in four domains:
- Who needs to disclose? Which members of the research project need to provide COI disclosures?
- This group could include principal investigator(s), co-investigators, research assistants, and other research staff.
- What needs to be disclosed?
- This information might include direct financial interests, indirect financial support such as support for travel to attend meetings, and non-financial COI.
- How distant a relationship may an individual have with an investigator and still be required to disclose COI?
- This group almost always includes a spouse, but also could include children, parents, siblings, or other extended family members.
- To whom does the information need to be disclosed?
- The target could be a specific official or committee of the IRB, or potentially the research participants.
Maintaining high ethical standards of conduct in research is a high prority for VA. It requires attention to activities of both investigators and IRBs -- and requires going beyond reacting to problems when they are identified. VA should aim that research conducted at all VA insitutions is held to the same high standard, much as it has done with clinical care over the past 15 years. To do so, authors of this review suggest that VA:
- Conduct a descriptive study of current COI practices for investigators and IRB members at all VA facilities;
- Use this information to determine which areas of current practices have unjustifiable levels of variation across sites;
- Convene stakeholders to determine best practices for these processes;
- Create VA-wide policy about these practices; and
- Monitor implementation across facilities.
VA strives to provide, and patients have come to expect, a high standard of clinical care at all VA facilities. Veterans should expect similar ethical standards of research across all VA facilities. Research-informed policy can ensure that COI disclosure be made as standard as clinical care, while allowing local flexibility when it is justified. After ensuring uniform disclosure practices, the next step will be to provide national VA guidelines on managing COI for individuals (investigators) and IRBs. While preservation of local autonomy is important for providing insitutions with the flexibility they need, some system-wide principles would be useful to help local sites inform COI management decisions.
Of note, since many VA insitutions that conduct research have university affiliates, a potential complicating factor is the lack of harmony between VA COI policies and that of university affliates.
This report is a product of VA/HSR&D's Quality Enhancement Research Initiative's (QUERI) Evidence-Based Synthesis Program (ESP), which was established to provide timely and accurate synthesis of targeted healthcare topics of particular importance to VA managers and policymakers -- and to disseminate these reports throughout VA.
Shekelle P, Ruelaz A, Miake-Lye I, Beroes J, and Newberry S. Maintaining Research Integrity: A Systematic Review of the Role of the Institutional Review Board in Managing Conflict of Interest, VA-ESP Project #05-226;2012.
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