Myths

There are a lot of myths out there about IRB review. These myths are always being raised as fuel for the arguments of the IRB critics and, unfortunately, many IRBs succumb to these myths and provide "horror" stories for the critics. I'd like to debunk some of these myths in this posting.

The first is the myth that the ethical principles and the regulations require risk-free research. There is nothing in either that requires research to be risk free. What the regulations require are that 1) risks are minimized "by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk" [45CFR46.111(a)(1)] and 2) "Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result" [45 CFR 46.111(a)(2). The key concepts here are that research should not unnecessarily expose subjects to risk and that risks are reasonable in relation to benefits, including the benefit of acquiring knowledge. Subjects may be put at risk as long as there is sufficient benefit to justify the risk. I can't imagine any researcher who would put subjects at risk if there was no benefit to the knowledge being obtained or who would put subjects at more risk than is necessary to obtain the information that is needed.

The second myth is that the regulations require absolute confidentiality and, if possible, anonymity in research. Again, there is nothing in the ethical principles or the regulations that requires that. What the regulations say is "When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data" [45 CFR 46.111(a)(7). The key concepts here are "when appropriate" and "adequate provisions". Where confidentiality is not appropriate to the research, such as when the subjects want to be identified or the information is so innocuous that no reasonable person could care whether anyone knew what they said, then confidentiality is not required. In fact, the principle of Respect for Persons in the Belmont Report requires us to respect the wishes of the subjects with regard to confidentiality. On the other hand, the principle of informed consent requires us to make sure that the subjects understand what will happen to the information they provide and whether they will be identified.

Finally, there is the myth that signed, written consent forms are always required in research. Here, too, the regulations do not require consent forms in all research. The regulations, in 45 CFR 46.117(c), provide for a waiver of documentation of consent where the research is minimal risk and the research "...involves no procedures for which written consent is normally required outside of the research context." Interviews, survey, and questionnaires - the procedures most commonly used by social researchers - are done all of the time in the "real world" without signed consent forms, so, if they are minimal risk, they don't require signed consent forms in research. In fact, even if the research does not qualify for this waiver (e.g., more than minimal risk), the regulations provide for a "short form" procedure to document oral consent [45 CFR 46.116(b)(2).

So, IRBs that require risk-free procedures, absolute confidentiality or signed consent forms that invalidate the research are not complying with either the spirit or the letter of the regulations. Admittedly, IRBs are not as knowledgeable about how to use the flexibility in the regulations as they should be. Also, it is easier to apply strict, inflexible requirements than to consider how to apply the flexibility on a case-by-case basis. We need to continue and strengthen our efforts to educate IRBs on how to use the flexibility in the regulations.

Why not exempt social research?

One of the major propositions that the critics of IRB review of social research put forth is that minimal risk social research with competent adults should be completely exempt from IRB review. On the surface, this makes some sense. We're talking about research that is unlikely to harm anyone and where adults can decide for themselves whether to participate. Why do we need to review such research? Based on my experience personally reviewing thousands of research protocols in the social sciences, there is one basic problem with this - researchers are human beings. Human beings are not perfect - they overlook things, make mistakes and and can't be totally objective about their own work. If researchers were perfect, if they always took all of the ethical issues into account when planning and conducting their research, then we wouldn't need IRB review. But they are not perfect - none of us are perfect. So, every research activity needs an independent, objective review.

That being said, IRBs are not perfect either. IRBs are made up of human beings as well. In my experience, IRB members often become hyper-critical when they review other researchers' protocols. They tend to drift into the mind set of "what are we going to find wrong with this one." IRB members have to keep reminding themselves that the IRB is not like a funding agency scientific review panel, they are not there to critique the research, but to make sure that the research is being done ethically. In fact, I often say that the mission of the IRB is not to protect human subjects but to facilitate ethical research. Every time they review a protocol they should be thinking "how can we help this good research go forward, ethically."

If researchers would recognize the necessity and value of the IRB review and IRB members (and administrators) would recognize that their mission is to help the researchers do it right rather than catch them doing it wrong, then a lot of the tension between IRBs and researchers would go away.

Appeals

At a recent seminar held CUNY on IRBs and social/behavioral research, the question of an appeal process for IRB review was raised. This is an issue that has repeatedly been brought up as a criticism of the IRB process and I thought I’d address it.

First of all, the provision in the regulations that states, “…officials [of an institution] may not approve the research if it has not been approved by an IRB” [46.112] is there to minimize the influence of institutional conflicts of interest. If Dr. Smith, who has a multi-million dollar grant, complained to the President of the institution about an IRB decision and the President could overrule the IRB, then the protection of the subjects by the IRB process would be undermined. This decisional independence is essential for the IRB to fulfill its mission.That being said, IRBs are not autonomous entities unanswerable to anyone, as many critics claim. IRBs are agents of the institutions, which have the responsibility to ensure that the IRB process is not only in compliance with the regulations but also effective, efficient and appropriate to the research being reviewed. The FWA assigns that responsibility to the Institutional Official who signs the FWA.

So, while the institution cannot overrule negative decisions by the IRB, it can intervene if the process is inappropriate. This is similar to the US judicial system. The judicial appeal system does not rule on the outcome of trials, but on the process. You cannot appeal just because you disagree with the outcome of your trial, but you can appeal if you believe that you have been denied due process. Similarly, a researcher should not be able to appeal because he or she disagrees with the IRB’s decision. But, if he or she believes that the process was not fair, the decision was arbitrary or capricious, or did not have an appropriate ethical or regulatory basis, then the researcher has the right to appeal that to the Institutional Official. The IO should investigate the process and, if it is determined that the process was inappropriate, then the IRB should reconsider the decision.

In addition, the institution should oversee the IRB’s policies and procedures. The IRB should be responsible for explaining the basis for what it does and ensuring that its policies and procedures are appropriate for the research it reviews. How this is accomplished is up to the institution and depends on the culture and governance system at the institution. I strongly recommend that all institutions set up some sort of advisory committee for its HRPP. Again, this committee would not have any say over IRB decisions, but would have input on the IRB’s policies and procedures. The IRB should provide regular reports on its activities to this committee and the committee should review the HRPP policies and procedures. This would provide necessary transparency to the IRB review process and provide a voice for the concerns of the research community.

The perception that the IRB is not answerable to anyone undermines the research community’s trust in the IRB review process and could lead to an adversarial relationship between the IRB and the research community. Such an adversarial relationship puts subjects at risk because it increases the likelihood that researchers are not forthcoming to the IRB and that research is conducted without IRB approval.

Reinvigoration

OK, what's the point of having a blog if you don't keep it up. This is what I've been hearing from a number of people, including my wife. I plead guilty as charged and now pledge to post to this blog on a weekly basis. In fact, if anyone sees that I have missed a week, please send me an email and remind me.