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.