Thursday, March 8, 2012
In a previous post, I argued that our current system of regulating innovative medical activities—under which the requirement of prior ethical oversight depends on whether what is being done falls within the regulatory definition of “research” with “human subjects”—can result in insufficient attention to ethical issues raised by activities that, although technically not “research,” rely on risky and unproven interventions.
Another consequence of the assumption that “research” necessarily requires greater oversight than other innovative activities is that it can lead to excessive attention to activities that do meet the definition of research but that do not raise the kind of ethical concerns that warrant IRB review.
An example is survey and interview research. Existing regulations recognize that most survey or interview studies do not warrant case-by-case case IRB oversight, and explicitly declare such research “exempt” from the requirement of IRB review if certain conditions are met. The problem, though, is that some institutions insist that only the IRB—not an individual researcher or academic department—has the right to determine when a survey or interview qualifies for the exemption. Thus, as long as an activity falls within the broad regulatory definition of “human subject research” the researcher is required to apply to the IRB for an official “exemption” determination, and cannot begin the research until someone from the IRB office confirms that the exemption criteria do in fact apply.
While the process of applying for an exemption is less onerous than having to seek IRB review and approval of a protocol, it can nonetheless impose burdens and delays. Moreover, if the premise behind the exemption is that certain types of low-risk research should be allowed to proceed without any IRB oversight, it seems contradictory to require researchers to apply to the IRB and wait until their “exemption applications” are approved.
Last summer’s Advance Notice of Proposed Rulemaking for Revisions to the Common Rule took a welcome step towards remedying this problem by proposing the replacement of existing “exemption” categories with a new category of “excused” research, which was defined to include all surveys and interviews with competent adults (a broader category than what is recognized under the existing exemption regulations, which generally apply only to studies in which identifiable information about participants will not be recorded). Under the ANPRM, researchers would be able to begin “excused” studies after filing a simple registration form, without the need to wait for an official sign-off from an IRB representative. As a condition of registration, researchers would have to affirm their compliance with minimum standards for data security and information protection.
I was therefore discouraged to learn last week, at a meeting of the Secretary’s Advisory Committee for Human Research Protections, that a “strong majority” of comments received on the ANPRM were resistant to the idea of letting researchers begin survey or interview projects based on their own assessment of whether their studies fell under the “excused review” criteria. Citing researchers’ lack of “objectivity” and “expertise,” these commentators suggested that, before beginning their studies, researchers should be required to submit an explanation of why they believe the excused designation is warranted, and then wait for an official go-ahead from an IRB official before the research begins. Such an approach would undermine one of the ANPRM’s main benefits, which is to make it possible for researchers to initiate survey and interview studies without having to ask the IRB first.
Federal regulators are now considering whether to incorporate the ANPRM’s proposed framework into future regulatory revisions.