Global implications of proposed revisions to the Common Rule

For decades, criticism have been directed at Institutional Review Boards (IRBs) and the federal regulations they apply for the protection of human participants in scientific research. The procedures are thought to be too cumbersome, too bureaucratic, and too inconsistently applied. Studies that are low-risk are treated almost on a part with those of higher risk by the regulatory system, and in this way attention can get distracted from the main event, i.e. research studies in which participants really could get harmed. The IRBs were seen to be either losing their mission (with procedures that did not seem to help protect research participants) or expanding their mission in illegitimate ways (examining research methodology, tracking down potential conflicts of interest, etc.). Some researchers, of course, mostly railed at IRBs for being too damned slow, and impeding the progress of their (brilliant, earth-shattering) research.

But some of the more serious criticisms must have hit the mark, because the US government's Office of Management and Budget convened a working group to brainstorm revisions to federal regulations ('Common Rule'), and the group drafted an Advance Notice of Proposed Rulemaking (ANPRM) for public comment. The ANPRM appears in dense type for 20 pages in the Federal Register, and contains a daunting 74 questions for comment. For those not yet ready to dive headlong into the regulatory depths, Emanuel and Menikoff have published a useful summary of highlights in the New England Journal of Medicine.

Personally, I was wondering what the impact the proposed new revisions would have on international research. Changing the US Common Rule is no purely domestic matter; much research covered by the US federal regulations takes place abroad, and its provisions influence the regulations of other countries -- in this way the Common Rule has tremendous global reach. On the face of it, the proposed revisions don't have much of an international flavor to them, but I have been reflecting on possible implications.

• Changes to annual review. The ANPRM floats the idea that there be no annual ethical review for studies involving minimal risk, unless an ethics reviewer can justify the need for continuing review. One would generally take it on faith that the research is proceeding as planned, with no modifications that could impact on the well-being of research participants. In my experiences in developing world settings, this is already happening in many cases: once a study is approved, it is approved pretty much forever. This is at least partly because continuing review requires infrastructure and monitoring (and file cabinets) that ethics committees in some settings just don't have. So some parts of the world are ahead of the curve on this one. What ANPRM might call streamlining, others might call poverty.

• The new category of 'excused' studies. The ANPRM proposes a new category of review: studies that are excused from being reviewed by IRBs. These are studies in which the risks are 'informational', i.e. the risks are mainly from leaked disclosure of information rather than research interventions. Again, research ethics committees in developing countries might be ahead of the game here. The majority of social and behavioral studies have mainly 'informational' risks, and in many resource-poor countries, such studies are not reviewed at all. The whole category of non-biomedical research has been 'excused.' So if the revision goes through, this will be a confirmation of what is already happening, or rather, what is not happening.

• Centralizing multi-site studies. Some studies have very many sites, and having the study reviewed by different IRBs at the different sites has often been a nightmarish experience. The ANPRM sensibly proposes that multi-site studies should have one IRB of record. What does this mean for international research? The ANPRM does not propose that a US IRB be the sole IRB of record when research is taking place at a foreign site. Local ethics committee review still makes sense '... because it might be difficult for an IRB in the US to adequately evaluate local conditions in a foreign country that could play an important role in the ethical evaluation of the study.' Why this could not also be true within a country as vast and diverse as the United States is not clear, but at least it means that past efforts to establish ethics committees abroad have not been in vain.

• Control of biospecimens. The ANPRM is basically proposing one-time, general and 'open' consent processes in which participants agree to all their samples to be used by researchers in the future (for as yet unknown purposes) without reconsenting them. Here one might have some pushback from developing countries: the ownership of samples is still very much up in the air, and when samples are collected in many developing countries, they tend to end up in refrigerators in Maryland.

There is much more to be thought about -- this is just a first stab of what this wind of change in research protections may be bringing about.