To the Editor: Dr McWilliams and colleagues1 found that review of a protocol for a multicenter genetic epidemiology study by local institutional review boards (IRBs) was highly variable. They concluded that multiple-site IRB review is inconsistent and inefficient, and thus they recommended centralized review for such studies.
The data, however, also reveal considerable consistency between IRBs, judging by the 94% of sites that refused to waive written consent, and by the 77% that found the protocol "nonexpeditable." The data also suggest that there is variability in resources available to IRBs, as well as in standards that address the readability of consent documents. The latter factor appears to result in cycles of revisions and rebuttals, thereby lengthening time to approval.
The function of IRBs is to protect human participants through analysis of risks and benefits, and this seemed alive and well among the IRBs in the study of McWilliams et al. The "local" nature of research review in multicenter studies is required by federal regulations that charged IRBs of each participating entity in cooperative research to "safeguard the rights and welfare of human subjects."2
Is not diversity a desirable feature of the system? Is not a bit of inconvenience for researchers a healthy price to pay to keep applied ethics outside of supercommittees? Wouldn't a national panel of ethicists and scientists ruling on multicenter protocols be a form of ethics by decree? The assessment of risk is not quantitative science, hence a cross-sectional subjective opinion seems preferable. Local assessment should improve readability of consent forms by using members of the community from which the participants are drawn, as well as honoring prevailing local ethical views.
Centralization initiatives may appear convenient, but with time also may erode the system beyond recognition, leaving ethical decisions to parties with a 1-sided agenda, such as investigators, funding institutions, and university-based ethicists. Protocol reviews could be improved by education, ad hoc consultation, and funding but not by transferring decision power, which in turn may substitute dictum for debate. The rationale for community-based review is the same that empowered school boards to produce curricula and juries to award verdicts while complying with existing regulations. Perhaps it is less expeditious, less convenient, and more expensive, but it is a more genuine representation of foundational principles and an assurance to the reputation of the human research endeavor.
Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature
Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal
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