Reform needed for research on human subjects

There is no greater burden of responsibility for scientists than that placed on those who conduct medical research on human subjects, according to an Editorial in Nature this week (448, 511-512; 2007). On the rare occasions that this duty is inappropriately discharged, the results can be devastating. Even so, once the initial outcry dies down, little tends to change.

The diverse collection of institutional review boards (IRBs) that oversee such research in the United States barely qualifies as a ‘system’. Despite repeated attempts by the Institute of Medicine and others to highlight their shortfalls, the quality and effectiveness of the boards remain patchy (see the News Feature on page 530 of the same issue of the journal).

To strengthen the way human clinical trials are overseen, adequate funding for the Office for Human Research Protections and more widespread accreditation of the IRBs (ensuring proper training and support for committee members) would be a start. But this is not enough, states the Editorial — real improvements in the IRB procedures are required. Some have suggested that the review of multicentre studies needs to be centralized, and certainly clearer ethical guidelines for local review boards could be provided (for example, on the question of payment for volunteers).

The Nature journals’ policy for authors concerning research on human subjects is available here. As ever, your comments and suggestions are welcome.

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