Ethical Overkill: Institutions should take a unified look at protections for research on human subjects

The most important resource needed to conduct research on humans, it is said, is not brainpower or money: it is trust. In the United States, as elsewhere, hundreds of institutions and thousands of investigators work to protect that trust by carefully evaluating proposals for clinical trials and other research that uses human subjects.

Each US institution hosting such a study typically conducts its own ethical review of the proposal. The review process serves many functions: it is an expression of the responsibility that these investigators feel towards protecting their local community, an opportunity to tweak protocols to adapt to the community’s specific needs, and a protection against potential lawsuits resulting from a flawed research protocol.

Sadly, evidence suggests that much of this effort is misplaced. A 2010 survey of 45 institutions reviewing the same protocol found that local scrutiny resulted in no substantial changes (B. Ravina et al. Ann. Neurol. 67, 258–260; 2010). Instead, most alterations simply inserted standardized institutional language — unrelated to the proposed study — to the informed-consent document signed by research participants before they...