How Much Oversight Is Necessary to Protect Human Subjects?

To the Editor: In his discussion of the institutional review board (IRB) process, Mr Annas¹ suggests that consent forms initially intended to protect human research subjects have been transformed into a tool to protect researchers and institutions. To the extent that this transformation has occurred, the explanation may be straightforward. Many research projects entail so little risk to patients that the only measurable risk is that posed by the legal system or regulatory agencies to an institution or researcher accused of violating process. Although the tort system may eventually address its problem with so-called junk science,² the IRB system currently seems to be enamored with process, which for some research largely represents "junk regulation." Even for research where the risk of harm to any patient is less than that of daily activities such as discarding old tax returns or driving to the store, the IRB system soldiers on as if it were preventing atrocities.