Sir

Although I am sympathetic to the suggestion made in Scott Kim and colleagues' Commentary (Nature 457, 534–535; 2009) that we deregulate minimal-risk research by treating it as exempt from assessment by institutional review boards (IRBs), I do not believe that their proposal provides adequate protection for human subjects.

Most institutions require their researchers to submit a short application to the IRB requesting an exemption, but once an exemption is granted, the IRB need not ever see the research again (Center for Advanced Study Improving the System for Protecting Human Subjects: Counteracting IRB 'Mission Creep'; CAS, 2006). The problem with treating minimal-risk research as exempt is that such studies are not risk-free. Researchers and institutions need to ensure that risks are adequately addressed. An independent body such as the IRB can make useful suggestions for minimizing risks, protecting confidentiality and interacting with human subjects. It can also provide continuing review and supervision of research, which is valuable when unanticipated problems arise or a study changes course.

Although minimal-risk studies do not call for as much scrutiny as more risky ones, they still require some independent overview. Minimal-risk social-science research, for example, can involve questioning people about sensitive topics such as sexuality, domestic violence or illicit drug use. And in minimal-risk biomedical research, risks may be associated with protecting the confidentiality of genomic samples or data.

A wiser proposal, which has received some attention in the literature, would be to make better use of the expedited review option for minimal-risk research; indeed, the CAS study above notes that IRBs are not making adequate use of this option. In expedited review, the IRB chair or another designated person conducts the review. Studies that are approved are subjected to the same review criteria that are applied to studies reviewed by the full board, as well as receiving continuing review. Expedited review can reduce the administrative burden without compromising the rights or welfare of human subjects.