Privacy and Health Research. Consent, and Irb Review


The Federal Common Rule and other laws and regulations require many protections for human subjects of research. The main social instruments are informed consent of the data- subject, and Institutional Review Board (IRB) supervision. Both of these mechanisms have served society well. But both now need to be renewed.

For formal clinical trials and some other research, informed consent is routinely sought, Institutional Review Boards supervise the research, and other protections are enforced. But for many other kinds of research, for a variety of reasons notice is not routinely given nor explicit consent sought, and indeed these may be practically impossible to seek. The policy and pragmatic questions are obvious.

Retrospective studies, such as epidemiological reviews initiated years after the medical events, pose both special research opportunities and special ethical problems. So do secondary studies in databases. How should identifiability and consent be dealt with when such reviews are undertaken? And in general when data are collected, how broad consent should be sought for perhaps unanticipatable future studies?

There is no doubt that IRBs enhance research-subject protections and provide much public reassurance. They are an integral part of biomedical research. But it is less clear that IRBs have been attending as vigorously to privacy risks as they have to physical and emotional risks. For many IRBs the workload already is heavy. Now they may well have to be asked to become more deeply engaged with the privacy and confidentiality aspects of subject protection than they have been, in database research as well as in direct experimentation, and with genetic privacy. Whether they are able and willing to do so should be assessed.