The purpose of an institutional review board (often abbreviated IRB) is not to decide whether a proposed study will produce valuable information or whether it is statistically sound. The board’s purpose is, in the words of one university’s board, “to protect the rights and welfare of human subjects (including patients) recruited to participate in research activities.” The board reviews the plan of the study and can require changes. It reviews the consent form to ensure that subjects are informed about the nature of the study and about any potential risks. Once research begins, the board monitors its progress at least once a year.

The most pressing issue concerning institutional review boards is whether their workload has become so large that their effectiveness in protecting subjects drops. When the government temporarily stopped human-subject research at Duke University Medical Center in 1999 due to inadequate protection of subjects, more than 2000 studies at Duke were in progress. That’s a lot of review work. There are shorter review procedures for projects that involve only minimal risks to subjects, such as most sample surveys. When a board is overloaded, there is a temptation to put more proposals in the minimal-risk category to speed the work.