Should Researchers Have More IRB Discretion?

A report issued this month by the American Association of University Professors concludes that academic researchers should have the authority to decide whether their proposed studies require review by an institutional review board (IRB).  examines the 1100 public responses that the U.S. Department of Health and Human Services received to its 2011 request for suggestions on improving the Common Rule, as the regulations governing research on human subjects are widely known. At present, the rule provides researchers no discretion in determining whether a federally funded project requires IRB approval, essentially mandating that all work on human subjects undergo ethical review.

The report proposes, however, that research that “(a) imposes no more than minimal risk of harm on its subjects, or (b) consists entirely in speech or writing, freely engaged in, between subject and researcher” should be “straightforwardly exempt” from IRB review.  Researchers would presumably judge for themselves whether a project is exempt under these guidelines.

The IRB system grew out of public reaction to the notorious U.S. Public Health Service’s Tuskegee Syphilis Study and other projects that seriously harmed unwitting subjects. Rather than vesting in a central authority the power to evaluate proposed projects, the government opted for local IRBs at each institution. These review boards consist of at least five members who theoretically are qualified to make those assessments.

Under the current setup, though, “horror stories abound” of demands for “inappropriate, indeed absurd, alterations in research protocols,” and rejections of surveys with questions that might embarrass or dismay “their (autonomous adult) subjects,” the report states. Life scientists have also objected to a system that they believe “inappropriately steers scarce resources toward the review of minimal risk research, produces inconsistent results from one IRB to the next, and imposes a heavy administrative burden,” it continues.  Problems often arise because committee members may “have no special competence in assessing research projects in the wide range of disciplines they are called on to assess … and whose judgments about whether to permit the research to be carried out at all are, in most institutions, final.”

But after “drawing attention to complaints about the system,” the report also notes that “many people report favorable experiences with it. Many researchers have thanked IRBs for helping them think through the moral issues raised by their work, and many present and former IRB members report that their IRB contributed substantially to developing the research projects they assessed and to protecting the research subjects.”  Nonetheless, the balance between the system’s risks and benefits is unclear, the report concludes, because no “comprehensive formal study” has ever weighed them.

Opportunity knocks: But which door should you open?

A Law (Not) Unto Itself