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Reforming IRBs

March 6, 2013

A new report by the American Association of University Professors recommends curtailing the power of institutional review boards (IRB) and entrusting researchers with the ability to decide whether individual projects involving human subjects should be exempt from regulation.

“When one steps back from it, one can find oneself amazed that such an institution has developed on university campuses across the country,” the report concludes, criticizing the IRB system for leaving the fate of research projects up to “members [who] 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.”

The U.S. Department of Health and Human Services in 2011 called for input on how it regulates research on human subjects, also known as the Common Rule. The request generated over 1,100 responses. In its report, the AAUP compiled recurring trends seen in responses from researchers representing behavioral and social sciences, and history, oral history and folklore associations -- chosen because of the high number of complaints from researchers within those fields.

“[T]he fact that more than eleven hundred responses were submitted to the government’s [advance notice of proposed rulemaking] suggests there is a deep and widespread dissatisfaction with the current regulations,” the report says. “We express a hope that comparably deep rethinking of the current regulations will be undertaken in response to them.”

Apart from the common complaint that more types of research be exempt from an IRB review, the AAUP found researchers are worried the system imposes excessive and sometimes inappropriate reporting requirements. Many researchers also highlight the need for an appeals process for rejected research projects, while they are divided on regulations governing the confidentiality of data.

The AAUP traces most of the criticism aggregated in its report to a 1995 decision by the Department of Health and Human Services that recommended "investigators should not have the authority to make 
an independent determination that research involving human subjects is exempt" from IRB reviews. Prior to that decision, the AAUP writes “the IRB system provoked relatively few complaints of infringement of academic freedom.”

“The rules had fundamentally changed: the mistrust of researchers that is expressed in the 1995 recommendation, and enforced since then, is quite remarkable,” the report states. “We can think of no one single emendation in the current regulations that would contribute more to the improvement of the IRB system than a rescinding of that recommendation.”

The AAUP reiterates several of the points made in its 2006 report on the IRB system -- especially in support of recommendations that would give researchers more control of their projects.

Specifically, the AAUP would carve out an exemption for all research conducted solely by interviewing or surveying, as well as for research that imposes only a “minimal risk of harm on its subjects.”

“You do not need to get approval from an appropriately chosen Moral Review Board if you want to invite your neighbor to tell you about his or her voting preferences, or about the teaching of evolution, or about anything else, whether your aim is to do research or merely pass the time while waiting for the bus and whether, given that the conversation is public, your neighbor will have been caused a harm by it,” the report says.

The report uses a similar argument to address the confidentiality of research data. “[W]e can see no reason for believing that IRB members are any better equipped to assess practices for protecting research data in a discipline than members of the relevant discipline are,” the report says, although it also supports stricter demands for data protection imposed by individual institutions.

The AAUP also suggests the faculty grievance committee could be involved in an appeals process, since an IRB rejection could mean scrapping a project due to lack of federal funding.

Despite its criticisms, the AAUP stopped short of recommending the IRB system be eliminated completely.

“[W]e think it out of the question that the clock be turned back to a time when there was no regulation at all of research on human subjects,” the report says, adding, “In any case, it would be politically impossible to turn it back.”

 

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