Publication Date

February 1, 2006

One cause of the current crisis with IRBs is what is called "mission creep" in a new white paper originating from a conference at the University of Illinois. IRBs experiencing mission creep misdirect their energies and other resources to low-risk research and often unnecessarily reject proposals, thus threatening academic freedom and diverting resources away from truly risky research that needs oversight. Researchers and IRB professionals are beginning to recognize the negative consequences of mission creep. The Health and Human Services Secretary’s Advisory Committee on Human Research Protections (SACHRP) has appointed a committee to begin to investigate the situation and make recommendations.

An invitational conference at the University of Illinois on Human Subject Protection Regulations and Research Outside the Biomedical Sphere, analyzed much of this dialogue. A white paper emanating from this conference (and available at examines the problem and proposes some solutions, many of which can be implemented at the local IRB level within existing regulations.

The white paper suggests first collecting data to get concrete information about the scope of the problem; reclassifying the proposals submitted to IRBs according to degree of risk, so not all projects have to be reviewed with the same degree of scrutiny; and finally suggests that some methodologies are not well served by being in the IRB purview. The white paper makes it clear that the time has come to clarify the scope and purpose of IRB review and that researchers and human subjects alike need IRBs to become more effective through being more selective.

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