Wednesday, October 28, 2009

AAHRPP Policy on FWAs Remains Blurry

Back in July, I reported on the AAHRPP's ambiguous position on whether the institutions it accredits may "uncheck the box" on their federalwide assurances.

AAHRPP's new Final Revised Accreditation Standards fail to resolve this ambiguity. They require that an accredited organization apply "its HRPP [Human Research Protection Program] to all research regardless of funding source, type of research, or place of conduct of the research," but do not state not whether that HRPP must track federal regulations in all cases.

Interviewed for the October 2009 Report on Research Compliance, AAHRPP President Marjorie Speers had this to say:

We believe an organization must protect participants in all of the human research it conducts, whether or not it receives federal funding . . . As an accrediting organization, we don't have an opinion on whether or not an institution should 'check the box,' on their FWAs to OHRP. If an institution 'checks the box,' then we hold the institution to follow the regulations to all research to which 'the box' applies. If the boxes are unchecked, we hold the organization to have equivalent protections in place for all research.

This does little to clarify matters. What are "equivalent protections" to those specified in federal regulations? Were AAHRPP site visitors correct to tell the University of California "that in order for a human research protection program to be accredited, it must apply the Common Rule and its subparts to all human research at the institution, irrespective of funding"? Or can a university add new categories for exemption and expedited review, as advocated by Lisa Leiden, and consider those equivalent to the federal categories?

Unchecking the box is one of the leading proposed remedies for IRB overreach. It is a pity that AAHRPP has missed this opportunity to address this movement more directly.

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