Sunday, October 18, 2009

OHRP Grudgingly Okays Self-Exemption

In his May 14 speech, "The Legal Assault on the Common Rule," OHRP director Jerry Menikoff pledged that his office would issue new guidance on the Common Rule exemptions. While OHRP would still recommend that investigators not be empowered to decide for themselves whether their research is exempt, it would also emphasize that "it's just a recommendation. You don't have to follow it."

Five months later, OHRP has kept that promise, issuing a new document entitled FAQs: Exempt Research Determination. While the new guidance continues to recommend that "because of the potential for conflict of interest, investigators not be given the authority to make an independent determination," it makes clear that this is not a regulatory requirement. It even goes further, offering a somewhat detailed scenario that would satisfy regulatory requirements:

For example, an institution might craft a checklist for certain exemption categories, with questions that are easily answered "yes" or "no" by an investigator, with certain answers leading to a clear conclusion that the study is exempt. The institution might allow a researcher to immediately begin a study after having completed such a checklist and filed it, together with accompanying documents, with an appropriate institutional office, without waiting for or requiring any prior review of that filing. Similarly, a web-based form might be created that served the same purpose, allowing the researcher to begin the research immediately after submitting the required information using the web form. In both instances, the key issue would be whether these procedures lead to correct determinations that studies are exempt.

While this is certainly a step in the right direction, it leaves unanswered the question of why OHRP still deprecates such a system of "independent determination." In particular, the new guidance claims that "an institutional policy that allowed investigators to make their own exemption determinations, without additional protections, would likely risk inaccurate determinations." What is the basis of this claim? Has anyone done a study showing that investigators make poor determinations? What does it even mean to make an inaccurate determination, when federal officials themselves appear unable to apply the exemptions to hypothetical projects?

The truth is that OPRR's 1995 guidance was less a response to any misapplication of the exemptions than part of a larger effort to look busy amid national concern about human radiation experiments conducted decades before OPRR's creation. Rather than reconsidering its panicked advice from that period, OHRP has merely acknowledged that its recommendation has no basis in the regulations.

Note: As of this posting (18 October 2009), the bottom of the page with the new guidance reads "Last revised: April 20, 2009." An OHRP representative tells me this is an error, and that the new guidance was in fact posted on 14 October 2009.

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