Saturday, October 31, 2009

AAHRPP Retreats from "Objective Data"

In July I posted my comments on AAHRPP's Proposed Revised Standards. At the time, I applauded Element I.5.B for insisting that "based on objective data, the Organization identifies strengths and weaknesses of the Human Research Protection Program, makes improvements, when necessary, and monitors the effectiveness of the improvements."

How disappointing, then, to find that the Final Revised Accreditation Standards omit the phrase about objective data. Are we to infer that AAHRPP considers objective data too difficult a standard, and wants institutions to base their programs on subjective impressions? Of course, most of the IRB regime is based on such guesswork, but I had thought that AAHRPP seeks to raise the level of IRB review.

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.

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.

Friday, October 9, 2009

Oral History Association Considers Guideline Revisions

At its annual meeting next week, members of the Oral History Association will vote on a set of General Principles for Oral History and Best Practices for Oral History.

The most striking feature of the new guidelines is that they avoid the confusing format of the existing Evaluation Guidelines, which pose dozens of questions without offering the proper answers or explaining whether answers might vary by project. Instead, the new guidelines present clear, declarative statements about how best to conduct oral history.

A more substantive change concerns harm. The existing guidelines state that "interviewers should guard against possible exploitation of interviewees and be sensitive to the ways in which their interviews might be used," and they suggest that interviewers must endeavor "to prevent any exploitation of or harm to interviewees." While the new guidelines offer many specific protections to narrators, they eliminate this vague language of exploitation and harm. And they caution that interviewers cannot guarantee control over the interpretation and presentation of interviews.

More generally, while the guidelines reflect historians' concerns with informed consent, they show the irrelevance to historical research of the biomedical concerns of risk/benefit analysis and equitable selection of subjects. There is more to research ethics than what is contained in the Belmont Report.