Wednesday, November 28, 2012

What Is This Thing Called Research?

I have posted the paper I prepared for the May 2012 Petrie-Flom conference as "What is this Thing Called Research? (May 7, 2012),

A shorter version will appear in a book to be published by the MIT Press, tentatively entitled The Future of Human Subjects Research Regulation.

Here is the abstract:

Palys and Lowman on Boston College: "Be Suspicious of Universities"

Ted Palys and John Lowman of the School of Criminology at Simon Fraser University provide a helpful overview of the Boston College Belfast Project oral history legal case while condeming Boston College's actions before and after the arrival of the subpoena. Though the article is marred by an incomplete understanding of U.S. human subjects regulations, it makes a strong case that universities need to practice "ethical and legal due diligence" before promising confidentiality to research participants.

[Ted Palys and John Lowman. “Defending Research Confidentiality ‘To the Extent the Law Allows:’ Lessons From the Boston College Subpoenas.” Journal of Academic Ethics 10, no. 4 (2012): 271–297. doi:10.1007/s10805-012-9172-5.]

Autoethnographer Finds REB Review Intimidating

Lee Murray describes getting REB approval for her doctoral research at the University of Saskatchewan. Though she was able to devise a proposal that passed the committee "without taking away from what I want to accomplish," she was left feeling she "would not want to make the journey again."

[Lee Murray, Debbie Pushor, and Pat Renihan. “Reflections on the Ethics-Approval Process.” Qualitative Inquiry 18, no. 1 (January 2012): 43–54. doi:10.1177/1077800411427845.]

Monday, November 26, 2012

Meyer: "IRB Review Has Only One Step"

Writing on Bill of Health, the blog of the Petrie-Flom Center, Michelle Meyer argues that while human subjects "regulations in theory establish three risk-based tiers of review — human subjects research (HSR) otherwise subject to IRB review that the regulations nevertheless exempt; HSR that is eligible for expedited review; and HSR that requires review by a fully convened IRB (everything else) — in practice, the first two tiers tend to collapse into the third. In this sense, and now I borrow from Matthew Stephenson and Adrian Vermeule, IRB review has only one step."

[Meyer, Michelle. “Exempt Research & Expedited IRB Review: Curb Your Enthusiasm |.” Bill of Health, October 22, 2012.]

I think this implies that even projects that are not federally funded, that don't meet the regulatory definition of human subjects research, or that fit one of the exemption categories are apt to go to full board review.

While it's easy enough to find examples of projects that suffered more scrutiny than required by the regulations, I would note that the exempt and expedited categories remain large. For example, the University of Michigan reports that only 11 percent of projects brought to the Health Sciences and Behavioral Sciences Institutional Review Boards required full review. (Table 4)

Monday, November 5, 2012

Is Boston College Still Clueless about Oral History?

H-Oralhist is running a thread of responses to an oral historian who is seeking IRB approval. One response came from Jillian Maxey, a Ph.D. candidate in Comparative Theology at Boston College.

She writes,

I am working through my IRB proposal right now. I am interviewing key scholars in my field and will be identifying them by name in my dissertation. One person to whom I spoke who serves on the IRB balked at this at first. When I insisted that it was necessary she gave me some tips for articulating the need to the IRB. I'm just wondering if anyone has experience with this or knows of any oral history publications that name participants that I could use to backup my proposal.

Can it be that a year and a half into an international legal controversy involving oral history recordings stored at Boston College, its IRB still doesn't know that oral historians identify their narrators by name? If so, that's all the more reason to think that IRB oversight is not the right response to the Boston College case.

Friday, November 2, 2012

What Has OHRP Told Huron It Hasn't Told Me?

The Huron Consulting Group is advertising a free webinar on November 7 entitled "OHRP Regulatory Interpretations That You Need To Know, But Have Never Been Told." The press release explains:

The Health and Human Services (HHS) human subjects regulations aren't always clear-cut and often times Institutional Review Boards (IRBs) and researchers struggle with how to interpret them. During this webinar, the presenters will share the knowledge Huron has gained through communications with Office for Human Research Protections (OHRP) about topics such as:
  • How to handle "protocol exceptions for a single subject"
  • When an unanticipated problem involving risks to subjects or others does not have to be reported to OHRP
  • Whether the IRB has to require the submission of the names of all study staff on a research study
  • When Subpart C does not apply to a subject who becomes incarcerated

I am troubled by the premise of this webinar: that OHRP has passed on important information to a private consulting firm without posting it for public use. For some topics, this may be puffery by Huron. For example, OHRP has issued public guidance on "What happens if a human subject becomes a prisoner during the course of a research study?" But I don't know of similar guidance on topics like "protocol exceptions for a single subject." If OHRP has in fact made such regulatory interpretations, why aren't they on its website?