What Good Are Statements of Committee Approval?

Sara Jordan and Phillip Gray argue that public administration journals should follow medical journals' requirements "that all articles describe informed consent and ethics committee approval or why these were waived."

[Sara R. Jordan and Phillip W. Gray. “Reporting Ethics Committee Approval in Public Administration Research.” Science and Engineering Ethics (April 2013): 1–21. Accessed May 6, 2013. doi:10.1007/s11948-013-9436-5.]

Mortifyingly Stupid CITI Training Kills Oral History Course

Writing on H-Oral, Carl Kramer, the retired director of the Institute for Local and Oral History, Indiana University Southeast, reports that Indiana University's requirement of the mortifyingly stupid CITI Program dissuaded him from requiring oral history students to conduct actual interviews:

The issue is whether the training is relevant to oral history. Last year, I planned to have the students in my Oral History course at Indiana University Southeast interview baby boomers who grew up in a nearby former company town. The local library had conducted a similar project of the previous generation about 25 years earlier, and I thought it would be a great follow up. But meanwhile, Indiana University had adopted a national training program for human subjects research that was oriented toward biomedical and psychological standards, including units on dealing with pregnant women and fetuses, HIPPA, medically-oriented conflict of interest issues. It took me approximately seven hours to review the tutorial and take the exam. As an instructor who has conducted hundreds of interviews for many years, I concluded that if it took me that long to take an exam whose content was largely irrelevant to oral history, then I could not reasonably require my students to take it. So I ended up giving them the option of doing an interview or taking a final exam. The split was about 50-50, with the majority opting for the final exam. This was for an expedited review project through the IRB. I retired from the institute under which I taught the course, and I would never again teach a course that required such an irrelevant exam.

His comment comes in reply to a posting by a Kent State graduate student who may lose grant funding because she relied on OHRP's 2003 letter stating that "oral history interviewing activities, in general, are not designed to contribute to generalizable knowledge and, therefore, do not involve research as defined by Department of Health and Human Services (HHS) regulations at 45 CFR 46.102(d) and do not need to be reviewed by an institutional review board (IRB)."

What Can One University Do?

A few weeks ago, a correspondent asked me what reforms individual universities can implement while awaiting systemic, regulatory reform. It's an excellent question, so here's a roundup from material previously covered on the blog.

No university has adopted all of these measures, and at least one of these measures has not been adopted by any. But most of them are in place already, and there's no reason they can't spread.

Boston College Oral History Roundup

I rely on the exceptionally thorough Boston College Subpoena News for updates on the efforts of the United Kingdom and United States governments to get access to oral history interviews of participants in Northern Ireland's Troubles, but I feel I should flag three items of special interest to readers of this blog.

Federal Demonstration Parternship Pilots Exempt Wizard

In response to concern about "Over-review of Exempt Research", the Federal Demonstration Partnership is testing an Exempt Wizard, which would allow researchers to fill in a computer form and learn if their projects are exempt, rather than waiting for an IRB or IRB staff to make that determination.

Boston University, University of Michigan, Michigan State University, College of Charleston, Sacramento State, New York University, and the University of Washington are participating in the trial.

This sounds most promising.

REB Members Beg U of Ottawa to Defend Confidentiality

IRB apologists sometimes argue that IRB review is necessary to ensure that universities will defend researchers and their participants from litigation. Boston College Subpoena News reminds us that ethics approval is no guarantee of such support.

[“News of Interest: Canadian Academics Strongly Defend Research Confidentiality, Call for University Support of Researchers.” Boston College Subpoena News, April 9, 2013. http://bostoncollegesubpoena.wordpress.com/2013/04/09/news-of-interest-canadian-academics-strongly-defend-research-confidentiality-call-for-university-support-of-researchers/.]

Rivera: Faculty Researchers Are Notoriously Poor Judges of Risks

Suzanne Rivera, Associate Vice President for Research at Case Western Reserve University and member of the Secretary's Advisory Committee on Human Research Protections, responds to the AAUP's IRB report by asserting that faculty are inept at making determinations of exemption. I question this claim.

[Rivera, Suzanne A. “Academic Freedom and Responsibility |.” Bill of Health. Accessed March 28, 2013. http://blogs.law.harvard.edu/billofhealth/2013/03/24/academic-freedom-and-responsibility/. h/t Michelle Meyer]

Report from the National Academies Workshop

Last week I attended the Revisions to the “Common Rule” in Relation to Behavioral and Social Sciences Workshop sponsored by the National Academies.

I live-tweeted the event on my @IRBblog account, and I have collected those tweets on Storify.

What follows are what I consider some of the key messages from selected presenters. The statements following each name represent my summary of the remarks, not necessarily a quotation or paraphrase.

National Academies Post Workshop Agenda

The National Academies has posted the agenda for their Workshop on Proposed Revisions to the Common Rule in Relation to Behavioral and Social Sciences, to be held tomorrow and Friday in Washington, D.C.

I plan to attend and to post comments to this blog. If I can establish WiFi, I may also live tweet at @IRBblog.

On Signing the Markingson Petition

By April 1942, the Pentagon was 40 percent over budget, partly because it had been enlarged since first approved, but mostly because the original estimate of $35 million had never been realistic. Lieutenant General Brehon Somervell delayed telling Congress, but in June he finally sent Colonel Leslie Groves to appear before a House Apppropriations subcommittee.