Monday, February 8, 2016

Fifty Years of IRBs

As has been widely not reported, today marks the fiftieth anniversary the issuance of U.S. Public Health Service Policy and Procedure Order (PPO) #129, which mandated that each recipient of a PHS grant involving human beings secure prior review by “a committee of his institutional associates.” From this document flowed all subsequent IRB policies, in the United States and in several other countries.

To honor the occasion, I have posted a PDF of the order on my page of IRB documents.

(Not really. A correspondent was looking for a copy, and I posted it for her.)

Thursday, January 21, 2016

Advice on Scholarly Blogging

Alice Dreger is soliciting advice “for a young scholar thinking of starting a blog.” My wife and I have each maintained blogs for several years, and here’s what we’ve come up with.

Sunday, January 17, 2016

Political Scientists Complain about Lost Exemption

Political scientists and law professors are protesting the proposed elimination of the current exemption for research about public officials and candidates for office. The drafters may have eliminated the exemption by mistake, thinking that such research was exempted by other provisions of the proposed rule, which turns out not to be the case.

Friday, January 1, 2016

My NPRM Comments

Perhaps 2016 will be the year when OHRP makes good on its 2007 promise to “give more guidance on how to make the decision on what is research and what is not,” in the form of a promulgated revision to the Common Rule. If so, Happy New Year, OHRP!

Wth these hopes, I have submitted my own comments on the NPRM. I have posted a copy of the PDF I submitted, and below is a web version with links.

Thursday, December 31, 2015

NPRM: How to Exclude Journalism?

Few if any argue that journalists should be required to submit their work to IRB review. Some IRB apologists think journalism is too important to bear restriction, while others consider it so full of “blatant bias and even hyperbole” that it doesn’t deserve the dignity of review. But all participants in the debate, at least in United States, seem uncomfortable with the idea of subjecting journalists to prior restraint.

The question, as always, is how to draw the line between journalism and regulated forms of conversation. The NPRM’s proposed rule attempts to do so with a specific exclusion for “Oral history, journalism, biography, and historical scholarship activities that focus directly on the specific individuals about whom the information is collected.” Will that suffice?

Neither the NPRM's language nor SACHRP's proposed replacement is quite right, so let me suggest an alternative.

PRIM&R and SACHRP Attack Social Science Exclusion

In their comments on the NPRM, SACHRP and PRIM&R oppose the proposed exclusion of “Research, not including interventions, that involves the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) uninfluenced by the investigators” (§ ll.101(b)(2)(i)); they want such research to be moved from the excluded to the exempt category. But they differ in what they think the consequences of such a move would be; SACHRP thinks that researchers would face low barriers, while PRIM&R sees a chance for its members to continue to exert more control than is authorized by regulations. Both groups fail to represent the researchers most likely to conduct these kinds of studies.

Monday, December 28, 2015

I Agree With PRIM&R on Something

PRIM&R has posted its draft comments on the NPRM. I have found something to agree with.

PRIM&R writes:

Over the past 25 years, the difficulty of getting all of the agencies to agree on the Common Rule was cited as the grounds for concluding that changing any provisions would require a Herculean effort. It may well be that revising the entire Common Rule at once is a task that can only be undertaken once in a generation.

But if the current NPRM, issued four years after the ANPRM to revise the Common Rule (July 26, 2011), underlines how daunting a comprehensive revision can be, it also shows that the best, evidence-based revisions will not emerge from a process that tries to make all needed revisions at once. By perpetuating the view that regulations cannot be revised when needed, the current approach risks locking in place for another 25 years a number of provisions in the NPRM that even its most enthusiastic supporters admit are flawed in important ways.

Instead, we recommend that the relevant agencies pursue an issue-by-issue approach in which it is possible to “drill down” on an issue, to consider all the sections of the regulations where it arises and all the evidence that is available—and that is needed—to resolve it well. Further, the agencies should address each issue more openly, developing and relying upon evidence, and allowing consensus to emerge and revisions to be crafted that will work well for all stakeholders. This approach would not only produce better results, but would signal that, once adopted, any provision can be changed if it does not work as well as intended.

Yes, indeed.

I don’t go so far as to agree with PRIM&R that the proposed rule should be scrapped. Historians have already waited too long for their freedom. But even the best rules deserve reexamination more frequently than once every 25 or 35 years.

I would also note that PRIM&R embodies the system’s longstanding failure to consult “all stakeholders.” If PRIM&R is serious about that phrase, it should endorse the American Anthropological Association’s call for “a commission constituted specifically of social scientists (e.g., sociologists and the like), humanistic social researchers (e.g., cultural anthropologists and the like), and humanists (e.g., historians, legal scholars, and the like) … tasked with developing alternative guidance appropriate for their fields.”

In NPRM Comments, Historians Applaud Proposed Rule

In addition to the formal comments from the National Coalition for History, endorsed by other scholarly associations, individual historians have begun submitting comments on the notice of proposed rulemaking. Without exception, they endorse the proposal to free oral history from IRB review. The only opposition comes from a professor of education and psychology who seems to suggest that tribal governments should hold veto power over oral history research.

Here are some of the highlights, alphabetical by last name. I have edited some for brevity. Full comments can be found at!documentDetail;D=HHS-OPHS–2015–0008–0001

Saturday, December 12, 2015

Blog Day

The Institutional Review Blog is nine years old today. It continues its original mission of aggregating news and commentary about IRB review of research in the humanities and social sciences, such as Wednesday’s report of an article from Feminist Studies. And it has never been closer to its goal of regulatory reform.