Revised Common Rule Delayed at Least 6 Months

The new Common Rule was supposed to go into effect today, but OHRP has declared a six month delay in the implementation of most of its parts. This apparently includes a delay in the redefinition of research and the liberation of oral history.

Reforms for “21st century science” would have been good for the 20th too

A group of 11 researchers and IRB professionals, most of them affiliated with the University of California, San Diego, report on a brainstorming session from early 2015. They argue that readable consent forms, expert review, a less punitive system, and more exemptions would better serve researchers and participants. While they present their ideas as “a human research protections system that is responsive to 21st century science,” the measures they propose are equally valid for research as it has been practiced for decades.

[Cinnamon Bloss et al., “Reimagining Human Research Protections for 21st Century Science,” Journal of Medical Internet Research 18, no. 12 (2016): e329, doi:10.2196/jmir.6634.]

NSF Officer Misstates Belmont and Common Rule Standards

In the final contribution to the PS symposium, Lee Demetrius Walker, currently serving as program officer for the Political Science Program at the National Science Foundation, acknowledges the problems of applying a biomedical review system to social science. But he misstates the Belmont and Common Rule standards for assessing research.

[Lee Demetrius Walker, “National Science Foundation, Institutional Review Boards, and Political and Social Science,” PS: Political Science & Politics 49, no. 02 (April 2016): 309–12, doi:10.1017/S1049096516000263.]

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.

NPRM: Will Political Science Interviews Require Review?

What do we know about interview research under the NPRM?

Whatever its final provisions, the new Common Rule seems bound to be much harder to follow than, say, Canada’s TCPS2. The proposed rule is full of cross references from one section to the next, and often to other documents, such as Subpart D or the Belmont Report. This makes it hard to figure out what it says about any given form of research.

Here’s what I’ve been able to figure out about one form: interview research. My sense is that the NPRM proposes to eliminate IRB review for the vast majority of conversations between consenting adults, but it may unintentionally impose review on projects that do not merit it.

Exemption by the Numbers?

Two computer researchers describe a system at Microsoft Research designed to provide automatic approval for low-risk studies. Rather than follow the Common Rule’s exemption model of requiring IRB review if any of a series of conditions is met, the Microsoft system assigns numerical values to aspects of a proposal that bear some risk to participants. Proposals with a low total get immediate approval from an Excel spreadsheet.

[Bowser, Anne, and Janice Y. Tsai. “Supporting Ethical Web Research: A New Research Ethics Review.” In Proceedings of the 24th International Conference on World Wide Web, 151–61. WWW ’15. Republic and Canton of Geneva, Switzerland: International World Wide Web Conferences Steering Committee, 2015. doi:10.1145/2736277.2741654.]

Exemptions Don't Come to PRIM&R's Mind

In October, PRIM&R hosted a webinar on "Protecting Human Subjects in Qualitative Research: Ethical Considerations for IRBs and Researchers," hosted by Julie Simpson, director of research integrity services at the University of New Hampshire.

A follow up question, just posted the PRIM&R Blog, suggests that Simpson is unfamiliar with the Common Rule:

AS: Under what circumstances might qualitative research not require IRB review?
JS: None come to mind at this time. If the activity is research and it involves human subjects, then it needs IRB review.

Of course, 45 CFR 46.101 lists several circumstances in which human subjects research does not require IRB review, some of them--particularly (b)(2) and (b)(3)--of enormous importance to qualitative researchers.

To be sure, OHRP is primarily responsible for discouraging institutions from recognizing the exemptions. But it is a pity to see PRIM&R spread such misinformation.

SACHRP: Exempt Research May "Be Subject to IRB Review"

As reported by Erica Check Hayden in Nature, at its March meeting, SACHRP endorsed "Considerations and Recommendations Concerning Internet Research and Human Subjects Research Regulations, with Revisions," prepared by Elizabeth Buchanan and Dean Gallant. The guidance offers some common sense, but it struggles with the legacy of the poorly drafted Common Rule. And it threatens to make matters worse by suggesting that some exempt research may "be subject to IRB review."

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.

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.

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.

Journal Retracts Interview-Based Article for Lack of IRB Approval

Retraction Watch reports that Social Science & Medicine has retracted an article based on interviews with Costa Rican healthcare providers, apparently because it did not receive the IRB approval it claimed.

[“Social Sciences Paper Retracted for Lack of Ethical Approval.” Retraction Watch, February 25, 2013. http://retractionwatch.wordpress.com/2013/02/25/social-sciences-paper-retracted-for-lack-of-ethical-approval/; Goldade, Kate, and Kolawole S. Okuyemi. “RETRACTED: Deservingness to State Health Services for South–South Migrants: A Preliminary Study of Costa Rican Providers’ Views.” Social Science & Medicine 74, no. 6 (March 2012): 882–886. doi:10.1016/j.socscimed.2011.06.045.]

Northeastern U. IRB Makes Sex Research Untenable

Carey Noland, associate professor of communcation studies at Northeastern University, complains that "many IRBs . . . seem to have difficulty accurately assessing the potential harm involved with qualitative research on sex."

[Carey M. Noland, “Institutional Barriers to Research on Sensitive Topics: Case of Sex Communication Research Among University Students.” Journal of Research Practice 8, no. 1 (November 24, 2012): Article M2, http://jrp.icaap.org/index.php/jrp/article/view/332/262]

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. https://blogs.law.harvard.edu/billofhealth/2012/10/22/exempt-human-subjects-research-expedited-irb-review-curb-your-enthusiasm/]

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)

IRB Chair Denies Being a Vampire

Patricia Price, a geographer and IRB chair at Florida International University, assures us that her board is not "a malevolent, vampirish entity."

[Patricia L. Price, "Geography, Me, and the IRB: From Roadblock to Resource," Professional Geographer 64, no. 1 (2012): 34-42, DOI:10.1080/00330124.2011.596789]

IRB Sought to Monitor Interviews with Elected Officials

The first article in the Professional Geographer special issue argues that the IRB system assumes that the researcher is a "powerful, knowing agent who assembles a scientific methodology that is always of potential harm to the researched," while subjects are always "less knowing" and vulnerable. As a result, scholars "face the presumption of guilt while seeking to prove innocence in the IRB process of application, negotiation, and usually, but not painlessly, final approval to conduct research."

[Deborah G. Martin and Joshua Inwood. “Subjectivity, Power, and the IRB,” Professional Geographer 64, no. 1 (2012): 7–15, DOI:10.1080/00330124.2011.596781.]

Philosopher and IRB Chair Call for Repeal of IRB Exemptions

Writing in IRB: Ethics & Human Research, Mahesh Ananth and Michael Scheessele, both of Indiana University South Bend, argue against exempting all minimal-risk research from IRB review. They do so in terms that would require the repeal of the 45 CFR 46.101 exemptions, though it is not clear they understand the implications of their own argument.

[Mahesh Ananth and Michael R. Scheessele, "Exempting All Minimal-Risk Research from IRB Review: Pruning or Poisoning the Regulatory Tree?" IRB: Ethics & Human Research 34, no. 2 (April 2012): 9–14.]

Li and Brown Continue Negotiations

A correspondent asks for an update in the case of Jin Li, the Brown professor who sued her university after its IRB restricted her research.

I checked Public Access to Court Electronic Records (PACER) and found that on January 13, the parties jointly asked for an extension of the discovery deadline, telling the court "that they continue to negotiate a settlement of the claims. Due to the efforts made negotiating a settlement, only minimal discovery has been propounded so far. As such, if the parties are unable to settle, then the parties will need time to complete formal discovery."

I have posted the motion and other key documents on my IRB Documents page.

ANPRM: May I Be Excused?

One of the boldest proposals in the ANPRM, and one of enormous importance to social scientists, is the idea of replacing the current category of exempt reseach with a new category of "Excused" research. This proposal could reduce IRB and IRB-office intrusion into a great deal of social research. But, depending on the details, it could instead convert an enormous amount of presently exempt research into research subject to expedited or even full-board review.

Social scientists will need to be very careful as they respond to this proposal.