Friday, December 12, 2014

Blog Day

Eight years of the Institutional Review Blog.

As Inside Higher Ed reported at the time

Schrag said that the problems with IRBs will probably remain for some time. “I think the regulations themselves are poorly drafted, with terms that are not well defined, and I anticipate problems until they are amended,” he said. “Perhaps until then, I’m going to have to keep up the blog.”

Can't be soon enough.

Tuesday, November 25, 2014

Was OHRP Ever an Independent Watchdog?

Public Citizen is upset that NIH will get to write much of the NPRM. I don't understand why that matters.

Internal E-Mails Suggest NPRM is Coming

According to an open letter to HHS secretary Sylvia Mathews Burwell, Public Citizen obtained "very recent internal emails" among officials at the Office of Management and Budget and the Department of Health and Human Services, showing that the latter is actively working on a Notice of Proposed Rulemaking (NPRM) to revise the Common Rule.

I'll write separately about the substantive issue raised by Public Citizen. For now, the news is that as of November 13, 2014, senior officials were actively working to write an NPRM.

Well I, for one, am very interested to see what's going to happen next.

Friday, November 7, 2014

New Book on Research Confidentiality

Ted Palys and John Lowman have published Protecting Research Confidentiality: What Happens When Law and Ethics Collide.

[Palys, Ted, and John Lowman. Protecting Research Confidentiality: What Happens When Law and Ethics Collide. Toronto: James Lorimer & Company, 2014.]

Over the years, I've learned a great deal from these two scholars about the ethics and law of research confidentiality in the social sciences, and I look forward to reading this compendium of what they have learned from their studies and their own struggles with their university.

Tuesday, November 4, 2014

OHRP Claims to Be "Working Very Hard" on NPRM

Writing for the Chronicle of Higher Education, Christopher Shea notes that though two years passed between the 2012 Future of Human Subjects Research Regulation conference at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the publication of the conference volume in July 2014, the delay of the next step in regulatory reform--a notice of proposed rulemaking (NPRM)--means that the book remains timely.

[Shea, Christopher. “New Rules for Human-Subject Research Are Delayed and Debated.” Chronicle of Higher Education, November 3, 2014.]

One also hopes that it won't be timely forever. Shea writes,

A spokesman for the Office for Human Research Protections, which is part of the Department of Health and Human Services, could not provide a timetable but told The Chronicle late last month, "I can assure you that this continues to be an HHS priority, and all the relevant parties are still working very hard on this."

Or, as they might have put it, "We have top men working on it right now."

Thursday, October 30, 2014

University of Washington IRB Demanded Dangerous Consent Form

The recent Nature story on ethics consultancies includes an example of counterproductive interference by an intransigent IRB.

[Dolgin, Elie. “Human-Subjects Research: The Ethics Squad.” Nature 514, no. 7523 (October 21, 2014): 418–20. doi:10.1038/514418a.]

Wednesday, October 29, 2014

Ethics Consultancies—A Non-Coercive Alternative to IRBs?

For some time, I've thought that the real problem with IRBs may be the coercive power granted to them. This relieves them of the need to make arguments strong enough to persuade researchers, and in some cases leads them instead to make demands based weak or even wrongheaded thinking.

This week, Nature reports on an alternative (or supplementary) model, the ethics consultancy.

[Dolgin, Elie. “Human-Subjects Research: The Ethics Squad.” Nature 514, no. 7523 (October 21, 2014): 418–20. doi:10.1038/514418a.]

Sunday, September 28, 2014

Briefly Noted: Whitney, Bell, Elliott

Lacking time for full comment, I briefly note the publication of these two important, critical essays. Citations omitted from the quoted passages.

Wednesday, August 27, 2014

You Can't Ask That

The Washington Monthly's fall college issue features my essay on IRBs. Nothing that will surprise regular readers of this blog, but perhaps this will reach new readers.

[Schrag, Zachary M. “You Can’t Ask That.” Washington Monthly, September/October 2014.]