Seton Hall Law plans November conference on Revised Common Rule

On November 9, I will join other scholars to discuss the revised Common Rule at a one-day conference hosted by Seton Hall University: Reimagining Human Subject Protection for the 21st Century: A Critical Assessment of the Revised Common Rule.

The agenda is online at https://law.shu.edu/docsnoncommonspot/images/events/human-subject-agenda.pdf

Scoping Out the Common Rule

Thursday I'll speak at a meeting to discuss "Revising and Expanding the Scope of the Common Rule," Evanston, IL.

Join us live or on the web.

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."

Bell: Ethnography Shouldn't Be Like Victorian Sex

Writing in American Anthropologist, Kirsten Bell argues that ethnography should not be seen as a violation to which an informant must consent, and "although the concept of informed consent has now been enshrined in the AAA Code of Ethics for more than 15 years, the reality is that it is not an appropriate standard with which to judge ethnographic fieldwork."

[Bell, Kirsten. "Resisting Commensurability: Against Informed Consent as an Anthropological Virtue." American Anthropologist, July 21, 2014, doi:10.1111/aman.12122.]

New Book on Human Subjects Research Regulation

MIT Press has published Human Subjects Research Regulation: Perspectives on the Future, eds. I. Glenn Cohen and Holly Fernandez Lynch.

The volume emerges from the May 2012 conference, "The Future of Human Subjects Regulation," sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. (See Against Armchair Ethics: Some Reflections from Petrie-Flom.)

My own contribution is a chapter entitled, "What Is This Thing Called Research?" I have a preliminary version online at SSRN.

Though published three years after the ANPRM, the book has hit print before an NPRM. Pity.

"The Freedoms We Are Committed to Protect"

The Hinckley Institute of Politics, University of Utah, has posted a videorecording of my lecture there last month.

"'The Freedoms We Are Committed to Protect': Political Science, Academic Freedom, and Institutional Review Boards in Historical Perspective.” Keynote address, Symposium on Field Research and US Institutional Review Board Policy, University of Utah, March 2014. http://youtu.be/uwIFyDgLklU

Symposium: Field Research and US Institutional Review Board Policy

This month the Political Science Department, University of Utah, will host a symposium entitled, "Field Research and US Institutional Review Board Policy." Sponsored by the Betty Glad Memorial Fund, the symposium will take place March 20 [8:45 am - 5:30 pm] and March 21 [9:00 am - 3:30 pm].

The description follows:

University of Utah Plans Symposium on IRB Policy

On March 20 and 21, the University of Utah Political Science Department will host a symposium, Field Research and US Institutional Review Board Policy.

I will give the keynote address, "'The Freedoms We are Committed to Protect': Political Science, Academic Freedom, and Institutional Review Boards in Historical Perspective."

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.

National Academies Run Workshops on Common Rule Revisions

The National Academies are running workshops on "Revisions to the Common Rule for the Protection of Human Subjects in Research in the Behavioral and Social Sciences." I was unaware of the first two meetings in January, but I hope to attend the upcoming meetings on March 21 and 22.

New Brunswick Declaration Seeks Respect for Researchers and Participants

Back in October, I participated in the Ethics Rupture summit, hosted by the University of New Brunswick and St. Thomas University of Fredericton, New Brunswick.

One product of that conference is the New Brunswick Declaration: A Declaration on Research Ethics, Integrity and Governance. It's only a page long and therefore hardly bears summarizing, but I would note its desire to "encourage regulators and administrators to nurture a regulatory culture that grants researchers the same level of respect that researchers should offer research participants." That shouldn't be a radical demand, but it is.

Journal of Law, Medicine & Ethics Symposium Reexamines Research Ethics

The Winter 2012 issue of the Journal of Law, Medicine & Ethics features presented at a November 2011 Wake Forest University Center for Bioethics, Health, and Society presented a conference entitled "Research Ethics: Reexamining Key Concerns."

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), http://ssrn.com/abstract=2182297.

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:

Farewell, Fredericton!

I made it home from the Ethics Rupture conference in time to defend my basement against Hurricane Sandy.

It was delightful to meet so many scholars--several of whom have been cited in this blog over the years--with such deep knowledge of the problems of ethics review and creative ideas for improving it.

The conference was recorded, and a podcast should appear before too long. Also, we hope to publish a conference volume. As time permits, I will blog some of the things I learned there.

I thank all those who organized and hosted the conference, especially Will van den Hoonaard.

One Year Since ANPRM Comment Deadline

Today marks the first anniversary of the deadline for comments on the ANPRM. The federal government received more than 1100 comments in response to its proposals and queries. I have heard nothing official, and only vague and contradictory rumors, about what progress, if any, has taken place in the past year.

Meanwhile, I am attending Will C. van den Hoonaard's Ethics Rupture conference, and I am delighted to meet in person so many people with whom I have corresponded and whose work I have read. But I am saddened to hear Canadian scholars' frustration that the revision of the TCPS has not done more to allow them to conduct research according to the ethical and methodological standards of their disciplines.

Fredericton to Host Summit on Research-Ethics Review Alternatives

Will C. van den Hoonaard, author of The Seduction of Ethics, is organizing a conference to be held next month in Fredericton, New Brunswick, entitled "Ethics Rupture: An Invitational Summit about Alternatives to Research-Ethics Review."

Harvard Law Today Reports on ANPRM Conference

Harvard Law Today, published by Harvard Law School, reports on May's conference on the ANPRM, held at the school's Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics.

["The Future of Human Subjects Research Regulation," Harvard Law Today, July 2012.]

The article highlights the plenary address by Greg Koski, former director of OHRP.

Koski said regulation has been dominated by human-subject protectionism and an ethical-review system that has “devolved to regulatory compliance oversight.” The result, he said, is a system that is “inefficient and burdensome.” His recommendation, he said, was to replace the current system with one modeled after medical training and certification.

He said: “If we were able to develop a paradigm of professionalism in human research, it would likely be every bit as effective, less costly, less burdensome and more efficient than the protectionist, compliance-focused system that we are now seeking to reform. I would argue that reform of our current system is perhaps not the most appropriate or even adequate approach to try to achieve the goals that we seek.”

Petrie-Flom Center Posts ANPRM Conference Program

The Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics at Harvard Law School has circulated the following announcement, concerning a conference at which I will speak. I am happy to post the announcement in full.

"Informed Consent Is 20 Pages of Nothing"

Nature reporter Daniel Cressy writes that

Informing clinical-trial participants of the risks they face is a cornerstone of modern medical research, and it is enshrined as a human right in international codes of ethics. But an influential group of ethicists and medical researchers warned at a meeting in Brussels last week that the process has become a box-ticking exercise focused more on offering legal protection to a trial’s organizer than actually protecting patients.

[Daniel Cressey, "Informed Consent on Trial," Nature 482, 16 (2 February 2012) doi:10.1038/482016a]

Ethicists are particularly alarmed by the steady growth in the length of consent forms.

In many cases “the informed consent is 20 pages of nothing,” says Harry Bleiberg, an oncologist formerly at the Jules Bordet Institute in Brussels who is now a medical consultant for the pharmaceutical industry.

While consent forms have grown longer, it is not clear that they were ever anything other than "a box-ticking exercise focused more on offering legal protection to a trial’s organizer than actually protecting patients." Perhaps Cressey wrote "has become a box-ticking exercise" when he meant "remains a box-ticking exercise."