Elliott Wants to Scrap IRBs

Carl Elliott, author of White Coat, Black Hat: Adventures on the Dark Side of Medicine, calls IRBs "incapable" and wants them replaced.

[Carl Elliott, Useless Pharmaceutical Studies, Real Harm, New York Times, 29 July 2011.]

Report on Research Compliance on ANPRM

The August issue of Report on Research Compliance covers ANPRM.

["Human Research Protections Prerule Mandates Regs for Non-Govt. Studies," Report on Research Compliance, August 2011]

The report has a statement from Art Caplan:

“These are long-overdue changes,” Art Caplan, director of the Center for Bioethics at the University of Pennsylvania, told RRC. “The current system involves too much red tape and paperwork in proportion to the protection given to subjects. In some ways the system of human subjects protection — informed consent and review by IRBs [i.e., institutional review boards] — has been hijacked by legal concerns so that more attention is given to institutional and investigator protection than subject empower- ment. These changes help remedy that problem.”

Your humble blogger is also quoted, complaining about the lack of attention to the experience of other countries. I did overlook ANPRM's footnote 28: "Cribb R. Ethical regulation and humanities research in Australia: Problems and consequences. Monash Bioethics Rev 2004;23(3):39–57." Other than that, has anyone found references to the workings of ethics committees in other countries?

ANPRM Hits Federal Register; Comments Due September 26

The ANPRM is in today's Federal Register, Volume 76 Issue 143 (Tuesday, July 26, 2011)

Comments are therefore due before 5 p.m. on September 26, 2011.

Emanuel and Menikoff Explain the ANPRM

Ezekiel Emanuel, head of the Department of Bioethics at NIH, and Jerry Menikoff, director of OHRP, explain the ANPRM for readers of the New England Journal of Medicine.

[Ezekiel J. Emanuel and Jerry Menikoff, "Reforming the Regulations Governing Research with Human Subjects," New England Journal of Medicine, 25 July 2011. h/t Michelle Meyer]

The essay is a very helpful introduction to the ANPRM, clearer than the ANPRM itself. The authors conclude,

After 20 years, and the introduction of significant changes to the research landscape, many believe that the Common Rule needs revision. The ANPRM offers a rare opportunity for needed modernization that is consistent with the President’s mandate to enhance protections while simultaneously eliminating unreasonable burdens. Not everyone will agree with every proposed change. But the ideal should not be the enemy of substantial progress in achieving these two important goals. If this reform effort fails, 20 years from now, someone might write an article for the Journal to bemoan the fact that the Common Rule has undergone essentially no change in 40 years.

Fine, I'll say it. I agree with Jerry Menikoff.

New York Times Reports on ANPRM

Andrew Pollack, "Rule Changes Proposed for Research on Humans," New York Times, 24 July 2011.

Like the Washington Post story, this lacks any explanation of who wrote the ANPRM or why it came out now. But it does have some good quotations:

“It’s a terrible drag on getting good research done,” said Dr. Robert J. Levine, a professor of medicine and a bioethicist at Yale who headed the university’s institutional review board for 31 years. He said Sunday that while he had not thoroughly reviewed the government’s lengthy proposal, he was encouraged by what he had seen.

and

Carl Wieman, associate director for science at the White House Office of Science and Technology Policy, said it was now difficult to observe teachers and students in classrooms to help determine what makes a good teacher, given all the consent required. “You’re not doing anything here except watching people,” he said.

Washington Post Reports on ANPRM

David Brown, "U.S. proposes rule changes for human-subject research," Washington Post, 23 July 2011.

Feds Ponder Biggest IRB Rules Changes in 30 Years!

On Friday, the U.S. Department of Health and Human Services posted an Advance Notice of Proposed Rulemaking (ANPRM), Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators, to be published in the July 25 Federal Register.

The ANPRM seeks to "enhance the effectiveness of the research oversight system by improving the protections for human subjects while also reducing burdens, delays, and ambiguity for investigators and research subjects." In 92 pages, it suggests dozens of potential changes, some of them quite major. They would represent the biggest regulatory changes to the US IRB system since the revision of 45 CFR 46 in 1981.

Watch this space for extensive and frequent commentary on specific provisions in the proposal as I draft comments prior to the end of the 60 day comment period. (September 22? How do they count these things?)

For now, I will just register my delight that the federal government has finally acknowledged that the flaws in the present system are not mere anomalies, but represent systematic problems that demand regulatory reform.

Oh, and thanks for the three citations to my work! Attention has been paid!

U of Michigan Reports Some Progress

The University of Michigan has released the results of a 2009 survey of investigator experiences in human research. The survey suggests that matters have improved somewhat since the university launched its HRPP Policy Innovation and Demonstration Initiative in 2007, but that more work remains to be done.

[Survey Research Center, Institute for Social Research, University of Michigan, "2009 Follow-Up Survey of Investigator Experiences in Human Research," December 2010. h/t: Human Research Protections Blog.]

Alarmist Views on Harvard Facebook Study

The Chronicle of Higher Ed reports a debate over a study of Facebook profiles, started in 2006 by Jason Kaufman of Harvard's Berkman Center for Internet & Society. The debate suggests that researchers may not be aware of how easy it can be to identify allegedly anonymous institutions and individuals, but that neither IRBs nor outside critics may understand all the implications of a study either.

[Marc Parry, "Harvard's Privacy Meltdown," Chronicle of Higher Education, 10 July 2011.]

DOJ: "There Is No Academic Privilege"

As reported in Inside Higher Ed, the Department of Justice has filed a brief in the British government's effort to gain access to oral history records at Boston College. The Department asks the court to honor the U.S. attorney's subpoena on the grounds that "there is no academic privilege which shields the material from disclosure."

SACHRP to Hear from Presidential Commission

The Secretary’s Advisory Committee on Human Research Protections (SACHRP)
has posted the agenda for its July meeting. The committee will receive a briefing on the Presidential Commission for the Study of Bioethical Issues from the commission's executive director.

Any chance the phrases "nitpicking monster" or "mortifyingly stupid" will be used?

The committee will also get a report from its own Subcommittee on Harmonization.