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.

NIH Policy Makes Interviewing Children Easier

Susan Ridgely, assistant professor of religious studies at the University of Wisconsin at Oshkosh, finds that IRBs can cause trouble for qualitative researchers who want to talk with children, but that IRB review has some benefits. Moreover, since the NIH started calling for children to be included in medical studies, she is finding it easier to get IRB permission to speak to children.

[Susan B. Ridgely, “Doing Ethnography with Child Consultants: Making the IRB Process Work.” Journal of American Folklore 125, no. 3 (2012): 474–485.]

Talk at NIH

On March 5 I will speak to the Bioethics Interest Group at the National Institutes of Health on the topic "Blunder at Belmont: The 1970s Origins of IRB Mission Creep."

Those familiar with my first book may appreciate the irony of my speaking in the William H. Natcher Building.

NIH Pledges $1 Million for Research on IRB Regulations

A January 10 HHS press release notes that "the National Institutes of Health is committing $1 million to support research that will be used to evaluate the impact of the revisions to the HHS regulations governing human subject research that are currently being considered. Assessing the impact of the revisions that are ultimately implemented will be critical to the development of an evidence-based approach to ensuring the effectiveness of human research subject protections."

You have my attention.

h/t: Theresa Defino.

Kojo Nnamdi Show on Common Rule Now Online

Yesterday I had the pleasure of joining Jerry Menikoff of OHRP and Kathy Hudson of NIH on an episode of the Kojo Nnamdi Show entitled, "Rethinking the "Common Rule": The Ethics of Research with Human Subjects." We received many thoughtful, informed comments and questions.

I don't think any of us said anything that will surprise those who have followed the ANPRM debate closely, but I was pleased to hear Dr. Hudson concede that "The level to which current IRB protections actually protect participants is a somewhat understudied area. And I would hope that as we put these new rules in place that we can actually try to measure how effective they are in protecting participants in research."

In other words, after 45 years of imposing IRB review on researchers, we might begin asking if it does any good.

The audio recording and a transcript are now online at the link above.

NIH Bioethicist Grady Questions IRB Effectiveness

JAMA has published an interesting exchange concerning the lack of data about IRB effectiveness.

[Christine Grady, "Do IRBs protect human research participants?," JAMA 304 (2010):1122-3; James Feldman, "Institutional Review Boards and Protecting Human Research Participants," and Christine Grady, "Institutional Review Boards and Protecting Human Research Participants—Reply," JAMA 304 (2010): 2591-2592.]

In the September 8 issue, Christine Grady of the Department of Bioethics, National Institutes of Health Clinical Center, quotes David Hyman's charge that "Despite their prevalence, there is no empirical evidence IRB oversight has any benefit whatsoever—let alone benefit that exceeds the cost." Grady is less blunt, but her message is the same:

Without evaluative data, it is unclear to what extent IRBs achieve their goal of enhancing participant protection and whether they unnecessarily impede or create barriers to valuable and ethically appropriate clinical research. This lack of data is complicated by the reality of no agreed-on metrics or outcome measures for evaluating IRB effectiveness. Although available data suggest a need for more efficiency and less variation in IRB review, neither efficiency nor consistency directly gauges effectiveness in protecting research participants. Protection from unnecessary or excessive risk of harm is an important measure of IRB effectiveness, yet no systematic collection of data on research risks, no system for aggregating risks across studies, and no reliable denominator of annual research participants exist. Even if aggregate risk data were easily available, it may be difficult to quantify the specific contribution of IRB review to reducing risk because protection of research participants is not limited to the IRB.

Serious efforts are needed to address these concerns and provide evidence of IRB effectiveness.

The December 15 issue features a reply by James Feldman of the Boston University School of Medicine. Feldman makes two points.

First, he doubts that IRBs cause that much trouble:

The critique of IRBs by Bledsoe et al, which was cited as evidence that they stifle research without protecting participants, is based on a single-site report of the results of an e-mail survey mailed to 3 social science departments with a total of 27 respondents. The evidence that IRBs have "disrupted student careers [and] set back tenure clocks" should also meet a reasonable standard of evidence.

OK, but what is that standard of evidence? In the absence of federal funding to study systematically a problem created by federal regulations, how much are frustrated researchers expected to do to demonstrate the problem? In other words, how many horror stories would Feldman need to change his views?

Having insisted that evidence is necessary to show the costs of IRB review, Feldman then asserts that no evidence is needed to show its benefit:

I believe that the effectiveness of IRBs in protecting human participants from research risks is analogous to preventive medicine. It is difficult to derive evidence that can quantify the effectiveness of a specific preventive intervention (new cases of HIV prevented? new injuries prevented?). However, evidence of preventable injury or illness makes a case for the need for effective prevention. Similarly, the tragic and prevalent cases of research abuse and injury make a compelling case for more rather than less review by IRBs that are independent, experienced, and knowledgeable.

As Grady points out in her reply to the letter, even if we accept the analogy, the IRB system does not meet the standards we impose on preventive medicine. She writes, "clinicians and public health officials do rely on evidence of the risks, benefits, and effectiveness of an intervention in preventing HIV or injuries or other conditions to justify adopting one particular preventive intervention rather than another and to defend the necessary investment of resources."

Exactly. As it stands, IRBs are the Avandia of ethics.

Menikoff Passes the Buck

Joseph Millum, bioethicist at the National Institutes of Health, and Jerry Menikoff, director of the Office for Human Research Protections, acknowledge the widespread dissatisfaction with present human subjects regulations and wish that "ethics review could be streamlined under the current regulations if institutions, IRBs, and researchers adhered strictly to the definition of human subjects research and used the available options for exemptions, expedited review, and centralized review—options that remain underused in biomedical research." But they put too much blame for this overregulation on IRBs and research institutions rather than on their own agencies.

[Joseph Millum and Jerry Menikoff, "Streamlining Ethical Review," Annals of Internal Medicine 153, no. 10 (November 15, 2010): 655-657.]

Stark Wants to Scrap IRBs

Sociologist Laura Stark is a careful observer of the IRB system, having based her dissertation on archival research and direct observations of three university IRBs. In 2008, I complained that the dissertation, "Morality in Science," reported but failed to condemn bad IRB behavior. In a newly published essay, Stark takes a more critical stance.

[Laura Stark, "Gaps in Medical Research Ethics," Los Angeles Times, 8 October 2010.]

In her essay, Stark traces today's IRB system back to systems established in the 1960s at the NIH Clinical Center, which performed experiments on "hundreds of healthy prisoners, conscientious objectors, unemployed people and students living in their hospital as subjects." She finds that system included two basic flaws: it failed to inform the public about what was going, and it gave no voice to dissenting members of ethics boards. These flaws, she argues, remain in today's system of ethics review.

To remedy them, Stark proposes that the new Presidential Commission for the Study of Bioethical Issues "rebuild the regulations from the ground up." She writes,

New rules should include these changes:

Replace the thousands of local review boards that labor independently at universities and hospitals here and abroad with a small number of ethics-review networks organized around specific research methods rather than around institutions. The networks would be better equipped to handle multi-site studies that are now commonplace, and would remove the political biases of some outlier institutions.

Consider the advantages and disadvantages of outsourcing ethics review to private companies, which review research for a fee.

Finally, empower research participants by posting the results of ethics reviews online. The current system includes community representatives who presumably speak on behalf of research participants, but that's not good enough.

Though the essay does not specifically mention IRB review of research in the social sciences and humanities, the dissertation gives examples in which the lack of transparency and lack of expertise impeded such projects. Thus, Stark's call for expert boards and published results of ethics review could address non-biomedical research as well as the medical research that is her chief concern. And while Stark presents her proposals as ways to ensure better protection for research participants, they could also benefit those researchers who now fall victim to inexpert boards. Because the current system fails both researchers and participants, reform can benefit them both.

Stark should realize that the changes she proposes would require more than "rebuild[ing] the regulations from the ground up," since the requirement for local IRBs is encoded in federal statute, not just regulations. But a wholesale reconsideration of the IRB system by the presidential commission would be a fine first step.