The Cost of Ethical Review, Part III: Hindering HIV Prevention

Risk-averse IRBs are hindering potentially life-saving research, write Brian Mustanski and Celia Fisher. “Critical advances in HIV prevention among AMSM [adolescent men who have sex with men],” they note, “have been impeded by the failure of IRBs to apply federal regulations permitting adolescents to self-consent to research without parental involvement.”

[Mustanski, B., & Fisher, C. B. (2016). HIV Rates Are Increasing in Gay/Bisexual Teens: IRB Barriers to Research Must Be Resolved to Bend the Curve. American Journal of Preventive Medicine, In Press. doi:10.1016/j.amepre.2016.02.026.]

Fifty Years of IRBs

As has been widely not reported, today marks the fiftieth anniversary the issuance of U.S. Public Health Service Policy and Procedure Order (PPO) #129, which mandated that each recipient of a PHS grant involving human beings secure prior review by “a committee of his institutional associates.” From this document flowed all subsequent IRB policies, in the United States and in several other countries.

To honor the occasion, I have posted a PDF of the order on my page of IRB documents.

(Not really. A correspondent was looking for a copy, and I posted it for her.)

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.]

IRB Still Isn't Peer Review

A bit off-topic here (this is a health-related study), but here's an illustration of the benefits of IRB shopping.

[Cordner, Alissa, and Phil Brown. “Moments of Uncertainty: Ethical Considerations and Emerging Contaminants.” Sociological Forum 28, no. 3 (September 2013): 469–94. doi:10.1111/socf.12034.]

Public Health Scholars Question Bioethics Framework

Amy L. Fairchild and David Merritt Johns, both with the Center for the History and Ethics of Public Health, Department of Sociomedical Sciences, Mailman School of Public Health, Columbia University, find that bioethics is "the wrong framework of accountability for some domains of inquiry."

[Amy L. Fairchild and David Merritt Johns. “Beyond Bioethics: Reckoning With the Public Health Paradigm,” American Journal of Public Health 102, no. 8 (August 2012): 1447–1450, DOI: 10.2105/AJPH.2012.300661.]

I Hope You All Get Pox

This is a little off-topic for the blog, but to understand the IRB system, it helps to understand the history of the U.S. Public Health Service, and to understand the history of the U.S. Public Health Service, it helps to read Michael Willrich's Pox: An American History, which I just finished reading and am very glad to plug.

The history of public health is a struggle between the desire for liberty and the desire for health, since many of the most effective public health measures--quarantine, health codes, compulsory vaccination, and perhaps bans on 20-ounce soft drinks--are also infringements of liberty. Willrich's account of smallpox at the turn of the twentieth century does a marvellous job at presenting both sides of this struggle. It explains laypeople's legitimate fears about the doctors and health officers who came to snatch them and their children, but also why those health officers took pride in their snatching. We may wonder who in today's IRB debate most resembles the arrogant vaccinators of a century ago: researchers seeking scientific progress, or ethics boards seeking to restrain them?

Health Researcher Complains of "Social Science Types" and HIPAA

Since I have frequently documented the complaints of social scientists who suffer from inappopriate conditions imposed by medically oriented IRBs, it seems fair to report a story going the other way, related on a Scientific American blog by Judy Stone, MD:

This past summer, I went to India to volunteer at a hospital and to try and help them with their self-identified problem with tuberculosis. There was considerable debate as to whether or not IRB approval was necessary—my infectious disease colleagues felt it was not, as it was part of a public health initiative and the "research" was no different than that conducted every day in public health departments. The social science types at the U.S. university I was working with all insisted we obtain IRB approval, a time-consuming and, in some settings, expensive process. (Many IRBs levy an administrative charge of $1-2,000 per study). And the folks in India could have cared less, nor did they understand the fuss, as there is next to no patient privacy in their crowded facility, nor was it culturally relevant. All they wanted was help caring for their patients.

Stone does not relate what happened next: whether she did, in fact, seek IRB approval, and--if so--what level review she received or what kinds of restrictions she faced.

Ultimately, Stone blames not the social science types but flaws in the regulations and laws, especially HIPAA, which she blames for "failing to provide any protection for clinical research subjects [while] increasing research costs and probably reducing participation . . ." She hopes "that reason will prevail, and the HIPAA rules will be eliminated for clinical research."

First, Do Some Harm, Part III: Loosies in San Francisco

The third recent document illustrating the problem of applying the Hippocratic maxim to non-medical research is Leslie E. Wolf, "The Research Ethics Committee Is Not the Enemy: Oversight of Community-Based Participatory Research," Journal of Empirical Research on Human Research Ethics 5, no. 4 (December 2010): 77–86. It offers a clear example of the kind of valuable research that is impeded by simplistic medical ethics.
‌

U.S. Apologizes for 1940s Human Subjects Research

This is a little off topic for the blog, but today Secretary of State Hillary Clinton and Health and Human Services Secretary Kathleen Sebelius apologized to Guatemala for experiments done there in the late 1940s. Researchers led by a Public Health Service doctor conducted various studies of syphilis, some of which included the deliberate infection of people without their consent.

The story was brought to light by Susan M. Reverby, Marion Butler McLean Professor in the History of Ideas and Professor of Women's and Gender Studies at Wellesley College. Her article, "''Normal Exposure' and Inoculation Syphilis: A PHS 'Tuskegee' Doctor in Guatemala, 1946-48, will appear in the Journal of Policy History in 2011, in a special issue on human subjects research that I edited.

UPDATE: The New York Times has a more complete story, including a nice mention of the Journal of Policy History.

Study Finds IRBs Impose Inappropriate Forms and Guidelines

I thank Brad Gray for alerting me to:

Sarah Flicker et al., "Ethical Dilemmas in Community-Based Participatory Research: Recommendations for Institutional Review Boards," Journal of Urban Health 84 (July 2007); 478-493.

I do not have access to the full article, but here's the abstract:

National and international codes of research conduct have been established in most industrialized nations to ensure greater adherence to ethical research practices. Despite these safeguards, however, traditional research approaches often continue to stigmatize marginalized and vulnerable communities. Community-based participatory research (CBPR) has evolved as an effective new research paradigm that attempts to make research a more inclusive and democratic process by fostering the development of partnerships between communities and academics to address community-relevant research priorities. As such, it attempts to redress ethical concerns that have emerged out of more traditional paradigms. Nevertheless, new and emerging ethical dilemmas are commonly associated with CBPR and are rarely addressed in traditional ethical reviews. We conducted a content analysis of forms and guidelines commonly used by institutional review boards (IRBs) in the USA and research ethics boards (REBs) in Canada. Our intent was to see if the forms used by boards reflected common CBPR experience. We drew our sample from affiliated members of the US-based Association of Schools of Public Health and from Canadian universities that offered graduate public health training. This convenience sample (n = 30) was garnered from programs where application forms were available online for download between July and August, 2004. Results show that ethical review forms and guidelines overwhelmingly operate within a biomedical framework that rarely takes into account common CBPR experience. They are primarily focused on the principle of assessing risk to individuals and not to communities and continue to perpetuate the notion that the domain of “knowledge production” is the sole right of academic researchers. Consequently, IRBs and REBs may be unintentionally placing communities at risk by continuing to use procedures inappropriate or unsuitable for CBPR. IRB/REB procedures require a new framework more suitable for CBPR, and we propose alternative questions and procedures that may be utilized when assessing the ethical appropriateness of CBPR.