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.]

Washington Post Confuses "Research," "Experiment," and "Medical Experiment"

On January 1, the Washington Post ran an editorial, "Medical Experiments on Humans," claiming that "in 2010, the federal government funded 55,000 experiments worldwide on human subjects" and citing "Moral Science."

But "Moral Science" does not make that claim. Rather, it states that "The federal government supported more than 55,000 human subjects research projects around the globe in fiscal year 2010, mostly in medical and health-related research, but also in other fields such as education and engineering." It does not break the 55,000 figure into experimental and non-experimental approaches.

The editorial shows some awareness of the complexity of human subjects research, noting that many people "take part in projects fueled by federal dollars that focus on social science and education research." But the editorial's headline, "Medical Experiments," does not match the data in the body of the editorial. As we proceed with regulatory reform, I hope editorial boards will learn to read and write more carefully.

The Ethical Imperialism of Moral Science

I have posted extended comments about Moral Science as

Zachary M. Schrag, "The Ethical Imperialism of Moral Science," Bioethics Forum, 4 January 2012.

Does Moral Science Think the System is Working?

I am struggling to understand an apparent contradiction in the Presidential Commission's report, Moral Science.

On page 42, we learn that

The current U.S. system provides substantial protections for the health, rights, and welfare of research subjects and, in general, serves to "protect people from harm or unethical treatment" when they volunteer to participate as subjects in scientific studies supported by the federal government.

But on page 55, the report concedes that

There remains a dearth of knowledge about the actual efficacy of human subjects protections. Given this, the Commission recommends that the federal government support an expanded operational research agenda to study the effectiveness of human subjects protections.

If there is a dearth of knowledge about the actual efficacy of human subjects protections, how could the Commission conclude that the current system serves to protect people from harm or unethical treatment?

And if there is a dearth of knowledge about the actual efficacy of human subjects protections, why does the Commission recommend that the federal government "require that all federal agencies conducting human subjects research adopt human subjects regulations that are consistent with the ethical requirements of the Common Rule"?

Presidential Commission Prescribes Medical Ethics for Everyone

The Presidential Commission for the Study of Bioethical Issues has released a 200-page report, Moral Science: Protecting Participants in Human Subjects Research. Continuing a decades-old tradition, the report treats medical experimentation as the model for all research with human beings, ignoring the rights and responsibilities of researchers in other fields.

[Presidential Commission for the Study of Bioethical Issues, Moral Science: Protecting Participants in Human Subjects Research, December 2011]

Emanuel: ANPRM Will End Reliance on Worthless Gut Reactions

I watched the webcast of this morning's appearance by Ezekiel Emanuel before the Presidential Commission for the Study of Bioethical Issues. There were no huge surprises in Emanuel's presentation; much of it repeated points he had made in the New England Journal of Medicine. But I found some of his remarks, and the Commission's response, noteworthy.

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.

The CITI Program as Mortifyingly Stupid, Marxist Doxology

The Presidential Commission for the Study of Bioethical Issues has posted videos and transcripts of its Meeting Five, held May 18 and 19 in New York City. I earlier linked to the Commission's summary of the statement by Ronald Bayer, professor and co-chair of the Center for the History of Ethics of Public Health at the Mailman School of Public Health at Columbia University. Now that we have the verbatim text, it is worth quoting as well.

Overall, Bayer lamented that the IRB system has "turned itself into an object of ridicule and sometimes contempt in a way that I think is dangerous to those who believe in the ethical conduct of research."

Particularly choice is Bayer's description of the CITI Program, a widely used online training course in research ethics, which Columbia University requires researchers to complete every three years.

Ethics Experts Stupefied by a "Nitpicking Monster"

blog.Bioethics.gov, the official blog of the Presidential Commission for the Study of Bioethical Issues, reports on two experts' frustration with the gap between the good intentions behind the IRB system and the depressing reality faced by researchers.

My Comments to the Presidential Commission

I rather belatedly learned that the Presidential Commission for the Study of Bioethical Issues was seeking public comment on the Federal and international standards for protecting the health and well-being of participants in scientific studies supported by the Federal Government. The deadline for comments is tomorrow, May 2.

Here are my comments, hastily cribbed from the conclusion of my book:

Bioethical Issues Commission Narrows Scope of Investigation

In January, I complained that President Obama had asked the Commission for the Study of Bioethical Issues for "a thorough review of human subjects protection to determine if federal regulations and international standards adequately guard the health and well-being of participants in scientific studies supported by the federal government."

Obama’s Impossible Request

Bioethics Forum has published my essay, "Obama’s Impossible Request," which concerns the president's November 24 charge to the Presidential Commission for the Study of Bioethical Issues.

President Obama asked the commission for "a thorough review of human subjects protection to determine if federal regulations and international standards adequately guard the health and well-being of participants in scientific studies supported by the federal government." I term this an impossible request.