(This is the second of two posts on the recent report of the Presidential Commission for the Study of Bioethical Issues regarding protections for human research participants. The first post is available at this link.)
The Hastings Center Report, the preeminent bioethics journal, requires all contributors to disclose any potential conflicts of interest they might have regarding the subjects of their submissions. The journal defines “conflicts of interest” as “any personal or professional affiliations, any financial interests, and/or any past, present, or anticipated activities that may compromise the quality or objectivity of a manuscript or review.” It offers authors the following rule of thumb when determining what interests to declare: “Is there anything [that] would likely cause readers to second-guess your objectivity if it were to emerge after publication?” If, for example, an author argues that existing protections for human research participants are fundamentally sound and robust, a reader might find that conclusion less credible if she knows the author leads an institution that earns significant sums of money from conducting human subjects research.
In other words, if President Obama’s ethics commission (the PCSBI) had sought to publish their report on protections of human research subjects in The Hastings Center Report, The American Journal of Bioethics, or many other academic journals, the Commissioners would have been required to disclose any interests that might undermine the objectivity of their analyses and recommendations. A cursory glance at the PCSBI’s roster suggests several members would have had substantial interests to declare.
The purpose of the PCSBI’s report was to evaluate the adequacy of protections for human research participants. Several of the Commissioners either personally conduct such research or oversee institutions that do:
- The PCSBI’s chair, Amy Gutmann, is President of the University of Pennsylvania, which conducts many clinical trials — including the 1999 gene therapy trial that suffered from “a litany of deficiencies” and resulted in the death of Jesse Gelsinger.
- The vice chair, James Wagner, is President of Emory University, which likewise has an enormous financial interest in clinical trials. Emory is also the institution that failed to take meaningful action against Dr. Charles Nemeroff after the University’s own conflict of interest committee “detailed multiple ‘serious’ and ‘significant’ violations of university procedures intended to protect patients.”
- Commissioner Barbara Atkinson, the Executive Vice Chancellor of the University of Kansas Medical Center and Executive Dean of the University of Kansas School of Medicine, leads an institution that is currently knowingly allowing a researcher with a fake PhD to serve as principal investigator of an experiment on pregnant women and their fetuses.
In sum, these are quite literally the people and institutions that federal regulations are designed to protect research participants from. They are also the people and institutions that would be subject to any regulatory changes that might result from the PCSBI’s recommendations. If, for example, those regulations made clinical trials more expensive, or exposed research institutions to greater liability or other penalties, those increased expenses would likely affect the bottom lines at places like Penn, Emory and the University of Kansas. Yet I’ve been unable to find any acknowledgement of these potential conflicts in the PCSBI’s report, on its website, or in the transcripts of its public meetings.
Perhaps the Commission has thought deeply about potential conflicts among its members. Perhaps they determined there were none, or have implemented protections to guard against their influence. But without disclosing any of that information, there is no way for the public to assess the objectivity of the PCSBI’s report or the adequacy of any steps it has taken to address potential conflicts. Instead one is left to wonder whether the Commission’s general endorsement of existing protections for human subjects research, its meager recommendations for change, and its deference to the pharmaceutical industry may have been influenced by some Commissioners’ substantial institutional interests in the rules governing clinical trials.
At the very least, the PCSBI should publicly address any conflicts of interest among its members and describe the Commission’s conflicts policies. A Presidential commission — particularly a commission on ethics — should adhere to ethical standards that at least match, if not exceed, the baseline requirements for publishing in academic journals. As Dr. Gutmann herself has said, “The more transparent and open our deliberations . . . the better our recommendations will be.” Failing to heed that advice opens the door for guys like me to write posts like this.
That said, it is far from clear that merely disclosing such conflicts would be sufficient to protect against bias in the task of assessing the adequacy of protections for research participants. Paradoxically, research suggests that rather than reducing bias, “disclosure [of an advisor's conflict of interest] can increase the bias . . . because it leads advisors to feel morally licensed and strategically encouraged to exaggerate their advice even further.” Accordingly it is reasonable to ask whether conflicted Commissioners should have recused themselves from participating in the human subjects investigation, in order to promote public confidence in the objectivity of the PCSBI’s report. Simply disclosing conflicts of interest does nothing to mitigate the inherent dubiousness of entrusting the evaluation of human subjects protections to the leaders of the very institutions that are experimenting on people.
Ironically, the government originally asked the Institute of Medicine to conduct the investigation of the Guatemala syphilis study — the scandal that prompted this review of human subjects protections. The Obama administration decided to transfer that responsibility to the PCSBI because “the government learned that the Institute of Medicine had identified a potential conflict of interest owing to an historical overlapping personal relationship between its leaders and funders of the research in Guatemala.” Consequently, President Obama transferred the investigation to the PCSBI “to ensure the integrity of the investigation and to assure its independence.” In light of this history one would have expected the Commission to be acutely aware of the need to address potential conflicts of interest among its members.
The PCSBI’s Commissioners are probably well-meaning, ethical people. But the purpose of conflict of interest rules isn’t merely to police bad actors, but to help good actors police themselves against improper — and unconscious — influences. It would be nice to see some evidence that the Commissioners are doing that.
(Note: I’ve made a couple inquiries to the PCSBI’s staff about how the Commission is dealing with potential conflicts of interest, but have yet to hear back from them. If I get a response, I’ll post it in the comments below.)