Your second point raises the possibility that leading a university that earns substantial sums from conducting clinical trials may not represent a conflict with respect to examining the adequacy of research subject protections. You suggest tougher rules might not harm research universities because the rules would apply to all universities competing for clinical trials. That seems plausible if clinical trials take place in an efficient market. But it seems equally likely that uniformly-applied, expensive new rules would simply cut universities’ margins across the board. It also seems reasonable to expect that university administrators (and their legal counsel) generally would not favor new rules that would subject them to heightened litigation risks or federal penalties, regardless of whether other universities were subject to the same increased risks. Similarly, I think we would have reason to be skeptical of, say, PhRMA’s recommendations regarding human subjects protections even if any resulting regulations were applied to all competing drug companies.

In addition to having an interest in avoiding increased risks and operating expenses, university presidents have a strong interest in protecting their institution’s reputations. Had the PCSBI chosen to include in its report notable cases of unethical treatment of research subjects in federally-funded research, it wouldn’t have had to look far. But, incredibly, a report whose sole purpose was to assess the adequacy of research participant protections does not describe a single instance in which those protections failed or researchers acted unethically. Was that decision influenced by the fact that going down that road might have led to Penn’s and Emory’s own doors — e.g., in the death of Jesse Gelsinger and the failure to enforce ethics rules against Dr. Nemeroff? Who knows? But a reader might be forgiven for believing that the leaders of these institutions aren’t eager to keep these incidents in the public eye.

If some Commissioners had interests that conflicted with undertaking an objective assessment of human subjects protections, should those interests have been disclosed? As I read The Hastings Center Report’s rules, I believe disclosure would be required in this case, but obviously I can’t answer on the editors’ behalf. (I’ve sent an inquiry to the journal and will post the answer here if I receive one.) You raise an interesting suggestion that the Commissioners need not disclose their conflicts because they’re obvious to readers, in the same way that one would understand the position of a priest reporting on misconduct at a church. I don’t think the conflicts of the Commissioners in this case are similarly on display. The fact that James Wagner leads a university does not make clear that he oversees an institution that conducts clinical trials (many universities don’t), let alone the fact that Emory is “the nation’s fourth leading contributor to drug discovery among U.S. public-sector institutions,” that it “has received more than $788M in licensing fees from commercialized products,” or that it “continues to receive approximately $20M a year via licensed products.”

But ultimately the deeper problem here isn’t as much about disclosure as about whether leaders of institutions that earn millions from conducting clinical trials should be participating in — and, indeed, directing — an ostensibly independent assessment of human subjects protections. I would suggest they should not for the same reasons we shouldn’t trust oil companies to evaluate our environmental protection laws, and we wouldn’t put foxes on a Presidential Commission for the Study of Henhouse Protection Issues. In my view the historical conflicts that prevented the IOM from studying the Guatemala scandal pale in comparison to the current conflicts of several members of the PCSBI.

(1) I understand your interpretation of the Hastings Center Report conflict-of-interest rules. But are those rules ordinarily interpreted to require a disclosure when a president of a research university or an actual researcher writes about regulations on experimental research? It may not be enough to find some cases where there are such disclosures because authors might be excessively cautious. To find an important omission on the part of PCSBI members, it would be more convincing if you could show that researchers rarely *fail* to make such disclosures.

(2) Given that research universities are, in some respects, competing against each other for research dollars, if the rules got stricter, would they really have that much of a negative impact on research universities? Or would the fact that everyone would be subject to the same rules largely soften their impact on any particular school?

(3) Could one argue that the disclosures need not be made because anyone who has the objectivity concerns that you have can see them just by looking at the bio information that (I presume) is in the report? Suppose, for example, that a catholic priest conducts an investigation into an alleged church sexual abuse case. Wouldn’t the fact that the priest makes clear that he is, in fact, a priest suffice to disclose at least some potential conflict in the investigation? In other words, might disclosures be more important in cases where potential conflicts of interest are more difficult to spot, as where a person has a non-public relationship with a pharmaceutical company that stands to profit from the publication?

-Adam Kolber