Dr. Adil E. Shamoo of the University of Maryland School of Medicine kindly sent me a copy of his new article, "Universal and Uniform Protections of Human Subjects in Research," The American Journal of Bioethics 7 (December 2007): 7-9, co-authored with Jack Schwartz of the Maryland Attorney General’s Office.
The article calls for a federal law "to require that all human subject research in the United States, regardless of funding source or relationship to FDA marketing approval, be undertaken only after IRB review and with the informed consent of subjects." Barring that, it applauds state laws to that effect, such as the one passed in Maryland in 2002, which states that "a person may not conduct research using a human subject unless the person conducts the research in accordance with the federal regulations on the protection of human subjects . . . notwithstanding any provision in the federal regulations on the protection of human subjects that limits the applicability of the federal regulations to certain research . . . ." (13 Maryland Code §13-2002)
Having read the current New Yorker's story on "Guinea-Pigging," which states that 70 percent of drug trials now take place in the private sector, I can see the reason to regulate biomedical research through the state's police power, rather than through funding restrictions. But aside from a quick mention that research sponsored by the National Endowment for the Humanities is not subject to the Common Rule, the article does not mention the law's effect on the humanities and social sciences. This is a bit surprising, given Shamoo's earlier argument in the Chronicle of Higher Education that human subjects regulations "have handicapped researchers whose work poses no threat to humans." This being the case, why would he want to extend those same regulations to countless researchers not previously covered by them? And do the authors expect all journalists and oral historians in the state to be subject to IRB review, the way that many university-affiliated journalists and oral historians are now?
I wrote to both authors, and here is what I learned from them:
* Shamoo does not believe that the law requires Maryland journalists to seek IRB approval of their work.
* Schwartz does not believe that the law requires Maryland oral historians to seek IRB approval of their work, relying on a 22 November 2005 message from Michael Carome of OHRP.
* According to Schwartz, "The Maryland law, like every bill passed by the Maryland Legislature, was reviewed for constitutionality. This overall review did not address whether some hypothetical application of the law, under a specific set of facts, might raise First Amendment or other constitutional concerns."
* According to Schwartz, the Maryland attorney general's office has not brought any enforcement actions since the law's passage in 2002.
This last point is the key; a law that lies dormant for five years is unlikely to have any effect on anybody, so perhaps Shamoo and Schwartz have reason to think it will not handicap researchers more than they already are handicapped by existing federal regulation. Indeed, the legions of journalists, book authors, and market researchers who conduct interview and survey research outside of universities may have little to fear from a law that has not been enforced and might well fail constitutional scrutiny if it were.
But Shamoo and Schwartz ignore the potential effect of the law on social science and humanities researchers within universities, the very ones for whom Shamoo earlier expressed concern. These researchers have led a growing movement to get their universities to agree to review only research funded by the federal government. Such a move would free few, if any, university-affiliated biomedical researchers from oversight, since their expensive research is generally federally funded. Rather, it would free up the very kind of research that Shamoo considers too low-risk to merit review. But if the state imposes the same regulations regardless of the source of funding, university IRBs can close this door.
Thus, if the law has any effect at all, it will not be what Shamoo and Schwartz claim: "universal application of the ethical standards applicable to human subjects research." Instead, it will be the continued regulation of research by university-affiliated researchers while non-affiliated researchers conducting the same activities work in freedom. The result will not be uniformity, but entrenched disparity.
Shamoo's heart is in the right place. As he wrote in his Chronicle piece, "I have long advocated the creation of universal rules for all human-subject research, whether or not it receives federal funds. But an equally urgent reform is to exempt from present and future regulation any research that poses little or no risk to human subjects." Unfortunately, the state of Maryland has not treated exemption of social research as "equally urgent" to the universalization of rules. Thus, the effect of the law, if any, is to eliminate a path to the very type of exemption that Shamoo champions. Once again, regulators write rules in response to serious concerns about medical experimentation, with little or no attention to the social sciences and humanities.