More Comments on Maryland's IRB Law

In January 2008, I commented on Adil E. Shamoo and Jack Schwartz, "Universal and Uniform Protections of Human Subjects in Research," American Journal of Bioethics 7 (December 2007): 7-9. That essay applauded a 2002 Maryland law that seeks to impose federal regulations on all human subjects research conducted within the state, even if not conducted at an institution with an FWA. As I noted at the time, the law is of dubious constitutionality, and it has probably survived this long only because it has never been enforced.

The November 2008 issue of the same journal reprints the Shamoo/Schwartz essay as a "target article," along with eight invited commentaries. Several of the commentaries complain that the federal regulations--and therefore the Maryland law--are insufficiently protective, rather than overly broad, but none of these address social science.

Three commentators do address Shamoo and Schwartz's failure to consider the impact on social science research. Neil W. Schluger complains that "their solution will do very little to protect human subjects, and perversely, it may actually make the situation worse by simply piling more studies into an overburdened and flawed system." (13) He notes that

a very large percentage of studies that IRBs review are studies involving minimal risk to subjects. Many of these are observational studies, reviews of existing data, studies in which the only intervention is administration of a questionnaire, or other types if studies where there really is no reasonable expectation that any harm could result. Although such studies can be reviewed by the use of expedited review procedures without convening the full IRB, they still require considerable administrative and regulatory oversight by IRB staff. Further efforts should be made to reduce the work associated with these harmless studies. (14)

David B. Resnik notes that the idea of regulating all research nationwide has been kicking around since 1995, and has been the subject of six failed bills in Congress. But, he continues, "it is not obvious that society would gain much by requiring an organization, such as Gallup or ABC News, to submit a proposal to an institutional review board (IRB) to conduct an anonymous survey each time that it decides to gauge public opinion on a particular issue. Social resources might be better spent overseeing riskier research, such as clinical trials." (6) He concludes that "Any proposal that is made into a law should include adequate provisions for exempting some low risk research and clarifying the definitions of important terms." (8)

Lisa M. Rasmussen complains that the Shamoo/Schwartz position "makes no distinction between highly risky biomedical research and, on the opposite end of the spectrum, research that involves no more risk than we all accept daily. Does beneficence really require that human subjects be protected from answering questionnaires or being interviewed? If so, why does this protection not extend to marketing, polling, or journalism?" (18)

Instead, Rasmussen proposes

the one-time approval of research “templates.” Taking advantage of the fact that a great deal of research follows traditional disciplinary methods, this model suggests that IRBs could approve a variety of research templates (written, for example, by discipline-specific bodies such as the American Psychological Association (Washington, DC), or by a researcher whose classes may repeat experiments semester after semester), and grant automatic exemption to any researcher using such templates. Accountability and oversight could be ensured by requiring the researcher to submit a simple form to the IRB agreeing to use such a template (which would also include provisions for protecting confidential data). Were this form electronically based, research could proceed as soon as the form was submitted, without requiring submission of a protocol or awaiting approval. This achieves the goals of both minimizing bureaucracy and protecting human subjects. It meets our moral obligations to human subjects of research without uniformly requiring IRB oversight of research. (18)

Rasmussen concludes that "universal and uniform regulation of all human subject research is well-meaning but un-nuanced." (18)

It is a pity that the journal does not print a reply by Shamoo and Schwartz. As I noted in my post last year, Shamoo himself has suggested that what he terms "low-risk research" is overregulated. I remain puzzled why he favors state laws that promise even more regulation of such research.

How State IRB Laws Threaten the Social Sciences: A Comment on Shamoo and Schwartz

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.