Wednesday, January 30, 2008

Must Employees Consent?

Two recent items concerning IRBs and studies of job performance caught my eye.

The more prominent item was a December 30, 2007, New York Times op-ed, "A Lifesaving Checklist" by Dr. Atul Gawande. Gawande describes efforts by the Johns Hopkins University and the Michigan Health and Hospital Association to offer five-step checklists to intensive-care providers, to help them remember to wash their hands and take other steps to avoid infection. OHRP shut the project down, even though it had been ruled exempt by the Hopkins IRB. (So much for local control.)

Although I try to keep this blog focused on issues concerning the humanities and social sciences, and to avoid issues concerning strictly medical research, I was struck by OHRP's determination that "the subjects of the research were both the healthcare providers at the participating ICUs and their patients." Are healthcare providers really human subjects in a case like this?

A similar question arose in a non-medical setting a few weeks later. In her pseudonymous blog on Education Week, eduwonkette complained that New York City teachers were being studied without their consent and without the approval of an IRB. Since eduwonkette herself concedes that "teachers did not need to consent in this case, as they are government employees and their employers can collect whatever data they want," I don't understand why she thought an IRB should be involved. But it does suggest that the question of studying employee effectiveness is not limited to medical contexts.

Poking around in my research notes, I find that at the July 1977 meeting of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Dr. Karen Lebacqz raised just this issue as a hypothetical:

"Suppose you want to do a study that involves changing the delivery of services in a mental institution ward. The patients in the institution are the ones that you want to study in terms of what the impact is on their recovery rates and so on. The staff who work on that ward will also be very directly impacted by the research. Do they constitute subjects, even though the design and the purpose of the research is not set up to study the impact on them of what you are going to do?"

While Albert Jonsen initially suggested that the staff would constitute subjects, other commissioners disagreed:

Lebacqz. “There is a very direct impact on the licensed staff.

Ryan. “Then the administrator can force it on them as a condition of employment.

Turtle. “Yes, I was going to say, that is the whole key, it is a condition of employment. Many things that, while I am a great libertarian here, lots of things I ask the people who work for me to do, I don’t ask them for their informed consent.”

[National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Transcript, Meeting #32, July 1977 (Bethesda: The Commission, 1977), 133-135.]

After this exchange, the commission moved onto another subject, suggesting a consensus that employees are not human subjects whose informed consent is required. In its recent determination letters on the checklist project, OHRP has ruled the opposite.

I don't expect the compliance officers at OHRP to be familiar with the commission's deliberations, and I fault the commission for not defining human subjects more carefully. But it's worth noting how far OHRP has strayed from the commission whose work nominally informs its decisions.

Monday, January 21, 2008

How IRBs Decide--Badly: A Comment on Laura Stark's "Morality in Science"

Laura Stark's recent essay in Law & Society Review led me to her 2006 Princeton University dissertation, "Morality in Science: How Research Is Evaluated in the Age of Human Subjects Regulation." The heart of the dissertation is her description of the workings of three university IRBs--one in a medical school and two at universities without medical schools--based on recordings of their meetings and her direct observation of the IRBs at work. It makes for fascinating reading, and I applaud Stark for her achievement even as I disagree with her conclusions.

Stark claims to be neutral about IRBs' ability to perform their stated task: protecting the subjects of research. She writes, "My goal is not to judge the 'fairness' and 'effectiveness' of IRBs myself." (7) And she correctly notes that the ethical acceptability of an IRB-approved project is a "social truth," not an empirical one. (244) But her tone is generally sympathetic to the IRBs. For example, she writes that IRBs' "forms of evaluation provide directed, tangible ways for board members to carrying out their review process, given the practical difficulty of applying unmediated, abstract ethics principles," making the IRB members sound like heroes who have achieved a workable system against the odds. (186)

Indeed, in some cases she reports, IRBs seem to be doing some good. For example, a physiologist and a nurse had a fruitful debate about the need for a quick medical screening of subjects in an exercise study (197-200). That's an example of an IRB with multiple experts on a single type of research--something I hope is reasonably common in much biomedical research. But most of Stark's observations are distressing in ways I don't think she appreciates. Here, then, are some of the actions she observed, along with my reasons for finding in them an indictment of the IRB system as presently run.

Sunday, January 13, 2008

Johns Hopkins Dean: Generalizable Means "Hypothesis-Based"

In his comments on Inside Higher Ed's recent story on oral history and IRBs, Eaton Lattman, Dean of Research at Johns Hopkins Krieger School of Arts and Sciences, writes that "many oral history projects probably do not meet the OHRP definition of research, and are therefore free from the need to go to an IRB for approval. They are not hypothesis-based projects and they do not produce generalizable results."

This interpretation of generalizability is consistent, as best I can tell, with the intent of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which first established generalizability as part of the definition of human subjects research. It also resembles Columbia University's recent statement on oral history.

Dean Lattman's comment contrasts with definitions put forward by Michael Carome of OHRP and consultant Jeffrey Cohen, who maintain an oral history project is generalizable research if it lacks a hypothesis but draws conclusions, informs policy, or creates an archive for use by future researchers.

Thus, Hopkins joins Columbia and Northwestern in explicitly freeing oral history--as practiced by oral historians--from IRB review. While such advances are welcome, more welcome still would be a statement along the same lines from OHRP itself.

Sunday, January 6, 2008

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.

Friday, January 4, 2008

Inside Higher Ed Reports on Comments to OHRP

Scott Jaschik's January 3 Inside Higher Ed story, "Threat Seen to Oral History," reports on the comments submitted to OHRP by the AHA and by me. The story is a helpful summary of key issues, and the comments following it indicate the passion this issue arouses in scholars in a range of fields.