5 Questions With . . . Laura Stark on Human-Subject Regulations

Assistant Professor Laura Stark hopes her new book can inform scientists, scholars, students and research participants of new research regulations created by the Office of Human Research Protections.

In this issue of The Wesleyan Connection, we ask 5 Questions of Laura Stark, assistant professor of sociology, assistant professor of science in society, assistant professor of environmental studies. Stark recently published a new book, Behind Closed Doors: IRBs and the Making of Ethical Research.

Q: Professor Stark, what inspired you to study institutional review boards (IRBs), which regulate research on human subjects?

A: I first became interested in this project in 2002 because of a great coincidence of scholarship. At the time, I was reading historical works that explained why the Nuremberg Code after World War II had so little effect on medical research in the U.S. I was also going through IRB training to conduct interviews as part of a research study, and found that the IRB training manuals attribute the modern origins of American research ethics to the Nuremberg Code. The two contradictory accounts intrigued me. I am generally interested in how new knowledge is produced in science and medicine, and I also think it’s important to use research methods appropriate to the question at hand (which is why I use both ethnographic and historical methods in the book). As a result, I started to explore how the ethics evaluation process developed historically and how it works today, and investigate the conflicting accounts of the importance of the Nuremberg Code.

I was excited at the prospect of exploring uncharted territory by observing IRB meetings and reconsidering the history of IRBs using new historical materials from the National Institutes of Health.

Q: What was most striking about the IRBs you observed?

A: As an ethnographer, I was struck by how similar these different IRB “field sites” felt to me. Each was a day’s drive from my home, each was composed of quite different individuals, and each used a lot of discretion in evaluating researchers’ proposal. Yet their methods for reaching decisions were remarkably similar. The three boards didn’t communicate with each other and they certainly weren’t trying to model on each other, and yet they use similar decision-making techniques.

As I argue in the book, these similarities are a function of the common configuration of IRBs all around the country. Since 1966, The U.S. surgeon general has required all universities, hospitals and other organizations that receive federal funding for research on people to get prior approval from a human-subjects review committee. In 1974, the Office of Human Research Protections enacted formal regulations of these boards, dictating how many people may sit on a board, who can serve, and how they should interact.

All boards are comprised of members who have expertise in different fields. Each member tries to persuade the group that his position is the right one, based on his own expertise, and the entire board must reach a consensus at the end. About 95 percent of the time, boards will approve a study with modifications; outright approvals or denials are rare. In this way, IRBs play a critical role in shaping the direction of research in this country. They aren’t involved in the research taking place, but they have a hand in determining how it is conducted.

Q: Do you find IRBs to be an overall effective model of regulating ethical research on human subjects, and where do you see room for improvement?

A: The Office of Human Research Protections is overhauling research regulations this year, and I hope my book can inform changes that are productive for the entire research community—scientists, scholars, students and research participants alike.

I find it very interesting that we’ve come to define “ethical research” as “research that has been approved by an IRB.” I don’t think those two should necessarily be synonymous. I’d like to see the revised regulations open up our definition of ethical research. Currently, all research involving human beings must go through an IRB, but I’d like to explore whether we can carve out areas where that’s unnecessary. For example, oral history and observational research could be potential exceptions. Research performed by students could be another.

Q: What advice would you give a fellow researcher who is preparing to submit a research proposal to an IRB?

A: I am eager for my book to be a resource for researchers. Here are a few pointers (based on my experience with IRBs generally, not specifically with Wesleyan’s IRB):

• Familiarize yourself with the regulations and interpret them conservatively. Reviewers often take this as a good-faith effort to engage the ethics review process. Moreover, by proposing ethics practices you find workable, you can avoid having the board impose practices.

• Consult with administrators before submitting a study for review. Ask for points of clarification or suggestions on how to meet your research needs within the regulations’ framework.

• In your application, cite examples of studies (especially published studies) with a similar research population and method as your own. Provide evidence of research participants’ experiences in similar studies to justify the level and types of risks and benefits they can expect. If no similar studies exist, you can propose conducting a brief pilot study, or volunteer to allow reviewers to follow up in the early stages of the full study.

• Remember that IRB members are above all concerned with the quality of the consent process. Give priority to consent procedures (which do not necessarily have to include a signed form).

• Attend review meetings when possible, or send a proxy. Regulations require that these meetings be open to the public, even if they’re customarily held in closed session.

Q: Please tell me about the oral histories you’ve been conducting with people who served as healthy research subjects at the NIH Clinical Center in the 1950s and 1960s.

A: For my next book project, I am interested in studying how people’s sense of what constitutes ethical medical research has changed profoundly since World War II. With help from my two excellent research assistants, Eliana Theodorou ’12 and Erin Kelly ’12, I am tracking down and interviewing people who served as “normal control” research subjects at the NIH Clinical Center during the Cold War decades. “These individuals—members of the Brethren and Mennonite churches in the early years—were religious objectors to the Korean War, and were allowed to fulfill their service by living at the research hospital and serving in experiments. In the mid-1950s, NIH changed federal policies to allow research to be conducted on all healthy civilians, not only conscientious objectors After that, other members of the church agreed to participate as part of Christian mission work. Then the program expanded to college students—in one of the earliest unpaid internships programs!

I’ve collected more than 50 oral histories and supplementary documents, which I plan to compile in a digital archive. I will write a book on the experiences of the “normal controls” based on these materials, which I hope will encourage people to rethink the history of postwar medicine by considering the perspective of the research participants.