The primary responsibility of any institutional review board (IRB) is to protect research subjects. However, a study published in the March-April 2011 issue of IRB: Ethics & Human Research suggests that IRB members feel pressure from multiples charges and potentially conflicting goals.
Ann Freeman Cook, PhD, and Helena Hoas, PhD, both from the National Rural Bioethics Project at The University of Montana in Missoula, interviewed a board member or chair from 40 IRBs in diverse healthcare settings. The interviews relied on a standard instrument with 14 open-ended questions covering a variety of issues, including how the board deals with conflicting interests.
The answers are far from comforting.
“Regardless of the type of IRB they served on [independent, academic, medical school, hospital, or community/tribal], respondents acknowledged the tension created by the competing goals of protecting research participants and facilitating the research enterprise,” the authors write.
Despite the fact that all respondents acknowledged that clinical research can generate income for an institution or an individual researcher, some boards consider the topic off limits. For example, the study authors quote one interviewee from a hospital IRB as saying “‘[compensation for the researcher] is not discussed, not discussed at all. It is definitely something that in our environment people don’t want to talk about. It is the unknown.’”
Other interviewees said that asking about such issues would be seen as “obstructing the interests of the researchers and their institutions,” according to Drs. Cook and Hoas.
Meanwhile, however, all of the IRB members interviewed said their boards have to rely in good part on the researchers to ensure that the consent process is carried out ethically. The boards do pay substantial attention to the consent forms, but, members acknowledged in the interviews, that is only part of the consent process. And few boards have the ability or time to monitor how the researchers perform the consent process.
In an email interview, Dr. Hoas said she thinks the increasing amounts of money in research and medicine exacerbates the conflicts for IRBs. “We heard statements like ‘It is not the IRBs’ responsibility to only protect human subjects. They have multiple missions,’” Dr. Hoas wrote.
Dr. Hoas’s view, however, is clear from the next comment in her email: “As far as we can tell, that is not the intention of the legislation and the Common Rule.”
Yet, she notes, there has been little research into the impact of potential conflicts. And, as the authors write in the paper itself, there is no current guide for IRBs regarding how much financial information they should ask for or consider when reviewing a study.
Drs. Cook and Hoas did not include information about whether the IRB members interviewed were employees of the institution or if they were a community representative. Given the potential for institutional conflict of interest (see my previous post), it would be interesting to know if community members have different concerns or views regarding potential conflicts. For example, do they feel they can resist pressure from the institution to approve studies, or do these members feel a need to go with the flow of the overall board?
The authors acknowledge that the study, which used a convenience sample, could be subject to self-selection bias. Yet, imperfect as the study may be, I think it raises important issues about the independence of IRBs and about their ability to put patients first.