Conflict-of-interest report includes IRB guidelines
IRBs should work closely with conflict committees
A recent report offers universities, researchers, and IRBs guidance in navigating the tricky channels created by increased funding and collaboration in research by universities and private industry. "One of the reasons for our taking up this issue of conflict of interest is that the number of collaborations between universities and industry and pharmaceutical companies has escalated," says Nils Hasselmo, president of the Association of American Universities (AAU) in Washington, DC.
The AAU formed a task force on research accountability that released in October 2001 the Report on Individual and Institutional Financial Conflict of Interest. "These collaborations have escalated, and we operate on the assumption that these are beneficial relationships, but they need to be monitored so credibility of research is not undermined," Hasselmo says.
The AAU’s motivation is both to offer universities guidance on how to protect themselves against having produced research where results were skewed because of an investigator’s personal financial interest and also to prevent the public from perceiving this to be the case when it isn’t true, Hasselmo says. Although the AAU report recommends universities form conflict review committees, it also notes the important roles that IRBs have in this process.
Disclose financial information
For example, one recommendation is that universities disclose financial information in the human participant review process, giving the campus IRB jurisdiction over determining whether a relevant financial interest should be disclosed to human participants in research. (See "Two points in the AAU report pertain to IRBs" in this issue.)
"Essentially, the bottom line is that there needs to be coordination between the IRB and the other entity with the institution that manages conflict-of-interest disclosure as it relates to how research is implemented," says Mark Brenner, PhD, vice chancellor for research and graduate education at Indiana University — Purdue University Indianapolis, and associate vice president for research for Indiana University in Indianapolis. Brenner was a member of the task force that wrote the AAU conflict-of-interest report.
Conflicts come in all sizes
Conflict of interest is not always of a financial nature. There also are conflicts of commitment, such as when an investigator is giving all of his or her attention to one project at the expense of other duties, notes David Skorton, MD, vice president for research at the University of Iowa in Iowa City. Skorton is a member of the AAU task force and the first president of the Association for Accreditation of Human Research Protection Programs, which is the first national accreditation program for human research programs. "Then there is the conflict of interest of resources," Skorton says. "Is the person using resources for his or her own good rather than for the university’s best interests?"
To meet National Institutes of Health requirements, most universities have a conflict-of-interest committee that focuses on financial conflicts, but the AAU report goes a step further: "What we’re saying in this document is that institutions should address conflict of interest regardless of funding, and that management needs to be done by a committee ideally," Brenner says.
For several reasons, it’s not a good idea to have the IRB fulfill dual duties and be the committee that looks at conflict-of-interest issues, as well as human subject protection, Skorton and Brenner say. "The AAU position recognizes that there is a lot more to this than what the IRB normally has to deal with, and we’d like to keep the IRB focused on protecting research participants," Brenner says. "But this has to be worked out according to what’s most appropriate for a research institution."
IRBs already are enormously burdened with their traditional responsibilities that will only increase, so there is no reason why they should be asked to take on the duties of a conflict-of-interest committee, which will review nonhuman research as well as research involving human subjects, Skorton says. "It’s not really fair to ask a group of people who were brought together in one area of human subject protections to review another area," he points out.
However, when the research involves human subjects then it needs to be coordinated between the conflict-of-interest review committee and the IRB, Brenner says.
Develop a strategy
Here are two strategies for how this can work, Brenner says:
• Model 1. Disclosures are sent through the general conflict review process, and when human subjects are involved, they refer it for additional review by the IRB. "They each have a certain level of independence, and one cannot overrule the other," Brenner explains. "So they each have the capacity to say No,’ or to say Modify,’ but one can’t speak on behalf of the other and say Go ahead and do it.’"
In this scenario, the disclosure would be submitted to the institution and conflict review committee, and they would make a determination of the appropriateness of the research activity by approving, disapproving, altering, or creating a management plan, Brenner says. "What I mean by that is they will impose the right kind of oversight to ensure objectivity is occurring, and they might put certain restrictions on how the work is done," Brenner says. Then the IRB will review the disclosure and research proposal in terms of risk vs. benefit, and they may want to further alter the management plan within the context of maximizing the protection of the human participants, Brenner says. "And there’s a further distinction: the IRB ought to seriously consider whether this financial conflict of interest should be disclosed to participants in the consent form and what the disclosure should look like," he says.
• Model 2. The second way this could work would be to have the initial disclosure sent to both the conflict review group and the IRB simultaneously. "Once they receive it, there would be coordination between the two committees," Brenner says. "Some will argue the first model is better because the heavy lifting can be done by the conflict review committee, and the IRB should do the reviewing afterward," Brenner says.
On the other hand, it may be more efficient to have both groups reviewing the research simultaneously, Skorton suggests. "It’s very reasonable to have both groups doing their things at the same time," Skorton says. "But it’s important [that] the IRB does not complete its work until the conflict-of-interest committee has spoken." Most institutions should have a routing procedure that begins when an investigator is applying for external funding, Skorton says. "They have to answer questions about whether a conflict exists by university definitions, but it’s also important to be concerned about conflicts that occur when research receives internal funding," Skorton adds.
Develop a set of questions
Here are two sample questions, regarding conflict of interest, that the University of Iowa uses on its IRB New Project application:
- Do you or any member of your research team have a conflict of interest regarding this study? (see www.uiowa.edu/~vpr/research/coi.htm)
- If yes, has the required University of Iowa Statement of Financial Interest Form been filed?
IRBs also should decide when to require investigators to disclose financial conflicts of interest to their research participants. "The inclination more often than not is to disclose the involvement," Brenner says. "If it’s an inconsequential relationship, but still has financial interest, and if the IRB feels there is no likelihood that the investigator is going to be influenced, then they may decide it may be more of a distraction to an already complicated consent form," he adds. Some IRBs will require all research with financial conflict of interest to be disclosed on consent forms because they believe it’s the research participant’s right to know, Brenner adds.
The AAU report doesn’t say which policy is better. "I think the feeling was on the task force that we didn’t want to second-guess the IRBs," Brenner says. "They understand the study and participant population and will come to an appropriate decision."
Financial conflict of interest among university-produced research was not an issue before 1980 when the Bayh-Dole Act was passed. The legislation gave intellectual property rights to universities for research conducted, resulting in the university’s ability to transfer the rights to industry for commercial purposes, Hasselmo says. "Before that, the intellectual property rights belonged to the federal government," he notes. As a result of the legislation, industries increasingly have funded research because they want access to what could be produced, and universities have a lot of expertise that could be useful to corporations, Hasselmo says. Although collaborations did exist prior to 1980, there was no big incentive for universities to become involved with research that could result in manufacturing a product, he adds.
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