Conflicts of Interest and IRB Reviews

As an IRB Chair, I'm confronting how to deal with conflicts of interest (COI) on the part of a researcher proposing a human subjects study. The physical risks in this case are minimal. But, the population is vulnerable and the main risk is that bad science could be misleading, causing subjects to spend their money on useless products. The project could raise unfounded hopes, or make important discoveries.

The initial response of the IRB and the institutional committee on COI was to require disclosure. But, this does nothing to protect a desparate patient. Management of the COI is needed. Once that is done, what the subject needs to know is that after considering the management steps, that the IRB approves of the study. I've come across this helpful document on COI from the National Human Research Protections Advisory Committee (NHRPAC) -- a letter from the committee regarding how to deal with COI in human subjects research.

Particularly helpful are the following statements (emphasis added):

NHRPAC would advise that in a research protocol in which an actual conflict of interest has been identified in the financial disclosure process, subjects could be advised in the informed consent process (and/or in the form itself) of the possible conflict and the nature of that conflict, with the terms, conditions and extent of disclosure calibrated by the conflict of interest committee and the IRB to correspond to the level of risk that the possible conflict poses. Conflict management strategies should also be disclosed, so that research subjects have general knowledge of the conflict of interest identification and management processes, and how those apply to the study in which the subjects is considering her enrollment. Conflicts management strategies may include, for example, mandating independent monitoring of informed consent, outside evaluation of subjects’ eligibility for a trial, independent review of adverse events reports and research records, and peer review of data analysis and interpretation.

The NHRPAC gave an example of a disclosure:

Every research scientist and physician at Mercy Hospital, and Mercy Hospital itself, must disclose significant financial interests in private companies or entities that may be related to this research study. Our Hospital committees have reviewed this information and have concluded that there are some financial relationships between the researchers or Mercy itself on the one hand, and the company that is funding this research, on the other. [insert some degree of specific disclosure here, if warranted, as to the interests and the conflicts management strategies]. However, after considering this information, our Hospital committees believe that there are no conflicts of interest that [or no conflicts of interests that, when taken with the conflicts management strategies discussed above] will influence the way you will be treated in this study or the way in which this research study will be conducted. If you would like to have more information about Mercy Hospital’s review process in general, or in regard to this study, please ask the researchers or the research coordinator, and they will assist you. You may also ask Mercy Hospital’s patient advocate, who also can arrange for you to have this information. If, because of this information, you choose not to participate in this study, this will have no effect in your continued health care at Mercy. Participation in all research, including this study, is entirely voluntary, and you may withdraw from participating at any time.

... under NHRPAC’s approach, disclosure of troubling financial relationships or actual conflicts to research subjects is not the preferred methodology for protecting subjects, but is an adjunct method for allowing subjects to have access to information that some may find relevant to their choices to participate in research.

In summary, a majority of NHRPAC preferred the approach of financial disclosure, conflicts analysis, conflicts management, and carefully calibrated "specific" disclosure, or "generic" disclosure, with ready availability to subjects of more specific information upon their request. Under these recommendations, therefore, institutional and researcher disclosure and management of conflicts precedes research approval; and simple disclosure to research subjects is not substituted for the duty of an IRB, institution or researcher aggressively to identify and manage possible conflicts according to their established processes.

The tough part is deciding what is sufficient management of a particular COI.