Many IRB members have financial relationships with companies

While most avoid conflicts of interest, clearer policies and more oversight may be needed

More than one-third of the members of Institutional Review Boards (IRBs) – committees at medical research organizations charged with ensuring that clinical studies uphold patient rights and follow ethical guidelines – have financial relationships with commercial firms. In the Nov. 30 New England Journal of Medicine, investigators from the Massachusetts General Hospital (MGH) Institute for Health Policy report the results of a survey of IRB members from academic medical centers across the U.S. While most IRB members did not believe that industry relationships have compromised the review process, a few reported that they had participated in discussions or voted on studies despite having industry relationships that could be conflicts of interest.

“The IRB process must be independent and objective,” noted Eric G. Campbell, PhD, of the MGH Institute for Health Policy, the study’s principal investigator. “Financial relationships with study sponsors create competing interests that could undermine the objectivity of the IRB process. Policies and practices regarding the disclosure and management of such relationships among IRB members need to withstand intense scrutiny, and our results suggest that we can do much better.”

Every institution in the U.S. that conducts research involving human participants must have an IRB, which is responsible for reviewing proposed studies to make sure the rights and safety of participants are protected and that study protocols are scientifically valid and follow ethical and regulatory guidelines. IRBs also monitor the conduct of studies to make sure that appropriate practices are maintained. While researchers’ industry relationships have been an area of concern for several years, no previous studies have examined the extent and impact of such relationships among IRB members.

During 2005, the MGH research team conducted an anonymous survey of almost 900 members of IRBs at medical schools and research hospitals across the country. Questionnaires were sent to a random sample of IRB members asking whether they had specific relationships with companies – including paid consultant, officer or director, scientific advisory board or speakers bureau member, and recipient of royalties or research funds. Some respondents noted the potential benefits to the research process of industry relationships – such as giving IRB members a better understanding of industry standards and how products may relate to others currently on the market.