Overseeing the Overseers

By: Gary Miller, CIS Compliance Associate
garymiller@cis-partners.com

What happens when the individuals or groups, put in place to be the formal oversight of a process, have insufficient oversight themselves? Eric G. Campbell, PhD, of the MGH Institute for Health Policy, says in situations such as these, they cannot accomplish their fundamental mission of ensuring appropriate conduct.1 In this case he speaks of the IRBs (Institutional Review Boards) , “committees charged with ensuring that clinical studies uphold patient rights and follow ethical guidelines.”1

In a study done by the Massachusetts General Hospital Institute for Health Policy, it was discovered that many IRBs do not require members to disclose industrial relationships, and that procedures for defining , reporting, and handling conflicts vary widely among institutions.1 Research Hospitals, and subsequently the millions of patients impacted by the decisions these IRBs are making, rely on these committees to have safe, ethical, and successful trials as their main goal, with total disregard for any personal or business benefit. Without a proper, consistent policy on relationship disclosure and conflict of interest measures, who is to know the agenda of the members of these committees?

The FDA, under the Bioresearch Monitoring (BIMO) Program, “conducts inspections to determine if IRBs are operating in compliance with current FDA regulations and statutory requirements and if the IRBs are following their own written procedures.”2 In reviewing the Information Sheet Guidance For IRBs, Clinical Investigator and Sponsors: FDA Institutional Review Board Inspections, published by the FDA, it is unclear who, if anyone, reviews the actual policies under which the IRBs are operating. As shown in this study, however, it is clear the policies that some IRBs have in place are lacking vital regulations necessary for them to fulfill their main purpose of ethical guidance.

The FDA, along with the Department of Health and Human Services (HHS), has recently released a Final Rule on IRB registration requirements, stating the need for IRBs to register with the federal government through a system maintained by the HHS. The rule states that the IRB registration requirements will make it easier for FDA to inspect IRBs and to convey information to them.3 However, the final rule seems to omit addressing the issue of conflict of interest disclosure. The final rule does not mandate the need to disclose conflicts of interest that may exist within an IRB, continuing this gap between protocol and proper agenda.

As CIS continues to grow its breadth of expertise, and with the publication of this study, research hospitals may be looking for resources to review the policies and protocols they have in place for their IRBs. This will ensure they are prepared for any inspections conducted by the FDA, and will ultimately allow the IRBs to properly perform their job on a consistent and honest basis.

1. Boards Overseeing Clinical Studies Don't Always Require Members To Disclose Potential Conflicts, Article Date: 27 Mar 2009 - 2:00 PDT, Sue McGreevey, Massachusetts General Hospital, http://www.medicalnewstoday.com/articles/143853.php

2. Information Sheet Guidance For IRBs, Clinical Investigator and Sponsors s: FDA Institutional Review Board Inspections, http://www.fda.gov/oc/ohrt/irbs/reviewboard.pdf