What is the Sunshine Act?
Over the past seven months, the clinical research community has worked to meet its first reporting deadline under the Physician Payments Sunshine Act. The intent of the Sunshine Act, part of the Affordable Care Act, was to provide more information about the nature of payments made by pharmaceutical companies to active doctors. Under the act, pharmaceutical sponsors must report regularly what kind of payments they have made to doctors. The first reporting period ran from August 2013 to March 31, 2014. The provided information will be available this autumn for public view. (Information about the Sunshine Act is widely available on the web; here are links to the government website; to the American Medical Association’s discussion; and a May 2013 New England Journal of Medicine article).
IRB payments to board members do not fall under the Sunshine Act
In the run up to the March deadline, a number of independent IRBs received requests to report on the fees paid to scientific members of their boards. Some interpretations of the regulations suggested that since sponsors pay independent IRBs, and some independent IRBs pay board members, then the fees received should be reported under the Sunshine Act. After collaborative research, discussion, and analysis, Quorum along with eight other independent IRBs concluded that those stipends did not fall under the Sunshine Acts reporting requirements.
Why doesn’t an IRB’s payments to board members fall under the Sunshine Act?
The reasoning boiled down to a three-part argument:
- The work for which IRB members are paid does not match the work the Sunshine Act seeks to report;
- Neither are the payments to IRBs the types of fees the Sunshine Act asks for; and
- IRB members already face strict restrictions about any conflicts of interest that relate to their work.
The Consortium of Independent Review Boards (CIRB) issued this analysis on behalf of its members and other independent IRBs. On the first point, CIRB noted that the Sunshine Act calls for reporting on actions that involve the practice of medicine. Members of an IRB review medical research; they are not practicing medicine (or endorsing drugs or procedures, the target of the Sunshine Act). The task of reading and analyzing how a proposal for research will affect the people participating in the study was not the kind of work the Sunshine Act sought to track. (While most IRBs have medical doctors on their boards, this is not a specific regulatory requirement. The regulations call for ‘scientific members. And a physician board member may be retired, involved solely in research, work administration, or have careers other than seeing patients.)
On the second point, IRB review is a required feature of most research that using human subjects. According to federal regulations, sponsors and investigators must have IRB oversight for most research that will involve people. But engaging an IRB does not mean that a certain physician –or even any physician—will review that particular protocol. As a result, payments for IRB oversight do not trigger directly payments to practicing doctors, and so the type of payment is outside what the Sunshine Act requires.
On the third point, existing federal guidelines prohibit IRB members from reviewing research in which they may have a conflict of interest. IRBs must ensure that any members, physicians or otherwise, have no influencing interest in a particular study. (IRBs have varied ways of managing their conflict of interest policies, such as regular financial reporting, and recusing members from voting on anything that represents—or creates the impression of–a conflict of interest. In addition, IRBs which maintain accreditation agree to establish strict conflict of interest procedure that go beyond the letter of the regulations.)
How can I get more information?
The independent IRBs who collaborated on this response can provide the document to anyone interested, as well as standard language for contracts or services agreements. If you’d like a copy of this document, click here to request a copy from Quorum Review.