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What is the Sunshine Act?

Over the past seven months, the clinical research communityhas worked to meet its f irst reporting deadline underthe Physician Payments Sunshine Act. The intent of theSunshine Act, part of the Af f ordable Care Act, was to providemore inf ormation about the nature of payments made bypharmaceutical companies to active doctors. Under the act,pharmaceutical sponsors must report regularly what kind ofpayments they have made to doctors. The f irst reportingperiod ran f rom August 2013 to March 31, 2014. The providedinf ormation will be available this autumn f or public view.(Inf ormation about the Sunshine Act is widely available on theweb; here are links to the government website; tothe American Medical Association’s discussion; and a May2013 New England Journal of Medicine article).

IRB payments to board members do not fallunder the Sunshine Act

In the run up to the March deadline, a number of independent IRBs received requests to report on thef ees paid to scientif ic members of their boards. Some interpretations of the regulations suggestedthat since sponsors pay independent IRBs, and some independent IRBs pay board members, thenthe f ees received should be reported under the Sunshine Act. Af ter collaborative research,discussion, and analysis, Quorum along with eight other independent IRBs concluded that thosestipends did not f all 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:

1. The work f or which IRB members are paid does not match the work the Sunshine Act seeks toreport;

2. Neither are the payments to IRBs the types of f ees the Sunshine Act asks f or; and

3. IRB members already f ace strict restrictions about any conf licts of interest that relate to theirwork.

The Consortium of Independent Review Boards (CIRB) issued this analysis on behalf of its membersand other independent IRBs. On the f irst point, CIRB noted that the Sunshine Act calls f or reportingon actions that involve the practice of medicine. Members ofan IRB review medical research; they are not practicingmedicine (or endorsing drugs or procedures, the target of theSunshine Act). The task of reading and analyzing how aproposal f or research will af f ect the people participating inthe study was not the kind of work the Sunshine Act soughtto track. (While most IRBs have medical doctors on theirboards, this is not a specif ic regulatory requirement. Theregulations call f or ‘scientif ic members. And a physician boardmember may be retired, involved solely in research, workadministration, or have careers other than seeing patients.)

On the second point, IRB review is a required f eature of mostresearch that using human subjects. According to f ederalregulations, sponsors and investigators must have IRBoversight f or most research that will involve people. Butengaging an IRB does not mean that a certain physician –oreven any physician—will review that particular protocol. As aresult, payments f or IRB oversight do not trigger directly payments to practicing doctors, and so thetype of payment is outside what the Sunshine Act requires.

On the third point, existing f ederal guidelines prohibit IRB members f rom reviewing research in whichthey may have a conf lict of interest. IRBs must ensure that any members, physicians or otherwise,have no inf luencing interest in a particular study. (IRBs have varied ways of managing their conf lict ofinterest policies, such as regular f inancial reporting, and recusing members f rom voting on anythingthat represents—or creates the impression of –a conf lict of interest. In addition, IRBs whichmaintain accreditation agree to establish strict conf lict of interest procedure that go beyond theletter of the regulations.)

How can I get more information?

The independent IRBs who collaborated on this response can provide the document to anyoneinterested, as well as standard language f or contracts or services agreements. If you’d like a copy ofthis document, click here to request a copy f rom Quorum Review.