Sunshine Act Reporting and your IRB Members.

1. Quorum Blog
quorumreview.com/sunshine-act-reporting-irb-members/
What is the Sunshine Act?
Over the past seven months, the clinical research community
has worked to meet its f irst reporting deadline under
the Physician Payments Sunshine Act. The intent of the
Sunshine Act, part of the Af f ordable Care Act, was to provide
more inf ormation 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 f irst reporting
period ran f rom August 2013 to March 31, 2014. The provided
inf ormation will be available this autumn f or public view.
(Inf ormation 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
f ees paid to scientif ic 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 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 those
stipends did not f all under the Sunshine Acts reporting requirements.
Why doesn’t an IRB’s payments to board members fall under the Sunshine

2. 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 to
report;
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 their
work.
The Consortium of Independent Review Boards (CIRB) issued this analysis on behalf of its members
and other independent IRBs. On the f irst point, CIRB noted that the Sunshine Act calls f or 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 f or research will af f ect 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 specif ic regulatory requirement. The
regulations call f or ‘scientif ic 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 f eature of most
research that using human subjects. According to f ederal
regulations, sponsors and investigators must have IRB
oversight f or 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 f or 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 f ederal guidelines prohibit IRB members f rom reviewing research in which
they 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 of
interest policies, such as regular f inancial reporting, and recusing members f rom voting on anything
that represents—or creates the impression of –a conf lict of interest. In addition, IRBs which
maintain accreditation agree to establish strict conf lict 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 f or contracts or services agreements. If you’d like a copy of
this document, click here to request a copy f rom Quorum Review.