1 GRADUATE COUNCIL MEETING 18 January 2012 102 Kern ...

Minutes of the Meeting December 14, 2011
The Graduate Council -5-
Ms. Thurley reported that in 1995, the U.S. Public Health Service (PHS), part of the Department of
Health and Human Services, passed a regulation requiring institutions who receive federal funding to enact a
policy regarding conflict of interest. Since 1995, Penn State has had a robust conflicts of interest policy and has
required examination of financial disclosures with regard to consultation and compensation, company
ownership, IP, which includes patents, royalties, etc., and positions held (e.g., CEOs, members of boards, etc.).
She noted that Penn State’s current policy (RA-20) deals with “transactional disclosures,” requiring that any
significant financial or business interests by investigators be reported (funded or unfunded research) at the time
of the transaction or activity; investigators must answer questions on the conflict of interest on-line disclosure
form (COINS). She noted that the College of Medicine uses a different model, in which all investigators
disclose all significant financial or business interests annually.
She indicated that the National Institutes of Health (NIH) initiated changes about three years ago that
impact Penn State’s policies. There was considerable media attention when Senator Grassley of Iowa identified
discrepancies in reporting at several institutions. NIH was informed that revisions were needed and that
institutions needed to be transparent about all conflicts or potential conflicts. In August 2011 revisions were
published with an implementation deadline of August 2012; some of the changes will be implemented at Penn
State beginning in March 2012, with full compliance planned by the August deadline.
Ms. Thurley presented the revisions, which include a new definition of investigator: anyone who is
responsible for the design, conduct, or publication of research. This includes faculty, students, and staff involved
in research activities. The previous threshold for reporting purposes was $10,000; the new threshold will be
$5,000, and this includes both public and non-public companies. This changes the previously allowed exclusions
for compensation for working with non-profits. Travel sponsored or reimbursed by outside entities must now be
disclosed, with no minimum threshold for reporting (this does not include travel paid for under a sponsored
award). She added that exclusions will remain for some funding sources (e.g., federal, state, and local
government agencies). Funding provided by other institutions of higher education, private foundations, and
medical schools also is excluded.
She noted that the new policy will mimic the College of Medicine’s current model. All investigators
will be required to complete annual disclosures (beginning in 2012). Implementation at Penn State will be
staggered for all investigators; and so in year one, all investigators who meet the new definition and have
PHS/NSF funding or pending funding will be the first to be required to annually disclose. Over years two and
three the requirement will be implemented to include all colleges, units, and campuses and all investigators.
Ms. Thurley reported that the sponsored awards database will be used to identify those investigators who must
report. She indicated also that Penn State will be federally required to train investigators every four years
regarding this requirement, and Penn State will be required to provide public accessibility to any conflicts of
interests related to PHS funded research that the University identifies. If a conflict is identified in PHSsponsored
research, Penn State must provide a written response to the requestor within five business days; or
Penn State must publicly post all identified COI related to PHS research on its website. She added that the new
PHS regulation outlines a non-compliance process that will only apply to PHS sponsored research (e.g., NIH
research); and that process involves retrospective review of the research for bias and reporting of any bias found
and the University’s plan to mitigate the bias to the PHS sponsoring agency. The COI Office will continue to
investigate and respond to all reports of non-compliance (e.g., implement corrective actions and
education/training) under the revised University policy; however, the retrospective review for bias will be
reserved for PHS-sponsored research only.
Ms. Thurley then outlined the implementation process. She reported that her office has participated in a
number of national webinars and has sought input on the policy from the Provost and the Vice President for
Research, the College of Medicine COI Administrators, the Senate Committee on Research, the COI
Committee, CIC Colleagues (benchmarking), and other Penn State offices. She indicated that the Provost is