University's new Industry Relations policy initiatedTweet
By Cindy Abole
Earlier this spring, the MUSC Board of Trustees approved the Industry Relations Policy, a newly authored institutional policy aimed at addressing the new climate of university-industry relationships and furthering the institution’s goal to establish ethical, consistent principals and standards for faculty, students and staff across campus.
The new policy updates and expands existing policies established previously by the Medical University Hospital Authority’s Professional Relations Policy, which is now MUSC’s Industry Relations Policy.
According to Mary Evelyn Armstrong, the campus’ Conflict of Interest officer, this revised new policy serves as a tool to help faculty and other employees navigate appropriate university-industry relationships. The policy exists to protect patients, employees and the university as the institution pursues industry partnerships and interacts with industry to advance research, clinical care and educational initiatives for MUSC. The new Industry Relations Policy covers all trustees, officers, faculty, administrators, staff, students and trainees working as full-time, part-time, temporary and contract employees of MUSC, MUHA, MUSC Physicians, the MUSC Foundation and the Foundation for Research Development.
“The new policy applies to the entire MUSC community, from instructor to dean to president,” said Armstrong. “Its purpose is to establish a framework for how individuals and the Institution can engage in ethical interactions with industry as we pursue entrepreneurial activities that advance research and clinical work."
The process for change started in 2012 under the direction of then-Provost and former MUSC Interim President Mark Sothmann, Ph.D. Sothmann quickly established an Industry Relations Committee composed of university and faculty leaders and experts who evaluated standards and collaborated in reviewing and revising the policy. The group was led by Bruce Elliott, M.D. senior associate dean for clinical affairs and Institutional Conflict of Interest official and chair.
“MUSC leadership recognized the importance of having consistent standards to apply across the MUSC enterprise,” said Sothmann. “Many provisions that were in the MUHA policy also are included in the Industry Relations Policy, but previous enforcement outside of MUHA was a challenge since we have so many employees who fall under the University and its affiliates who are not subject to MUHA policies.”
With the new Industry Relations Policy, ethical principles for industry relationships can be applied equitably throughout the enterprise.”
In addition to providing guidelines and defining university relationships and activities relating to industry partnerships and appropriate interaction, the Industry Relations Policy articulates approved and prohibited activities and promotes full disclosure and transparency.
It is imperative for MUSC to effectively address and comply with increasing federal scrutiny and regulatory oversight related to conflicts of interest, according to Armstrong. New federal regulations took effect in 2012 which focused on financial conflicts of interest related to Public Health Service–funded research.
In the same year, the MUSC board of trustees approved the MUSC/MUHA Conflict of Interest Policy, which is separate from the Industry Relations Policy. The MUSC/MUHA COI Policy ensures compliance with these federal COI regulations by outlining the Institution’s annual disclosure requirements and establishing measures that should be taken to manage, reduce or eliminate conflicts of interest related to one’s institutional responsibilities and research.
In an effort to create more public transparency, the Physician Payments Sunshine Act (a section of the Affordable Care Act) requires drug and medical device manufacturers to report payments and gifts given to physicians and teaching hospitals.
This information will be reported to the Centers for Medicare and Medicaid Services, and the first set of data will be made publicly available Sept. 30. Physicians and teaching hospitals will be able to register on the CMS website and review their data prior to publication. Phase I of registration is currently open and Phase II is set to begin in mid-July.
In addition, conflict of interest guidelines by the American Association of Medical Colleges, the Board of Internal Medicine, the Institute of Medicine and other professional organizations as well as new federal laws such as the Physician Payments Sunshine Act address physician best practices that relate to conflict of interest management and were a motivator driving MUSC and other teaching hospitals to strengthen their policies related to industry interactions.
"It's fortunate that MUSC leadership has felt strongly about revitalizing this policy and offered their support," said Elliott. "In today's growing climate of transparency, we were focused on doing the right thing to meet federal and state ethics laws, HIPPA and all conflict of interest policies as we continue to focus on advancing the everyday missions of the institution."
According to Sothmann, the Physician Payments Sunshine Act was an important catalyst to getting the Industry Relations Policy finalized and implemented. He said MUSC leadership and the board of trustees felt it was essential for leadership to provide faculty-physicians with a meaningful framework and useful tool to guide their industry interactions throughout every step of the process.
The Industry Relations Committee analyzed the enterprise’s operations, faculty needs, institutional goals related to the university’s strategic plan and other resources to strike the right balance, according to Armstrong. The group examined a variety of topics including industry-sponsored and non-accredited speaking engagements; training and marketing; branding and promotion. They also included provisions to protect faculty members’ intellectual independence and academic
freedom in industry supported activities.
Key representation in the Industry Relations Committee included the appointment of a Faculty Senate liaison Natalie Sutkowski, Ph.D. Sutkowski, in turn, worked directly with a senate ad hoc committee to garner advice from individual faculty members on issues and different aspects of the policy. After spending a great deal of time developing and revising policy, Sutkowski is pleased with the outcome and process.
“Overall, the revised policy is immensely better than what we started with when the committee initially met. I feel most faculty now understand why many of the ethical guidelines have been put into place and do not take issue with the new restrictions,” said Sutkowski.
Policy topics of high interest among faculty included consulting for industry on personal leave time, industry-sponsored educational programming, sponsored meals and gifts and preserving intellectual freedom.
“Intellectual freedom is integrally important to our faculty. The policy could not be perceived as restricting the faculty members’ intellectual freedom in any way. On the other hand, ethical interactions with pharmaceutical and medical product industries have been changing in recent years and the university needed to take into account new policies like the Physician Payments Sunshine Act. Many of our faculty are very conscious of ethical concerns, but did not feel that they were doing anything wrong, and were worried that their efforts might be restricted or prohibited. Thus, it was important for the Industry Relations Committee to recognize faculty concerns during the revision process while educating them on the changing ethical climate,” Sutkowski said.
She added, “The faculty senate is grateful to Dr. Sothmann for ensuring that the senate played an active role in revising the IR policy, since the policy greatly affects our faculty members. Dr. Elliott clearly had spent a lot of time researching the new ethical guidelines that other academic medical centers are currently adopting. He did an admirable job educating the committee members on the important highlights. Each member of the Industry Relations Committee made significant contributions to this effort, as did the senate leaders and each of the senate ad hoc committee members.”
With regard to policy concerning industry–sponsored meals, employees can only accept food at events open to the community at large or as part of a contract. The new policy restricts pharmaceutical or industry companies from bringing food to employees at work areas or hosting a meal for employees.
“We understand that everyone at MUSC is striving to do what is best for our patients, for our community and for the Institution. It is vital that we protect the integrity of our operations from outside influences that could have a negative impact or that would even appear to have an impact on our actions and decisions,” Armstrong said.
A preliminary draft of the IR policy was presented to members of the Deans’ Council in October. From late October to December, feedback was gathered by college deans, department chairs and faculty senate members during the public comment period. In January, the policy was formally presented to the faculty senate and later, to the MUSC board of trustees in February for final approval.
Currently, Armstrong and the COI Office continue to focus on promoting awareness and education about the IR policy among the MUSC community.
Additionally, the University COI Committee is using annual disclosures from the recent April disclosure cycle as an opportunity to educate individuals about the new policy and how it affects activities and previous interaction. Employees, students and trainees are expected to end any noncompliant activities as soon as possible.
University Conflict of Interest Committee
Bruce Elliott, M.D., chair and senior associate dean for Clinical Affairs, institutional official-Conflict of Interest; Julie Acker, senior director of Compliance, MUSC Physicians; Mary Evelyn Armstrong, Conflict of Interest officer; Mark Barry, DDS, College of Dental Medicine; Judy R. Dubno, Ph.D., Department of Otolaryngology; Annette Drachman, Esq., MUSC general counsel; Philip Hall, PharmD, College of Pharmacy MUSC campus dean; Edward Krug, Ph.D., College of Graduate Studies; Marilyn Schaffner, Ph.D., MUHA Clinical Services; Reece Smith, MUHA director of compliance; Cynthia Teeter, University compliance officer;
and Bart Yancey, Office of the President