COI Committees

Background and History

The consistent and appropriate reporting of Conflict of Interest (COI) and the elimination or management of conflicts involving students, faculty, staff, administrators and assets are important for compliance with federal and state regulations as well as to ensure that the University, the Medical University Hospital Authority and our entities' (including but not limited to the Medical University of South Carolina Physicians, MUSC Community Physicians, the MUSC Foundation and the Zucker Institute for Innovation Commercialization) reputations are not compromised by even an appearance of conflict of interest. Heightened public awareness and mandated federal guidelines, combined with the continued rapid growth of technology transfer activities and the ever increasing engagement of the Institution’s students, faculty and staff in commercial enterprises, substantiate the significant involvement of this designated Committee in monitoring and providing enterprise-wide oversight in COI issues.

On May 17, 2012, the Board of Trustees of the Medical University of South Carolina approved policies and procedures regarding conflict of interest relative to the mission of the Institution. The overarching purpose of this Committee is to 1) assist the Executive Vice President for Academic Affairs and Provost in administering the Board of Trustees policies regarding conflict of interest; and 2) to protect the credibility and integrity of the Institution’s students, faculty and staff so that the public may have trust and confidence that the actions of MUSC students and employees are not partial to nor influenced by personal financial gain.

Classification and Terms of Review

The Enterprise Conflict of Interest Committee is an Enterprise level standing committee. The University Executive Vice President for Academic Affairs and Provost will review this charter triennially, or as required to address institutional needs, for the continued need for the Committee and for revisions as appropriate.

Formal Charges

Consistent with current MUSC Enterprise policies and procedures that address COI of its students, employees and the institution, the Enterprise Conflict of Interest Committee shall directly assume the following functions:

1. Review of existing policies related to the reporting and management of potential student, faculty, staff and institutional COI. If applicable, to recommend new and/or revised policies and procedures to ensure appropriate oversight and management of Enterprise COI issues as well as maintain compliance with applicable state and federal policies and guidelines.
2. Maintain awareness of COI policies and guidelines issued by professional organizations and associations of academic institutions, e.g. Association of American Medical Colleges (AAMC), Association of American Universities (AAU), Council on Governmental Relations (COGR), National Association of State Universities and Land-Grant Colleges (NASULGC), and to respond on behalf of the Institution to requests for comments from such organizations.
3. Review COI disclosures at the request of the Conflict of Interest Office, department/division chairs and managers, college deans, and senior officers of the Institution. Recommend to the individual, supervisor and the Executive Vice President for Academic Affairs and Provost appropriate COI management plans as warranted.
4. Maintain a central record and ensure the monitoring of approved COI management plans developed in response to disclosure of significant financial interest in external entities by applicable students, faculty or staff and report any such conflict to the appropriate federal agencies as required by federal regulations.
5. Oversee the preparation of case studies and model plans for managing COI of students, faculty and staff who disclose significant financial interest in external entities, and disseminate model COI management plans and/or other management tools that may provide guidance and recommendations to department chairs/managers, deans and senior administrators.
6. Procurement of and/or development of training and educational materials for students, faculty, staff and senior administrators on the topic of COI.
7. Provide assistance to the Executive Vice President for Academic Affairs and Provost in determining how generic COI cases involving students, faculty, staff and designated administrators may be prevented, managed, reduced or eliminated.
8. Assist the Executive Vice President for Academic Affairs and Provost in developing reasonable sanctions for individuals who are non-compliant with established COI management plans and/or fail to comply with approved and mandated disclosure requirements.
9. Review and approve the annual report addressing the activities and future directions of the Enterprise Conflict of Interest Committee for subsequent dissemination to the Executive Vice President for Academic Affairs and Provost, the President, and any other administrative and/or governing units these two officers may select.

Reporting Channels/Procedures

The Committee shall report directly to the Executive Vice President for Academic Affairs and Provost and will copy reports of the Committee’s final deliberations as appropriate to the Vice President for Research and the MUSC, MUHA and MUSCP compliance officers.

Subcommittees

Ad Hoc Conflict of Interest Committees may be formed as non-standing Enterprise committees by the Enterprise Conflict of Interest Committee 1) to provide a specific review of an individual conflict of interest case that falls outside of the focus of an existing standing Conflict of Interest Committee, or 2) to establish or expedite an operational process, e.g., the initial evaluation of submitted disclosures. The Enterprise Conflict of Interest Committee will authorize and charge the individual Ad Hoc Committee and will define their responsibilities, their reporting mechanism and their limited existence. There may be as many ad hoc, task oriented subcommittees appointed as needed by the Enterprise Conflict of Interest Committee Chair.

Membership

Overseeing every aspect of COI is a complex operation. Members are required to deal with federal and state requirements, Enterprise policy development, evaluate personal business/financial interests, non-compliance and oversee the management of COI. The tasks require Enterprise personnel from a variety of areas of expertise, who have demonstrated a high level of analytical thinking, professionalism and discretion. Collectively, the Enterprise Conflict of Interest Committee should be composed of faculty and staff who share a recognition that conflicts of interest are likely to occur in all mission areas, and that conflict of interest involving our institutional officers, students, faculty and staff must be managed in a manner that does not harm the integrity of the Institution.

The voting members of the Enterprise Conflict of Interest Committee entrusted with the Committee’s final decision shall, at a minimum, consist of the Committee Chair and the six (6) faculty members currently serving as the College Deans, or their appointed designee(s), and a minimum of one (1) MUSC Health System representative. In addition, the Research Conflict of Interest Committee Chair will be a standing, voting member of the Enterprise Conflict of Interest Committee, serving as a liaison between these committees.

In addition, the Enterprise Conflict of Interest Committee shall have the following ex-officio membership, or their designees, who shall be non-voting members. By right of office or center, department, and/or institute representation they are: MUSC General Counsel; MUSC Conflict of Interest Officer; MUSC Chief of Staff, Office of the President; MUSC Director of Strategic Risk; MUHA Director of Legal Affairs; Director of Compliance and Privacy Officer, University; Chief Compliance and Privacy Officer, MUHA; Chief Compliance and Privacy Officer, MUSCP; Chief Executive Officer, Zucker Institute for Innovation Commercialization; MUSC Hollings Cancer Center; South Carolina Clinical & Translational Research (SCTR) Institute.

Additional voting and/or ex-officio members may be appointed at the discretion of the Executive Vice President for Academic Affairs and Provost to ensure adequate representation across the MUSC Enterprise. Further, guests may be invited by the Enterprise Conflict of Interest Committee Chair to attend committee meetings to provide expertise or further insight to matters under committee review, as appropriate.

Officers

The Committee Chair shall 1) be a faculty member in good standing, 2) shall serve as the senior officer of the Enterprise Conflict of Interest Committee, and 3) be appointed by the Executive Vice President for Academic Affairs and Provost.

The standing Committee Vice Chair will be the Research Conflict of Interest Committee Chair or alternative member appointed by the Executive Vice President for Academic Affairs and Provost, with the authority to conduct any necessary business during the Chair’s absence. The Vice Chair will serve at the pleasure of the Committee Chair with the concurrence of the Executive Vice President for Academic Affairs and Provost.

Frequency of Meetings

The Committee shall schedule quarterly meetings. Additional meetings may be called or regularly scheduled meetings may be cancelled by the Committee Chair or by two-thirds of the voting members of the Committee. Cancellation of a scheduled meeting should involve the lack of urgent business or if a quorum (50% or greater) of members will be unable to attend.

Notice of Meetings

An annual schedule of Enterprise Conflict of Interest Committee meetings shall be determined at the beginning of each academic year.

Meeting Agenda and Support Material

A formal meeting agenda and appropriate supportive materials shall be available for each Committee member.

Committee Minutes

Minutes of each meeting shall be prepared in draft form for approval by a simple majority of the voting members of the Committee and documented in the minutes of the subsequent meeting.

Committee and Subcommittee Reports

The Committee Chair shall make all needed written reports, recommendations, or inquiries on behalf of the Enterprise Conflict of Interest Committee to the Executive Vice President for Academic Affairs and Provost. Formal recommendations from Ad Hoc Committees shall be reflected in the Enterprise Conflict of Interest Committee's Annual Report.

Staff Support

The Office of the Executive Vice President for Academic Affairs and Provost shall provide staff assistance to the Committee and its chair, as required.

Meeting Quorum

Attendance by 50% or greater of the Committee's members will constitute a quorum for conducting official business.

Amendment to This Charter

Should any amendment to this charter be required, the Executive Vice President for Academic Affairs and Provost shall work with the Enterprise Conflict of Interest Committee Chair to craft an amendment suitable to all parties. The amended charter shall be completed, signed and issued with all possible haste. When the initiative for such an amendment comes from the Committee, a written request from the Chair to the Executive Vice President for Academic Affairs and Provost shall be provided.

Background and History

In furtherance of the mission of the Medical University of South Carolina, and in compliance with federal regulations, an institutional goal is to advance scientific discoveries that benefit humanity. In 1980, the United States Congress explicitly sanctioned and facilitated by legislation, the commercialization of inventions by permitting academic institutions and scientists to benefit financially if their federally sponsored research leads to commercial products. In addition, interaction between research universities and industry enhances the rapid application of scientific discoveries to the needs of society and maintains international competitiveness of domestic industries.

In 1995, The Board of Trustees of the Medical University of South Carolina approved policies and procedures regarding conflict of interest in relationship to “sponsored research projects, research education and university service”. The purpose of the Research Conflict of Interest Committee is to protect the credibility and integrity of the Institution’s faculty and staff so that public trust and confidence in faculty and staff actions are shown to be without interest in personal gains, financial or otherwise. Policies and procedures regarding conflict of interest are provided in the Medical University Hospital Authority Policies and Procedures, are referenced in the MUSC Faculty Handbook, and can be found on the MUSC Conflict of Interest website (musc.edu/coi). The governing board of the Institution remains sensitive in the oversight of all potentially conflicting situations to ensure that MUSC is in compliance with all state and federal laws.

As the Medical University of South Carolina conducts research funded by the Public Health Service, it is required by federal law to maintain an appropriate written, enforced policy on conflict of interest that complies with 42 CFR Part 50 Subpart F “Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought”.

External business/financial interests are disclosed on an annual basis. Whenever a new external business/financial interest arises or when a significant change occurs concerning an existing disclosure, a new disclosure form is completed and submitted for review either in advance of the anticipated change or within 30 days of the event.

Classification

The Research Conflict of Interest Committee is an enterprise-wide standing committee. The Executive Vice President for Academic Affairs and Provost will review the Charter triennially, or as required to address institutional needs, for the continued need for the Committee and for revisions, as appropriate.

Formal Charges

The MUSC Research Conflict of Interest Committee shall establish and maintain oversight of any perceived or real conflict arising directly or indirectly from research, whether sponsored research, non-sponsored research, start-up ventures, or other activities that require research objectivity under circumstances that could be influenced by personal financial gain. Questions of financial conflict of interest associated with research activities, whether perceived or real, should be referred to this Committee. Specific charges for the Committee are to:

• Conduct an assessment of all annual External Business/Financial Interest Disclosures with real and/or perceived conflict of interest related to research activities as well as other potential sources of conflict of interest related disclosure, e.g., Proposal Data Sheets, outside professional activity related to faculty start-up ventures and applications for IRB approval.
• Report to the MUSC Conflict of Interest Official and the Vice President for Research the nature of the conflict of interest and the action taken by the Committee.
• Approve or disapprove plans to manage perceived or real conflict of interest, where appropriate, and recommend any corrective actions as necessary to assure that the approved management plan is followed.
• Provide minutes of Committee meetings as well as an annual report of the Committee’s activities to the MUSC Conflict of Interest Official and the Vice President for Research.
• Maintain an awareness of financial conflict of interest related policies and guidelines issued by entities that sponsor research such as Public Health Service (PHS) (e.g., Health and Human Services (HHS)), National Institutes of Health (NIH), Food and Drug Administration (FDA), National Science Foundation (NSF), industry, foundations and not for profit organizations.
• Review existing policies related to the reporting and management of potential faculty, staff, and institutional financial conflict of interest at the request of the Enterprise Conflict of Interest Committee and the MUSC Conflict of Interest Official, if applicable, to recommend new and/or revised policies and procedures to ensure appropriate oversight and management of institutional financial conflict of interest related to research.

Reporting Channels/Procedures

The Research Conflict of Interest Committee Chair will be a standing member of the Enterprise Conflict of Interest Committee, serving as a liaison between these committees. The Committee shall report to the MUSC Conflict of Interest Official and will copy reports of the Committee’s final deliberations as appropriate to the Vice President for Research and the University Compliance & Privacy Officer or Medical University Hospital Authority (MUHA) Compliance & Privacy Officer, as applicable.

Violations of University and/or MUHA policies, including failure to avoid a prohibited activity or disclose a conflict of interest in a timely manner, will be addressed in accordance with applicable policies and procedures that may include disciplinary actions up to and including termination of employment.

If an investigator has failed to comply with the MUSC conflict of interest policy and this has potentially biased the design, conduct or reporting of the PHS funded research, the Director of the Office of Research and Sponsored Programs will promptly notify the awarding agency of the corrective action implemented.

Membership/Terms of Appointment

The MUSC Research Conflict of Interest Committee shall be composed of faculty and research related support staff. The committee will have at least one (1) faculty member from each college for representation; therefore, a minimum of six (6) voting members of the Committee shall be composed of individuals who hold faculty appointments representing the academic disciplines that are involved in scholarly research. In addition, a minimum of one (1) voting member will represent the MUSC Health System and associated research endeavors. All members shall be nominated by the applicable College Dean/MUSC Health leadership, or designee, and appointed by the Executive Vice President for Academic Affairs and Provost to serve a two-year term and may be re-appointed once for a successive two-year term. Committee members may serve beyond their term until new members are appointed.

In addition, the Committee shall have the following non-voting members, or their designees, who shall serve in an ex officio capacity: MUSC Conflict of Interest Officer; Vice President for Research; Director, Office of Research and Sponsored Programs; MUSC General Counsel; Chief Executive Officer, Zucker Institute for Innovation Commercialization; Director, Office of Research Integrity; Director of Compliance and Privacy Officer, University; Director, Insurance Services.

All Committee members must agree and complete statements indicating that all information and deliberations are confidential.

Officers

A Chair shall be appointed by the Executive Vice President for Academic Affairs and Provost and will serve a two-year term and may be reappointed at the discretion of the Executive Vice President for Academic Affairs and Provost. Upon the recommendation of the Committee Chair, a Vice Chair may also be nominated by the committee and appointed by the Executive Vice President for Academic Affairs and Provost for an undeclared term and with the authority to conduct any necessary business during the Chair’s absence.

Ad-Hoc Subcommittees

There may be ad-hoc, task-oriented subcommittees appointed as needed by the Chair.

Frequency of Meetings

The Committee shall meet quarterly. Additional meetings may be called as needed. Regularly scheduled meetings may be cancelled by the Committee Chair or by two-thirds of the voting members of the Committee. Cancellation of a scheduled meeting should involve the lack of urgent business or if a quorum (simple majority) of members will be unable to attend.

Notice of Meetings

An annual schedule of Committee meetings shall be determined at the beginning of each academic year.

Meeting Agenda and Support Material

A formal meeting agenda and appropriate supportive materials shall be available for each Committee member.

Committee Minutes

The minutes of each meeting shall be prepared in draft form for approval by a simple majority of the voting members of the Committee at the subsequent committee meeting. Approval of the meeting minutes will be documented in the subsequent meeting minutes. Because of the need to resolve particular issues in a timely manner, it is important that the draft minutes containing all actions or rulings be forwarded to the MUSC Conflict of Interest Official, with copies to the Vice President for Research, within two (2) weeks of the meeting.

Committee Reports

The Committee Chair shall make available all needed written reports, recommendations, or inquiries on behalf of the Committee to the MUSC Conflict of Interest Official. Formal rulings of the Committee will be reported in Committee minutes and in the Committee’s annual report. Records of all financial disclosures and all actions taken by the Research Conflict of Interest Committee will be maintained for at least three (3) years from the date of submission of the final expenditures report(s) for the applicable project(s) or, where applicable, from other dates specified in South Carolina State law, 42 CFR 50 Subpart F or by other federal funding or oversight agencies.

Staff Support

The Office of the Executive Vice President for Academic Affairs and Provost will provide staff assistance to the Committee and its Chair, as required.

Meeting Quorum

A simple majority of the voting Committee membership will constitute the necessary quorum for conducting official Committee business.

Amendment to This Charter

Should any amendment to this charter be required, the Executive Vice President for Academic Affairs and Provost shall work with the Committee Chair to craft an amendment suitable to all parties. The amended charter shall be completed, signed and issued with all possible haste. When the initiative for such an amendment comes from the Committee, a written request from the Chair to the Vice President for Academic Affairs and Provost shall be provided.