The major responsibilities each party has in connection with the COI policies at Weill Cornell Medicine are as follows:
Center for Technology Licensing (CTL)
- Appoint a representative to serve as a voting member of the CAP and provide subject-matter expertise.
- Inform CAP and research personnel of required fCOI reporting related to licensing activity.
Chief Research Compliance Officer & Research Integrity Officer
- Investigate situations of potential research COI and COC non-compliance and report to the CAP, university executives, and external agencies as necessary.
- Serves as a voting member of the CAP and provide subject-matter expertise.
- Oversees the Office of Conflict of Interest.
Conflicts Advisory Panel
- Ensure that all real or apparent conflicts of interest and commitment are identified and managed.
- Review COI reports and determine whether a real or apparent COI exists.
- Determine and promulgate management plans required to reduce or eliminate real or apparent COI.
- Monitor compliance with management plans.
- Review management plan appeals and appeal recommendations from the Provost for Medical Affairs.
- Issue binding decisions on management plan appeals.
- Participate in investigation of cases of potential non-compliance. Report findings in accordance with policies and regulations.
Institutional Review Board
- Ensure the protection of human participants as subjects of research.
- Ensure that all required fCOI review and management requirements are met prior to approving protocols.
- May add human participant protection measures to a management plan, but may not delete plan requirements.
- Appoint a representative to serve as a voting member of the CAP and provide subject-matter expertise.
Office of Compliance
- Collaborate with the Office of Conflict of Interest on managing business conflicts of interest.
- Appoint a representative to serve as a voting member of the CAP and provide subject-matter expertise.
Office of Conflict of Interest
- Provide regulatory, policy, and procedural expertise and administrative support to the Conflicts Advisory Panel (CAP).
- Manage the COI and COC reporting process.
- Assist in review of COI reports, determination of whether a real or apparent COI exists, and development of management plans.
- Assist and advise research personnel, units, university management, and others, as appropriate, on COI management, regulations, policy, and procedures.
- Make available to unit heads the information related to a real or potential conflicts of commitment, and any non-research conflict of interest disclosed in a COI report.
Office of External Affairs
- Appoint a representative to serve as a voting member of the CAP and provide subject-matter expertise.
- Ensure that COI disclosures are included in external press releases and media inquiries comply with COI policies and guidelines.
OSRA; JCTO; CCTO
Office of Sponsored Research Administration (OSRA); Joint Clinical Trials Office (JCTO); Cancer Clinical Trials Office (CCTO)
- OSRA - Appoint a representative to serve as a voting member of the CAP and provide subject-matter expertise.
- Coordinate with the Office of Conflict of Interest to ensure that all required fCOI review and management requirements are met prior to submitting proposals and executing awards and other institutional agreements.
Principal Investigator (PI)
- Identify all research personnel on proposals and research projects and co-investigators on Institutional Review Board protocols, inform them of related fCOI reporting requirements, and ensure that they submit fCOI reports prior to proposal or protocol submission.
Provost for Medical Affairs and Dean of the Medical College
- Appoint the Chairperson and Vice Chairperson of the CAP.
- Provide input on management plans at the request of the CAP.
- Review appeals of CAP decisions and may make recommendations to delete requirements of a management plan, but may not alter or remove requirements. May add requirements to a management plan.
- Implement sanctions for non-compliance with timely filing of reports or non-compliance with an approved management plan.
Unit/Unit Head
- Ensure that new employees and existing employees complete a COI Survey within the required timeframe.
- Review Quarterly Entity reports for department personnel disclosures.
- If required by the CAP, assist in development and implementation of management plans for fCOI related to research or business conflicts.
- As required by the CAP, implement aspects of management plans and report on plan compliance.
- Confer as requested with the Dean regarding sanctions for noncompliance.
University Counsel
- Appoint a representative to serve as a voting member of the CAP and provide subject matter expertise.
WCM Workforce Members
- Report external commitments and financial interests fully, accurately, timely, in accordance with the requirements set forth by this policy.
- Follow the terms of required management plans.
- Subject to sanctions for non-compliance with management plan requirements.