The major responsibilities each party has in connection with the COI policies at Weill Cornell Campus are as follows:
Center for Technology Licensing (CTL)
- Appoint a representative to serve as a non-voting member of the CAP and provide subject-matter expertise.
- Inform CAP and research personnel of required fCOI reporting related to licensing activity.
Conflicts Advisory Panel
- Ensure that all real or apparent financial conflicts of interest (fCOI) related to research are identified and managed.
- Review fCOI reports and determine whether a real or apparent fCOI exists.
- Determine and promulgate management plans required to reduce or eliminate real or apparent fCOI.
- 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.
Conflicts Office Administrator/Conflicts Specialist(s) (WCMC)
- Provide regulatory, policy, and procedural expertise and administrative support to the Conflicts Advisory Panel (CAP).
- Manage the fCOI reporting process.
- Assist in review of fCOI reports, determination of whether a real or apparent fCOI exists, and development of management plans.
- Assist and advise research personnel, units, university management, and others, as appropriate, on fCOI management, regulations, policy, and procedures.
- Make available to unit heads the information related to a real or potential conflict of commitment, and any non-research conflict of interest disclosed in an fCOI report.
Director, Research Integrity
- Investigate situations of potential fCOI non-compliance and report to the CAP, university executives, and external agencies as necessary.
- Report to federal agencies, sponsors, and other regulatory bodies as necessary.
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.
Key Personnel
See Research Personnel responsibilities.
Office of Research Integrity (ORI), WCM
- Appoint a representative to serve as a non-voting member of the CAP and provide subject-matter expertise.
- Provide fCOI administrators to support the CAP and other functions necessary to the execution of this policy (see Conflicts Office Administrator responsibilities).
OSRA; JCTO; BioPharma Alliances and Research Collaboration
Office of Sponsored Research Administration (OSRA); Joint Clinical Trials Office (JCTO); Office of BioPharma Alliances and Research Collaborations [WCM]:
- Appoint a representative to serve as a non-voting member of the CAP and provide subject-matter expertise.
- Coordinate with CAP 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 members 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.
Research Personnel
- 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.
- May submit a written request for reconsideration of a management plan.
- Subject to sanctions for non-compliance with management plan requirements.
Unit/Unit Head
- Determine if new employees or employees assuming new responsibilities are research personnel and if so, ensure that they complete an fCOI report within the required timeframe.
- If required by the CAP, assist in development and implementation of management plans for fCOI related to research.
- 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 non-voting member of the CAP and provide subject matter expertise