Resolution of Conflicts – Management Plans
How will I know when and how my issues have been resolved?
You will receive e-mail notification of the management plan from Mount Sinai's Program for the Protection of Human Subjects (PPHS), even if your research doesn't involve human subjects.
What is a Management Plan?
A Management Plan is developed by the Financial Conflicts of Interest in Research Committee when it determines that imposing specific restrictions can effectively reduce or eliminate a financial conflict, whether individual or institutional, so that the research can proceed.
What elements typically comprise a Management Plan?
A Management Plan often contains one or more of the following features (see the policy for more details):
- Disclosure Requirement - A conflicted individual will be required to disclose relevant financial interests to the public, e.g., in publications and at presentations, to other members of the research team, to trainees, and to human subjects (via consent forms).
- Limitations on Role of a Covered Person with a Financial Interest - Role limitations for the conflicted individual may include: removal as P.I. on the study; restrictions on access to data and/or to subjects; prohibition against determining whether adverse events can be reported.
- Equity Restrictions - A conflicted individual may be asked to place stock in escrow or not to exercise stock options without prior permission from the Committee.
- Divestiture - A conflicted individual may be instructed to relinquish specified financial interests by a certain date.
- Data and Safety Monitoring - The Financial Conflicts of Interest in Research Committee might ask Mount Sinai's Program for the Protection of Human Subjects (PPHS) to review/revise the proposed safety monitoring in light of the financial conflict
- Implementation of Good Laboratory Practices - Guidelines for the sound collection, storage and analysis of data will help ensure that financial interests do not bias the study.
- Severance of Relationships - A conflicted individual may be asked to end a relationship that poses an actual or potential conflict, e.g., terminate a consulting arrangement or resign from an advisory board.
- Oversight - An impartial third party, e.g., an oversight team, may be assigned to monitor the research activity.
- Audit - For human subjects research, periodic audits of clinical trial conduct (recruitment, consent, subject-staff interaction, research staff-PI interactions, and reporting of SAEs) may be conducted. For laboratory research, periodic audits for adherence with good laboratory practices may be conducted.
Once I agree to the Management Plan, is there anything else I need to do regarding conflict of interest and the research project?
You will need to: a) Follow the actions outlined in the management plan; b) promptly report any changes in relevant financial interests by submitting an updated disclosure form; and c) cooperate in any project audit undertaken by the Office of Compliance.
Conflict of Interest Helpline
Office of the Dean
One Gustave L. Levy Place
New York, NY 10029