STANDING COMMITTEE ON CONFLICTS OF INTEREST AND COMMITMENT

The Standing Committee is responsible for reviewing the implementation of the policy on a regular basis and providing oversight to assure that the policy is applied consistently to the Faculty including both those based in the quadrangle and those based in the affiliated Hospitals. The Standing Committee is responsible for reviewing cases which may be referred to it where the application of the policy to an individual is unclear. Finally, the Standing Committee will continue to review both the policies of other institutions and any government requirements in this area and to recommend changes to the policy when appropriate.

The Office of the Dean is responsible for overseeing the implementation of the policy by all affiliated institutions, including the process and mechanism for disclosure and resolution. This Office will review all breaches of the disclosure process, including (a) failures to comply with such process, whether by virtue of a Faculty Member's refusal to respond or by his/her responding with incomplete or knowingly inaccurate information, (b) failures to remedy conflicts, and (c) failures to comply with a prescribed oversight plan. Such cases will be forwarded to the Standing Committee for review. Based on its review, the Committee will make recommendations to the Dean for further action. In all cases, Faculty Members will be provided the explicit opportunity to respond in person and in writing to the issues raised in the course of such review. Any such written response will be appended to the Committee's report for review by the Dean and, in the case of Hospital-based Faculty Members, the Hospital CEO. The Committee will also be available to advise affiliated Hospitals on the application of the guidelines to specific cases as disclosed by their Faculty.

DISCLOSURE PROCESS AND IMPLEMENTATION

Submission of Disclosure Forms

1. The Office of the Dean is responsible for the dissemination, collection and review of the disclosure forms for members of the Faculty of Medicine. Each Hospital will designate a responsible office or individual to serve as a liaison representative to the Office of the Dean.

2. All members of the Faculty of Medicine, both full- and part-time, are required to complete and submit a disclosure form on a regular basis. Updated forms must be submitted throughout the year if changes arise which the Faculty Member believes may either: (a) give rise to a conflict of interest or (b) eliminate a conflict previously disclosed.

3. Individuals holding fellowship positions are not required to complete and submit a disclosure form unless they believe that they are involved in or may be involved in a situation which gives rise to a conflict of interest. The Office of the Dean is responsible for sending individuals who hold fellowship positions appropriate notification of their obligations under the policy.

4. Disclosure forms should be returned to the Office of the Dean for initial review. The Office of the Dean will be responsibile for providing the forms to the designated Hospital liaison representative for Hospital review.

   In consultation with the Office of the Dean, each Hospital will establish its own mechanism for review of the forms to ensure compliance with the disclosure process. This mechanism will include written reminders for Faculty Members to return disclosure forms, as well as statements encouraging Faculty Members to seek assistance in the event of questions or special circumstances. Offices providing such assistance will be designated in each of the Hospitals as well as in the Quadrangle. Regardless of the mechanism selected, disclosure forms which implicate any conflict category should be reviewed regularly by the department head.

   The disclosure forms will be considered strictly confidential, and it will be the responsibility of the designated offices in the Quadrangle and Hospitals to ensure that the information disclosed in the forms is available only to the individuals duly charged with the responsibility for review. Similarly, offices of department heads, the Dean and the President will be required to establish means for the preservation of confidentiality.

5. In the case of Faculty Members who hold the positions of CEO (or equivalent title) of an affiliated hospital, Dean or Executive Dean of the Faculty of Medicine, or heads of departments, the annual, as well as interim, disclosure and review processes will proceed as follows:
   • chairs of the preclinical departments will report directly to the Dean of the Faculty of Medicine;

   • chairs of the clinical departments will report directly to the Hospital CEO, with copies to the Dean;

   • the Dean and Executive Deans of the Faculty of Medicine will report to the University President;

   • hospital CEOs (or individuals with equivalent title) will report to the Executive Committee of the Board of Trustees of the hospital, with copies to the Dean.

Following disclosure and upon receipt of disclosure forms from the Office of the Dean, each institution will review the forms for its Faculty and the Office of the Dean will review forms for Quadrangle-based faculty. Each institution will notify the Office for Research Issues in the Office of the Dean of the resolution of identified Category 1(a) and 1(b) conflicts as well as those instances that may require review and approval by the Standing Committee.

The CEOs and the department heads are expected to notify the Office of the Dean immediately of any cases that require review by the Standing Committee, no matter when the cases occur.

Establishment of Oversight Protocols

The hospital CEO (in the case of hospital-based Faculty) and the Standing Committee (in the case of quadrangle-based Faculty) are responsible for designing and proposing appropriate oversight mechanisms. They are expected to seek advice from individuals outside as well as within their institutions in preparing such mechanisms. The associated rationale and details must be presented to the Office of the Dean for review and approval.

Implementation Process under Public Health Service and National Science Foundation Regulations

1. Disclosure required by the Public Health Service and National Science Foundation regulations should be made on appropriate forms at the time of grant application submission to the appropriate offices in the Quadrangle and affiliated institutions.

2. Resolution of impermissible Category I(a) conflicts (Clinical Research) identified in the federal application disclosure process should be made by the appropriate Quadrangle or affiliated Hospital officials. Notice of such resolution should be forwarded to the Office for Research Issues in the Office of the Dean. The Standing Committee will review these and other resolutions as appropriate.

3. Decisions as to the appropriate resolutions of Category I(j) conflicts (non-clinical research) identified in the federal application process should be made by the appropriate Quadrangle or affiliated Hospital officials. Notice of such resolutions should be forwarded to the Office for Research Issues of the Office of the Dean. The Standing Committee will not as a matter of course review such resolution decisions, but reserves the right to do so.

4. In the case of Public Health Service funding applicants, appropriate Quadrangle and affiliated Hospital officials are responsible for notifying the Public Health Service, prior to the institution's expenditure of any funds under the award, of the existence, but not the nature, of a conflict and that the conflict will be managed, reduced or eliminated, at least on an interim basis, within 60 days after it is identified. Such officials are also responsible for informing the Public Health Service that corrective action has been or will be taken when an applicant Faculty Member does not comply with the policy.

5. In the case of National Science Foundation funding applicants, appropriate Quadrangle and affiliated Hospital officials are responsible for certifying to the National Science Foundation that all identified conflicts have been satisfactorily managed, reduced or eliminated prior to the institution's expenditure of any funds under the award.

COMPLIANCE RESPONSIBILITY

Instances of deliberate breach of policy, including failure to file or knowingly filing an incomplete, erroneous, or misleading disclosure form, violations of the guidelines or failure to comply with prescribed monitoring procedures, will be adjudicated in accordance with applicable disciplinary policies and procedures of the Faculty of Medicine and of the affiliated hospitals. Possible sanctions will include the following:

1. Formal admonition;

2. The inclusion in the Faculty Member's file of a letter from the Office of the Dean indicating that the individual's good standing as a member of the Faculty has been called into question;

3. Ineligibility of the Faculty Member for grant applications, Institutional Review Board (IRB) approval, or supervision of graduate students;

4. Non-renewal of appointment;

5. Dismissal from the Faculty of Medicine.

Adopted by the Faculty Council, March 22, 1990
Amendments Adopted September 22, 1993
Amendments Adopted September 20, 1995

Adopted by the Harvard Medical Center, May 16, 1990
Amendments Adopted December 13, 1993
Amendments Adopted December 18, 1995

Amended May 25, 2000

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Go to:

Policy on Conflicts of Interest and Commitment

Guidelines for Conflicts of Interest

Appendix A - Operating Definitions (previous section)

Appendix B - Implementation

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© 1996 President and Fellows of Harvard College. All rights reserved. Materials adapted from the paper version of Faculty Policies on Integrity in Science, available from the Office for Research Issues, Harvard Medical School, 25 Shattuck Street, Boston, MA 02115. (617) 432-3191.