Frequently Asked Questions for COI
A conflict of commitment occurs when the commitment to external activities of a faculty or staff member adversely affects his or her capacity to meet University responsibilities.
Yale’s Faculty Handbook provides guidance about the amount of time that may be given by faculty members to outside activities; it stipulates, for example, that a faculty member may not accept salaried employment at another institution while a full-time employee of Yale, that faculty may not spend more than one day in a seven–day work week on consulting activities, and that faculty ownership or management of private enterprises is subject to review and to limitations. It is important to recognize, however, that the obligations of Yale faculty move beyond the letter of these obligations to their spirit. The University requires that its faculty will meet their classes, but it also expects that they will be available to students outside of the classroom, will carry their share of committee responsibilities, will remain productively involved in their research and other scholarly pursuits, and, where applicable, will meet their clinical obligations. External activities that compromise or diminish a faculty member’s capacity to meet these obligations represent a conflict of commitment.
Full–time non–faculty employees are expected to satisfy all of the requirements of their jobs, and should not permit outside activities to interfere with the performance of their Yale obligations. Some departments prohibit staff employees from consulting or engaging in other outside employment because of the likelihood of such interference. Other departments may permit certain outside activities, with appropriate notice to and written approval by the employee’s supervisor, so long as they do not interfere with employees’ Yale obligations.
Your dean, department chair, or direct supervisor is in the best position to determine whether your outside activities pose a conflict of commitment and is your initial contact for discussing potential options for eliminating conflicts of commitment. In order to assure the elimination of the conflict of commitment, your dean, department chair, or direct supervisor may seek further consultation with the Provost.
If you are NOT responsible for the design, conduct or reporting of research funded by the Public Health Service (PHS) or other agencies/sponsors that have adopted the PHS regulations): You are not required to disclose travel expenses.
If you ARE responsible for the design, conduct or reporting of research funded by the Public Health Service (or other agencies/sponsors that have adopted the PHS regulations): You must disclose third party paid travel related to your institutional responsibilities that exceeds $5,000 per year from a single entity.
Third party paid travel means:
- Third party directly pays in whole or in part for travel on your behalf
- You pay for travel and third party reimburses you in whole or in part
- Yale pays in whole or in part for travel and the third party reimburses Yale
PHS regulations require you to disclose travel paid by:
- External professional organizations and societies;
- Academic journals and publishing companies; and
- ANY travel reimbursed or sponsored by a foreign Institution of higher education or the government of another country.
PHS regulations exclude travel paid by:
- Yale or funded by a sponsored award to Yale;
- U.S. Federal, state or local government agencies;
- U.S. Institutions of higher education or U.S. research institutes; and
- U.S. academic teaching hospitals or U.S. medical centers that are affiliated with U.S. Institutions of higher education.
The following is a list of PHS agencies and other sponsors that have adopted the PHS regulations:
- Administration on Aging (AoA)
- Administration for Children and Families (ACF)
- Agency for Healthcare Research & Quality (AHRQ)
- Agency for Toxic Substances & Disease Registry (ATSDR)
- Alliance for Clinical Trials in Oncology (ACTO)
- Alliance for Lupus Research (ALR)
- American Cancer Society (ACS)
- American College of Radiology Imaging Network (ACRIN)
- American College of Surgeons Oncology Group (ACOSOG)
- American Heart Association (AHA)
- American Lung Association (ALA)
- Arthritis Foundation (AF)
- California Breast Cancer Research Program (CBCRP)
- California HIV/AIDS Research Program (CHRP)
- Cancer and Leukemia Group B (CALGB)
- Centers for Disease Control & Prevention (CDC)
- Centers for Medicare and Medicaid
- Children’s Oncology Group (COG)
- Eastern Cooperative Oncology Group (ECOG)
- ECOG-ACRIN Cancer Research Group
- Food and Drug Administration (FDA)
- Gynecologic Oncology Group (GOG)
- Health Resources & Services Administration (HRSA)
- Indian Health Service (IHS)
- Juvenile Diabetes Research Foundation (JDRF)
- Lupus Foundation of America (LFA)
- National Institutes of Health (NIH)
- National Surgical Adjuvant Breast and Bowel Project (NSABP)
- North Central Cancer Treatment group (NCCTG)
- NRG Oncology Foundation, Inc (NRGOF)
- Patient-Centered Outcomes Research Institute (PCORI)
- Radiation Therapy Oncology Group (RTOG)
- Society for Academic Emergency Medicine Foundation (SAEMF)
- Southwest Oncology Group (SWOG)
- Substance Abuse & Mental Health Services Administration (SAMHSA)
- Susan G. Komen for the Cure
If, after reading the questions on the Disclosure Form, you are unsure as to whether or not you should report an outside activity/financial interest then you should err on the side of caution and disclose the information. If an issue should arise in the future, having reported the activity/relationship offers some protection to you and the University in terms of how the matter is perceived by others. Failure to report an activity/relationship may be misinterpreted as a desire to hide the activity. No one is criticized for “over–reporting.”
Yes. If you do not have any outside activities or external financial interests, you can simply answer “no” to the Screening Questions in Part One of the Disclosure Form.
Yes. University Policy requires disclosure of outside activities and financial interests. While many of these activities do not constitute a conflict of interest or conflict of commitment, they must be reported on the forms approved by the Provost.
Certain disclosures of a routine and “de minimis” nature may qualify for expedited review by either the COI Office or the COI Committee Chair. Other, more complex disclosures are presented to the Provost’s Committee on Conflict of Interest and Conflict of Commitment (COI Committee). The COI Committee will determine whether an apparent or actual conflict of interest exists, and, if so, by what means the conflict should be managed or avoided. The COI Committee convenes once each month. Disclosures received after the agenda for a monthly meeting has been established are reviewed at the following meeting.
Federal policy requires that prior to the expenditure of any funds under an award, any conflicts of interest be satisfactorily managed, reduced or eliminated in accordance with the Institution’s COI policy.
Federal regulation requires that prior to the expenditure of any funds under an award, any conflicts of interest be satisfactorily managed, reduced or eliminated in accordance with the Institution’s COI policy. Therefore, in order to facilitate your award set-up you should ensure that disclosures for all investigators and individuals who are designated by the PI to be responsible for the design, conduct or reporting of the research project have been submitted and updated in a timely fashion. Disclosure forms should be submitted with enough time to allow for the COI to manage, reduce or eliminate any financial conflicts of interest prior to the date you expect the award to be set-up.
If your annual COI anniversary date coincides with your annual grant renewal date you should consider submitting your disclosure earlier than required. Note that the Training Management System (TMS) will send you an email notice 30 days prior to an approaching disclosure anniversary date. In addition, your prompt response to requests from the COI Office for clarifications/additional information will help to facilitate a more timely review of your disclosure. Since the COI Office cannot process incomplete forms, disclosers should make every effort to provide all of the information required by the Disclosure Form.
If any significant financial interests are identified in your disclosure, these interests will be compared to each new research award on which you are identified as responsible for the design, conduct, or reporting of the research to determine if a COI exists related to that research award. This is called a “transactional review”. Certain sponsors require that they be notified of the existence of a conflict of interest and require details about the nature of the FCOI and the management plan.
A management plan is developed to manage, reduce, or eliminate any conflicts of interest identified during the review process. Considerations in the development of a management plan may include:
- The number of days spent interacting with the external entity;
- Complexity and extent of the relationship between the external entity and your University activities;
- Degree to which the involved parties stand to benefit (or may be negatively impacted);
- Level of the external interest associated with an activity;
- Value of the external interest;
- Degree of risk to human research participants.
Your disclosure will be maintained in confidence as far as possible. The information you submit will not be shared except with those who have a need to know. In addition to Yale employees with a need to know, disclosure may be made to the government, to the extent required by law, and, for faculty who serve as members of a health care institution’s medical staff or affiliated medical staff, disclosure may be made to that institution for purposes of its COI process.
PHS regulations require that prior to the expenditure of any funds under a PHS-funded research project, Yale must make publicly available information about any significant financial interest (SFI) that has been determined to be a financial conflict of interest (fCOI) and is held by senior/key personnel.
Yale has created a web form for the public to submit written requests directly to Yale’s COI Office. The information that Yale is required to provide includes:
- the Investigator’s name;
- the Investigator’s title and role with respect to the research project;
- the name of the entity in which the significant financial interest is held;
- the nature of the significant financial interest; and
- the approximate dollar value of the significant financial interest (in dollar ranges, e.g., $5,000-$9,999; $10,000-$19,999)
If you are not satisfied with the decision of the Provost’s COI Committee, you may contact the COI Committee Chair to discuss your concerns and alternative solutions. You may also request that the matter be referred to the Provost for a decision. Any matter referred to the Provost in this way shall be accompanied by a written statement of the findings and recommendations of the Provost’s Committee, with copies to the individual, and the appropriate dean or department chair. The Provost will notify the individual, the Provost’s Committee, and the dean or department chair of his or her decision.
The Provost’s decision will be final, and any failure by the individual to adhere to the decision will be cause for disciplinary action, including, in severe cases, termination.