Why Does Yale Have This Policy and Process?
Yale University is committed to the idea that a great university should reach out to the world. Thus, faculty and staff are encouraged to participate in sponsored research, to consult widely and to engage in activities that may benefit not only the participants and the University but also the public at large.
There is little doubt that such interactions play an important role in the transfer of knowledge and technological advances from the University to the community. It is also true however, that as the number and complexity of university-industry relationships has increased there has been a corresponding increase in public concern that financial conflicts of interest may introduce bias into research, compromise dissemination of research results and delay trainee progress.
Unaddressed these concerns can lead to a decrease in public confidence in the results of academic research.
In 1995 the NIH and NSF, issued coordinated regulations designed to assure the objectivity of research funded by these federal agencies. The regulations require institutions to develop their own policies and procedures for review and management of investigator financial conflicts of interest.
Yale established its policy on Conflict of Interest and Conflict of Commitment both to assure the public that objective standards have been applied to the design conduct and reporting of research and to comply with federal regulations.
The Policy requires annual disclosure of outside activities and financial interests.
To Whom Does The Policy Apply?
Yale’s policy applies to all faculty with greater than a 50% time appointment and all faculty and non-faculty personnel who are responsible for the design, conduct or reporting of research.
What Must I Do?
All persons to whom the Policy applies must submit an annual Conflict of Interest/Conflict of Commitment (COI/COC) form disclosing their external activities and financial interests.
Yale’s policy requires disclosures to be “in writing”. Currently forms are available in pdf format and must be printed before being filled out. However, the University is developing a new, web-based COI-COC Disclosure Form. This new form will provide an interactive and more efficient means for faculty and other research personnel to meet their obligations to disclose outside activities and financial interests.
Those investigators proposing research involving human subjects must file an additional COI disclosure with the IRB which is specific to the research being reviewed by the IRB. That form is available on the HIC website.
What Happens To The Information I Provide?
Data revealed in the disclosure are considered confidential and are only shared with those who have a need to know. All people who have access to the data agree to maintain the confidentiality of the information.
Annual Disclosures are reviewed in a multi-step process. The first review is the responsibility of a department chair, senior administrator, or supervisor and is focused on review of conflict of commitment. These initial reviewers are charged with determining whether faculty members are meeting their Yale responsibilities and complying with the Yale consulting policy which limits outside activities to one day in seven during periods when working on a Yale appointment (52 days for 12 month appointees, 36 days during 9 months for Academic Year appointees).
When the dept chair or other initial reviewer has completed his or her review and signed off on the form it is forwarded to the Provost’s COI/COC committee for review.
N.B. The COI/COC Committee begins its review process only after the disclosure has been signed by the initial reviewer and received by the committee.
What Is Involved In The Committee Review?
In accordance with Yale Policy and Federal regulations the committee is charged with determining if a potential, real or perceived individual financial conflict of interest exists which could:
- Directly and significantly impact the design, conduct or reporting of a research project or program
- Appear to compromise the mentoring of students or trainees
- Result in biased purchasing or procurement decisions including letting of subagreements.
If the Committee determines that any or all of the above situations exist, the committee will develop appropriate safeguards and/or management plans to decrease, manage or eliminate such conflicts.
Forms which disclose no outside activity, or minimal outside activity are reviewed by either the COI Office or the Chair or Vice-Chair of the COI/COC Committee and assigned a status in an expedited manner.
Forms which disclose outside financial interests related to Yale activities are generally reviewed by the Chair or Vice-Chair of the Committee before presentation to the full committee for discussion and disposition. The Committee meets once a month.
Disclosures are reviewed according to the following principles:
a) The nature and size of the financial holding
b) The relationship of the financial interest to the research activity of the disclosing party.
Is the objectivity of externally sponsored research potentially compromised by the dislcosers financial interests?
c) Is the company a Yale Start-up? Note that special rules apply to association with Yale start-up companies.
d) Does Yale purchase goods and services from the company in which the discloser has a significant financial interest?
If yes then purchasing protections should be put in place, which may include 1) recusal from purchasing decisions, 2) additional oversight of purchasing decisions, 3) extra documentation of the need for sole source procurements, etc.
e) Does the company fund the discloser’s research?
As part of the management plan the committee will usually require evidence that the company sponsored research has not interfered with regular scholarly activity. A listing of current research grants and contracts and current publications (Schedule D) is usually requested in these situations.
f) Are students or other trainees involved in company funded research?
If students or other trainees are involved in company sponsored research the Committee will ask that the student be informed of the mentor’s financial interest. Further the Committee will request that the student/trainee be provided with the name of another faculty member to call on should he or she have questions or concerns about involvement in this research. In general the DGS or Post-Doctoral Office representative performs this function.
g) Are human subjects involved in the research?
When a form discloses a significant financial interest and related human subject research the Committee shall, as required by Yale policy on COI in clinical research require the investigator to minimize the potential for conflict of interest by reducing or eliminating the interest. The investigator may choose to retain the financial interest in which case he or she must usually cease direct involvement in the research.
How Long Does The Process Take?
While the committee strives to review all disclosures within a month of receipt the need for additional information or negotiation of an acceptable management plan can delay a final disposition. Forms received after the agenda for a monthly meeting has been established will be reviewed at the following meeting.
Incomplete forms are not reviewed until all necessary information has been provided to the COI Office. The new web-based forms will decrease the number of incomplete forms.
Why Won’t Yale GCA Set Up My Award While My COI Status Is Pending?
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.
What Can I Do To Facilitate My Award Set-Up?
Prompt responses to requests from the COI office for additional information or clarifications will facilitate a decision on your disclosure.
In addition if your annual COI anniversary date coincides with your annual grant renewal date you should consider submitting your disclosure earlier than required. Note that TMS will send you an e-mail notice 60 days prior to an approaching disclosure anniversary date.