Conflict of Interest, Conflict of Commitment and Outside Professional Activities
Note about recently revised Conflict of Interest (COI) policy and new COI trainng requirement
A number of recent events highlighted risks to academic institution from inattention to conflicts of interest. We decided that WHOI’s Conflict of Interest and Conflict of Committment (COI) policy required revision to incorporate changes in the NSF Conflict of Interest Grantee Standards and updated practices of other agencies (e.g., NIH). WHOI’s General Counsel and the Director of Research worked with Staff Council to develop and revise the COI policy, and to determine the level of COI training and who should be trained. The revised Conflict of Interest (COI) policy and COI training requirement is the result of a review lasting more than a year and a half.
In order to reduce potential conflicts of interest and commitment, it is critical that WHOI Investigators and Administrators know how to identify potential conflicts and bring them forward to the Advisory Committee on Ethics, Conflicts and Security (ACECS) for review. The leader in COI training is the organization CITI. Since most federal agencies and departments leave it up to individual institutions to establish and enforce their COI policies, WHOI looked for a widely accepted and comprehensive training program to provide up-to-date understanding of conflict definitions and issues. The appropriate level of training was discussed at length both by the COI task force and at Staff Council. It was determined that the comprehensive approach based on Public Health Service (i.e. NIH) requirements would be the most protective for WHOI.
The CITI COI training for WHOI Investigators and administrators has 3 modules; the first is an overview of the other two modules. The second module on Financial Conflict of Interest (FCOI) is geared to the NIH grants because that agency has the clearest and most specific regulations. This module will be revised to be more WHOI-specific and to minimize reference to Public Health Service funding, but specifics about FCOI and reporting that are consistent with WHOI policy will remain. The third CITI module on Conflicts of Commitments, Conflicts of Conscience and Institutional Conflicts of Interest is general information relevant to all Individuals at WHOI. To keep costs down, WHOI Initially adopted the CITI COI standard training, but we plan to customize the training for later this year. (People who have taken the current CITI COI training do not need to take training for another 4 years. Training is required every 4 years.)If you have questions about the COI forms or training, please contact the General Counsel, Chris Land (firstname.lastname@example.org) or Vice President for Research, Larry Madin (email@example.com).
Policy Statement & Reason for the Policy
A conflict of interest (COI) can be any situation in which financial or other personal considerations have the potential to compromise a researcher’s professional judgment and objectivity in the design, conduct or reporting of research. This Policy is intended to ensure that all Scientific and Technical staff are free from the influence of personal considerations when representing the Institution, engaging in research, or making or providing public commentary. Further, the Policy requires that WHOI officers, Trustees, Scientific and Technical Staff, and administrators avoid or mitigate real or perceived financial conflicts of interest and ensure that their activities and interests do not conflict with their obligations to WHOI, to science, and to the public’s trust.
WHOI has a responsibility to ensure that it preserves the integrity of its research enterprise, the Institution as a whole, WHOI’s mission, and the public’s trust. Conflicts of interest or commitment, and misrepresentation are matters of concern to the Institution and may carry legal and regulatory implications. In particular, as the Institution is the administrator of sponsored research funds, it is obligated to ensure that such funds are used for the intended purpose and not for improper or inappropriate personal gain. This policy is to ensure that an individual's activities are in concert with the interests and mission of the Institution and that the Institution has sufficient information to arrive at a reasonable decision as to the appropriateness of activities.
In order to promote and protect academic freedom, and the integrity and the mission of the Institution, this policy is implemented to provide transparency and to ensure the resolution of any real, potential, or apparent COI or Conflict of Committment (COC). The Policy provides and requires that WHOI officers, Trustees, Scientific and Technical Staff, and administrators avoid or mitigate real or perceived financial conflicts of interest and ensure that their activities and interests do not conflict with their obligations to WHOI, WHOI’s mission, to science, and to the public’s trust. Conflicts of Interest and Conflicts of Commitment can arise naturally from engagement with the world outside the Institution, and the mere existence of a COI or COC does not necessarily imply wrongdoing. However, both actual conflicts and the appearance of conflicts can be harmful to the Institution, WHOI’s mission, and to the Individual involved.
Disclosure and consultation continue to be the best means for avoiding conflicts of interest. Conflict of Interest and Conflict of Commitment situations are often complex and judgments may differ on whether or not a conflict, in fact, exists. Therefore, the goal of a policy of disclosure and consultation is to prevent Individuals from inadvertently placing themselves or the Institution in a position of conflict or apparent conflict.
The Institution requires that Individuals disclose certain financial interests, enabling WHOI to determine if a financial interest creates a conflict of interest or the appearance of a conflict of interest. A real or perceived conflict does not imply wrongdoing, and does not necessarily mean, for instance, that a researcher may not retain the financial interest and still undertake the affected research. Some conflicts must be eliminated, but often WHOI can work with the Individual to manage a conflict or the appearance of a conflict so that the activity can continue in a way that minimizes the possibility of bias and preserves objectivity. Proper management of a conflict depends on full and prompt disclosure. Furthermore, the Institution recognizes that while an individual's primary professional commitment is to the Institution, outside consulting and other forms of independent work are accepted activities. Involvement in outside professional activities, both public and private, often serves not only the participant but the Institution and the field of ocean sciences as well.
A COI or COC may exist when an Individual has a personal economic or political interest to the extent that it affects, or provides an incentive to affect, the Individual’s performance.Further, any effort to influence the Institution’s work or direct its resources could be a potential conflict. This can arise when research is Industry-Sponsored or with a Financially-Interested Company. To maintain independence, the methods, processes, and conclusions must remain in the hands of the Individuals, with results or data to be made publicly available and/or subject to peer review.
If an actual, apparent, or potential COI or COC exists or develops, the affected Individual should fully disclose the relevant information to the greatest extent possible to his or her administrative supervisors, Department Chair, the Deputy Director and Vice President for Research (DDVPR), or the General Counsel in advance and, unless the conflict is waived in writing by the Director of Research or General Counsel, abstain from acting on behalf of WHOI with respect to the matter in which he or she has a conflict.
Any Individual must seek review from either the Department, Chair, Supervisor, Deputy Director and Vice President for Research (DDVPR) or the Advisory Committee on Ethics, Conflicts, and Secutiry (ACECS) before engaging in activity that presents a potential conflict or appearance of a conflict or which calls into question the independence of the Individual or the Institution.
The duty of disclosure is ongoing and continuing. If an actual apparent or potential conflict of interest emerges or is revealed, disclosure should be made as soon as practical including, but not limited to, updating the Disclosure form.
The Conflict Disclosure form (Form for Individuals with WHOI email / without WHOI mail) must be completed and submitted sufficiently in advance of any anticipated agreement or other form of commitment, however informal, by the Individual to allow the appropriate individual(s) the opportunity to make inquiry as to the nature or extent of the activity, to reach a decision as to Institutional involvement, to require or suggest changes in or additions to any agreements or understandings that are to apply, and to explore patent possibilities, potential conflicts of interest or attention, and the like.
Disclosures with issues or concerns will be reviewed by ACECS.
Who must disclose COI and COC?
All Individuals who have an apparent, potential, or real COI or COC.
Individuals are all personnel at WHOI including the Scientific and Technical Staff, Trustees, Administrative Staff and all other employees, students and post docs, and anyone who has a WHOI appointment including visitors, guests, Emeritus, and adjuncts.
Resident and Nonresident Guest Investigators, Visiting Scholars who received or are expected to receive more than $5000 from WHOI are required to file a WHOI Disclosure Form. All prospective employees, Guest Investigators and Visiting Scholars will receive this policy and a copy of the form when receiving an appointment at WHOI.
All Individuals who are listed as a Principal Investigator on a proposals or on an award must have submitted all relevant financial disclosures and have had COI training at the time that proposal is submitted to an Organization and at the time of the award.
Any pending employee, post-doc or JP student named on a WHOI proposal.
Any MIT faculty who has a faculty appointment at WHOI and who is not receiving funding from a project at WHOI does not have to disclose.
(For Public Health Service disclosure, Investigators are defined as the principal investigator (PI), co-principal investigator, or any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research or educational activities funded or proposed for funding.)
The Deputy Director and Vice President for Research in consultation with the General Counsel may, at their discretion, choose to exclude certain affiliates from this Policy.
What must be disclosed?
Individuals must disclose potential conflicts of interest or conflicts of commitment as discussed or found under the General Policy. Examples of COI and COC and Examples for ACECS review.
For the Annual Disclosure form that is due 31 January of each year, Individuals report on the previous year's activities.
If there are changes after 31 January, a revised activity disclosure form should be submitted.
When in doubt, disclose.
Reporting by Individuals
All Individuals are required to report annually on all of their outside professional activities and to disclose significant financial interest in entities that would be affected by funded research. The Conflict Disclosure form (Form for Individuals with WHOI email / without WHOI mail) is to be submitted to the Supervisor, Department Chair, Administrative Manager, DDVPR, Director, or Executive Committee of the Board of Trustees, as appropriate, not later than January 31st for the previous year's activities. If no activity has been performed, this should be so indicated on the Conflict Disclosure Form.
If a conflict or potential arises between annual reporting, the Disclosure Report form must be updated. It is the duty of the Individual to keep the Disclosure Report form current and to update the form as needed during the year.
Any new employee or Individual newly affiliated with WHOI will fill out the Conflict Disclosure format check-in or with their Department.
Institution's Training of Individuals for COI & COC
The Institution’s training* every 4 years is required by the following Individuals:
Principal Investigators (This includes Scientists, Senior Technical Staff, and any other Individual named as a Principal Investigator on a proposal, contract or an award.)
Any Individual involved in the design, conduct or reporting of proposed or funded research from a Public Health Services Agency (e.g., NIH).
Department and Centers:
All Administrators and Administrative Professionals
Directorate- all membersAll Directors and staff of the following:
President and Director’s Office
Deputy Director and Vice President for Research Office
Finance & Accounting
Grants and Contract Services
Office of Technology Transfer
Environmental Health & Safety
Facilities and Services
Administrative staff of Marine Operations
All members of ACECS
The Institution’s Training* is also required immediately under the designated circumstances.
- The Institution changes the Conflict of Interest and Conflict of Commitment policies in a manner that affects an Individual’s requirements.
- A Principal Investigator is new to the Institution.
- The Institution finds that an Individual is not in compliance with the Institution’s Financial Conflict of Interest policy or management plan.
Review of activity Disclosure and potential COI
Any referral of COI and COM by Designees or others are reviewed and analyzed by ACECS. The annual Conflict Disclosure Form and updated disclosures may be reviewed by the ACECS and ACECS will reference NSF, NIH, AGU, and other principles of scientific integrity in making its review and determinations.
In the event that a COI or COC determination is made by ACECS, it will be reported in writing to the DDVPR. The DDVPR makes the determination in writing to the affected employee(s), with a copy to the Director. In addition, ACECS will inform any and all appropriate Institution offices and departments of this action, along with any restrictions and/or conditions that have been imposed as a consequence. Such offices could include, but not be limited to, Controller's, Procurement, Human Resources, and Grant and Contract Services.
Individuals must work with the DDVPR and the General Counsel to identify, disclose and satisfactorily resolve conflicts of interest when they arise.
The DDVPR and/or the General Counsel may, when necessary, confer with the Audit and Risk Committee of the Board of Trustees about the satisfactory resolution of conflicts of interest or conflicts of commitment when they arise.
Examples of Conflict Mitigation
Examples of conditions or restrictions that might be imposed to manage, reduce or eliminate COI or COC include, but are not limited to:
- public disclosure of significant financial interests;
- monitoring of research by independent reviewers;
- modification of the research plan;
- disqualification from participation in the portion of the research that would be affected by significant financial interests;
- divestiture of significant financial interests; or
- severance of relationships that create conflicts.
Appeal of Conflict Determinations
If an Individual elects to appeal the action taken by the DDVPR. The Director will conduct an independent review and his/her determination shall be binding. The Director has the ultimate authority and responsibility to determine when the foregoing policy applies and what steps, including procedural enforcement and sanctions, should be taken to correct a situation deemed not in the best interests of the Institution.
Failure to Comply with the Policy
Failure to comply with this Policy may result in sanctions, including a formal reprimand in an Individual’s personnel file, adverse impact on Individual’s evaluation and any potential raises, disclosure to federal agencies and/or the public, and termination of Individual’s employment or affiliate status.
Last updated: January 8, 2017