See also: Conflict of Interest Form.
Section 1. Introduction and Overview
The purpose of this policy is to outline an institutional approach to the identification and management of conflicts of interest, in a fashion which will foster both the conduct of scholarly activities and ensure compliance with Public Health Service and National Science Foundation regulations.
The regulations require that any faculty and staff member in a position to influence the outcome of a NSF or PHS funded project asserts that he or she has no financial conflict of interest with regard to the project, or report any conflict that does exist. The College is required to attest to such declarations for all NSF and PHS grants and a new form has been developed to enable our compliance with the regulations. If a financial conflict of interest does exist reasonable efforts will be made to work with the investigators in order to manage those conflicts. A College committee is established to review positive financial conflict of interest disclosures and to work with the investigator to resolve the conflict. If a conflict cannot be resolved to the investigators satisfaction, an appeal may be made to the Provost for a binding decision. Details of the above procedures are presented in the policy statement presented below. The form to be submitted with grant proposals is Attachment 1.
Currently a significant financial interest is defined as payments within a 12 month period amounting to $10,000 or more; or ownership of 5% or more of a business involved in any way with the sponsored research. The above limits apply in aggregate to the investigator and the investigators spouse and dependent children.
Section 2. Applicable Regulations
The National Science Foundation (NSF) Investigator Financial Disclosure Policy and the U.S. Public Health Service (PHS) regulations in 42 CFR Part 50, and 45 CFR part 94, under the heading of Objectivity in Research are effective as of October 1, 1995, and carry the weight of federal regulation. The federal policies stipulate requirements for:
- annual financial disclosures on the part of ALL research investigators supported by NSF or PHS (defined in Section 3 with required form as Attachment 1);
- institutional certification that all proposed and ongoing NIH/NSF sponsored research is either free of conflicts of interest, or that such conflicts are adequately managed (detailed in Section 4);
- the implementation of an institutional mechanism for managing conflicts of interest in research;
- keeping NIH/NSF informed if the College is unable to satisfactorily manage actual or potential conflicts of interest;
- sanctions where appropriate (Section 7); and,
- maintenance of records relating to this policy, for at least three years following the termination of a given project.
Section 3. Definitions
Firm, franchise, association, organization, holding company, joint stock company, receivership, business or real estate trust, or any other legal entity organized for profit or charitable purposes.
Business means any corporation, partnership, sole proprietorship, firm, franchise, association, organization, holding company, joint stock company, receivership, business or real estate trust, or any other legal entity organized for profit or charitable purposes.
Conflict of Interest means a situation in which significant financial interests in a business, or other personal considerations provided by a business, may compromise, or have the appearance of compromising, an investigator’s professional judgment in conducting or reporting research, the results of which could affect the aforementioned business, either directly or indirectly.
Immediate Family means the investigator’s spouse, minor children and any other persons living in the same household.
Investigator means the principal investigator and any other person at Williams College who is responsible for the design, conduct or reporting of research, and the investigators immediate family. This shall include faculty and research staff (research associates and assistants, visiting scientists, and students engaged in research conducted in the department).
Participate means to be part of the described activity in any capacity, including but not limited to serving as the principal investigator, co-investigator or research collaborator. The term is not intended to apply to individuals who provide primarily technical support who are purely advisory, with no direct access to the data (e.g., control over its collection or analysis) unless they are in a position to influence the study’s results or have privileged information as to the outcome.
Significant Financial Interest means anything of monetary value, including, but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options or other ownership interests); and intellectual property rights (e.g., patents, copyrights and royalties from such rights). The term does not include:
- Salary, royalties, or other remuneration from Williams College;
- Income from seminars, lectures, or teaching engagements sponsored by public or non-profit entities;
- Income from service on advisory committees or review panels for public or non-profit entities; or
- An equity interest that when aggregated for the investigator and the investigators spouse and dependent children, meets both of the following tests: Does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair marked value, and does not represent more than 5% ownership interest in any single entity; or,
- Salary, royalties or other payments what when aggregated for the investigator and the investigators spouse and dependent children over the next 12 months, are not expected to exceed $10,000.
Research means a systematic investigation designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social sciences research. The term encompasses basic and applied research, and product development.
Technology means any compound, drug, device, diagnostic, medical, dental or surgical procedure intended for use in health care or health care delivery.
Section 4. Key Elements of the Policy
The Williams College Conflict of Interest Policy is designated to identify actual or potential sources of conflicts of interest in research; and to either eliminate, reduce or manage such conflicts. As such, the following sub-sections outline the procedures which will be followed to assure compliance with this policy, and all applicable federal regulations related to conflicts of interest.
4.1 Notification of Investigators
Upon adoption of this policy, a copy will be sent to all Faculty and Staff (as defined in Section 3 above), and become part of the faculty and staff handbooks. Any changes of the policy will be annotated and distributed to all investigators included in a revised version of the policy located in the handbooks. This will be the responsibility of the Office of the Provost.
The Dean’s Office shall, subsequent to the initial distribution of this policy, provide a copy of the policy to all new faculty hired and any visiting faculty appointed on a non-paid basis.
The Williams College Personnel Office shall, subsequent to the initial distribution of this policy, provide a copy of the policy to all new research and administrative staff hired by Williams.
4.2 Financial Disclosure Procedures
Each grant applicant and co-applicant participating in a sponsored project covered by this policy must disclose whether or not he or she has external affiliations that may constitute a conflict as described above. A Disclosure Form (Attachment 1) is to be completed and submitted to the Office of the Provost at the same time the grant proposal is submitted for institutional approval. The form must be updated on an annual basis and whenever new financial interests are secured. Negative disclosures will be filed in the Office of the Provost with no further review required. Positive disclosure forms will be reviewed by a Conflict Review Committee consisting of the Assistant to the President for Affirmative Action and Government Relations, the Associate Provost, and the appropriate chair from the divisional research funding committees. The review must be completed prior to the College’s acceptance of the sponsored project or creation of a budget or subcontracts for the acquisition of goods and services. All materials relating to positive disclosures will be kept in strict confidence in the Office of the Provost.
In addition, investigators will be responsible for ensuring that an updated Williams College Conflict of Interest Financial Disclosure form shall be completed and filed at any time during a year when an investigators significant financial interests may change.
4.3 Review of Financial Disclosure and Certification of Conflict of Interest Status
Upon review of the College Conflict of Interest Financial Disclosure form, the Associate Provost shall be responsible for notifying the Provost of the conflict of interest status of all investigators. Certification that investigators have complied with the requirement to complete the Colleges Conflict of Interest Financial Disclosure form and that NO Conflict of Interest exists will be accomplished each time an investigator submits a proposal for extramural funding.
In the event a conflict of interest has been identified, the Associate Provost shall notify the other committee members that such a conflict has been identified, and that steps have been initiated to eliminate or manage the conflict of interest, as outlined in Section 4.5 below. During that period of resolution, no award of extramural support (which are the subject of the conflict of interest) for the investigator(s) shall be accepted by the College. Once a resolution of the conflict has been achieved, the Associate Provost will notify the Provost of the terms of the resolution, and authority to process all proposals will be reinstated.
In the event that the College is unable to resolve the conflict within 45 days of discovery, the Associate Provost shall notify the Provost of this, and the facts surrounding that case. In the event that notification of research sponsors is required, the Associate Provost will be responsible for effecting this notification.
4.4 Resolution and/or Management of Conflicts of Interest
If a conflict of interest has been identified as a result of the procedures outlined in Section 4.3 above, the Associate Provost will be responsible for taking the appropriate following action(s):
- Notify the investigator(s) that as a result of the financial disclosure process, a conflict of interest has been discovered in relation to research in which to investigator(s) are involved.
- Refer the matter to the College’s Conflict of Interest Management Committee
4.5 Conflict of Interest Management Committee
The committee will be responsible for reviewing cases referred to it by the Associate Provost in order to determine whether the financial interest identified in the disclosure process could affect the design, conduct, or reporting of the research of the affected investigator(s), and determine what conditions or restrictions, if any, should be imposed by the College to manager such conflicts; or, it may decide that the probability that the financial interest would affect the design, conduct or reporting of the research is too remote to warrant any specific conditions or restrictions. The committee will be authorized to request any other information that it deems necessary to assist it in this determination.
Examples of conditions or restrictions that might be imposed to manage actual or potential conflicts of interest include:
- public disclosure of significant financial interests;
- monitoring of the research by independent reviewers;
- modification of the research plan;
- disqualification from participation in all or a portion of the research subject to the conflict of interest;
- divestiture of the financial interest; or,
- severance of relationships that create actual or potential conflicts.
This committee’s operating guidelines will be developed subsequent to the adoption of this policy. Every effort will be made to maintain the privacy of information gathered in the Committee’s deliberations, within the limits imposed by applicable laws and regulations.
4.6 Maintenance of Records
All records related to the implementation of this policy, e.g., Conflict of Interest Financial Disclosure forms, minutes of meetings called to resolve or manage conflicts, minutes of the meetings of the College’s Conflict of Interest Management Committee, notifications to funding agencies, etc., shall be maintained in the Office of the Provost. These records shall be maintained, with an appropriate degree of security, for a period of at least three years following the investigator’s departure from Williams College.
4.7 Notification of Research Sponsors
The Associate Provost shall be responsible for timely notification of research sponsors, as may be required by the sponsors’ policies or agreements between Williams College and the sponsors, of any actual or potential conflicts of interest, including any measures taken to reduce, manage or eliminate such conflicts.
Section 5. Appeals
In situations where the investigator(s) disputes the decision of the conflict of interest management committee, the matter will be referred to the Provost whose decision regarding the management of conflicts of interest shall be final.
Section 6. Prohibited Activities
Consistent with the regulations outlined in Section 2, it is the policy of Williams College that conflicts of interest in research may be allowable, provided that an acceptable plan of management, as outlined in Section 4 above, can be developed and implemented in situations where such conflicts arise, as long as such management plans are not in conflict with applicable federal regulations.
The only exception to this is that investigators may not engage in research activities sponsored by businesses in which those investigators have an ownership interest equaling 5% or more of the outstanding stock (or other ownership interests) of that business.
Examples of Activities which are not a Conflict of Interest
- Receiving royalties for copyrights and patents obtained in accordance with College policy and State law.
- Receiving honoraria for giving seminars or guest lectures.
- Duty to professional organizations, peer review panels, publication boards, and accreditation bodies.
- Ownership of company where there is no relationship to College grant funded research.
- Ownership in a company where the only involvement with the College is paid consulting.
- Ownership of mutual funds which may invest in companies that support the investigators research.
Section 7. Sanctions and Penalties
Sanctions and penalties for those who knowingly and willfully disregard this policy, or refuse to comply with its terms, will be determined by the Dean of the Faculty. Sanctions include, but are not restricted to:
- Letter of reprimand
- Notification to professional and/or scientific societies, funding agencies and/or professional journals
- Reassignment of duties
- Termination of grant support
- Adjustment of research space allocation
- Adjustment of salary
Section 8. References
The following references on conflict of interest are intended to serve as an educational resource for the Williams College research community. It is neither an exhaustive, nor particularly current set of citations. It will, however, provide interested parties with information about this complicated and important issue.
- Barinaga, M., Conflicts of Interest, Confusion on the Cutting Edge. Science 1992; 257:616-619
- Blumenthal, D., Academic-Industry Relationships in the Life Sciences. JAMA 1992; 268:334403349
- Djerassi, C., Basic Research, The Gray Zone. Science 1993; 261:972-973
- Jackson, M. Guidelines for Dealing with Faculty Conflicts of Commitment and Conflicts of Interest in Research. Association of American Medical Colleges, 1990.
- Kassirer, J. and Angell, M., Financial Conflicts if Interest in Biomedical Research. NEJM 1993; 329:570-571
- Korn, D., Conflicts of Interest in Academic Health Centers. Association of Academic Health Centers, 1990.
- Koshland, D., Conflict of Interest Policy. Science 1992; 257:595
- Krimsky, S., Statement on University-Industry Relations, Conflict of Interest and Disclosure. Testimony Before the Hose Subcommittee on Regulation, Business Opportunities and Technology 1993
- Marshall, E., When Does Intellectual Passion Become Conflict of Interest? Science 1992; 257:620-623
- Relman, A., Dealing with Conflicts of Interest. NEJM 1985; 313:749-751
- Rothman, K., Conflict of Interest, The New McCarthyism in Science. JAMA 1993; 269:2782-2784
- Thompson, D., Understanding Financial Conflicts of Interest. NEJM 1993; 329:573-576