PHS/NIH Financial Conflict of Interest Policy
These guidelines define Hamilton College’s policy and procedures regarding financial conflicts of interest in relationship to sponsored projects funded by the entities of the Public Health Service (PHS) and involving research, education, and College service. Their purpose is to protect the credibility and integrity of the College's faculty and staff so that public trust and confidence in the College's sponsored activities is ensured.
In accordance with Federal regulations, the College has a responsibility to manage, reduce, or eliminate any actual or potential conflicts of interest that may be presented by a financial interest of an investigator. Thus, the College requires that investigators disclose any significant financial interest that may reasonably appear to be affected by sponsored projects.
The Department of Health and Human Services amended its regulations related to financial disclosure on 8/25/2011. All institutions applying for funding by the National Institutes of Health (NIH) and other entities of the Public Health Service (PHS) are required to have a policy compliant with these amended regulations. This PHS/NIH Financial Conflict of Interest Policy is designed to comply with the federal regulations and hereby incorporates by reference 42 CFR chapter I, subchapter D, part 50.
This policy is adopted in addition to and as a supplement to the Hamilton College institutional “Policy of Investigator Conflict of Interest.”
These guidelines define general Hamilton College policy and procedures regarding conflicts of interest in relationship to sponsored projects funded by the Public Health Service. Their purpose is to protect the credibility and integrity of the College's faculty and staff so that public trust and confidence in the College's PHS-funded sponsored activities is ensured.
This policy applies to all Investigators of the College (as defined by the policy) who are involved with PHS-funded research. The Institutional Official is responsible for ensuring implementation of this policy and may suspend all relevant activities until the financial conflict of interest is resolved or other action deemed appropriate by the Institutional Official is implemented. Violation of any part of these policies may also constitute cause for disciplinary or other administrative action pursuant to University policy.
A potential Conflict of Interest occurs when there is a divergence between an individual's private interests and his or her professional obligations to the College such that an independent observer might reasonably question whether the individual's professional actions or decisions are determined by considerations of personal gain, financial or otherwise. An actual conflict of interest depends on the situation and not on the character or actions of the individual. For the purposes of this policy, a Financial Conflict of Interest exists when the College, through procedures described herein, reasonably determines that a significant financial interest could directly and significantly affect the design, conduct, or reporting of sponsored projects.
Investigator means the principal investigator/project director, co-principal investigators, and any other person who is responsible for the design, conduct, or reporting of research, educational, or service activities funded, or proposed for funding, by an external sponsor.
Institutional Official means the individual within the College who is responsible for the solicitation and review of disclosures of significantly financial interests including those of the Investigator’s family related to the Investigator’s institutional responsibilities. For the purposes of this policy the Institutional Official is _the Controller_.
Institutional Responsibilities means the Investigator’s responsibilities on behalf of the College, which are defined by the College as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as institutional review boards.
Financial Interest means anything of monetary value received or held by an Investigator or an Investigator’s Family, whether or not the value is readily ascertainable, including but not limited to: salary or other payments for serviced (e.g., consulting fees, honoraria, or paid authorships for other than scholarly works); any equity interests (e.g., stocks, stock options, or other ownership interests); and intellectual property rights and interest (e.g., patents, trademarks, service marks, and copyrights), upon receipt of royalties or other income related to such intellectual property rights and interests.
The term does not include:
(1) Salary, royalties, or other remuneration from the College;
(2) Income from investment vehicle, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles; or
(3) Salary, royalties or other payments that when aggregated for the Investigator and the Investigator's spouse or domestic partner and dependent children over the next twelve months, are not expected to exceed $5,000; or
(3) Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities; or
(4) Income from authorship of academic or scholarly works; or
(5) Income from service on advisory committees or review panels for public or nonprofit entities.
Provided, however, that the exclusions in the first three items shall not apply if the compensation or transfer of an equity interest is conditioned upon a particular outcome in a sponsored research project.
Significant Financial Interest means anything of monetary value that appears to be related to the Investigator’s institutional responsibilities, including, but not limited to:
* salary or other payments for services (e.g., consulting fees or honoraria) as defined as the aggregate value of any salary or other payments for services received during the 12 month period preceding the disclosure, and the value of any equity interest during the 12 month period preceding or as of the date of disclosure, exceeds $5,000;
* equity interests (e.g., stocks, stock options or other ownership interests) as defined as the aggregate value of any salary or other payments for services received during the 12 month period preceding the disclosure, and the value of any equity interest during the 12 month period preceding or as of the date of disclosure, exceeds $5,000;
* intellectual property rights (e.g., patents, copyrights and royalties from such rights) not reimbursed through the College.
Disclosure of Financial Interest
All Investigators are required to disclose their outside financial interests to the College on an annual and ad hoc basis, as described below, using the Significant Financial Interest Disclosure Form. Forms are available on the Office of Foundation, Corporate and Governemnt Relations web site.
1. Each Investigator is required to disclose the following Significant Financial Interests:
(i) Any Significant Financial Interest of the Investigator that would reasonably appear to be affected by the research or educational activities funded, or proposed for funding, by an external sponsor; or
(ii) Any Significant Financial Interest of the Investigator in an entity whose financial interest would reasonably appear to be affected by the research or educational activities funded, or proposed for funding, by an external sponsor.
Regardless of the above minimum requirements, a faculty or staff member, in his or her own best interest, may choose to disclose any other financial or related interest that could present an actual conflict of interest or be perceived to present a conflict of interest. Disclosure is a key factor in protecting one's reputation and career from potentially embarrassing or harmful allegations of misconduct.
The Project Director or Principle Investigator on a proposed PHS application is responsible for obtaining a PHS Financial Conflict of Interest Disclosure Form from all participating investigators.
2. Each Investigator shall complete a Disclosure Statement Regarding External Affiliations and attach all required supporting documentation. The completed Disclosure Form must be submitted to the Controller’s office. Supporting documentation that identifies the affiliation or entity involved and the nature and amount of the interest and/or income should be submitted in a sealed envelope marked confidential and accompany the Disclosure Form.
3. As required by Federal regulation, all Significant Financial Interests must be disclosed prior to the time a proposal is submitted. All financial disclosures must be updated by Investigators during the period of the award on an annual basis or as new reportable Significant Financial Interests are obtained. New reportable Significant Financial Interests must be reported with 30 days of discovering or acquiring the Significant Financial Interest.
4) Travel: Investigators must also disclose reimbursed or sponsored travel related to the institutional responsibilities, as defined above. Such disclosures must, at a minimum, include the purpose of the trip, the identity of the sponsor/organizer, the destination, the duration, and, if known, the monetary value.
Excluded from this requirement is reimbursed travel or sponsored travel by federal, state, or local government agencies, an institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.
The Institution Official will determine if any travel requires further investigation, including determination or disclosure of the monetary value.
1. The Controller shall review all financial disclosures to determine whether a conflict of interest exists. A conflict of interest exists when the review reasonably determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of the proposed sponsored project. If the Controller determines that there is a potential for conflict of interest covered by this policy, then the Controller and the Dean of Faculty will determine what conditions or restrictions, if any, should be imposed by the institution to eliminate, reduce or manage actual or potential conflicts.
2. Prior to submitting a proposal that involves disclosure of Significant Financial Interests or after a new Significant Financial Interest has been discovered or acquired, the Investigator should discuss with appropriate College officials proposed measures that will be taken to manage, reduce, or eliminate any actual or potential conflict of interest presented by a Significant Financial Interest. Such measures could include:
(1) Public disclosure of significant financial interests;
(2) Review of research protocol by independent reviewers;
(3) Monitoring of research by independent reviewers;
(4) Modification of research plan;
Following review of the Disclosure materials the Controller or the Dean of Faculty may impose additional conditions or restrictions, including the following:
(1) Modification of the research plan;
(2) Disqualification from participation in all or a portion of the research funded;
(3) Divestiture of significant financial interests; or
(4) Severance of relationships that create actual or potential conflicts.
The Controller or the Dean will require that a plan for reducing or eliminating conflicts of interest be incorporated into a Memo of Understanding between the College and the Investigator, providing a management plan on an on-going basis until completion of the PHS-funded research project.
3. To address complex situations, oversight committees may be established by the Institutional Official to periodically review the ongoing activity, to monitor the conduct of the activity (including use of students and postdoctoral appointees), to ensure open and timely dissemination of the research results, and to otherwise oversee compliance with the management plan.
Reporting to PHS
Should any reported conflict or non-compliance require reporting to PHS, the Institutional Official will report in accordance with PHS regulations. The College is required to provide the following information:
• Grant number
• Project Director/Principle Investigator
• Name of Investigator with FCOI
• Name of Entity with which the investigator has a FCOI
• Nature of FCOI (e.g., consulting fees, travel, equity, etc)
• Value of financial interest
• A description of how the financial interest relates to PHS-funded research and the basis for the Institution’s determination that the financial interest conflicts with such research
• Key elements of the Institution’s management plan
Annual reports to PHS must include the above and 1) the status of the FCOI and 2) changes to management plan.
Violations of Conflict of Interest Policy
Whenever an Investigator has violated this policy or the terms of any resolution plan (including failure to file or knowingly filing incomplete, erroneous, or misleading disclosure forms) the Controller shall notify the Dean of Faculty, who will impose – or, if the violation has been discovered by the Dean of Faculty, who will initiate the imposition of – sanctions or institute disciplinary proceedings against the violating individual, including suspension of all relevant activities until the matter is resolved.
In addition, the College shall follow Federal regulations regarding the notification of the sponsoring agency in the event an Investigator has failed to comply with this policy. The sponsor may take its own action as it deems appropriate, including the suspension of funding for the Investigator until the matter is resolved.
In addition, if the Institutional Official determines that a Financial Conflict of Interest was not identified or managed in a timely manner, including but not limited to an Investigator’s failure to disclose a Significant Financial Interest that is determined to be a Financial Conflict of Interest, or failure by an Investigator to materially comply with a management plan for a Financial Conflict of Interest, a committee appointed by the Institutional Official will complete a retrospective review of the Investigator’s activities and the research project to determine whether the research conducted during the period of non-compliance was biased in the design, conduct or reporting of the research.
Documentation of the retrospective review shall include the project number, project title, PI, name of Investigator with the Financial Conflict of Interest, name of the entity with which the Investigator has the Financial Conflict of Interest, reason(s) for the retrospective review, detailed methodology used for the retrospective review, and findings and conclusions of the review. This review shall take place within 120 days of the Institution’s determination of non-disclosure.
The Institutional Official or designee will update any previously submitted report to the PHS or the prime PHS-awardee relating to the research, specifying the actions that will be taken to manage the Financial Conflict of Interest going forward. If bias is found, the report will include a mitigation report in accordance with the PHS regulations, including a description of the impact of the bias on the research project and the plan of action to eliminate or mitigate the effect of the bias.
Records of investigator financial disclosures and of actions taken to manage actual or potential conflicts of interest, shall be retained by the Controller’s Office until 3 years after the later of the termination or completion of the award to which they relate, or the resolution of any government action involving those records.
Collaborators/subrecipients/subcontractors from other organizations must either comply with this policy or provide a certification that their organizations are in compliance with PHS regulations regarding investigator significant financial interest disclosure and that their portion of the project is in compliance with their institutional policies.
Each Investigator must complete training on this Policy prior to engaging in research funded by PHS, and at least every four years thereafter. They must also complete training within a reasonable period of time as determined by the Institutional Official in the event that this Policy is substantively amended in a manner that affects the requirements of Investigators, or if it is determined that the Investigator has not complied with this policy or with a management plan related to their activities. The Office of Foundation, Corporate, and Government Relations will provide links to training modules on their website and will maintain records that demonstrate proof of training.
Prior to the expenditure of funds, the Institution, through the Office of Foundation, Corporate, and Government Relations, will ensure public accessibility of information about any FCOI, via response to requestor within five business days of the request, information concerning any Significant Financial Interest that meets the following criteria:
a) The Significant Financial Interest was disclosed and is still held by the Investigator;
b) A determination has been made that the Significant Financial Interest is related to the PHS-funded research; and
c) A determination has been made that the Significant Financial Interest is a Financial Conflict of Interest.
The information to be made available shall be consistent with the requirements of the PHS policy.