Research Financial Conflict of Interest Policy

Policy Author

SVPAA/Provost

Responsible Office-Department

SVPAA/Provost

Effective Date of Policy

Fall 2021

Policy Currently Under Review

I. PURPOSE

The integrity of the College as a community of scholars requires the open exchange of ideas in an atmosphere free from commercial conflict and influence. When an investigator involved in research has significant financial interests in a company, organization, or institution external to the College, or receives compensation, funding, or other assistance from entities external to the College that can be affected by the investigator’s research, there is the potential for the creation of a conflict of interest or the appearance of a conflict. Therefore, the College must ensure that reports of research and scholarship can be disseminated on an open and timely basis without externally imposed requirements of restriction or review, in keeping with long-honored academic traditions. To this end, all members of the College community are expected to be open about any involvements with, and obligations to, external parties that could be interpreted as leading to such requirements or restrictions. This is especially important in those cases where relationships with external parties could lead to personal financial benefit from their scholarly work or ideas, or from the scholarly work or ideas of colleagues, including students, staff, administrators and faculty. The objective of this Policy and the federal regulations on which it is based is to promote “objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, or reporting of funded research will be free from bias resulting from conflicting financial interests of an Investigator” (defined below) 45 CFR § 50.601 and 94.1. This policy will help faculty and other personnel more effectively manage potential conflicts in the course of their research activities. By reporting financial interests and managing conflicts from the start, the College and the investigator can work together to prevent outcomes that may be harmful to either the investigator or the College at large. To achieve these ends, the College requires Investigators seeking research funding (including but  not  limited  to  grants,  cooperative  agreements,  and  contracts)  or having obtained research funding from the Public Health Service (PHS), the National Science Foundation (NSF), Health and Human Services (HHS), or other federal agencies or organizations comply with the following policy on the disclosure of significant financial interests and the management and reporting of Financial Conflicts of Interest.

II. DEFINITIONS

A. “Investigator” refers to the principal investigator(s) (PI), co-investigator, and any other person who is responsible for the administration, design, conduct, or reporting of sponsored research; research involving the use of College resources that are not generally available to the College community; internally funded research that involves human subjects; or proposals for funding. This definition is not limited to those titled or budgeted as investigator on a particular proposal. Students, staff, administrators and other relevant personnel may be considered investigators where, in the judgment of an academic advisor or other relevant supervisor, the student or other personnel is working relatively autonomously and should be considered an investigator.

B. “Significant financial interest” (SFI) means one or more of the following interests of the Investigator (and those of the Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’s College responsibilities:

a. Remuneration including salary, honoraria, paid authorship, royalties, equity interests (stock, stock options) or other ownership interests from a publicly traded entity that when aggregated exceeds $5,000 in the preceding 12 months, including salary and consulting fees.

b. Remuneration including salary and equity interests (stock, stock options) or other ownership interests from a non-publicly traded entity that when aggregated exceeds $5,000 in the preceding 12 months, where the aggregated fair market value exceeds $5,000.

c. Intellectual property rights and interests upon receipt of income related to such rights and interests.

d. Reimbursed or sponsored travel expense by a non-government entity other than Daemen, related to the investigator’s College responsibilities.

Significant financial interest does NOT include:

a. Salary, royalties, or other remuneration from the College;

b. Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities;

c. Income from service on advisory committees or review panels for public or nonprofit entities;

d. Equity managed by an unrelated, unbiased third party (e.g., invested in a mutual fund).

C. “Research Financial Conflict of Interest” (RFCOI) exists when a Significant Financial Interest could directly, adversely, and significantly affect the design, conduct, or reporting of funded research or educational activities.

D. “Research” means a systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge, including, but not limited to, research relating broadly to public health, behavioral and social-sciences for which research funding is available from Public Health Service (PHS), Health and Human Services (HHS) or the National Science Foundation (NSF) or other funding sources.

III. RESEARCH CONFLICT OF INTEREST COMMITTEE

Research Conflict of Interest Committee” (RCOIC) refers to the standing College committee that advises the Vice President for Academic Affairs (VPAA) and the Vice President for Business Affairs (VPBA) on conflict of interest matters and assists in related decision-making. The Committee consists of the VPAA, the VPBA, a representative from the Board of Trustees Audit Committee, the Chair of the Human Subjects Research Review Committee (if the research involves human subjects) and at least two additional tenured faculty members. Depending on the nature and scope of the potential conflict, additional administrators, staff, or faculty (with relevant expertise) or an external expert, may be requested to assist in this review, and the committee may request additional information from the Investigator who disclosed the SFI.

IV. RESPONSIBILITIES

A. College Responsibilities:

1. Maintain an up-to-date, written, enforced policy on RFCOI that complies with all government requirements, and make such policy available on the Daemen College Web site. (AGSPS)
2. Inform each Investigator of the College’s policy on RFCOI, the Investigator’s responsibilities regarding disclosure of SFI, and of applicable government regulations.
3. Require every Investigator to disclose the Investigator’s SFI and those of his/her spouse and dependent children prior to applying for or participating in funded research.
4. If the College will be carrying out funded research by a subrecipient, establish a written agreement that ensures that the subrecipient will comply with either a compliant RFCOI Policy of the subrecipient or the College’s Policy and that the subrecipient will timely disclose any SFI. If the subrecipient will comply with its own policy, the agreement must provide that the subrecipient will report to the appropriate Daemen official all identified RFCOIs on a timely basis. If the subrecipient ages to comply with Daemen’s policy, it must report to the College all SFIs in accordance with the procedure provided in the Agreement.
5. Require each Investigator to complete training on RFCOI policies prior to engaging in funded research. If the College determines that an Investigator is not in compliance with this Policy or is new, training will be required immediately. Investigators will receive training, at least every four (4) years.
6. Provide RFCOI reports of investigators and subrecipients as required by government funding sources.
7. Determine through the Research Conflict of Interest Committee (RCOIC) whether an RFCOI’s exists and take appropriate actions to manage RFCOI’s.
8. Maintain records relating to all Investigator disclosures of Research Financial Conflict of Interests and the College’s review of, and response to, such disclosures and make such records available to funding sources when required.
9. Establish adequate enforcement mechanisms and provide for appropriate sanctions to ensure Investigator compliance with this policy.
10. Certify to funding sources that the College has a written and enforced process to identify and manage RFCOIs.

B. Principal Investigator (PI) Responsibilities:

1. For each funded research project, determine who meets the definition of “investigator.”
2. Ensure that each Investigator receives appropriate RFCOI training and files a RFCOI disclosure with the VPAA or AGSPS in accordance with this policy.
3. Collects the required contact information on each Investigator and maintains and updates such information.
4. Submits names, contact information, and role of each Investigator to the Office of Academic Grants & Sponsored Program Services prior to submission of a proposal for funded research and updates this information immediately if changes occur.

C. Investigator Responsibilities:

1. File a SFI disclosures statement (Attachment A) including any reimbursed and sponsored travel expenses in accordance with this Disclosure statements must be provided i) prior to an application for funded research; i) annually. ii) within 30 days of discovery of or acquiring a SFI; iii) with submission to the college institutional review board (IRB/Human Subjects Research Review Committee); and iv) annually.
2. Submit updated contact information to the Principal Investigator.
3. Complete RFCOI training in accordance with this policy.

D. Vice President for Academic Affairs (VPAA): The VPAA, as the cabinet member to which faculty members (investigators) report, and in accordance with the College’s General Conflict of Interest Policy, is the first recipient of all RFCOI disclosures. The VPAA’s responsibilities include:

1. Delivering a copy of each Disclosure Form to the Vice President for Business Affairs (VPBA).
2. Per the Daemen Conflict of Interest Policy, maintaining all research-related disclosure materials.
3. Providing appropriate training regarding FCOI’s as required by this policy, to faculty investigators.
4. Preparing all required documents involving faculty investigators for funding agencies and authorizing the transmission of all required documents to the respective funding Once the documents are prepared, this transmission is traditionally done electronically and may be assigned to the Office of Academic Grants and Sponsored Program Services or other designee.
5. Certifying that for faculty investigators all financial conflict of interest disclosure requirements have been met prior to submitting a proposal to a funding agency and/or prior to expenditure of The VPAA reserves the right to not authorize expenditure of funds (i.e. freeze funds) if investigators fail to comply with this policy.
6. Serve as Chair of the Conflict of Interest Committee (RCOIC) when the potential or actual conflict of interest involves a faculty member.

E. Vice President for Business Affairs (VPBA):

1. The VPBA will receive copies of disclosure forms and participate in decision making as a member of the RCOIC.
2. In cases where non-faculty members are investigators, the VPBA is responsible for providing appropriate training regarding RFCOI’s as required by this policy.
3. In cases where non-faculty members are investigators, the VPBA is responsible for preparing all required documents for funding agencies and authorizing the transmission of all required documents to the respectivefunding agencies. Once the documents are prepared, this transmission is traditionally done electronically and may be assigned to the Office of Academic Grants and Sponsored Program Services or other designee.
4. The VPBA is responsible, with respect to non-faculty investigators, for certifying that all financial conflict of interest disclosure requirements have been met prior to submitting a proposal to a funding agency and/or prior to expenditure of The VPBA reserves the right to not authorize expenditure of funds (i.e. freeze funds) if investigators fail to comply with this policy.
5. Serve as Chair of the Research Conflict of Interest Committee (RCOIC) (defined below) when the potential or actual conflict of interest involves investigators other than faculty members.

F. Research Conflict of Interest Committee (RCOIC): Constituted as noted above, the RCOIC will conduct evaluation of all disclosures by investigators made under this policy; make determinations as to whether an FCOI exists; develop and implement management plans for FCOI’s subject to this policy; ensure enforcement of management plans and other actions to ensure policy compliance; and conduct retrospective reviews of potential instances of noncompliance with this policy. The RCOIC will render a decision in writing. In the event that the VPAA, or VPBA, is an investigator and/or involved in an actual or potential research conflict of interest, the Board of Trustees Audit Committee will appoint a qualified individual to fulfill the VPAA’s, or VPBA’s, role in matters addressing that conflict. G. Responsibilities of the Executive Director, Office of Academic Grants & Sponsored Program Services (AGSPS):

1. The AGSPS is responsible for ensuring that this policy is available on the Daemen website.
2. Upon learning that a Daemen employee is interested in applying for funded research inform the principal investigator of this policy.
3. Collect and maintain contact information on all Investigators and communicate this information to the VPAA, including those who are not Daemen employees.
4. Ensure that the Principal Investigator, VPAA, and VPBA have reviewed and approved funding proposals prior to submission, including certifying compliance with this policy, when applicable.
5. As the Authorized Organizational Representative (AOR) and Signing Official (SO) with the institutional authority to legally bind the institution in grant-administration matters by providing signature approval on grant application submissions, the AGSPS certifies the accuracy and completion of proposals as well as compliance with this policy and the relevant funding regulations. Accordingly, the AGSPS has the right to not transmit a proposal if proper institutional procedures have not been followed or the necessary approvals have not been obtained.
6. Serve as the point person for public accessibility inquiries, if and when requested.

V. REVIEW AND MANAGEMENT OF DISCLOSURES AND CONFLICTS

1. Review: The RCOIC shall review each disclosed SFI and determine whether a RFCOI, as defined above, If it is determined that there exists a RFCOI, the Committee shall determine what conditions or restrictions, if any, should be imposed by the College to manage, reduce, or eliminate such conflict or interest. Review shall be completed within 30 days of submission. If a SFI is disclosed or discovered subsequent to the funding application, the RCOIC must review and report whether a RFCOI exists with 60 days of disclosure or discovery.
2. Management of Conflicts: If the RCOIC determines that a SFI constitutes a RFCOI, the Committee shall determine the conditions or restrictions to be imposed and implemented as part of a formal management plan in order to manage or eliminate the The Management Plan may include, but is not limited to:

a. Monitoring of research by independent reviewers;

b. Modification of the research plan;

c. Change of personnel or responsibilities for all or a portion of the research;

d. Disqualification from participation in the portion of the research that would be affected by SFI’s;

e. Divestiture of SFI or other action to eliminate or reduce the FCOI;

f. Severance of relationships that create conflicts;

g. Public disclosure of FCOI’s;

h. For projects involving human subjects research, disclosure directly to the participants

3. Retrospective Review: If it is determined by the COIC that a FCOI was not disclosed by an investigator or a FCOI was not managed or the Management Plan was not complied with, the COIC will conduct and document a retrospective review and determine whether any portion of the research was biased by such If bias is found, the VPAA must notify the funding source and submit a report describing the College’s actions to eliminate or mitigate the bias. The Retrospective Review must be implemented within 10 days of being notified of a FCOI and the timeframe covered by the retrospective review must be documented with a rationale for the time frame selected. In addition, the RCOIC must also specify the management plan for ongoing research during the retrospective review process which may include any actions previously described in the Management of Conflicts Section above.

The VPAA shall communicate the Committee’s determination and the means identified for eliminating or managing the RFCOI to the individual Investigator(s), the relevant Principal Investigator or Project Director (if applicable), the appropriate department chair or administrative supervisor, and, as necessary, the funding source.

VI. REPORTING OF RFCOIs

Prior to the expenditure of PHS or HHS funds, the College shall report to the funding source any and all FCOIs found by the RCOIC and the details of the Plan instituted to manage or eliminate the RFCOI. If a RFCOI is discovered after the research funding has begun, the College will submit a report to the funding source containing the Management Plan, the results of any retrospective review and sufficient information to allow the funding source to understand the nature and extent of the RFCOI. This report will be submitted within 60 days of discovery of the RFCOI. For a RFCOI previously reported, the College will prepare and furnish the funding source an annual report addressing the status of the RFCOI and any changes in the Management Plan. Such report shall be submitted for the duration of the project.

VII. SANCTIONS

Federal regulations require the College to impose sanctions or take other administrative actions where appropriate. The College maintains the right to impose sanctions on Investigators for failure to disclose SFI’s and for failure to abide by this Policy. Sanctions may include restrictions on future submission of research proposals and other disciplinary actions, up to and including dismissal, as described in the College’s Research Integrity Policy and Section XII of the Faculty Handbook.

VIII. RECORD RETENTION

Federal regulations require the College to maintain records of all financial disclosures and all actions taken by the College for a minimum of three (3) years from the date of submission of the final expenditure report at the completion of the grant, or if any litigation, claim, financial management review, or audit is started before the expiration of the 3-year period, until all such actions have been resolved and final action taken.

IX. PUBLIC ACCESSIBILITY

Prior to expenditure of any PHS or HHS research funds, the College shall establish a publically accessible website to receive and respond to reports concerning a disclosed SFI that was determined to be a RFCOI where the RFCOI still exists. Within 5 days the College must provide the requester the name, title, and role of the investigator as well as the nature and appropriate dollar amount of the SFI. This website must be updated annually and within 60 days of receipt of a RFCOI not previously disclosed.