NIH Policy on Financial Conflict of Interest
Policy on Financial Conflict of Interest Applicable to the U.S. Department of Health and Human Services and Public Health Services-Funded Research
Hawai‘i Pacific University (HPU) is committed to the advancement of its faculty and staff. HPU recognizes, however, that individuals have interests outside of the university setting that may influence, or appear to influence, the performance of that person’s institutional responsibilities.
Federal regulations require identification, disclosure, management and/or reporting of conflicts of interest (COI) related to research and other sponsored projects. This Policy addresses the specific requirements of the Public Health Services (PHS)/National Institutes of Health (NIH) and its 2011 Revised Financial Conflict of Interest Regulation, Promoting Objectivity in Research (42 CFR Part 50 Subpart F).
This policy governing Financial Conflict of Interest (FCOI) applies to all HPU Investigators funded by the PHS. The Institutional Official (IO) is responsible for ensuring implementation of this policy and may suspend all relevant activities until a FCOI is resolved or other action deemed appropriate by the IO is implemented. Violation of any part of these policies may also constitute cause for disciplinary or other administrative action pursuant to HPU policy.
Family means any member of the Investigator’s immediate family, specifically, the individual, spouse, significant other or dependent children (Investigator’s Family).
Financial Interest, as applied to this document, means anything of monetary value received or held by an Investigator’s Family, whether or not the value is readily ascertainable, including, but not limited to: salary or other payments for services (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 interests (e.g., patents, trademarks, service marks, copyrights), upon receipt of income related to such intellectual property rights and interests.
For Investigators, Financial Interest also includes any reimbursed or sponsored travel undertaken by the Investigator. This includes travel that is paid on behalf of the Investigator rather than reimbursed, even if the exact monetary value is not readily available. It excludes travel reimbursed or sponsored by U.S. Federal, state or local governmental agencies, U.S. institutions of higher education, research institutes affiliated with institutions of higher education, academic teaching hospitals, and medical centers.
Significant Financial Interest means a Financial Interest that reasonably appears to be related to the Investigator’s Institutional Responsibilities, AND:
a) if with a publicly traded entity, 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; or
b) if with a non-publicly traded entity, the aggregate value of any salary or other payments for services received during the 12-month period preceding the disclosure exceeds $5,000; or
c) if with a non-publicly-traded entity, is an equity interest of any value during the 12-month period preceding or as of the date of disclosure; or
d) is income related to intellectual property rights and interests that is not disbursed through HPU.
Significant Financial Interest does NOT include:
a) salary, royalties, or other remuneration from HPU;
b) income from the authorship of academic or scholarly works;
c) income from seminars, lectures, or teaching engagements sponsored by or from advisory committees or review panels for U.S. Federal, state or local governmental agencies; U.S. institutions of higher education (as defined at 20 U.S.C. 1001(a)); U.S. research institutes affiliated with institutions of higher education, academic teaching hospitals, and medical centers; or
d) equity interests or income from investment vehicles, such as mutual funds and retirement accounts, so long as the Investigator does not directly control the investment decisions made in these vehicles.
Financial Conflict of Interest (FCOI) means a Significant Financial Interest that the Institution reasonably determines could directly and significantly affect the design, conduct or reporting of Institutional research.
Institutional Official (IO) means the individual within HPU that is responsible for the review of disclosures of significant financial interests as referred by the Director of Research Compliance, including those of the Investigator’s Family, related to the Investigator’s institutional responsibilities. For the purposes of this policy, the IO is the Vice President of Academic Affairs or authorized designee.
Institutional responsibilities means the Investigator’s responsibilities associated with his or her Institutional appointment or position, such as research, teaching, clinical activities, administration, and institutional, internal and external professional committee service.
Investigator means any individual who is responsible for the design, conduct, or reporting of PHS sponsored research, or proposals for such funding. This definition is not limited to those titled or budgeted as principal investigator or co-investigator on a particular proposal, and may include postdoctoral associates, senior scientists, or graduate students. The definition may also include collaborators or consultants, as appropriate.
Public Health Service or PHS means the Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority of the PHS may be delegated. The components of the PHS include, but are not limited to, the Centers for Disease Control and Prevention, the Health Resources and Services Administration and the National Institutes of Health. Research means a systematic investigation, study, or experiment designed to contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research. The term encompasses basic and applied research (e.g., a published article, book or book chapter) and product development (e.g., a diagnostic test or drug).
CONFLICT OF INTEREST:
This policy informs faculty about situations that generate conflicts of interest related to research, provides mechanisms for Investigators and HPU to manage those conflicts of interest that arise, and describes situations that are prohibited. Every Investigator has an obligation to become familiar with, and abide by, the provisions of this policy. If a situation raising questions of conflict of interest arises, an Investigator should discuss the situation with the Director of Research Compliance, who may refer the issue to the IO.
1) DISCLOSURE OF FINANCIAL INTERESTS
All PHS Investigators are required to disclose their outside financial interests to HPU as described below. The Director of Research Compliance is responsible for the distribution, receipt, processing, initial review and retention of disclosure forms. The IO or designee is responsible for the final review of the disclosure forms.
The Investigator is encouraged 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.
a) Annual Disclosures
All Investigators must disclose their Significant Financial Interests on an annual basis to the Director of Research Compliance. All forms should be submitted to the Director of Research Compliance by February 1 for the previous calendar year.
b) Ad hoc Disclosures
In addition to annual disclosure, certain situations require ad hoc disclosure.
All Investigators must disclose their Significant Financial Interests to HPU, through the Director of Research Compliance, within 30 days of their initial appointment or employment.
Prior to entering into sponsored projects or applications for sponsored projects, where the Investigator has a Significant Financial Interest, the Investigator must submit to the Director of Research Compliance an ad hoc disclosure of his or her Significant Financial Interests with the outside entity. HPU will not submit a research proposal unless Investigator(s) has (have) submitted such ad hoc disclosures.
In addition, all Investigators must submit to the Director of Research Compliance an ad hoc disclosure of any Significant Financial Interest they acquire during the course of the year, within thirty (30) days of discovering or acquiring the Significant Financial Interest.
Investigators must also disclose reimbursed or sponsored travel related to their institutional responsibilities, as defined above in the definition of Financial Interest. Such disclosures must include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, the duration, and, if known, the monetary value. The Director of Research Compliance will determine if additional information is needed (e.g., the monetary value if not already disclosed) to determine whether the travel constitutes a FCOI with the Investigator’s research.
2) REVIEW AND DECISION OF THE INSTITUTIONAL OFFICIAL
If the disclosure form reveals a Significant Financial Interest, it will be reviewed promptly by the Director of Research Compliance for a determination of whether it constitutes a FCOI. If a FCOI exists, the Director of Research Compliance will confer with the IO, and action will be taken to eliminate, reduce, or manage the conflict, as appropriate.
A FCOI will exist when the Director of Research Compliance in consultation with the IO determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of PHS-supported research. If the Director of Research Compliance in consultation with the IO determines that there is a FCOI that can be managed, the IO must require and approve a written management plan before any related research goes forward. The affected Investigator is responsible for developing and submitting a proposed management plan, in consultation with the Director of Research Compliance and the IO.
To address complex situations, oversight committees may be established by the Director of Research Compliance and/or the IO 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.
3) REPORTING TO PHS
Should any reported conflict or non-compliance require reporting to PHS, the IO will report in accordance with PHS regulations. If the funding for the research is made available from a prime PHS-awardee, such reporting shall be made available to the prime awardee so that they may fulfill their reporting obligations to the PHS.
If HPU receives funding as a prime PHS-awardee and transfers funds to a subrecipient:
HPU will incorporate, as part of the written agreement, terms that establish whether HPU’s FCOI policy or the subrecipient’s FCOI policy will apply to subrecipient Investigators. This agreement will include relevant time periods for the subrecipient to meet FCOI identification, disclosure and/or reporting requirements both to HPU and to the funding agency.
4) INVESTIGATOR NON-COMPLIANCE
a) Disciplinary Action
In the event of an Investigator’s failure to comply with this Policy, the IO may suspend all relevant activities or take other disciplinary action until the matter is resolved or other action deemed appropriate by the IO is implemented.
An IO’s decision to impose sanctions on an Investigator because of failure to comply with this Policy, or failure to comply with the decision of the IO, will be described in a written explanation of the decision to the investigator and, where applicable, the IRB, and will notify the individual of the right to appeal the decision.
b) Retrospective Review
In addition, if the Director of Research Compliance determines that a FCOI 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 FCOI, or failure by an Investigator to materially comply with a management plan for a FCOI, the Director of
Research Compliance 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 grant/contract number, project title, Principal Investigator, name of the Investigator with the FCOI, name of the entity with which the Investigator has the FCOI, reason(s) for the retrospective review, detailed methodology used for the retrospective review, and findings and conclusions of the review.
The IO 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 FCOI 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.
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 Director of Research Compliance 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 training module is located at https://www.citiprogram.org/default.asp?language=english.
6) RECORD RETENTION
The Office of University Counsel will retain all disclosure forms, conflict management plans, and related documents for a period of three years from the date the final expenditure report is submitted to the PHS or to the prime PHS awardee, if applicable.
To the extent permitted by law, all disclosure forms, conflict management plans, and related information will be confidential. However, HPU may make such information available to an agency funding research of the faculty member, to a requestor of information concerning FCOI related to PHS funding or, if HPU is a subrecipient, to the primary entity who made the funding available to HPU, if requested or required. If HPU is requested to provide disclosure forms, conflict management plans, and related information to an outside entity, the Investigator will be informed of this disclosure.
8) PUBLIC ACCESSIBILITY
Prior to the expenditure of funds, HPU will respond to any 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 FCOI.
The information to be made available shall be consistent with the requirements of the PHS policy.
Requests for this information must be made to: Hawai‘i Pacific University, Office of University Counsel, 1164 Bishop Street, Suite 1609, Honolulu, HI 96813.
9) REGULATORY AUTHORITY
This policy implements the requirements of 42 CFR 50 and 45 CFR 94; where there are substantive differences between this policy and the requirements, the requirements shall take precedence.