Policies

HRF FINANCIAL CONFLICT OF INTEREST POLICY FOR INTEGRITY EXTERNALLY FUNDED RESEARCH

Introduction

Health Research Foundation (HRF) has the goal of conducting and disseminating research findings with high levels of integrity to maintain funders and public trust in the Foundation. The Foundation recognizes its responsibility and the responsibility of all its researchers and research assistants to carry out their duties in a manner that promotes and preserves proper management, trust and confidence in the integrity of the research process at HRF. In accordance with this policy, in all externally funded research irrespective of the source, researchers must report their or their family’s significant financial interests timely. This is required to ensure that actual, potential and apparent financial conflicts of interest can be identified and managed appropriately. The principal investigators in all externally funded projects are particularly required to ensure that all co-investigators are in compliance with this policy.

Purpose

The purpose of this Financial Conflict of Interest Policy for Integrity in Externally Funded Research is to assure that research activities are conducted with the highest standards of ethics and integrity and in accordance with applicable national laws related to financial conflicts of interest. It provides a clear process of disclosure, review, and proper management of actual, potential, or apparent conflicts of interest between an investigator’s research duties and his/her personal financial interests.

This policy is written to confirm with regulatory requirements regarding Financial Conflicts of Interest locally and internationally, which all require that all research investigators funded by external funds disclose personal financial interests that could create an actual or potential conflict.

Applicability

This Policy is applicable to all Investigators involved in research for or on behalf of HRF, regardless of the funding source, Centre hosting the research, and irrespective of whether the investigators are full-time or part-time staff of HRF, student, visiting, or partner researchers. This Policy also extends to any subcontractors, sub-grantees or sub-awardees (Sub-recipients) at other institutions conducting Research for or on behalf of HRF.

Policy Details

I. DEFINITIONS

The following definitions apply to this policy

Financial Conflict of Interest (FCOI): a Significant Financial Interest that could directly and significantly affect the design, conduct or reporting of research.

Financial Conflict of Interest Committee (FCOI Committee): a committee created to review and provide recommendations for the management of Significant Financial Interests in accordance with this Policy.

Financial Conflict of Interest Management Plan (FCOI Management Plan): means a plan

developed in accordance with this Policy for the management, reduction, or elimination of an identified Significant Financial Interest.

Financial Conflict of Interest Report (FCOI Report): HRF’s report of a Financial Conflict of Interest to the responding awarding agency.

Financial Interest: anything of monetary value, whether or not the value is readily ascertainable.

Institutional Responsibilities: an Investigator’s professional activities on behalf of HRF (e.g., teaching, administration, research, clinical care, or service on IRB panels, editorial boards or peer review panels).

Investigator: any principal investigator, project manager, research analyst, or member of the research team identified as key personnel (on the grant or contract application, progress report, or any other report) and/or other individuals that the principal investigator identifies as having substantial independent decision making with respect to the design, conduct or reporting of research, including coinvestigators, collaborators or consultants.

Institutional Official: means the designated individual within HRF responsible for the management of this Policy, including the solicitation and review of disclosures of Significant Financial Interests, training of Investigators, record retention, and reporting to funding agencies, sponsors and the public as detailed herein.

Significant Financial Interest (SFI):

(1) A financial interest consisting of one or more of the following interests of the Investigator (aggregated together with those of the Investigator’s spouse/domestic partner or dependent children) that reasonably appear to be related to the Investigator’s Institutional Responsibilities:

1. With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000;
2. With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse, same-sex domestic partner or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest);
3. intellectual property rights and interests (e.g., patents, copyrights), a significant financial interest exists upon receipt of income related to such rights and interests; or
4. any third-party reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and/or the Investigator’s spouse, domestic partner, and dependent children) that is related to the Investigator’s Institutional Responsibilities. This disclosure requirement excludes travel paid for by HRF
5. holding any position of influence (e.g., director, officer, trustee, dean, or faculty) in a non-HRF entity.

(2) The term significant financial interest does not include the following:

1. Salary, royalties, or other remuneration paid by HRF to the Investigator if the Investigator is currently employed or otherwise appointed by HRF, including intellectual property rights assigned to HRF and agreements to share in royalties related to such rights;
2. Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles;
3. Income from seminars, lectures, or teaching engagements sponsored by government agencies, higher education institutions, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education; or
4. Income from service on advisory committees or review panels for government agencies, Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.

Research: 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).

II. DISCLOSURE PROCEDURES

1. Annual Disclosure Requirements

All Investigators must report any Significant Financial Interest that reasonably appears related to the Investigator’s Institutional Responsibilities on an annual basis utilizing a Significant Financial Interest Disclosure Form (SFI Disclosure Form).

1. Ad Hoc and Continuing Disclosure Requirements

In addition to the annual disclosure requirements, certain situations require ad hoc disclosure. Investigators new to HRF must complete and submit a SFI Disclosure Form, within thirty (30) days of their initial employment or appointment.

All Investigators also have an ongoing obligation to update disclosures to reflect changes in or additions of Significant Financial Interests. Investigators must disclose within thirty (30) days after a new Significant Financial Interest is acquired or discovered (e.g. through purchase, marriage, or inheritance). These ongoing disclosure obligations apply to any reimbursed or sponsored travel expenses that constitute a Significant Financial Interest under this Policy. Travel expenses paid by a third party through a grant to, or a contract with HRF do not need to be reported.

1. Sponsored Research Disclosure Requirements

Prior to entering into or submitting a letter of intent, proposal or application for a sponsored Research project, Investigators or their designees are responsible for accurately completing a Proposal Disclosure Form, which details information about the study and lists HRF and external Investigators and Sub-recipients on the study. The Investigators will then be prompted to complete an SFI Disclosure Form.

Each year of a sponsored grant or contract, an Investigator must update his/her SFI Disclosure Form. The form must be updated at the time of the annual progress report, twelve (12) months after the notice of award, or the initiation of Research, whichever date is earliest.

III. REVIEW, MANAGEMENT AND REPORTING PROCEDURES

1. Institutional Official Review and Responsibilities

The Institutional Official, or his/her designee, will review all SFI Disclosure Forms and will conduct a preliminary inquiry regarding any SFI Disclosure Form that identifies a Significant Financial Interest. Prior to the initiation of any inquiry, the Institutional Official will consult with the Office of Compliance and follow its directions regarding appropriate procedures to afford the maximum confidentiality and privilege protection for the investigation.

The Institutional Official will forward all SFI Disclosure Forms revealing a Significant Financial Interest to the Financial Conflict of Interest Committee (the “FCOI Committee”) for review, along with the Institutional Official’s recommendations as to which Significant Financial Interests warrant further inquiry to determine whether a Financial Conflict of Interest exists. It is also the responsibility of the Institutional Official to perform the following tasks, as more fully described in this Policy:

1. Conduct a preliminary investigation of any other reports of Significant Financial Interests and forward such reports to the attention of the FCOI Committee along with a recommendation as to whether the Significant Financial Interest warrants further investigation;
2. Implement and manage the training of Investigators in accordance with this Policy;
3. Maintain an up-to-date version of this Policy on HRF’s website;
4. Oversee initial and ongoing reporting to sponsors, as required; respond to requests from the public regarding Financial Conflicts of Interest
5. Implement and monitor compliance with FCOI Management Plans;
6. Coordinate with the FCOI Committee to impose disciplinary sanctions for violations of this Policy or any FCOI Management Policy;
7. Oversee the retrospective review and related procedures if a Financial Conflict of Interest is not identified or managed in a timely manner; and
8. Maintain records relating to training, disclosures, review and response under this Policy.
9. Financial Conflict of Interest Review Committee

The FCOI Committee is responsible for investigating Significant Financial Interests as necessary and determining whether a Financial Conflict of Interest exists. A Financial Conflict of Interest will exist if the FCOI Committee determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of the Research. Per this Policy, Investigators cannot make the decision about whether a Significant Financial Interest must be managed or whether it is a Financial Conflict of Interest; this determination is made through the review process. The FCOI committee will decide on the appropriate action to manage, reduce or eliminate any Financial Conflict of Interest and, with support from the Institutional Official, will develop an FCOI Management Plan if needed, as more fully described below.

It is also the responsibility of the FCOI Committee to perform the following tasks, as more fully described in this Policy:

1. Review any reports made regarding Significant Financial Interests, whether made on pertinent forms or otherwise brought to the attention of the FCOI Committee;
2. Request and review any additional materials needed to fully evaluate the relationship of the Financial Interest to the Research;
3. Recommend whether the Significant Financial Interest requires a FCOI Management Plan to manage, reduce, or eliminate the Financial Interest and to develop such a plan with support from the Institutional Officer;
4. Identify what particular Research project a Significant Financial Interest is related to and determine whether the Significant Financial Interest is a Financial Conflict of Interest that must be reported to the external funding agency or other sponsor, as applicable;
5. With respect to Research involving human subjects, evaluate Significant Financial Interest and recommend appropriate management measures and reporting to IRB panels;
6. Investigate allegations of noncompliance with this Policy or any FCOI Management Plan, to determine corrective actions, disciplinary sanctions, and sponsor reporting, as necessary.
7. FCOI Management Plans

The FCOI Committee, with support from the Institutional Official, will develop plans for the management, reduction, or elimination of identified Significant Financial Interests as necessary. A FCOI Management Plan will focus on the steps by which the objectivity of the Research can be ensured which may include, but not be limited to:

1. Public disclosure of an Investigator’s Significant Financial Interest;
2. For Research involving human subjects, disclosure of Investigator Financial Interests directly to participants;
3. Appointment of an independent reviewer of data, manuscripts, and/or presentations;
4. Modification of any Research proposal or plan;
5. Change in personnel or personnel responsibilities, or disqualification of an Investigator from participating in all or a portion of any Research;
6. Reduction or elimination by an Investigator of a Financial Interest.

For any FCOI Management Plan, the affected Investigator must agree in writing to the FCOI Management Plan and the proposed management strategies contained therein before the Research goes forward.

1. Research Involving Human Subjects

Special precautions must be taken to avoid bias with respect to Research involving human subjects involving the evaluation of strategies or products that may affect or be affected by the Financial Interests of HRF or her Investigators. An HRF Investigator shall not ordinarily participate in any Research involving human subjects that encompasses evaluation of such a strategy or product if he/she has a Significant Financial Interest that could directly and significantly affect the design, conduct or reporting of the Research unless he/she presents a compelling justification for a waiver of this Policy based on his/her unique qualifications as an Investigator. The FCOI Committee will review the compelling justification to determine if a waiver is justified.  If the FCOI Committee determines that a waiver is justified, it will coordinate with the Institutional Official to develop a FCOI Management Plan with stringent management measures to ensure the safety of the human participants and the integrity of the Research.

For all Research involving human subjects, the outcome of FCOI Committee reviews and any recommended FCOI Management Plans will be communicated to the appropriate Institutional Review Board (IRB) for review and approval. The IRB may require additional measures to protect the safety and welfare of Research subjects under their purview.

1. FCOI Reporting to External Sponsors

Sponsor regulations may require that HRF report to the funding agency Financial Conflicts of Interest related to sponsored Research. No expenditure of funds shall occur with respect to any externally funded Research project for which the FCOI Committee has determined that a FCOI Management Plan is required unless and until HRF has provided the funding agency with a FCOI Report containing the following information:

1. Project Number
2. PI or Contact PI if multiple PI model is used;
3. Name of the Investigator with the Financial Conflict of Interest;
4. Name of the entity with which the Investigator has a Financial Conflict of Interest;
5. Nature of the Financial Interest (e.g. equity, consulting fee, travel reimbursement, honorarium)
6. Value of the Financial Interest, or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measure of fair market value;
7. A description of how the Financial Interest relates to the funded Research and the basis for HRF’ determination that the Financial Interest conflicts with such Research; and
8. A description of key elements of the Institution’s FCOI Management Plan including:
   1. Role and principal duties of the conflicted Investigator in the Research project;
   2. Conditions of the FCOI Management Plan;
   3. How the FCOI Management Plan is designed to safeguard objectivity in the Research project;
   4. Confirmation of the Investigator’s agreement to the FCOI Management Plan;
   5. How the FCOI Management Plan will be monitored to ensure Investigator compliance; and
   6. Other information as needed or requested by the funding agency.

For any Significant Financial Interest that is identified after the funding for the Research is awarded, including Significant Financial Interests identified by Investigators new to the project, HRF will determine whether a Financial Conflict of Interest exists and whether a FCOI Management Plan is required. HRF shall provide a FCOI Report with the information above to the funding agency within sixty (60) days of identification of the Significant Financial Interest.

Additionally, each award year HRF must provide the PHS-funding agency an annual FCOI Report that addresses the status of the Financial Conflict of Interest and any changes to the FCOI Management Plan for the duration of the project period (including extensions with or without funding). The annual FCOI Report shall specify whether the Financial Conflict of Interest is still being managed or explain why the Financial Conflict of Interest no longer exists. HRF must report to the funding agency the annual FCOI Report at the time of the progress report.

1. FCOI Reporting to Other Sponsors

With respect to Research funded by a sponsor other than a foreign government agency, the Institutional Official shall review the funding agreement and determine all required reporting to sponsor. The Institutional Official will implement procedures to ensure compliance with all reporting and other Financial Conflict of Interest requirements contained in the funding agreement.

1. Reports to Foreign Government Funding Agencies-supported Research

As may be required by the regulations and upon written request, the Institutional Official shall provide to any requestor written information about Financial Conflicts of Interest, which were determined to be a Financial Conflict of Interest. Requests must be in writing and received through the official correspondence. The request must identify the specific project number and the name of Investigator for whom information is being requested. The request must include a named recipient and return address. HRF will note in its written response that the information is current as of the date of the correspondence, and is subject to updates at least annually and within sixty (60) days of HRF’s identification of a new Financial Conflict of Interest, which must be requested under separate cover by the requestor.

The following information will be provided to the requestor:

1. Project Number
2. Name of the Investigator with a Financial Conflict of Interest;
3. Investigator’s title and role with respect to the Research project;
4. Nature of the Financial Interest (e.g. equity, consulting fee, travel reimbursement, honorarium); and
5. Value of the Financial Interest (in ranges), or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measure of fair market value.

IV. SUB-RECIPIENT MONITORING

For Research covered by this Policy that involves subcontractors, sub-grantees or sub-awardees at other institutions (Sub-recipients), HRF must take reasonable steps to ensure that any Sub-recipient Investigator complies with this policy by:

• Requiring a written agreement from Sub-recipients that establishes whether HRF’s policy or the Sub-recipient’s policy shall apply to the Sub-recipient’s Investigators
  • If the Sub-recipient’s policy is used, the Sub-recipient must certify that its financial conflict of interest policy is compliant with the requirements of the funding agency and will be responsible for ensuring that the Sub-recipient institution and its Investigators comply with the funder required regulations. Sub-recipients must report to HRF as the awardee institution, any identified Financial Conflict of Interest no later than 45 days after identification of the Financial Conflict of Interest by the Sub-recipient. The details of the Financial Conflict of Interest will be reported to the funding agency as required under applicable regulations or policies.
  • If HRF’s policy is used, the Sub-recipient must ensure that its Investigators submit the SFI Disclosure Form to HRF at the time of application by HRF or at the time the Sub-recipient signs an institutional letter of support if during an on-going award grant or contract.
• Reporting to the funding agency any Sub-recipient Financial Conflicts of Interest prior to the execution of the sub-agreement or within sixty (60) days of identification of a new Financial Conflict of Interest by the Sub-recipient or HRF that arises during the term of the sub-agreement.

For Research funded by any sponsor, the Institutional Official shall be responsible for determining and ensuring compliance with any additional Sub-recipient monitoring, disclosure or other requirements contained in the funding agreement.

V. TRAINING

Each Investigator must complete training prior to engaging in Research, at least every four years, and immediately when:

1. HRF revises this Policy in any manner that affects Investigator requirements;
2. An Investigator is new to HRF; or
3. An Investigator is not in compliance with this Policy or FCOI Management Plan.

Each Investigator is ultimately responsible for ensuring that he/she makes any necessary disclosures to HRF required by this Policy and follows any prescribed plan for the management, reduction, or elimination of an identified Significant Financial Interest. Failure to do so shall be deemed a violation of this Policy and may result in sanctions on the Investigator.

VI. COMPLIANCE

1. Oversight

The Institutional Official will maintain an up-to-date version of this Policy on HRF’s website and is responsible for training on and ensuring compliance with this Policy and the procedures contained herein. In cases where a FCOI Management Plan has been developed, it is the task of the Institutional Official to implement and oversee compliance with such FCOI Management Plan on an ongoing basis.

1. Review and Sanctions

The FCOI Committee shall be responsible for investigating any alleged violations of this Policy. The FCOI Committee will follow directions from the Office of Compliance regarding appropriate procedures to afford the maximum confidentiality and privilege protection for all such investigations. In investigating any violation of this Policy, the FCOI Committee shall determine if the violation has biased the design, conduct or reporting of the Research and whether such Research is funded by an outside sponsor. The FCOI Committee will promptly report the results of such investigations to the Institutional Official along with any appropriate corrective actions to maintain the objectivity of the Research, sponsor reporting or other recommended notifications. The Institutional Official shall implement such corrective actions, including suspension of the Research project, as the FCOI Committee deems necessary to maintain the objectivity of the Research. The Institutional Official will promptly notify the applicable sponsor for any project in which Research is suspended pending conclusion of the retrospective review process described below.

The Institutional Official, in consultation with the FCOI Committee will decide on appropriate sanctions or disciplinary actions to be taken in accordance with HRF’s Code of Ethics, the Employee Handbook and other established HRF policies and procedures. Sanctions for non-compliance may include reprimands or other appropriate measures, up to and including termination. The Institutional Official will promptly notify the affected Investigator in writing of the results of the investigation and plans for disciplinary action against the Investigator, if applicable.

1. Retrospective Review Procedures

In addition to the above review and sanctions, Investigators are subject to the following retrospective review procedures when a Financial Conflict of Interest is not identified or managed in a timely manner. This includes any failure by an Investigator to disclose a Significant Financial Interest that is determined by HRF to constitute a Financial Conflict of Interest, failure by HRF to review or manage such a Financial Conflict of Interest, or failure by the Investigator to comply with a FCOI Management Plan. The Institutional Official is responsible for overseeing the procedures outlined below.

1. HRF must implement, on at least an interim basis, a FCOI Management Plan that shall specify the actions that have been, and will be, taken to manage such Financial Conflict of Interest going forward;
2. Within 120 days of HRF’s determination of noncompliance, HRF must complete a retrospective review of the Investigator’s activities and the affected Research project to determine whether any Research, or portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct, or reporting of such Research;
3. HRF must document the retrospective review and include, at minimum, the following information:
   1. Project number;
   2. Project title;
   3. PI or contact PI if a multiple PI model is used;
   4. Name of the Investigator with the Financial Conflict of Interest;
   5. Name of the entity with which the Investigator has a Financial Conflict of Interest;
   6. Reason(s) for the retrospective review;
   7. Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed);
   8. Findings of the review; and
   9. Conclusions of the review.
4. The Institutional Official shall promptly notify the Vice President for Research, The Compliance Officer and any other department involved in the study, of the results of any retrospective review. Such notification shall include a determination of whether the violation appears to have biased the design, conduct or reporting of Research, a copy of the retrospective review documentation described above, and a description of corrective actions taken. The Institutional Official will also submit recommendations for sponsor and/or other appropriate notifications, including affected HRF departments, for approval.
5. Based on the results of the retrospective review, if appropriate, HRF shall update the previously submitted FCOI Report, specifying the actions that will be taken to manage the Financial Conflict of Interest going forward.
6. For foreign government agencies sponsored Research, if the results of the retrospective review indicate bias, HRF is required to notify the funding agency promptly and submit a mitigation report to the funding agency. The mitigation report must include, at a minimum, the key elements documented in the retrospective review above and a description of the impact of the bias on the Research project and HRF’s plan of action or actions taken to eliminate or mitigate the effect of the bias (e.g., impact on the research project; extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable). Thereafter, HRF will submit to the awarding agency FCOI Reports annually. Depending on the nature of the Financial Conflict of Interest, HRF may determine that additional interim measures are necessary with regard to the Investigator’s participation in the PHS funded Research project between the date that the Financial Conflict of Interest or the Investigator’s noncompliance is determined and the completion of HRF’s retrospective review.
7. In any case that a clinical Research project, whose purpose is to evaluate the safety or effectiveness of a drug, medical device or treatment has been designed, conducted or reported by an Investigator with a conflicting interest that was not reported or managed as required by this Policy or the applicable regulations, then HRF shall, at minimum, require the Investigator involved to disclose the conflicting interest in each public presentation of the results of the Research and to request an addendum to previously published presentations. An Investigator who has failed to report a Significant Financial Interest related to clinical Research will also be subject to sanctions under this Policy.

 

VII. GENERAL PRINCIPLES

1. Confidentiality

To the extent permitted by law, all SFI Disclosure Forms, FCOI Management Plans, and related information will be treated as privileged and confidential. However, HRF may be required to make such information available to foreign government funding agencies, to a requestor of information concerning Financial Conflict of Interests related to such funding or to the primary entity who made the funding available to HRF, if requested or required. If HRF is requested to provide SFI Disclosure Forms, FCOI Management Plans, and related information to an outside entity, the Investigator will be informed of this disclosure.

The Institutional Official, the FCOI Committee and any other parties involved in reviews or investigations under this Policy will follow directions from the Office of Compliance regarding appropriate procedures to afford the maximum confidentiality and privilege protection for any such reviews or investigations.

1. Record Retention

The Institutional Official shall be responsible for maintaining records, identifiable to each project, all transactional reports of Significant Financial Interests, and all actions taken by the FCOI Committee or other appropriate departments within HRF to manage any actual or potential Financial Conflicts of Interest at least three (3) years from: (a) the date of submission of the final expenditures report, for federally funded grants; (b) from the date of termination or completion of the award; or (c) from the date of the resolution of any action by any governmental agency involving the records; or (d) as applicable, from any other regulations in force.

 

History/Revision Dates

Date Revised By

August , 2023 1^st Revision

January, 2013 Original Policy Adopted

 

Contact Information

For questions or concerns regarding this policy, please contact:

Dr. Maboh Michel Nkwati

Email: maboh@hrfbuea.org