Conflict of Interest in Research Policy
Gladstone is committed to ensuring that the design, conduct, and reporting of any research involving Gladstone staff will not be biased by any conflicting financial interest of any researcher, his/her spouse, and/or dependent children. The Public Health Service (PHS) requires that researchers disclose any significant financial interest as defined by federal regulations (42 CFR Part 50 Subpart F) that reasonably appears to be related to the Investigator's institutional responsibilities. The Gladstone Institutes Conflict of Interest Committee is responsible for reviewing any possible conflict of interest involving a significant financial interest.
Questions regarding this policy may be directed to:
Vice President for Intellectual Property and Legal Affairs
CONFLICT OF INTEREST – OBJECTIVITY IN PHS-FUNDED RESEARCH
POLICY: Gladstone is committed to ensuring that the design, conduct, and reporting of any research involving Gladstone Staff or the use of Gladstone funds or facilities will not be biased by any conflicting financial interest of any researcher, his/her spouse, and/or dependent children. The U.S. PHS requires that researchers disclose any significant financial interest as defined by federal regulations (42 CFR Part 50 Subpart F) that reasonably appear to be related to their professional responsibilities or activities. The PHS has exempted Small Business Innovative Research (SBIR) and Small Business Technology Transfer (STTR), Phase I applications from these requirements.
A Gladstone Staff member is considered to have a potential conflict of interest when he/she or his/her spouse or dependent children (i.e., immediate family) has a significant financial interest that is related to, or is in an entity whose activities are related to, that Gladstone Staff member's responsibilities at Gladstone. Included in such responsibilities are all activities in which he/she is engaged in the areas of teaching, research, patient care, research consultation, Gladstone or UCSF committee memberships, or administrative responsibilities.
APPLICABILITY: This policy applies to all Gladstone Staff who fit the definition of Investigator, below, in regard to any activity funded by or for which research funding is sought from the PHS. Subcontractors, collaborators, visiting researchers, consortium members, or consultants may also be subject to this policy if they are responsible for the design, conduct or reporting of PHS-funded research or research that is proposed for PHS funding.
DEFINITIONS for purposes of this Policy:
COIC means the Gladstone Conflict of Interest Committee.
Disclosure of significant financial interests means an Investigator's disclosure of significant financial interests to Gladstone.
Financial conflict of interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
FCOI report means Gladstone's report of a financial conflict of interest to a PHS Awarding Component.
Financial interest means anything of monetary value, whether or not the value is readily ascertainable.
HHS means the United States Department of Health and Human Services, and any components of the Department to which the authority involved may be delegated.
Institutional responsibilities means an Investigator's professional responsibilities on behalf of Gladstone such as research, research consultation, teaching, professional practice, Gladstone or UCSF committee memberships, and administrative responsibilities.
Investigator means the project director or principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS, or proposed for such funding, which may include, for example, collaborators or consultants.
Manage means taking action to address a financial conflict of interest, which can include reducing or eliminating the financial conflict of interest, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.
PD/PI means a project director or principal investigator of a PHS-funded research project; the PD/PI is included in the definitions of senior/key personnel and investigator under this subpart.
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 involved may be delegated, including the National Institutes of Health (NIH).
PHS Awarding Component means the organizational unit of the PHS that funds the research that is subject to this subpart.
Public Health Service Act or PHS Act means the statute codified at 42 U.S.C. 201 et seq.
Research means a systematic investigation, study or experiment 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 (e.g., a published article, book or book chapter) and product development (e.g., a diagnostic test or drug). As used in this policy, the term includes any such activity for which research funding is available from a PHS Awarding Component through a grant or cooperative agreement, whether authorized under the PHS Act or other statutory authority, such as a research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project, or research resources award.
Senior/key personnel means the PD/PI and any other person identified as senior/key personnel by Gladstone in the grant application, progress report, or any other report submitted to the PHS by the Institution under this subpart.
Significant financial interest means:
- A financial interest consisting of 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 institutional responsibilities:
- 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. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value;
- 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 or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest); or
- Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
- Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their institutional responsibilities; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by a Federal, state, or local government agency, 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 disclosure will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. Gladstone official(s) will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes a financial conflict of interest with the PHS-funded research.
- The term significant financial interest does not include the following types of financial interests: salary, royalties, or other remuneration paid by Gladstone to the Investigator if the Investigator is currently employed or otherwise appointed by Gladstone, including intellectual property rights assigned to Gladstone and agreements to share in royalties related to such rights; 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; income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency, 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; or income from service on advisory committees or review panels for a Federal, state, or local government agency, 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.
All Gladstone Staff will be provided a copy of this Policy at the time of employment or first access to Gladstone funds or facilities, and annually thereafter, by the Intellectual Property Department.
- Potential conflicts of interest must be disclosed by Gladstone Staff to the COIC immediately. Without limiting the foregoing, before submitting a PHS application with respect to a project, Investigator(s) must complete and submit to the Vice President for Intellectual Property and Legal Affairs a Gladstone Outside Activities & Financial Disclosure (OAFD) form reporting any Significant Financial Interest(s), as defined in this Policy.
- The Grants and Contracts Officer will send the Investigator(s) involved in such PHS application an OAFD form. This form must be completed and submitted to the Intellectual Property department before the grant proposal is submitted. The Grants and Contracts Officer will verify that a current OAFD form has been completed for each involved Gladstone Staff member before submission of such proposals.
- Each Investigator participating in PHS-funded research must update his or her disclosure annually during the period of the award to reflect any information not disclosed initially or updates to any previously-disclosed Significant Financial Interests (e.g., the updated value of previously disclosed equity interests). Investigators are also required to report a new Significant Financial Interest within 30 days of discovering or acquiring the interest.
Review and Management of Financial Disclosures
- Completed OAFD forms will be sent by the Intellectual Property Department to the applicable Institute Director or the President for review in accordance with this Policy. If in his/her judgment, the OAFD form indicates a potential conflict of interest or a Significant Financial Interest that is related to PHS-funded research, the OAFD form will be referred to the COIC.
- Review of disclosures by the Institute Director, President or COIC shall include a determination of whether an Investigator's Significant Financial Interest is related to a PHS-funded research project at Gladstone and, if so, whether the Significant Financial Interest constitutes a financial conflict of interest.
- An Investigator's Significant Financial Interest is related to PHS-funded research when (i) the Significant Financial Interest could be affected by the PHS-funded research or (ii) the Significant Financial Interest is in an entity whose financial interest could be affected by the research.
- A financial conflict of interest exists when an Investigator's Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
- The Investigator involved in review by the COIC will be notified in writing of the COIC's determination. Gladstone will take such actions as are necessary to manage financial conflicts of interest in PHS-funded research, including, prior to the expenditure of PHS award funds, development and implementation of a management plan that specifies the actions that have been or will be taken to manage, reduce or eliminate the financial conflict of interest.
- Whenever, in the course of an ongoing PHS-funded research project, a Significant Financial Interest is disclosed by a new Investigator or an existing Investigator discloses a Significant Financial Interest not previously reported, or it comes to the attention of Gladstone officials that a Significant Financial Interest related to the PHS-funded research was not disclosed in a timely manner by an Investigator, the interest shall be reviewed within 60 days and a decision shall be made as to whether the Significant Financial Interest constitutes a financial conflict of interest. If Gladstone determines that a financial conflict of interest exists, Gladstone shall implement, on at least an interim basis, a management plan that shall specify the actions that have been, or will be taken, to manage the Financial Conflict of Interest.
Financial Conflict of Interest Reports by Gladstone
- Prior to the expenditure of any funds under a PHS-funded research award, Gladstone shall submit to the PHS Awarding Component a financial conflict of interest report (Report) regarding any Significant Financial Interests related to the PHS-funded research that Gladstone finds to be conflicting and implement a management plan as set forth in this Policy. In addition, if, during the course of a PHS-funded research project and subsequent to its initial Report, Gladstone identifies a financial conflict of interest, Gladstone will provide the PHS Awarding Component with a Report, and implement a management plan, within 60 days of identifying the financial conflict of interest.
- For any financial conflict of interest previously reported by Gladstone to PHS, Gladstone shall provide updated Reports annually for the duration of the PHS-funded research project (including extensions with or without funds) in the time and manner specified by the PHS Awarding Component.
- Any required Reports shall be submitted to the PHS Awarding Component by the Gladstone Grants and Contracts Department.
- If Gladstone identifies a Significant Financial Interest that was not disclosed timely by the Investigator or, for whatever reason, was not previously reviewed by Gladstone during an ongoing PHS-funded research project (e.g., was not timely reviewed or reported by a subrecipient), Gladstone shall, within 60 days: review the Significant Financial Interest, determine whether it is related to PHS-funded research, determine whether a financial conflict of interest exists, and if so, implement, on at least an interim basis, a management plan that shall specify the actions that have been, and will be, taken to manage such financial conflict of interest going forward.
- In addition, whenever a financial conflict of interest in PHS-funded research is not identified or managed in a timely manner, Gladstone shall, within 120 days of the determination of noncompliance, complete a retrospective review of the Investigator's activities and the PHS-funded research project to determine whether any PHS-funded research, or portion thereof, conducted during the time period of noncompliance, was biased in the design, conduct, or reporting of such research. Gladstone shall document the review in accordance with PHS requirements.
- Based on the results of the retrospective review, Gladstone will, if appropriate, update the previously submitted Reports affected by the review, specifying the actions that will be taken to manage the financial conflict of interest going forward. If the retrospective review determines that the research was biased in its design, conduct or reporting, Gladstone, through its Grants and Contracts Department, will promptly notify and submit a mitigation report to PHS.
- Furthermore, in any case in which the U.S. Department of Health and Human Services determines that a PHS-funded project of clinical research evaluating 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 managed or reported by Gladstone as required by this Policy, Gladstone shall require the Investigator to disclose the conflicting interest in each public presentation of the results of the research and to request an addendum to previously published presentations.
Maintenance and Disclosure of Records
- In accordance with PHS requirements, the Intellectual Property Department will maintain records relating to all financial disclosures made by Investigators engaged in PHS-funded research, as well as Gladstone's review of, and response to, such disclosures (whether or not a disclosure resulted in Gladstone's determination of a financial conflict of interest) and all actions taken under this Policy (including any retrospective review, if applicable) for at least 3 years from submission of the final expenditures report for a grant or cooperative agreement and 3 years after final payment for a contract, or for such longer periods as prescribed in applicable regulations, and will make such records available in appropriate circumstances for inspection and review upon request by duly authorized agencies.
- In addition, Gladstone, through the Intellectual Property Department, will provide a written response to a requestor within 5 business days of a request for information concerning a Significant Financial Interest held by a Project Director/Principal Investigator and any other person identified by Gladstone to PHS as senior/key personnel if Gladstone has determined that the Significant Financial Interest constitutes a financial conflict of interest in PHS-funded research.
Subgrantees, Contractors, and Collaborators
- If Gladstone carries out PHS-funded research through a subrecipient (e.g., subgrantees, contractors, or collaborators), Gladstone, through the Gladstone Grants and Contracts Department, will include in its written agreement with the subrecipient a statement as to whether the financial conflicts of interest policy of Gladstone or that of the subrecipient applies to the subrecipient's Investigators.
- If the subrecipient's financial conflicts of interest policy applies to subrecipient Investigators, the subrecipient shall certify as part of the agreement that its policy complies with the PHS regulations. If the subrecipient cannot make such a certification, Gladstone's policy will apply to subrecipient Investigators to the extent necessary for compliance with the PHS regulations.
- If the subrecipient's financial conflict of interest policy applies, Gladstone, through the Gladstone Grants and Contracts Department, will include in the subrecipient agreement time periods for the subrecipient to report all identified financial conflicts of interests to Gladstone. Such time periods must provide Gladstone with sufficient time to review the reports and make timely reports to PHS, as necessary.
- If subrecipient Investigators are subject to Gladstone's policy, the subrecipient agreement will specify time periods for the subrecipient to submit subrecipient Investigators' disclosures of Significant Financial Interests to Gladstone so that Gladstone has sufficient time to review the disclosures and comply timely with its review, management, and reporting obligations under this Policy.
Notification to PHS
Gladstone, through the Intellectual Property Department, will promptly notify the PHS Awarding Component of failure of an Investigator to comply with this Policy or with a management plan provided for hereunder has biased the design, conduct, or reporting of PHS-funded research.
Investigators engaged in PHS-funded research are required to complete training regarding their responsibilities under this Policy prior to engaging in any PHS-funded research project and at least every 4 years. Investigators must complete such training immediately if they are new to Gladstone, if Gladstone revises this Policy or its conflict of interest procedures in a manner that affects the requirements of Investigators, or if Gladstone finds that the Investigator is not in compliance with this Policy or a management plan adopted thereunder.