Policy Statement
Gladstone is committed to ensuring that the design, conduct, and reporting of any research involving Gladstone Staff or the use of Gladstone funds, facilities, or other resources, will not be biased by any conflicting financial interest of any researcher, their spouse, and/or dependent children.
A Gladstone Staff member is considered to have a potential conflict of interest when they or their 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 they are engaged in the areas of teaching, research, patient care, research consultation, Gladstone or UCSF committee memberships, and administrative responsibilities.
Scope
This policy applies to all Gladstone Staff who fit the definition of Investigator, below, with regard to any activity funded by, or for which research funding is sought from, the U.S. Public Health Service (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
Additional Authority
The U.S. PHS requires that researchers disclose all foreign and domestic significant financial interests 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.
See also Policy Number 05.03.02 Conflict of Interest, Policy Number 05.03.03 Outside Professional Activities, and 08.01.13 Distribution and Receipt of Research Materials.
Definitions
- COIC means the Gladstone Conflict of Interest Committee (COIC).
- Disclosure of Significant Financial Interests, as defined by the NIH, means an Investigator’s disclosure of significant financial interests to Gladstone.
- Entity means any domestic or foreign, public or private, organization (excluding a Federal agency) from which an Investigator (and spouse and dependent children) receives remuneration or in which any person has an ownership or equity interest.
- 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 FCOI, which can include reducing or eliminating the FCOI, 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 policy.
- 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.
- 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 for purposes of this policy, 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 Gladstone under 42 CFR Part 50 Subpart F.
- Significant Financial Interest(SFI) means any financial interest held by an Investigator (and/or their spouse or dependent children) that has monetary value, whether or not the value is readily ascertainable, that reasonably appears to be related to the Investigator’s Gladstone responsibilities, including the following:
- Remuneration and Equity Interests:
- Publicly traded companies: the value of any remuneration (e.g, salary, consulting fees, honoraria, paid authorship, etc.) received from a publicly traded entity, including foreign entities, in the twelve months preceding the disclosure and the value of any equity interest (e.g., stock, stock option, or other ownership interest) in the entity at the date of disclosure that, when aggregated, exceeds $5,000.
- Privately held companies: the value of any remuneration (e.g., salary, consulting fees, honoraria, paid authorship, etc.) received from a non-publicly traded entity, including foreign entities, in the twelve months preceding the disclosure, when aggregated exceeds $5,000, or when the Investigator (and/or their spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest).
- Intellectual property rights and interests: the value of royalties from patents and copyrights not arising out of Gladstone employment paid to an Investigator (and/or their spouse or dependent children) that when aggregated by entity exceeds $5,000.
- Reimbursed or sponsored travel related to institutional responsibilities that when aggregated by entity exceeds $5,000. This disclosure requirement does not include travel that is reimbursed or sponsored by a Federal, state, or local government agency located in the United States, a United States institution of higher education, or an academic teaching hospital, a medical center, or a research institute affiliated with a United States institution of higher education.
- 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 located in the United States, a United States institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with a United States institution of higher education.
- Income from service on advisory committees or review panels for a Federal, state, or local government agency located in the United States, a United States institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with a United States institution of higher education.
POLICY REQUIREMENTS AND PROCEDURES
Notice
- All Gladstone Staff will be provided a copy of this Policy at the time of employment, and annually thereafter, by the Sr. Director of Sponsored Programs and Research Compliance (SPARC) during the annual disclosure process.
- Training
- Investigators must undergo training on the conflict-of-interest regulations prior to the expenditure of funds on any PHS-funded research.
- Training must be renewed at least every four years thereafter.
- Investigators who come to Gladstone from other institutions must undergo Gladstone’s training prior to the expenditure of funds on any PHS-funded research project.
- Retraining will be necessary should Gladstone revise either its policy or guidelines concerning conflicts of interest in a manner that impacts the requirements of Investigators, or in instances of noncompliance with this policy or a management plan.
- Disclosures
- The Sr. Director of SPARC is the designated institutional official responsible for the solicitation and review of SFI disclosures from each Investigator who is planning to participate in, or is participating in, PHS-funded research, and extended to other federal agency funding by Gladstone policy.
- Investigators engaging in, or proposing to engage in, PHS-funded research are required to report all significant financial interests (see the definition) held by themselves or their spouse or dependent children that reasonably appear to be related to the Investigator’s institutional responsibilities. SFIs include remuneration, equity interests, royalties from patents and copyrights, and sponsored or reimbursed travel.
- Annual Disclosures: SFIs are to be reported on the Significant Financial Interest (New Entity) form annually as part of Gladstone’s conflict of interest reporting process.
- The Sr. Director of SPARC will notify Investigators when the period for disclosure opens.
- The form must be completed annually even if there are no SFIs to report.
- In addition, Investigators must update their Significant Financial Interest (New Entity) form within 30 days of acquiring or discovering a new SFI.
- Research-Based (Project) Disclosures: Prior to submitting a PHS application for a project, Investigator(s) are required to report SFIs on the Significant Financial Interest Disclosure (SFID) for Research Proposals form.
- The Grant Administrator will send the Investigator(s) involved in a PHS application a link to the SFID for Research Proposals form. This form must be completed and submitted before the grant proposal is submitted to the sponsor.
- The form must be completed even if there are no SFIs to report.
- Annual Disclosures: SFIs are to be reported on the Significant Financial Interest (New Entity) form annually as part of Gladstone’s conflict of interest reporting process.
- Review and Management of Disclosures
- Gladstone has an obligation to manage any financial conflicts of interest as part of ensuring the integrity of research. To meet this obligation, the Sr. Director of SPARC reviews all completed disclosure forms and, if in their judgment, a disclosure form indicates a potential conflict of interest related to PHS-funded research, refers the disclosure to the COIC Chair for review.
- Review of disclosures by the COIC Chair will include a determination of whether an Investigator’s SFI is related to a PHS-funded research project at Gladstone and, if so, whether the SFI constitutes a FCOI and thus a management plan is required. The Chair has the discretion to call for a full COIC review.
- An Investigator’s SFI is related to PHS-funded research when (i) the SFI could be affected by the PHS-funded research or (ii) the SFi is in an entity whose financial interest could be affected by the research.
- A FCOI exists when an Investigator’s SFI could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
- The Investigator involved in review by the COIC Chair/COIC will be notified in writing of the determination.
- During an ongoing PHS-funded research project, if an Investigator who is new to the project discloses a SFI or an existing Investigator discloses a new SFI to Gladstone, within 60 days, the disclosure will be reviewed, a determination made whether an Investigator’s SFI is related to a PHS-funded research project at Gladstone and, if so, whether the SFI constitutes a FCOI for which a management plan will be implemented that specifies the actions that have been or will be taken to manage, reduce or eliminate the FCOI.
- Gladstone will take such actions as are necessary to manage FCOIs in PHS-funded research, including, prior to the expenditure of PHS award funds, developing and implementing a management plan that specifies the actions that have been or will be taken to manage, reduce or eliminate the financial conflict of interest.
- Should the COIC determine the FCOI cannot be managed, reduced or eliminated, the COIC will consult with the President. The President at such time can determine if additional outside expertise is needed to review the FCOI and if other options are available to manage, reduce, or eliminate the financial conflict of interest.
- FCOI Reports to Funding Agencies
- Prior to the expenditure of any funds under a PHS-funded research project and the implementation of a management plan, Gladstone will submit a FCOI Report to the PHS-Awarding Component regarding any SFI related to the PHS-funded research that Gladstone finds to be conflicting.
- For any FCOI previously reported by Gladstone to PHS, Gladstone will 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 will be submitted to the PHS Awarding Component by the Gladstone Sponsored Programs and Research Compliance Department.
- Retrospective Reviews
- If Gladstone identifies a SFI that was not disclosed timely by an Investigator or was not previously reviewed by Gladstone during an ongoing PHS-funded research project (e.g., was not timely reviewed or reported by a subrecipient), within 60 days, the disclosure will be reviewed, a determination made whether an Investigator’s SFI is related to a PHS-funded research project at Gladstone and, if so, whether the SFI constitutes a FCOI for which a management plan will be implemented that specifies the actions that have been or will be taken to manage, reduce or eliminate the FCOI.
- In addition, whenever a FCOI is not identified or managed in a timely manner including failure by the Investigator to disclose a SFI that is determined to be a FCOI, failure by Gladstone to review or manage a FCOI, or failure by the Investigator to comply with a FCOI management plan, Gladstone will, within 120 days of determining noncompliance, complete a retrospective review of the Investigator’s activities and the PHS-funded research project to determine whether any PHS-funded research conducted during the period of noncompliance, was biased in the design, conduct, or reporting of the research.
- 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 FCOI going forward.
- If the retrospective review determines that the research was biased in its design, conduct or reporting, Gladstone, through its Sponsored Programs and Research Compliance Department, will promptly notify and submit a mitigation report to PHS.
- Ongoing Monitoring
- When Gladstone implements a management plan, compliance with the plan will be monitored until the completion of the PHS-funded research project for as long as the FCOI exists with the funding.
- Noncompliance and Remedies
- Gladstone, through the Sr. Director of SPARC, will promptly notify the PHS Awarding Component if failure of an Investigator to comply with this Policy or a management plan appears to have biased the design, conduct, or reporting of PHS-funded research.
- 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 will 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 in addition to notifying lab members and collaborators to which this disclosure may be applicable.
- Maintenance, Retention, and Inspection of Records
- In accordance with PHS requirements, the Sr. Director of SPARC 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 and all actions taken under this Policy.
- These records will be retained 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 such longer periods as prescribed in applicable regulations.
- The records will be made available in appropriate circumstances for inspection and review upon request by duly authorized agencies.
- Subgrantees, Contractractors, and Collaborators
- If Gladstone carries out PHS-funded research through a subrecipient (e.g., subgrantees, contractors, or collaborators), Gladstone, through the Sponsored Programs and Research Compliance 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 must 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 Sponsored Projects and Research Compliance Department, will include in the subrecipient agreement time periods for the subrecipient to report all identified financial conflicts of interest 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 SFIs 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.
- Public Accessibility
- In accordance with Federal regulations, certain information about identified conflicts of interest of Investigators who are named as Senior/Key personnel on research funded by the PHS must be made available to the public.
- Gladstone, through the Sr. Director of SPARC will provide a written response to a requestor within 5 business days of a request for information concerning a SFI 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 SFI constitutes a FCOI in PHS-funded research.
FURTHER INFORMATION
Questions regarding this policy can be directed to:
Julia Roudabush
Senior Director, Sponsored Programs and Research Compliance
415-734-2056 - Remuneration and Equity Interests: