This protocol along with the policy and procedure titled, Financial Conflict of Interest in PHS-Funded Projects, constitute the PRNA FCOI policy. Capital terms in this protocol shall have the same meaning as set forth in the policy. This protocol outlines the procedure that will be followed as per regulation (Title 42 CFR 50.601-50.607).
This document specifies the FCOI protocol for PHS-funded research: that is the step-by-step implementation of the PRNA FCOI policy.
1. Who is required to disclose financial interests
Employees planning to or participating in research activity that is either partially or wholly supported by PHS funds are required to disclose financial interests (“PHS-funded Investigators”).
2. SFI disclosure
PHS-funded Investigators are required to disclose SFIs to either a member of the PRNA MT or the designated PRNA FCOI official, as follows:
1. Employees planning to participate in PHS-funded research are required to disclose all SFI's prior to submission of an application for PHS-funded research.
2. Once the research project has been funded all PHS-funded investigators shall submit SFI Disclosures within thirty (30) days of acquiring any new or increased SFI,
- When a new investigator joins an ongoing PHS-funded project, the investigator shall submit SFI disclosures within thirty (30) days of joining the project.
3. All PHS-funded investigators shall submit an updated SFI disclosure annually.
4.SFI disclosures (except travel) must include the following information:
1. Identity of the sponsor/organizer; and
2.Nature of SFI (e.g., salary, license income, stock).
5. Externally funded travel also constitutes SFI, and therefore the disclosure requirements in 2 (i)-(iii) apply. That is, PHS-funded investigators shall submit SFI Disclosures for externally funded travel: prior to submission of an application for PHS-funded research; and for PHS-funded projects within thirty (30) days of externally funded travel and in an annual update. The following travel related information must be disclosed:
- Identity of the sponsor/organizer,
- Destination, and,
3. Review of disclosures
All SFI disclosures, including those submitted by a new investigator who joins an ongoing PHS-funded project, will be reviewed by the designated PRNA FCOI official. The review will determine whether an SFI is related to the PHS-funded research and therefore an FCOI. The designated PRNA FCOI official may involve the relevant investigator in the review, and request additional information from the investigator.
When an SFI that was not disclosed by a PHS-funded Investigator in a timely manner is identified, the designated PRNA FCOI official will determine if FCOI exists, develop and implement a management plan within sixty (60) days after the identification of the SFI. In addition, the designated PRNA FCOI official will conduct a retrospective review of SFIs for the PHS-funded investigator within one hundred twenty (120) days and document it.
4. Management of FCOI
For each disclosure that leads to determination of FCOI, the PRNA MT will discuss and approve the implementation of a management plan developed by the designated PRNA FCOI official. PHS-funded Investigators with an identified FCOI must comply with the management plan. The management plan will include the following elements at a minimum:
1. The role and principal duties of the conflicted PHS-funded Investigator in the research project;
2. Conditions of the management plan (see examples below);
3. How the management plan is designed to safeguard objectivity in the research project;
4. Confirmation of the PHS-funded Investigator’s agreement to the management plan; and
5. How the management plan will be monitored to ensure PHS-funded Investigator compliance.
Examples of conditions or restrictions that might be imposed to manage a PHS-funded Investigator’s FCOI include, but are not limited to:
- Public disclosure of financial conflicts of interests (e.g., when presenting or publishing the research; to staff members working on the project; to Institution’s Institutional Review Board(s));
- For research projects involving human subjects research, disclosure of financial conflicts of interest directly to participants;
- Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the Financial Conflict of Interest;
- Modification of the research plan;
- Change of personnel or personnel responsibilities, or disqualifications of personnel from participation in all or a portion of the research;
- Reduction or elimination of the financial interest (e.g., sale of an equity interest); or
- Severance of relationships that create financial conflicts.
5. Reporting FCOI to PHS Awarding Component (e.g. the NIH)
Based on the FCOI management plan, the designated PRNA FCOI official will submit an initial FCOI report to the PHS-funding component, for example NIH. The report will be submitted, for example using eRA Commons for NIH, and consist of all elements required by the regulation.
The FCOI report for will be submitted prior to the expenditure of funds under the Notice of Award. FCOIs identified during the period of award will be submitted to NIH within sixty (60) days of identification, including for new investigators joining an ongoing PHS-funded project.
Annual FCOI reports (or revised reports as a result of retrospective reviews) will also be submitted and will include the status of financial conflict, i.e., whether the financial conflict is still being managed or explains why the financial conflict no longer exists. These FCOI reports will also include a description of any changes to the management plan since the last FCOI report.
6. Training for FCOI
PHS-funded Investigators must undergo training with respect to this Policy and PHS FCOI rules and regulations, as follows:
1. When a new employee joins PRNA;
2.Prior to participating in PHS-funded research, and at least once every four years;
3. When the PRNA FCOI policy changes in a manner that effects PHS-funded Investigator disclosure or compliance requirements; and,
4. If PRNA MT determines that a PHS-funded Investigator is not compliant with the FCOI Policy or an FCOI Management Plan.
NIH web-based training (http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.html) will be used. Employees must save and print the FCOI Certificate as proof of completion.
7. Sanctions for violation of policy
Disclosure of SFI is essential for PRNA to implement its FCOI policy. If a PHS-funded Investigator fails to comply with this policy (with regard for instance to the SFI disclosure requirement or implementation of an FCOI management plan), and appears to have biased the PHS-funded research, the PRNA MT will implement a mitigation plan and require that the Investigator disclose the FCOI in each public presentation of the results of the research, and to remedy previously published presentations with an FCOI disclosure addendum. In addition, the employee may be subject to employment discipline including, without limitation, suspension or termination of employment.
In any case, the PHS-funding agency will be promptly notified.
8. Retention of records
Records of financial disclosures and any resulting action will be maintained for three (3) years from the date of submission of the final expenditures report.
9. Subrecipient compliance
When working with a subrecipient, a written agreement will be put in place to clarify: (a) which organization’s (prime awardee or subrecipient) FCOI policy will be followed, and, (b) in either case, clarify the timeline for disclosure and reporting. Note that the prime awardee is responsible for monitoring subrecipient’ s compliance with the Financial Conflict of Interest regulation, management plans, and for reporting all identified financial conflicts of interest.
10. Public Accessibility
As required by PHS regulation, the PRNA FCOI policy is being made accessible on PRNA web site.
If a PHS-funded investigator holds financial interests that are determined to be FCOI, as required by PHS regulation, these will also be posted on the web site, as follows:
1. Include the minimum elements required by the regulation;
2. Update within sixty (60) days of a newly identified FCOI;
3. Update annually; and
4. Remain available for three (3) years.