Related to the 2011 Revised Financial Conflict of Interest (FCOI) Regulation, Promoting Objectivity in Research (42 CFR Part 50 Subpart F). The purpose of this document is to provide an overview of Applied BioMath’s FCOI Policy.
Applied BioMath will be compliant with this FCOI Policy within 120 days of May 21, 2021, for all existing PHS grants as of May 21, 2021.
1. Applied BioMath will review FCOI guidelines yearly and revise the existing policy so it is compliant or confirm the policy is compliant with FCOI guidelines.
2. Applied BioMath will maintain and enforce its FCOI policy, and it confirms that it meets or exceeds the regulatory requirements.
3. The policy will apply to each Investigator (PI), as defined by the regulation, who is planning to participate in or is participating in Public Health Service (PHS) funded research.
4. Applied BioMath will certify, in each application for funding, that Applied BioMath:
- Has in effect an up to date, written and enforced administrative process to identify and manage FCOI.
- Shall promote and enforce PI compliance with the regulation.
- Shall manage FCOI and provide initial and ongoing (yearly) FCOI reports.
- Agrees to make FCOI and Significant Financial Information (SFI) information (including related Institutional reviews and determinations) available to HHS, promptly, within two weeks, upon request.
- Shall fully comply with the regulation’s requirements.
5. Training Requirements:
- Applied BioMath will inform each new PI, and existing PI yearly (per 42 CFR 50.604(b))
- Applied BioMath’s FCOI policy
- The PI must share their disclosure responsibilities with Applied BioMath yearly
- The PI must confirm that they read and understood Federal Regulations 42 CFR 50.604(b)
- Each new and existing PI will complete yearly FCOI training for PHS-funded grants (per 42 CFR 50.604(b))
- This training must be completed prior to any new PHS-funded grants.
- At least every four years
- And immediately (within one week), if any of the following:
- Applied BioMath revises the FCOI policy that affects PIs.
- A PI is new to Applied BioMath.
- A PI is not complaint with the Applied BioMath FCOI policy or management plan.
6. Disclosure, Review, and Monitoring Requirements
- Each PI will disclose SFI (and those of the PI’s spouse and dependent children) related to Applied BioMath that meets or exceeds the regulatory definition of SFI (per 42 CFR 50.603 and 42 CFR 50.604(e)(1)-(3)):
- No later than at the time of application for PHS-funded research
- At least annually during the period of the award
- Within 30 days of discovering or acquiring a new SFI
- Applied BioMath will designate the Applied BioMath FCOI Official (which may be a named individual, and/or one or all of the Co-founders of Applied BioMath), to (per 42 CFR 50.604(d)):
- Solicit and review disclosures of SFIs of PIs (and those of the PI’s spouse and dependent children) related to an PI’s Applied BioMath’s responsibilities.
- Applied BioMath will provide adequate guidelines consistent with the regulation for the Applied BioMath FCOI Official(s) to determine whether a PI’s SFI is related to PHS-funded research and, if so related, whether the SFI is an FCOI (per 42 CFR 50.604(f)).
- Applied BioMath’s established process requires the designated Applied BioMath FCOI Official(s), prior to Institution’s expenditure of funds, to:
- Review all PI SFI disclosures
- Determine if any SFIs relate to PHS-funded research.
- Determine if an FCOI exists (SFI that could directly and significantly affect the design, conduct, or reporting of the NIH-funded research
- Develop and implement management plans, as needed to manage FCOIs
- Applied BioMath will follow its process to review disclosures of SFIs, make determination of FCOIs, and implement a management plan when required for a PI who is new to participating in the research project or for an existing Investigator who discloses a new SFI (per 42 CFR 50.605(a)(2))
- Applied BioMath will review disclosures of SFIs, make determination of FCOIs, and implement a management plan within sixty days whenever Applied BioMath identifies an SFI that was not disclosed timely by a PI or not previously reviewed by Applied BioMath (per 42 CFR 50.605(a)(3) and (i) – (iii))
- Applied BioMath will take such actions as necessary to manage FCOIs, including any financial conflicts of a subrecipient Investigator, if applicable, and monitor PI compliance with management plans until completion of the project (per 42 CFR 50.604 (g) and 42 CFR 50.605(a)(4))
7. Reporting Requirements to NIH
- Applied BioMath will send initial, annual (i.e., ongoing) and revised FCOI reports, including all reporting elements required by the regulation, to the NIH for the Institution and its subrecipients, if applicable, as required by the regulation (per 42 CFR 50.604(h) and 42 CFR 50.605(b)):
- Prior to the expenditure of funds
- Within 60 days of identification for a PI who is newly participating in the project
- Within 60 days for new, or newly identified, FCOIs for existing PI
- At least annually (at the same time as when the Institution is required to submit the annual progress report, multi-year progress report, if applicable, or at time of extension) to provide the status of the FCOI and any changes to the management plan, if applicable, until the completion of the project.
- Following a retrospective review to update a previously submitted report, if appropriate (per 42 CFR 50.605(a)(3)(iii))
- Applied BioMath will notify NIH promptly (within two weeks) if bias is found with the design, conduct or reporting of NIH-funded research and will submit a Mitigation Report in accordance with the regulation (per 42 CFR 50.605(a)(3)(iii)).
- This procedure will include all reporting elements as required by the regulation.
- Applied BioMath will notify the NIH promptly (within two weeks) if a PI fails to comply with the Applied BioMath’s FCOI policy or a FCOI management plan appears to have biased the design, conduct, or reporting of the NIH-funded research (per 42 CFR 50.606(a)).
- Applied BioMath will notify NIH promptly and take corrective action for noncompliance with the Applied BioMath’s policy or the management plan.
8. Maintenance of Records
- Applied BioMath will maintain all FCOI-related records that meets or exceeds the regulatory requirements (per 42 CFR 50.604(i)):
- For at least 3 years from the date the final expenditures report is submitted to the PHS (NIH).
- From other dates specified in 45 CFR 75.361, where applicable.
9. Enforcement Mechanisms and Remedies and Noncompliance
- Applied BioMath has adequate enforcement mechanisms and will provide for employee sanctions or other administrative actions to ensure PI compliance (per 42 CFR 50.604(j)).
- Applied BioMath will complete and document retrospective reviews within 120 days of the Applied BioMath’s determination of noncompliance for SFIs not disclosed timely or previously reviewed or whenever an FCOI is not identified or managed in a timely manner and to document the reviews consistent with the regulation (per 42 CFR 50.605(a)(3)).
- Applied BioMath ensures that in any case in which the Department of Health and Human Services determines that a PHS-funded research project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by a PI with an FCOI that was not managed or reported by the Institution as required by the regulation, Applied BioMath shall require the Investigator involved to (per 42 CFR 50.606(c)):
- Disclose the FCOI in each public presentation of the results of the research, and
- To request an addendum to previously published presentations.
- At this time (May 21, 2021), Applied BioMath does not have nor intends to have any PHS-funded research project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment that has been designed, conducted, or reported by a PI at Applied BioMath
- For clarity Applied BioMath does conduct PHS-funded research on the development of scientific methods and software that can be used to predict the safety or effectiveness. However, the use of the methods and the clinical research is not part of the PHS-funded research.
10. Subrecipient Requirements
- Applied BioMath will address subrecipient requirements (per 42 CFR 50.604(c) and NIH Grants Policy Statement 15.2.1).
- Where applicable, Applied BioMath, via a written agreement, whether the subrecipient will follow the FCOI policy of the awardee Institution (Applied BioMath) or the FCOI policy of the subrecipient (per 42 CFR 50.604(c)(1)(i)-(iii)).
- If applicable, Applied BioMath will obtain a certification from the subrecipient that its FCOI policy complies with the regulation.
- If applicable, Applied BioMath will include in the written subrecipient agreement a requirement for the subrecipient to report identified FCOIs for its PIs in a time frame that allows the awardee Institution (Applied BioMath) to report identified FCOIs to the NIH as required by the regulation.
- Alternatively, if applicable, Applied BioMath will include in the written agreement a requirement to solicit and review subrecipient PI disclosures that enable the awardee Institution (Applied BioMath) to identify, manage and report identified FCOIs to the NIH.
11. Public Accessibility Requirements
- Applied Biomath’s FCOI policy will be publicly accessible (per 42 CFR 50.604(a) and NIH GPS 4.1.10)):
- Applied BioMath will post the FCOI policy on the Applied BioMath’s public website.
- Applied BioMath will make available information concerning identified FCOIs held by senior/key personnel (as defined by the regulation), publicly accessible prior to the expenditure of funds. Per 42 CFR 50.605(a)(5)(i)-(iv) the information will:
- Include the minimum elements as provided in the regulation.
- Be posted on a Public Website or made available within 5 calendar days of a written request.
- Be updated, at least annually (Web site only but any response to a written request should include the updated information)
- Be updated, within 60 days of a newly identified FCOI (Web site only but any response to a written request should include the updated information)
- Remain available for three years from the date the information was most recently updated.
12. This document has been reviewed and up to date as of May 21, 2021 and is up to date with the eRA Commons Checklist for Policy Development Related to the 2011 Revised Financial Conflict of Interest (FCOI) Regulation, Promoting Objectivity in Research (42 CFR Part 50 Subpart F), dated April 21, 2020 (Maintenance of Records and Public Accessibility Requirements sections. Also added links to regulation and NIH GPS).