Financial Conflict of Interest (FCOI) and Other
Description: Financial Conflict of Interest (FCOI) and Other Support NIH and Grantees Working Together Diane Dean Romeo Tengey 1 Introduction Key Topics: Commitment Transparency Financial Conflicts of Interest (FCOI) Other Support Disclosure
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slide1. Financial Conflict of Interest (FCOI) and Other Support NIH and Grantees Working Together Diane Dean
Romeo Tengey 1<br>
slide2. Introduction Key Topics:
Commitment Transparency
Financial Conflicts of Interest (FCOI)
Other Support
Disclosure Requirements for FCOI and Other Support
Who, What, Why, When?
Best Practices<br>
slide3. What is commitment transparency? Transparency and reporting of all research activities, domestic and foreign
Openness and transparency enables productive collaboration and helps ensure appropriate disclosure of potential conflicts of interest and commitment
The consequences of non-disclosure threatens the integrity of research, Federal interests, and distorts NIH funding decisions 3<br>
slide4. Commitment Transparency 4 Key concepts:
Financial Conflicts of Interest:
A financial interest/relationship which could directly and significantly affect the design, conduct, or reporting of NIH-funded research
Other Support/Conflicts of Commitment
Conflicting obligations between or among multiple employers or entities.<br>
slide5. Financial Conflicts of Interest (FCOI) Requirements
42 CFR Part 50 Subpart F (grants and cooperative agreements)
NIH Grants Policy Statement (NIH GPS), Section 4.1.10, Financial Conflict of Interest 5<br>
slide6. Purpose To promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of NIH-funded research grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest. 6<br>
slide7. Disclosure Requirements – Who? Who must disclose?
Investigators
Investigator is defined by the regulation as the PD/PI and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research that is proposed or funded by NIH. Other persons may include collaborators or consultants, for example. 7<br>
slide8. Disclosure Requirements – What? What must Investigators disclose?
Investigators disclose their significant financial interests (SFIs) and those of their spouse and dependent children to their institutions.
What is a significant financial interest?
Remuneration (for example salary and any payment for services, consultant fees, honoraria, and paid authorship) greater $5,000/year
Equity interest in a publicly traded entity (subject to a dollar threshold) and in all non-publicly traded entities (no threshold)
Intellectual property rights and interests (e.g., patents, copyrights) greater than $5,000/year
Reimbursed or sponsored travel (e.g., greater than $5,000/year) 8<br>
slide9. Disclosure Requirements – When? When must Investigators disclose this information to their institution?
At the time of application
Within 30 days of acquiring or discovering a new SFI
On an annual basis as prescribed by the institution 9<br>
slide10. How Information is Used by NIH NIH extramural staff review all FCOI reports
NIH Program Officials:
have scientific expertise and knowledge of the funded project to determine if the institution’s actions are sufficient to manage the reported FCOI
may determine that more information or clarification is needed or that institution's actions are not sufficient to manage the FCOI 10<br>
slide11. Who Is Responsible? Who is responsible for ensuring that complete and accurate FCOI information is reported to NIH?
Recipient institutions are responsible for reporting complete and accurate FCOI information to NIH
Investigators are responsible for disclosing complete and accurate SFI information to their institutions. 11<br>
slide12. Financial Conflict of Interest (FCOI)<br>
slide13. OTHER SUPPORT 13<br>
slide14. Other Support: Sources of Disclosure Requirements Sources of Disclosure Requirements:
NIH GPS, Section 2.5.1, Just-In-Time Procedures
NIH requests Information on other active and pending support as part of the Just-in-Time procedures.
National Security Presidential Memorandum (NSPM)-33
NSPM-33 requires all federal research funding agencies to strengthen and standardize disclosure requirements for institutions and researchers receiving federally funded awards. NIH policies align with the NSPM-33 disclosure requirements.
National Defense Authorization Act (NDAA) Section 223
Disclosure of Funding Sources in Applications for Federal Research and Development Awards
Applies to all applicants for research and development awards from Federal Research Agencies<br>
slide15. Other Support: Purpose To identify and resolve overlap in applications prior to award.
Overlap - scientific, budgetary, or commitment - is not permitted.<br>
slide16. Overlap Scientific overlap:
Substantially the same research is proposed in more than one application or is submitted to two or more funding sources for review and funding consideration
Specific research objective and the research design for accomplishing the objective are the same or closely related in two or more applications or awards, regardless of the funding source.
Budgetary overlap:
Duplicate or equivalent budgetary items (e.g., equipment, salaries) are requested in an application but already provided by another source.
Commitment overlap:
An individual's time commitment exceeds 100 percent (i.e., 12 person months), whether or not salary support is requested in the application.<br>
slide17. Disclosure Requirements – Who? Who must disclose?
Other Support information is requested for:
All individuals designated by the institution in an application as senior/key personnel, except
Program Directors, training faculty, and other individuals involved in the oversight of training grants
Individuals categorized as Other Significant Contributors
All senior/key personnel, excluding consultants, in Research Performance Progress Report (RPPR) when there has been a change in active other support, except
Program Directors, training faculty, and other individuals involved in the oversight of training grants<br>
slide18. Disclosure Requirements - When? When is Other Support submitted?
When requested by NIH as part of the Just-In-Time procedures
When there has been a change in active Other Support for all senior/key personnel, it should be reflected in RPPRs
When a recipient organization discovers that a PI or other Senior/Key personnel on an active NIH grant failed to disclose Other Support information outside of Just-in-Time or the RPPR, as applicable, the recipient must submit updated Other Support to the Grants Management Specialist named in the Notice of Award as soon as it becomes known. 18<br>
slide19. Disclosure Requirements – What? What must be disclosed :
All resources made available to a researcher in support of and/or related to all of their research endeavors, regardless of whether or not they have monetary value and regardless of whether they are based at the institution the researcher identifies for the current grant. This includes:
Resources and/or financial support from all foreign and domestic entities, that are available to the researcher.
Consulting agreements, when the PD/PI or other senior/key personnel will be conducting research as part of the consulting activities.
In-kind contributions, e.g., office/laboratory space, equipment, supplies, etc.
If the time commitment or dollar value of the in-kind contribution is not readily ascertainable, the recipient must provide reasonable estimates.<br>
slide20. 20 Disclosure Requirements Other Support does not include:
Training awards
Prizes
Gifts
Gifts are resources provided where there is no expectation of anything (e.g., time, services, specific research activities, money, etc.) in return. An item or service given with the expectation of an associated time commitment is not a gift and is instead an in-kind contribution and must be reported as Other Support –NIH GPS Section 2.5.1
Start-up support provided to the individual by the applicant organization
Consulting activities where the PD/PI or other senior/key personnel is not conducting research (e.g., no authorship or co-authorship of publications is anticipated from the activity)<br>
slide21. How Other Support Information is Used by NIH NIH extramural staff review and assess other support information prior to award to ensure that:
Sufficient levels of effort are committed to the project
There is no scientific overlap
There is no budgetary overlap
There is no commitment overlap,
Only funds necessary to the approved project are included in the award<br>
slide22. Who is responsible? Who is responsible for ensuring that complete and accurate other support information is reported to NIH?
Recipient institutions are responsible for reporting complete and accurate other support information to NIH.
Senior/Key Personnel are responsible for disclosing complete and accurate other support information to their institutions.<br>
slide23. Why is it important to disclose? INTEGRITY – promotes transparency, honesty, accountability, objectivity, respect, freedom of inquiry, reciprocity, and merit-based competition throughout the research community
OVERLAP – increases the risk of budgetary, commitment, and/or scientific overlap due to non-disclosure and diminishes the agency’s ability to adequately assess a researcher’s qualifications and capacity.
PROTECTING THE INSTITUTION’S REPUTATION – The public may question the institution’s scientific integrity.
COMPLIANCE – The failure to submit complete other support information and comply with the FCOI requirements represents a violation of the terms and conditions of NIH awards, including Federal regulations. Such noncompliance may impact funding decisions, compromise the objectivity of NIH-funded research, result in the loss of patent rights, etc.
Institutions will implement and monitor corrective actions, examples:
Report to NIH more frequently
Refund/repay grant funds –(for overlap or biased research)
Comply with Specific Award Conditions (SACs) imposed by NIH<br>
slide24. Case Study 1 24<br>
slide25. Case Study 1 Person A, a professor at 123 Medical University (domestic entity) failed to disclose the following to the university:
various foreign affiliations, positions, foreign funding via grants, contracts, honors and awards, from 2012-2020.
outside SFIs, which included a multi-million-dollar investment in another company, where Person A had ~57% equity and was the founder, president, and signing official.
Person A marked “no” on the University’s internal annual significant financial interest (SFI) disclosure form – a false statement
On NIH funded grants, the University declares that there are no FCOI to disclose or manage.
The University became aware of this situation because NIH inquired about the company and Person A’s investments. 25<br>
slide26. Case Study 1 - Outcome Based on NIH’s findings and guidance:
123 University investigated the issues, validated that there were FCOIs, conducted a retrospective FCOI review, and reported the details to NIH.
NIH worked with the institution to develop a corrective action plan.
123 University implemented corrective actions on Person A and across the institution, which included:
Refunding NIH-funded grants because of its failure to meet its own FCOI policies.
Person A was prohibited from participating in NIH-funded research activities for one fiscal year and replaced as PI and Sr./Key Personnel on NIH-funded grants.
Developing a robust plan in place for oversight of Person A’s activities; providing FCOI and disclosure trainings to Person A.
Assessing its FCOI program, including its ability to identify and develop appropriate management plans for COI's stemming from faculty start-up companies and provide the outcome of the report to NIH. 26<br>
slide27. Case Study 2 27<br>
slide28. Case Study 2 Person D did not disclose the following to 123 Medical University:
foreign affiliations, foreign honor/awards, foreign funding
Receipt of multiple foreign grants, where Person D is listed as PI, and devoting significant effort to these foreign funded grants (full-time contract at a foreign funded University).
Person D also had significant involvement, as PD/PI and Sr./Key Personnel, in many NIH-funded grants.
123 Medical University was not aware of Person D’s foreign affiliations and foreign funded grants, and therefore could not report/submit accurate Other Support information, as required in the Just-in-Time information via eRA or in the RPPRs. 28<br>
slide29. Case Study 2 - Outcome Based on NIH’s findings and guidance:
NIH reported the foreign talents contract to 123 Medical University.
123 Medical University investigated the issues and reported the details to NIH. NIH reviewed/analyzed the details, which included commitment and budgetary overlap for Person D and found there was no scientific overlap.
NIH worked with 123 University and negotiated the corrective action plan.
123 University implemented corrective actions on Person D, which included:
Prohibiting Person D from participating as PI or Senior Key Personnel for a one-year period.
Replacing Person D as PI or Sr./Key Personnel on NIH-funded grants
Requesting a bilateral termination of an Investigator-initiated NIH-funded grant, where Person D was listed as PI
Refunding Person D’s salary, fringe, and associated F&A costs for all fiscal years where commitment overlap was identified.
Developing a monitoring plan for oversight of Person D’s research activities, which included FCOI disclosure trainings. 29<br>
slide30. Verify Disclosures for FCOI and Other Support – Best Practices Possible approaches:
Search internet sites to determine if there is public information available about possible other interests or associations with another entity
Cross reference FCOI and other support disclosures
Compare information to previous disclosures
Review outside activity/consulting arrangements (approved and disapproved)
Review support included in publication citations provided by the Investigator in the grant application
Talk to investors about their disclosed financial interests and other support to verify and clarify information.
Review pertinent data in Institutional files
Review travel information to determine the purpose, which may indicate other affiliations.
Require the Investigators to certify that they have fully and completely disclosed or face institutional disciplinary action 30<br>
slide31. Take aways FCOI focuses on Investigator financial interests
Other Support focuses on all resources available to the investigator that are in support of their research endeavors
Similarities between FCOI and Other Support:
NIH funding decisions may be affected
Both pertain to domestic and foreign entities and interests
Accurate reporting to NIH hinges on the Investigator disclosing complete and accurate information to the institution. 31<br>
slide32. Important Reminders Recipients are required to submit complete and accurate information to NIH
Institutions must ensure that investigators understand their disclosure responsibilities
Institutional policies must be current and align with NIH requirements and Federal regulations, although they can be more restrictive
Institutions are expected to have systems, policies, and procedures in place by which they manage FCOI and Other Support
Institutions must comply with the Federal reporting requirements
Notify NIH immediately when there are changes to information that has been reported to NIH or when undisclosed information has been discovered
When in doubt, ask early and often!<br>
slide33. Have Questions? If you have any more questions, please contact us at:
FCOI Compliance: FCOICompliance@mail.nih.gov
Other Support: GrantsPolicy@mail.nih.gov 33<br>
slide34. Appendix 34<br>
slide35. References 42 CFR Part 50 Subpart F – Promoting Objectivity In Research.
45 CFR Part 94 – Responsible Prospective Contractors.
NIH Guide Notice NOT-OD-22-210, Financial Conflict of Interest (FCOI) and Other Support Reminders
NIH GPS Section 4.1.10, Financial Conflict of Interest.
NIH GPS Section 2.5.1, Just-In-Time Procedures.
National Security Presidential Memorandum (NSPM)-33.
National Defense Authorization Act (NDAA) Section 223.
Frequently Asked Questions (FAQs)
Other Support
FCOI 35<br>
slide36. Summary 36<br>
Romeo Tengey 1<br>
slide2. Introduction Key Topics:
Commitment Transparency
Financial Conflicts of Interest (FCOI)
Other Support
Disclosure Requirements for FCOI and Other Support
Who, What, Why, When?
Best Practices<br>
slide3. What is commitment transparency? Transparency and reporting of all research activities, domestic and foreign
Openness and transparency enables productive collaboration and helps ensure appropriate disclosure of potential conflicts of interest and commitment
The consequences of non-disclosure threatens the integrity of research, Federal interests, and distorts NIH funding decisions 3<br>
slide4. Commitment Transparency 4 Key concepts:
Financial Conflicts of Interest:
A financial interest/relationship which could directly and significantly affect the design, conduct, or reporting of NIH-funded research
Other Support/Conflicts of Commitment
Conflicting obligations between or among multiple employers or entities.<br>
slide5. Financial Conflicts of Interest (FCOI) Requirements
42 CFR Part 50 Subpart F (grants and cooperative agreements)
NIH Grants Policy Statement (NIH GPS), Section 4.1.10, Financial Conflict of Interest 5<br>
slide6. Purpose To promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of NIH-funded research grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest. 6<br>
slide7. Disclosure Requirements – Who? Who must disclose?
Investigators
Investigator is defined by the regulation as the PD/PI and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research that is proposed or funded by NIH. Other persons may include collaborators or consultants, for example. 7<br>
slide8. Disclosure Requirements – What? What must Investigators disclose?
Investigators disclose their significant financial interests (SFIs) and those of their spouse and dependent children to their institutions.
What is a significant financial interest?
Remuneration (for example salary and any payment for services, consultant fees, honoraria, and paid authorship) greater $5,000/year
Equity interest in a publicly traded entity (subject to a dollar threshold) and in all non-publicly traded entities (no threshold)
Intellectual property rights and interests (e.g., patents, copyrights) greater than $5,000/year
Reimbursed or sponsored travel (e.g., greater than $5,000/year) 8<br>
slide9. Disclosure Requirements – When? When must Investigators disclose this information to their institution?
At the time of application
Within 30 days of acquiring or discovering a new SFI
On an annual basis as prescribed by the institution 9<br>
slide10. How Information is Used by NIH NIH extramural staff review all FCOI reports
NIH Program Officials:
have scientific expertise and knowledge of the funded project to determine if the institution’s actions are sufficient to manage the reported FCOI
may determine that more information or clarification is needed or that institution's actions are not sufficient to manage the FCOI 10<br>
slide11. Who Is Responsible? Who is responsible for ensuring that complete and accurate FCOI information is reported to NIH?
Recipient institutions are responsible for reporting complete and accurate FCOI information to NIH
Investigators are responsible for disclosing complete and accurate SFI information to their institutions. 11<br>
slide12. Financial Conflict of Interest (FCOI)<br>
slide13. OTHER SUPPORT 13<br>
slide14. Other Support: Sources of Disclosure Requirements Sources of Disclosure Requirements:
NIH GPS, Section 2.5.1, Just-In-Time Procedures
NIH requests Information on other active and pending support as part of the Just-in-Time procedures.
National Security Presidential Memorandum (NSPM)-33
NSPM-33 requires all federal research funding agencies to strengthen and standardize disclosure requirements for institutions and researchers receiving federally funded awards. NIH policies align with the NSPM-33 disclosure requirements.
National Defense Authorization Act (NDAA) Section 223
Disclosure of Funding Sources in Applications for Federal Research and Development Awards
Applies to all applicants for research and development awards from Federal Research Agencies<br>
slide15. Other Support: Purpose To identify and resolve overlap in applications prior to award.
Overlap - scientific, budgetary, or commitment - is not permitted.<br>
slide16. Overlap Scientific overlap:
Substantially the same research is proposed in more than one application or is submitted to two or more funding sources for review and funding consideration
Specific research objective and the research design for accomplishing the objective are the same or closely related in two or more applications or awards, regardless of the funding source.
Budgetary overlap:
Duplicate or equivalent budgetary items (e.g., equipment, salaries) are requested in an application but already provided by another source.
Commitment overlap:
An individual's time commitment exceeds 100 percent (i.e., 12 person months), whether or not salary support is requested in the application.<br>
slide17. Disclosure Requirements – Who? Who must disclose?
Other Support information is requested for:
All individuals designated by the institution in an application as senior/key personnel, except
Program Directors, training faculty, and other individuals involved in the oversight of training grants
Individuals categorized as Other Significant Contributors
All senior/key personnel, excluding consultants, in Research Performance Progress Report (RPPR) when there has been a change in active other support, except
Program Directors, training faculty, and other individuals involved in the oversight of training grants<br>
slide18. Disclosure Requirements - When? When is Other Support submitted?
When requested by NIH as part of the Just-In-Time procedures
When there has been a change in active Other Support for all senior/key personnel, it should be reflected in RPPRs
When a recipient organization discovers that a PI or other Senior/Key personnel on an active NIH grant failed to disclose Other Support information outside of Just-in-Time or the RPPR, as applicable, the recipient must submit updated Other Support to the Grants Management Specialist named in the Notice of Award as soon as it becomes known. 18<br>
slide19. Disclosure Requirements – What? What must be disclosed :
All resources made available to a researcher in support of and/or related to all of their research endeavors, regardless of whether or not they have monetary value and regardless of whether they are based at the institution the researcher identifies for the current grant. This includes:
Resources and/or financial support from all foreign and domestic entities, that are available to the researcher.
Consulting agreements, when the PD/PI or other senior/key personnel will be conducting research as part of the consulting activities.
In-kind contributions, e.g., office/laboratory space, equipment, supplies, etc.
If the time commitment or dollar value of the in-kind contribution is not readily ascertainable, the recipient must provide reasonable estimates.<br>
slide20. 20 Disclosure Requirements Other Support does not include:
Training awards
Prizes
Gifts
Gifts are resources provided where there is no expectation of anything (e.g., time, services, specific research activities, money, etc.) in return. An item or service given with the expectation of an associated time commitment is not a gift and is instead an in-kind contribution and must be reported as Other Support –NIH GPS Section 2.5.1
Start-up support provided to the individual by the applicant organization
Consulting activities where the PD/PI or other senior/key personnel is not conducting research (e.g., no authorship or co-authorship of publications is anticipated from the activity)<br>
slide21. How Other Support Information is Used by NIH NIH extramural staff review and assess other support information prior to award to ensure that:
Sufficient levels of effort are committed to the project
There is no scientific overlap
There is no budgetary overlap
There is no commitment overlap,
Only funds necessary to the approved project are included in the award<br>
slide22. Who is responsible? Who is responsible for ensuring that complete and accurate other support information is reported to NIH?
Recipient institutions are responsible for reporting complete and accurate other support information to NIH.
Senior/Key Personnel are responsible for disclosing complete and accurate other support information to their institutions.<br>
slide23. Why is it important to disclose? INTEGRITY – promotes transparency, honesty, accountability, objectivity, respect, freedom of inquiry, reciprocity, and merit-based competition throughout the research community
OVERLAP – increases the risk of budgetary, commitment, and/or scientific overlap due to non-disclosure and diminishes the agency’s ability to adequately assess a researcher’s qualifications and capacity.
PROTECTING THE INSTITUTION’S REPUTATION – The public may question the institution’s scientific integrity.
COMPLIANCE – The failure to submit complete other support information and comply with the FCOI requirements represents a violation of the terms and conditions of NIH awards, including Federal regulations. Such noncompliance may impact funding decisions, compromise the objectivity of NIH-funded research, result in the loss of patent rights, etc.
Institutions will implement and monitor corrective actions, examples:
Report to NIH more frequently
Refund/repay grant funds –(for overlap or biased research)
Comply with Specific Award Conditions (SACs) imposed by NIH<br>
slide24. Case Study 1 24<br>
slide25. Case Study 1 Person A, a professor at 123 Medical University (domestic entity) failed to disclose the following to the university:
various foreign affiliations, positions, foreign funding via grants, contracts, honors and awards, from 2012-2020.
outside SFIs, which included a multi-million-dollar investment in another company, where Person A had ~57% equity and was the founder, president, and signing official.
Person A marked “no” on the University’s internal annual significant financial interest (SFI) disclosure form – a false statement
On NIH funded grants, the University declares that there are no FCOI to disclose or manage.
The University became aware of this situation because NIH inquired about the company and Person A’s investments. 25<br>
slide26. Case Study 1 - Outcome Based on NIH’s findings and guidance:
123 University investigated the issues, validated that there were FCOIs, conducted a retrospective FCOI review, and reported the details to NIH.
NIH worked with the institution to develop a corrective action plan.
123 University implemented corrective actions on Person A and across the institution, which included:
Refunding NIH-funded grants because of its failure to meet its own FCOI policies.
Person A was prohibited from participating in NIH-funded research activities for one fiscal year and replaced as PI and Sr./Key Personnel on NIH-funded grants.
Developing a robust plan in place for oversight of Person A’s activities; providing FCOI and disclosure trainings to Person A.
Assessing its FCOI program, including its ability to identify and develop appropriate management plans for COI's stemming from faculty start-up companies and provide the outcome of the report to NIH. 26<br>
slide27. Case Study 2 27<br>
slide28. Case Study 2 Person D did not disclose the following to 123 Medical University:
foreign affiliations, foreign honor/awards, foreign funding
Receipt of multiple foreign grants, where Person D is listed as PI, and devoting significant effort to these foreign funded grants (full-time contract at a foreign funded University).
Person D also had significant involvement, as PD/PI and Sr./Key Personnel, in many NIH-funded grants.
123 Medical University was not aware of Person D’s foreign affiliations and foreign funded grants, and therefore could not report/submit accurate Other Support information, as required in the Just-in-Time information via eRA or in the RPPRs. 28<br>
slide29. Case Study 2 - Outcome Based on NIH’s findings and guidance:
NIH reported the foreign talents contract to 123 Medical University.
123 Medical University investigated the issues and reported the details to NIH. NIH reviewed/analyzed the details, which included commitment and budgetary overlap for Person D and found there was no scientific overlap.
NIH worked with 123 University and negotiated the corrective action plan.
123 University implemented corrective actions on Person D, which included:
Prohibiting Person D from participating as PI or Senior Key Personnel for a one-year period.
Replacing Person D as PI or Sr./Key Personnel on NIH-funded grants
Requesting a bilateral termination of an Investigator-initiated NIH-funded grant, where Person D was listed as PI
Refunding Person D’s salary, fringe, and associated F&A costs for all fiscal years where commitment overlap was identified.
Developing a monitoring plan for oversight of Person D’s research activities, which included FCOI disclosure trainings. 29<br>
slide30. Verify Disclosures for FCOI and Other Support – Best Practices Possible approaches:
Search internet sites to determine if there is public information available about possible other interests or associations with another entity
Cross reference FCOI and other support disclosures
Compare information to previous disclosures
Review outside activity/consulting arrangements (approved and disapproved)
Review support included in publication citations provided by the Investigator in the grant application
Talk to investors about their disclosed financial interests and other support to verify and clarify information.
Review pertinent data in Institutional files
Review travel information to determine the purpose, which may indicate other affiliations.
Require the Investigators to certify that they have fully and completely disclosed or face institutional disciplinary action 30<br>
slide31. Take aways FCOI focuses on Investigator financial interests
Other Support focuses on all resources available to the investigator that are in support of their research endeavors
Similarities between FCOI and Other Support:
NIH funding decisions may be affected
Both pertain to domestic and foreign entities and interests
Accurate reporting to NIH hinges on the Investigator disclosing complete and accurate information to the institution. 31<br>
slide32. Important Reminders Recipients are required to submit complete and accurate information to NIH
Institutions must ensure that investigators understand their disclosure responsibilities
Institutional policies must be current and align with NIH requirements and Federal regulations, although they can be more restrictive
Institutions are expected to have systems, policies, and procedures in place by which they manage FCOI and Other Support
Institutions must comply with the Federal reporting requirements
Notify NIH immediately when there are changes to information that has been reported to NIH or when undisclosed information has been discovered
When in doubt, ask early and often!<br>
slide33. Have Questions? If you have any more questions, please contact us at:
FCOI Compliance: FCOICompliance@mail.nih.gov
Other Support: GrantsPolicy@mail.nih.gov 33<br>
slide34. Appendix 34<br>
slide35. References 42 CFR Part 50 Subpart F – Promoting Objectivity In Research.
45 CFR Part 94 – Responsible Prospective Contractors.
NIH Guide Notice NOT-OD-22-210, Financial Conflict of Interest (FCOI) and Other Support Reminders
NIH GPS Section 4.1.10, Financial Conflict of Interest.
NIH GPS Section 2.5.1, Just-In-Time Procedures.
National Security Presidential Memorandum (NSPM)-33.
National Defense Authorization Act (NDAA) Section 223.
Frequently Asked Questions (FAQs)
Other Support
FCOI 35<br>
slide36. Summary 36<br>