Research integrity & compliance

Financial Conflict
of Interest Policy

Requirements for the disclosure, review, management, and reporting of financial interests in PHS/NIH-funded research at the Biomedical Research Foundation.

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Compliance at a glance

Three deadlines
to remember.

For Investigators participating in PHS/NIH-funded research.

01

30 days

Disclose

Report a newly discovered or acquired SFI.

02

60 days

Review & report

Complete institutional review and reporting during an award.

03

4 years

Renew training

Complete required Investigator training at least this often.

Compliance at a glance

Three deadlines
to remember.

For Investigators participating in PHS/NIH-funded research.

01

30 days

Disclose

Report a newly discovered or acquired SFI.

02

60 days

Review & report

Complete institutional review and reporting during an award.

03

4 years

Renew training

Complete required Investigator training at least this often.

01  Policy overview

Protecting objectivity in publicly funded research.


This policy implements 42 CFR Part 50 Subpart F for grants and cooperative agreements issued by the National Institutes of Health. It establishes BRF’s process for identifying and addressing financial interests that could affect the design, conduct, or reporting of research.


It applies based on a person’s responsibilities—not title—and may include principal investigators, project directors, collaborators, consultants, subcontractors, and other individuals with independent responsibility for the research.

01  Policy overview

Protecting objectivity

in
publicly funded research.


This policy implements 42 CFR Part 50 Subpart F for grants and cooperative agreements issued by the National Institutes of Health. It establishes BRF’s process for identifying and addressing financial interests that could affect the design, conduct, or reporting of research.


It applies based on a person’s responsibilities—not title—and may include principal investigators, project directors, collaborators, consultants, subcontractors, and other individuals with independent responsibility for the research.

Investigator responsibilities

When must an SFI
be disclosed?


01

At application

Before participating in the project, including for an Investigator who joins after submission.


02

Every year

Submit an updated disclosure on or before September 1 throughout the award period.


03

When circumstances change

Within 30 days of discovering or acquiring a new SFI or reportable sponsored travel.


Investigator responsibilities

When must an SFI
be disclosed?


01

At application

Before participating in the project, including for an Investigator who joins after submission.


02

Every year

Submit an updated disclosure on or before September 1 throughout the award period.


03

When circumstances change

Within 30 days of discovering or acquiring a new SFI or reportable sponsored travel.


02 inside the policy

Explore all 18 sections

This page is a guide. Refer to the official PDF for complete requirements and controlling language.

01

Introduction

Purpose, governing regulations, and BRF’s commitment to objective research.

02

Applicability

Who must follow the policy across BRF’s PHS/NIH-funded research.

03

Definitions

Key terms, including Investigator, SFI, FCOI, and Senior/Key Personnel.

04

SFI disclosure requirements

When and how Investigators must disclose significant financial interests.

05

Review of disclosures

How the Designated Official evaluates disclosures before and during an award.

06

Relatedness & FCOI

How BRF determines whether an SFI relates to research and creates a conflict.

07

Management of FCOIs

Measures BRF may require to protect the objectivity of the research.

08

Monitoring compliance

Ongoing oversight of Investigator compliance with management plans.

09

Public accessibility

Access to this policy and qualifying FCOI information for Senior/Key Personnel.

10

Reporting FCOIs

Initial, annual, revised, and mitigation reports submitted through eRA Commons.

11

Training requirements

Training before participation, every four years, and when circumstances require.

12

Noncompliance

Corrective action, retrospective review, and mitigation when bias is identified.

13

Clinical research

Additional action when unmanaged conflict affects clinical research.

14

Subrecipients

Written agreement and reporting requirements for subrecipient organizations.

15

Maintenance of records

Retention of disclosures, reviews, determinations, and related actions.

16

Enforcement

Consequences for Investigators who do not comply with the policy.

17

Resources

Federal regulations, NIH guidance, training, FAQs, and compliance contacts.

18

Points of contact

How to ask a policy question or disclose a financial interest.

02 inside the policy

Explore all 18 sections

This page is a guide. Refer to the official PDF for complete requirements and controlling language.

01

Introduction

Purpose, governing regulations, and BRF’s commitment to objective research.

02

Applicability

Who must follow the policy across BRF’s PHS/NIH-funded research.

03

Definitions

Key terms, including Investigator, SFI, FCOI, and Senior/Key Personnel.

04

SFI disclosure requirements

When and how Investigators must disclose significant financial interests.

05

Review of disclosures

How the Designated Official evaluates disclosures before and during an award.

06

Relatedness & FCOI

How BRF determines whether an SFI relates to research and creates a conflict.

07

Management of FCOIs

Measures BRF may require to protect the objectivity of the research.

08

Monitoring compliance

Ongoing oversight of Investigator compliance with management plans.

09

Public accessibility

Access to this policy and qualifying FCOI information for Senior/Key Personnel.

10

Reporting FCOIs

Initial, annual, revised, and mitigation reports submitted through eRA Commons.

11

Training requirements

Training before participation, every four years, and when circumstances require.

12

Noncompliance

Corrective action, retrospective review, and mitigation when bias is identified.

13

Clinical research

Additional action when unmanaged conflict affects clinical research.

14

Subrecipients

Written agreement and reporting requirements for subrecipient organizations.

15

Maintenance of records

Retention of disclosures, reviews, determinations, and related actions.

16

Enforcement

Consequences for Investigators who do not comply with the policy.

17

Resources

Federal regulations, NIH guidance, training, FAQs, and compliance contacts.

18

Points of contact

How to ask a policy question or disclose a financial interest.

Questions or disclosures

Contact the Designated Official.

Questions or disclosures

Contact the Designated Official.

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