Conflicts of Interest & Financial Disclosure

Assessment for research conflicts of interest management, financial disclosure requirements, and institutional COI policies per PHS and NSF regulations

ResearchUniversityBiotechPharma minutes18 questions

1. COI Policy & Training

Is institutional COI policy compliant with PHS regulations (42 CFR Part 50 Subpart F)?*

PHS policy: Significant Financial Interest (SFI) defined as >$5,000, disclosure timing, management plans, public accessibility

Are all investigators trained on COI policy prior to research and at least every 4 years?*

Training: Initial before engaging in research, every 4 years, immediately if policy changes or non-compliance

Does policy define Significant Financial Interest (SFI) and Financial Conflict of Interest (FCOI)?*

SFI: >$5,000 from publicly traded entity, any amount from non-publicly traded, IP rights; FCOI: SFI that could bias research

2. Financial Disclosure

Are investigators required to disclose SFIs before proposal submission and within 30 days of discovery?*

Disclosure timing: At proposal, annually, within 30 days of new SFI (new payment, marriage, entity creation)

Do disclosures cover investigator, spouse, and dependent children per PHS requirements?*

Family members: Spouse, dependent children financial interests aggregated with investigator

Are disclosures collected for subrecipient investigators on PHS-funded projects?*

Subrecipient COI: Subrecipient certification of policy compliance OR disclosure to prime institution

3. Management & Reporting

Are FCOIs reviewed and managed within 60 days of identification?*

Management timeline: 60 days to determine FCOI exists and implement management plan before research

Are FCOI management plans documented with specific conditions (e.g., disclosure, monitoring, disqualification)?*

Management strategies: Public disclosure, monitoring by independent reviewer, modification of research design, disqualification

Are FCOIs reported to PHS awarding component prior to expenditure of funds?*

FCOI Report to PHS: Before spending funds, within 60 days of new FCOI, annually with progress report

4. Institutional Responsibilities

Is designated official responsible for soliciting and reviewing disclosures appointed?*

COI Official: Authority to review SFIs, determine FCOIs, oversee management plans, training administration

Is COI policy publicly accessible (e.g., website) per PHS requirements?*

Public accessibility: Policy posted on institutional website, available upon request within 5 business days

Are retrospective reviews conducted if FCOI not managed or disclosed in timely manner?*

Retrospective review: Determine if research biased, mitigation report to PHS within 120 days

5. Clinical Trial Disclosures

Are financial interests disclosed to IRB for clinical research per FDA 21 CFR Part 54?*

FDA COI: Clinical investigators disclose compensation, equity, IP from sponsor; disclosed in marketing application

Are clinical trial participants informed of investigator financial interests?*

Informed consent: Disclosure of significant payments from sponsor in consent form; state disclosure policies vary

Is investigator compensation from sponsor reviewed for reasonableness?*

Fair market value: Compensation commensurate with effort, not per-patient payments (AKS risk), documented rationale

6. Public Disclosure & Transparency

Are responses provided to public requests for investigator FCOIs within 5 business days?*

Public disclosure: Name, title, role, entity, nature of SFI (no dollar amounts); maintain for 3 years

Are FCOIs disclosed in publications, presentations, and external professional activities?*

Academic disclosure: Journal author disclosures, CME speaker disclosures, consulting/advisory roles

Are institutional COI records maintained for at least 3 years after final expenditures report?*

Recordkeeping: Disclosures, reviews, management plans, training records; available for PHS audit

Please answer all required questions to see your results