Greater Boston Chinese Golden Age Center (GBCGAC)
I. Purpose and Applicability
This policy implements the requirements of 42 CFR Part 50 Subpart F, Promoting Objectivity in Research, applicable to all Investigators participating in Public Health Service (PHS)-funded research through GBCGAC. It applies to all grants, cooperative agreements, and subawards where the originating sponsor is a PHS agency.
II. Definitions
Investigator: Any project director, principal investigator, or other person responsible for the design, conduct, or reporting of PHS-funded research.
Institutional Responsibilities: Professional duties on behalf of GBCGAC, including research, teaching, administration, and service activities.
Significant Financial Interest (SFI): Defined as per 42 CFR 50.603 and includes:
Remuneration and equity interests exceeding $5,000 from a publicly traded entity.
Any equity interest or remuneration exceeding $5,000 in a non-publicly traded entity.
Income from intellectual property rights exceeding $5,000.
Sponsored travel exceeding $5,000 (excluding exempt sources).
Financial Conflict of Interest (FCOI): An SFI that could directly and significantly affect the design, conduct, or reporting of the research.
III. Investigator Responsibilities
All Investigators must:
Disclose all SFIs (and those of their spouse and dependent children) prior to application for PHS-funded research.
Update disclosures annually and within 30 days of discovering a new SFI.
Complete required FCOI training prior to engaging in PHS-funded research, every four years, and immediately if:
GBCGAC’s FCOI policy changes.
The Investigator is new to the institution.
The Investigator is found noncompliant.
IV. Institutional Responsibilities
GBCGAC will:
Designate an FCOI Official or Committee to review disclosures.
Determine whether an SFI is related to PHS-funded research and whether it constitutes an FCOI.
Develop and implement management plans to mitigate FCOIs.
Maintain records of all disclosures and actions for at least 3 years.
Monitor compliance with management plans until completion of the research.
V. Management of FCOIs
Management strategies may include:
Public disclosure of the conflict.
Appointment of independent monitors.
Modification of research plans.
Reduction or elimination of the financial interest.
Recusal from research roles.
VI. Reporting to NIH
GBCGAC will report identified FCOIs to NIH via the eRA Commons FCOI Module:
Prior to expenditure of funds.
Within 60 days of identifying a new FCOI.
Annually to update the status of the FCOI and any changes to the management plan.
Following retrospective review if noncompliance is discovered.
VII. Retrospective Review and Mitigation
If a FCOI is not identified or managed in a timely manner, GBCGAC will:
Complete a retrospective review within 120 days.
Document methodology, findings, and conclusions.
Submit a mitigation report if bias is found.
VIII. Subrecipient Compliance
GBCGAC will establish a written agreement requiring subrecipients to:
Follow either their own FCOI policy (certified to be compliant with PHS regulations) or GBCGAC’s policy.
Report identified FCOIs to GBCGAC in a timeframe that allows reporting to NIH.
IX. Public Accessibility
GBCGAC will:
Post this FCOI policy on its publicly accessible website.
Make information concerning identified FCOIs for senior/key personnel publicly accessible before the expenditure of funds.
X. Enforcement and Sanctions
Noncompliance with this policy or related management plans may result in:
Disciplinary action.
Suspension of research activities.
Termination of employment or research funding.
Effective Date: March 27, 2025
Approved by: Ruth C. Moy, Executive Director .
