The federal Department of Health and Human Services has developed regulations (42 CFR Part 50 Subpart F and 45 CFR Part 94) on Promoting Objectivity in Research. These regulations describe the actions required of individuals and organizations to promote objectivity in PHS-funded research. This policy outlines LIPO-IMMUNO TECH’s implementation of these regulatory requirements.

Definitions

Financial Conflict of Interest (FCOI): A significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.

Financial Interest: Anything of monetary value, whether or not the value is readily ascertainable.

Institutional Responsibilities: Professional activities performed on behalf of LIPO-IMMUNO TECH, such as administration, research, or consulting.

Designated Official: Dr. Besim Ogretmen, responsible for overseeing the FCOI process, including reviewing disclosures of significant financial interests.

Investigator: The project director, principal investigator, or any individual responsible for the design, conduct, or reporting of research funded by a PHS/NIH award.

Research: Systematic investigations contributing to generalizable knowledge, including studies, experiments, or product development.

PHS: The Public Health Service of the U.S. Department of Health and Human Services, including components like the NIH.

Senior/Key Personnel: Individuals identified as key personnel in grant applications or reports to the PHS/NIH.

Significant Financial Interest (SFI):

1. Financial interests of the investigator (and their spouse or dependent children) exceeding $5,000, aggregated, in publicly or non-publicly traded entities or intellectual property rights.

2. Does not include:

   • Salary or royalties paid by LIPO-IMMUNO TECH.

   • Income from investment vehicles like mutual funds.

   • Income from seminars, lectures, or advisory committees sponsored by U.S. governmental or academic institutions.

Disclosure Requirements

Investigators must disclose all SFIs to LIPO-IMMUNO TECH’s designated official:

• At the time of application for funding.

• Annually during the award period.

• Within 30 days of discovering or acquiring a new SFI.

Disclosures must include information about reimbursed or sponsored travel exceeding $5,000 and any foreign financial interests.

Review and Management of Disclosures

The designated official will review all disclosures of SFIs to determine their relatedness to PHS/NIH-funded research and assess whether an FCOI exists. If a conflict is identified, management strategies may include:

• Public disclosure of the conflict.

• Appointment of an independent monitor.

• Modification of the research plan.

• Reduction or elimination of the financial interest.

• Disqualification from participation in certain research activities.

No expenditures under an NIH award will be allowed until FCOI requirements are met.

Public Accessibility

LIPO-IMMUNO TECH ensures public access to FCOI information, including:

• Investigator’s name and role.

• Entity name where SFI is held.

• Nature and value of the SFI.

Requests for information will be addressed within five business days, and updates to publicly accessible records will occur annually or within 60 days of new disclosures.

Reporting to NIH

Prior to expending any funds, LIPO-IMMUNO TECH will report FCOIs to NIH, including:

• Nature of the conflict.

• Management plan details.

Annual updates on the status of FCOIs will be provided, and new conflicts will be reported within 60 days of identification.

Training Requirements

All investigators must complete FCOI training:

• Prior to engaging in PHS-funded research.

• Every four years.

• Immediately if policy revisions or compliance issues arise.

Training resources, including the NIH’s FCOI tutorial, are available here.

Subrecipient Requirements

Subrecipients conducting PHS-funded research must comply with LIPO-IMMUNO TECH’s FCOI Policy or certify compliance with federal regulations. Agreements with subrecipients will include terms to ensure timely reporting of FCOIs.

Record Maintenance

Records of disclosures, reviews, and management plans will be maintained for at least three years from the date of final expenditure reports or as specified by federal regulations.

Non-Compliance

Failure to comply with this policy may result in disciplinary actions, including:

• Letters of reprimand.

• Restrictions on fund usage.

• Termination of employment or disqualification from research.

Useful Resources

• FCOI Regulation (42 CFR Part 50 Subpart F)

• NIH FCOI Webpage

• FCOI Training Resources

For further questions, please contact:

• Dr. Besim Ogretmen: ogretmen@musc.edu