Overview
As a steward of the public trust, Rady Children’s Hospital-San Diego is committed to the principle that its research be carried out with integrity, open inquiry, and rigorous analysis, free from outside conflicts of interest that might compromise, or give the appearance of compromising, the sound professional judgment of its investigators. Rady Children’s Department of Research Administration and Compliance are jointly responsible for oversight and administration of the FCOI program, which includes training on FCOI, disclosure review of all reported financial interests, effective monitoring and management of FCOI matters and reporting to appropriate federal agencies as needed.
Federal Regulations
Institutions that apply for or receive Public Health Service (PHS) research funding, including Rady Children’s, must adhere to Financial Conflict of Interest (FCOI) regulations. The regulations are effective August 24, 2012 for all grant applications initiated or awards received on or after that date.
Changes to the FCOI regulations are primarily focused on:
- Lower financial disclosure thresholds
- New conflict of interest training requirements
- Increased transparency for travel reimbursement
- New public accessibility requirements
Responsibilities of PHS-Funded Investigators
- All workforce members with systems access are required to complete required online training through the Rady Children’s Learning Center Intranet page. The training is called “Promoting Objectivity and Transparency in Research.” Log on at https://radychildrens.csod.com; if you already have access, click here to go directly to the training. Individuals without systems access must contact the Research Administration Office.
- Submit disclosures as outlined in the FCOI Policy using the online disclosure system. The FCOI Policy and Disclosure forms can be obtained from the Research Administration Office.
- Understand that some details of investigator disclosures must be made available on a publicly accessible website.
Definitions
The terms below are official defined in the FCOI Policy along with other FCOI terms.
Investigator
For the purposes of FCOI, investigator means any individual responsible for the design, conduct, or reporting of the results of work performed or to be performed under the PHS-sponsored project. This includes the Principal Investigator, Co-Investigators, Collaborators, Consultants, and any other individual who has responsibility for designing, conducting, or reporting of research funded by PHS or proposed for such funding. The term Investigator includes the Investigator’s spouse and dependent children.
Financial Conflict of Interest
A Financial Conflict of Interest exists when the Institution reasonably determines that an Investigator’s Significant Financial Interest is related to a NIH-funded research project and could directly and significantly affect the design, conduct or reporting of the NIH-funded research.
Significant Financial Interest
Anything of monetary value, including but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options or other ownership interests); and intellectual property rights (e.g., patents, copyrights and royalties from such rights).
Additional Resources
2011 Public Health Service (PHS) Regulations: Responsibility of applicants for promoting objectivity in research for which PHS funding is sought.
http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf
National Institute of Health FCOI Frequently Asked Questions
http://grants.nih.gov/grants/policy/coi/coi_faqs.htm
National Institutes of Health, Office of Extramural Research Grants Policy & Guidance
http://grants.nih.gov/grants/policy/policy.htm
Rady Children’s Training and Disclosure
- Complete the Financial Conflict of Interest Training on the Rady Children’s Learning Center Intranet page (ONLY if you have not taken the training in the last four years). The training is called “Promoting Objectivity and Transparency in Research.” Log on at https://radychildrens.csod.com; if you already have access, click here to go directly to the training.
- Submit a Financial Conflict of Interest disclosure form. The form can be completed and submitted online at http://www.surveygizmo.com/s3/2561894/88846cada6fd.
Questions
Please contact the Rady Children’s Research Administration Office for additional information.