Financial Conflicts Of Interest
Midwestern University (MWU) and its research grant applicants must comply with new financial conflict of interest (FCOI) requirements (42 CFR Part 50 Subpart F) by August 24, 2012. MWU's Office of Research & Sponsored Programs (ORSP) is committed to helping our applicants understand and meet the new requirements that this regulation places on grant applicants and MWU.
What is the PURPOSE of the FCOI regulation?
The FCOI regulation was established to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under NIH grants or cooperative agreements will be free from bias resulting from Investigator FCOIs.
WHICH agencies do these changes apply to?
These changes are applicable to Investigators involved with Public Health Service (PHS) funded research, which includes the:
- National Institutes of Health (NIH)
- Health Resources and Services Administration (HRSA)
- Agency for Healthcare Research and Quality (AHRQ)
- Food and Drug Administration (FDA)
- Centers for Disease Control (CDC)
- Substance Abuse & Mental Health Services Administration (SAMHS)
- Office of Public Health & Science (OPHS)
- Indian Health Service (HIS)
WHO is covered by this regulation?
Investigators: This regulation applies to each Investigator who is planning to participate in, or is participating in PHS-funded research. Investigator is broadly defined as "the Project Director or Principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the NIH, or proposed for such funding, including persons who are subgrantees, contractors, consortium participants, collaborators, or consultants." The regulation is applicable to Investigators applying for all NIH award programs, excluding Small Business Innovative Research (SBIR) and Small Business Technology Transfer Research (STTR) Phase I applications.
Institutions: This regulation applies to MWU because we receive funds from a PHS entity. To be in full compliance with the regulation, MWU must revise our FCOI policy, have it publicly available on our website, and implement it by August 24, 2012.
A good number of changes have occurred, but we anticipate the biggest changes that MWU grant applicants will notice include:
- New mandatory training requirements
- Changes to MWU's ORSP COI policy and what must be disclosed
A summary of what changed, put out by the NIH, can be found here: Summary of Major FCOI Changes.
So what do I need to do to be compliant?
- First, please review MWU's FCOI Training slides
- Second, please read MWU's Conflict of Interest on Extramurally Funded Programs Policy Finally, please fill out the Conflict of Interest Policy Disclosure Form C, obtain your supervisor's signature, and return a scanned copy to the ORSP (firstname.lastname@example.org) along with your documentation of training certificate.
- Please contact the ORSP if you have any questions
- Upon completion, please fill out the Certificate at the end, documenting that you have completed MWU's FCOI Training
Portions of the above explanations were excerpted from the National Institutes of Health Office of Extramural Research's FCOI tutorial.