2022 Updates to COI Policy 1-006
Introduction and Background
The previous policy version was approved in February 2021 on an interim basis. Additional policy changes were made to ensure compliance with new federal regulation. In December 2021, the U.S. Department of Energy ("DOE") released an updated conflict of interest policy (largely aligned with existing U.S. Public Health Service (“PHS”) requirements). In January 2022, the Biden Administration put forth a call for federal agencies to standardize their grant applications (which may result in other federal sponsors releasing updated COI policies, as well).
The University of Utah Conflict of Interest Office (“COI Office”) revised the following regulations, as outlined in more detail below:
- [Interim] Policy 1-006: Individual Financial Conflict of Interest Policy (“Policy 1-006”);
- [Interim] Rule 1-006C: Individual Financial Conflict of Interest in Research (“Rule 1-006C”);
- New Procedure 1-006B: Conflict of Interest Office Procedures Related to Requirements for Federally Funded Research (“Procedure 1-006B”); and
- Guideline 1-006A: Determining “Relatedness” to Research (“Guideline 1-006A”).
Summary of Revisions to Individual Financial Conflict of Interest Policy 1-006 and Associated Regulations
Key Changes to Policy 1-006: Individual Financial Conflict of Interest Policy
- Modification to the definition of “Investigator” to include Senior/Key Personnel, and, for Research sponsored by the DOE, individuals who participate in the design, conduct, or reporting of Research;
- Modifications to travel disclosure requirements for Investigators who participate
in federally funded Research, which (A) add requirements from the DOE COI Policy and
(B) provide a general statement that other federal requirements may apply (in anticipation
of future changes to federal policies).
Key Changes to Rule 1-006C: Individual Financial Conflicts of Interest in Research
- Modification to exclusions from the definition of “Significant Financial Interest” to reflect new policy requirements from the DOE and the addition of a general statement that other federal requirements may apply (in anticipation of future changes to federal policies);
- Modification to expand PHS requirements as applicable when other federal sponsors have adopted requirements that are substantially similar to PHS requirements;
- Restructuring to move requirements specific to federally funded Research (i.e., reporting, retrospective reviews/mitigation plans, public accessibility, record retention) performed by the COI Office to a new Procedure 1-006B; and
- Clarified requirements for Subrecipients that apply regardless of funding source.
New Procedure 1-006B: Conflict of Interest Office Procedures Related to Requirements for Federally Funded Research
- Moved requirements specific to federally funded Research (i.e., reporting, retrospective reviews/mitigation plans, public accessibility, record retention) performed by the COI Office from Rule 1-006C to a new Procedure 1-006B, and expanded the applicability of those requirements to other federal sponsors that have adopted requirements that are substantially similar to PHS requirements.
- Procedure 1-006B maintains the existing PHS requirements, but gives the Vice President for Research the flexibility to adjust Procedure 1-006B as federal sponsors modify their requirements in response to the Biden Administration’s request. Requirements for individual Investigators, such as when Investigators must report a Significant Financial Interest and which financial interests constitute Financial Conflict of Interest, remain in Rule 1-006C.
Key Changes to Guideline 1-006: Determining “Relatedness” to Research
- Added language required by the DOE COI Policy that the COI Committee consider a Significant Financial Interest to be related to Research when the Significant Financial Interest could affect the Research.
Next Steps: Training and Implementation
The policy revisions are effective April 12, 2022. Revisions have been made to the Business Relationship Reporting system. The following educational resources have been provided:
- Retraining of University employees and investigators is required, due to federal regulation that requires retraining when policy is revised in a way that materially affects requirements. This training is availble within the Business Relationship Reporting system.
- The COI Office is available for personal and group consulations.
- Individual Financial Conflict of Interest Policy 1-006
- Rule 1-006C: Individual Financial Conflict of Interest in Research
- Legislative History