Multiple Pathways for Conflict of Interest Management

As the effective date approaches for implementation of the new PHS regulations, some institutions are still defining their processes for disclosure and certification.  Among the most robust processes are those that include multiple pathways:

  • Annual Disclosure – collected for all subject employees during a period defined by the institution, or around an anniversary date specific to the individual.  In either case, this generally requires an affirmative response on the part of the employee, declaring the absence as much as existence of reportable external relationships.  The workflow process can be segregated, eliminating the need to review disclosures that declare an absence of reportable relationships.
  • Reporting of Sponsored Travel – collected for all subject employees, to account for any reportable sponsored travel not already declared on the annual disclosure, within 30 days of the event.  The workflow process for review of these submissions can be distinct from annual disclosure, depending on the need for management.
  • Update to External Relationships – collected for all subject employees, to account for any changes in external activities or holdings, within 30 days of the event.  These submissions generally follow the same workflow as annual disclosure, and may affect the anniversary date of certification.
  • Project Certification – collected at the time of project submission, generally a short affirmation that disclosure and reporting of sponsored travel is current.  These submissions generally do not require any independent review, but allow the institution to base review of the current project in the context of the previously submitted disclosure.  Depending on institution processes, this may affect the anniversary date of certification.
  • External Activity Approval Request – collected before the individual engages in a new external activity.  Approval of external activity can subsequently inform some of what the individual should include in their annual disclosure.  The workflow process for review of these submissions can be distinct from annual disclosure, depending on the need for management.

The key to successful implementation of multiple pathways is proper definition of the data to be captured in each submission, the workflow path for each submission, the impact on certification status, and the impact on subsequent submissions.

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