DHHS recently published their changes to the regulations concerning management of conflict of interest where PHS funding is involved. These changes can be readily accounted for using configurations within the InfoEd suite:
- Definition of Significant Financial Interest:
- Amending the definition of SFI to include a de minimis threshold of $5,000 for disclosure that generally applies to payments and/or equity interests as well as any equity interest in non-publicly traded entities.
- Expanding Investigator disclosure requirements to include SFIs that are related to an Investigator’s institutional responsibilities, with Institutions responsible for determining whether a disclosed SFI constitutes an FCOI.
- Excluding income from government agencies or Institutions of higher education for seminars, lectures, teaching, or service on advisory or review panels.
Routing functions can be used to automatically distinguish between disclosures that have financial interest and those that do not, sending these disclosures down different paths and resulting in different end points. Codes and Tables can be used to define standardized values for both type of activity and type of income, to promote full disclosure as well as correct categorization of income specifically included or excluded from the requirements. This is particularly useful regarding income that was not specified in the previous regulations.
- Training and Certification Requirements:
- Institutions to require each Investigator to complete training related to the FCOI and/or other FCOI-related requirements at least every four years or immediately under designated circumstances.
- Institutions to require each Investigator to complete training when the Institution revises its financial conflicts of interest policies.
- Institutions to require each Investigator to complete training when an Investigator moves to a new Institution.
- Institutions to require each Investigator to complete training when the Institution finds that the Investigator is not in compliance with the regulations or with the Institution financial conflicts of interest policy or management plan.
Certification tracking can be used to identify completion of training and certification period. The history and current status of certification can be reported through personnel administration, and selectively exposed on the personnel pages within records on which the investigator is named.
- Public Disclosure of Financial Conflicts of Interest:
- Before spending funds for PHS-supported research, an Institution shall post on a publicly accessible Web site information on SFIs of senior/key personnel that the Institution determines are related to the PHS-funded research and constitute an FCOI.
- If an Institution does not have a current presence on a publicly accessible Web site, the Institution may make the information available in writing within five business days of any request.
- If the Institution acquires a presence on a publicly accessible Web site during the time of the PHS award, the requirement to post the information on that Web site will apply within 30 calendar days.
Codes and Tables can be used to define standardized values for review outcomes, to distinguish activities determined to be reportable FCOI. Combinations of web services or database queries can then be used to extract information on relevant research activity and FCOI to be posted on a public web site, or provided in response to an information request.
