CTSI Announcement

Clinical Research Participant Compensation Policy and SOP

October 7, 2019

A new policy and standard operating procedure (SOP) has been developed to clarify the process of paying clinical research participants during their participation in our clinical research studies. Here are some highlights from the revised policy and SOP, which I have attached for your convenience:

 

  • There are currently 4 methods of payment available:

1.       ClinCard (the preferred method)

2.       Check (must be issued by Accounts Payable)

3.       Cash

4.       Gift Cards (through Purchasing Department)

 

  • Study teams will be required to obtain a W-9 (or W-8BEN for foreign individuals) from all participants receiving compensation on their studies, unless their study meets one of the following exclusion criteria:

  • No participant within the study will receive more than $200 in any calendar year for participating in the study. This will require an attestation from the Principal Investigator or an appropriate designee in OnCore.
  • No participant will receive more than $600 in total in any calendar year in a given study, and one of the following additional situations is true:
    • The research study is being conducted offsite and has no study visits at a Wake Forest Baptist Health facility (e.g., survey studies performed online). This will require an attestation from the Principal Investigator or an appropriate designee in OnCore.
    • The research study primarily involves vulnerable populations, in which a collection of a W-9 (or W-8BEN for foreign individuals) would significantly reduce the number of participants recruited, thus resulting in negative effects to the study results. This will require an attestation from the Principal Investigator or an appropriate designee in OnCore.

 

Study teams can contact the Office of Clinical Research (ocr@wakehealth.edu) for any clarifications needed regarding the exclusion criteria.

 

  • ClinCard: W-9 must be obtained from each participant (only once) unless exclusion attestation is completed.
  • Check: W-9 always required
  • Gift Cards: Only use if study meets W-9 exclusion criteria above
  • Cash: Only use if study meets W-9 exclusion criteria above

 

Read the Full Policy on the Institutional SharePoint site. 

 

Thanks

CTSI would like to thank Financial Services, Internal Audit, and the members of the Department of Family Medicine and Public Health Sciences for coming together to find common ground related to the recruitment of vulnerable populations in clinical research and the payment of these populations.