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  5. Closing or Extending a Study

Closing or Extending a Study

Directive Statement

The Custodian for a Human Subject Payment Study Fund must return unused cash/gift cards/prepaid cards to Treasury Management and request close out of the study within 60 days of the study protocol expiration date.  Department administrators may request up to a 30-day extension period with appropriate justification.

Reason for Directive

The HSP system provides a secure database to house payment and participant information and improved compliance by the University of Florida for required reporting.  The University of Florida reports tax information to the IRS and other information to granting agencies.  Timely reconciliation and return of unused gift cards, debit cards, and cash reduces the risk of overcharging grants as well as the risk that funds could be misappropriated and not detected timely.

Who must comply?

All University departments.

Procedures

To close a study the study administrators should:

  1. Complete the research participant visit phase of study
  2. Record payments to study participants
  3. Reconcile the HSP Study Fund Request by comparing payment types on hand to UF financial records and HSP
  4. Resolve any differences
  5. Provide the study reconciliation and list of payment types that need to be returned for credit to Treasury Management
  6. Arrange for a time to return unused payment types to Treasury Management

Treasury Management verifies balances of payment type and prepares credit to original funding source.

To request extension beyond the expiration date of the IRB protocol, study administrators may contract Treasury Management in writing for up to a 30-day extension to complete recording study participant payment transactions and reconciliation activities.

Definitions

Human Subject

According to Federal Regulation 45 CFR 46 102.f, a human subject means a living individual about whom an investigator conducting research obtains:

  • Data through intervention or interaction with the individual
  • Identifiable private information

Examples of human subjects are a person who becomes a participant in research, data obtained through medical records, data obtained through surveys and data obtained from observation. [Back to Top]

Institutional Review Board (IRB)

The UF Institutional Review Boards (IRBs) are charged with protecting the rights and welfare of participants in clinical trials and other human subjects research studies.  UF IRBs review all research involving human subjects to ensure the welfare and rights of research participants are protected as mandated by federal and state laws, local policies, and ethical principles. [Back to Top]

Last Reviewed

05/01/2020: reviewed content

Resources

Institutional Review Boards (IRB)

Division of Sponsored Programs (DSP)

Contracts & Grants (C&G)

Training

PRV800 – HIPAA General Awareness

PRV804 – Protecting Social Security Numbers

RSH320 – Human Subject Payment

Contacts

Treasury Management: (352) 392-9057

treasury-HSP@admin.ufl.edu

Disbursements: (352) 392-1241

Contracts & Grants: (352) 392-1235

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