Subject Reimbursement


*PAYMENT OPTIONS *

There are 3 ways that study related compensation / reimbursement can be provided to research study participants.  The choice of options available for each applicable study are listed in the Informed Consent Document.

I.  PAYROLL

If an Augusta University employee participates in a research study, their study reimbursement is payable to them via payroll. These payments will be reflected on their W-2 to be in compliance with IRS regulations. The Research Subject Check Reimbursement Form must be completed.

II. CHECK REQUEST

III. CLINCARD

  • The ClinCard must be used if the study provides more than 1 payment to research participants provided that the participant is NOT an AU employee.

  • A request for setting up the study in ClinCard must be submitted to clincard@augusta.edu by completing the ClinCard Request Form  and attaching a copy of the IRB approved Informed Consent Document. Please note that the AU IRB approved language for the Informed Consent Document must be used and is found in the IRBNet Library.

  • The study visits and associated payment milestones will be set up in ClinCard by the Clinical Translational Finance Manager or other delegated Department Manager.

  • Research participants must be consented prior to receiving a ClinCard or having payments issued. Upon completion of the approved consenting process, the study participant will be provided an AU ClinCard and a Research Participant FAQ sheet.  The participant will be required to complete a ClinCard receipt and W-9, which will be retained by the study site.  Visit payments can then be issued to study participant.  If travel reimbursement is due to the research participant, original receipts or appropriate travel documentation must be retained by the study site.

*IS STUDY PARTICIPANT COMPENSATION TAXABLE OR NON TAXABLE? *

Often research studies provide payment or reimbursement to research participants. The amount of compensation may be minimal or in some cases research participants may earn thousands of dollars either through one high compensation study or through enrollment in multiple studies throughout the year. 

The IRS requires that individuals are responsible for reporting all payments to the IRS through their personal yearly tax return.  Augusta University is required to issue a Form 1099-MISC to any study participant who receives $600 or more per calendar year and report this payment to the IRS.  Box 3 on Form 1099-MISC is used to report “(a) payment or series of payments to individuals participating in a medical research study or studies.

Since AU cannot predict the total amount of total compensation that an individual may receive throughout the year (through participation in multiple studies), participants are required to provide personal information.  The amount and type of required personal information is detailed in the section below, Collection of Personal Information.  This information is used to ensure complete and appropriate reporting to the IRS in accordance with IRS policy.

There are some exclusions for IRS reporting

  • If research study participant receives reimbursements, or payments (with receipts) to cover expenses incurred by the participant because of their clinical trial participation, (most often travel-related), then the payments are not considered taxable income.  These payments would not be included in 1099 reporting.
  • If patient is diagnosed with a ‘RARE DISEASE’ and they are participating in a study providing treatments for this rare disease, they are allowed up to $2,000 per year without having the payment count as income that could jeopardize eligibility for Supplemental Security Income (SSI) and Medicaid.

*RESEARCH PARTICIPANTS –COLLECTION OF PERSONAL INFORMATION*

Collection, via W-9, of personal information (full name, address, and full social security number) is required for all research participants receiving compensation.  This information is used to ensure appropriate oversight and compliance with IRS requirements.  Waiver requests for consideration of alternative or limited collection of personal information may be requested.

*ALTERNATIVE PAYMENTS - WAIVERS*

Waiver Request Submission
Waiver requests for consideration of alternative or limited collection of personal information or alternative forms of research participant payment (including cash or alternative gift cards) may be requested.  Requests for a waiver may be submitted for a study by using the AU Research Participant - Waiver Request.

Waiver requests must detail the following:

  1. Reason for requesting the waiver
  2. Who will be receiving the compensation? 
  3. Who is the population for this study?
  4. Alternative process for subject compensation that is being requested
  5. Projected length of time for the completion of the study
  6. Total amount needed to provide alternative compensation

Waivers will be reviewed by:

  1. SVP Research or designee AND
  2. AU Controller or designee

Decisions on authorizing a waiver must be unanimous

*CONDITIONS OF AN APPROVED WAIVER*

Conditions of an Approved Waiver
There are normally two types of waivers that may be approved. The conditions for the waiver approval are listed below:

I.  Approved Waiver for Alternative Collection of Personal Information.  Waivers approved under this category may include any of the following:

  1. Waiver for entering the name, address, or social security number into the ClinCard system.
  2. The collection of name, address, and full social security number of all participants receiving compensation must be collected and maintained in a log file as specified in the Waiver Authorization.
  3. The collection of name and address and last four digits of social security number of all participants receiving compensation must be collected and maintained in a log file as specified in the Waiver Authorization.
  4. The log files must be stored and saved by the PI, in accordance with AU Research Data Storage policies.
  5. The log file must be provided to the Controller’s Office on a monthly basis to allow for oversight of IRS reporting requirements.
  6. Inclusion of appropriate language in the IRB approved Informed Consent Document would be based upon the conditions of the waiver.

II. An Approved Waiver to authorize an alternative payment process. Waivers approved under this category would require that the following process is followed:

  1. Inclusion of appropriate language in the IRB approved Informed Consent Document.
  2. Upon approval of the waiver, the Controller will issue funds to the Principal Investigator on a ClinCard, which will be the responsibility of the PI.
  3. The PI can use the ClinCard to withdraw funds from a bank or ATM in accordance with needs of the study or use the funds available on the ClinCard to purchase alternative forms of subject compensation (i.e. store specific gift cards, stuffed animals, etc.) as approved by the IRB.
  4. Funds withdrawn must be stored in a locked safe within the PI’s office.
  5. Dispensation of funds to study participants must be logged and tracked.

    A.  Study participants must sign a receipt acknowledging receipt of funds.  An AU study team member must also witness and sign the receipt.

    B.  Logs must be created and payments to study participants tracked via receipts.  Logs and receipts must be provided electronically to the Controller’s Office on a monthly basis to allow for oversight of IRS reporting requirements.

    C.  Personal information collected to ensure IRS compliance is defined by the amount of total compensation to study participant or as provided by the waiver request for consideration for alternative collection of personal  information.

  6. Loss of funds are the personal responsibility of the PI. Loss cannot be delegated to a member of the study team.
  7. Any unspent funds must be returned to the AU Controller’s Office upon the conclusion of the study and prior to study close-out.
  8. Issuance costs and fees will be charged to the study account.

 

Contact Us

   HS Campus, BA7300
   1120 15th Street,  Augusta, GA 30912
   706-721-5295    
   clincard@augusta.edu