3417 PR.01 Human Research Study Participant Remuneration

Revision Date: 
May 3, 2018

Contents

1.     Overview

2.     Remuneration Methods for Human Research Study Participants

3.     Reimbursement of Expenses to Study Participants

4.     Clearing an Advance

5.     Tax Information

6.     Roles & Responsibilities

This procedure addresses the methods to disburse remuneration to persons who participate in human research studies (i.e., study participants, human research subjects).  Depending on the research study, remuneration to human research study participants can take the following forms: A) OnCore ePayments Program through Bank of America; B) Spend Authorization (Cash Advance); C) Gift Cards/Certificates; D) Non-Cash Remuneration; and E) Remuneration via Check to Study Participants.  The decision to provide remuneration in any form requires the prior approval of the appropriate Yale Institutional Review Board (IRB).

Confidentiality Considerations:

The Principal Investigator (PI) is ultimately responsible for remuneration provided to study participants, using an appropriate method.  The PI and study team are responsible for maintaining the confidentiality of study participants receiving this remuneration.  Participant names and identifying information must not be shared with anyone outside of the study team. 

Remuneration for research studies may be made by any available method.  If, however, remuneration will be made via OnCore, check, or any other method requiring personally identifying information, the PI is responsible for first obtaining the appropriate informed consent/authorization from the study participant.  In order to be paid via OnCore, check, or any other method requiring personally identifiable information, study participants must agree to provide the information necessary for these payment methods.

There are several methods through which a PI and/or study team member may receive the necessary funds to provide human research study participants with their appropriate remuneration.  Yale has approved the following remuneration methods, detailed below: A) OnCore ePayments Program through Bank of America; B) Spend Authorization (Cash Advance); C) Gift Cards/Certificates; D) Non-Cash Remuneration; and E) Remuneration via Check to Study Participants.

OnCore is the preferred method for study participant remuneration.  All other methods (except checks to the study participants) are considered and treated as an advance (requiring proper clearing) to the requestor (PI or designee).

A.  OnCore ePayments Program through Bank of America

OnCore must be used for all Yale School of Medicine (YSM) clinical trials offering study participant remuneration initiated on or after January 1, 2018.  Additionally, OnCore must be used for all studies that have billable services.  (A billable service is defined as a service ordered in, or which could generate a charge from, EPIC.)  Remuneration through OnCore is processed as detailed below.

The OnCore Calendar is used to mark study participant visits as completed, which generates a payment order to the study participant.  Study participants will receive their payment card by mail within seven to ten (7-10) business days once OnCore enrollment is completed.  The card is funded when each visit is marked as “occurred” in OnCore and in accordance with the study participant’s Informed Consent Form.  Additional payments will be reloaded to the card within one to two (1-2) business days of visit completion (i.e., visit marked as “occurred” in OnCore).  Expense reimbursement is not permitted through the OnCore system (see Section 3 for information on expense reimbursements).  Study participants are provided instructions to immediately report lost cards.  Once reported, a replacement card will be mailed to the participant within seven to ten (7-10) business days. 

Yale Center for Clinical Investigation (YCCI) will work with departments participating in the OnCore ePayments Program to set up the appropriate Chart of Accounts (COA) in OnCore.  That COA will be debited on a monthly basis.

B.  Spend Authorization (Cash Advance)

The following guidelines should be followed when utilizing the Spend Authorization remuneration method:

  • Commingling of advances among PIs is not permitted; 
  • Commingling of advances for the same PI with different studies is not permitted;
  • Only one advance is permitted per study; 
  • All advances must include a start and end date
  • An advance request cannot exceed a three-month period
  • An advance must be cleared before a PI or his/her designee requests another advance; and
  • The Business Purpose for the advance must include the approved IRB Protocol Number.

In Workday, departments pre-authorize expenses using the “Create Spend Authorization” task. This action creates an authorization to incur a specific expense and a commitment of funds.  The Spend Authorization may also be used to request a cash advance in order to pay an expense.  The proper “Create Spend Authorization” process for study participant remuneration is as follows:

Estimate Future Spend and Create Spend Authorization (Cash Advance)

  • Click Create Spend Authorization
  • Enter Start and End dates
  • Enter Description, Business Purpose, and Justification
  • Select the appropriate Reimbursement Payment Type
  • Click + and enter Line Details
    • Study Participant Advance: Business Purpose must be Study Subject Advance and Expense Item must indicate Study Participant Advance
    • Click “YES” to cash advance requested
    • Add Yale’s approved IRB protocol number in the Memo line and identify the Principal Investigator (PI) in the Assignee worktag.
  • Click Submit

Cost Center Approver Reviews and Approves Spend Authorization

If the Spend Authorization was created by a Delegate, the PI or designee must review and approve the Spend Authorization before the transaction moves to the appropriate Cost Center Approver.

The Spend Authorization approval process is as follows:

  • The Cost Center P2P Approver - $1K approves the transaction; has no edit capability.
  • Spend Authorizations with a value greater than $1,000 and less than or equal to $10,000 will be approved by the Cost Center P2P Approver - $10K.
  • Spend Authorizations with a value greater than $10,000 are approved by the Cost Center P2P Approver - Unlimited (typically a Lead Administrator).
  • Spend Authorizations with a value greater than $25,000 are approved by the Controller.

The above approvals must be obtained before Accounts Payable or Treasury will disburse the payments.  The method of payment is selected in Workday as part of the Spend Authorization request and payment is disbursed to the PI or designee as follows:

  • Prepaid reloadable debit card
  • Prepaid gift card
  • Cash picked up at Treasury (up to $1,000)
  • Check payable to requestor
  • Direct deposit (as established in the requestor’s payment elections)

The funds can be used for distribution to human research study participants or can be used to purchase gift certificates/cards or other forms of remuneration.

Remuneration funds using this method must be cleared as described in Section 4.

C.  Gift Cards/Certificates

The following guidelines should be followed when utilizing gift cards/certificates for study participant remuneration:

  • Purchasing gift cards/certificates on PCards is not permitted;
  • Follow the Spend Authorization (Cash Advance) steps above in order to load the necessary funds to a reloadable Bank of America card; and   
  • Use the funded reloadable card to purchase the appropriate gift cards/certificates.

Remuneration funds using this method must be cleared as described in Section 4.

D.  Non-Cash Remuneration

The following guidelines should be followed when utilizing non-cash (e.g., books, toys) methods for study participant remuneration:

  • Purchasing non-cash remuneration for study participants on PCards is not permitted;
  • Follow the Spend Authorization (Cash Advance) steps above in order to load the necessary funds to a reloadable Bank of America card; and
  • Use the funded reloadable card to purchase the appropriate non-cash remuneration items.

Remuneration funds using this method must be cleared as described in Section 4.

E.  Remuneration via Check to Study Participants

Study participants may receive remuneration in the form of a check when payments are greater than or equal to $100.  For payments less than $100, please use one of the other remuneration methods described above.

In order to request a check for a study participant, access Workday’s “Supplier Invoice Request” feature.  Payments to study participants in the form of a check will require that they are set up in the University’s supplier database.  Before proceeding, the PI or designee should first determine if the study participant is already in the database.  If the study participant is not already in the database, enter the study participant using the “Create Supplier Request” in Workday upon enrollment in the study. 

The PI or designee should obtain a Transaction Control Number (TCN) using the TCN Generator.  This number should be entered into the Supplier Reference Field (SIR: CRXXXXXXX).  The request must include the Payee Name (the legal name of the person to which the check will be issued) and the Payee Address-Supplier Connection (payee’s mailing address).

As an alternative to mailing a check, the PI or designee may enter a special handling option, and the check can be picked up by an authorized individual at either the Treasury window at 2 Whitney or the Medical School Treasury window.  Under the “Honoraria, Royalties, Study Subject Payments, etc.” section, itemize all payments with a description of the service, the charging instructions, the appropriate spend category, and the amount.

In Workday, the request is automatically routed to the appropriate Cost Center Approver for final approval:

  • The Cost Center P2P Approver - $1K approves the transaction.
  • Supplier Invoice Requests with a value greater than $1,000 and less than or equal to $10,000 are approved by the Cost Center P2P Approver - $10K.
  • Supplier Invoice Requests with a value greater than $10,000 are approved by the Cost Center P2P Approver - Unlimited (typically a Lead Administrator).

Human research study participants may be reimbursed for expenses related to their participation (e.g., mileage, parking, meals).  To reimburse expenses to study participants, clear the advance as described below, charging the appropriate spend category (SC226 – Human Subject Payments).

Remuneration methods utilizing an advance (all above methods, with the exception of remuneration via OnCore or check to study participants) must be reconciled monthly and cleared within 3 months of opening the advance.  In order to clear the advance:

  • Create an Expense Report for the expenses (these are the Study Subject Payments) in Workday.  (This must be done by the same employee, or by a delegate on behalf of the employee, who requested the Spend Authorization.)
  • Once all expenses are listed, choose the appropriate Spend Authorization from the drop-down list (upper right-hand corner of the expense report), and the system will apply the amount of the expenses from the Spend Authorization to bring the expense report to $0.
  • All remaining cash balances (along with a Cash Sale) or Bank of America cards must be brought to the Treasury window.
  • For cards other than Bank of America, funds should be moved to a Prepaid before an additional advance is requested.

Prior to bringing the remaining cash balance to the treasury window, complete another Spend Authorization for the next three months of the study, if appropriate.  Treasury will work with Yale Shared Services (YSS) to close the original advance and then approve the next Spend Authorization.

For final clearing of an advance at the end of a study that has remaining cards:

  • Bank of America cards can be returned to Treasury.
  • Other gift cards/certificates cannot be held in Treasury; they must be moved by the department to a Prepaid to be used appropriately.

Remuneration made to a human research study participant may be considered taxable income to the participant.

For all U.S. human research study participants, if the total remuneration made by Yale during a calendar year is $600 or more, the University is required to provide the human research study participant with an Internal Revenue Service (IRS) Form 1099-MISC, Miscellaneous Income.

The University is required to report all remuneration to a human research study participant who is neither a U.S. citizen, U.S. permanent resident, nor resident alien, on an IRS Form 1042-S, Foreign Person’s U.S. Source Income Subject to Withholding.  Such remuneration may be subject to federal income tax withholding.  Please refer to Payments to Non-U.S. Individuals and Entities for additional information regarding documentation requirements, as well as withholding and reporting for individuals who are neither U.S. citizens, U.S. permanent residents, nor resident aliens.

The statement to be included in an Informed Consent form provided to participants is as follows:  According to the requirements of the Internal Revenue Service (IRS), payments that are made to you as a result of your participation in this study may be considered taxable income.

Researcher

The PI or his/her designee (i.e., someone with direct knowledge of the study) is responsible for:

  • safeguarding the funds, including gift cards/certificates or other compensation, until they are distributed;
  • issuing individual remuneration to human research study participants participating in the study;
  • maintaining appropriate supporting documentation verifying participation in the study for each human research study participant remuneration (e.g., receipts should be pre-numbered), remuneration logs, study participants identified to the extent possible; and
  • returning any cash or unused gift cards/certificates to the department’s business office to close the advance.

Department Business Office

The department business office must authorize all requests regarding human research study participant remuneration.  The department business office is responsible for:

  • ensuring the required information and appropriate authorizations are included with all requests regarding human research study participant remuneration;
  • ensuring the research study associated with the remuneration request has an IRB-approved protocol congruent with the funding source being charged (if applicable); 
  • ensuring the research study associated with the remuneration request has remuneration noted in the sponsored project budget of the funding source being charged (if applicable); and
  • following up with researchers to reconcile, clear, or close outstanding advances.