3417 PR.01 Human Research Study Participant Remuneration Process

Revision Date: 
March 19, 2024

Contents

1.      Overview and Foundational Principles

2.      OnCore ePayments

3.      Spend Authorization (Cash Advance)

4.      Gift Cards/Certificates

5.      Non-Cash Remuneration

6.      Remuneration Via Check

7.      Reimbursement/Payment of Study Participant Expenses

8.      Spend Category Summary for Study Participant Remuneration and Expenses

9.      Tax Information

10.    Roles & Responsibilities

1. Overview and Foundational Principles

This procedure describes the University-approved methods for remunerating individuals who participate in human research studies (“study participants”).  It applies to all members of the Yale community involved with the remuneration and/or reimbursement of human research study participants (“study participants”) in research conducted under the purview of the Yale-designated Institutional Review Board (“IRB”) (Yale IRB or an external IRB authorized by the Yale Human Research Protection Program (“HRPP”) to provide review of research on behalf of Yale).

The current University-approved remuneration methods are as follows: A) OnCore ePayments; B) Spend Authorization (cash advance) (including for gift cards/certificates and non-cash remuneration); and C) check.  Each method is described in the sections below.  This procedure also describes the process for reimbursing study participant expenses.  For a useful reference that summarizes the available remuneration methods, along with their requirements, benefits, and considerations/limitations, refer to Form 3417 FR.05 Study Participant Remuneration Methods Summary Matrix.

A. Remuneration Authorization and Responsibility

The decision to provide remuneration in any form requires the prior approval of the applicable IRB, in accordance with Yale HRPP requirements as outlined in the HRPP Policy and Standard Operating Procedure Manual and other related documents (see Yale Human Research Protection Program - Policies, Procedures, Guidance, and Related Documents).

Once approved, remuneration for research studies may be made by any available method as described in this procedure.  The Principal Investigator (“PI”) is ultimately responsible for remuneration provided to study participants, using a University-approved remuneration method.  This responsibility may be delegated to an appropriate individual on the study team (i.e., an appropriate individual is someone with direct knowledge of the study and its related expenditures).  An appropriate individual may include, for example, a Custodian responsible for administering Spend Authorizations.

Other mechanisms for remunerating and/or reimbursing study participants that do not involve members of the Yale community may also be approved by the IRB for specific studies.  Under such circumstances, IRB approval and a description in the consent form for how remuneration and/or reimbursement will be made to study participants is still required.  For example, when the study sponsor assumes responsibility for direct provision of the study remuneration or reimbursement to the participants, the terms of such arrangement are generally included in the contract with the sponsor.

B. Confidentiality Considerations

If remuneration is made via OnCore, check, or any other method requiring personally identifying information, the PI (or designee) is responsible for first obtaining the appropriate informed consent/authorization from the study participant.  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.

The PI and study team are responsible for maintaining the confidentiality of study participants receiving remuneration.

2. OnCore ePayments

OnCore is the preferred method for study participant remuneration.  All other methods (except payment via check) are considered and treated as an advance to the Requestor, requiring proper clearing as described in Section 3, below.  OnCore is an electronic system that uses ePayments.  Additional information about the system and instructions for access and use are available at: Welcome to OnCore.

Study participants receive ePayments from OnCore directly onto the prepaid reloadable debit card (“payment card”) issued to them (Note: study participants receive only one card, even if they are participants in multiple studies).  Study participants receive their payment card by mail within seven to ten (7-10) business days once OnCore enrollment is completed.  The OnCore Calendar is used to mark study participant visits as completed, which generates a payment order to the study participant.  The payment 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 are loaded to the card within one to two (1-2) business days of visit completion (i.e., visit marked as “occurred” in OnCore).

Upon receipt of their payment card, 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”) utilizes the Chart of Accounts (“COA”) listed in OnCore for the studies participating in the OnCore ePayments Program.  If no COA is listed, YCCI works with the department to set up the appropriate COA in OnCore.  That COA is then debited on a monthly basis.

Note: Expense reimbursement is not permitted through the OnCore system.  See Section 7, below, for information on expense reimbursements.

3. Spend Authorization (Cash Advance)

This section describes the end-to-end process for Spend Authorizations (sometimes referred to as study participant advances) from initiation to closure.  Among other details, it defines the steps necessary to:

  • Pre-authorize study participant advance requests to ensure required approvals are verified ahead of an advance being opened;
  • Verify the accuracy of open advances; and
  • Ensure the timely clearance of advances, the proper return of unspent cash advances, and the proper decrementing of balances in the general ledger.

A. General Rules and Guidelines for Spend Authorizations

When using a Spend Authorization as a remuneration method, the following apply:

  • When requesting a Spend Authorization, include the approved IRB protocol number in the memo field;
  • Commingling of advances among PIs is not permitted;
  • Commingling of advances for the same PI with different studies is not permitted;
  • Only one open advance at a time is permitted per study;
  • All advances must include a start and end date and may not exceed 90 days;
  • All advances must be reconciled at least monthly; and
  • The PI (or designee) must clear an advance before requesting a subsequent advance.

B. Definitions Applicable to Study Participant Advances

This subsection defines key functional concepts integral to the execution of the study participant advance process, including acronyms and key process terms/items.

Process Acronyms

Description

FRC

Financial Review Checklist

IRB

Institutional Review Board

PI

Principal Investigator

Process Terms/Items

Description

Custodian

An employee designated as responsible for the management and safekeeping of the funds related to a Spend Authorization (cash advance).  This individual must have direct knowledge of the study and its related expenditures.

Delegate (Workday Preparer)

An individual who has been assigned authority in Workday to prepare Expense Reports and Spend Authorizations on behalf of another person.

Principal Investigator

The individual responsible for the design, conduct, or reporting of research, or proposed for such funding.

Spend Authorization (cash advance)

An expense advance (cash advance) to pay for remuneration to study participants or for travel-related expenses that cannot be paid for any other way.  “Spend Authorization” also refers to the business process for expense advances in Workday.

Form 3417 FR.01 Study Participant Disbursement Request Form

The form used to capture information relevant to the Spend Authorization to facilitate Business Office review and pre-authorization of the request.

Form 3417 FR.02 Participant Research Record Log

The form used by the Custodian to track study participant payments.

Form 3417 FR.03 Monthly Reconciliation Form

The form used by the Custodian to reconcile the remaining funds on hand and the Spend Authorization outstanding balance in Workday.

Form 3417 FR.04 Reloadable Debit Card Tracker

The form used by the Custodian to track balances on their reloadable debit card.

Form 3417 FR.05 Study Participant Remuneration Methods Summary Matrix

The form that summarizes the available remuneration methods, along with their requirements, benefits, and considerations/limitations.

C. Pre-Authorization of a Request to Open a Spend Authorization

Pre-authorization is required before opening a Spend Authorization.  The steps in this subsection outline the process for pre-authorization.  Note: Complete this form once for each study/IRB protocol and Custodian.  An updated form is required if the information changes significantly (e.g., funding changes).

  1. The PI identifies the study where an expense advance is required to make payments to study participants.
  2. The PI obtains prior IRB protocol approval, congruent with the funding source being charged.
  3. The PI (or designee) completes Form 3417 FR.01 Study Participant Disbursement Request Form.
    • Both the PI and Custodian sign the form.
    • The PI (or designee) emails the Business Office with the completed form and the Economic Considerations page from the IRB Informed Consent Form (OR a copy of the approved waiver).
  4. The Business Office reviews the form to ensure the information is complete, accurate, and aligned with policy and procedure.  The Business Office:
    • Works with the form’s submitter to resolve any issues noted or outstanding questions.
    • Determines if the individual responsible for managing the funds is a new Custodian.
    • Signs the form and notifies the Custodian and the PI that they may proceed with creating a Spend Authorization in Workday.
    • Files the completed Form 3417 FR.01 Study Participant Disbursement Request Form appropriately.

D. Creation of a Spend Authorization in Workday

  1. General steps for creating a Spend Authorization in Workday can be found at Create/Clear Spend Authorization.
    • Specific information for study participation advances:
      • Select the appropriate Reimbursement Payment Type.  Available methods of disbursement to the PI (or designee) are as follows.  These funds may be used for distribution to study participants or may be used to purchase gift cards/certificates or other allowable forms of remuneration:
        • Prepaid reloadable debit card (for employee use only) (US Bank $15,000 limit. $10,000 will be loaded on day one and $5,000 on day two);
        • Gift card (physical card) – please also contact Treasury Services (“Treasury”), as additional information may be required;
        • Cash picked up at Treasury (up to $1,000);
        • Check payable to the Requestor; or
        • Direct deposit to Requestor (as established in the Requestor’s payment elections).
      • Available methods of disbursement directly to study participants are as follows.  For these methods, please also contact Treasury, as additional information may be required:
        • Gift card (digital card) – please also contact Treasury, as additional information may be required.
      • Business Purpose – Study Subject Advance.
      • Expense Item – Study Participant Advance.
      • Memo – Yale’s approved IRB protocol number.
      • Click on box for “Cash Advance Selected or Requested.”
  2. If the method of payment is a prepaid reloadable debit card and the employee does not already have a card, the Business Office needs to pre-order the card before the Cost Center P2P Approver(s) approves the Spend Authorization.  To do so:
    • The Business Office emails treasury.fa1@yale.edu or treasury.manager@yale.edu with the cardholder’s name, address, and last four digits of their Social Security number.
    • The card is mailed to the cardholder’s home address and is embossed with the employee’s name.
      • Note: Please allow 7-10 business days for the card to arrive.
    • Once the card is received, the Spend Authorization can be processed.
    • Be sure to select “Prepaid Reloadable Debit Card” as the Reimbursement Payment Type.

E. Review and Approval of Spend Authorization in Workday

Once the Custodian (or delegate) submits the Spend Authorization request in Workday, the request routes for approval.  The steps in this subsection outline the process for reviewing and approving the Spend Authorization.

  1. The Spend Authorization request routes to the Cost Center P2P 1K Approver’s Workday inbox.  It routes to subsequent approvers based on the amount of the transaction and the individuals’ Workday approval authority limits.
    • If the Spend Authorization was created by a delegate, the employee whose name is on the advance must review and approve the Spend Authorization before the transaction routes to the appropriate Cost Center P2P Approver.
  2. When the Cost Center P2P Approver(s) review the Spend Authorization request, they review for the following criteria:
    • If the method of payment is a prepaid reloadable debit card, ensure the steps described in subsection D.2., above, were followed.
      • NoteIf the card has not been received when the Spend Authorization is approved, Treasury will return the Spend Authorization and request that it be resubmitted when the card is received.
    • Ensure the Spend Authorization is complete and contains all pertinent/required information and documentation.
    • Ensure the transaction is appropriate to approve based on the criteria established in Procedure 1101 PR.06 Approval Authority.
    • Determine if there are any open Spend Authorizations on the IRB protocol.  Open Spend Authorizations are identified by an “approved” status in Workday.  These Spend Authorizations require review to ensure they are fully cleared or have Expense Reports pending that will fully clear the Spend Authorization once approved.  To make this determination:
      • Run the “Find Spend Authorization/Cash Advances – Yale” report in Workday with the parameter of “Approved.”
      • Review the list for the IRB protocol in the new Spend Authorization. This is listed in the Memo field.
        • If Spend Authorizations show Expense Reports pending approval that will fully clear the Spend Authorization after being approved, then those Expense Reports need to be reviewed and approved before the Spend Authorization is approved.
        • If Spend Authorizations do not show either Expense Reports or Cash Sales pending approval, contact the Custodian to take action by submitting an Expense Report that will need to be fully approved before the new Spend Authorization is approved.
        • If Spend Authorizations have a $0 balance, close the Spend Authorization by following the steps described in subsection 3.K., below.
        • If there is an exceptional circumstance requiring an additional advance against the same IRB protocol, email controllers.office@yale.edu to request a policy exception (individuals in the Yale School of Medicine (“YSM”) may also email ysmcontroller@yale.edu).

F. Disbursements of Advances

This subsection describes the process for the disbursement of approved advances and details the associated responsibilities.

  1. Once the Spend Authorization is approved by the Cost Center P2P Approver(s) in Workday:
    • If the payment is via a prepaid reloadable debit card, funds are loaded to the card after the Spend Authorization is fully approved. (US Bank limit $15,000.  $10,000 will be loaded on day one and $5,000 will be loaded on day two).
    • If the payment is cash, the Custodian picks up the funds from Treasury.
      • The Custodian monitors the Process History section of the submitted Spend Authorization and proceeds to Treasury when the status shows that the Spend Authorization is pending Treasury approval.
    • If the payment is via gift cards (physical cards), the Custodian picks up the cards from Treasury.
      • The Custodian monitors the Process History section of the submitted Spend Authorization and proceeds to Treasury when the status shows that the Spend Authorization is approved by Treasury.
    • If the payment is a check to the Requestor, the check is mailed to Requester or, if special handling is requested, it is sent to Treasury.
      • The Custodian receives an email from Accounts Payable when special handling checks are ready for pick up at Treasury.
    • Direct deposits are made to the individual’s bank account as maintained in Workday.
    • If the payment is via gift cards (digital cards), they are distributed directly to the study participants according to the information the Requestor provides to Treasury.
    • Note: Spend Authorizations over $25K are automatically routed to the Controller’s Office for review and approval in Workday before funds are disbursed.  This happens after the Cost Center P2P approval(s).
  2. The Custodian ensures that funds are secured appropriately per Yale Policy: Policy 2815 Petty Cash Funds.  The Custodian is also responsible for the following:
    • Maintaining appropriate supporting documentation verifying participation in the study for each study participant remuneration (e.g., receipts should be pre-numbered), remuneration logs, and study participants identified to the extent possible;
    • Reconciling the Spend Authorization balance every 30 days, utilizing Form 3417 FR.03 Monthly Reconciliation Form (or an alternative form/method that serves an equivalent function); and 
    • Returning any unused cash or gift cards/certificates to the departmental Business Office to close the advance.
  3. The Custodian begins to disburse funds in accordance with the approved IRB protocol and maintains documentation to support proper reconciliation of the advance and charging of expenses.
    • Documentation includes, but is not limited to, Form 3417 FR.02 Participant Research Record Log (or an alternative form/method that serves an equivalent function) and Form 3417 FR.03 Monthly Reconciliation Form (or an alternative form/method that serves an equivalent function).

G. Department Business Office Monitoring Spend Authorizations

Once a Spend Authorization is approved and funds are disbursed, there are several ongoing monitoring activities required to take place.  This subsection details those activities and their associated roles and responsibilities.

  1. Once the funds are disbursed to the Custodian, the Business Office begins the monthly review of Spend Authorizations in line with the requirements noted on the FRC.
  2. More information on the FRC can be found at:
  3. The recommended report to facilitate this review is the “Find Spend Authorizations – Yale” Report in Workday.
  4. The Business Office reviews open Spend Authorizations for the following criteria.  If any of these criteria are present, the Business Office team member should contact the Custodian to resolve the issue.
    • Spend Authorizations open past 90 days.  Contact the Custodian to ensure all expenses to date have been processed on an Expense Report and determine if the Spend Authorization is still needed.
      • If the Spend Authorization is still needed, contact controllers.office@yale.edu to request a policy exception to allow the Spend Authorization to remain open longer than 90 days.
      • If the Spend Authorization is no longer needed, file a final Expense Report and close the Spend Authorization by following the steps described in subsection 3.H., below.
    • Spend Authorizations that have not had an interim Expense Report filed within the last 30 days.  Contact the Custodian to request that they submit an Expense Report.
    • Spend Authorizations on grants or contracts that are ending soon and/or have a financial report coming due.  Contact the Custodian to request that they submit an Expense Report to ensure expenses are charged timely and the advance is properly closed once the grant ends.
    • Worker assigned is terminated or on an extended leave of absence and the department requires assistance to properly close an advance.  Contact the Finance Support Center (“FSC”) at askfinance@yale.edu for assistance.
    • Review the outstanding balance for accuracy:
      • If a discrepancy is identified, research the transaction and/or accounting history to determine what happened.
      • Contact askfinance@yale.edu for guidance on next steps.
  5. It is recommended that the Business Office also periodically reviews Spend Authorizations in draft status that need to be submitted or deleted.

H. Submitting Expense Reports and Clearing Spend Authorizations

This subsection describes the processes and responsibilities for submitting periodic Expense Reports and clearing Spend Authorizations.

  1. At a minimum, Expense Reports should be submitted every 30 days to properly charge expenses and reduce the advance balance.  Spend Authorizations must be fully cleared/closed within 90 days of opening the advance.
  2. The Custodian (or delegate) creates an Expense Report and associates it with the Spend Authorization.
    • Additional guidance on submitting an Expense Report to clear a Spend Authorization can be found at the links below: 
    • Ensure that Form 3417 FR.02 Participant Research Record Log (or an alternative form/method that serves an equivalent function) is complete and attached to the Expense Report prior to submission
  3. Important Note – “Final Expense Report for Spend Authorization” button:
    • If an Expense Report is NOT the final Expense Report for a Spend Authorization, DO NOT select the “Final Expense Report for Spend Authorization” button.  Please see the screenshot below demonstrating the location of this button in the Workday interface.  ONLY select this button if the Spend Authorization is fully expended and/or is being closed.  By clicking the “Final Expense Report for Spend Authorization” button, Expense Reports will no longer be able to be linked to the Spend Authorization.
      • Note: If the “Final Expense Report for Spend Authorization” button was incorrectly checked on an approved Expense Report, contact the FSC at askfinance@yale.edu for assistance.
    •  If an Expense Report IS the final Expense Report for a Spend Authorization, be sure to select the “Final Expense Report for Spend Authorization” button.  Failing to do so will leave the Spend Authorization open.
  4. Once the final Expense Report for the Spend Authorization is submitted, any remaining cash or gift cards must be returned:
    • The Custodian notifies their Business Office of unspent funds.
    • The Cost Center P2P Approver(s) reviews and approves the Expense Report.
    • Unspent funds are returned via the methods outlined in subsection 3.I., below.

I. Returning Unspent Funds from a Spend Authorization

This subsection describes, based on type of funds received, the processes for returning unspent funds from closed Spend Authorizations.

  1. Cash:
    • The Cost Center Cash Sale Specialist follows the instructions for “Repaying Unspent Cash Advance Balance on Spend Authorizations” at Accounting Manual – Advances and Spend Authorizations.
    • The Custodian return the funds with the Cash Sale tracking slip, via check or cash, to Treasury.
    • Notice routes to Accounts Payable in Workday for all cash sales using RC153, Repayment of Cash Advance.  Accounts Payable applies the returned funds to the open Spend Authorization.
  2. Prepaid reloadable debit cards:
    • The Business Office emails Treasury (treasury.fa1@yale.edu or treasury.fa4@yale.edu) to request that the remaining funds be unloaded from the card.
      • Be sure to provide the cardholder’s name, remaining balance amount, and the Spend Authorization number.
    • Treasury unloads the remaining balance from the card and notifies Accounts Payable.
    • Accounts Payable reduces the Spend Authorization’s outstanding balance in Workday.
  3. Gift Cards:
    • Gift cards cannot be returned to Treasury.  They should instead be moved by the department to a prepaid account to be used appropriately.  Prior to moving funds to a prepaid account, departments should contact the Controller’s Office (controllers.office@yale.edu) for approval and guidance on the appropriate accounting treatment and subsequent responsibilities.

J. Uncollectible Balances on Spend Authorizations

In limited circumstances, a situation may arise in which a Spend Authorization’s remaining balance does not have substantiated expenses and the department is unable to collect the remaining balance.  In such a situation:

  1. The Custodian (or delegate) submits an Expense Report to recognize a loss.

K. Closing Spend Authorizations

This subsection describes the steps for ultimately closing a Spend Authorization.

  1. The Spend Authorization must be closed if the IRB protocol ends or if there is a hiatus of more than 90 days.
  2. The Spend Authorization must be closed prior to the relevant Custodian terminating from Yale or in the event they no longer have first-hand knowledge of the related study.
  3. If there is no outstanding balance and the “Final Expense Report for Spend Authorization” box is checked in the fully approved final expense report, the Spend Authorization is closed automatically.
    • The Workday status changes from “open” to “closed.”
  4. A Central mass close process exists that automatically closes Spend Authorizations three (3) months after the end date where the cash advance balance is $0.
  5. If the department has a need to close the advance more timely, the individual whose name the advance is under can do so manually following the steps outlined in Create/Clear a Spend Authorization.

4.Gift Cards/Certificates

This section describes the processes applicable to using gift cards/certificates as the remuneration method for study participants.  When using this method of remuneration, the following apply:

  • Purchasing gift cards/certificates on Pcards is not permitted.
  • Follow the Spend Authorization steps described in Section 3, above, in order to obtain the necessary funds.   
  • Use the funds obtained to purchase the desired gift cards/certificates.
    • Note: unused gift cards/certificates generally cannot be returned.  As such, please be sure to only purchase as many as will be used.
  • Remuneration funds using this method must be cleared, and the corresponding Spend Authorization closed, as described in Section 3, above.

5. Non-Cash Remuneration

This section describes the processes applicable to using gift non-cash items (e.g., books, toys) as the remuneration method for study participants.  When using this method of remuneration, the following apply:

  • Purchasing non-cash remuneration items on PCards is not permitted.
  • Follow the Spend Authorization steps described in Section 3, above, in order to obtain the necessary funds.   
  • Use the funds obtained to purchase the desired non-cash remuneration items.
  • Remuneration funds using this method must be cleared, and the corresponding Spend Authorization closed, as described in Section 3, above.

6. Remuneration Via Check

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.

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.  See Procedure 3401 PR.01 Supplier Setup and Change

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 at 333 Cedar. 

In Workday, the request is automatically routed to the appropriate Cost Center Approver(s) for final approval.

7. Reimbursement/Payment of Study Participant Expenses

In general, study participants may be reimbursed for expenses they incur related to their participation (e.g., mileage, parking, meals).  The appropriate method for reimbursing study participants for these expenses is with funds obtained through a Spend Authorization (as described in Section 3, above).  These expenses should be charged using the appropriate spend category (see Section 8, below).  Reimbursed expenses must be cleared, and the corresponding Spend Authorization closed, as described in Section 3, above.

As an alternative to reimbursement, departments may instead choose to pay directly for expenses study participants incur related to their participation (e.g., mileage, parking, meals).  For example, a department may use a PCard or other payment mechanism.  In all cases of such direct payments, the expenses should be charged using the appropriate spend category (see Section 8, below).

8. Spend Category Summary for Study Participant Remuneration and Expenses

Departments remunerating and/or covering expenses for study participants should use the appropriate spend categories when processing the payments to ensure the correct accounting.  The table below provides a summary of the appropriate spend categories for specific activities:

Business Use Case

Spend Category

Advances and ePayments – remuneration through spend authorizations (including gift cards, prepaid reloadable debit cards, non-cash remuneration) and OnCore ePayments

Human Research Payments (SC226)*

Direct payment – remuneration via other method (e.g., check)

Human Research Payments (SC226)*

Parking, Uber/Taxi, or Mileage – reimbursement to study participant

Travel - Domestic - Transportation (SC745)#

Parking, Uber/Taxi, or Mileage – reimbursement to study participant (Yale employee via Workday)

Travel - Domestic - Transportation (SC745)#

Parking, Uber/Taxi, or Mileage – paid on behalf of study participant via PCard or other method

Travel - Domestic - Transportation (SC745)#

Meal – reimbursement to study participant

Group Meals and Food – not individual travel (SC249)

Meal – reimbursement to study participant (Yale employee via Workday)

Group Meals and Food – not individual travel (SC249)

Meal – paid on behalf of study participant via PCard or other method

Group Meals and Food – not individual travel (SC249)

*Payments in excess of $600 to a given payee within the calendar year may be reportable on Form 1099 (see Section 9, below).

#SC745 is for domestic activity.  Select SC740 instead if the activity is international.

9. Tax Information

Remuneration made to a human research study participant may be considered taxable income to the participant.  Expense reimbursements are not taxable.

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.

10. Roles & Responsibilities

Controller’s Office

  • Interprets this procedure.
  • Reviews exception requests and, when appropriate, grants exceptions, in consultation with the Provost’s Office, General Counsel, or an Officer of the Corporation, as appropriate.

Custodian

  • For remuneration methods that require a Custodian (i.e., Spend Authorizations), serves under the PI as an individual with direct knowledge of the study and its related expenditures.
  • Responsible for safeguarding remuneration funds until they are distributed and maintaining adequate control over the funds.
  • Responsible for properly administering, monitoring, clearing, and closing Spend Authorizations, including performing monthly reconciliations.
  • Responsible for performing their duties in accordance with the requirements of this procedure.   

Departmental Business Office

  • Authorizes requests within their area regarding study participant remuneration, in accordance with the requirements of this procedure.
  • Ensures the research study associated with the remuneration request has an IRB-approved protocol that appropriately identifies the funding source being charged (if applicable).
  • Ensures the research study associated with the remuneration request has remuneration noted in the sponsored project budget of the funding source being charged (if applicable).
  • Ensures in their area compliance with this procedure.

Institutional Review Board (“IRB”)

  • Reviews requests to provide remuneration to study participants and holds authority to approve such requests.

Principal Investigator (“PI”)

  • Ultimately responsible for remuneration provided to study participants, using an appropriate method.
  • The PI is responsible for the following, but may delegate responsibility to an appropriate individual on their study team (i.e., an appropriate individual is someone with direct knowledge of the study and its related expenditures):
    • Responsible for obtaining IRB approval for study participant remuneration.
    • Responsible for maintaining the confidentiality of study participants receiving remuneration.
    • Responsible for obtaining the appropriate informed consent/authorization from study participants to be paid via any method requiring personally identifiable information.
    • Responsible for safeguarding remuneration funds until they are distributed.
    • Responsible for remunerating study participants in accordance with the requirements of this procedure.

Yale Human Research Protection Program (“HRPP”)

  • Ensures compliance with applicable regulatory and institutional requirements involving human subjects research conducted under the purview of the Yale-designated Institutional Review Board (“IRB”) (Yale IRB or an external IRB authorized by the Yale Human Research Protection Program (“HRPP”) to provide review of research on behalf of Yale).