Human Subjects Compensation Training

Human Subjects Compensation Training January 18, 2005

Presented by: • Liz Rulli, Director of Financial Affairs, Office of the Vice Provost for Research • Kendra Merriman, Assistant Comptroller, Disbursements • Gayle Stetler, Cash Analyst, Office of Investments

Training Objectives • Explain the process that results in a human subjects study being approved • Discuss the role of the PI, Human Subject Office, Human Subjects Committee, Business Office, Disbursements and Investment Office in the human subject compensation process • Explain the current, and new options for Human Subject Compensation

Training Objectives • Describe the processes for making and managing different forms of human subject payments • Outline the expectations and responsibilities of the business office in human subject compensation • Discuss some non-routine issues that arise and how to address them • Provide resources to help you as you assist faculty with the process of compensating human subjects

Compliance Requirements • Purdue University is mandated by 45 CFR 46 to establish and support an Institutional Review Board (IRB) • Encompasses all research involving human participation, both funded and not funded. • Purdue’s policy is outlined in Executive Memorandum B-45 • Non-compliance could result in loss of federal funding or suspension of all federally sponsored research

The IRB Committee • Known as the Committee on the Use of Human Research Subjects, Institutional Review Board, or IRB • Comprised of members appointed by President Jischke • Membership includes faculty who are involved in human subjects research and community members • IRB Office within the Office of the Vice Provost for Research

Mission of the IRB Committee • The mission of the Committee is to protect the privacy, safety, welfare, and rights of human research subjects through a thorough evaluation of recruitment procedures, informed consent processes, and analyses of the risks to the subjects relative to the benefits of the research.

Role of the IRB • As of July 2004, two separate IRB committees exist at Purdue: • Biomedical • Social/behavioral • The committees meet monthly to review human subject protocols

Protocol vs. Proposal • Research proposal to a funding agency • Proposal transmittal check sheet indicates use of human subjects • A human subject protocol is a separate document prepared by the PI • A protocol may be associated with one or more research proposals, or no current external funding. • A protocol may or may not include compensation.

Compensation vs. Benefit • A participant may receive benefit from participating in a research study that is not compensation (e.g. access to a drug that is being tested, or results of a study). • Compensation may be included in a protocol to encourage subject participation. • The IRB reviews the compensation to ensure that it is not of a coercive nature (could bias the research study).

IRB Review Process • Faculty submit protocols to the IRB Office • The IRB staff classify as exempt, expedited or full review • Expedited protocols are reviewed by IRB staff/ IRB Committee chairs • Those studies requiring full review go before the IRB Committee each month • A protocol may be approved, denied, or revisions may be requested.

Human Subject Protocols and SPS Accounts • Review by Research Administration area within the Office of the Vice Provost for Research • A new sponsored program account will not be established, or an existing account will be locked if an approved protocol does not exist or is expired

Protocols that Include Compensation • For protocols that include compensation, the IRB Office sends an e-mail (approx. monthly) to the Directors of Financial Affairs for each school/college: Protocol# PI Dept Date Appr. Compensation 04-612 Elicker, James G. CDFS 09/02/2004 10.00 04-634 Roberts, Felicia COMM 09/09/2004 2.00 04-636 Mills, Juline HTM 09/23/2004 100.00 04-639 Dalal, Reeshad PSYC 09/16/2004 gift certificate 04-640 Bendito, Petronio A. VPA 09/23/2004 40.00 04-646 Salvendy, Gavriel IE 10/08/2004 8.00/hr

Business Office Expectations • Upon receipt of the e-mail from the IRB Office, contact the faculty member to discuss the method that will be used to pay the human subjects. • Ensure that the method, type, and amount of compensation planned by the PI meet the criteria identified in the approved human subject protocol.

Business Office Expectations • Review the “guidance sheet” with the faculty member and leave a copy with the PI for future reference • Guidance sheet: • contains websites for reference • explains the different payment types • explains benefits and requirements surrounding each

Business Office Expectations • The appropriate source of funds for the compensation should be identified. • The business office should facilitate all financial aspects of the process, such as: • setting up of bank accounts (if needed) • establishing account reconciliation processes • establishing logs • Processing invoice vouchers, etc. … depending on the method of payment

Business Office Expectations • Understand nature of study, and circumstances that would cause the compensation to change from what was included in the protocol • For example, the participant is to receive $300 for participating in 3 sessions, but it is possible an individual may only participate in one session, and therefore receives $100. • When amounts requested for payment are different than proposed, the business office should consult with the PI and the IRB office as necessary.

Role of Sponsored Program Services • Human subject payments (made by invoice vouchers or request for electronic funds transfer) must be approved (pre-audited) by SPS. • SPS should be consulted if there are questions about allowability or what is included in the approved budget

Disbursements/Accounting • Depending on the payment type, processes the necessary payments • Serves as a resource to the business office to help with questions • Communicates any policy or procedures changes that would impact human subject compensation

Role of Investments • Sets up university bank accounts when needed as part of a human subjects compensation method

Forms of Human Subjects Compensation • Approved methods include: • Check (Accounts Payable) • Check (Revolving Fund) • Cash (Advance to PI) • Gift Certificates (NEW) • Coupons (NEW) • Giveaways (NEW) • Food (NEW)

Check(via Accounts Payable) • Used for individual payments of $50 or more • Invoice voucher prepared with a human subjects log • Include protocol #, not study title, on invoice voucher • Object code 5-5613 Human Subjects Payments must be used • SPS approval of the invoice voucher is required for funds 500-699. • For non SPS funds, the business office must ensure an approved protocol exists and amounts are consistent with protocol

1. Check (via Accounts Payable) • Checks mailed or requested in advance to be handed out • Checks to be handed out require seven business days advance processing • Departments should hand deliver to Accounting Services • Help establish reasonable expectations for processing • Checks not distributed must be promptly cancelled by contacting disbursements

1. Disbursement’s Role in Invoice Voucher Processing • Reviews Invoice Voucher • Ensures necessary approvals are in place • Addresses any tax requirements • Generates payment

1. Invoice Vouchers to Non-resident Aliens • A separate invoice voucher must be prepared for payments to non-resident aliens • Glacier must be completed by the participant and attached to the invoice voucher. • Taxes equal to 30% of the payment will be withheld (you will want to alert PI’s to this)

Check (via revolving fund)for individual payments less than $50 • Used for projects involving a large number of subjects or lasting an extended period of time. • A separate revolving fund (checking account) may be established. • A log must be maintained • The subject must sign the log

2. Bank Account Procedures • Investments will work with the requesting department to determine: • The appropriate type of bank account • The bank where the account is to be opened • Appropriate signatures • How the funding of the account will be handled

2. Investments will do the following: • Send the bank procedures manual • Prepare resolution authorizing the designated custodian and signatories to operate the bank account • Contact the bank to open account and obtain signature cards • Arrange for monthly statements to be mailed from bank to the account “Control” • Retain copies of signature cards and resolution

2. The Business Office will: • Obtain signature on signature cards from appropriate personnel and return to Investments • Designated “Control” will create a bank account file (Bank statement, reconciliation, all pertinent correspondence) to be appropriately secured • Reconcile account and submit reconciliation to the revolving fund clerk/Accounting Services by the 20th of each month.

2. Check (via revolving fund) for individual payments less than $50 • At no time may the account be overdrawn • Voided checks must be retained and returned to the business office • SPS approval is obtained on the Form 52A (request for electronic funds transfer) that reimburses the revolving fund for check disbursed. • For non SPS funds, the business office must ensure an approved protocol exists and amounts are consistent with protocol • Object code 5-5613 Human Subjects Payments must be used

2. Revolving Fund & Change Fund Procedures can be found at: • http://www.purdue.edu/account/Reference/Revolving_Funds/procedures-i.htm • This site includes detailed guidance for: • Establishment • Managing interest • Cash versus checking accounts • Creating of checking accounts • Handling of bank charges

2. Revolving Funds (cont’d) • Managing expenditures • Replenishment of revolving funds • Reporting requirements • Closing the fund and checking account

3. Cash (via cash advance) for payments less than $50 • An invoice voucher (Form 56) is prepared in the name of the PI, business manager, or business assistant • Object code 5-5613 Human Subjects Payments must be used • SPS approval of the invoice voucher is required for funds 500-699. • For non SPS funds, the business office must ensure an approved protocol exists and amounts are consistent with protocol

3. Cash (via cash advance) for payments less than $50 • A cash-handling plan must be completed for locations disbursing cash • The request for funds should be made close to the time funds will be disbursed • Checks made payable to the project director or other appropriate staff member must be cashed

3. Cash (via cash advance) for payments less than $50 • Funds cannot be deposited into personal accounts nor can separate accounts be established to hold these funds • Cash must be appropriately secured • Unused funds must be promptly returned to the Business Office

3. Cash (via cash advance) for payments less than $50 • A log must be maintained • The business office reconciles the original disbursement, participant payments, and excess cash • The business office prepares a Cash Receipts Voucher (CRV) to deposit unused funds. CRV’s are taken to the Bursar’s Office for deposit

3. Cash (via cash advance) for payments less than $50 • A Cash Advance Reconciliation Statement of Condition must be returned to the Tax group monthly with the human subjects recipient log • When the project is complete, or human subject compensation activity has ended, a final reconciliation statement should be submitted

4. Gift Certificates • Gift certificates (not gift cards) may be issued in lieu of cash or check • The face value of the certificate must be less than $50 • A log must be maintained • The subject must sign the log • The log must be provided to the business office monthly

4. Gift Certificates • Certificates must be secured as if they were cash • The IRS considers gift certificates to be cash equivalent – thus the same tax rules apply to these as with more traditional payment methods

4. Gift Certificates • Gift certificates may be purchased using a departmental purchasing card • Gift certificates for lottery tickets, alcoholic beverages, or tobacco products are not allowable under any circumstances • Object code 5-5636 Cash Eq Human Subjects Pmts must be used. • The business office must ensure an approved protocol exists and amounts are consistent with protocol for all funds (exercising SPS/Comptroller delegation) • Cash handling plan is required

4. Unused Gift Certificates • Unused certificates must be returned to the business office • The business office reconciles the log to the original purchase and unused certificates • Unused certificates may be used: • For another study • For future use in the same study • For another appropriate use in the department

4. Unused Gift Certificates • Costs must be moved to appropriate account • Be aware of potential for certificate expiration or loss of value • It is not allowable to give unused certificates to faculty or staff as a recognition or award

4. Gift Certificates of Nominal Value • Certificates of nominal value mailed to respondents of a survey • Nominal value would be amounts of less than $15 that are not recurring • PI must keep a record of certificates but subject signature is not required

4. Why not Gift Cards? • The University cannot verify and validate the stored value of a gift card • Some gift cards charge fees, or may expire or lose value • It would be embarrassing for a participant to attempt to use a gift card and learn it did not have the value expected

5. Coupons • Received free of charge from various vendors as a marketing tool (i.e. free pizza) • Are of nominal value • Logs are not required • SPS approval is not required, as there is no expenditure reflected on the SPS account • Coupons for lottery tickets, alcoholic beverages, or tobacco products are not allowable under any circumstances • Unused coupons may be handled similarly to unused gift certificates

6. Giveaways • Items of a nominal value may be given to each participant • Giveaway items must have prior sponsor approval before expenditure can occur • Contact SPS for assistance if these were not originally budgeted • The business office must ensure an approved protocol exists and amounts are consistent with protocol for all funds (exercising SPS/Comptroller delegation)

6. Giveaways • Giveaways items should be secured to prevent theft or loss • Non-promotional giveaway items of nominal value (e.g. small toys) • Must be less than $15 • Gift certificates may be purchased using a departmental purchasing card • NEW Object code 5-5637 Non-cash Human Subjects Payments must be used • Business Office maintains supporting documentation

6. Purdue Promotional Giveaways • Items of nominal value used for Purdue promotional or marketing purposes (e.g. pens, coffee mugs) • Contain a university school or departmental logo • Should be administered according to the guidelines for promotional giveaways

Food/Meals asHuman Subject Compensation • Meals for focus groups, etc. may be included as human subject compensation • Must have prior sponsor approval before expenditure can occur • Contact SPS for assistance if these were not originally budgeted • The business office must ensure an approved protocol exists and amounts are consistent with protocol for all funds (exercising SPS/Comptroller delegation)

7. Food/Meals as Human Subject Compensation • P-card that allows food purchases should be used • NEW Object code 5-5637 Non-cash Human Subjects Payments must be used • Do not use any other food, hospitality or entertainment object codes • Business office maintains support documentation

Human Subjects Compensation Training