Human Subjects Compensation Training January 18, 2005

Human Subjects Compensation TrainingJanuary 18, 2005

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

Presented by:

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.


Review the “guidance sheet” with the faculty member and leave a copy with the PI for future reference

Guidance sheet:contains websites for referenceexplains the different payment typesexplains benefits and requirements

surrounding each


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 protocolFor 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:

1. Check (Accounts Payable)

2. Check (Revolving Fund)

3. Cash (Advance to PI)

4. Gift Certificates (NEW)

5. Coupons (NEW)

6. Giveaways (NEW)

7. Food (NEW)

1. 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)

2. 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 accountThe bank where the account is to be openedAppropriate signaturesHow 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:

EstablishmentManaging interestCash versus checking accountsCreating of checking accountsHandling of bank charges

2. Revolving Funds (cont’d)

Managing expendituresReplenishment of revolving fundsReporting requirementsClosing 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


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


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


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

logoShould be administered according to the

guidelines for promotional giveaways

7. 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


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

Drawings and Raffles There has been past practice of entering

participants names in a drawing for a prize as part of human subjects compensation

We have received a legal opinion that these types of drawings must be open to anyone (not just the research participants) or they could constitute an illegal lottery.

Difficult to show benefit to a sponsored program, and reduce incentive to research participants

Drawings and raffles may not be used as human subject compensation

A university-wide policy regarding this issue is being developed.

Protocols that Contain Unallowable forms of Compensation If during the protocol review process IRB

staff identify forms of compensation that are not allowable under Purdue policies, they will work with the staff of the OVPR Office and PI’s business office to bring these situations to the attention of the PI.

Deviations and Exceptions

Deviations from the amount and method of payment approved by the IRB must be reviewed by the IRB

The Comptroller must approve any exception to these payment methods.

Items of Special Interest

PI Personal Funds A PI may use personal funds for human

subjects payments and not request reimbursement. This is still an issue for the IRB, but there is no business/cash management issue.


Dollar bills in mailings A PI may include a $1 bill in a survey

instrument. This may be an exempt activity, and therefore, have no IRB issue, but have a business/cash management issue. A log of survey recipients/mailings should be maintained.


Invoice Vouchers under $50 A payment may be anticipated to exceed

$50, but be prorated resulting in a less than $50 payment. An invoice voucher could still be prepared with the circumstance noted.

Items of Special InterestKey/Code system As with all financial and personnel data the

business office handles, appropriate care should be used regarding confidentiality of participant information.

In some sensitive studies, the PI may chose to use a key/code system. The business office would have a log indicating that “Person A” received $10. The PI would retain a key “Person A = John Smith”

The key/code system is not appropriate for invoice voucher payments.

Contacts

Kendra Merriman [email protected] Liz Rulli [email protected] Gayle Stetler [email protected] The IRB Office [email protected] Robin Bhaerman, IRB Administrator [email protected] Peter Dunn, Associate VPR [email protected] Becky White, Assistant Dir., SPS [email protected] Kathy Vanderwall, Endowment and Investment

Accountant, [email protected]

Forms and Resources IRB website http://www.irb.purdue.edu/ Business Procedures Manual

http://www.purdue.edu/taxes/Consultant_Payments/humansubjectpymts.htm Detailed Procedures Logs and forms Guidance sheet

This presentation ‘Human Subject Compensation Training’ http://www.purdue.edu/taxes/Human_Subjects/

Questions…

Documents

Human Subjects Compensation Training January 18, 2005