Paying Research Subjects: Regulations, Policy, and Research

1. Paying Research Subjects: Regulations, Policy, and Research Monika Markowitz, PhD, MSN, RN, MA Office of Research Compliance and Education Office of the Vice President for Research Betsy Ripley, MD, MS Professor, Internal Medicine – Division of Nephrology Chair, IRB Leadership and Enhancement Committee 4th Friday for Research Coordinators October 2009

2. Determining Coercion and Undue Influence • Belmont: Payment can be undue when either excessive or inappropriate • Webster dictionary definition of coercion “the use of express or implied threats of violence or reprisal… or other intimidating behavior that puts a person in immediate fear of the consequences in order to compel that person to act against his or her will” • Perhaps a better question: Is the individual likely to act against their better judgment in order to receive the payment?

3. Undue Influence or Coercive?

4. Examples of Potential Problems with Payment • Healthy volunteer in a pharmacokinetic study received $1000. For a “less risky” study he later said “$400 seems cheap” • HIV positive or not for $40 or $400 • Pharmaceutical study dispute between investigator and sponsor as to what was appropriate payment • NIH sleep study false history given. Participant died in the study. She had received $1300 for that and a previous study.

5. Guidelines and Regulations

7. Ethical Debate • Autonomy • Vulnerable Populations • Children • Patient Participants • Uninsured Participants • Integrity of the study

8. Autonomy • Ashcroft: Freedom of contract • Kuczewski: those who are desperate for treatment and those that enroll for payment have their autonomy compromised • IRB role: Assure that the competent individual is given the information required to make an informed decision- consent process. For the incompetent person assure the LAR understands and acts in the individuals best interest.

9. Children • American Academy of Pediatrics (1995) • Payment is consistent with the “traditions and ethics of society” • 2 safeguards recommended • Parents should receive no more than a token gesture of appreciation • Payment given directly to children should not be disclosed until the end of the study. • Potential concern: Who is receiving the payment and who is subjected to the risks? Who is experiencing the cost? • IRB: Determine why the payment is being given- reimbursement for expenses, incentive, or token of appreciation. Determine who will receive the payment and how. Informing Children or LAR?

10. Patient Participants • FDA neither supports nor prohibits • Macklin (1982) “it is ethically inappropriate to pay patients” • Resnik (2001) Therapeutic misconception in addition to payment may make unhealthy subjects more prone to undue influence • Grady (2001) Payment may be a demonstration of respect and appreciation • Uninsured Patient Population: Pace (2003): Those doing research as a means of obtaining health care and uninsured may stand to benefit less from the research findings • IRB: Ensure participants understand the treatment options, the research nature of the study, and the risks/benefits

11. Integrity of the Study • Reduction in the quality of the information they provide • Bentley and Thacker (2004) study of pharmacy students showed that payment influenced some respondents’ potential to conceal information about restricted activities • The expectation of payment by participants and the impact on smaller unfunded studies.

12. Choosing Appropriate Payment • Menikoff (2001) include risk as a determinant • Heath (2001) based on investigator’s and study needs • Grady (2001) standardized and calculated like unskilled laborers • Shamoo and Resnik (2001) guaranteed a minimum wage but no upper limit and the use of collective bargaining • Lemmons and Elliiott (2001) business relationship including workers compensation and safe working conditions • McEachern (2005) occasional participant versus professional participant (temporary versus career workers)

13. Empirical Research • IRB Members at VCU • Investigators and non-investigators at VCU • WIRB Members • National Survey of Investigators • National Survey of IRB Chairs Asked to respond to impact of payment on research participation involving: - Questionnaires -Substance Abuse - HIV Risk Reduction -Hypertension

14. Reasons for Payment

15. Participant Factors for Determining Payment

16. Study Related Factors for Determining Payment

17. What is the most important factor for determining payment?Top Three Factors • VCU Investigators • Risk to participants 46.7% • Time Involvement 19.1% • Inconvenience 15.7% • VCU IRB • Risk to participants 50% • Inconvenience 26.5% • Time Involvement 18% • VCU Non- Investigators • Risk to participants 71.4% • Time Involvement 10.1% • Inconvenience 5.4% • WIRB • Inconvenience 25% • Risk to participant 24% • Time Involvement 24%

18. $ Payment for Research Activities Investigators IRB Chairs

19. Paying VCU research subjects to participate in research - Policy • Gift card/cash policy for research subject compensation: Gift Card Policy http://www.vcu.edu/procurement/GiftCardPolicy.doc Since January 2009! • IRS thinks of gift cards as cash – need SS#’s and W9

20. Procure gift cards for 2 purposes: • Compensating participants in an IRB-approved study/ clinical trial • Compensating those completing a University- approved survey • Should not be purchased in advance • If immediate compensation is necessary, required VP approval

21. Obtaining gift cards (if SS# collected): • Treasury Services – Wachovia VISA gift cards $25 – 100 increments ($1.95 fee per card) See order form on policy. Submit form and completed W-9s to Accounts Payable. Picked up within 10 days from Cashier’s Office. • Purchase Order for cards from retail stores – eg. < $25, submit PO and W9s to Procurement; no reimbursements for advance purchased gift cards • Petty Cash – W9s and Direct Pay form to Accounts Payable after service performed to replenish Petty Cash account

22. Procedure for subject compensation:(See Gift Card Policy for specifics) • Informed consent form describes need for SS#; however refusal to do so does not preclude participation • Participant completes Substitute W9 form – with SS# Logistics: • For Wachovia gift cards, order form to Treasury Services, W9s to Procurement, pick up from Cashier’s Office • For purchase order, submit PO and W9s to Procurement • Petty Cash – Direct Pay form and W9s to Procurement

23. Options if SS# not collected • gift catalog – See Attachment A for catalog ordering • gift certificate – For specific item Neither of above considered a monetary compensation if below $50 3) gift card with permission of VP - Still requires W9 without SS#, account index for 28% withholding, spreadsheet maintenance; permission of VP

24. Maintain all records • Safeguard gift cards – same as cash • PIs/coordinators responsible to maintain logs on each compensated participant: gift card ID, value, subject name, W9 document • Regular reconciliation • Gift card logs subject to audit similar to Petty Cash funds