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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

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paying research subjects regulations policy and research

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

determining coercion and undue influence
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?
examples of potential problems with payment
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.
ethical debate
Ethical Debate
  • Autonomy
  • Vulnerable Populations
    • Children
    • Patient Participants
    • Uninsured Participants
  • Integrity of the study
autonomy
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.
children
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?
patient participants
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
integrity of the study
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.
choosing appropriate payment
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)
empirical research
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

what is the most important factor for determining payment top three factors
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%
payment for research activities
$ Payment for Research Activities

Investigators

IRB Chairs

paying vcu research subjects to participate in research policy
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
procure gift cards for 2 purposes
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
obtaining gift cards if ss collected
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
procedure for subject compensation see gift card policy for specifics
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
options if ss not collected
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

maintain all records
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
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