Paying research subjects regulations policy and research
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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: Policy

  • 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): Policy

  • 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: Policy(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 Policy

  • 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 Policy

  • 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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