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

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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?


Undue influence or coercive

Undue Influence or Coercive?


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.


Guidelines and regulations

Guidelines and Regulations


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


Reasons for payment

Reasons for Payment


Participant factors for determining payment

Participant Factors for Determining Payment


Study related factors for determining payment

Study Related Factors for Determining Payment


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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