Paying Research Subjects: Regulations, Policy, and Research Monika Markowitz, PhD, MSN, RN, MA Office of Research Compliance and Education Office of the.

Paying Research Subjects: Regulations, Policy, and Research

Monika Markowitz, PhD, MSN, RN, MAOffice of Research Compliance and Education

Office of the Vice President for ResearchBetsy Ripley, MD, MS

Professor, Internal Medicine – Division of NephrologyChair, IRB Leadership and Enhancement Committee

4th Friday for Research CoordinatorsOctober 2009

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?

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

GuidelineGuideline RecommendationRecommendation

Nuremburg Code Nuremburg Code (Nuremberg 1947)(Nuremberg 1947)

Informed consent must be Informed consent must be without without coercioncoercion in any form. in any form.

Federal Regulations Federal Regulations Section 46.116 Section 46.116 (Department of (Department of Health & Human Health & Human Services [DHHS], Services [DHHS], 1997)1997)

Seek consent which Seek consent which minimizes the minimizes the possibility of coercion or undue possibility of coercion or undue influence.influence.

GuidelineGuideline RecommendationRecommendation

FDA Information Sheet FDA Information Sheet (Department of Health (Department of Health & Human Services & Human Services [DHHS], 1998)[DHHS], 1998)

Payment is not uncommon. FDA does not Payment is not uncommon. FDA does not endorse or prohibit but does charge the endorse or prohibit but does charge the research ethics committee research ethics committee with reviewing with reviewing the amount, method and timing of the the amount, method and timing of the distribution to assure that it is distribution to assure that it is not undue or not undue or coercivecoercive. .

OHRP IRB Guidebook OHRP IRB Guidebook (Office of Protection (Office of Protection from Research Risk, from Research Risk, 1993)1993)

Although varying opinions exist, OHRP does Although varying opinions exist, OHRP does not recommend nor prohibit payment. It not recommend nor prohibit payment. It notes that free healthcare for persons with notes that free healthcare for persons with limited resources and major medical limited resources and major medical problems may be a significant inducement to problems may be a significant inducement to participate. There is no consensus as to participate. There is no consensus as to whether this is acceptable.whether this is acceptable.

Ethical Debate

• Autonomy• Vulnerable Populations– Children

– Patient Participants

– Uninsured Participants

• Integrity of the study

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• 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• 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

• 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

• 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 • 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

ReasonReason National National InvestigatInvestigatorsors

National National IRBIRB

WIRBWIRB

ReimbursementReimbursement ImportantImportant ImportantImportant ImportantImportant

Compensation Compensation for for InconvenienceInconvenience

ImportantImportant ImportantImportant ImportantImportant

Incentive for Incentive for EnrollmentEnrollment

ImportantImportant ImportantImportant Not Not ImportantImportant

AppreciationAppreciation ImportantImportant NeutralNeutral Not Not ImportantImportant

Participant Factors for Determining Payment

Participant Participant FactorsFactors

National National InvestigatorsInvestigators

National National

IRBIRB

RiskRisk ImportantImportant ImportantImportant

InconvenienceInconvenience ImportantImportant ImportantImportant

IncomeIncome Not ImportantNot Important Not ImportantNot Important

DemographicsDemographics Not ImportantNot Important Not ImportantNot Important

Study Related Factors for Determining Payment

Study Related Study Related FactorsFactors

National National InvestigatorsInvestigators

National National

IRBIRB

BudgetBudget ImportantImportant Not ImportantNot Important

Anticipated Difficulty Anticipated Difficulty RecruitingRecruiting

ImportantImportant ImportantImportant

Funding SourceFunding Source Not ImportantNot Important Not ImportantNot Important

N needed to recruitN needed to recruit NeutralNeutral Not ImportantNot Important

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

TherapeuticNon Therapeutic Therapeutic

Non Therapeutic

Clinic Visit 26 26 24 27Blood Sample 15 17 20 22Urine Sample 9 10 12 14Overnight Stay 107 115 132 1421 hr of Survey 19 21 22 24

X Ray 22 26 29 25

Investigators IRB Chairs

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:

• Compensating participants in an IRB-approved study/ clinical trial

• Compensating those completing a University- approved survey

Should not be purchased in advanceIf immediate compensation is necessary,

required VP approval

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)

• 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

1) gift catalog – See Attachment A for catalog ordering

2) gift certificate – For specific item Neither of above considered a monetary

compensation if below $503) gift card with permission of VP - Still requires

W9 without SS#, account index for 28% withholding, spreadsheet maintenance; permission of VP

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