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Why Do We Offer Payment to Research Participants, and What Are the Regulatory

Parameters?

Models of conceptualizing payment

Christine Grady Department of Bioethics

NIH Clinical Center December 9, 2016.

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Disclaimer

The views expressed are my own and do not represent the positions or policies of the NIH, DHHS, or US government I have no conflicts of interest to disclose

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Why do we offer payment to research participants?

• “It is a poorly kept secret in the world of clinical trials that issues with patient recruitment and enrollment are the primary causes for missing clinical trial timelines. Most of us have seen the data. We know that for each day a company goes beyond the planned deadline for a clinical trial, that company could be losing as much as $600,000 in foregone sales of smaller products and as much as $8 million on blockbuster drugs. As necessity is the mother of invention, it comes as no surprise that sponsors and CROs are looking to any and all means by which to increase the rate of patient enrollment.”

ISR-The Expanding Web of Patient Recruitment, 2014

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Why do we offer payment to research participants?

• We offer payment to enhance participant recruitment and enrollment

• Does offering payment to research participants increase the rate of enrollment? Survey response rates Healthy volunteer studies Clinical trials?

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Treweek S. et al Methods to Improve Recruitment to Clinical Trials Cochrane Review 2013

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Treweek S. et al Methods to Improve Recruitment to Clinical Trials Cochrane Review. BMJ Open 2013

*3 studies- two hypothetical

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Why do we offer payment to research participants?

• Enable participation

• Make participation - revenue-neutral

• Compensate for time, contribution, risk

• Minimize possibility of exploitation

• Demonstrate respect and gratitude

(Payment for any of these reasons might facilitate recruitment)

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Models for paying research participants

• Market model

• Wage payment model

• Reimbursement model

• Appreciation model

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Models for paying research participants

• Market model- incentives, risk

• Wage payment model- time and contribution, enabling participation

• Reimbursement model- expenses, revenue-

neutral

• Appreciation model- respect/gratitude

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Dickert N, Grady C. 1999

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Reimbursement model

Advantages • Reduces financial sacrifice

of participants • Does not preferentially

favor any one group • Provides no incentive to

conceal information or remain uninformed

• Reduces chance of money unduly influencing decisions

Disadvantages • May not act as sufficient

incentive for recruitment • Leaves time

uncompensated • if time reimbursed: • Pays differentially for same

function • May lead to targeting lower

paid individuals

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Market model

AAdvantages • Likely to enhance/facilitate

recruitment • Reduces financial sacrifice

of participants- in fact, they may profit

Disadvantages • May provide incentive to

remain uninformed or to misrepresent

• May be unduly influential • May lead to interstudy

competition (crowding out)

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Appreciation model

Advantages • Rewards valuable

contribution • Expresses appreciation

without undermining volunteerism

• Might enhance recruitment*

Disadvantages • Might not affect

recruitment • Still requires financial

sacrifice • No basis for determining

magnitude of “reward”

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Wage payment

Advantagesd • Provides standardization

across studies • Adheres to the principle of

justice by paying similar amounts for similar contribution

• Reduces potential for undue inducement

• Reduces financial sacrifice and provides some wage

Disadvantages • Might not be adequate for

recruitment • Financial sacrifice for

wealthier population, more attractive to financially disadvantaged

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Largent et al. 2012

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Objections to the wage payment model

1. Too restrictive/paternalistic. Payment should be more liberal

2. Should be controlled/regulated, work environment

3. Still may be unduly influential

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Phillips, T JLME 2011

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Deciding whether and how much payment to offer to research participants

• Models respond to justification for offering payment and provide general guidance regarding how

• Consideration of institutional guidelines, local societal, legal, cultural norms

• Details

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• Thank you