This document summarizes a presentation on bioethics at the NIH regarding why payment is offered to research participants and regulatory parameters around payment models. It discusses how payment can enhance recruitment rates for clinical trials, as well as four common models for paying participants: the market model, wage payment model, reimbursement model, and appreciation model. Each model is described and their advantages and disadvantages are outlined. The document also discusses objections to the wage payment model and factors to consider when deciding payment amounts for research participants.

1. BIOETHICS AT THE NIH
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.

2. BIOETHICS AT THE NIH
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

3. BIOETHICS AT THE NIH
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

4. BIOETHICS AT THE NIH
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?

5. BIOETHICS AT THE NIH
Treweek S. et al Methods
to Improve Recruitment
to Clinical Trials
Cochrane Review 2013

6. BIOETHICS AT THE NIH
Treweek S. et al Methods to
Improve Recruitment to
Clinical Trials Cochrane
Review. BMJ Open 2013
*3 studies- two
hypothetical

7. BIOETHICS AT THE NIH
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)

8. BIOETHICS AT THE NIH
Models for paying research participants
• Market model
• Wage payment model
• Reimbursement model
• Appreciation model

9. BIOETHICS AT THE NIH
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

10. BIOETHICS AT THE NIH
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

12. BIOETHICS AT THE NIH
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)

13. BIOETHICS AT THE NIH
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”

14. BIOETHICS AT THE NIH
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

15. BIOETHICS AT THE NIH
Largent et al. 2012

16. BIOETHICS AT THE NIH
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

17. BIOETHICS AT THE NIH
Phillips, T JLME 2011

18. BIOETHICS AT THE NIH
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

19. BIOETHICS AT THE NIH
• Thank you