betsy ripley, "what do we know about payments to research participants?"
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Quality Clinical Research
Paying Research Participants
Betsy Ripley, MD, MSProfessor of MedicineVCU Clinical Research Compliance OfficerVCU Senior IRB ChairAssociate Chair VCU IM Faculty Development
Quality Clinical Research
Conflict of Interest
I have no conflicts of interest with this presentation
Quality Clinical Research
BenefitsRisk
Quality Clinical Research
Types of Paying Studies and Types of Subjects
Studies by type of subject enrolled
Type of study TotalPhase 1 Phase 2 Phase 3 Phase 4 Physiologic Behavioral Other
Studies that enroll only healthy subjects 16 5 1 1 37 35 18 113 (24.2%)Studies that enroll only patient-subjects 10 52 97 35 21 39 32 286 (61.2%)Studies that enroll both types of subjects 0 1 2 0 30 8 27 68 (14.6%)Total 26 (5.6%) 58 (12.4%) 100 (21.4%) 36 (7.7%) 88 (18.8%) 82 (17.6%) 77 (16.5%) 467 (100%)
Grady et al Contemporary Clinical Trials 2005
Quality Clinical Research
How much are participants paid, in what circumstances, and for what reasons?
Quality Clinical Research
Types of Payments
$Prorated
Single or multiple payments
Completion Bonus
Cash
GiftCards
Raffle
Course Credit
Gift Catalog
Food and Snacks
Movie Tickets
Check
Quality Clinical ResearchLatterman and Merz AJOB 2001
126 studies 1997-98
On average paid $9.50/hr plus an average sum of over $12 for additional separable tasks in the study
Quality Clinical Research
Highest Dollar Amount Offered by Studies
Studies by type of subject enrolled $ < 50 (%) $50–99 (%)
$100–249 (%)
$250–499 (%)
$500–999 (%) $1000+ (%)
Median $ amount Mean $ amount ( ± SD)
Studies that enrolled only healthy subjects N = 113 25.7 17.7 28.3 18.6 7.1 2.7 $100 $205 ± 282
Studies that enrolled only patient-subjects N = 286 9.4 11.5 38.8 22.7 11.9 5.6 $200 $306 ± 342
Studies that enrolled both types of subjects N = 68 30.9 17.7 20.6 19.1 10.3 1.5 $100 $199 ± 232Total number of studies 16.5 13.9 33.6 21.2 10.5 4.3 $155 $266 ± 318
Grady et al Contemporary Clinical Trials 2005
Quality Clinical Research
Procedure NIH data
Johns Hopkins drug development unit Partners
Data from Ripley survey
Clinic visit (return visit blood and physical) $30 $40.00/visit $30–75 $25–26Blood sample $20 $3.00/sample $5–25 $16–20Urine sample $10 Not available Not available $12Questionnaire (1 hour) $30 Not available $5–30 $21
MRI scan $50 Not available $50–200 Not availableLumbar puncture $50 $75 $100 Not available
Dominguez et al Contemp Clinical Trials 2012
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Do different types of research (Phase 1, Phase 3, more than minimal risk etc.) generally pay more/less than others?
Quality Clinical Research
Highest Dollar Amount Offered
$ < 50 (%) $50–99 (%)$100–249 (%)
$250–499 (%)
$500–999 (%) $1000+ (%)
Median $ amount
Mean $ amount ± SD
Phase 1 0 0 42.3 30.8 15.4 11.5 $275 $451 ± 446Phase 2 2 5.2 36 25.9 24.1 6.9 $278 $410 ± 390Phase 3 0 5 42 36 10 7 $275 $361 ± 328Phase 4 0 8.3 58.3 25 8.3 0 $200 $236 ± 170Physiologic 13.6 14.8 28.4 23.9 14.8 4.6 $200 $290 ± 313Behavioral 45.1 25.6 17.1 6.1 3.7 2.4 $50 $128 ± 251Other 33.8 26 31.2 6.5 2.6 0 $55 $107 ± 143Total 16.5 13.9 33.6 21.2 10.5 4.3 $155 $266 ± 318
Grady et al Contemporary Clinical Trials 2005
Quality Clinical Research
Hypertension Placebo Controlled Completion
21%
Prorated34%
Prorated w ith bonus26%
Money82%
Gift3%
No payment or Parking
16%
Pilot Exercise Study
Completion18%
Prorated34%
Prorated w ith bonus15%
Money68%No payment
or Parking23%
Gift10%
Substance Abuse Survey
Completion28%
Prorated21%
Prorated w ith bonus
9%
Money58%
Gift24%
No payment or Parking
18%
Pharmacokinetic Healthy Volunteer
Completion68%
Prorated26%
Prorated w ith bonus
0%
Money93%
No payment or Parking
3%
Gift3%
Children's Asthma StudyCompletion
6%
Prorated17%
Prorated w ith bonus19%
No payment or Parking
14%
Gift44%
Money42%
Parent of the Child in the Asthma Study
Completion8%
Prorated11%
Prorated w ith bonus
5%
Money24%
Gift3%
No payment or Parking
73%
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Model Component
Lupus Registry
Substance Abuse Survey and Urine Drug Screen
Twin DNA and Survey
Cancer Treatment Trial
Healthy Volunteer PK Study
HTN Placebo Trial
Increase RiskBorderline Decrease p=0.08
Increase p=0.0005
Increase p=0.07
Increase p=0.03 Increase p=0.07
Increase Inconvenience
Increase p=0.03
Increase P<0.0001
Decrease p=0.02
Increase p=0.008
Increase p=0.08
Increase Difficulty Recruiting
Increase p<0.0001
Increase p<0.0001
Increase P<0.0001
Increase p=0.05
Important Funding Source
Increase p=0.004 Increase p=0.02
Important Healthy Volunteer
Increase p<0.0001
Increase p=0.004
Important Patient Income
Increase p=0.002
Male Respondents
Increase p=0.05
Quality Clinical Research
What do we know about payment to participants?
The simple answer:
It depends!
Quality Clinical Research
The Likert Scale of Paying Participants
No Pay A lot of Pay
No Concern A lot of Concern
Ethical Concern for Paying
Ethical Concern for Not Paying
Quality Clinical Research
What gaps are there in our knowledge?
• Who?• Who are we paying?
• Within a study, across studies
• Types of subjects• Types of studies
• When?• When are we paying
• Prorated, completion bonus
• What?• What are we paying ?
• Where?• Where do we
document?
• How?• How are we paying?• How much?
• Why?• Does it matter?
Quality Clinical Research
Betsy Ripley, MD, MSVCU Clinical Research Compliance OfficerVCU Senior IRB Chair