betsy ripley, "what do we know about payments to research participants?"

Quality Clinical Research

Paying Research Participants

Betsy Ripley, MD, MSProfessor of MedicineVCU Clinical Research Compliance OfficerVCU Senior IRB ChairAssociate Chair VCU IM Faculty Development


Conflict of Interest

I have no conflicts of interest with this presentation


Invitation to Participate…. Boston in Dec.

$


BenefitsRisk

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How prevalent is payment?


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


The One Type of Subject Not Receiving Payment

Prisoners


How much are participants paid, in what circumstances, and for what reasons?


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


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


Quality Clinical ResearchRipley et al JERHRE 2010


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

Quality Clinical ResearchRipley et al JERHRE 2010


Ripley et al JERHRE 2010


Do different types of research (Phase 1, Phase 3, more than minimal risk etc.) generally pay more/less than others?


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



Hypertension Placebo Controlled Completion

21%

Prorated34%

Prorated w ith bonus26%

Money82%

Gift3%

No payment or Parking

16%

Pilot Exercise Study

Completion18%

Prorated34%


Money68%No payment

or Parking23%

Gift10%

Substance Abuse Survey

Completion28%

Prorated21%

Prorated w ith bonus

9%

Money58%

Gift24%


18%

Pharmacokinetic Healthy Volunteer

Completion68%

Prorated26%


0%

Money93%


3%

Gift3%

Children's Asthma StudyCompletion

6%

Prorated17%



14%

Gift44%

Money42%

Parent of the Child in the Asthma Study

Completion8%

Prorated11%


5%

Money24%

Gift3%


73%


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


What do we know about payment to participants?

The simple answer:

It depends!


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


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?


Betsy Ripley, MD, MSVCU Clinical Research Compliance OfficerVCU Senior IRB Chair

[email protected]

betsy ripley, "what do we know about payments to research participants?"

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