a case for treating clinical trial participation as labour/media... · a case for treating clinical...
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A Case For Treating Clinical Trial
Participation As Labour
Andrew D. Ross, Ph.D.
Jr. Clinical Ethicist, Central Zone
AHS Clinical Ethics Service
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This presentation is based on a paper written prior to the
author’s employment with Alberta Health Services. The
views expressed are entirely the author’s and should not be
taken to represent the views or policies of Alberta Health
Services or the Clinical Ethics Service.
Disclaimer
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1. Review the background to the problem of exploitation of
participants in clinical drug trials.
2. Discuss a series of possible objections to treating clinical
trial participation as a form of labour.
3. Discuss a series of possible reasons to prohibit or
minimize monetary offers as a means of compensating
participants in clinical drug trials.
Session Objectives
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1. Background
– Situation of clinical trial participants in the current system
– Exploitation concerns
Outline
2. Participation as Labour
– Prima facie case
– Potential objections
– Implications
3. Competing Concerns
– Reasons to prohibit, limit or minimize monetary compensation
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1. Background
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Clinical Trials
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1. Scientific: provide evidence of efficacy and
safety of the investigational intervention
Dual Purpose of Clinical Trials
2. Pragmatic: satisfy prerequisite for regulatory
approval to bring the new intervention to market
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Participants in clinical trials are generally supposed
to be acting altruistically…
An Uncomfortable Situation
…but this “altruism” feeds the extremely lucrative
global pharmaceutical industry.
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Exploitation Concerns
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Exploitation - Definition
To exploit someone is to take unfair advantage
of them. Exploitation can be consensual, and
even a mutually-beneficial interaction can be
exploitative.
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How to Determine “Fairness”?
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2. Participation as Labour
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What is Labour?
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Labour is the use of human resources as a factor in
the production (or attempted production) of
something of value.
What is Labour?
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Prima Facie Case
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Objections
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Objection: Direct Health Benefit
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Objection: Motivation
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Objection: Passivity
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Objection: No Free (Un-Coerced)
Labour
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Objection: Medical Research is
Unique!
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• It may be appropriate to use existing standards of fairness
in labour exchange to judge the fairness of clinical trials
towards participants
• It does not (yet) follow that clinical trial participants should
be paid
Implications
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An Important Distinction
Commercial v. Non-Commercial
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Exploitation & Compensation
“Healthy Subjects” v. “Patient Subjects”
Commercial v. Non-Commercial Research
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3. Competing Concerns
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Exploitation & Compensation
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Money, Labour and Exploitation
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Undue Inducement
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Undue Inducement (continued)
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Bad Incentive
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“Crowding Out”
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Compensation Model Desiderata
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Thank you for listening!
Andrew D. Ross, Ph.D.
Jr. Clinical Ethicist, Central Zone
AHS Clinical Ethics Service
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Questions?
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