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1 1 A Case For Treating Clinical Trial Participation As Labour Andrew D. Ross, Ph.D. Jr. Clinical Ethicist, Central Zone AHS Clinical Ethics Service [email protected]

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Page 1: A Case For Treating Clinical Trial Participation As Labour/media... · A Case For Treating Clinical Trial Participation As Labour Andrew D. Ross, Ph.D. ... Clinical labor: Tissue

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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

[email protected]

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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

[email protected]

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Questions?

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Bentley, J. P. & Thacker, P. G. (2004). The influence of risk and monetary payment on

the research participation decision making process. Journal of Medical Ethics, 30(3),

293-298.

Black, J., Hashimzade, N., & Myles, G. (2009). Factor(s) of production. A dictionary of

economics (3rd ed.,) Oxford University Press.

Brazier, M. (2008). Exploitation and enrichment: The paradox of medical

experimentation.

Journal of Medical Ethics, 34(3), 180-183.

Chambers, T. (2001). Participation as commodity, participation as gift. The American

Journal of Bioethics, 1(2), 48-48.

Cooper, M. & Waldby, C. (2014). Clinical labor: Tissue donors and research subjects in

the global bioeconomy. Durham: Duke University Press.

References (1)

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Cryder, C. E. et al. (2010). Informative inducement: Study payment as a signal of risk.

Social Science & Medicine, 70(3), 455-464.

Dickert, N. & Grady, C. (1999). What's the price of a research subject? Approaches to

payment for research participation. New England Journal of Medicine, 341(3), 198-

203.

Emanuel, E. (2004). Ending concerns about undue inducement. Journal of Law,

Medicine & Ethics, 32(1), 100-105.

Grady, C. (2001). Money for research participation: Does it jeopardize informed

consent? The American Journal of Bioethics, 1(2), 40-44.

Halpern, S. D. et al. (2004). Empirical assessment of whether moderate payments are

undue or unjust inducements for participation in clinical trials. Archives of Internal

Medicine, 164(7), 801-803.

References (2)

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Lemmens, T. & Elliott, C. (1999). Guinea pigs on the payroll: The ethics of paying

research subjects. Accountability in Research, 7(1), 3-20.

Macklin, R. (1981). 'Due' and 'undue' inducements: On paying money to research

subjects. IRB: Ethics and Human Research, 3(5), 1-6.

McNeill, P. (1997). Paying people to participate in research: Why not? Bioethics, 11(5),

390-396.

Phillips, T. (2011). A living wage for research subjects. Journal of Law, Medicine &

Ethics, 39(2), 243-253.

Sachs, B. (2010). The exceptional ethics of the investigator-subject relationship.

Journal of Medicine and Philosophy, 35(1), 64-80.

References (3)

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Sample, R. (2003). Exploitation: What it is and why it's wrong. Lanham, MD: Rowman &

Littlefield.

Savulescu, J. (2001). The fiction of "undue inducement": Why researchers should be

allowed to pay participants any amount of money for any reasonable research

project. The American Journal of Bioethics, 1(2), 1g-3g.

Stunkel, L. et al. (2010). Comprehension and informed consent: Assessing the effect of

a short consent form. IRB: Ethics & Human Research, 32(4), 1-9.

Wilkinson, M. & Moore, A. (1997). Inducement in research. Bioethics, 11(5), 373-389.

References (4)