Justice in Recruitment and Research

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Justice in Recruitment and Research

• Ethics in Mental Health Research

2
Problem statement

• Tensions arise as we seek to balance concerns of
  justice with concerns to protect participants and
  respect their autonomy

3
Part I Overview
4
Justice concerns in research An Overview

• Equal ability to say noensuring that vulnerable
  participants are not unduly influenced or
  exploited
• This was the primary focus of the Belmont Report
  (sections B3 and C3)
• Will provide primary starting point for our
  analyses

5
Justice Overview

• Equal access to research studies
• This demand arose from HIV and breast cancer
  advocates. Protection at the cost of exclusion
  was no longer considered acceptable

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Justice Overview

• Equal access to the fruits of research
• Belmont notes that those who participate in
  research should also enjoy the fruits of research
• Ongoing problem giving inadequate access to
  health care challenge in international settings

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Justice Overview

• Restorative justice
• Regulations currently require researchers to
  disclose whether compensation will be available
  for research-related injury
• However, restitution or compensation is not
  required

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Justice Overview

• Procedural justice
• Communities are frequently demanding more input
  regarding study questions, funding priorities,
  anticipated benefits, etc
• Participant and public responsibilities
• If the public enjoys the fruits of research (and
  we do), is there a duty to participate in
  research?
• If an individual consents to participate, is
  there a duty to follow the study protocol?
• Should incentives be tied to satisfactory
  participation?

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Part II Protection vs. Access and Just
Compensation
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Coercion, undue influence, and benefit

• Distinguishing coercion, undue influence and
  benefits that legitimately motivate is difficult
• Coercion strong element of manipulation seeks
  to force participation by presenting alternatives
  of non-participation as unattractive /
  unreasonable
• Does label of coercion depend on moral factors?
  (Appelbaum, 1995)
• Participants original position (e.g., already
  legitimately institutionalized)
• Authority to make demands (e.g., boss or teacher)

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Coercion, undue influence and benefit

• Legitimate benefit least manipulative simply
  makes motivation intelligible/reasonable
• Undue influence middle ground. But what
  distinguishes it? Is the benefit irresistible? Do
  we expect great individual differences?
• Key element voluntariness is restricted, people
  find it harder than usual to say no

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Signs of undue influence

• Concern with undue influence should be
  proportionate to risks/benefits
• What are the signs of undue influence?
• Disproportionate number of subjects enrolling
  given risks / benefit ratio?
• Subjects willing to lie or deceive to qualify for
  study?
• Subjects uninterested in risks / benefits?

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Two basic forms of undue influence

• Deference to authority
• Financial incentives

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Deference to authority

• Problem is especially acute with
• Children
• Students
• Prisoners
• Patients
• Compliance with will of authority may be out of
  fear or desire to please

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Deference to authority

• Minimizing risks of infringing on voluntariness
• Excluding population
• Using consent monitors
• IRB review of incentives and processes
• Providing options to participation to get similar
  benefits

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Financial incentives

• Payment in narrow sense is not supposed to count
  as a benefit (IRB handbook) in IRB review.
• But there are variations of financial
  incentives (i.e., benefits of financial worth)
• Cash payments
• Other material benefits, e.g., computers
• Medical care

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Is a fixed dollar amount too much?

• No
• Different people attach different value to money
• E.g., dollar is worth more the less you have
• E.g., some pursue money more avidly
• In the work force, determinations of fair pay
  depend on many factors, some subject related some
  job related

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Basic problem

• High payments
• Advantages will recruit across economic groups
  may show respect for value of time or risks
  undertaken
• Disadvantages increased risk of undue influence
• Low payments
• Advantages reduced risk of undue influence
• Disadvantages may disvalue time of participants
  may reveal overly paternalistic attitude may
  lead to disproportionate participation by poor
  people

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Macklins solution

• No happy solution exists. Can only choose least
  offensive option
• Do pay for time, but
• Err on side of low payments (e.g., around minimum
  wage) because high payments will introduce new
  problems

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Ackermans solution Participants as contracted
workers

• Five conditions determine fair treatment
• Decent working conditions acceptable level of
  risks
• Offer a living wage appropriate for unskilled
  labor
• Payments should increase in proportion to
  arduousness of work
• Payments increased in proportion to social value
  of the work
• Insurance should be provided against
  unforeseeable injuries

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Can capacity testing help?

• Should we ignore other factors and focus on
  capacity?
• That is, focus on whether participant
  understands, appreciates, reasons with, and
  articulates risks and benefits and a motive for
  participating?
• If incentives lead to disinterest in risks /
  benefits, then participant is excluded

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Disclosure Back to basics

• The most basic condition for voluntariness is
  provision of adequate information
• Double speak is often a problem with medical
  research promises of medical benefits
  (Hochhauser)
• Risks may be inadequately disclosed
• Money may be over-emphasized to distract from
  other information
• Inclusion / exclusion criteria may be under
  emphasized
• Review of recruitment materials by IRBs is
  appropriate

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References

• Ackerman, T. F. (1989). "An Ethical Framework for
  the Practice of Paying Research Subjects." IRB A
  Review of Human Subjects Research 11(4) 1-4.
• Appelbaum, P. S. (1995). "Consent and Coercion
  Research with Involuntarily Treated Persons with
  Mental Illness or Substance Abuse."
  Accountability in Research 4(1) 69-79.
• Hochhauser, M. (2002). ""Therapeutic
  Misconception" and "Recruiting Doublespeak" in
  the informed Consent Process." IRB Ethics
  Human Research 24(1) 11-12.
• Kahn, J. P., Mastroianni, A. C., Sugarman, J.
  (Eds.). (1998). Beyond consent seeking justice
  in research. New York Oxford University Press.

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References

• Levine, C. (1996). Changing views of justice
  after Belmont AIDS and the inclusion of
  'vulnerable' subjects. In H. Y. Vanderpool (Ed.),
  The ethics of research involving human subjects
  (pp. 105-126). Frederick, MD University
  Publishing Group.
• Macklin, R. (1981). "'Due' and 'Undue'
  Inducements On Paying Money to Research
  Subjects." IRB A Review of Human Subjects
  Research 3(5) 1-6.