Ethics in research involving prisoners

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Ethics in research involving prisoners

• Jörg Pont

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Medical experiments in prisoners before world
war II

• 1906 Bilibid prison Manila Cholera
• 1912 Beri-Beri
• 1915 Mississipi prison Pellagra
• 1919-22 St Quentin, CA Testis
  transplants

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Medical experiments in prisoners during world
war II

• Nazi concentration camps Typhus,epidem.jaundice,
  gasgangrene, malaria, freezing
  sterilization,coagulation, seawater, high
  altitude, low pressure, bone regeneration,
  phopshorus burns
• Japanese Unit 731 Mustard gas, plague,
  anthrax, typhus
• Illinois Stateville penitentiary Malaria
• Massachusetts prison Beef blood injections
• Atlanta prisons Malaria

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Medical experiments in prisoners after world
war II

• 1950 Univ Pennsylvania Viral hepatitis
• 1952 Ohio state prison Cancer cell inj.
• 1951-60 Pennsylvania prisons Psychopharmaca
• 1963-73 Oregon/Washington Testis irradiation
  
• 1952-74 Holmesburg prison 33 pharma companies
  test 153 drugs (Dioxin, pain
  tolerance, hallucinogens, warfare
  agents, tropical diseases)
• Up to 1975
• 90 of all US pharma products and Phase I
  studies almost exclusively tested in prisoners

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20th century documents on Research Ethics

• 1900 Yellow Fever Commission
• 1900 Berlin Code of Ethics
• 1931 German Law on New Therapies and
  Experimentation
• 1947 The Nuremberg Code
• 1964 (?2004) WMA Declaration of Helsinki
• 1974 (?1991)US Federal Regulations Common Rule
• 1979 US Belmont Report
• 1980 FDA banned Phase I studies from prisons
• 1993 (? 2002) CIOMS Guidelines

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Lessons learnt from history

• Codes and declarations are not enough
• Common denominator ?
• Prisoners are attractive for research

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Eisenberg D, 2006

• The common denominator was the belief that caring
  for society takes precedence over caring for the
  individual.

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Prisoners are attractive for biomedical
researchers

• Cheap
• Easy to motivate
• Stable research subjects
• Continuity of follow-up
• Closed research environment
• Prison walls keep inmates inside and public eyes
  outside.

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Prisoners a vulnerable population subject to
abuse and exploitation

• No liberty
• Impaired autonomy and privacy
• Impecunious
• Health care facilities deficient
• High prevalence of reading/learning
  disabilities illiteracy, language barriers mental
  impairments psychiatric disorders substance
  abuse and addiction
• Ethnic and cultural minorities

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The Nuremberg Code

• person involved should have legal capacity to
  give consent should be so situated as to be able
  to exercise free power of choice, without the
  intervention of any element of force, fraud,
  deceit, duress, over-reaching, or other ulterior
  form of constraint or coercion and should have
  sufficient knowledge and comprehension of the
  elements of the subject matter involved as to
  enable him to make an understanding and
  enlightened decision. .

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The Nuremberg Code

• person involved should have legal capacity to
  give consent should be so situated as to be able
  to exercise free power of choice, without the
  intervention of any element of force, fraud,
  deceit, duress, over-reaching, or other ulterior
  form of constraint or coercion and should have
  sufficient knowledge and comprehension of the
  elements of the subject matter involved as to
  enable him to make an understanding and
  enlightened decision. .

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Prisoners a vulnerable population subject to
abuse and exploitation

• No liberty
• Impaired autonomy and privacy
• Impecunious
• Health care facilities deficient
• High prevalence of reading/learning
  disabilities illiteracy, language barriers mental
  impairments psychiatric disorders substance
  abuse and addiction
• Ethnic and cultural minorities

• ? Informed consent ?

?
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UNHCHR,1989 Body of Principles for the
Protection of Persons Under Any Form of Detention
or Imprisonment

• Principle 22
• No detained or imprisoned person shall, even
  with his consent, be subjected to any medical or
  scientific experimentation which may be
  detrimental to his health.

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Current main problems in prison health

• Drug abuse/addiction
• Transmissable diseases
• HC, HIV, TB
• Mental health disorders
• Violence
• Suicide

• Overcrowding
• Lack of resources

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The CPT Standards CPT European Commission for
Prevention of Torture and Inhuman or Degrading
Treatment or Punishment

• 48)The CPT would add that it favours research
  concerning custodial pathology or epidemiology or
  other aspects specific to the condition of
  prisoners.

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• Protect from exploitation

• Access to participate
• benefit from research

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• In particular, the committee rejects strong
  protectionism because it discounts the notion
  that researchers can be trusted to act virtuously
  in the protection of subjects.
• ..the myopic emphasis on informed
  consent.should be abandoned in favor of a
  risk-benefit paradigm.
• the potential benefit of a research protocol
  can justify research involving prisoners.

Ethical Considerations for Research Involving
Prisoners, Institute of Medicine (2006)
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Justification of research involving prisoners

• Results yielded cannot be obtained by research in
  the community
• Benefit for prisoners is highly probable and the
  risk low
• Access of prisoner patients to Phase III trials

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Prerequisites of research involving prisoners (I)

• Information comprehensive comprehensible,
  ongoing
• Informed consent no coercion, no inducement
• on-site monitored
• Confidentiality and privacy respected and limits
  defined and explained
• Fair, random recruitment of participants
• Adequate health standards existent

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Prerequisites of research involving prisoners (II)

• Project planning with prisoners and prison
  administration
• Central national registration of the research
• Safety and security issues
• Publication and providing results to prisoners
• Approval of independent ethical committee
  including prisoner representatives

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• Prison Health Research Network
• www.phrn.nhs.uk

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Researchers Handbook A Guide for Researchers
in Prison Health Edited by Adrian J Hayes
and Jane Senior
Prison Health Research Network Manchester Third
Edition 2007
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Informed consent

• Nature of consent
• Adequacy of information
• Competence/capacity of decision making
• Freedom of choice

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Criteria for Decision-Making Capacity
(Appelbaum PS, NEJM 2007)

• Communicate a choice
• Understand the relevant information
• Appreciate the situation and its consequences
• Reason about decision options

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• Most major medical ethic lapses can be traced
  back to a single flawed philosophy. The ability
  to trample the rights of fellow human beings is
  rooted in a belief that the needs of society
  outweigh the needs of the individual.

Eisenberg D, 2006
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• prisoners
• stable long-time permanent study group
  (Dr.A.Sabin)
• wealth of testmaterial (Dr.Kligman)
• stable group of patients
• are guaranteed to show up
• stable group of people, assurance of
  continuity

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• 1906 Bilibid prison Manila Cholera 13
• 1915 Mississipi prison Pelagra
• 1919-22 St Quentin Testicular transplant
• 1941-45 Nazi concentration camps Sterilization,
  Typhus,epidem.jaundice High altitude, low
  pressure, freezing, seawater, coagulation, bone
  regeneration, malaria, phopshorus burns
• 1939-45 Pingfan Unit 731 Mustard gas, plague,
  anthrax, Typhus
• 1944-46 Illinois Stateville penitentiary Malaria
  (400)
• 1942 Massachusetts prison beef blood injections
• 1945 Atlanta prisons Malaria (800)
• 1950 Univ Pennsylvania viral hepatitis (200 women
  prisoners)
• 50ies MSKCC Ohio state prison inj cancer cells
  (100)
• 1959 Dr. Sabin polio vaccine (133)
• 1951-60 US army Pensylvania prisoners
  Psychopharmaca
• 1952-74 Holmesburg Phil. skin exposures dioxin
  (33 comp, 153 drugs)
• 1963-73 Oregon/Washington prisonersTesticular
  irradiation

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• Persons deprived of their liberty retain all
  rights that are not lawfully taken away by the
  decision sentencing them or remanding them in
  custody.
• European Prison Rules, Rec (2006)2
• Council of Europe

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The CPT standards

• 48) As regards the issue of medical research
  with prisoners, it is clear that that a very
  cautious approach must be followed, given the
  risk of prisoners agreement to participate being
  influenced by their penal situation. Safeguards
  should exist to ensure that any prisoner
  concerned has given his free and informed
  consent. The rules should be those prevailing in
  the community, with the intervention of a board
  of ethics.
• The CPT would add that it favours research
  concerning custodial pathology or epidemiology or
  other aspects specific to the condition of
  prisoners

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Prison Health is Public Health
WHO Moscow Declaration 2003