Research%20Ethics

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Research Ethics

• Philosophy 2803
• Lecture VI
• Feb. 19, 2003

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Research Ethics

• Medical research shares some issues with medical
  practice, but also raises some distinct issues
• Our focus will be on issues surrounding research
  on human subjects
• Brief history of research ethics
• Discussion of present day standards
• Some Issues in Research Ethics

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Some History

• Early codes of medical ethics tended to treat
  research as part of overall code of medical
  ethics
• Today, treated as a distinct area
• Thomas Percival
• 1803 - first code of medical ethics to include
  requirements concerning research?
• The use of experimental techniques on patients
  should be scrupulously and conscientiously
  governed by sound reason and undertaken only
  after consulting with other physicians
• No mention of seeking the consent of the subject

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Paternalistic Research Ethics

• It is our duty and our right to perform an
  experiment on a man whenever it can save his
  life, cure him or gain him some personal benefit.
  So, among the experiments that might be tried
  on man, those that can only harm are forbidden.
  Those that are innocent are permissible, and
  those that may do good are obligatory.
• 1865 - Claude Bernard, an influential French
  physiologist,
• the founder of experimental medicine?
• Remember discussion of models for relationships
  with patients. Paternalism is historically
  important

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William Beaumont - Research Ethics Pioneer?

• Some credit Beaumont with the oldest code
  specifically focussed on human experimentation
  (1833)
• 5. The voluntary consent of the subject is
  necessary
• 6. The experiment is to be discontinued when it
  causes distress to the subject
• 7. The project must be abandoned when the subject
  becomes dissatisfied.
• Some dispute about whether code actually existed.
  

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Policy vs. Practice

• Ironically, some of the earliest and clearest
  pronouncements on the importance of consent in
  medical research are to be found in earlly 20th
  century Germany
• A 1931 directive from the German Reich Minister
  of the Interior forbids innovative therapy
  unless the subject or his legal representative
  has unambiguously consented to the procedure in
  the light of relevant information provided in
  advance

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The Nuremberg Code

• The modern era in research ethics begins with the
  Nuremberg Code (1947)
• Produced as part of the Doctors Trial, part of
  the post W.W.II war crimes tribunal
• Response to research atrocities
• Deliberate infection with malaria, smallpox,
  cholera
• Sexual sterilization experiments
• Cold temperature experiments

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From the Nuremberg Code

• The voluntary consent of the human subject is
  absolutely essential.
• This means that the person involved should have
  legal capacity to give consent should be so
  situated as to be able to exercise free power of
  choice and should have sufficient knowledge and
  comprehension of the elements of the subject
  matter involve as to enable him to make an
  understanding and enlightened decision. This
  latter element requires that before the
  acceptance of an affirmative decision by the
  experimental subject there should be known to him
  the nature, duration and purpose of the
  experiment the methods and means by which it is
  to be conducted all inconveniences and hazards
  reasonably to be expected and the effects upon
  his health or person which may possibly come from
  his participation in the experiment.

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Not the End of Atrocities

• Unfortunately, as already noted policy is one
  thing and practice another
• Tuskegee Syphilis Experiment (1932-1972)
• CIA funded LSD Experiments in Montreal (1950s
  1960s)

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The Helsinki Declarations

• 1964 World Medical Associations Declaration of
  Helsinki replaces the Nuremberg Code
• Less stringent on consent, allows for proxy
  consent
• Since revised in 1975, 1983, 1989, 1996 and 2000
• See pp. 261-264 for 1996 version

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Halushka v. U. of Saskatchewan(1965 Sask.
Court of Appeal)

• Student paid 50 to participate in anesthetic
  drug trial
• Told a catheter (i.e., tube) would be inserted
  into his left arm
• Not told the catheter would be advanced into his
  heart
• Suffered cardiac arrest, residual injuries
• Court duty owed by researchers is at least as
  great as, if not greater than, the duty owed by
  the ordinary physician or surgeon (p. 260)
• U. of Saskatchewan held liable
• Few Canadian cases on research ethics, this case
  established Canadian standard

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Present Day

• Many codes and policies (e.g., CMA), but no
  comprehensive legislation
• Tri-Council Policy Statement on the Ethical
  Conduct of Research Involving Human Subjects
  (1998) is most important policy
• Canadian Institutes of Health Research (CIHR)
• Natural Sciences Engineering Research Council
  (NSERC)
• Social Sciences Humanities Research Council
  (SSHRC)
• Reading on pp. 244-251 is a draft version of this
  policy

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Tri-Council Policy Statement

• Sets out requirements for research ethics review
• Research Ethics Board (REB)
• Sets standards on
• Informed Consent (or Proxy Consent)
• Privacy Confidentiality
• Conflict of Interest
• Inclusiveness
• Human Genetic Research
• New Reproductive Technologies

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Local REBs

• MUN Human Investigations Committee (HIC)
• Health related research
• MUN Interdisciplinary Committee on Ethics in
  Human Research (ICEHR)
• All other human subjects research
• Soon (?) The Provincial Health Research Ethics
  Board
• Would be a first in Canada
• Prompted by some research horror stories in NL

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Case 1 Dr. A

• Dr. A. is approached by a drug company about
  participating in a clinical trial of a new
  anti-psychotic drug.
• If he accepts, he will, as usual, hospitalize any
  new psychotic patients he encounters
• Then, patients will be randomly assigned
  treatment with either the new drug or a placebo
  (i.e., a sugar pill)
• Informed consent will be obtained for each
  patient (by proxy, if necessary)
• Adapted from Weijer et al, 1997 Bioethics for
  Clinicians 10. Research Ethics. CMAJ, pp.
  1153-4

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Case 2 Dr. B

• Dr. B is a family practitioner whose practice
  specializes in patients infected with HIV
• Parasol, a pharmaceutical company, writes to Dr.
  B requesting that he provide them with the names
  of patients that might be eligible for enrollment
  into clinical trials of their new HIV drug.
• Parasol will pay Dr. B 100 for each name he
  provides.
• Adapted from Weijer et al, 1997 Bioethics for
  Clinicians 10. Research Ethics. CMAJ, pp. 1153

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Case 3 Dr. C

• Dr. C approaches the management of a seniors
  home about possibly enrolling some of the homes
  residents in a clinical drug trial.
• It is hoped the drug will reduce the progression
  of Alzheimers disease.
• Dr. C wishes to enroll patients in the middle
  stages of Alzheimers, i.e., suffering some
  impairment, but not a complete lack of mental
  capacity
• The management of the home refuse to even
  consider the possibility, claiming this research
  will inevitably exploit the residents.

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Issues Raised by the Cases Consent

• Consent becomes even more important in research
  ethics than in clinical practice
• This is because, unlike treatment, research often
  cannot be justified on grounds of beneficence
  towards the patient
• Distinction between therapeutic research and
  non-therapeutic research important
• Creates problems when dealing with incompetent
  patients

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Issues Raised by the Cases Consent

• Dr. A - Consent is not enough
• Harm to patients by being on placebo if effective
  treatment is already available
• Importance of non-maleficence, particularly in
  the absence of full autonomy
• A recent development in research ethics
• At one time, placebo trials were often required

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Issues Conflict of Interest

• Currently a hot issue, e.g.,
• Dr. B
• Physicians sent to conferences in Aruba by drug
  companies
• Per patient fees for enrolling patients in
  clinical trials
• Are these things acceptable?
• What if Dr. B told his patients about the fee?

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Issues Conflict of Interest

• Remember many kinds of conflict of interest
• Fame
• Publishable results
• Tenure
• Medical breakthroughs to benefit society,
• Commercial breakthroughs
• At a minimum, disclosure of a conflict is morally
  required

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Issues Confidentiality

• Confidentiality
• Dr. B - Referral without consent
• Autonomy Non-maleficence both support
  confidentiality
• Under what conditions may information about
  patients/research subjects be released?
• In clinical practice, very limited exceptions
• Concern with public safety may override
  confidentiality (E.g., communicable disease,
  threat to others)

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Issues Confidentiality in Research

• Clash between confidentiality need to share
  data
• Requires efforts to protect at least disclosure
  of level of confidentiality
• Problem of anonymizing data
• Removing name is not always enough
• E.g., study on a outport community that describes
  a male subject with 3 children a rare heart
  condition
• Genetic research raises some particular problems
• Information is about families, not individuals
• Duty/right to inform relatives of risks we
  discover?

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Issues Research involving Incompetent Subjects

• Dr. A, Dr. C Is it permissible to conduct
  experiments on incompetent people even with proxy
  consent?
• Distinction between therapeutic non-therapeutic
  research
• Therapeutic aims at benefiting the
  patient/subject
• Non-therapeutic may aim at benefiting people with
  same condition as the subject, but not this
  subject
• Can appeal to beneficence to justify therapeutic
  research
• With non-therapeutic research, no autonomy and no
  beneficence

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Issues Research involving Incompetent Subjects

• Must not forget need to develop treatments for
  incompetent patients (Dr. A, Dr. C)
• General approach is that minimal risk is OK if
• Substitute decision maker gives OK
• Research cannot be done on competent patients
• Subject does not dissent (ideally, gives assent)
• Research is related to childhood conditions/
  appropriate mental condition (see pp. 268-270)
• Beneficence to group