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Research%20Ethics

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Title: Research%20Ethics


1
Research Ethics
  • Philosophy 2803
  • Lecture VI
  • Feb. 19, 2003

2
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

3
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

4
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

5
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.

6
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

7
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

8
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.

9
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)

10
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

11
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

12
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

13
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

14
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

15
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

16
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

17
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.

18
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

19
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

20
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?

21
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

22
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)

23
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?

24
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

25
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
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