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Research Involving Human Subjects: Ethics, Law and Regulation

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determines whether particular set of regulations or research ethics guidelines must be followed ... safeguard rights and well-being of research subjects ... – PowerPoint PPT presentation

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Title: Research Involving Human Subjects: Ethics, Law and Regulation


1
Research Involving Human Subjects Ethics, Law
and Regulation
  • December 2002

2
William Beaumont Alexis St. Martin
  • Beaumont carried out a series of experiments on
    Alexis St. Martin over a period of many years
  • Was Beaumont a pioneer in ethical research or
    someone who abused his research subject?
  • Be careful of applying present-day standards to
    historical figures
  • The prime value of this case lies in what it
    tells us about how to do things today, not
    whether Beaumont was a good or bad man

3
Beaumont (1785-1853)
  • Had a 2 year apprenticeship with a country
    doctor
  • Enlisted as a surgeons mate in 1812. Briefly
    left the army after the War of 1812, but rejoined
    as a surgeon in 1820
  • 1822 Encounters St. Martin
  • 1833 Experiments and Observations on the
    Gastric Juices and the Physiology of Digestion
  • produced a picture of the living stomach that
    has required only a little updating in the
    century and a half since he made his
    observations.

4
St. Martin (1803?-1880)
  • June 6, 1822 St. Martin, a French-Canadian
    working for the American Fur Company, was
    accidentally shot in Northern Michigan
  • The result was a fistula exposing part of St.
    Martins lung and stomach
  • St. Martin survived, but the fistula never closed
    fully
  • After 8-10 months of attempts to close it,
    Beaumont concluded that the only means of doing
    so was to suture the sides together, an
    operation to which the patient would not submit.

5
The Experiments
  • First experiment in May, 1823?
  • Administering a cathartic by pouring it in
  • Literally hundreds between 1825 and 1833, most
    involving inserting or removing material through
    the valve in St. Martins stomach

6
The Relationship
  • 1825 Beaumont carried out experiments from
    May-August then St. Martin returned to Canada …
    without obtaining my consent. (18)
  • In correspondence, Beaumont described this as a
    faithless absconding.
  • 1829 St. Martin enters Beaumonts service in
    August
  • St. Martin performed all the duties of a common
    servant when experiments were not being carried
    out. (19)
  • This continues until March, 1831, when Beaumont
    allows St. Martin to return home.

7
The Relationship
  • 1832 In October, St. Martin returns.
  • The two sign a contract binding St. Martin to
    obey, suffer comply with all reasonable
    proper orders or experiments.
  • In exchange, St. Martin was to receive 150 plus
    room and board.
  • In 1832, St. Martin was persuaded to join the
    U.S. Army for a period of 5 years. He was
    eventually assigned to Beaumont as an assistant

8
The Relationship
  • 1833 A new contract is signed, for 2 years at
    200 a year
  • Shortly afterward, Beaumont advances St. Martin
    some of the 200 in order for St. Martin to
    return his family to Canada.
  • St. Martin never returned, although Beaumont made
    increasingly lucrative offers (500/year in 1850,
    shortly before Beaumonts death)

9
Beaumont as Medical Ethics Pioneer?
  • Beecher (1970) credits Beaumont with producing
    the oldest American code concerning human
    experimentation
  • 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.
  • There is, however, some dispute about whether
    this code actually existed. (Numbers, 1979)

10
Some Issues
  • When did Beaumont take St. Martin into his home?
  • Beaumont tells us it was before he began using
    St. Martin as a research subject. Others
    (Numbers, 1979) say it was after.
  • Returning to Canada without my permission?
  • Some experiments clearly caused St. Martin
    discomfort
  • Payment for participation in research

11
Outline
  • A. what is research?
  • B. rationale for research ethics review
  • C. ethical/legal/regulatory framework
    for human subject research in Canada
  • D. some major ethical/legal issues in biomedical
    research

12
What is Research?
  • sometimes difficult to distinguish research from
    therapy
  • often carried out simultaneously
  • investigators often physicians
  • terminology - therapeutic research, clinical
    research, experimental interventions
  • research vs. innovative care

13
Research and/or Therapy?
  • Why is the distinction important?
  • determines whether particular set of regulations
    or research ethics guidelines must be followed
  • determines whether prior approval by a Research
    Ethics Board (REB) is required
  • affects the legal standard for disclosure of
    information
  • may affect ability of substitute decision-maker
    to give consent

14
What is Human Subject Research?
  • the generation of data about persons, through
    intervention or otherwise, that goes beyond that
    necessary for the persons immediate well-being
  • 1987 MRC Guidelines
  • an activity that involves a systematic
    investigation to establish facts, principles or
    generalizable knowledge
  • 1998 Tri-Council Policy Statement Ethical
    Conduct of Research Involving Humans

15
Rationale For Research Ethics Review
  • part of crucial system of checks and balances
  • safeguard rights and well-being of research
    subjects
  • address actual, perceived, potential conflicts of
    interest
  • reinforce and rehabilitate public trust in
    medical research

16
Rationale For Research Ethics Review
  • inherent tension between primary aims of research
    and treatment
  • when patients participate in clinical research,
    physician-investigator may experience this
    tension
  • notion of clinical equipoise
  • - RCTs ethically acceptable where expert
    community in state of honest professional
    disagreement as to relative merits of two
    alternatives

17
Research Codes and Guidelines
  • primary purpose - to protect the physical
    well-being, dignity and integrity of individuals
    who serve as participants
  • interests of investigators in pursuing their
    professions
  • interests of society in increasing knowledge re
    public and individual health

18
Historical Context
  • will be covered in future session
  • several instances of research controversies and
    atrocities in many different countries
  • a number of international instruments have been
    developed to try to address ethical standards and
    regulation of human subject research

19
Governance of Human Subject Research in Canada
  • in Canada, no comprehensive legislation to
    regulate all research involving humans
  • - biomedical research governed by law that is
    primarily directed to other purposes
  • - some legislation applies almost inadvertently
    to research
  • - other legislation re health care deliberately
    excludes research from its ambit
  • - role of the common law- consent, negligence,
    etc.
  • - Quebec - Civil Code

20
Newfoundland Legislation
  • some statutes in NF containing provisions
    applicable to research
  • - Advance Health Care Directives Act
  • - Access to Information and Protection of Privacy
    Act
  • - Hospitals Act
  • - Human Tissue Act

21
Codes, Guidelines and Policies
  • these extra-legal instruments play important
    role in regulation of research in Canada
  • promulgated by governmental bodies, funding
    agencies, professional organizations and local
    institutions
  • ethics codes, guidelines and policy statements
    usually lack means of direct legal enforcement
  • however may be relied on by courts to indicate
    applicable standards of conduct

22
Tri-Council Policy Statement on the Ethical
Conduct of Research Involving Human Subjects
(1998)
  • MRC, NSERC, SSHRC
  • context - the need for research, guiding ethical
    principles, subject-centered perspective
  • research requiring ethics review, REBs
  • consent, confidentiality, conflict of interest
  • inclusion in research - women, incompetent
    individuals, aboriginal people
  • clinical trials
  • human genetic research, research on
    embryos/fetuses and human tissues

23
CMA Code of Ethics
  • duty of physicians to obtain from research ethics
    committee review and approval of research
    involving humans
  • duty of physicians to obtain informed consent
    from potential research subjects
  • duty to report unethical research behaviour

24
Some Major Ethical/Legal Issues in Medical
Research
  • 1. conflicts of interest
  • 2. consent - informed, voluntary
  • 3. confidentiality, access to information
  • 4. scope of acceptable research
  • 5. children, mentally incompetent individuals
  • 6. justice in recruitment of subjects

25
Conflicts of Interest
  • investigators interests
  • - fame, publishable results, medical
    breakthroughs to benefit society
  • financial conflicts of interest
  • - pharmaceutical companies
  • - partnerships between academic institutions and
    corporations
  • - commercial value of research results

26
Conflicts of Interest and REBs
  • one role of REBs is conflict of interest
    oversight
  • - financial conflicts
  • - impact of conflicts on informed consent
  • conflicts of interest involving the REB
  • - membership, operation within institution
  • - collegiality, concerns about promotion,
    bringing valuable research funding into
    institution, etc.

27
Consent - General Principles
  • capacity
  • - must be given by person legally capable of
    making decision
  • voluntary
  • - no coercion/undue influence
  • specific
  • - to procedure(s), physician(s) involved
  • informed
  • - disclosure/discussion required

28
Consent to Research in the Courts
  • two categories of research dealt with differently
    by the courts
  • 1. consent to research with no intended benefit
    for participants
  • 2. consent to research with intended benefit with
    participants

29
Research with no Intended Benefit for Participants
  • Halushka v. U. of Saskatchewan (Sask. C.A. 1965)
  • - healthy university student paid 50 to
    participate in anesthetic drug trial, requiring
    cardiac catheterization
  • - told test was nothing to worry about
  • - suffered cardiac arrest, residual injuries
  • Court held duty of disclosure of investigators
    at least as great as, if not greater than, duty
    of ordinary physician/surgeon to patient
  • - full and frank disclosure
  • - no therapeutic privilege, no waiver

30
Research with no Intended Benefit for Participants
  • Weiss v. Solomon (Que. Sup. Ct. 1989)
  • - trial of ophthalmic drops in reducing post-op
    retinal edema
  • - fluorescein angiography used to verify effects
    of drops
  • - told risks discomfort, nausea and minor
    allergic reactions
  • - patient died from severe allergic reaction
  • Court held investigator and REB at fault for
    failure to warn of all the risks involved in the
    research
  • - all risks must be disclosed, even if
    rare/remote, particularly if serious
    consequences
  • - court based decision in part on Helsinki
    Declaration

31
Research with Intended Benefit for Participants
  • no Canadian cases involving research pursuant to
    protocol reviewed for ethical/scientific merit
  • cases involving individual MDs testing
    therapeutic innovations of their own design in
    course of Dr.-pt. relationship
  • courts have applied standard of disclosure
    generally applied to Dr.-pt. relationship - What
    would reasonable pt. want to know?
  • fact that procedure unique or experimental
    something most people would want to know

32
Confidentiality
  • general obligation of confidentiality owed by
    physicians to patients extends to researchers
  • embodied in research codes, guidelines
  • REBs typically require policies re storage and
    destruction of data and samples, anonymization of
    data
  • should also be addressed in consent forms

33
Confidentiality
  • tension between need to share data and privacy of
    subjects
  • beware of over-promising confidentiality
  • - access to data for safety and ethics
    monitoring
  • - Health Protection Branch, Health Canada
  • - periodic review by REBs
  • - genetic research
  • - right to know/right not to know?
  • - duty/right to inform relatives of their risks?
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