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Research Involving Human Subjects: Ethics, Law and Regulation


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

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

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

Beaumont (1785-1853)
  • Had a 2 year apprenticeship with a country
  • 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

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
  • 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.

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

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
  • 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.

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

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)

Beaumont as Medical Ethics Pioneer?
  • Beecher (1970) credits Beaumont with producing
    the oldest American code concerning human
  • 5. The voluntary consent of the subject is
  • 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)

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
  • Payment for participation in research

  • 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

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

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
  • may affect ability of substitute decision-maker
    to give consent

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

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

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
  • notion of clinical equipoise
  • - RCTs ethically acceptable where expert
    community in state of honest professional
    disagreement as to relative merits of two

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
  • interests of society in increasing knowledge re
    public and individual health

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

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,
  • - Quebec - Civil Code

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

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
  • 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

Tri-Council Policy Statement on the Ethical
Conduct of Research Involving Human Subjects
  • 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

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

Some Major Ethical/Legal Issues in Medical
  • 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

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

Conflicts of Interest and REBs
  • one role of REBs is conflict of interest
  • - 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.

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

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

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

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
  • - all risks must be disclosed, even if
    rare/remote, particularly if serious
  • - court based decision in part on Helsinki

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

  • 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
  • should also be addressed in consent forms

  • tension between need to share data and privacy of
  • beware of over-promising confidentiality
  • - access to data for safety and ethics
  • - 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?