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Ethics in Clinical Research Dr' R' B' Ghooi ICRI, Delhi


Having taken the Hippocratic oath, most doctors wonder why we talk of ethics. ... treatments and other brutal 'de-patterning' techniques that all but erased the ... – PowerPoint PPT presentation

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Title: Ethics in Clinical Research Dr' R' B' Ghooi ICRI, Delhi

Ethics in Clinical ResearchDr. R. B.
GhooiICRI, Delhi
Ethical Codes
  • Primum non nocere
  • First do no harm
  • Having taken the Hippocratic oath, most doctors
    wonder why we talk of ethics.
  • Codes and laws are made only when it is found
    that behaviour of some individuals is not

  • Ethics
  • 1. A set of principles of right conduct.
  • 2. A theory or a system of moral values
  • 3. The rules or standards governing the conduct
    of a person or the members of a profession
    medical ethics.

Major Violations
  • Nazi War Crimes (1939-45)
  • Nazi doctors conducted a series of ill planned
    cruel experiments on prisoners, in detention
    camps. A number of the doctors were tried in
    Nuremberg in 1946, and some sentenced to death.
    These experiments led to the establishment of the
    Nuremberg Code.

Patients Ward No. 2 Auschwitz
Medical expert Dr. Leo Alexander points to scars
of wounds inflicted on Jadwiga Dzidos legs
Nuremberg Trials
Other Violations
  • Tuskegee Syphilis Study (1932-72)
  • The Syphilis Study at Tuskegee involved 399 men
    who were infected with syphilis. An additional
    201 men who were not infected with the disease
    served as controls. All of the syphilitic men
    were in the late stage of the disease when the
    study began. None were given any treatment.

Other Violations
  • Human Radiation Experiments (1944-74)
  • Jewish Chronic Disease Study (1963-66)
  • Willow brook Study (1963-66)
  • The Montreal Study (1976)

Jewish Chronic Disease Study
The Study
  • In 1963, studies were undertaken at New York
    City's Jewish Chronic Disease Hospital to develop
    information on the nature of the human transplant
    rejection process. These studies involved the
    injection of live cancer cells into patients who
    were hospitalized with various chronic
    debilitating diseases
  • Patients were not told that they would receive
    cancer cells because, in the view of the
    investigators, this would frighten the patients

Willowbrook Study
  • From 1963 to 1966, the Willowbrook Study involved
    a group of children with mental retardation, at
    the Willowbrook State Hospital in New York. These
    innocent children were fed extracts of stools
    from infected individuals and later subjects
    received injections of more purified virus
  • Investigators defended the injections by pointing
    out that the vast majority of them acquired the
    infection anyway while at Willowbrook, and it
    would be better for them to be infected under
    carefully controlled research conditions.
  • The study's purpose was to study the history of
    the disease when left untreated and later to
    assess the effects of gamma globulin as a
    therapeutic intervention.

The Montreal Study
  • Ewen Cameron, a deeply controversial psychiatrist
    at Montreal's Royal Victoria Hospital, used the
    CIA's money to finance work using LSD, which he
    believed had therapeutic value. His work has also
    been the subject of ongoing claims by former
    victims of his other treatments. Cameron, a
    psychiatrist with Montreal's Allan memorial
    Institute, used now-discredited methods including
    massive electroshock treatments and other brutal
    "de-patterning" techniques that all but erased
    the personalities of some of his patients. His
    methods were said to have been aimed at easing
    depression and other mental illnesses, but it
    later emerged that the mind-control experiments
    were part of the CIA plan.

In India too
  • In an attempt to study rates of progression of
    uterine cervical dysplasias to malignancy, the
    Indian Council of Medical Research during 1976-88
    allocated 1158 women with varying degrees of
    cervical dysplasias to long term follow up. The
    development of carcinoma in situ was defined as
    the end point for treatment.
  • Doctors in India are questioning the ethics of a
    study which observed the natural course of
    precancerous uterine cervical lesions without
    treatment in women who had not given written
    consent to take part. In at least nine women the
    lesions progressed to invasive cancer, and 62
    women developed carcinoma in situ of the cervix
    before they were treated.
  • -BMJ 19973141065 (12 April)

Codes of Ethics
  • The Nuremberg Code 1947
  • Universal Declaration of Human Rights 1948
  • Declaration of Helsinki 1964
  • Belmont Report 1979
  • FDA Regulations (21 CFR 50) 1980
  • CIOMS Guidelines 1982
  • The Common Rule 1992
  • OHRP 2000
  • ICMR Guidelines - 2000

Nuremberg Code
  • Sets out guidelines for research in 10 points
  • Important focus on Voluntary consent
  • Focus on scientific research and protection of
    subjects from physical and mental harm
  • Rights and dignity of subjects to be protected
    and trials to be terminated if there is risk to
    the subjects.

Belmont Report
  • Respect for Persons (Autonomy)
  • Beneficence
  • Justice

  • Respect for persons demands that each individual
    taking part in research does so with voluntary
    consent and with information. This is the basis
    of Informed Consent.
  • Special protection needs to be given to persons
    with limited autonomy.

  • Human participants are treated in an ethical
    manner, respecting their decision, protecting
    them from harm, and make efforts to secure their
    well being.
  • The researcher is obliged to maximize benefits
    and minimize risks to participants.

  • Difficult issue.
  • Distribution of risks and benefits fairly.
  • Participants should not be chosen on the basis
  • of availability and vulnerability.
  • Equal opportunity and risk irrespective of
    gender, skin colour, economic status or any
    other such basis.

The need for protection
  • Promote the safety and well-being of human
  • participants in research.
  • Maintain the ethical values and principles
    underlying research.
  • Implement scientifically valid research.
  • Allay concerns by the general public about the
    responsible conduct of research.

  • A living individual about whom the researcher
    gathers personal data through intervention or
  • Identifiable private information.
  • If a participant provides information about
    another individual- Third Party.

Vulnerable Populations
  • Children.
  • Individuals with questionable capacity to
  • Prisoners.
  • Foetuses and pregnant women.
  • The terminally ill.
  • Students/employees.
  • Comatose patients.

  • Prisoners
  • Employees
  • Illiterates
  • Handicapped persons
  • Women in general (illiterate, widows)
  • Children (orphans, children of prisoners,
    mentally handicapped children)

  • Are all children equally protected?
  • Should step parents/managers of orphanages be
    accepted as legally acceptable representatives?
  • Should orphans, street children be given a
    greater protection?
  • Should there be special protection for mentally
    physically challenged children

  • Are all women equally autonomous?
  • Mentally and physically challenged women/ widows
    are more vulnerable in our country
  • Women with female offspring are at a greater
    pressure from in-laws and peers

Institution Review Board
  • It is recognized that Investigators alone may not
    ensure compliance with ethical norms.
  • IRBs comprise sufficiently qualified individuals
    who have no vested interest in the research study
    or its outcomes. Their responsibility is to
    ensure that all research studies are ethical and

Ethics Bodies
  • Independent Ethics Committees (IEC)
  • Institutional Review Board (IRB)
  • Similar composition, role and function. They
    differ in the area of control

Participants Rights
  • The biggest threat to a participant's rights is
    the researcher.
  • The most powerful protector of a participant's
    right is also the researcher.
  • Vigilance at every level will ensure that the
    researcher does not turn from a protector to

Ethics Training
  • Available from NIH Online Certification
  • Go to http//
  • Click Human Participant Protections Education for
    Research TeamsA free, Web-based course developed
    at the National Institutes of Health for
    physicians, nurses, and other members of clinical
    research teams. This online course satisfies the
    NIH human subjects training requirement for
    extramural researchers obtaining Federal funds.

The Victims
  • Here are a few of the victims of Nazi
    researchers, people who have been compelled to
    part in trials. are 8 of the 20 children on whom
    Dr. Kurt Heissmeyer conducted Tuberculosis
    research. After removal of their lymph nodes they
    were administered TB bacilli (intravenously and
    directly in the lungs). The children became very
    sick, but surprisingly they survived the
    starvation and sickness. They were later given
    morphine and hanged to hide evidence of these

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Never Again
  • The role of ethics is to ensure that Dachau,
    Auschwitz, Tuskegee and Willowbrook are consigned
    to the dustbin of history.

Thank You
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