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ETHICS IN MEDICAL RESEARCH

Danny Hilmanto & Rovina Ruslami

Health Research Ethics Committee
Faculty of Medicine Universitas Padjajaran

The primary purpose of medical research involving human subjects is to

understand the causes, development and effects of diseases
and improve preventive, diagnostic and therapeutic interventions
(methods, procedures and treatments).

WMA Declaration of Helsinki, v 2013: A6

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Even the best proven interventions

must be evaluated continually through research
for their safety, effectiveness, efViciency, accessibility and quality.

WMA Declaration of Helsinki, v 2013: A6

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How can the rights of individual persons be reconciled with the

demands of medical research?
BeneVits of medical research have come with a heavy price

There are many examples of studies that have violated the rights and dignity of
participants
In some cases, costing participants their health or even their lives

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The good physician, Virst, do no harm

But thenhistory shows us..

Asth
I ma S
WWI I ents) Tuskegee t
2001 udy
p e ri m
ex Syphilis experiment
(NAZI 9-1945
19 3 1932-1972

)
Willowbrook Vizer
1963-1966 rovan (P
T
1996

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NAZI doctors (WWII)

The Tuskegee Syphilis Study (1932-1972)

Willowbrook Hepatitis Study (1950s)

The Jewish Chronic Disease Hospital (1960s)

San Antonio Contraception Study (1970s)

The Thalidomide Experience

John Hopkins Study

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Experimentation to Holocaust
Victims
No voluntary consent
Subjects not killed by experiments
would be killed and dissected
1947: Doctors trial at
Nuremberg

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1947: the Nuremberg Code
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Effects of Untreated Syphilis in the Negro Males

Funded by US Public Health Service (study run for 40 yrs) in Alabama
Thought they were receiving beneKicial treatment: LP & pink tablets

No medicine is offered when it is
becomes available (penicillin)

1997: apology to 8 survivors

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Mentally compromised children at the Willowbrook State School in NYCwho were purposely
exposed to hepatitis virus.
Problem of hepatitis (the risk of having hepatitis is 30-50%).


Healthy children intentionally given hepatitis C
virus
Monitored to see effects of -
globulin

They will get it anyway

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22 elderly chronically ill (old) patients injected with live cancer cells
Purpose was to discover the secret of how the bodies Vight the invasion of
malignant cells
Covered-up by hospital administration

They will die anyway

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Evaluate the effectiveness of female birth

control pills.
Indigent patients with no other place to go
for advice or medication but the clinic.
Randomized: active contraceptive and
PLACEBO.
Women not informed.
Results: High number of unplanned
pregnancies in placebo group.

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Safety in pregnant women has not been established.

It caused 10,000 - 20,000 birth defects WITHIN YEARS

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18-year-old James Gelsinger died during a gene-

therapy trial (Boston)

Issues:
ConKlict of Interest
Researcher James Wilson held a 30% equity stake in the company that
owned the rights to license the drug that Wilson was testing.
Data safety monitoring
Informed consent

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Recruitment of
subordinate
sta

informa(on pertaining to
the toxic eect of the
chemical already available
was not known to the
inves(gator

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THE ESSENCE & LESSONS LEARNT

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Competition
in research
environment
Sponsor
Research Researchers
Interests
activities Subjects
Government

Unfairness
Dishonesty

Needs of ethical guidelines

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1946 1947 1948 1964

Nuremberg trial Nuremberg Code UN adoption of Declaration of
of doctors outlining ethical Universal Declaration Helsinki
responsible for Nazi principles required for of Human Rights International
experiment research agreement on
recommendations
(WMA)

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1979 1982 1993 1996

Belmont report International Ethics WHO ICH/GCP
Guidelines for Biomedical
promoting for research Research Involving International Ethical International
Human Subjects Guidelines for Conference on
Biomedical Research Harmonization Good
National Commission for the Council of the International
Protection of Human Subject of
Involving Human Clinical Practice
Organization of Medical Subjects
Biomedical and Behavioral
Research
Science (CIOMS)

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Nuremberg Code was the Virst ethical code;

formed by jurists for use in a legal trial; had
little in;luence on the actual conduct of
research L

There was a need for professional guidelines

designed by physicians for physicians

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Virtually, every period of scandal in medical research has

been followed by attempts to codify rules and guidelines to
govern research.

Atrocities or dilemmas vs. milestone documents, put forward
to guide the ethical conduct of research.

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An international ethical and scientiVic quality standard for designing,

conducting, recording and reporting trials that involve the
participation of human subjects

to ensures
- protection of participants
- credibility of data

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National Commission for the Protection of Human Subject of Biomedical and Behavioral Research

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Treat individuals as autonomous agents (Autonomy) & self determination

Voluntary
Informed consent
ConKidentiality
Can stop participation anytime

persons with diminished autonomy
(vulnerable subjects)

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Children
Mentally Challenged
Not to include unless the study demands
Institutionalized Individuals
special groups
Subordinates/ Staff/ employee
Students Informed consent from the legal guardians
Prisoners Informed consent from the individuals
Pregnant/ Lactating women wherever possible
Disease/condition No inducement of guardians
Poor
Assent from minors
Military
Tribal Respect their right to refuse participation
Uneducated
Ethnic minorities/refugees
Homeless/frail and old

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DO NO HARM
Maximize possible beneVit and minimize potential risk

Do unto others as you wou would have them

do unto you

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To treat each person according to what is morally right and proper

Equitable distribution of both burdens and beneKits of the research

Individual justice & Social justice (well discussed in the next topic)

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the systematic analysis of such questions

to ensure that study participants are protected,
and ultimately, that clinical research is conducted in a way
that serves the needs of such participants and of society as a
whole.
(Weijer, Dickens & Meslin, 1997)

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Most people say that it is the intellect which makes a great scientist.
They are wrong: it is character. 30

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