Research Ethics: Marina Topuridze MD, MS

Research Ethics
Marina Topuridze MD, MS

L. Sakvarelidze National Center for Disease Control
and Public Health
Pre WWII
Edward Jenner (1789)

Smallpox Vaccine
Claude Bernard (1865)
Ethical Maxims
Louis Pasteur (1885)
Rabies Vaccine
Walter Reed (1900)
Yellow Fever
The Nazi Doctors Trial
• At the 1946-1947 Nuremberg War Crime Trial, 23

defendants were tried, including eminent professors
of medicine and public servants.
• 1,750 victims were identified in the indictment, a
small proportion those who were killed or injured as
a result of medical experimentation in the
concentration camps.
Nuremberg
During the Nuremberg
War Crimes Trials, 23
German doctors were
charged with crimes
against humanity for
“performing medical
experiments upon concentration camp inmates and other living
human subjects, without their consent, in the course of which
experiments the defendants committed the murders, brutalities,
cruelties, tortures, atrocities, and other inhuman acts.”
The Nuremberg Code
1. 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, without the intervention of any
element of force, fraud, deceit, duress, overreaching, or other
ulterior form of constraint or coercion ...
2. The experiment should be such as to yield fruitful results for the
good of society, unprocurable by other methods or means of
study, and not random and unnecessary in nature.
3. The experiment should be so designed and based on the results
of animal experimentation and a knowledge of the natural history
of the disease or other problem under study that the anticipated
results will justify the performance of the experiment.
The Nuremberg Code (2)
4. The experiment should be so conducted as to avoid all

unnecessary physical and mental suffering and injury.
5. No experiment should be conducted where there is an a priori
reason to believe that death or disabling injury will occur;
except, perhaps in those experiments where the experimental
physicians also serve as subjects.
6. The degree of risk to be taken should never exceed that
determined by the humanitarian importance of the problem to
be solved by the experiment.
7. Proper preparations should be made and adequate facilities
provided to protect the experimental subject against even
remote possibilities of injury, disability, or death.
Myths Perpetuated at Nuremberg
• Nazi Experiments Were Bad

Science.
• Researchers Routinely Obtain
Informed Consent.
1931 German Research Regulations
Medical science, if it is not to come to a standstill, cannot refrain from introducing
in suitable cases New Therapy using as yet insufficiently tested agents and
methods. Also, medical science cannot dispense completely with Human
Experimentation.
Medical ethics rejects any exploitation of social or economic need in conducting

New Therapy.
(a) Without consent, non-therapeutic research is under no

circumstances permissible.
(b) Any human experimentation which could as well -be carried out in animal
experimentation is not permissible. Only after all basic information has been
obtained should Human Experimentation begin. This information should first
be obtained by means of scientific biological or laboratory research and
animal experimentation for reasons of clarification and safety. Given these
presuppositions, unfounded or random Human Experimentation is
impermissible.
Translation: Hans Martin Sass

The Nuremberg Code (1947)
As part of the verdict, the Court enumerated some rules for
"Permissible Medical Experiments", now known as the
“Nuremberg Code”. These rules include:
• voluntary consent
• benefits outweigh risks
• ability of the subject to terminate participation
Declaration of Helsinki
Recommendations Guiding Medical Doctors in

Biomedical Research Involving Human
Subjects
Adopted by the 18th World Medical Assembly, Helsinki, Finland, 1964 and as
revised by the World Medical Assembly in Tokyo, Japan in 1975, in Venice, Italy in
1983, and in Hong Kong in 1989 and the 48th General Assembly, Somerset West,
Republic of South Africa, October 1996
“Concern for the interests of the subject must always prevail

over the interests of science and society.”
Post WWII
• Willowbrook (1950s)
mentally retarded children were deliberately infected with hepatitis virus
• Jewish Chronic Disease Hospital (1960s)

Live cancer cells were injected into 22 senile patients
• Milgram (1963)
"Behavioral study of obedience"
• Humphries (1970)
Tearoom Trade: Impersonal Sex in Public Places
20th Century US Research Scandals
• Tuskegee Study of Untreated Syphilis in the Negro Male

(1932-72).
• US Human Radiation Experiments (1944-74).
• Guatemala Study of STI Transmission and Treatment

(1946-48).
• Jewish Chronic Disease Hospital Study (1963).
• Milgram Experiment on Obedience to Authority (1963).
• Willowbrook Study of Infectious Hepatitis (1963-66).

20th Century US Research Scandals
https://www.youtube.com/watch?v=xOYLCy5PVgM
Tuskegee Syphilis Study
American medical research
project conducted by the
U.S. Public Health Service
from 1932 to 1972,
examined the natural course
of untreated syphilis in black
American men. The subjects, all impoverished
sharecroppers from Macon county,
Alabama, were unknowing participants
in the study; they were not told that they
had syphilis, nor were they offered
effective treatment.
Tuskegee Syphilis Experiments (1932-72)
Beecher Article
“Ethics and clinical research”
Henry K. Beecher
New Engl J Med 274 (1966):1354-60
• 22 published medical studies presenting risk to subjects
without their knowledge or approval
• Published in some of the most prestigious journals and
conducted at some of the most prestigious institutions
Public Health Service Policy
• NIH Director and Surgeon General requested that the National
Advisory Health Council review human subject protections
• Council recommended prior institutional review for PHS
supported research to:
– Protect of the rights and welfare of the subjects
– Assure appropriate methods of informed consent
– Determine acceptable balance of risks and benefits
• Adopted as Public Health Service policy in 1966
• Beginnings of the Institutional Review Board (IRB)
National Research Act
• 1973 Kennedy Hearings “Quality of Health
Care - Human Experimentation”
• 1974 National Research Act
– Established the “National Commission for the
Protection of Human Subjects of Biomedical and
Behavioral Research”
– Required IRBs at institutions receiving HEW
support for human subjects research
The Belmont Report
Ethical Principles and Guidelines for the Protection of
Human Subjects of Research
The National Commission for the Protection of Human Subjects of

Biomedical and Behavioral Research
April 18, 1979
The Belmont Report
Basic Ethical Principles:
• Respect for Persons
– Individual autonomy
– Protection of individuals with reduced autonomy
• Beneficence
– Maximize benefits and minimize harms
• Justice
– Equitable distribution of research costs and benefits
Federal Regulations and Policy
45 CFR 46 - Basic DHHS Policy for Protection of Human
Research Subjects
Originally adopted May, 1974, Revised January 13, 1981,
Revised June 18, 1991
Additional protections for vulnerable populations
in Subparts B-D
Federal Policy for the Protection of Human Subjects - “The
Common Rule” June 18, 1991
Departments of Agriculture, Energy, Commerce, HUD, Justice, Defense,
Education, Veterans Affairs, Transportation, and HHS. NSF, NASA, EPA,
AID, Social Security Administration, CIA, and the Consumer Product
Safety Commission.
Basic Protections
The regulations contain three basic protections
for human subjects:
• Institutional Assurances
• IRB Review
• Informed Consent
Institutional Responsibilities
• Institutions bear full responsibility for all research
involving human subjects covered under their
Assurance
• All requirements of 45 CFR 46 must be met for all
federally-sponsored research
• OHRP strongly encourages institutions to embrace
the HHS regulations regardless of sponsorship, and
to commit to this standard in their Assurance.
IRB Decision Matrix
BENEFICENCE JUSTICE
Risk/Benefit Analysis Subject selection
Experimental Design Inclusion/exclusion
Qualifications of PI Recruitment
RESPECT FOR PERSONS

Informed consent Protection of subjects (especially
Surrogate consent vulnerable populations)
Assent
The Consent Process
Informed consent is not a single event or just a form to be
signed -- rather, it is an educational process that takes place
between the investigator and the prospective subject.
The basic elements of the consent process include:

• full disclosure of the nature of the research and the subject's
participation,
• adequate comprehension on the part of the potential
subjects, and
• the subject's voluntary choice to participate.
Casebook on Ethical Issues in
International Health Research
Authors:
WHO
http://www.who.int/rpc/publications/ethics_casebook/en/

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Research Ethics

Marina Topuridze MD, MS

Edward Jenner (1789)

• At the 1946-1947 Nuremberg War Crime Trial, 23

1. The voluntary consent of the human subject is absolutely

4. The experiment should be so conducted as to avoid all

• Nazi Experiments Were Bad

Medical ethics rejects any exploitation of social or economic need in conducting

(a) Without consent, non-therapeutic research is under no

Translation: Hans Martin Sass

Recommendations Guiding Medical Doctors in

“Concern for the interests of the subject must always prevail

• Jewish Chronic Disease Hospital (1960s)

• Tuskegee Study of Untreated Syphilis in the Negro Male

• US Human Radiation Experiments (1944-74).

• Guatemala Study of STI Transmission and Treatment

• Jewish Chronic Disease Hospital Study (1963).

• Milgram Experiment on Obedience to Authority (1963).

• Willowbrook Study of Infectious Hepatitis (1963-66).

The National Commission for the Protection of Human Subjects of

RESPECT FOR PERSONS

The basic elements of the consent process include:

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