ANKITA PATEL

THE NUREMBERG CODE

DECLARATION OF HELSINKI

THE BELMONT REPORT

Tuskegee Syphilis Study 1940s

Radiation Experiments Begins - 1932

1940s - Nazi Experiments

1947- Nuremberg Code

1950s-1961 Thalidomide Tragedy

1962 Kefauver-Harris Amendments Food, Drug and Cosmetic Act

1964 Declaration of Helsinki

1974 - National Research Act

1972 - Tuskeegee Study Exposed

1979 - Belmont Report

THE Nuremberg Code is the most important document in the history of the ethics of medical research.

The Code was formulated 50 years ago, in August 1947, in Nuremberg, Germany, by American judges sitting in judgment of Nazi doctors accused of conducting murderous and torturous human experiments in the concentration camps.

THE NUREMBERG CODE

Voluntary informed consent Experiment should be for the good of society, results not

obtainable by other means Experiment should be based upon prior animal studies Physical and mental suffering and injury should be avoided There should be no expectation that death or disabling

injury will occur from the experiment Risk vs. benefit Protect subjects against injury, disability, or death Only scientifically qualified individuals should conduct

human experimentation Subject can terminate her/his involvement

Basic 10 principles:

Purpose: It served as a blueprint for today’s

principles that ensure the rights of subjects in medical research.

Because of its link with the horrors of World War II and the use of prisoners in Nazi concentration camps for medical experimentation, debate continues today about the authority of the Code, its applicability to modern medical research, and even its authorship.

So, The Nuremberg code has no legal force behind it, and it would be erroneous even to credit it as the framework on which all future codes have been based.

The Declaration of Helsinki (DoH) is, indisputably, a remarkable document. It is the mission of the medical doctor to safeguard the health of the people.

The British Medical Journal announced the emergence of the DoH in its 18 July 1964 edition with the following words: ‘A draft code of ethics on human experimentation was published in the British Medical Journal of 27 October 1962.

DECLARATION OF HELSINKI

Safeguarding research subjects Informed consent Minimizing risk Adhering to an approved research plan/protocol

As a result, the principles have been embodied in subsequent UK and international guidance and

regulations

A revised version was accepted as the final draft at the meeting of the World Medical Association in Helsinki in June 1964, It is to be known as the Declaration of Helsinki Attached to just over 700 words of the text of the original DoH.

In its 40-year lifetime the Declaration has been revised five times and has risen to a position of prominence as a guiding statement of ethical principles for doctors involved in medical research.

Adopted by the 18th WMA General Assembly Helsinki, Finland, June 1964 and amended by the 29th WMA General Assembly, Tokyo, Japan, October 1975.

35th WMA General Assembly, Venice, Italy, October1983.

41st WMA General Assembly, Hong Kongng September,1989

48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996 and the 52nd WMA General Assembly, Edinburgh, Scotland, October 2000.

WMA General Assembly, Washington 2002.

Thus, Both the Nuremberg Code and the Declaration of Helsinki served as models for the current U.S. federal research regulations, which require not only the informed consent of the research subject (with proxy consent sometimes acceptable, as for young children), but also prior peer review of research protocols by a committee (the institutional review board of the hospital or research institution) that includes a representative of the community.

The Nuremberg Code focuses on the human rights of research subjects, the Declaration of Helsinki focuses on the obligations of physician-investigators to research subjects, and the federal regulations emphasize the obligations of research institutions that receive federal funds.

Due to the publicity from the Syphilis Study, the National Research Act of 1974 was passed.

The National Research Act created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

The Commission charge was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human participants and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles.

National Research Act (1974)

Carrying out its charge, the Commission prepared the Belmont Report in 1979.

The Belmont Report is a statement of basic ethical principles and guidelines that provide “an analytical framework to guide the resolution of the ethical problems arising from research with human subjects.”

National Commission for the Protection of Human Subjects of Biomedical and

Behavioral Research

A. boundaries between practice and research,

B. basic ethical principles,C. applications.

The framework of the Belmont Report is presented in three

discussion topics:

Term Term Definition Outcome

Practice Interventions designed solely to enhance the well-being of an individual

Reasonable expectation of success

Research Activity designed to test a hypothesis; contributes to generalized knowledge

Permits a conclusion to be drawn

A. Boundaries between Practice and Research

1.Respect for Persons

2.Beneficence

3. Justice

B. Consists of 3 basic principles:

Treat people as autonomous (having the right to self-govern) agents.

Protect those who have diminished autonomy (vulnerable populations), e.g. children, prisoners, elderly.

1. Respect for Persons

Do no harm,

Maximize benefits/minimize risks,

NOT an act of kindness or charity, but a concrete obligation

2. Beneficence

Treat people fairly Do not exploit those who are readily

available or malleable Fair distribution of the risks and the

benefits of research based upon the problem/issue under investigation

3. Justice

Consideration of the three general principles in the conduct of research lead to the consideration of:

Informed Consent process

Risk/Benefits assessment

Selection of research participants

C. Application

IRB Members should consider the following…

Informed Consent Process Information - Does the consent form provide all the

information necessary for the individual to make a reasoned decision?

Comprehension - Is the consent form crafted in language understandable to the potential participant?

Voluntariness - Does the consent form and clearly indicate that participation in the research is voluntary?

What additional protections can be in place to protect those with limited autonomy?

How to determine whether one lacks the autonomy to make a reasoned decision?

Application ofRespect for Persons

Assessment of Risks and Benefits Risk refers to the probability of harm; when considering

risk, one should consider both the probability and the severity of the envisioned harm; while the term, benefit refers to something that promotes health, well-being, or welfare.

What are the risks of harm to the participants (consider physical, psychological, social, and economic harms)? Are the risks justified? Can they be minimized?

Can the research design be improved to minimize risk and maximize benefit?

What are the benefits (to the participant; to society)?

Applications ofBeneficence

Selection of Subjects Is the potential subject pool appropriate for

the research?

Is it appropriate to involve vulnerable populations (e.g., economically disadvantaged; limited cognitive capacity) in the research or are they being enrolled because it is convenient or because they are easily manipulated as a result of their situation?

Are the recruitment procedures fair and impartial?

Are the inclusion and exclusion criteria fair and appropriate?

Applications of Justice

Thus, The Belmont Report attempts to summarize the basic ethical principles identified by the Commission in the course of its deliberations. It is the outgrowth of an intensive four-day period of discussions that were held in February 1976 at the Smithsonian Institution’s Belmont Conference Center supplemented by the monthly deliberations of the Commission that were held over a period of nearly four years. It is a statement of basic ethical principles and guidelines that should assist in resolving the ethical problems that surround the conduct of research with human subjects.

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