What historical event led to the formation of our current ethical guidelines for research with human participants?

The recognition of the need for guidelines dealing with human subjects in research emerged following the Nuremberg trials, where the medical experimentation abuses of World War II Nazi doctors came to public attention. This led to the creation of the Nuremberg Code in 1945, the first legal attempt to deal with ethical issues of modern research. As biomedical research efforts expanded the international need for a more specific code of ethics was formulated in the 1964 Declaration of Helsinki.

In the United States, by 1953 the National Institutes of Health required that all proposed clinical research projects at its center in Bethesda obtain approval from a protection of human subjects review panel. In 1966, the United States Public Health Service issued its first set of regulations extending this review requirement to all "extramural" research supported by the agency. These rules were further revised in 1971 and 1974 and led to the establishment of institutional review boards (IRBs) at hundreds of institutions receiving federal funding for research.

During this period revelations of human subjects’ abuse in the U.S. culminated in the 1972 public disclosure of the 30-year government supported Tuskegee Syphilis Study, in which 300 black rural men were left untreated for diagnosed syphilis after effective antibiotics became available. This prompted Public Law 93-348 calling for the establishment of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. In 1979 the Commission published recommendations, known as the Belmont Report, which served as the basis for revised federal regulations published in the Federal Register in 1979 and subsequently revised several times resulting in the current Code of Federal Regulations Title 45-Part 46 Protection of Human Subjects (45 CFR 46) effective as of 1991.

The Belmont Report established three general ethical principles that continue to be applied to the research of human subjects:

• Beneficence: To maximize benefits for science, humanity, and research participants and to avoid or minimize risk or harm.
• Respect: To protect the autonomy and privacy rights of participants.
• Justice: To ensure the fair distribution among persons and groups of the costs and benefits of research.

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Out of the horrors of World War II came the Nuremberg Code, the prototype for human research protection.

We can trace today’s research ethics principles directly to the inhumane experimentation on prisoners in the Nazi death camps during World War II. In 1947, during the Nuremberg War Crime Trials that followed the end of that war, the Nuremberg Code was drafted as a set of standards for judging physicians and scientists who had conducted biomedical experiments on concentration camp prisoners. The code includes such principles as informed consent and absence of coercion, properly formulated scientific experimentation, and beneficence toward experiment subjects.

This code, along with the Helsinki Declaration of 1964 (revised in 1975) and the Belmont Report of 1979, among others, became the prototype of many later codes intended to assure that research involving human subjects would be carried out in an ethical manner. From these evolved the ethics principles of the National Institutes of Health Office of Human Subject Research now governing such research.

For more on ethical issues and clinical trial lawsuits, check out the upcoming July issue of Applied Clinical Trials to read John F. Kouten's feature article: A Ten Step Trial Crisis Plan.

Source: The National Institutes of Health, Office of Human Subjects Research, Regulations & Ethical Guidelines (bioethics.od.nih.gov/IRB.html).

Nuremberg Doctors Trial Nazi physicians and administrators prosecuted by U.S. military tribunal for major war crimes, including medical experiments conducted on prisoners of war.

Significant violations of personal autonomy, malevolence, unjustifiable harm

Nuremberg Code Issued by the tribunal during the verdict, established first code of research ethics, 1947

Declaration of Helsinki World Medical Association code of ethics on human experimentation, 1964

Thalidomide anti-nausea drug stalled during FDA approval, birth defects mount

Risk unbalanced by benefit, informed consent, unproven drug safety and efficacy

Kefauver-Harris Amendments passed to strengthen FDA regulations (est. 1938) governing the drug development process, 1962

Beecher article, Ethics and Clinical Research examples of unethical biomedical research culled from recent literature, 1966.

Disregard for informed consent, unnecessary harm

Uniform Requirements for Manuscripts Submitted to Biomedical JournalsIssued by the International Committee of Medical Journal Editors, commonly referred to as the "Vancouver Group" 

Social and behavior research illuminates need for participant protections beyond the scope of biomedical studies:

Humphrey's Tearoom Trade, 1970

Stanford Prison Experiment, 1971

Milgram's "destructive obedience" Study, 1974

Deception, emotional and psychological harms, violations of privacy and confidentiality

American Psychological Association develops Research Principles, 1973, emphasizing the researcher's personal responsibility for ethical decision making

Tuskegee Syphilis Study NY Times article unveiled 40 year U.S. Public Health Service study in which poor, African-American men with syphilis were studied but left untreated, 1972.

Uninformed consent, injustice, risk to participants and family members

Led to formation of the National Research Act, 1974 and created initial guidelines for human subjects research in the Code of Federal Regulations

Resulted in The Belmont Report, by the Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979

Increase in production of legitimate but sophisticated medical devices such as the Dalkon Shield, Intraocular Lenses, and Cardiac Pacemakers drove Congress toward improved device regulations.

Unproven safety of marketed medical devices

Cooper Committee recommendations to regulate medical devices culminate in the Medical Device Amendments of 1976

Past research experiments exposed, lead to public mistrust:

Human Radiation Experiments 

Willowbrook State School Hepatitis Studies

Tudor "Monster" Study of Orphans

Unjustified physical and emotional harms, exploitation of vulnerable populations, absence of informed consent

President Clinton establishes the Advisory Committee on Human Radiation Experiments (1994) and the National Bioethics Advisory Commission (1995-2001)

Jesse Gelsinger dies in a gene therapy clinical trial in 1999; unethical research conduct uncovered

Conflict of interest, insufficient informed consent

Office for Human Research Protections issues Financial Conflict of Interest guidance, 2001

U.S. PHS Syphilis Study in Guatemala (1946-48) exposed

Absence of consent, injustice, risk to participants and family members, exploitation of vulnerable populations

President Obama establishes the Presidential Commission for the Study of Bioethical Issues in 2009 and requests investigation of Guatemala Syphilis Study, 2010

What led to the creation of ethical guidelines for research?

What historical event triggered the establishment of ethical guidelines for the treatment of human subjects involved in medical or scientific research?

What are two historical events that have influenced the development of ethical codes and regulations for nursing and healthcare research?

What famous case began human subjects research ethics?