Hippocrates (400 BCE) and Oath: “Do no harm ...“
Individual responsibility of researcher - two millennia
Walter Reed (1900) Consent forms in Spanish and English: malaria research
Nuremburg Code (1946) Twenty-six medical researchers from holocaust tried for unethical conduct toward “vulnerable” population. Rules and principles developed.
Wichita, Kansas (1950’s) Secret audio taping of jury deliberations for legal research. University of Chicago challenged in Congress by James Eastland (of Ruleville, MS).
NIH Clinical Research Center at Bethesda (1960) sets up internal review committee and many other research hospitals voluntarily follow suit.
Thalidomide, an experimental drug in Europe was allowed for use in the United States with waiver of clinical trials by FDA(1962). Those receiving drug were not warned that it was still ‘experimental’.
Sloan-Kettering conducts research using “live” cancer cells on humans (1963). Subjects were told that research was testing their resistance to cancer, but not that they would receive live cancer cells. One MD tried to stop it and took Sloan-Kettering to court where defendants were convicted of assault & battery. Malpractice was also shown.
James Shannon (1964) at NIH reviews protections for all human subjects in NIH funded research. Agency begins taking a leading role in protecting human subjects.
Stanley Milgram (1965) conducted famous research on ‘obedience’, using deception as part of the design. Despite debriefing, a strong outcry from other professionals.
Henry K. Beecher (1966) reviewed biomedical research literature and showed that human subjects protections were violated in over 500 papers. His analysis was published in the New England Journal of Medicine and in two books (see References).
PHS research on untreated syphilis (1972) was initiated in the Alabama in the 1930’s. The longitudinal project continued for years, and even after the use of penicillin, 300+ African American subjects were left untreated (and uninformed). Senator Edward Kennedy challenged this research in Congress.
The National Research Act (1974) was passed by Congress. IRB’s were established and a National Commission for Protection of Human Subjects was established.
The Belmont Report (1978) was published, based on the Presidentially commissioned work of MD Psychologists, Lawyers, and Biomedical and Behavioral Ethicists. This beautifully reasoned and written document proposed to go beyond “rules and regulations” to propose principles to use in judgments about protecting human subjects.
- Respect for Persons
Vulnerable subject samples (1980-present). More recently, guidelines and regulations have been developed to guide researchers on protecting rights of “vulnerable” subjects including economically disadvantaged, minority, prisoners, mentally incompetent, pregnant mothers, fetuses, and even fetal tissues. While these issues are important, the volume of effort by Congress and federal agencies clearly illustrate political implications, rather than the moral or ethical considerations which are more important