The need for laws and regulations surrounding primary research arose in earnest after World War II. The immediate aftermath of the Holocaust and the methods used by Nazi researchers brought the ethics of research to the forefront; however, a codified and written-out guideline (The Belmont Report) was not completed until the late 1970s, prompted by unethical experimentation happening in the U.S. While the first two examples below are considered extreme and predated the Belmont Report, unethical research still happens today and even a supposedly “innocent” study could have dire consequences.
Nazi Germany and the Nuremberg Code
In the early 1940s in Germany, Nazi doctors conducted human experimentation on unwilling test subjects in concentration camps; one way of describing the procedures could be to call it medical torture. After the Allied Forces won World War II, United States authorities who held the Nuremberg Palace of Justice used that building to host the Doctors’ Trial, in which Nazi researchers were charged with crimes against humanity for unethical research practices. After the Subsequent Nuremberg Trials, many people felt compelled to create laws to codify some research guidelines to protect research participants and define acceptable relationships between researchers and research participants.
In 1949, the Nuremberg Code was published as a set of guidelines to guide researchers who work with human subjects. Among the main points of the code are the following concepts: participants must continually give their voluntary consent, the study must have the goal of producing good for society, and considerations must be taken to protect participants from even the remote possibility of physical and mental injury.
Tuskegee Syphilis Study
An example of unethical research is the Tuskegee syphilis study, which was conducted by the U.S. Public Health Service from 1932 to 1972. The participants in this study were poor African American men in the vicinity of Tuskegee, Alabama, who had syphilis and who were told that they were being treated for “bad blood.” Although they were given some free medical care, they were not treated for their syphilis. Instead, they were observed to see how the disease developed in untreated patients. Even after the use of penicillin became the standard treatment for syphilis in the 1940s, these men continued to be denied treatment without being given an opportunity to leave the study. The study was eventually discontinued only after its details were made known to the general public by journalists and activists.
The Belmont Report
The Belmont Report was first written by the National Commission for the Protection of Human Services of Biomedical and Behavioral Research. Prompted in part by problems arising from the Tuskegee Syphilis Study, the Department of Health, Education and Welfare revised and expanded its regulations for the protection of human subjects in the late 1970s and early 1980s. In 1978, the Commission’s report was released, and it was published in 1979 in the Federal Register. It was named the Belmont Report for the Belmont Conference Center, where the National Commission met when first drafting the report. The Belmont Report is one of the leading works concerning ethics and health care research. It allows for the protection of participants in clinical trials and research studies.
The Belmont Report names the three fundamental ethical principles for using any human subjects for research:
- Respect for Persons: protecting the autonomy of all people and treating them with courtesy and respect and allowing for informed consent. Researchers must be truthful and conduct no deception;
- Beneficence: The philosophy of “Do no harm” while maximizing benefits for the research project and minimizing risks to the research subjects; and
- Justice: ensuring reasonable, non-exploitative, and well-considered procedures are administered fairly—the fair distribution of costs and benefits to potential research participants—and equally.
Today, the Belmont Report continues as an essential reference for Institutional Review Boards (IRBs) that review human subject research proposals involving human subjects in order to ensure that the research meets the ethical foundations of the regulations.
As the next example shows, application of these principles in conducting primary research requires careful consideration and implementation of various tasks, including informed consent and risk-benefit assessment.
In 2001, long after the Belmont Report and IRBs were established, a professor at Columbia University’s business school wanted to see how restaurants responded to complaints. Professor Frank Flynn sent 240 restaurants a fictitious letter that said he and his wife had suffered from food poisoning after visiting the respective restaurants. Chefs and owners were shocked by the letter and began recalling their food, cancelling orders, and even firing some employees. The dean of the Columbia business school as well as Professor Flynn apologized, but the damage had already been done. Almost a dozen restaurants filed a lawsuit against Flynn, Columbia, or both. While this incident is cited in multiple law review cases discussing the liability of universities, researchers, and IRB, the professor did not go through the proper IRB procedures. (For more information, read the case study and a New York Times article.)