Phase one of a clinical trial to test a COVID-19 vaccine has begun at Kaiser Permanente Washington Health Research Institute in Seattle. This trial will consist of 45 healthy adults, who have volunteered, ages 18 to 55 years old. It will take place during a 6-week period. The trial is being funded by the National Institute of Allergy and Infectious Diseases, and the National Institute of Health. It is odd to think that humans are the test subjects because no one knows what the results will be, death? Yet, we use them anyway to ensure that the product being tested won’t kill mass numbers of the public. Human test subject aren’t without protection when they walk into the research clinic. This blog will examine the federal policies protecting human test subject.
Part One: National Research Act. This Act was signed into law by President Richard Nixon in 1974. Under this new law the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was formed. Why was there such a need for this? After the world saw what could happen with human experiment during World War Two by the Nazis Party, there was the Tuskegee Syphilis study in which black men with syphilis were denied treatment. The main purpose of the National Research Act was to establish basic ethical principles to be followed when doing experiments on human subject. This leads into the Belmont Report. To understand the Federal Policy for the Protection of Human subjects, first the Belmont Reports must be discussed.
Part Two: The Belmont Report. This report gets its name from the location where the commission had its 4-day summit in February 1976. It took place at the Smithsonian Institute’s Belmont Conference center, which would eventually meet many times after the original summit to revise and expand their ideas, until the final report was released in 1979. In the end the results would establish three underlying ethical principles that could be used as a guide for research on human subjects. The first principle is “Respect for persons: all individuals should be treated as autonomous agents, and persons with diminished autonomy are entitled to protection.” The second principle is as follows: “Beneficence: researchers should maximize possible benefits and minimize possible harm.” Third, and final, principle: “Justice: All persons should be treated equally, and the selection of research subjects should be scrutinized so that no one is systematically selected on the basis of race, ethnicity, class or other factors.”
Part Three: The Federal Policy for the Protection of Human Subjects. Common Rule, or as it is known by its long name, The Federal Policy for the Protection of Human Subjects, is exactly what the title states. It came to be in 1991 and is heavily influenced by the Belmont Report. From this 15 different federal departments and agencies adopted the policy. It includes four parts: the Federal Policy (Common Rule), additional protections for pregnant women, and more, additional protection for prisoners, and additional protections for children. The Federal Policy outlines the basic provisions for Institutional Review Boards, and Assurances of Compliance. The head of an agency/department has final say on whether or not an activity happens which is covered under the Common Rule. If you would like to read the Common Rule here is the link.
I hope this blog was informative, and you learned about federal provisions to protect human subjects.
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