In a series of articles, we will present the newest in research administration from the Journal of Research Administration. To read the full JRA, please see here.
Author:
Kristi N. Hottenstein, PhD, University of Michigan-Flint
In 2010 the United States government spent over $16.5 billion dollars on human subject research conducted at institutions of higher education and other non-governmental institutions (AAUP, 2013). Over 55,000 human subject research projects were conducted by the 18 U.S. federal agencies that same year. By 2015, 98,352 clinical trials were being conducted in the United States, putting the U.S. at the forefront of biomedical research (U.S. National Institutes of Health, 2016). Human subject research in the United States is regulated through the Common Rule within the Code of Federal Regulations, a uniform set of rules for the protection of human subjects. The need to protect human subjects is crucial but some argue current government regulations are too strenuous and impede legitimate research. There are mixed reviews among administrators and academicians possibly arising as a result of a shift from individual to collective responsibility in the protection of human subjects and it has left many within the research community feeling uneasy about IRBs.
The ethical treatment of human subjects dates as far back as 1760 B.C.E. where government penalties for medical error were acknowledged in Hammurabi’s Code (Sanders & Ballengee- Morris, 2008). The Hippocratic oath, required of physicians as early as the late 4th century B.C.E., states “to abstain from all intentional wrong-doing and harm, especially from abusing the bodies of man or woman, found or free” (Sanders & Ballengee-Morris, 2008, p. 313). The Nuremberg Code, established in 1947, was a result of unethical medical experiments conducted on concentration camp prisoners in Germany and in German-occupied countries. The Nuremburg Code helped place human subject research on the U.S. governmental agenda (U.S. Department of Health and Human Services, 2016a). Although the code never became law in neither Germany nor the United States, it was the basis for the Code of Federal Regulations, Title 45, part 46, which was adopted in 1991, over 40 years later (White, 2007). In 1953, the National Institutes for Health (NIH) opened their Clinical Center in response to the growth in clinical research following World War II (Bankert & Amdur, 2006). It was also during this time social scientists experienced a funding boom in the United States increasing the volume of social and behavioral research being conducted (Stark, 2007). Social and behavioral research’s utilization of human subjects gained attention in 1961 with Stanley Milgram’s study on obedience to authority (Stark, 2007). This well-known and highly debated experiment was the first outside the biomedical venue to receive such publicity. In 1966 the U.S. Surgeon General became involved in the regulating of human subjects by requiring reviews of studies receiving funding from the U.S. Public Health Service.
To read the full manuscript, please click here.
Interested in becoming a Journal Author? Please see here and submit a manuscript.
#insights#ResearchAdministration