The standard of the day: The interfacing of science and society in human subject research. A gap study in the development of informed consent.

摘要

“Radioactive Milk Fed to Retarded Children” was the headline in the Boston Globe that introduced the public to the fact that studies that utilized radioactive materials had been conducted on children who were residents at a state school in Massachusetts. This school was administered by the Department of Mental Hygiene at that time. This label clumped together persons who were mentally retarded, mentally ill, physically disabled or deformed, and/or otherwise socioculturally deemed unacceptable or inferior. This included issues such as alcoholism or prostitution. The courts could deem someone (legally) “a stubborn child” due to truancy or family conflict and have them committed to such a state school. Many times the problems in school arose from LD or ADHD/ADD issues. Other times it was just a very large immigrant family. For any and all of these reasons, a child, or adult, could be put into Fernald State School (among others in the Commonwealth of Massachusetts). Many of the children were then abandoned by their families and became legal wards of the state. This severe segregation and isolation led institutions to be a perfect location for medical and other forms of research.; the worst horror stories possible. Radioactivity used in research done in the 1940s–70s? Obviously, it would show devious and evil intent and action by the researchers. But I did not find evil. I found paternalistic mores and prejudice that allowed nationally respected scientists to conduct well intentioned and academically/medically supervised research, given all appropriate permission and published in respected journals of the day such that it was not just credible but excellent research. Of its kind and in its day. Hence it met and even exceeded the “standard of the day”. But it broke the standards of our day. This dissertation outlines the full discovery process and details the studies to answer questions about the past but raise new ones about the present. Is the bioethical standard used today sufficient to disallow retrospective judgment in 30–50 years on our biomedical research today? My answer is no.