known. Researchers make informed guesses so that deaths of study participants are rare events. But clinical drug trials are human experiments and people do die. In the absence of detailed animal studies, experiments done directly on humans are viewed with great suspicion and are usually proscribed.
Taking steps to ensure the safety of medical research participants is a relatively new aspect of public policy. As recently as the early 1970s, unethical medical experimentation was being done on human subjects. Researchers in the infamous Tuskegee Syphilis Study (completed in 1972) and in the notorious Willowbrook State School hepatitis study (terminated in 1966) violated the human rights of the adults and children who served as study participants.
At Willowbrook (an institution housing mentally disabled children) researchers studied the natural history and epidemiology of hepatitis by exposing children to live virus. Parents were made to understand that hard-to-come-by places at Willowbrook would be obtained if they allowed their children to be research subjects. The Tuskegee study investigated the natural progression of syphilis in African-American sharecroppers who had the disease. Effective treatment for syphilis (penicillin) was withheld from these men in direct violation of their human rights as enumerated in the Nuremberg Code and Helsinki Declaration.
Revelations of the circumstances involved in the Willowbrook and Tuskegee studies led to the findings of the Belmont Report and the establishment of Office for Human Research Protections, part of the U.S. Department of Health and Human Services. The Belmont Report enumerated four primary principles of bioethics -
· Respect for persons (autonomy)
The first attempt at introducing a cloned embryo into a woman’s uterus will have no precedent. It will be a total shot in the dark, truly “boldly going where no one has gone before”. As a society we need to determine whether the risks of such a step justify the potential benefits.