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Human Rights, Medical Research and Reproductive Cloning

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Safe human reproductive cloning can only be achieved by conducting research and developing techniques that ensure the safety of the gestating mother and the health and welfare of the child. The huge obstacle to designing safe procedures is that any such research will involve experimentation on humans.

Medical experiments on humans are conducted all the time, but new drugs, procedures, and devices are tested on animals first. Clinical drug trials are a classic example of human experimentation. Phase I clinical trials are the “safety” phase of bringing a new drug to market. Animal testing has been done, most often in mice. Data have been reported and analyzed, and the FDA has permitted human testing to proceed.

But the side effects in humans and the proper dosages are completely unknown. 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)

· Beneficence

· Nonmaleficence

· Justice

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.

David Lemberg, M.S. in Bioethics, Albany Medical College, May 2010. Consultant, Author, Speaker. Research interests – health care and health care policy, reproductive technologies, genetics and genomics, K-12 science education. Executive Producer, SCIENCE AND SOCIETY, http://scienceandsociety.net

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