| Safe human reproductive cloning can only be | | | | adults and children who served as study participants. |
| achieved by conducting research and developing | | | | At Willowbrook (an institution housing mentally |
| techniques that ensure the safety of the gestating | | | | disabled children) researchers studied the natural |
| mother and the health and welfare of the child. The | | | | history and epidemiology of hepatitis by exposing |
| huge obstacle to designing safe procedures is that | | | | children to live virus. Parents were made to |
| any such research will involve experimentation on | | | | understand that hard-to-come-by places at |
| humans. | | | | Willowbrook would be obtained if they allowed their |
| Medical experiments on humans are conducted all the | | | | children to be research subjects. The Tuskegee |
| time, but new drugs, procedures, and devices are | | | | study investigated the natural progression of syphilis |
| tested on animals first. Clinical drug trials are a classic | | | | in African-American sharecroppers who had the |
| example of human experimentation. Phase I clinical | | | | disease. Effective treatment for syphilis (penicillin) |
| trials are the "safety" phase of bringing a new drug | | | | was withheld from these men in direct violation of |
| to market. Animal testing has been done, most often | | | | their human rights as enumerated in the Nuremberg |
| in mice. Data have been reported and analyzed, and | | | | Code and Helsinki Declaration. |
| the FDA has permitted human testing to proceed. | | | | Revelations of the circumstances involved in the |
| But the side effects in humans and the proper | | | | Willowbrook and Tuskegee studies led to the findings |
| dosages are completely unknown. Researchers make | | | | of the Belmont Report and the establishment of |
| informed guesses so that deaths of study | | | | Office for Human Research Protections, part of the |
| participants are rare events. But clinical drug trials are | | | | U.S. Department of Health and Human Services. The |
| human experiments and people do die. In the | | | | Belmont Report enumerated four primary principles of |
| absence of detailed animal studies, experiments done | | | | bioethics - |
| directly on humans are viewed with great suspicion | | | | · Respect for persons (autonomy) |
| and are usually proscribed. | | | | · Beneficence |
| Taking steps to ensure the safety of medical | | | | · Nonmaleficence |
| research participants is a relatively new aspect of | | | | · Justice |
| public policy. As recently as the early 1970s, unethical | | | | The first attempt at introducing a cloned embryo into |
| medical experimentation was being done on human | | | | a woman's uterus will have no precedent. It will be a |
| subjects. Researchers in the infamous Tuskegee | | | | total shot in the dark, truly "boldly going where no |
| Syphilis Study (completed in 1972) and in the | | | | one has gone before". As a society we need to |
| notorious Willowbrook State School hepatitis study | | | | determine whether the risks of such a step justify |
| (terminated in 1966) violated the human rights of the | | | | the potential benefits. |