Question

Are there any procedures in place to prevent the type of unethical research displayed in the Tuskegee Study? Explain

Answer 1

The Tuskegee Study was conducted in in 1932 in African American male population- 600 suffering from Syphilis disease and 201 without Syphilis. The researchers did not take informed consent from these men. The men were told that they were being treated for ‘bad blood’, which was used for illnesses. However, none of the infected males were given proper treatment for Syphilis. The men were only given free medical examinations, and meals along with burial insurance. The study was conducted for over 40 years. It was later concluded that the study provided minimal information while the risk to the patients were very high. The subjects were also not allowed to quit the study.

The study was unethical as no informed consent was obtained. In US, the National Research Act was signed into law as an aftermath of the Tuskegee study. It created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

The proper way to conduct as scientific study is to first take informed consent of the subjects enrolled in the study. The subject has to authorize the researcher to conduct any investigations on them. If the patient cannot give the consent, the patients surrogate should make decisions on the patient’s behalf. The investigator should understand whether the subjects can understand the relevant scientific/medical information and also understand the implications of the treatment alternatives. The subject should make an independent and voluntary decision for participation in study. Relevant information should be given accurately and sensitively. The hypothesis, nature and purpose of the study, the risks to the subjects as well as benefits etc should be properly indicated. The signature of the subject/patient should be taken on consent form and the record should be kept.

Further, all human studies have to be reviewed and revised after recommendation from the Institutional Review Boards. Ethics committees have to be instituted which review human studies and allow/disallow them based on the recommendations.

The Federal Policy for the Protection of Human Subjects has been adopted in 1991 to protect Human subjects. The National Bioethics Advisory commission reviews current regulation, policies and procedures to safeguard volunteers in Human Studies.