Research Implications

How Tuskegee Changed Research Practices

After the Tuskegee Study, the government changed its research practices to prevent a repeat of the mistakes made in Tuskegee.

In 1974, the National Research Act was signed into law, creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral ResearchExternal. The group identified basic principles of research conduct and suggested ways to ensure those principles were followed.

In addition to the panel’s recommendations, regulations were passed in 1974 that required researchers to get voluntary informed consent from all persons taking part in studies done or funded by the Department of Health, Education, and Welfare (DHEW). They also required that all DHEW-supported studies using human subjects be reviewed by Institutional Review Boards, which read study protocols and decide whether they meet ethical standards.

The rules and policies for human subjects research have been reviewed and revised many times since they were first approved. From 1980-1983, the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral ResearchExternal looked at federal rules for doing research on human subjects to see how well those rules were being followed. An Ethics Advisory Board was formed in the late 1970s to review ethical issues of biomedical research. In 1991, federal departments and agencies (16 total) adopted the Federal Policy for the Protection of Human Subjects.

Efforts to promote the highest ethical standards in research are still going on today. In October 1995, President Bill Clinton created a National Bioethics Advisory CommissionExternal, funded and led by the Department of Health and Human Services. The commission’s task was to review current regulations, policies, and procedures to ensure all possible safeguards are in place to protect research volunteers. It was succeeded by the President’s Council on BioethicsExternal, which was established in 2001, and then the Presidential Commission for the Study of Bioethical IssuesExternal established in 2009.