In one of the darkest chapters in medical ethics, the United States government ran an experiment from the 1930s to the 1970s in which it withheld treatment and medical information from rural African-American men suffering from syphilis. The public uproar generated by the Tuskegee Syphilis Study eventually resulted in regulations restricting government-supported research testing on humans. These regulations are called the “Common Rule,” and they are right now up for their first full update.
The Common Rule, also known as the “Federal Policy for the Protection of Human Subjects,” is supposed to affirmatively protect us from the abuses of the future. However, the proposed regulation is lousy with loopholes, including ones that could exempt tracking online behavior and experiments related to intelligence activities.
File a comment on the “Federal Policy for the Protection of Human Subjects” through Regulations.gov.
What is the Common Rule
The Common Rule was created in 1991 as an outgrowth of the Belmont Report, a series of ethical and principles and guidelines created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to address issues raised by the Tuskegee experiment. The Common Rule claims to strike a balance between the three goals identified in the Belmont Report: 1) respecting persons, 2) ‘beneficence’ (i.e.,maximizing the social value of science and research), and 3) justice.
This federal policy purportedly binds the Department of Health and Human Services (HHS) and numerous other agencies, including the CIA and Department of Homeland Security (per Executive Order 12333). But as we’ve seen, these agencies are adept at honing in on small loopholes, so the proposed language needs a serious edit if it is going to provide any real protection.
EFF filed a comment when HHS first proposed this update in 2011, and we are drafting a new comment laying out our biggest concerns to file by January 6, 2016.