INFORMED CONSENT
"All participants in an experimental program should be informed in advance of all features of the treatment and measurement process that they will be experiencing that would subject them to any obvious risk or jeopardy and
that would be likely to influence their decision to participate in the program or their conduct
as participants in the program."
that would be likely to influence their decision to participate in the program or their conduct
as participants in the program."
- The Belmont Report (1979)
THE BELMONT REPORT
After the National Research Act was passed, changes in bioethics policy ensued. The act "established a National Advisory Council for the Protection of Subjects of Biomedical and Behavioral Research", a council which formed the Belmont Report, a vital document in bioethics. This report outlines three principles:
"Respect for persons (the recognition of the right of persons to exercise autonomy), beneficence (the minimization of risk incurred by research subjects and the maximization of benefits to them and others), and justice" - Susan B. Reverby, author of "Examining Tuskegee"
and "Tuskegee's Truths" (2000) |
"[The] Tuskegee syphilis study used disadvantaged, rural black men to study the untreated course of a disease that is by no means confined to that population. These subjects were deprived of demonstrably effective treatment in order not to interrupt the project, long after such treatment became generally available."
- The Belmont Report (1979)
Excerpt from the Belmont Report
ESTABLISHMENT OF INFORMED CONSENT
The theory of informed consent condemns research practices of the past, in which doctors decided all aspects of patient involvement in research. The Belmont Report established new guidelines and commenced an era in which informed consent became the cornerstone of bioethics.
"All those medicine commercials you see on television where they spend 90% of the time telling you all the horrible the things that could go wrong? That’s informed consent.. The disclaimers you see on the medicine commercials aren't mandated by the Tuskegee study, but they are directly influenced from it. It touches the lives of everyone." - Jean Heller, investigative reporter,
in a student phone interview |
Excerpt from the Belmont Report
|
"What is Informed Consent?" (Cohen 2011)
|
If you are a doctor and you want to do a human experiment ... that gets one penny of federal money, you have got to go through all of these hoops that were set up by the National Institutes of Health to justify your protocol to guarantee informed consent... if you don't meet anyone of of those criteria... and you do the study anyway and you are found out, your institution, not you, your Institution, will lose every penny of federal money it gets. - Jean Heller, investigative reporter,
in a student phone interview |