Ethical and legal codes that govern medical practice also apply to clinical trials. Our clinical research is federally regulated with safeguards to protect the participants. The trials follow study plans which detail what researchers may do during the course of the study. Individual participants’ names will remain secret to protect their identity. Below are national and international guidelines that all human research submitted to the FDA is compelled to follow.
The Belmont Report
On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, there-by creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Three principles, or general prescriptive judgments, that are relevant to research involving human subjects are identified in this statement: the principles of respect of persons, beneficence and justice.
Declaration of Helsinki
The World Medical Association (WMA) developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects in 1964. This statement lists 35 guiding principles for all human medical research.
Office of Human Research Protections
The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS).