, a human subject is “a living individual about whom an investigator (whether professional or student) conducting research: Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or.

The Common Rule applies to human subjects research conducted, supported or otherwise subject to regulation by the VA. If VA investigators receive support from DHHS (NIH, CDC, etc.), additional subparts of 45 CFR Part 46 may apply. What is a Federal Wide Assurance (FWA)?

The Common Rule is a 1981 rule of ethics in the United States regarding biomedical and behavioral research involving human subjects. A significant revision became effective July 2018.

The Federal Policy for the Protection of Human Subjects is known as the “Common Rule” because it has been adopted by a number of federal departments and agencies.

The document on “Recommendations guiding doctors in clinical research” came to be known as the “Declaration of Helsinki”. It was the first international set of ethical principles for research involving human subjects. In the following years this guideline became the most influential one and still is.

The Declaration of Helsinki (DoH) is the World Medical Association’s (WMA) best-known policy statement. The first version was adopted in 1964 and has been amended seven times since, most recently at the General Assembly in October 2013.

The 10 elements of the code are:

• Voluntary consent is essential.
• The results of any experiment must be for the greater good of society.
• Human experiments should be based on previous animal experimentation.
• Experiments should be conducted by avoiding physical/mental suffering and injury.

Three basic principles, among those generally accepted in our cultural tradition, are particularly relevant to the ethics of research involving human subjects: the principles of respect of persons, beneficence and justice.