ORI Introduction to RCR: Chapter 3. The Protection of Human Subjects
The use of human subjects in research benefits society in many ways, from contributing to the development of new drugs and medical procedures to understanding how we think and act. It also can and has imposed unacceptable risks on research subjects. To help ensure that the risks do not outweigh the benefits, human subjects research is carefully regulated by society.
Investigators who conduct research involving humans that is subject to regulation must comply with all relevant Federal regulations as well as any applicable state and local laws, regulations, and policies related to the protection of human subjects. They are also expected to follow other relevant codes that have been formulated by professional groups. To meet these responsibilities requires, among other things:
knowing what research is subject to regulation,
understanding and following the rules for project approval,
getting appropriate training, and
accepting continuing responsibility for compliance through all stages of a project.
If you expect to use or study living humans in your research, no matter how harmless that use may seem, and receive Federal funding, familiarize yourself with your responsibilitiesand check with someone in a position of authority before making any contacts or undertaking any work.
Designing a responsible informed-consent form