IRB Consent Process
In order to involve a human subject in research, a researcher must obtain the legally effective informed consent of the subject or the subject's legally authorized representative. Special care must be exercised when the subjects are legal minors or adults legally incapable of giving consent.
Informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form. By federal law, researchers are to keep signed informed consent forms for three years (45 CFR 46.116).
The informed consent process begins when you first approach potential subjects and continues throughout your research. Typically, it involves:
- presenting information that enables an individual to knowledgeably and voluntarily decide whether or not to participate as a research subject
- documenting consent with a written form signed by the subject
- responding to the subject’s questions/concerns during the research and communicating any new findings that may affect the subject’s willingness to continue participating.