Informed consent is an essential component of research involving human subjects. Informed consent means the knowing, legally effective consent of an individual or his/her legally authorized representative. Individuals who choose to participate in research must be given sufficient information about the research, understand the information provided to them, and must be able to voluntarily participate in research under non-coercive conditions.
Written signed consent is required for research involving human subjects, unless there are compelling reasons to waive consent. Research investigators need to provide justification for any proposed changes to consent procedures.
Assent generally is required for research where minors are involved. Minors age 12 and over are considered capable of giving written assent and minors age 7-12 generally are able to give verbal assent.
Consent for anonymous questionnaires: Certain kinds of survey research use anonymous surveys where the identity of the subjects is not known by the investigator. With the permission of the IRB, a researcher can document informed consent from participants by providing them with a cover letter or set of instructions that includes the following information: a) a description of the research project; b) contact information for the investigator should the participant(s) have any questions; c) a statement that the survey is anonymous; and d) a statement that returning the questionnaire indicates informed consent and that participation is voluntary.
"Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards for informed consent are satisfied."
-The Belmont Report, The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, April 18, 1979