Informed Consent
Back to IRB Handbook Table of Contents
Informed consent is one of the primary ethical requirements underpinning research with human subjects. It is not just a piece of paper but an ongoing process that assures prospective subjects understand the nature of the research and can knowledgeably and voluntarily decide whether or not to participate.
Subjects must always retain the right to withdraw from participating in research. They must be informed of any new findings that would affect their willingness to participate.
Federal regulations give the elements to be contained in all consent forms. In the Kent State University HSRB application packet these elements have been formatted into a fill-in-the-blanks template that researchers can use to develop the consent form so it is specific to their research and also fulfills federal requirements.
Children under twelve will give assent to their participation in research. There is no strictly prescribed way to obtain assent and the procedure may be adapted to the particular circumstances. Generally, the researcher would introduce himself and explain in appropriate language the purpose of the study and what he wants the child to do, (avoiding terms such as "help" and "cooperate," which might suggest coercion). He would then ask whether the child wants to participate, if there are any questions, and assure the child he can stop at any time.