Skip to main content

Do I need to get it in writing?


Most subjects make their decision regarding whether to participate in research during the initial contact. The researcher should avoid the potential for any misunderstandings and provide the subjects with sufficient time to reflect on the nature of their proposed participation.

The second step in the consent process is the presentation of a written consent form to individuals who express an interest in participating in the study, unless the research qualifies for an exception, waiver or alteration of documented informed consent. Written informed consent is not always necessary or appropriate in some educational, social and behavioral science research. 

When written informed consent is appropriate, a member of the study team should insure that the subject reads and understands the consent form. Federal regulations require that all consent form statements should describe the nature of the research and the request for human subjects' participation in language that is understandable to each potential subject. Consent forms should avoid technical jargon or terminology that is not defined; the forms should also adjust for educational backgrounds, mental abilities and ages of the intended participants.