Signed consent forms are not required for studies determined to be FLEX or exempt. However, other laws or regulations, such as FERPA, may require that a signature be obtained.

An IRB may also waive the requirement for the researcher to obtain signed consent forms for some or all enrolled participants if it finds that one of the following is met:

  1. That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; OR
  2. That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

In cases in which the signature requirement is waived, the IRB may require the researcher to provide study participants with a written statement regarding the research. Under some circumstances, a verbal consent process may be more appropriate. In either case, the researcher must maintain a record of the process they followed when obtaining informed consent from each participant.

Examples of minimal risk studies that may be eligible for a waiver of documentation include, but are not limited to: Surveys (mailed, in person, or online), interviews (via telephone or in person), educational tests, focus groups, and ethnographic fieldwork.

If you are proposing to use a handout, webpage, posting, or verbal consent process, the planned content must be reviewed by the IRB and the title of this document should match your intended process. For example, if you plan to use a verbal consent process, submit a “Verbal Consent Guide”. We recommend avoiding the use of scripts so that you have the freedom to be more conversational. If you plan to provide a written statement at the beginning of a survey, submit an “Explanation of Research”. Please do not title this document “Waiver of Documentation” or “Consent Form”.

Regardless of the type of consent process used, the most of the elements of consent must still be present. Please refer to the templates and samples on the HRPP website.