The standard method for documenting that participants have provided informed consent is to have each individual participant sign an Informed Consent Form that contains all the Required Elements of Informed Consent. However, with some research methods and/or prospective participant populations, the standard method of documenting Informed Consent may not be appropriate. In such cases, Investigators should use alternate methods to obtain documentation of Informed Consent or request a Waiver of Documentation of Informed Consent.
Two procedures may be used to obtain and document informed consent. The first and most common involves a written consent form which embodies all the content requirements outlined above. The second involves a verbal presentation with a “short form” consent document stating that all the elements of consent have been presented verbally to the subject. In both cases the signature of the participant (or the subject’s legally authorized representative), is required, thus “documenting” consent.
- Written Consent Form
This document, containing all the elements of consent, is reviewed and discussed with each potential participant or the legal representative. The participant signs and dates the consent form to document the decision to participate. In using this procedure, investigators must keep in mind that consent is a process. It is not sufficient to hand potential participants a document and ask them to sign. Investigators should plan a consent process that gives potential participants the opportunity to ask questions and time to think about whether they want to participate or not. If the research procedures are complex or involve some risk, potential participants may need extra time to digest the information and to consult with others about their participation. Investigators should also plan time for discussion that allows them to ensure that participants understand the research procedures. Potential participants should never feel rushed or pressured to make a decision and sign a document.
- Verbal Presentation with Short Form
With this method, a verbal script is used to present the elements of consent to potential participants (or legal representative). After the verbal presentation, the participants sign a short form indicating that the elements of consent have been presented verbally, that the information presented was understood, and that they agree to participate in the research. There must be a witness to the verbal presentation, and he/she must sign the verbal script and short form to verify that the presentation took place. Use of a short form procedure is uncommon, but in some instances in which participants' limitations (e.g. participants have physical limitations, are illiterate, or do not speak English) make it difficult to read, this procedure may be more appropriate than a written consent document. As with a written consent document, however, it is important for investigators to allow time for discussion and not pressure potential participants into making a quick decision. When this method is used, the IRB must review a complete script of the information to be presented to the participants.
Once a research project and the corresponding consent form(s) have been approved by the IRB, the consent form will be stamped with the approval and expiration dates for the project. The stamped consent form will be sent to the primary investigator and copies of the date stamped form must be used in obtaining consent. If anything on the form needs to be changed or updated, investigators must submit the revised form to the IRB for review and approval before it is implemented; if approved, the revised form will be stamped again with the approval and expiration dates. It is the responsibility of the primary investigator to obtain a properly executed consent form from each participant. Furthermore, such documents (and any other materials that contains names or identifying characteristics of participants) must be kept secure at all times.
Investigators are strongly encouraged to use the Consent Form Templates when constructing written consent forms. When use of a short form seems appropriate, investigators should contact the Compliance Manager or IRB Chair for information about constructing such a form.