Consent, Assent and Waivers
Researchers are required to obtain the informed consent of all participants in human subjects research prior to enrolling those individuals in a study. The individual’s consent must be voluntary and based upon adequate knowledge of the purpose, risks, and potential benefits of a research study. All potential participants should also be informed of their right to abstain from participation or to withdraw consent to participate at any time without reprisal. After ensuring that a person has understood the information, the researcher should then obtain the person’s consent, preferably in writing.
In cases where individuals are unable to provide consent, either because they are minors or because they are physically or mentally incapable of making informed decisions, researchers are required to obtain “assent” or agreement to participate in a study from the individual. No individual should be enrolled in a study if they do not want to participate, even in cases where their legal guardian consents to their participation. When possible, an assent form should be used to document an individual’s assent.
The IRB may waive the requirement to obtain a subject’s consent, or to obtain documentation of the consent, when specific regulatory criteria are met.
In some circumstances, informed consent information may be presented electronically and/or the documentation of consent (that is, the subject’s signature) may also be obtained electronically. See the GUIDANCE document listed below, the ITHS website about REDCap e-consent and the UW IT webpage about DocuSign.