The informed consent document represents a process of communicating the research project to potential participants and obtaining agreement to participate. Written informed consent is most often required. A legal representative (guardian) must provide informed consent for those who are unable to provide consent, such as children and the mentally disabled. A copy of the consent form should be given to the person signing the form. Where informed consent is needed, the IRB must approve the actual document used in the research. Please use the Consent Template, which contains the essential elements for informed consent. Consent forms are secured and retained for 3-5 years unless otherwise designated by the researcher or committee.
Informed consent is required for data collected with identifiers, including code numbers that are connected to a person's identity. Essential elements of informed consent include:
Informed consent is not required if data is drawn from public or observed behavior or if data does not contain identifying information or if the identifying information is removed and destroyed. In some cases, informed consent can be waived, such as when (1) the research could not practicably be carried out without the waiver or alteration; and (2) whenever appropriate, the participants will be provided with additional pertinent information after participation.