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:
- Readability for the target audience (a 6th to 8th grade reading level is often recommended for adult subjects). In Microsoft Word, readability statistics can be determined by going to tools, options, spelling/grammar, and checking the box marked readability statistics after highlighting the passage in question.
- Avoidance of technical jargon.
- An explanation of all elements of the research (what is expected of the subject).
- Full disclosure of research aims and methods (including video taping or audio taping) whenever feasible; minimizing level of deception.
- Full disclosure of anticipated risks and benefits.
- Full disclosure of access to information including who will see and maintain the data and the potential for loss of anonymity or confidentiality.
- Full disclosure of the voluntary nature of the research including a statement that the participant may decline participation or may withdraw from the research at any time without affecting the relationship between the researcher, institutions and participant.
- Full disclosure of the specific responsibilities of the participant and the researcher.
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.