Informed consent is the term given to the communication process that allows individuals to make an informed choice before deciding if they wish to participate in a research project or research study. This process is reflected in an informed consent document that contains specific, required information which is regulated by the federal government. The informed consent document serves as the formal authorization by an individual of their agreement to participate in the proposed research.
The human subjects in your project must participate willingly, having been adequately informed about the research. If the human subjects in your project are part of a vulnerable population (i.e. prisoners, cognitively impaired individuals, or minors), special protections are required. Contact the IRB Office for more information.
Guidelines for Preparing a Written Consent. Except where noted, written informed consent must contain all sections described in the templates.
The consent form should be able to be read easily (5th to 8th grade level) and should be formatted to separate required elements of the informed consent process (i.e. Risks & Benefits, Explanation of the Research Study, etc). For example, create section headings to guide the reader or use topic sentences to highlight pertinent information in each new section. Please do not include a copy of this consent form template with your application; only include the consent form you plan to use.
Each section includes instructions for preparation and provides suggested text of the information to be included. Please customize the suggested text to adequately describe the research project.
If informed consent will be obtained in a language other than English, please include a copy of the consent document in that language, as well as a copy of the English version.