Informed consent is the process of informing potential volunteers about the key facts of a research study.
The human subjects in your study must participate willingly, after having been adequately informed about the research. Voluntary participation means that subjects have enough information to give true informed consent.
If the human subjects in your study are part of a vulnerable population, such as prisoners or children, special protections are required. For more information on vulnerable populations, please contact the Office of Research Compliance.
Consent documents and study recruitment materials must be clearly written and understandable to subjects. The language must be non-technical (comparable to the language in a newspaper or general circulation magazine). Scientific, technical, and medical terms must be plainly defined. It is often recommended that the informed consent be written at the sixth to eighth grade reading level. The same applies to the assent forms for minors.
Informed consent may not include language that appears to waive subjects' legal rights or appears to release the investigator or anyone else involved in the study from liability or negligence. Templates and model consent forms are available from the ORC office or the ORC website.