Answer: Informed consent is the process of communication between the researcher and the participant in which all information that could affect willingness to participate is made clear and agreement to participate is obtained. Written consent is the evidence that this communication process has been accomplished.

Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. If the participant's native language is not English, translation assistance can be provided.

Yes. The Consent Writer program that ensures all the required elements of informed consent are addressed. It can also be used as guidance on what information should be on an informed consent form, and you can use it as a model. However, you may construct your own consent document using the basic required elements of informed consent which can be found in the Criteria for IRB approval of research (45 CFR 46.111).

Federal regulations require certain statements in a legally effective informed consent document. Because all projects are unique in their purposes and procedures, the specific wording in consent forms differs on a case-by-case basis. The HSC does provide a template for investigators to utilize as a starting point in drafting their consent forms which can be found at http://www2.kumc.edu/researchcompliance/hscforms.