What is an informed consent document? How does it differ from an information sheet?
An informed consent document is a document that records a subject’s voluntary participation in a research study and which provides the subject with a description of the study, the risks and benefits of the study to the subject and society, and contact information. Usually subjects are asked to provide written consent to participate in the study by signing the informed consent document, but there are times when written consent is not needed (e.g., if the data collected are to be anonymous). In those cases, a subject can be consented through consent discussion and be provided with an information sheet. This should provide a description of the study and contact information. If verbal consent is to obtained the researcher should provide a script for the IRB to review.
Related Questions
- The IDOC Cover Sheet lists the 1040EZ as a two-page document, but the second page is a worksheet that the student didn fill out. Does he/she need to send in the second page of the 1040EZ?
- The students IDOC Cover Sheet isn printing as a one-page document. What should he/she do?
- Does RCRC IRB have specific requirements for the Informed Consent Document?
