Informed Consent Guidance

Informed consent is the process of telling potential research participants about the key elements of a research study and what their participation will involve. The informed consent process is one of the central components of the ethical conduct of research with human subjects. Provided below is guidance on whether written consent must be obtained and instructions to develop the written consent document if required.

The new Common Rule regulations, which include changes in consent form requirements, will go into effect on January 21, 2019. The consent forms used for all new applications submitted after January 21 must comply with these regulations. For approved studies that need modifications or extensions after January 21, the consent forms must be updated to meet the new regulations if subjects are still being enrolled in the study.

The new Common Rule consent requirements primarily include the addition of a concise and focused summary of ‘key information’ before the body of the consent and a statement clarifying the future use of any biospecimens or private identifiable information (if applicable).

Page last updated 3:14 PM, January 14, 2019