Informed Consent

Federal regulations require that researchers obtain legally effective, documented, voluntary informed consent from prospective subjects (or subjects' legally authorized representatives) before subjects may be included in research.

The primary purpose of informed consent is to protect the prospective human subjects. Informed consent provides the individual with the pertinent information regarding the research in which s/he is being asked to participate, and the opportunity to make an informed decision regarding whether or not to participate in the research. 

Keep in mind that obtaining informed consent is a continuous process throughout the research, not simply a one-time event when a subject signs a form.

To ensure informed consent, researchers should:

  • Work to communicate clearly and effectively with their participants and to build trust and cooperation.

  • Openly and willingly explain their research, answer questions and be sensitive to the needs and concerns of their prospective research participants.

Informed consent forms and scripts should be written at an eighth-grade reading level to ensure that prospective subjects are truly informed. See the Informed Consent Template for an example of informed consent at the eighth grade reading level. (For additional help, see Readability Tools below.)

When using an informed consent form, a final version, as it will appear to your subjects (e.g., on letterhead), must be included in the protocol. 

If no informed consent form will be used, a waiver for documented informed consent must be requested and an information sheet and/or informed consent script may be required.

Further Explanation