IRB Informed Consent Process and Consent Forms

The central concept in the protection of human subjects is to ensure that the individual can make an informed decision on whether or not to participate in research. Prospective participants must be given adequate information on both the possible risks and the potential benefits of their involvement to allow them to make informed decisions. As a researcher, it is your responsibility to educate potential participants about risks and benefits, obtain their consent before involving them in your research, and keep them informed.

Informed consent is not a single event or just a form to be signed – rather, it is an educational process that takes place between the investigator and the prospective subject. The informed consent process is usually documented with a consent form signed by the research participant. In certain cases, documentation of consent may be waived and an information sheet used instead. Samples of both types of forms are provided below.

Sample Consent Forms

Other Resources