Informed Consent Overview - Module 1m Sec 1


Informed Consent Introduction
The Informed Consent Process
Basic Principles of Informed Consent
A Brief History
What Research Must Be Reviewed
IRB Review Criteria
Overview Quiz

II. The Informed Consent Process

Informed consent is a process that should be taken seriously. It is not just a matter of submitting a document or gaining a participant's consent. Obtaining a signed consent document that grants agreement to participate in a study is important, but it is just one step in the continuous process of informed consent.

Informed consent is about people's understanding and willingness to participate in your study and not about signing a form. Prospective participants in your research study must be fully educated about the purpose, the procedures, the potential risks and benefits of their involvement, and their alternatives to participation. A consent document that explains this information and more, is a vital part of the process. The opportunity to discuss any questions or concerns with a knowledgeable research team member is also necessary. In addition, prospective participants should be given time to think about their decision and to discuss it – if necessary -- with family, friends, or religious leaders.

Making an informed decision about participating in research includes having an understanding of the possible risks and benefits to their involvement, and knowing that they absolutely do not have to volunteer.