Informed Consent Overview - Module 1m Sec 2


Module 1 Objectives
The Process
Basic Principles
A Brief History
What Research Must Be Reviewed
IRB Review Criteria

The Process

btaining a signature on a consent document 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 understand the purpose, the procedures, the potential risks and benefits of their involvement, and their alternatives to participation. While a consent document that gives 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 may need time to think about their decision and to discuss it -- if necessary -- with family, friends, or religious advisors.

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

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