Informed Consent Overview - Module 1s Sec 2


Module 1 Objectives

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

The Process

Obtaining 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.