Informed Consent Process Toolkit

Obtaining informed consent is more than just a signature on a form.

Obtaining informed consent is an educational process that takes place between the Investigator and the prospective subject; the Investigator uses this opportunity to confirm that each participant understands what will happen and has the opportunity to ask questions.

The goal is to provide information so that prospective subjects understand the nature of the research and can knowledgeably and voluntarily decide whether or not to participate.  Informed consent is one of the primary ethical requirements of research with human subjects as it reflects the basic principle of respect for persons.

Investigators may seek consent only under circumstances that:

• provide the prospective subject (or representative) enough time to consider whether or not to participate,
• minimize the possibility of coercion (intimidation) or undue influence, and
• present the information in a language that is understandable to the subject or representative (the person who signed the consent form must be given a copy as a reference and reminder of the information conveyed