HOW TO PRINT To print this page, use your browser's print button. To print the entire document, download the PDF or click here and use your browser's print button. TOOLS & BACKGROUND MATERIALS OBA Brochure, "Deciding Whether to Participate in Gene Transfer Research" NHF Brochure, "What You Should Know About Enrolling in a Gene Therapy Trial" ECRI Brochure, "Should I Enter a Clinical Trial?" CDC Brochure, "Taking Part in Research Studies: What Questions Should I Ask?" NCI Brochure, "A Guide to Understanding Informed Consent" Annas GJ. Reforming Informed Consent to Genetic Research. JAMA 2001. Brody BA. Making informed consent meaningful. IRB: A Review of Human Subjects Research 2001. FDA Guidance on Consent Process
MAIN POINTS Informed consent is a communication process, not a form. Various methods and tools exist to improve comprehension of information.

DISCUSSION
Informed Consent - A Process, Not a Form: Informed consent is much more than a document or obtaining a participant's signature on a consent form. Informed consent is a process of communication between an investigator and a potential research participant.

The purpose of the consent process is to:

• Ensure that potential participants understand that they are being asked to participate in research, and that they appreciate the differences between research and treatment
• Foster potential research participants' understanding of what to expect from participation in a study
• Encourage and respond to questions about study participation
• Facilitate discussion, reflection, and free and informed decision making

The consent form serves as a record of the information conveyed to the potential participant about participation in the study. The signing of the consent form provides documentation that the individual has agreed to participate in the study.

Improving Understanding and Voluntariness: A crucial outcome of the consent process is that potential participants understand pertinent information about the research. Another important outcome is that potential participants understand that the choice to participate is theirs and that refusal to participate will not jeopardize their clinical care. A number of techniques have been shown to increase understanding and voluntariness, including:

• Having the potential participant take information home
• Having a relative or friend present during discussions with the researcher
• Using videotapes, question and answer pamphlets, drawings, computer modules, or other educational tools to provide information about the research
• Having a research nurse or another qualified person also talk to the potential participant and offer to answer questions

A number of concepts that are crucial to improving understanding and voluntariness are discussed more fully in the Voluntary Participation, Time for Decision-Making, Consent Form, and Comprehensibility sections.