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Informed Consent and HIPAA Authorization

Guidance and templates for informed consent and HIPAA authorization documents

Informed consent is the process through which researchers provide the necessary information to potential participants so that a knowledgeable decision can be made about whether the individuals wish to take part in a research study.  This is an ongoing process that begins with initial recruitment of subjects and continues after the initial oral or written agreement form an individual to participate in a research study.  This page provides informed consent templates and guidance regarding the consent process and when the consent process can be altered, obtaining assent from children, surrogate consent guidelines, and the consent process for illiterate or non-English speaking subjects.

General Guidance
Reading Level
Special Consent Processes
Additional Required Language

Informed Consent Guidance
Informed Consent
Assent of Minors
Genetic Research and Use of Storable Tissues
Consent Form Summary Information Sheet
VA Informed Consent Guidance
Re-Consenting Subjects Guidance
Emergency, One-Time-Use

Templates and Wizards
Consent Form Templates
Consent Form Wizard
Other Resources for Informed Consent

HIPAA Authorization
HIPAA Authorization Guidance


Keywords:CF, HIPAA, consent form requirements, wizard   Doc ID:18632
Owner:Molly L.Group:Health Sciences IRBs
Created:2011-05-23 18:00 CSTUpdated:2013-12-19 14:30 CST
Sites:Health Sciences IRBs
Feedback:  4   3