The AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research

The Agency for Healthcare Research and Quality (AHRQ) has developed the Informed Consent and Authorization Toolkit for Minimal Risk Research to facilitate the process of obtaining informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization from potential research subjects. This toolkit contains information for people responsible for ensuring that potential research subjects are informed in a manner that is consistent with medical ethics and regulatory guidelines.

Contents

Chapter 1. Background

• Why a Toolkit?
• Development of This Toolkit
• Informed Consent, HIPAA Authorization, and Adult Health Literacy

Chapter 2. How To Improve Informed Consent and Authorization

• Improving the Process
• Adopting New Processes and Documents in Your Institution
• Improving the Informed Consent and Authorization Process
• Using the Tool for Researcher's Certification of Consent and Authorization
• Improving the Forms
• Sample Documents for Informed Consent and HIPAA Authorization (English and Spanish versions)
• Adapting and Testing AHRQ Sample Documents

Chapter 3. Regulatory Requirements

Chapter 4. Resources

• Other Resources From the Department of Health and Human Services

References