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.
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Contents
Background
Why a Toolkit?
Development of This Toolkit
Informed Consent, HIPAA Authorization, and Adult Health Literacy
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
Regulatory Requirements
Resources
Other Resources From the Department of Health and Human Services
References
AHRQ Publication No. 09-0089-EF
Current as of September 2009
Internet Citation:
The AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research. AHRQ Publication No. 09-0089-EF, September 2009, Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/fund/informedconsent/
540 Gaither Road Rockville, MD 20850 