Informed Consent and Authorization Toolkit

Full title
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.

Note: This Toolkit has not been updated since the revised Common Rule became effective January 21, 2019. It therefore does not cover changes in the Common Rule, such as new requirements for the informed consent form and process regarding the information that must be given to prospective research subjects. You can access the Final Rule, 45 CFR 46, at https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=83cd09e1c0f5c6937cd9d7513160fc3f&pitd=20180719&n=pt45.1.46&r=PART&ty=HTML.

Contents

Chapter 1. Background

Chapter 2. How To Improve Informed Consent and Authorization

Chapter 3. Regulatory Requirements

Chapter 4. Resources

References

Page last reviewed April 2019
Page originally created September 2012
Internet Citation: The AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research. Content last reviewed April 2019. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/funding/policies/informedconsent/index.html
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