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.
- 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