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Free toolkit helps researchers obtain informed consent

The Agency for Healthcare Research and Quality (AHRQ) is offering a free toolkit to help researchers obtain research participants' informed consent and authorization to use their health data in accordance with the Privacy Rule of the Health Insurance Portability and Accounting Act (HIPAA). The toolkit provides information on how to ensure that people of all health literacy levels understand what studies entail and to what they are consenting when they agree to participate. AHRQ developed the toolkit because researchers often use long consent forms that potential study participants can find difficult to comprehend. Research also shows that a large proportion of study participants did not understand what they had consented to when they joined a study.

There is also evidence that Institutional Review Boards often fail to meet their own standards for the reading level of consent and data-use forms. The AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research, which was tested by researchers from Boston University, includes recommendations for improving the informed consent and authorization process; sample consent and HIPAA authorization documents in English and Spanish; recommendations for adapting and testing the documents; statutory requirements and exceptions; and a tool for researchers' certification of consent and authorization. It is available at www.ahrq.gov/fund/informedconsent.

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