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How do I develop consent forms and who reviews them?

Informed Consent forms are the primary way to inform a research participant about the details of your study. Once enrolled, participants may refer to this document for facts about the frequency of study visits, who to call for questions and other study-related information. It is very important that Informed Consent forms are easy to read, understandable and that all technical language is explained and defined. Participants must understand the potential risks and benefits, the difference between standard care and investigational care, the concepts of voluntariness and ability to withdraw consent at any time during the study.

The Code of Federal Regulations (45 Part 46.116) provides guidance on general requirements for a Informed Consent form. An Informed Informed Consent Checklist from OHRP clearly describes the basic required elements and additional elements in Informed Consent forms. Most IRBs will request that Informed Consent forms be written at a 6-8th grade reading level. Microsoft Word has a readability program which can be found under “Tools - Options”. But more importantly, you may want to ask persons similar to your study participants in age and educational level to read the form, ask questions, and provide suggestions for improvement.

Once your IRB has approved your study Informed Consent forms, you must send the approved version to your Program Director. Please forward the accompanying approval letter or the Informed Consent form with the official IRB stamp and date. NHLBI has Guidelines for Informed Consent forms in Multicenter Clinical Studies which outlines content and format for Informed Consent forms that will be used at multiple centers for a single protocol.

Your IRB may require that you include HIPAA Privacy Rule information in your Informed Consent form or that you create a separate form to explain this to research subjects. For more information see: What is HIPAA and how do I abide by the requirements?

Other resources to guide you in creating a good Informed Consent document:

Page Last Updated: February 2011
Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov

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