The consent process provides individuals with sufficient information for making informed decisions about participation in a clinical research study. The following documents are provided as a tool to assist NIA investigators for developing a comprehensive informed consent:

• Informed Consent Template [2] (MS Word, 115K) provides a general outline of a study specific informed consent document. It is crucial that investigators consult with their local IRB for any institution-specific templates and / or requirements regarding the format and content of the consent document.
• Informed Consent Checklist [3] (MS Word, 55K) presents required and additional elements of the consent forms as set forth in Code of Federal Regulations.