Clinical Research Study Investigator's Toolbox
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 (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 (MS Word, 55K) presents required and additional elements of the consent forms as set forth in Code of Federal Regulations.
Informed Consent Version Tracker (MS Excel, 20K) provides a template with two examples of tools that sites may use to track informed consent versions; this helps minimize the use of expired versions and the occurrence of consent deviations.