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.