Informed Consent

Investigators need to submit the final consent form to NCCAM prior to initiating the clinical study. The consent process provides individuals with sufficient information for making informed decisions about participation in a clinical research study. The following documents are examples of tools to assist NCCAM-funded investigators in developing a comprehensive informed consent:

• Informed Consent Checklist [34KB Word file]—presents required and additional elements of the consent form as set forth in the Code of Federal Regulations.
• Informed Consent Template [69KB Word file]—provides a general outline of a study-specific informed consent document. It is essential that investigators consult with their local institutional review board (IRB) for any institution-specific templates and/or requirements pertaining to the format and content of the consent document.