Informed Consent Writing

By Divya Bharti, Senior Medical Writer

Informed consent is one of the central protections the regulations provide to research participants. This tip sheet outlines the regulatory requirements for research informed consent forms (ICFs).  The regulatory requirements for informed consent will vary depending upon which regulations apply to the conduct of a particular study.

Note: Individual institutional review boards (IRBs) may have their own specific policies regarding how ICFs should be formatted, how to address certain regulatory criteria, and other considerations. Always check with your IRB of record to confirm you understand its requirements.

To print this checklist, right-click and select ‘Print’. You can then use this checklist offline as a PDF if desired.