This document replaces: ‘ Approval Dates on Consent Documents and Recruitment Materials ’ Statement of Practice. Click here for PDF version.

Effective December 3, 2018, the pre-transition informed consent template is no longer in use. All new informed consent documents must be based on the revised Common Rule informed consent template below.

To ensure that study teams are utilizing the most recently IRB-approved consent document at the time of amendment, IRBMED has standardized version control practices. Click here for PDF version.

The Food and Drug Administration’s regulation at 21 CFR 50.24 allows a narrow exception to the requirement to prospectively obtain and document informed consent from research subjects. According to the regulation, IRBs may approve certain emergency...

This template should be used when creating a One-Time Blood or Specimen Sample ( Minimal Risk ) informed consent document. You may not use this template if you plan to conduct genetic analysis on subjects’ samples you plan to submit subjects’...

This template should be used when creating an Eligibility Screening Informed Consent document. This template may be used only for eligibility screening and only if screening procedures pose no more than minimal risk to subjects. You may not use this...

In most cases, a potential research subject (or subject's representative) must be given an explanation of the protocol , including its risks , benefits , and alternatives. The subject's voluntary and un-coerced choice to participate must usually be...