Updated IRB Policy on Blood Volumes in Research
After reviewing current regulatory guidances and industry best practices, Advarra has updated its IRB policy for documenting total blood volume in research. The study ICF must include the number of blood draws a participant will experience, and the protocol must include general information about blood draws. This revised policy is effective immediately.
Federal regulations require the ICF describe study procedures, including blood draws and reasonably foreseeable risks which may result from blood draws, to help potential participants make an informed decision about participating in a clinical trial. Advarra does not require the total blood volume be detailed in the ICF.
The study protocol must include general information about blood draws but does not necessarily need to include details regarding the number of blood draws of volumes. However, depending on the study design and participant population, the IRB may require additional information regarding blood draws to help ensure risks to participants are minimized.
For more information on the regulatory requirements, please review FDA’s Informed Consent Information Sheet. Contact Business Development with questions about how this policy might apply to a specific study.