NCI CIRB Updated SOPs – Common Rule 2018 Requirements
Dear CIRB Stakeholders,
The CIRB policies have been updated to reflect the Common Rule 2018 Requirements per the revised regulations. The revised SOPs capture the Common Rule pre-2018 Requirements, 2018 Requirements, and FDA regulations. The CIRB is not transitioning any studies that were approved under the pre-2018 Requirements to the 2018 Requirements. These will remain under the pre-2018 Requirements for the life of the study. Since FDA did not adopt the revised Common Rule, FDA regulations are unchanged and will be followed for all applicable studies.
What you can expect?
- Continuing Review: The CIRB will continue to conduct continuing review for all studies under our purview.
- Adult Informed Consent Documents: The December 2018 NCI Informed Consent Template complies with the 2018 Requirements.
- Pediatric Informed Consent Documents: Pediatric studies approved after January 21, 2019 will use the COG template addressing regulatory changes.
- Broad Consent: The CIRB is not adopting the use of broad consent for future use of biological samples.
Click here for a summary of the changes to the SOPs.
Please contact the CIRB Helpdesk with any questions.