27
July
2022
|
08:13 AM
America/New_York

Changes Regarding Carilion Clinic's IRB

 

Change regarding Commercial IRB for Investigator-Initiated Studies
 

Please note that Carilion has determined not to renew a Master Service Agreement to rely on WCG commercial IRB for Investigator-Initiated studies. When WCG is the single IRB of Record (sIRB) chosen by the sponsor as the reviewing IRB for a multi-center industry-sponsored research study, WCG may still be selected as the reviewing IRB in PRISM. For studies that are not multi-center industry-sponsored studies, Advarra should be the selected IRB of Record.

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* Click here to access the PRIS3M Online IRB Submission System.

 

Documenting use of a Legally Authorized Representative in research studies
 

In order to simplify the documentation process for researchers, the process for documenting use of a Legally Authorized Representative in research studies has been revised.

Carilion IRB is no longer requiring the use of the separate LAR Assurance Form. Instead, the revised biomedical consent form template has a signature section pertaining to use of a LAR in research. This section must be reviewed and completed when a LAR will provide consent from a research participant.

If the study is approved for the use of a LAR, the IRB Approval letter will contain important information about use of LARs in the research study. Please review the information in the IRB Approval letter carefully. Failure to complete the consent form appropriately or failing to follow the information in the approval letter may constitute noncompliance.

The use of Legally Authorized Representatives for research consent must still be requested, justified, and approved by the IRB.

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