Updated WPPs and PROC and Informatics instructions
The IRB’s Written Policies and Procedures (WPPs) were updated as of 6/18/2021 to align policies with the recent RAMS-IRB patch updates and are now available on the IRB’s website.
Important Instructions and FAQ’s for studies that will use VCU Health patients, data, and/or facilities:
What should I do if a Protocol Review Oversight Committee (PROC) has not been formed for my study’s topic area yet? If you do not see a PROC listed yet at https://onetrac.vcu.edu/ for your topic area, provide the IRB with an uploaded Note to File explaining that a PROC is not operating yet for [insert name] topic area.
What if there are multiple disciplines involved in a protocol? Does only one PROC need to review? Yes, only one PROC should formally review the protocol.
What if my study is ongoing? Do I need to upload PROC approval in an amendment? Documentation of PROC review/approval is only required for new studies submitted on or after June 17, 2021. Studies that were IRB approved before that date are grandfathered in, and amendments for those studies would not go to a PROC.
Questions about PROCs should be directed to Mary Harmon at mary.harmon@vcuhealth.org
Important Instructions for studies that use VCU Health data (PHI):
Investigators obtaining PHI from VCU Health are reminded to go to https://informatics.vcu.edu to request the desired PHI. This generally applies to studies obtaining data under a waiver of authorization (full or partial waiver for recruitment), limited dataset, or de-identified data HIPAA pathways. It does not apply to studies obtaining data for which the study team has authorization from the participant.
This requirement is in VCU Health System Authority and Affiliates Policy COMP-014 (effective 4/26/21), which directs members of the study team (including principal investigators) to obtain PHI by consulting with VCU Informatics or using another method approved by the VCUHS Privacy Office to obtain the PHI from VCU Health records. The Privacy Office and Informatics staff are available for a consultation on alternate methods to obtain the data.
The VCU HRPP does not enforce this policy, but we will remind investigators about it whenever studies appear to be proposing to search medical records and/or abstract data without the services of VCU Informatics. If an alternate method of obtaining the PHI from VCU Health records has been approved by the Privacy Office, upload that approval in your IRB submission to let us know about it.
What if my study is ongoing? Do I need to consult with Informatics during an amendment? Consultation with Informatics is only required for new studies submitted on or after June 17, 2021. Studies that were IRB approved before that date are grandfathered in, and amendments for those studies would not need to go to Informatics UNLESS something about the access to/use of PHI is changing.
Questions should be directed to the Privacy Office at 804-828-0500 or complianceservices@vcuhealth.org
Categories Announcements and Updates, Uncategorized