CIRB Procedures
Version Date: 02/29/16
PROCEDURES:
New Submission
Study Team Responsibilities:
 Study team will obtain the applicable study documents from the CIRB.
 Enter Protocol Builder and complete submission documents for a protocol overseen by an outside IRB.
 The study team will add local context wording as designated by the CIRB to the consent form template,
and complete all applicable forms.
 The documents are reviewed by the UVa PI.
 Submit all required submission documents IRB-HSR.
 If the CIRB has previously approved the study, submit CIRB approval with initial documents. If the
CIRB has not yet approved the protocol, submit the CIRB approval to the IRB-HSR within 5 days of
receipt.
 The IRB-HSR will email the following to the study team:
 training certificate
 (if applicable) IRB-HSR/ Privacy Board Approval of any HIPAA waivers to the study team.
 Following receipt of documents from the IRB-HSR, the study team will submit applicable documents to
the CIRB.
IRB-HSR Administrative Responsibilities:
IRB-HSR staff will verify all training and documentation is in order and approvals from all other applicable
committees have been received.
An IRB-HSR/ Privacy Board Approval will be granted for any applicable HIPAA waivers.
Once this review is complete the documents will be emailed to the study team.
IRB-Staff- see info on U/ IRB/IRBHSR/ Admin FAQ/Central IRB’s
Local Context Wording for Consent Form
IT IS THE RESPONSIBILITY OF THE UVA STUDY TEAM TO VERIFY THAT ALL UVA LOCAL
CONTEXT WORDING IS INCLUDED IN THE CONSENT FORM.
THE IRB-HSR DOES NOT APPROVE THE CONSENT FORM.
Reminder: UVa has a required signature section for Surrogate Consent. This is typically a section that is
locked by the IRB of Record. It is the responsibility of the study team to work with the IRB of Record to make
sure the UVa required wording is inserted into the consent if the IRB of Record has approved the use of a
Legally Authorized Representative.
Unless otherwise notified in writing from the IRB-HSR, revisions to local context wording do NOT need to be
incorporated into previously approved consent forms.
Continuations
Study Team Responsibilities:
1. Continuation reviews will be completed by the CIRB.
2. Within 14 business days of receiving the continuation approval from the CIRB, the study team will
email (irbhsrcontinuations@virginia.edu) the following documents electronically to the IRB-HSR:
 CIRB continuation approval
 Documentation of any personnel changes since the last continuation approval using
the IRB-HSR Personnel Change Form
NOTE: The IRB-HSR will NOT sent out Status Forms or reminders for continuation
review. It is up to the study team to submit this information to the IRB-HSR.
IRB-HSR Administrative Responsibilities:
Upon receipt the IRB-HSR staff will:
 Update applicable personnel changes in IRB Online
 Verify current training in Humans Subject Research Protections and email the training certificate
to the study team.
Personnel Changes
Study Team Responsibilities:
Submit notification of a personnel change with a IRB-HSR Personnel Change Form. This may be done either at
the time of continuation review or at any other time during the year. If not done at the time of continuation
review note that it is critical that the applicable IRB of record is noted on the Personnel Change Form!
IRB-HSR Administrative Responsibilities:
Upon receipt the IRB-HSR staff will:
 Update applicable personnel changes in IRB Online
 Verify current training in Humans Subject Research Protections
 The training certificate is ONLY sent to the study team at the time of continuation.
 IMPORTANT: It is critical that the study team check the appropriate IRB of Record on the
Personnel Change form.
Modifications
Study Team Responsibilities:
1. Modification reviews will be completed by the CIRB. If a study is closed to enrollment, the CIRB will
notify the study team if they should use a revised consent form or an addendum they provide to reconsent the subject.
2. If a Consent Short Form is needed for a potential subject that speaks a language other than English or
Spanish, see the information located on Alternative IRB of Record.
3. No documentation is required by the IRB-HSR.
NOTE: The only exception to this are:
 Change of PI: Submit a signed CIRB Investigators Agreement to the IRB-HSR. Scan and
email to irbhsr-mods@virginia.edu

Change in the Recruitment section that would require a new HIPAA Waiver. The only change
that would require a new HIPAA Waiver would be if the study team now plans to add contacting
potential subjects by a person who is not a member of their health care team.
Advertisements
Study Team Responsibilities:
1. Advertisement review will be completed by the CIRB.
2. See How to submit advertising if the UVA IRB-HSR is not the IRB of record for your study
3.
IRB-HSR Administrative Responsibilities:
Upon receipt the IRB-HSR will update information in IRB Online and documentation will be filed
electronically in the IRB-HSR file. A receipt event is added into IRB Online. No approval from the IRB-HSR
is granted.
HIPAA Issues
The outside IRB will serve as the HIPAA Privacy Board as noted below. If the outside IRB will not serve as
the HIPAA Privacy Board (answered No below) all subjects must sign the IRB-HSR Stand Alone HIPAA
Authorization in addition to the study consent form. Links to the appropriate form may be found on the
Alternative IRB of Record website page.
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CITN CIRB (Fred Hutchinson Cancer Research Center IRB- NO
NCI CIRB- NO
NeuroNEXT CIRB (Partners IRB)-YES
PETAL CIRB (Vanderbilt IRB) - YES
Western IRB- NO
Data Breach
Any data breach will be reported per the UVa Information Security Incident Reporting Policy.
The data breach will be reported to the IRB of Record if the report meets the criteria of an Unanticipated
Problem.
Subjects Enrolled as Minors who Reach the Age of Majority
If a subject was enrolled while a minor and they have now reached the age of 18, you may use the following
two forms as a template to obtain consent of the subject.
Age of Majority: Cover Letter Template
Age of Majority Consent Addendum
Post Approval Monitoring
Post Approval Monitoring will be done by Post Approval Compliance Monitors from the UVa Office of the VP
for Research. Copies of the monitoring reports will be sent to the CIRB by the UVa study team.
Closures
When the protocol is CLOSED/ INACTIVE send an email notification to the IRB-HSR at irbhsr@virginia.edu.
DO NOT send any notification if the only status change is something like, closed to enrollment, or doing
follow-up or data analysis only.
Serious or Continuing Non-Compliance
The staff of the IRB-HSR will report any Serious or Continuing Non-compliance of which they become aware
to the IRB of Record and to UVa Institutional Officials.
Other Required Reporting
All reporting including the items noted below should be made by the UVa study team to the CIRB via
procedures outlined in their Standard Operating Procedures.
 Unanticipated problems including adverse events
 Injuries to subjects,
 Protocol deviations/violations
 Changes initiated without CIRB approval to eliminate apparent immediate hazards to subjects
 Complaints
 Non-compliance that does not rise to the level of serious or continuing.