Institutional Review Board for Health Sciences Research (IRB-HSR)

Resources

Central/Single IRB Procedures

PROCEDURES:

New Central/Single IRB Application Submission

Study Team Responsibilities:

IRB-HSR Administrative Responsibilities:-

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 BECAUSE UVA IS NOT THE IRB OF RECORD.

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.

Status Change


DO NOT send a notification of Status Change to the IRB-HSR unless the study is being closed.
See CLOSURE section below.

Continuations


Study Team Responsibilities:
  1. Continuation reviews will be completed by the IRB of Record.
  2. Within 14 business days of receiving the continuation approval from the IRB of Record, the study team will email (irbhsrcontinuations@virginia.edu) the following documents electronically to the IRB-HSR:
    • Continuation approval from the IRB of Record
    • 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 for continuation review. It is up to the study team to submit this information to the IRB-HSR. IRB-HSR does send out reminders when these documents have not been received

IRB-HSR Administrative Responsibilities:

Upon receipt the IRB-HSR staff will:

Personnel Changes

Study Team Responsibilities:
Submit notification of a personnel change with an IRB-HSR Personnel Change Form. This must be submitted to the IRB prior to a new individual having access to subjects or their identifiable data or specimens or when an individual is no longer working on the study. 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:

Modifications

Study Team Responsibilities:
  1. Modification reviews will be completed by the IRB of Record. If a study is closed to enrollment, the IRB of Record will notify the study team if they should use a revised consent form or an addendum they provide to re-consent 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.

  4. 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 IRB of Record.
  2. See How to submit advertising if the UVA IRB-HSR is not the IRB of record for your study
  3. Note that Marketing Approval may still be required for press releases that mention UVA and/or for ads that use the UVA logo. These should be submitted directly to Marketing and do not involve IRB-HSR.
  4. Submit UVA HS Clinical Trials Website ads along with documentation of approval from the IRB of Record to IRB-HSR

IRB-HSR Administrative Responsibilities:

  1. Not responsible for review.
  2. Responsible for uploading UVA HS Clinical Trials Website ads

HIPAA Issues

If the IRB of Record will not serve as the HIPAA Privacy Board all subjects enrolled at UVA 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.

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 IRB of Record by the UVa study team.

Closures

When the protocol is CLOSED/ INACTIVE send an email notification to the IRB-HSR atirbhsr@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.

Unanticipated Problems, Serious or Continuing Non-Compliance, Subject Complaints or Research Misconduct


Study team responsibilities:

IRB-HSR Administrative Responsibilities:

Last Modified: Wednesday, 24-Jan-2018 10:27:02 EST