PROCEDURES:

New Central/Single IRB Application Submission

Study Team Responsibilities:

  • Study team will obtain the applicable study documents from the IRB of Record. These include:

Current version of the protocol

Consent(s) with required local language inserted

  • The UVA study team OR the IRB of Recordwill add local context wording agreed upon by the UVA IRB and the IRB of Record to the consent form template approved by the IRB of Record

Original approval from the IRB of Record

Most recent continuation approval if applicable

  • Enter Protocol Builder and complete submission documents for a protocol overseen by an outside IRB.
  • The documents are reviewed by the UVa PI.
  • Submit the following documents to the UVA IRB all required submission documents IRB-HSR at

CIRB Application built in Protocol Builder

Data Security Plan

Protocol Coversheet

Any required local approvals (HIRE, Information Security, PRC, etc.)

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.
  • IF UVA IS ACTING AS THE PRIVACY BOARD an IRB-HSR/ Privacy Board Approval will be granted for any applicable HIPAA waivers.
  • The IRB-HSR will post the following documents in IRB Online

Training Certificate

(if applicable) IRB-HSR/ Privacy Board Approval of any HIPAA waivers to the study team.

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 sectionbelow.

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 () 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:

  • 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 anIRB-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:

  • 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 identify the appropriate IRB of Record on the Personnel Change form.

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.

NOTE: The only exception to this are:

  • Change of PI: Submit a signed CIRB Investigators Agreement to the IRB-HSR. Scan and email to
  • 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-HSRAdministrative 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 Boardall 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 at .

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:

  • The UVA study team will report the following to the IRB of Record :

Unanticipated problems including adverse events

Injuries to subjects,

Protocol deviations/violations

Changes initiated without approval from the IRB of Recordto eliminate apparent immediate hazards to subjects

Complaints

Non-compliance that does not rise to the level of serious or continuing.

  • UVA study team OR the IRB of Recordis responsible for notifying UVA IRB when Unanticipated Problems, issue of serious/continuing noncompliance, subject complaints or research noncompliance occur. The reason for this is that even if a UVA IRB is not responsible for reporting to outside agencies, they retain the a responsibility to report to institutional officials.
  • Report to UVA IRB using IRB-HSR procedures located
  • When completing the report it is advisable attach all applicable information (e.g. reports to IRB of Record, corrective action plans etc. )

IRB-HSRAdministrative Responsibilities:

  • If the IRB of Record is responsible for reporting Serious and Continuing Noncompliance to outside officials. UVA is not responsible for duplicate reporting however they do retain responsibility for reporting to Institutional Officials.
  • 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.
  • Any issues of suspected Research Misconduct will be reported to the University of Virginia Research Integrity Officer (RIO)

RECEIPTS

Study team responsibilities:

  • Submit all receipts to theIRB of Record. The IRB-HSR will not provide acknowledgement of receipt of study documentation as the IRB-HSR is not the IRB of Record

IRB-HSRAdministrative Responsibilities:

  • Return requests for receipt of acknowledgement to the study team

Additional Resources

Learning Shot: Single IRB Review for Multi-Site Studies

NIH Policy on the Use of a Single IRB for Multi-Site Research

NIH Single IRB Policy FAQs for Extramural Community

Scenarios to Illustrate the Use of Direct and Indirect Costs for Single IRB Review under the NIH Policy on the Use of a Single IRB for Multi-site Research

UVA IRB Reliance Agreements- Frequently Asked Questions