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

Getting Started

Reliance on a Non-UVA IRB to serve as the Single IRB (sIRB) of Record

Overview

UVA researchers are often engaged in non- exempt human subject research that may involve collaborators and/or human subjects at other institutions. Both OHRP and FDA permit an IRB/institution the option to rely on the review of another IRB. When this is the intention, the two institutions enter into an agreement referred to as a Reliance Agreement. These agreements are executed between a Reviewing IRB and one or more Relying Institutions and delineate the roles and responsibilities of the involved parties. The scope of the Reliance Agreement may be limited to a specific protocol or to a group of protocols agreed upon by both parties. UVA IRB-HSR will only enter into an IRB Reliance Agreement for a study that requires expedited or full board review only.

Definitions

IRB of Record: A reviewing IRB (non-UVA IRB) that assumes IRB responsibilities for another institution/site.

IRB Reliance Agreement: A formal, written agreement in which the reviewing IRB agrees to serve as the IRB of Record for a Relying institution/site. The signed agreement permits a single IRB to review human subject research activities for more than one site.

Relying Institution/Site: A relying institution/site is the site that has entered into an IRB Reliance Agreement with another site's IRB to serve as the IRB of Record.

Non-Exempt Human Subject Research: any human subject research that does not meet the Exempt criteria in 45CFR46.

Engagement of Organization in Non-Exempt Human Subject Research: An organization is considered engaged in human research when its employees or agents, for the purposes the research project obtain 1) data about the subjects of the research through intervention or interaction with them; 2) identifiable private information about the subjects of the research; 3) informed consent of human subjects for the research; OR 4) a direct federal award to conduct human subject research, even when all activities involving human subjects are carried out by subcontractors (i.e. employees or agents of another organization). HHS Guidance: Engagement in Human Subjects Research.

Data Coordinating Center (DCC): a site that is responsible for the collection, verification and storage of data collected from all sites involved in a multi-site trial.

The decision to rely on another IRB raises several issues to consider.

For Researchers: Agreements avoid duplicate IRB review across institutions, but do not lessen researchers' oversight across those sites. The Reviewing Site’s PI must act as overall PI, collecting all regulatory information from all sites and informing the Reviewing IRB. The Relying Site’s PI must communicate all regulatory information from their site to the Reviewing Site's PI.

Extent of reliance agreement: Agreements only cover IRB review: Institutional reviews (ancillary non-IRB reviews such as investigational pharmacy, radiation safety, InfoSec) still need to be conducted at each institution as necessary per institutional requirements.

SMART IRB:
SMART IRB (Streamlined, Multisite, Accelerated Resources for Trials IRB Reliance platform) is not an IRB; rather it is a nationwide platform designed to simplify the process to rely on another IRB. UVA has an IRB Reliance Agreement in place with SMART IRB (UVA Tracking #19810) and can rely on any non-UVA IRB that also has an IRB Reliance Agreement with SMART IRB. SMART IRB members are listed at SMART IRB Participating Institutions and SMART Standard Operating Procedures.

Institutions not affiliated with SMART:

UVA may also enter into an agreement with an institution that is not affiliated with SMART; a signed Reliance Agreement must be in place between the reviewing IRB and UVA in order to conduct the study at UVA. The IRB staff will work with the UVA study team to collect the necessary signatures.

Study Team Responsibilities:

Initial Submission: (allow up to 10 working days for IRB administrative review)

Enter Protocol Builder and submit the following completed documents to SIRB@virginia.edu:

  1. IRB Reliance Agreement Request Form: Non-UVA IRB as IRB of Record
  2. IRB Protocol coversheet
  3. IRB application (WORD version)
  4. Data Security plan
  5. Requirements for any ancillary approvals (e.g. HIRE, PRC, IBC, InFoSec)
  6. Current Version of the Sponsor protocol (non-UVA protocol)
  7. Original Approval notice from the IRB of record
  8. If applicable, most recent continuation approval notice

Note: The UVA study team will add local context wording to the UVA local consent form approved by the IRB of Record. It is the responsibility of the UVA study team to verify that all UVA local context wording is included in the consent form. An approval notice is NOT granted for the consent, as the UVA IRB is not the IRB of record. Even though the UVa IRB-HSR will not serve as the IRB of Record, we are responsible for verifying that other compliance and educational requirements are met.

UVa student, employee/ faculty member work on a protocol that has or will be approved by an outside IRB and the subjects will NOT be enrolled at UVA:

NOTE: A Determination of UVa Agent Form may be applicable in this situation, but not always. Review this document BEFORE completing the process for relying on an outside IRB. If your study does not fit under the UVA Agent process, you are required to submit as noted above under "Initial Submission".

Continuations

  1. Continuation reviews will be completed by the IRB of Record (non-UVA IRB).
  2. The IRB-HSR will NOT send out Status Forms for continuation review or when the documents are not received by the IRB-HSR. It is up to the study team to submit this information to the IRB-HSR; if a SIRB study expires, the UVA IRB-HSR will notify the study team.
  3. Within 14 business days of receiving the continuation approval from the IRB of Record, the study team will email the following documents to the IRB-HSR(irbhsrcontinuations@virginia.edu):
    • Continuation approval from the IRB of Record
    • Documentation of any personnel changes since the last continuation approval.
  4. The IRB-HSR will provide the UVA study team with an updated Training certification form only.

Personnel Changes

Submit notification of a personnel change with an IRB-HSR Personnel Change Form. This must be submitted to the IRB-HSR 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!

Modifications:

  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 whether a revised consent form or an addendum be used.
  2. If a modification is required to the Data Security plan, or Recruitment or payment section of the IRB application, the study team will submit the revised document and InfoSec approval to SIRB@virginia.edu, and the UVA IRB will receipt the document. No documentation will be returned to the study team. They can log into IRB online for review of the Receipt.
  3. If a Consent Short Form is required for a potential subject that speaks a language other than English or Spanish, see the information located on Consent Short forms for non-English Speaking Subjects.
    NOTE: The only exception to this are:
    • Change of PI: Submit a signed (revised) IRB Application 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/Recruitment Material:

  1. Advertisement review will be completed by the IRB of Record. The IRB-HSR does not review or approve recruitment material for protocols when not the IRB of record. Follow the IRB of record's procedures to obtain approval of the advertisement.
  2. To request an ad to be posted on the UVA Health System Clinical Trials website:
    1. Submit the approved ad with ad approval from the IRB of Record through www.uvahealth.com/clinicaltrials using the Submit a Trial for Advertisement link. This option provides the dropdown fields to choose keywords and categories.

    2. or
    3. Submit the approved ad with ad approval to IRBHSRads@virginia.edu with the keywords and categories indicated on the ad. Available words can be found following the Submit a Trial for Advertisement link.

    The use of the UVA HS Clinical Trials Website Posting template is strongly recommended as the website has specific fields for information to be entered. The UVA IRB-HSR will post the submitted ad and will provide documentation of receipt

  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

Consent Documents
The consent forms to be used at UVA will not be reviewed or approved by the IRB-HSR. A copy of the UVA consent boilerplate language is provided to the study team during the SIRB application review. The boilerplate language is provided to the IRB of record. This boilerplate language includes UVA specific information including headers, HIPAA/privacy language, compensation in case of injury, contact information etc).

Requests for Acknowledgement of Receipt

UVA-IRB-HSR is not responsible for providing Acknowledgement of Receipts for studies using a Non-UVA IRB. Study teams should submit those documents requiring acknowledgement to the IRB of record.

HIPAA Issues

If the IRB of Record will NOT serve as the HIPAA Privacy Board, then UVA IRB-HSR serves as the HIPAA Privacy Board AND all subjects enrolled at UVA must sign the IRB-HSR Stand Alone HIPAA Authorization (English or Spanish) in addition to the study consent form.

Data Breach

Any data breach must 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.

Subject Enrolled as Minor 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 and Age of Majority Consent

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/Status Change
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, closed to enrollment, or doing follow-up or data analysis only. No closure form is needed-this is email notification only.

Unanticipated Problems, Serious or Continuing Non-Compliance, Subject Complaints or Research Misconduct
The UVA study team will report the following to the overall PI who is then responsible for reporting to the IRB of record:
- Unanticipated problems including adverse events
- Injuries to subjects,
- Protocol deviations/violations
- Changes initiated without approval from the IRB of Record to eliminate apparent immediate hazards to subjects
- Complaints
- Non-compliance that does not rise to the level of serious or continuing

NON-UVA IRB’s with Established IRB Reliance Agreements with UVA
Fred Hutchinson Cancer Research Center IRB: Central IRB for Cancer Immunotherapy Trials Network (CITN) Protocols (CITN SIRB)
Researchers doing research within the CITN NIH consortium may use the Fred Hutchinson Cancer Research Center IRB. The IRB-HSR will serve as the HIPAA Privacy Board.

National Cancer Institute IRB: SIRB for NCI Protocols (NCI SIRB)
Researchers wishing to open cooperative group oncology trials that have been approved by the National Cancer Institute Central Institutional Review Board (NCI SIRB) may submit the appropriate paperwork to the IRB-HSR. The NCI SIRB does not oversee research involving prisoners.
The IRB-HSR will serve as the HIPAA Privacy Board. Use the HIPAA Authorization forms found on the IRB-HSR Website under FORMS.

Partners IRB: Central IRB for NeuroNEXT Protocols
NeuroNEXT: “NINDS Network for Excellence in Neuroscience Clinical Trials” Partners Healthcare System, Inc. (“Partners”) is made up of Massachusetts General Hospital (MGH) and Brigham and Women’s Hospital, Inc. (BWH) and is collectively known as “Partners Human Research Committee” (Partners). Partners has been selected by the National Institute of Neurological Disorders and Stroke (“NINDS”) to serve as the Central IRB for the NINDS Network for Excellence in Neuroscience Clinical Trials (“NeuroNEXT”). NeuroNEXT is a network of academic institutions (each a “NeuroNEXT Network Clinical Study Site” or “CSS”) established by NINDS to facilitate rapid development and implementation of protocols in neurological disorders affecting adult and/or pediatric populations. MGH is the Clinical Coordinating Center for NeuroNEXT (the “NeuroNEXT CCC”). UVa is a NeuroNEXT Clinical Study Site. The University of Iowa will serve as the Data Coordinating Center. (NeuroNEXT DCC).
Researchers doing research within the NeuroNEXT NIH consortium may use the Partners IRB. Partners IRB will also serve as the HIPAA Privacy Board. Consent short forms may be used for either IRB. If using forms from the IRB-HSR, use forms located on the IRB-HSR Website under Forms/ Consent Short Forms

Vanderbilt IRB: Central IRB for PETAL Protocols
PETAL: Prevention and Treatment of Acute Lung Injury
Researchers doing research within the PETAL consortium may use the Vanderbilt IRB. The Vanderbilt IRB will also serve as the HIPAA Privacy Board. Consent Short Forms may be obtained from the Vanderbilt IRB.

Additional Resources

Questions? Contact:

Eileen Sembrowich
Associate Director IRB-HSR
434-243-6542/ecs3b@virginia.edu

Joanna Faulconer
Compliance Coordinator IRB-HSR
434-982-1855/jld6p@virginia.edu