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

For information regarding Transfer of IRB Oversight FROM the UVA IRB to a Non-UVA IRB, see Transfer of IRB Oversight document.

Note:  For an overview of Single IRB review, please view the UVA Learning Shot found here:  https://hrpp.irb.virginia.edu/learningshots/Single-IRB-Review-for-Multi-Site-Studies/presentation.html

 

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 is the site that has entered into a 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): 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 under Participating Institutions. For additional information on the Master Agreement with SMART, see HERE.

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 on a stand-alone Reliance Agreement

UVA Study Team Responsibilities:

Enter CRConnect to complete study start-up.  For additional information on CRConnect, see HERE

Email: CRConnectSupport@hscmail.mcc.virginia.edu

 

Following completion of steps in CRConnect, the CRConnect system will automatically submit an initial email to the UVA IRB-HSR for administrative prereview. The submission will contain (at minimum) the following documents:

  1. IRB Reliance Agreement Request Form: Non-UVA IRB as IRB of Record
  2. IRB Protocol coversheet
  3. Non-UVA 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/Initial 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. Local Context language is appended to the IRB Reliance Agreement Request form. 

  • The documents will be reviewed by the IRB and returned to the individual that submitted the initial documents for pre-review via EMAIL with tracked changes and comments within 5 working days.
  • After all changes have been addressed, the study team will email the revised documents to the IRB-HSR administrative staffer that performed the pre-review.
  • The study team will be provided instructions on obtaining signatures for the Non-UVA IRB application via CRConnect.
  • The study team will receive email communication via IRB Pro that the study is open to enrollment.
  •  Reporting responsibilities for the UVA study team will also be provided. 

Note: Translation Requirements:

FULL BOARD STUDIES: If the UVA study team will use the short forms or full translation of the consent from the Non-UVA IRB, a certification of translation must be submitted.

FOR EXPEDITED STUDIES: If the UVA study team will use the short forms or full translation of the consent from the Non-UVA IRB, the IRB will accept any of the following documents:

  • Certification of translation from a vendor
  • Written confirmation of inclusion of the same information obtained from a back translation by a person independent of the study (e.g. one individual creates a written document in the new language, and another person reviews the English and new language version and confirms they include the same information; include any credentials, certifications, education, native language fluency, etc. of the individual confirming the two documents include the same information.)
  • Written confirmation of inclusion of the same information in both of the documents by an IRB member or other person who is fluent in both English and the language being translated. Study team must provide the written confirmation or verify the IRB has a member who is fluent in both languages who could conduct the review; include any credentials, certifications, education, native language fluency, etc. of the individual confirming the two documents include the same information.

 

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 via IRB PRO-Submit Documents: Continuations
  • Continuation approval from the IRB of Record
  • Documentation of any UVA personnel changes since the last continuation approval. 
  1. The IRB-HSR will provide the UVA study team with an updated Human Subject Research Training Certification Form only. 

Personnel Changes

When UVA is relying on a Non-UVA IRB, you may update study personnel via IRB PRO-Personnel Changes 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.  A change to the UVA PI requires a Modification submission-see below.

Modifications:   

  1. Modification reviews will be completed and approved by the IRB of Record.  If a study is closed to enrollment, the IRB of Record will notify the UVA study team whether a revised consent form or an addendum be used.
  2. All modifications that apply to a Change in study PI at UVA, a Non UVA IRB application, Data Security Plan, Recruitment or, Compensation will be submitted to the UVA IRB as a modification request via IRB PRO-Submit Documents: Modifications.  For additional information on Modifications see HERE.
  3. Any revisions to pertinent documents will be available in IRB PRO.  The UVA study team will not receive an assurance of approval.  IRB PRO will be the source of documentation that the UVA IRB has acknowledged the revisions.
  4. If a Consent Short Form is required for a potential subject that speaks a language other than English or Spanish, and the IRB of record does not have an available short form, the UVA study team can access these forms located on Consent Short forms for non-English Speaking Subjects.

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.
                                                                      or
  2. Submit the approved ad with ad approval to the UVA IRB via IRB PRO-Submit Documents, including 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

  1. 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.
  2. 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 by the UVA study teams will not be reviewed or approved by the UVA IRB-HSR.  A copy of the UVA local consent context language is provided to the study team with the Reliance Agreement Request form. This 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 (Reviewing IRB)  will NOT serve as the HIPAA Privacy Board, then UVA IRB-HSR will serve 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.  The UVA IRB will process a modification to include the use of the Short forms.  Submit a modification request via IRB PRO-Submit Documents.

 

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 if not otherwise provided by the Non-UVA IRB. 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.  

 

Reportable Events (does not include NCI CIRB):

All unanticipated problems, protocol deviations, suspensions and terminations, noncompliance, subject complaints, etc. that occur with a UVA subject or at UVA, should be reported to the ‘overall PI’ at the external institution that is serving as the IRB of Record/Reviewing IRB per the IRB of record’s standing operating procedures. The overall PI will be responsible for reporting these events to the Reviewing IRB. The Reviewing IRB of record will notify the UVA study team of any such issues.

Submit the following events to the Non-UVA IRB per Standard Operating Procedures of the Reviewing IRB:

o Unanticipated problems at UVA or from UVA subjects

o Serious adverse events with a UVA subject

o Serious or continuing noncompliance

o Injury to UVA subjects

o Protocol deviations at UVA

o Complaints occurring at UVA or with UVA subjects

o Changes initiated without IRB approval to eliminate apparent immediate hazard to subjects

 

IMPORTANT: The UVA IRB only needs to be made aware of any reports of unanticipated problems, serious or continuing noncompliance or subject complaints occurring at UVA.

For NCI-CIRB studies:

The UVA study team will submit any serious adverse events, reports of unanticipated problems, serious or continuing noncompliance or subject complaints occurring at UVA or from UVA subjects directly to the UVA IRB-HSR.

Submit the following events to the NCI CIRB per standard Operating Procedures of the NCI CIRB:

  • Injuries to subjects
  • Protocol deviations/violations
  • Changes initiated without IRB approval to eliminate apparent immediate hazards to subjects
  • Complaints
  • Non-compliance that does not rise to the level of serious or continuing non-compliance

UVA Privacy Plan:

Researchers at UVA are required to follow the UVA Privacy Plan when conducting studies that are overseen by a non-UVA IRB.  A direct link to the Privacy Plan is found HERE.

National Cancer Institute IRB: CIRB for NCI Protocols (NCI CIRB)
Researchers wishing to open cooperative group oncology trials that have been approved by the National Cancer Institute Central Institutional Review Board (NCI CIRB) may submit the appropriate paperwork to the IRB-HSR. The NCI CIRB 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.