Thomas Jefferson University

SMART IRB

SMART IRB Reliance Agreements

The SMART IRB Agreement is a national master agreement that allows institutions to avoid having to negotiate individual IRB authorization agreements per study or group of studies. Participating Institutions may cede review of human subjects research to any other Participating Institution’s IRB under this agreement.

Check the Participating Institutions list to see if your collaborator’s institution is a member of SMART IRB.

The Jefferson contact for questions regarding SMART IRB is Crystal Lijadu at Crystal.Lijadu@jefferson.edu or 215-503-3849.



Process flow for requesting reliance with a SMART IRB Participating Institution

Jefferson Relying on External IRB:  SMART IRB Member Institution

Jefferson study team creates a new submission application in the IRB Portal in order to process the reliance agreement:
  • Submission includes: OHR-1 (indicate SMART IRB and include Jefferson Personnel only), Protocol, summary of specific duties of Jefferson personnel and activities to occur at Jefferson, Main ICD, Approval Letter
The submission will be reviewed to verify eligibility to proceed with other Institutional IRB Review.
  • Once confirmed TJU will cede review via SMART IRB online platform or Letter of Acknowledgement (depending on reviewing IRB's preference)
  • Please note: This does not constitute authorization to begin research activities, see additional steps below
The submission will be administratively reviewed.
  • If applicable, the consent forms will be reviewed to ensure Jefferson template language is included, and the study team will work with Jefferson IRB to complete any requested local context information
  • Once correspondence is received from OHR confirming all applicable elements are in place, the study team will forward the study documents to the external IRB for review and approval
The study team will email the final approved protocol, consent form and any additional materials approved for use at Jefferson to the Jefferson IRB.
Upon receipt of all required documents, Jefferson IRB will provide study team with Study Activation email.
  • Research activities may now commence
  • As per the reliance agreement, the PI and study team remain responsible for ensuring all TJU IRB reporting requirements are maintained throughout the life of the study
  • The PI and study team are to provide TJU IRB with copy of annual and final reports submitted to the external IRB

 

Jefferson Reviewing IRB (IRB of Record):  SMART IRB Member Institution

TJU study team creates a new submission application in the IRB Portal following all institutional requirements.
  • Submission will be reviewed and approved
*If adding site(s) to existing study follow process beginning below:

Upon receipt of IRB approval, the study team creates an amendment application in the IRB Portal to add additional site(s):
  • Submission includes: OHR-12 (include name of local site, PI and key personnel, and summary of specific activities to occur at external site), proof of human subjects training for external PI and study personnel, completed local context questionnaire
  • If applicable, include site specific consent form and partially completed SMART IRB Acknowledgement (if utilizing this form)

PI/Study team go to SMART IRB website.

 

Note:  At this time investigators may utilize the SMART IRB Acknowledgement in lieu of the SMART IRB website

  • Request investigator access
  • Upon receiving access, create a new request for reliance:
  • Provide study details
  • List engaged sites
  • Identify activities and personnel at each site
  • Upload Protocol and consent templates

The amendment and SMART IRB reliance request will be reviewed.
  • If appropriate, Jefferson will provide study team with an Implementation checklist
  • The study team will share implementation checklist with local site/IRB
  • Upon approval of the amendment, the IRB will provide the study team with the approval letter and approved site specific consent
The Jefferson PI and study team are responsible for providing all IRB approved materials to local site PI and study team.


Request Investigator Access to SMART IRB

Access to SMART IRB Reliance allows research investigators or their designee to submit requests for IRB reliance. Typically, the SMART IRB request is initiated by researchers whose “Home Institution” IRB will be requested as the Reviewing IRB (the IRB accepting the reliance of other IRBs).

Request Investigator Access >>>

Initiating a Request in the SMART IRB Online Reliance System

  1. Log in to the Online Reliance System and click “New Request”.
  2. Provide the following information about your study:
  • Basic information about the research
    (title of study, a brief description)
  • Name of the Principal Investigator
  • Select the institution that you would like to serve as the Reviewing IRB
  • List funding sources
  • List the sites that will be engaged in human subjects research for the study
  • For each site, provide:
    • The site investigator’s name and contact information
    • Research personnel names and contact information
    • Information about research participants and research activities at the site
  • Upload supporting documents (PDFs only)
    • Research protocol
    • Consent templates
    • Other documentation
  1. Review the request for accuracy
  2. Submit the request. You can log back in to the Online Reliance System to track the progress of your request. You will be notified by email once a reliance decision has been reached.

Trial Innovation Network (TIN) Studies

TIN studies use SMART IRB, but have already identified an IRB of record, so would not require use of the SMART IRB Online Reliance System. TIN studies use IRB Reliance Exchange (IREx) to support single IRB review (to facilitate central IRB (CIRB) documentation, communication, and the exchange of information for all TIN studies). IRBs, coordinating centers, and study teams use IREx for the life of a TIN study. Johns Hopkins University, University of Utah, and Vanderbilt University Medical Center serve as single IRBs for TIN studies.
 

Process flow for requesting to rely on a SMART IRB/IREx Participating Institution

Jefferson Relying External IRB: 
SMART IRB/IREx Member Institution

Jefferson study team creates a new submission application in the IRB Portal in order to process the reliance agreement:
  • Submission includes: OHR-1 (indicate SMART IRB/IREx and include Jefferson Personnel only), Protocol, summary of specific duties of Jefferson personnel and activities to occur at Jefferson, Main ICD, Approval Letter, IREx study information sheet 
The submission will be reviewed to verify eligibility to proceed with other Institutional IRB Review.
  • Once confirmed TJU will cede review electronically
  • Please note: This does not constitute authorization to begin research activities, see additional steps below
The submission will be administratively reviewed.
  • If applicable, the consent form(s) will be reviewed to ensure TJU template language is included
  • Jefferson IRB will complete local context information on IREx
  • PI will complete PI Survey on IREx
  • Once correspondence is received from OHR confirming all applicable elements are in place, the study team will forward the consent form(s) to the external IRB for review and approval
The study team will email the final approved protocol, consent form and any additional materials approved for use at Jefferson to Jefferson IRB.
Upon receipt of all required documents, Jefferson IRB will provide study team with Study Activation email.
  • Research activities may now commence
  • As per the reliance agreement, the PI and study team remain responsible for ensuring all Jefferson IRB reporting requirements are maintained throughout the life of the study
  • The PI and study team are to provide Jefferson IRB with copy of annual and final reports submitted to the external IRB

Before Beginning Research Activities

Reliance decisions in SMART IRB/IREx apply only to the determination of IRB reliance, and do not reflect IRB approval of the research project itselfApproval for each collaborating institution must be obtained from the Reviewing IRB prior to beginning research with that site or its collaborators.

When the Jefferson IRB cedes review to another IRB, it is the PI’s responsibility to send all IRB approval notices from the reviewing IRB to Jefferson IRB. This includes all subsequent continuing review approval notices.

SMART IRB Reliance Documents

SMART IRB Reliance Resources

Additional SMART Resources may be found at: https://smartirb.org/resources