Alert for IRB prompt reporting for studies utilizing a sIRB!

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A recent update to STANFORD SOP FOR RELYING ON A SINGLE IRB (sIRB) requires that prompt reporting of events that occur at Stanford in studies under a sIRB (e.g., CIRB, WCG, Advarra, etc) are reported to SU IRB in accordance with the EVENTS AND INFORMATION THAT REQUIRE PROMPT REPORTING TO THE IRB. The reporting requirements for SU IRB may differ from the requirements of your study’s sIRB so it is critical to be aware of both, specifically what events must be reported and when they must be reported. There may be situations where you are required to report to one IRB or the other, or to both simultaneously.

Please review the reporting requirements for SU IRB and for your sIRB carefully to identify any differences. If you have any questions, reach out to the respective IRB and/or work with your manager. 

Updated IRB Policy and Guidance

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The Stanford HRPP Policy Manual (Chapters 3.9, 3.10 and 3.11) and Stanford Prompt Reporting Guidance (GUI-P13) have been updated effective July 2022.  

Substantial changes include: 

·        Updated definition of an Unanticipated Problem (UP) to (underlined text is new): 

o   Unexpected, and

o   Related or Possibly Related and

o   Places Subjects or Others at a Greater Risk of Harm (notably, this includes privacy-related risks)

·        Expanded definitions for: 

o   Noncompliance

o   Serious Noncompliance

o   Continuing Noncompliance

References:

Action: Please review the updated definition of a UP in the attached guidance or at the link below as this is substantially different from the prior definition. Please also review the updated definitions that will apply to various types of noncompliance. 

Additional training and communications will occur in various venues.

IRB Address Change

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All staff should be aware that the Stanford Institutional Review Board (IRB) has moved and officially changed their address.  The new location is a few blocks away from the old location, still on El Camino Real (at the corner of Park Blvd / Serra St).  This location is actually closer to the Cancer Center than the old location at El Camino Real and Page Mill.

All studies should update their materials, in particular the Form FDA 1572 (if used), with the new address.

Name of IRB:      Administrative Panels on Human Subjects in Medical Research (“Stanford IRB”);  Research Compliance Office; Stanford University

Address 1:           1705 El Camino Real

Address 2:           <LEAVE THIS LINE BLANK>

City:  Palo Alto          State:  CA                Country:  USA            Zip: 94306

Please note that it is important to use the full, formal name of the IRB, as above.  FDA has previously issued findings regarding the use of only “Stanford IRB.”  While the name provided is long, it is correct and fits within the provided field on the Form FDA 1572.

All drug studies conducted under an IND should update their Form FDA 1572 accordingly at the next revision.  If made aware of the change, some sponsors may ask for this immediately.

All Investigator-initiated Studies (IISs/IITs) for drugs should update their Form FDA 1572 at the next IND submission, and not later than the next IND annual report.

At this time, be sure to check that the list of physician sub-investigators is 100% in agreement between the Form FDA 1572 with eProtocol.

IRB Update: Extended Approval

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Based on the changes to the Federal Policy for the Protection of Human Subjects (‘Common Rule’), as of January 21, 2019, minimal risk studies (mainly IRB review type = expedited) do not need to be reviewed annually.

  • There will be no special IRB review type nor unique IRB form type for those minimal risk studies.
  • The expiration date for such studies will be 12/31/2999. In addition, in the approval letter and ICF will have ‘Does not expire’ phrase as an expiration date.
    • Note: Because OnCore is not able to handle an expiration year of 2999, those studies will have an expiration date of 12/31/2099.
  • Stanford’s IRB proactively initiated some IRB revisions to change the expiration date for such studies; this way research team is prevented to submitted an annual continuing review which is no longer needed for those minimal risk studies.
    • Note: Because OnCore’s structure, these IRB revisions need to be entered as ‘Continuing Review ‘ otherwise the new expiration date will not take effect in OnCore.
  • Modifications are still required to be submitted to the IRB.

Suggested Language Regarding IRB Approval Letters

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During recent audits a deficiency has been noted in how teams submitting eProtocol modifications note what changes are included in the modification. This has resulted in IRB Approval Letters with no mention of what was approved, which makes monitoring and auditing studies more time-consuming.

The IRB provides a text field on the Obligations page of the eProtocol application. This text field will be printed on the IRB Approval Letter after the word “Includes:” As a best practice, please utilize this text field when preparing IRB submissions to denote the following items:

  • List of all files attached during the modification (Sections 13, 14 & 16). Use the following naming convention: document name and number (i.e. protocol #, IB #, ICF, etc.), version number (if available), and date.
  • Personnel changes (include whether added or removed)
  • If an ICF was attached, include statement about who will be re-consented
    • Re-consenting might be required for patients on active treatment or follow up.
    • Re-consenting under the following circumstances is not required:
    • — Changes to the study team not the PI.
    • — Typographical errors noted in the consent document unless the error significantly changes the intent of the sentence.
    • For an initial application, include statement if short form consent process or wavier of authorization for chart review were submitted
    • If additional documents are attached during an IRB comment cycle, update the text field on the Obligations page.

      • If you have any concerns or questions about preparing eProtocol applications, please consider attending one of the monthly CCTO Orientation Session 3 courses hosted by CCTO Regulatory staff (STARS code: CCTO-0003). You may also submit a request for regulatory services through the new REDCap intake system, and a CCTO Regulatory specialist can prepare the IRB application or modification on your behalf.