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Update July 21, 2016

If you have any questions, please contact the JHM eIRB at jhmeirb@jhmi.edu or 410-955-3008.

As part of scheduled updates, the following changes will be made in eIRB2:

eIRB Application

1 - General Information

  • Q. 9:
    • OLD: Does this project ONLY involve retrospective review of charts and/or use of existing specimens?
    • REVISED: Does this project ONLY involve retrospective review of records already in existence at the time of this IRB application submission?
  • Q. 18: To accommodate the growing list of PCORI-PaTH sites, we've added “University of Utah PCORI-PaTH” as a primary affiliation.

6 – Protocol Information

  • NEW Q. 11:
    • Does your study involve organ transplantation from an HIV positive donor (living or deceased) to an HIV positive recipient?
      • If answered “YES”, a required upload field will appear: Upload a completed HIV+ Organ Transplant Form
  • Rationale for change: The NIH published a rule in the Federal Register implemented as part of the HOPE Act, by which Congress made legal these transplants. However, they can only be done under a research protocol approved by an IRB at an approved medical facility (JH is the first) with various other requirements, all of which we now need to account for in our reviews.

As a result of this change, you will be prompted to answer the new question(s) in the first Change in Research submission following the update.

9 – Support Information

  • Q.3:
    • OLD: Will data from this study be submitted to a Genome Wide Association Studies (GWAS) NIH database (e.g., dbGaP)?
    • REVISED: Will data from this study be submitted to a federal genomic database or repository (e.g., dbGaP)?
      • If answered “YES”, a new, required question will appear: Complete and upload the NIH Genomic Data Sharing certification form(s) required for institutional certification.**
  • Rationale for change: Compliance used to generate letters to NIH certifying on behalf of JH that all of the requirements for sharing with dbGaP and other federal genomic repositories were met. Very recently they decided to stop accepting these letters, and to require instead the completion of one more confusing certification forms posted on their website. We decided that it would be best to collect the form in eIRB with a new question, and also to allow the IRB compliance team to upload a signed form when finalized using an administrative function.

**As a result of this change, if you previously answered "YES" to Q. 3, you will be prompted to answer the new sub-question in the first Change in Research submission following the update.

10 – Study Location

  • University of Utah PCORI-PaTH” and “Geisinger Health System” have been added as study locations. “Geisinger Health System” was added as a primary affiliation in the April 2016 update.

11 – Sample Size

  • Q. 2 (How many participant will be consented (or enrolled with a waiver of consent) at Hopkins/Affiliates?) and Q4 (How many participants will be accrued at Hopkins/Affiliates?) were not validating as required questions. This has been resolved.

15 – Written Consent

  • NEW Q. 10:
    • Will any photographic images or recordings (video or audio) of participants be taken?
      • If answered “YES”, the following question will appear:
  • NEW Q. 11:
    • Will the images or recordings be taken in a space owned or leased by Hopkins/Affiliates?
      • If answered “YES”, the following question will appear:
  • NEW Q. 12:
    • Will the images or recordings be identifiable as defined by HIPAA?
      • If answered “NO”, additional questions will appear.
  • Rationale for change: These questions are required as part of a new ancillary review by the Images and Recordings Oversight Committee (IROC). Additional information about IROC review is discussed under “IRB Workflow” below.

As a result of this change, you will be prompted to answer the new question(s) in the first Change in Research submission following the update.

IRB Workflow

NEW ANCILLARY REVIEW: Images and Recordings Oversight Committee (IROC)

  • This is a NEW IRB ancillary review. IROC reviewers will be required to review applications based on the answers to new questions found in Section 15 (Written Consent). The IROC reviewer(s) will be required to record their review outcome in eIRB (Tabled, Approved, Determined Not Required) and communicate their concerns to the study team via email. The IRB CAN approve an application if IROC approval is pending. PLEASE NOTE: Any changes requested by the IROC committee AFTER IRB approval will require submission of a CIR.

Other Changes

Conflict of Interest Review:

  • Currently, the Conflict of Interest (COI) Committee is notified when a New Application is submitted w/a conflict (individual or institutional) indicated or a Change in Research Application is submitted w/a conflict indicated and the parent application does NOT indicate a conflict. They will now be notified to review applications for all of the following case scenarios:
    1. Add Study Member w/ conflict indicated
    2. Update of existing study member w/ conflict indicated
    3. Update of existing study member w/ conflict removed (removed conflict)
    4. Removal of existing study member w/conflict indicated
    5. Institutional COI’s: send notification if there are any changes with an ICOI (they get notified now if the parent ICOI = No and the CIR ICOI = Yes, but they would also like to be notified if the reverse occurs: Parent ICOI = Yes and CIR ICOI is changed to No.)