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Update November 5, 2011

November 5, 2011

As part of quarterly scheduled updates, the following changes have been made in eIRB:

  • Not Human Subjects Research (NHSR) Approval Letters – In certain instances, the language “IRB approval includes:” appears in NHSR Approval letters, followed by a list of approved study locations and study documents. This language has been replaced with “IRB Review includes the following:” and a list of study documents will no longer appear
  • Section 1 – General Information, Q. 6.0 –  "Exempt" has been changed to "Exempt/Not Human Subjects Research (NHSR
  • Section 4 – Exempt Research – The header and wizard names have been changed to “Exempt/NHSR”
  • Section 4 –Exempt Research, Q. 4.0 – new questions have been added. If the study is “Expedited” based on the answers to the questions, the eIRB system will automatically uncheck “Exempt/NHSR” and check “Expedited” in Section 1, General Information, Q. 6.0. Section 4 – Exempt Research will be hidden and Section 5 – Expedited Research will appear.
  • Exempt Wizard revision – name change for the Exempt Wizard: “Exempt/NHSR Wizard”. In addition, the pre-populated text that appears if the wizard determines that your study is not human subjects research has been revised:  “Stop Here. This activity is not human subjects research; no submission to the IRB is required. If you want IRB acknowledgment that this activity is not human subjects research, complete an eIRB exempt/not human subjects research application. At Screen 4 (Exempt/NHSR), Q. 1, insert "NHSR".
  • Section 6, Protocol Information, Q. 5.0 (text only) – added the following language: “Upload a track-changes protocol or summary of changes if changes are requested by the IRB or for Change in Research”
  • Section 14 – Consents and Waiver, Q. 2.0 – The check boxes for the short form consent languages were replaced with the following text: “Short forms are available on the eIRB website in the following languages: Arabic, Chinese, Haitian, Italian, Korean, Polish, Portuguese, Russian, Spanish, and Vietnamese.”  The “other” option was replaced with the following text: “If you plan to use a short form in another language, upload unapproved short form consent(s) and a Certificate of Translation on the Written Consent page of this application.”
  • Section 29 –Incidental Findings revisions (text only)
    •  Q. 4.0 – Added “if images will be read by radiologists attending for clinical service state below:”
    • Q. 5.0 – Added “Not required for reading by radiologists attending for clinical service:”
  • Section 10 – Study Location
    • Addition of “Inova Health System” and  “Peninsula Medical Center” as study locations and primary affiliations
    • Added another umbrella site: “Johns Hopkins Clinical Research Network (CRN) Sites:” which will include Inova and Peninsula as well as AAMC and GMBC (previously listed under “Sites with reciprocity or review agreements”)
  • Continuing Review Application – Section 2 (Renewal Summary, Q. 6.0) (text only)
    • Replaced “Upload most current DSMB report or interim findings:” with “Upload most current report from the DSMB or interim findings:”
    • Replaced “Explain why most current DSMB report is not available: ” with “Explain why most current report from the DSMB is not available:
  • "Respond To Issues" instructions (text only)
    •  Added additional instructions to “Respond to Issues” box – DO NOT copy and paste text from other systems into the box below!
  •  eIRB Application Modifications – General modifications have been made to the eIRB application to include new study locations (i.e., Sibley Memorial Hospital, Suburban Hospital) and future locations.