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Retrospective IRB Application

eIRB2 Training

IRB Compliance Training is required for all investigators who perform human subjects research. Use the IRB Compliance Training Tool to determine your course requirements.

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Expedited Retrospective IRB Application Template

Additional required forms for expedited retrospective application include eformB and the Application for IRB Waiver of HIPAA Privacy Authorization.

  1. Sign in to and click "Create New Application" in the left-hand sidebar.
  2. Section 1: General Information
    • Q2. Will PI obtain consent for this study – No
    • Q4. Title – "Johns Hopkins High-Value Practice Initiative: Retrospective evaluation of the utility of [INSERT DIAGNOSTIC TEST OR THERAPY] in patient care"
    • Q5. Research Question and Plan – Example: As a new institutional initiative, the Johns Hopkins High Value Practice Alliance has been formed, with the mission of conducting evidence based and data driven research projects that aim to reduce utilization of unnecessary tests. Our mission is to first confirm that patient care will not be compromised, by systematically demonstrating the relative lack of value of potentially unnecessary diagnostic tests. We plan to retrospectively review patient records between December 1, 2004 and December 1, 2014 and correlate with diagnostic test results for examinations that our physicians have observed as being potentially unnecessary. By retrospectively reviewing large numbers of cases, we aim to generate the data that will provide physicians with the reassurance necessary to reduce utilization in this institution and across the country.
    • Q6. Expedited Study
    • Q15. Study Team Members – Add names and affiliations. Include as "co-investigator" and select "no" for "consenting hopkins participants".
  3. Section 2: Study Team Compliance Training
    • Make sure to have completed HSR, H&R, COI, REWards, and CRBO training via myLearning portal.
  4. Section 7: Conflict of Interest – Section 8: Support Information
    • No conflict or support must exist in order to qualify for expedited review.
  5. Section 9: Study Location
    • Typically The Johns Hopkins Hospital and Bayview Medical Center.
  6. Section 10: Sample Size
    • No interaction involved.
  7. Section 11: Participant Information
    • Q1. Yes to identifiable information
    • Q2. Age range – 0-100
    • Q3. Study Population – Check all
    • Q5. No to healthy volunteers
    • Q6. Hopkins study populations – JHH/JHMBC adult ED, affiliate inpatient and affiliate outpatient.
  8. Section 12: Recruitment Information
    • Q1 – No intervention
    • Q8. Data sources – Hopkins Affiliates
    • Q11. IRB waiver – Upload completed form
  9. Section 13: Consent and Waivers
    • Q1. Consent waiver
  10. Section 16: Assent and Waivers — Children
    • Q1. Waiver or alteration of assent
    • Q6. No more than minimal risk
  11. Section 19: Supplemental Study Documents
    • Q2. Upload supplemental study documents – Upload standard descriptions or protocols used for the study or test you are investigating.
  12. Section 22: Human Biological Samples
    • Q1. No samples used.
  13. Section 33: SKCC CRO
    • Q1. Is the study cancer-related?
    • Q1. No for drug dispensing
  14. Section 35: Data Confidentiality
    • Q1. Yes to protect confidentiality
    • Q2. No certificate required.
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