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Forms, Tools, and Templates Related to the Revised Common Rule

  • JHM IRB Combined Informed Consent/HIPAA Authorization Template (December 2018, Version 16) - For use when submitting new applications on or after 12/15/2018. Please click HERE for more details regarding the use of this new template.
  • Key Information Guidance - This guidance is designed to assist researchers in addressing the new Revised Common Rule requirement that “Key Information” be presented first.
  • Informed Consent General Guidance - Please refer to this guidance for general information and instructions for preparing the JHM IRB Combined Informed Consent/HIPAA Authorization document.
  • MRI language - If your study includes research imaging in an MRI scanner, the language options outlined in this document should be included in the consent form.
  • Biospecimen testing language - If your study includes gene sequencing, creation of cell lines, genome/exome sequencing, or creation of pluripotent stem cells please use the suggested language in this document in your consent form.

All new research applications, including exempt applications, must be submitted to the JHM IRB for review through eIRB.  eIRB is an informatics tool that supports electronic, on-line submission of applications to the Johns Hopkins Medicine IRBs.

Application Forms

  • JHM IRB eFormA-Protocol - For eIRB studies ONLY
  • JHM IRB eFormB  eFormBs (used for retrospective chart reviews only) are required to be on the revised eFormB  as of January 15, 2016.  eFormBs not on the new template that are received after January 15, 2016 will be returned and the application will not be processed until the correct forms are submitted.
  • Data Security Checklist 
  • Data Security Profile 
  • eProgress Report - eIRB Continuing Review Progress Report
  • Changes in Research Application - No longer available. Use eIRB Change in Research to submit.
  • Continuing Review Application - No longer available. Use eIRB Continuing Review Application to submit.
  • Form A - No longer available. Use eFormA in eIRB to submit a revised Form A.
  • Research Determination Worksheet - We no longer accept Research Determination Worksheets in order to issue official IRB determinations. For Not Human Subjects Research (NHSR) projects, submission to the IRB is voluntary; if you would like documentation of an IRB determination of NHSR, submit an eIRB application checking "NHSR" at Screen 1, Question 6. For exempt projects, submission to the IRB is required; submit an eIRB application checking "Exempt" at Screen 1, Question 6.

Consent Forms


Problem/Event Report Form

  • RF3 - Event Report Summary Sheet
    Attach to the Continuing Review Application to summarize anticipated problems/events or Submit if sponsor requires adverse event reporting that does not meet JHM IRB requirements
  • RF4 - Protocol Deviation Summary Sheet
    (Attach to the Continuing Review application to summarize administrative and minor departures from protocol.)

Reliance Documents

Additional Forms