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Institutional Review Board

JHM IRB Forms

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Forms, Tools, and Templates Related to the Revised Common Rule (required for all NEW studies submitted after January 21, 2019)

For a list of all guidelines, policies, forms, tools, and templates related to the Revised Common Rule click HERE.

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  This form may ONLY be used for projects originally approved prior to January 21, 2019 which qualified as a retrospective chart review. eFormBs may no longer be used for any new application type. New applications submitted with an eFormB will be returned and the application will not be processed until the correct forms are submitted Instead, please submit the eForm S: see description below.
  • JHM IRB eFormE This form should be used for projects thought to qualify for exemption. This may include, interviews, surveys, public observations, educational tests, research conducted in normal educational settings or some behavioral interventions, if the intervention is considered to be benign. The only exception is secondary research activities. While some secondary research activities may qualify for exemption, for these projects, the eForm S should be used. Note: Applications submitted on or after 7/1/2024 will be returned to use the revised eForm E, version 2, dated 3/2024.

  • JHM IRB eFormQ This form should be used for projects thought to qualify as quality improvement projects. Applications submitted on or after 6/1/22 will be returned to use the revised eForm Q, version 3.1, dated 10/3/2023 [Please note: Investigators must complete and upload in their eIRB application the following tool for assistance with determining whether a project is research or quality improvement, however the IRB will make the final determination. ]

  • JHM IRB eFormR  eFormRs (used for research resource protocols) are required for all protocols  designed to cover the creation or set-up of a research resource as of 01/03/2019.  Common examples of research resources are a data or biospecimen repository and a recruitment database. Generally the purpose of a research resource is to help support current and future research rather than to answer any discrete research questions. If you intend to create a research resource, a separate IRB application is required for creation of the resource itself. Use this form to describe the resource you are creating, how it will be managed and how it will be accessed for future research use. eFormAs or eFormBs will no longer be acceptable for protocols designed to create a research resource. Note: Applications submitted on or after 7/1/2024 will be returned to use the revised eForm R, version 3, dated 3/2024.

    • eForm R Template: This instructional template provides guidance and template language that can be used to develop an eForm R protocol for projects that will involve creating a new research resource in the Precision Medicine Analytics Platform (PMAP) platform. The eForm R template should be downloaded from the link above. This tool serves as a guide for completing that form.

    • For step-by-step instructions for completing an eIRB application using an eForm R, please click HERE.

  • JHM IRB eFormS This form should be used for secondary research using identifiable private information and/or identifiable biospecimens. Data or samples are not required to be in existence at the time of the submission to the IRB in order to use this form. Projects involving secondary research of identifiable private information and/or identifiable biospecimens may qualify for exemption or may require expedited review. The IRB will make this determination as part of the review process. In certain cases, the identifiability of the data/biospecimens may be unclear, or may have had identifiers removed. However, this form should be used to describe all secondary research projects. Note: Applications submitted on or after 7/1/2024 will be returned to use the revised eForm S, version 7, dated 3/21/2024.

    • eForm S Template: This instructional template provides guidance and template language that can be used to develop an eForm S protocol for projects that will involve analysis of a data projection from an existing resource protocol [eForm R]. The eForm S template should be downloaded from the link above. This tool serves as a guide for completing that form. You may also find some of the sample language provided in the instructional template helpful for other secondary research studies that will obtain medical record data directly from EPIC or other JHM Clinical systems.

  • eProgress Report - eIRB Continuing Review Progress Report

Consent Forms

High Risk Review Forms

HIPAA Forms

IND/IDE Forms

NCI CIRB Forms

These forms should only be used for applications where the NCI CIRB is the IRB of record

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