eHIRB Guidance and Documents

Electronic Homewood Institutional Review Board (eHIRB) is a paperless, electronic method to submit, track, and review the scientific, regulatory, and compliance information required for the safe conduct of human subjects research at Homewood. All new applications and Further Study Actions (Continuing Reviews, Amendments, Reportable Events, and Study Closures) must be submitted through eHIRB.

eHIRB users should log in using their JHED ID and password. For assistance with JHED accounts, contact help@jhu.edu.

**Please Note: All users must log into the eHIRB system at least once before they can be added to a research protocol by someone else!

All faculty, staff, and students who conduct human subjects research must complete CITI training.

Please review the Getting Started documents and eHIRB FAQs, as well as the other applicable links below, before proceeding with a new application. If you have questions after reviewing all the below documents, please contact the HIRB Office.

eHIRB is located through the following link: http://ehirb.jhu.edu .

Application Materials

  • Exempt Applications

    Studies involving certain types of minimal risk research may qualify as exempt from full HIRB review. Studies that may qualify for exempt status may not be undertaken until HIRB verifies the exemption. Exempt applications must be submitted through eHIRB. All faculty, staff, and students who are listed on the IRB application must complete the CITI Training.

    Most new applications can be reviewed within two to six weeks after receipt of the complete application. Studies involving special populations, research at international sites, and/or multiple sites often require additional review time to ensure compliance with Federal regulations. If you are unsure if your study needs to be reviewed by the HIRB, please go to eHIRB and create a new application. In Section 1, Question 3.0 of the new application, select “Unsure if Review Required”. Answer the questions and if you are then still unsure, please contact the HIRB.

  • Expedited and Full Board Applications

    Some studies involving human research participants may qualify for expedited review. The application form for expedited and full board review is the same, but studies qualifying for expedited status may be reviewed by only one or two HIRB members rather than by the full board. All faculty, staff, and students who are listed on the IRB application must complete the CITI Training.

    Most new applications can be reviewed within two to six weeks after receipt of the complete application. Studies involving special populations (e.g., children), research at international sites, and/or multiple sites often require additional review time to ensure compliance with Federal regulations. If you are unsure if your study needs to be reviewed by the HIRB, please go to eHIRB and create a new application. In Section 1, Question 3.0 of the new application, select “Unsure if Review Required”. Answer the questions and if you are then still unsure, please contact the HIRB.

  • Getting Started

    Primer on the eHIRB system.

    View the Document
  • How to Submit a New Application

    To provide the user with step-by-step instructions on how to complete/submit a new protocol application.

    View the Document
  • Sample eHIRB Application

    Most new applications can be reviewed within two to six weeks after receipt of the complete application. Studies involving special populations (e.g., children), research at international sites, and/or multiple sites often require additional review time to ensure compliance with Federal regulations. If you are unsure if your study needs to be reviewed by the HIRB, please go to eHIRB and create a new application. In Section 1, Question 3.0 of the new application, select “Unsure if Review Required.” Answer the questions and if you are then still unsure, please contact the HIRB.

    View the Document

Further Study Action (FSA) Documents

  • Amendments and Changes

    Investigators must submit a request for changes to the approved application before implementation. This includes changes to their research team, research protocol, recruitment materials, measures, or consent documents. According to federal regulations, investigators may not implement changes without prior HIRB review and approval, unless necessary to eliminate immediate to participants.

    View the Document
  • Continuing Reviews

    Federal regulations require that all non-exempt studies approved by institutional review boards undergo continuing review at least once a year. Applications for continuing review must be submitted six weeks prior to the expiration of a study’s approval date to allow adequate time for review. Please note that failure to submit a continuing review application by the deadline requires that all research activities be stopped. A new application will then need to be submitted and approved by HIRB before study activities may resume.

    View the Document
  • Reportable Events

    Investigators must submit a report to HIRB when an unanticipated problem or adverse event occurs that poses risk to participants or others and is reasonably related to the conduct of the study.

    View the Document
  • Study Closures

    The PI should submit a study closure request once data analysis is complete and no further contact with participants is expected. Closing a study eliminates the need for HIRB approval and continuing review.

    View the Document

Consent Forms

  • Assent Template

    Can be used for oral or written assent of children. You will need to complete this for your study then upload as a Word document into eHIRB.

    Note: a request for the Use of Oral Consent (Waive Consent Documentation) for waiver of signed consent documentation and Waiver/Alteration for waiver or alteration of informed consent process must take place through eHIRB.

    View the Document
  • Certificate of Translation

    When some or all of the targeted population is not fluent in English, informed consent documents must be translated, typically after the HIRB has approved the English version, and the translation must be certified as accurate by a non-investigator using this form. The form and the translated consent documents should be uploaded in the Consent section of the application.

    View the Document
  • Consent Form Checklist

    Please use this form to ensure that all of the required elements and applicable additional elements of informed consent are present in the consent document(s).

    View the Document
  • Parental Permission Template

    Also can be used jointly for assent of older children. You will need to complete this for your study then upload as a Word document into eHIRB.

    View the Document
  • Written Informed Consent Template

    For adults. Oral scripts can be based on this document. You will need to complete this for your study then upload as a Word document into eHIRB.

    View the Document

Related Documents & Resources