All new applications and Further Study Actions (Continuing Reviews, Amendments, Reportable Events, and Study Closures) must be submitted through eHIRB (http://ehirb.jhu.edu). Please review the Getting Started documents and FAQs, as well as the applicable links below, before proceeding with a new application. If you have questions after reviewing all the below documents, please contact the HIRB.
Getting Started and FAQs
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.
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.
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. Expedited applications must be submitted through eHIRB. All faculty, staff, and students who are listed on the IRB application must complete the CITI Training.
Further Study Actions (FSAs): All Further Study Actions must be submitted through eHIRB. Click on the type of Further Study Action to review instructions for submission.
- 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 6 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.
- Amendments and Changes: Investigators must submit a request for changes to the approved application before implementation. This included 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.
- Reportable Events including Unanticipated Problems and Adverse 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.
- 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.
Additional Forms for Uploading into eHIRB
Consent Forms: You should complete the appropriate forms with your study information and upload them into eHIRB in the requested section.
- 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.
- 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.
- 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.
- Certificate of Translation: When some or all of the targeted population in not fluent in English, informed consent documents must be translated, typically after the HIRB has approved the English version, and the translation must be certfied as accurate by a noninvestigator using this form. The form and the translated consent documents should be uploaded in the Consent section of the application.