Please note: As of June 1, 2012 the HIRB will no longer accept paper applications for new studies. New applications after this date must be submitted through eHIRB (http://ehirb.jhu.edu)
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.
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.
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 completed at eHIRB.
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 completed at eHIRB.
Consent Forms: You should complete the appropriate forms with your study information and upload them into eHIRB in the requested section, if your application is being submitted through eHIRB.
- Written Informed Consent Template for adults. Oral scripts can be based on this document.
- Parental Permission Template also can be used jointly for assent of older children.
- Assent Template can be used for oral or written assent of children.
- Short Written Informed Consent Template typically for illiterate individuals. A script must accompany this form.
- For applications being submitted through eHIRB, the 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.
- Continuing Review
- 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 the complete stoppage of a study until a new application can be reviewed and approved by HIRB.
For approved protocols, request for Continuing Review will be accepted in paper format until December 31, 2012. After that time, all protocols must be entered into eHIRB at the time of Continuing Review. If you wish to transfer your paper application into eHIRB sooner, you may do so. If you wish to do this, you should submit your application in eHIRB as it is currently approved. In addition, on the last page of the electronic application, you should attach the completed form for eHIRB Application for Continuing Review. eHIRB Application for Continuing Review
Paper Application for Continuing Review
Additional Forms for Uploading into eHIRB
Certificate of Translation: When some or all of the targeted population in not fluent in Englih, 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. This form should then be uploaded on the last page of the eHIRB application, in the section entitled "Finalize". The translated consent documents should be uploaded in the Consent section of the application.
Additional Forms for Approved Paper Applications:
Research Team Member: With the Application for Expedited/Full Board Review, A Research Team Member form should be included for each research team member in addition to the PI and the student investigator or co-investigator who are listed in the application. To add a team member after initial approval of the study, a Research Team Member form must be sent to HIRB with an Application for Amendments and Changes.
Assent Checklist: When children are included in the participant population, investigators must include this checklist, in which child assent options are listed, with their Application for Expedited/Full Board Review.
- Child Checklist: When children are included in the participant population, investigators must include this checklist, in which the study’s risks and benefits to children are categorized, with their Application for Expedited/Full Board Review.
- Application for Amendments and Changes: Investigators should use this application to request HIRB review and approval of 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.
- Unanticipated Problems and Adverse Events: Investigators must submit this 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.
- Certificate of Translation: When some or all of the targeted population is not fluent in English, informed consent documents must be translated, typically after HIRB has approved the English version, and the translation must be certified as accurate by a noninvestigator using this form.
- Supervisor Plan: This is required for all student initiated studies and outlines what the PI is obligated to do in their role as supervisor of the research.
- Study Closure: The PI should submit this document to HIRB 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.