All new applications must be submitted through the electronic application system, PHIRST. If you need assistance with PHIRST, contact the PHIRST helpdesk email@example.com; weekdays between 9 am and 4 pm. Only the PI may actually submit the application to the IRB.
Each new application should include the following forms, as appropriate:
- For all studies - a Research Plan.
- Consent forms, assent forms (for children), and oral consent script templates, if appropriate.
- A Certificate of Translation Form, if the consent documentation will be translated from English into another language.
- A HIPAA Application for studies involving Protected Health Information (PHI), including JHM identifiable and de-identified clinical data, and non-JHU data.
- Permission letters if your research will be conducted at non-JHU sites.
- Ancillary approvals if your study requires review by Safety Committees (Biosafety, High Risk Review Committees, Pharmacy & Therapeutics, Radiation, Cinical Engineering, etc.), from other JH or affiliated Departments (SKCCC, JHCP, KKI, Emergency Department, Howard County General Hospital etc.), or outside entities like Baltimore City Health Department, Baltimore City Schools, and Maryland Department of Health.
Research applications will be triaged by the IRB Office to the level of review (administrative, exempt, expedited, and convened) that is required by JHU through its institutional and IRB policies.