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Submitting New Applications
All new applications must be submitted through the electronic application system, PHIRST. If you need assistance with PHIRST, contact the PHIRST helpdesk (phirsthelp@jhsph.edu ; 410-502-5780) weekdays between 9 am and 4 pm. Each person who will be listed as a PI, co-investigator, or student investigator on the study must register in PHIRST and upload a copy of his or her CITI human subjects ethics training certificate, or other training documentation for non-JHSPH personnel. Once a person is registered, and listed as a study team member, that person will have access to the electronic application and may answer questions or upload documents. Only the PI may actually submit the application to the IRB.
Each new application should include a research plan. The research plan template is posted under “Forms and Templates/Research Plan” on this web site. If the study involves interaction or intervention with human subjects, details about the recruitment and consent processes should be described in the research plan. Consent forms, assent forms (for children), and oral consent script templates are available under “Forms and Templates/Consent forms” on this web page. These templates should be used for your study and, when complete, uploaded into the PHIRST application.
If the study involves analysis of pre-existing data or specimens, the IRB has posted a flow chart that PIs (not students) may use to determine whether to submit the project (see: http://phirst.jhsph.edu/sph/Rooms/DisplayPages/LayoutInitial?Container=com.webridge.entity.Entity[OID[2EADD27183334D4EB0596E457DA53CD4]] ). The research plan template provides details about what information is needed. New applications are not required for adding investigators to an existing, ongoing IRB-approved protocol; please submit an amendment application to make this type of change to a study. The amendment application form can be found under “Forms and Templates/Amendments” on this web site.
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