New Applications (PHIRST)
All new applications must be submitted through the electronic application system, PHIRST. If you need assistance with PHIRST, contact the PHIRST helpdesk (firstname.lastname@example.org; 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 agrees to participate 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 the following forms, as appropriate:
- For all studies - a Research Plan.
- Consent documents for adults and oral consent script templates, if appropriate. Assent forms (for children)
- A Certificate of Translation Form, if the consent documentation will be translated from English into another language
- A Drug Data Sheet if your study involves the administration of a drug product
- A JHSPH IRB radiation review form, if your study involves radiation
- A Verification of Confidential Nature (VCN) form if the study will offer payment to participants and your study involves sensitive information and will not collect any identifiers as a confidentiality protection for participants.
- A Conflict of Interest Disclosure Form if anyone on the study team has a conflict of interest (COI)
- JH Biosafety Registration Forms: Registration of Research with Human Tissue, Infectious Agents, Pathogens, Oncogenes, or Toxins form and/or the Registration of Research with Recombinant DNA form if the study involves recombinant DNA, pathogenic organisms, infectious agents, biological toxins or human tissues by university or hospital faculty, students or staff
Check the JHSPH IRB forms page to see whether any others are relevant to your study.
If your project involves collaboration with another institution that has its own IRB with an FWA, and your role does not include responsibility for overseeing the interaction/intervention with human subjects or the informed consent process, and does not include your access to participants’ identifiable private information, but you are “engaged in” human subjects research under our guidance, you may wish to enter into an IRB Authorization Agreement which permits the JHSPH IRB to defer review to the collaborator’s IRB. Please contact the IRB Director if that is the case.