The IRB Application consists of several parts:
- The Application —Document written by the investigator that is an official account of the planned project.
- Supporting Documents—Documents attached to the application when submitted in one PDF file.
- Consent documents (Consent Document(s), Assent Document(s), PHI documents (if applicable), Debriefing Statements (if applicable), etc.)
- Recruiting documents (e.g. advertisements/poster/flyers, scripts, emails, social media posts, letters, etc.)
- Study instruments (e.g. surveys, questionnaires, interview guides, tests, photographs, etc.)
- If applicable, permission letters, including MOU’s, letters of support, or other assurances of collaboration.
- If applicable, grant proposal.
- Evidence of human subjects protection training, which is required for all principal investigators.
IRB Guidelines and Policies and Procedures
- For more information on whether or not your project requires IRB approval, please review this guidance on when IRB review is needed.
- For step-by-step instructions on how to fill out the IRB Application, please review these Application Guidelines.
- For more detailed definitions and policies regarding the IRB process and Loyola’s IRB Office, please review these policies and procedures.
Research involving human subjects may not begin until the application is approved by the IRB.
You will be notified by phone and/or email of any issues that may arise during the review and of the application's ultimate approval or denial. Upon notification of approval, you may begin your research. After the review is completed, both you and the faculty sponsor (if applicable) will be mailed a copy of the approval form, and ORSP will retain a copy of the approval form and application for at least three years after completion of the research.
IRB Submission Checklist
After all forms and documents have been signed where necessary and completed, please turn your application materials into a .pdf for submission. Applications must be submitted to Jill Hanson at firstname.lastname@example.org.
Before submitting your protocol, please make sure that:
- Spelling and grammar have been checked and are correct
- Signed Application (Principal Investigator, Faculty Sponsor)
- All supporting documents arranged in the following order:
- Consent Document(s)
- Recruitment Materials
- Study Instrument(s)
- Permission Letters (if applicable)
- Certificate of Education (if not already on file)
- Grant proposal narrative (if applicable)
- The application materials have been made into one PDF
- You have kept a copy of all application materials for your files
Requests for Amendment and Renewal
The request for amendment form must be used whenever a principal investigator seeks to make any change to an already approved application.
Committee approvals are for one-year periods. If research activity extends past one year, the applicant must submit a request for renewal form at least three weeks prior to the expiration of the initial approved period.
Any problems connected with the use of human subjects once the project has begun must be reported to ORSP immediately.
Please contact Jill Hanson at email@example.com or 410-617-2188 with questions.