- Review the Loyola University Maryland policies and procedures for research involving human participants.
- If required, complete the National Institutes of Health's Online Human Subjects Education program. Please review the information listed on the human subjects education page to determine requirements. A copy of the certificate, proving successful completion of the program, must be initially submitted with the human subjects application form. After that the certificate number and date will be held in the Institutional Review Board (IRB) database and there will be no need to resubmit the certificate with subsequent applications.
- Complete the Application for Approval of Human Subjects.
- If you believe your project qualifies for exempt or expedited review, please be sure to complete item 8 on the application form. Please note that the IRB committee reserves the right to change the review status of applications as necessary. Note that in order for an application to qualify as exempt, it must pose no risk or extremely minimal risk to participants. In order to qualify as expedited, the application must pose no more than minimal risk to participants.
- If you feel additional information may be necessary for the reviewer(s) to evaluate the project, you may attach a copy of the complete methodology and any other necessary information.
- Attach samples of all consent and/or assent documents to be used. If you are requesting that consent be waived, provide a justification explaining why a waiver is required.
- Sign the application form and, if you are a student, obtain the signature of your faculty sponsor.
- Submit the application with attachments to Nancy Dufau in the ORSP, Beatty Hall, Suite 116. If submitting via email please send to firstname.lastname@example.org.
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.
Exempt research must be reviewed by ORSP to confirm that it meets the criteria for exempt status. Once an application is received by ORSP, it will take about 2-3 business days to review. The ORSP may send applications submitted as exempt to additional IRB committee members for further review. This review process will take approximately three weeks.
Research that is eligible for expedited review must involve no more than minimal risk to participants in the study. After the application is received by the ORSP, it is sent to two IRB committee members for review. The expedited review process will take approximately three weeks. Annual review is required for expedited projects lasting longer than one year.
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 from 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 Nancy Dufau at email@example.com or 410-617-2004 with questions.