IRB Forms and Instructions

Overview

All applications to the IRB or ERC must be submitted electronically at www.irbnet.org. Emailed materials or hard copies will not be accepted. Failure to follow procedures will delay your application's review.

Please note: Full or expedited applications must be submitted to the IRB. Exempt application requests must be submitted to the ERC. If your research qualifies for a level of review other than that for which you've applied, we will forward it to the appropriate board for you.

Before Submitting Your Application

1. Read Marywood's IRB policies and procedures: These policies and procedures explain the categories of review and other requirements.
2. Complete online training courses: Principal investigators, co-investigators, sponsors, and research assistants must complete two training courses, one in Human Research and one in Responsible Conduct of Research, through the Collaborative Institutional Training Initiative (CITI) and/or the Center on Materials and Devices for Information Technology Research. Be sure to affiliate with Marywood University on those sites. Visit the Office of Research and Sponsored Programs' training page for details and links.
3. Register on IRBNet: Go to www.irbnet.org and click the "New User Registration" link in the upper right corner. Be sure to affiliate with Marywood University and confirm your registration by e-mail before proceeding. Co-investigators and research sponsors must also register.
4. Download all necessary forms and templates and gather supporting documentation: Please be sure to use our most recent forms, as they are updated often. IRB forms and templates are available on this page. ERC documents can be found on the ERC's website. What should you submit? Please see our checklist for required materials. PLEASE PROOFREAD AND RUN A SPELL CHECK ON ALL DOCUMENTS PRIOR TO SUBMISSION.
   
5. Review our meeting schedule and submission deadlines. Follow our meeting schedule and submission deadlines to allow adequate time for review. If you're a student planning to graduate in a given semester, you must apply during the semester prior to the one in which you plan to graduate.

Electronic Submission Instructions for IRBNet

1. Carefully review Marywood's IRBNET INSTRUCTIONS, or watch IRBNet's tutorial videos. Contact irbhelp@maryu.marywood.edu or call 570-348-6211, x. 2233 for the password to access these videos.
2. Submit your application to the appropriate board (IRB or ERC) at IRBNet.
3. Monitor your e-mail for communications from the board. Once the board notifies you, your decision letter can be accessed at IRBNet:
   1. Log in and select your existing project by clicking on its title.
   2. Click the "Project Overview" button on the left menu.
   3. Click "Review Details" in the middle of the page (blue link).
   4. Access the letter under "Board Documents" at the bottom section of the screen.
4. Do not create a new project when the IRB asks you to submit modifications or if you must submit a report. Your existing project packages must remain locked in order to maintain a submission trail, so you need to create a new package within the existing project (i.e., IRBNet# 12345-1, 12345-2, 12345-3, etc.). After clicking on the title of an existing package within the current project, click on the "Project History" button on the left menu, the "Create New Package" button at the bottom of the next screen, and then "New Document Package" next to the red arrow. From the next screen, you will be able to revise existing documents or upload new forms or materials. Review our IRBNet instructions for full details. See How to Track Changes for assistance with showing which modifications you have made.

Requirements After Your Application is Approved

1. Once approved, you'll find a final approval letter and stamped forms at IRBNet. Click on the approved package's title, which will bring you to the Project Overview page, and then click "Review Details" (blue link in the middle of the page). A decision letter and stamped documents may be viewed under "Board Documents" at the bottom of the page. All stamped, approved forms must be used in your project.
2. Deviations, violations, or adverse events must be reported to the IRB in a timely fashion, even if they seem minor. Please see our Reporting policies and procedures, as well as the the Protocol Deviation/Violation and Adverse Event forms on the right side of this page. To submit, please refer to step #4 above or our IRBNet instructions.
3. If you decide to revise or make additions to any part of your study, you must submit completed Request for Revisions to IRB Approved Research form, including all associated documentation, to the IRB. Please see the form on the right side of this page. To submit, please refer to step #4 above or our IRBNet instructions.
4. A status report is due 6 months after approval, and a final status report is due prior to the 1-year expiration date. To submit, please refer to step #4 above or our IRBNet instructions. If you expect your project to continue beyond the 1-year approval period, you must apply for renewal, allowing ample time for review so there is no lapse. All research activities must cease as of the expiration date, unless the board approves a renewal. Studies are not considered closed until both data collection and analysis have been completed. You must reapply if you don't finish your analysis prior to the approval's expiration.