Checklist for DNP Students Submitting a Project to the IRB
□Complete Human Subject Training through NIH, located: http://phrp.nihtraining.com/users/login.php □ Complete the HIPAA Research Training Tutorial, located: http://www.southalabama.edu/researchcompliance/pdf/USAHIPAATrainingforResearch.pdf (This tutorial is also available in IRBNet.org FORMS and TEMPLATES) □ Training Complete: Save certificate in accessible location in computer (it must be submitted through user profile in IRBNet) □ Faculty Advisor review and approval of project BEFORE any submissions to IRB Navigate to www.IRBNet.org □ Click New User Registration under the login in IRBNet.org (Demos and Support desk inquiries are routed back to Administrators at USA; please contact advisor for assistance. Contacting IRBNet will cause a 48 hour delay of communications) □ Complete the New User Registration, affiliating with the University of South Alabama. Confirmation email is generated to complete registration. Place DNP Student after last name in User Profile – this is for instructor tracking □ Log in to IRBNet through the confirmation email and click User Profile on the top right of the page: Scroll down and under Training and Credentials, click “Add New Record.” Attach and SUBMIT Training certificates saved previously to your computer. Reminder: “User Profile” is for training certificates/credentials only (please do not attach any other document). The training (along with any other documents attached) will now be attached permanently in the user profile. □ Create New Project; fill out the required information. Project status states “Work in progress” □ Download (IRBNet Forms and Templates) and complete the appropriate forms (i.e., CNL/DNP Quality Improvement Application Part B, Checklist for Children, Information Sheet, Questionnaire, etc.) □ Complete the IRB On‐line Document Part A, accessible through the Designer (add new document – On‐Line document / Drop down ‐ Add) 1 Revised 9/2013 □ Attach the Part B Application (CNL/DNP Quality Improvement Application Part B), Letter of Support from Agency, Process Map and any additional documents* needed for the project □ Share the package with your faculty advisor, granting them Full Access and any Co‐
Investigators** All key personnel must have IRBNet user profiles. Expedited Review projects must be shared with the Department Chair for an electronic signature. □ Link all training and any Co‐Investigators’ training to the package on the main Designer page □ You and your advisor (and department head, if applicable) must electronically sign the package. □ When all documents have been attached, training linked, and you and your advisor/ instructor have electronically signed, the project will be submitted to the IRB by your advisor/ instructor. The project will not be reviewed if submitted by anyone other than the instructor. The board action of submitted projects will change to “Pending Review” ‐ When the project has been reviewed and approved, the board action will change to Approved (Approval documents are located under “reviews”) Additional Guidance is located in the IRBNet Forms and Templates Library. For complete directions, consult the “USA IRBNet Guide” in the Forms and Templates Library, which includes submitting an amendment or renewal. * List of possible additional documents: Information Sheet, HIPAA Waiver, Consent, Surveys/Questionnaires, Interview Questions, Checklist for Research Involving Children, Advertisements (flyers, emails) and Approval Letter(s) from External research site(s) ** If there are any other Investigators on the project, they must have a user profile in order to be shared with on the project. Their Human Subjects training must also be uploaded to their profile in order to link it to the project. The IRB requires proof that everyone on the project has completed Human Subjects Training. Please remember, if instructions are not followed, the approval process
will be delayed
Per your advisor’s instructions: Closure ‐ when project has been completed, submit a closure form (located in Forms and Templates) by creating a new package (project history, create new package), attach the closure form, submit to IRB
2 Revised 9/2013