FAQS and additional resources
- Family Educational Rights and Privacy Act (FERPA)
- FDA Regulations
- Health Insurance Portability and Accountability Act (HIPAA)
- International Compilation of Human Research Standards
- NIH Clinical Trial Policies – Training Resources
- Office for Human Research Protections (OHRP)
- Research Participants Resources
- US Food and Drug Administration (FDA) – FDA Running Clinical Trails
- UA Tribal Community and Research Process Resources
- Cline Library
Research Librarian Resource: Brittany Blanchard, 928-523-7248
- Clinicaltrials.gov Registration at NAU
Assistant VP for Regulatory Compliance: David Faguy, 928-523-6117
- Comptroller Policies and Procedures – Participant Payment
- Conflict of Interest
- Data Classification and Handling Policy
- Family Educational Rights and Privacy Act (FERPA)
Program Coordinator: Karen Wagner, 928-523-5934
- HIPAA in Research at NAU
- NAU Conducting University Surveys Policy
- NAU International Travel Policy
- NAU Qualtrics Survey Tool
Qualtrics: Steven Burrell, 928-523-9998
- Research Data Use Committee: David Faguy, 928-523-6117
- Tribal Consultation Policy
NAU Tribal Liaison: Chad Hamill, 928-523-3849
How long will my review take? Accordion Closed
Times vary based on the quality of your submission and the volume of submissions received by the HRPP Office.
Where can I find my decision letter and stamped consent form? Accordion Closed
On the Reviews page in IRBNet.
How do I replace an existing document in IRBNet? Accordion Closed
On the Designer page, when your project is unlocked, you can replace a new version of an existing document by clicking on the pencil icon on the right side of the screen.
How do I add additional documents to my submission after I have submitted the package? Accordion Closed
Contact the IRB Office and request that your package be unlocked. If you submit additional documents in a new package, that package will be withdrawn.
How do I use track changes in Word? Accordion Closed
Using track changes is a requirement for the review process. View instructional tutorial.
Do I have to use the consent form templates in IRBNet? Accordion Closed
We encourage you to use the templates to ensure that you provide all the necessary information. It is not required, but we do not advise you to create your own consent forms. Please see the federal requirements.
When should I submit to the IRB for review? Accordion Closed
We ask that you submit at least 30 – 45 days prior to the start of the project.
Can I screen participants for eligibility before obtaining Informed Consent? Accordion Closed
Eligibility screening that is conducted prior to obtaining consent is referred to as “pre-screening.” Only information directly related to eligibility criteria may be obtained during pre-screening. If your study involves pre-screening, provide the following details in the Project Narrative:
- When, where, and how pre-screening will occur
- Whether the information will be recorded with identifiers
- How the pre-screening data will be used in the research
- When and how the pre-screening data will be destroyed and/or de-identified (for both eligible and ineligible persons)
- A pre-screening script. At a minimum, the script should include (1) a brief summary of the research project, (2) a statement that the purpose of pre-screening is to determine eligibility for the study, (3) a description of how the information will be used/destroyed; (4) an affirmation that the individual wishes to continue with pre-screening; and (5) the pre-screening questions.
How do I submit my conditions to approval? Accordion Closed
Conditions to approval should be submitted for acknowledgment by creating a new package with the existing project.
How do I resubmit my project for review if it has been administratively closed? Accordion Closed
Follow the steps for submitting a new application, uploading your existing documents. A mass upload is possible on the Designer page. To clone your existing application, chose the option “Clone one of my existing wizards”. Before you submit your new package, provide the IRBNet ID # for the closed project in the comments field.
What requires IRB review? Accordion Closed
A: A project requires IRB review if the study meets both the federal definitions of (1) research and (2) human subjects.
1) Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
2) Human subject means a living individual about whom an investigator (whether professional or student) conducting research:
(i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
(ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
What type of events need to be reported to the IRB? Accordion Closed
Please see the Reporting Local Information guidance for more information.
How do I navigate between packages in IRBNet? Accordion Closed
You can change packages by clicking on the blue triangle underneath the project title on the Designer page. See instructions here.
What are Faculty Advisor responsibilities? Accordion Closed
Faculty Advisor responsibilities:
*Developing sound research design for your student’s research project
*Developing, reviewing and approving all documents submitted for IRB review
* Directly supervising your student’s research project
* All additional obligations outlined in the IRB Investigator Responsibility Guidance document