Human Research Protection Program
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  • Human Research Protection Program (IRB)
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Resources and FAQs

Resources

External

  • 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)
    • Are you engaged in human subjects research?
  • Research Participants Resources
  • US Food and Drug Administration (FDA) – FDA Running Clinical Trails
  • UA Tribal Community and Research Process Resources

Internal

  • Cline Library
    Research Librarian Resource: Brittany Blanchard, 928-523-7248
  • Clinicaltrials.gov Registration at NAU
    Associate VP for Regulatory Compliance: Jason Wilder, 928-523-3780
  • Comptroller Policies and Procedures – Participant Payment
  • Conflict of Interest
  • Data Classification and Handling Policy
  • Family Educational Rights and Privacy Act (FERPA)
    Associate Registrar: Joseph Wright, 928-523-6150
  • FERPA Guideline
  • HIPAA in Research at NAU
  • NAU Conducting University Surveys Policy
  • NAU International Travel Policy
  • NAU PI Eligibility Policy
  • NAU Qualtrics Survey Tool
    Qualtrics: Steven Burrell, 928-523-9998
  • Research Data Use Committee: Jason Wilder, 928-523-3780
  • Tribal Consultation Policy
    NAU Tribal Liaison: Ann Marie Chischilly, 928-523-9651

FAQs

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 If you submit additional documents in a new package, that package will be withdrawn.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 acknowledgement 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. View package instructions.

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

How do I find messages that have been sent about my submission in IRBNet? Accordion Closed

All messages about a submission are captured in IRBNet. See message instructions for more details on locating them.

What is the difference between a CITI certificate and a CITI report? Accordion Closed

After completing a course, a certificate and a report are provided by CITI. View examples.

Human Research Protection Program (IRB)
Location
Building 20, 4th floor
Science Annex
525 S Beaver Street
Flagstaff, AZ 86011-4087
Mailing Address
PO Box 4062
Flagstaff, AZ 86011-4087
Email
IRB@nau.edu
Phone
928-523-9551