1. Everything You Wanted to Know about UOPX IRB
Knowledge Without Boundaries
July 21, 2017
Dr. Laura Brewer
Asst. Dean, Research Protection

2. Overview UOPX Institutional Review Board
Federal Regulations and Human Protections
Types of IRB Reviews
IRBNet Demo & Guidance Materials
Upcoming Changes to Federal Regulations
Q&A Session

3. What is the IRB?
The Institutional Review Board (IRB) is responsible to review and monitor human subjects research.
The IRB is responsible for protecting the rights and welfare of people involved in research.
The UOPX IRB is responsible for reviewing any human subjects research that involves University of Phoenix researchers.
UOPX Institutional Policy for IRB - 803

4. UOPX IRB Office
3.5 FT staff trained in the federal human subjects regulations and institutional human research protections policies and procedures.
Two IRB Coordinators
Deborah Fuller
Jared Strother
Assistant Dean of Research: Dr. Laura Brewer
Program Dean of Research & Dissertation Quality: Dr. Diane Gavin

5. UOPX Institutional Review Board
Meet Twice a Month
1st and 3rd Mondays
Quorum 5 members
10 members on our IRB
Chair: William Beck
3 External members
Expertise in our research content areas

6. Federal Regulations
The University of Phoenix IRB has a federal-wide assurance (FWA), which is recognized by the federal Office of Human Research Protection (OHRP).
The FWA is an agreement between UOPX and the Department of Health and Human Services (HHS) to comply with federal regulations regarding human subjects research (45 CFR 46).
NOTE: The Federal Human Subjects Regulations will be changing effective January 19, 2018 unless repealed by the new administration.

7. IRB Review – Belmont Report
The federal policy for the protection of human subjects (45 CFR 46) is based heavily on 3 ethical principles presented in the Belmont Report
Respect for Persons
Individuals have a right to decide to participate in research
Protect those with diminished capacity
Beneficence
Do no harm
Maximize possible benefits and minimize harm
Justice
People involved in research are treated fairly

8. Where can you find the UOPX IRB?
On the Research Hub: Institutional Review Board Page
IRBNet -
UOPX adopted IRBNet, and transitioned IRB reviews to IRBNet, beginning in November 2014.
IRBNet is a 3rd party, web-based, software designed to conduct IRB reviews
Researchers self-register and affiliate with the UOPX IRB

9. What is Research? Research is defined in 45 CFR 46.102(D):
a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

10. When is UOPX IRB Involved?
Our institution is considered Engaged in the research when its employees or agents for the purposes of the research project obtain:
Data about the subjects of the research through intervention or interaction with them;
Identifiable private information about the subjects of the research; or
The informed consent from the human subjects.

11. Reliance Agreements
When more than one institution with an FWA is engaged in the research.
Collaborative agreements for IRBs with FWA to reduce redundancy of reviews
One IRB conducts the IRB review and provides oversight
If a researcher needs more information about how to pursue a reliance agreement, they should see the GUIDANCE – Reliance Agreements

12. IRBNet Demonstration Building Projects
Submission Types: New, Revision, Response, Amendment, Continuing Review
Review Types: Admin, Exempt, Expedited, Full
Guidance Documents: IRBNet Forms and Templates
Checking Status: Real time status available within IRBNet
When should researchers contact the IRB Office?

13. IRB Review Process Understanding our review process
Pre-Review/Administrative Review
Content Review
Exempt
Expedited
Full Committee
If a researcher does not know what type of content review to request, they should see the GUIDANCE – OHRP Decision Tree Checklists

14. Upcoming Changes to the Regulations
The ‘Common Rule’ (45 CFR 46, Part A) impacts U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies.
A 6-year process to update the ‘Common Rule’ began in 2011 and went through years of public comment.
The revisions were published in the federal register on the last day of Obama’s Administration (1/19/2017) and are meant to go into effect 1/19/2018.
However, there is a possibility that the regulation change could be rescinded or ordered to be revised or not enforced.

15. Final Rule Changes
Changing structure of informed consent document and process to increase subject understanding
Requiring single Institutional Review Board (sIRB) review for cooperative research
Allowing the use of broad consent for future research for secondary studies on stored identifiable data or identifiable biospecimens
Eliminating continuing review for certain minimal risk research
Establishing new exempt categories of research based on level of risk posed to subjects that require “limited review”
And a few additional changes very specific to clinical trial research

16. Contact the IRB Office
Please contact the IRB Office after you review the just-in-time guidance materials in the IRBNet Forms and Templates library.
The best way for any researcher to contact us is over at
We are happy to talk to researchers over the phone, but given our limited staff, researchers might get a VM when they phone us ( ). We return all calls. That said, most likely we have the answer to your questions in the IRB guidance materials and we may be able to respond quicker at times to an .

17. Q&A Session
Questions about the University of Phoenix IRB or how to best protect human subjects in research?