IRB Corner: Understanding the OHRP Human Subject Regulations Decision Charts

IRB Corner: Understanding the OHRP Human Subject Regulations Decision Charts

This month in the IRB Corner, we want to introduce everyone to an important guidance document that will help researchers determine if and when an Institutional Review Board (IRB) review is needed on a project AND what type of review to request.

Doctoral students and faculty are aware of the critical IRB review that comes after the academic QRM proposal review and prior to beginning the students’ dissertation research activities.  However, our office has had questions from some faculty about when an IRB review is needed for their own research.  What all researchers (faculty and students) must keep in mind is that an IRB review is required from any researcher when research activities involve human subjects.  The IRB review is the same for any research, whether the research is conducted by a UOPX faculty member, a UOPX student, or a UOPX research staff member. Our IRB office must conduct a review of any proposed research under federal Office of Human Research Protection guidelines.

The Office of Human Research Protection (OHRP) is part of the Department of Health and Human Services. The OHRP provides support materials around the federal regulations designed to protect the rights and welfare of human subjects involved in research (45 CFR 46).  The OHRP Human Subject Regulations Decision Charts provide guidance about WHEN an IRB review is needed as well as considerations to determine WHAT TYPE of IRB review to request. Researchers will find within the IRBNet Forms and Templates library (accessed from left menu when logging in to IRBNet) the GUIDANCE – OHRP Decision Tree Checklists document, which will direct them to the OHRP website.

When is an IRB review needed?

The UOPX IRB reviews studies proposed by faculty, students, or employees of the University of Phoenix, as well as external researchers who wish to use the University of Phoenix for their studies as long as the study meets the OHRP definition of human subjects research.  Research is defined by federal human subjects research regulations (45 CFR 46) as an activity that is “a systematic investigation designed to develop or contribute to the generalizable knowledge”. 

NOTE: UOPX considers ALL dissertation studies “research.” Further, the federal human subjects research regulations (45 CFR 46) define “human subjects research” as activity that 1) obtains information about living individuals and 2) involves interventions or interactions with human subjects OR involves obtaining private information about living individuals for research purposes.  If your study involves human subjects research activities, then you must submit your project for IRB review BEFORE you engage in any research activity.

However, we ask that ALL researchers submit their study for IRB review so a determination can be made based upon current federal guidelines and the appropriate decision returned to the researcher. For grants, publications, and some presentations, researchers can be required to provide current institutional IRB approval for a study; failure to produce a current IRB approval can take a researcher out of grant awards, publication opportunities, or presentation situations. The UOPX IRB office’s mission is to help research happen across the campus; to do so means we need to review an IRB application from faculty and employees as well as students.

What type of IRB review is needed?

Last month in the IRB Corner, we discussed types of submissions (i.e. new projects, revisions, amendment/modification, continuing review, and response/follow up).  We want to direct researchers to the GUIDANCE – OHRP Decision Tree Checklists document referenced above for assistance in determining the type of IRB review to request.   Note that a submission type is different from a review type.  Review types are determined by the federal regulations (45 CFR 46). 

In particular, an exempt or expedited review can be requested for minimal risk studies (see 45 CFW 46.102(i) at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.102).  Depending on the design of the project, and the level of risk to the human subjects, researchers can request one of the following types of reviews:

  • Exempt Review: A study can be determined “exempt” from further oversight by the IRB.  Studies that qualify for an exempt review are minimal risk studies that fit into the six federal categories of “exempt” in the federal protection of human subjects regulations 45 CFW 46.101(b). See the OHRP Decision Tree Checklists – Charts 2, 3, 4, 5, 6, and 7). An exempt review is conducted by a trained IRB Office staff member and does not require a board meeting for action to be taken.
  • Expedited Review: Studies that qualify for an expedited review meet the definition of minimal risk and fit into one of the 9 federal Expedited categories (and the OHRP Decision Tree Checklists – Charts 8 and 9. An expedited review is completed by a member of the IRB assigned by the IRB Chair.  An expedited review can take place outside of an IRB Board meeting.  Some continuing reviews fit into expedited review categories 8 or 9.
  • Full Committee Review: Some studies will not qualify for an exempt or expedited review based on the federal regulations.  Typically these studies involve protected groups or occur in places that could involve potential risk, and these studies must be referred to the full committee to review, discuss, and take action on at a scheduled board meeting.  Currently, the board meets twice a month (1st and 3rd Monday each month).

We hope this helps answer some of your questions about when an IRB review is needed and types of IRB reviews.  Just remember: Whether faculty, employee, or student, if you are considering conducting research while you are affiliated with the University of Phoenix or the School of Advanced Studies, the UOPX IRB does need to review an IRB application for your research. After reviewing the guidance materials and, for students, after discussing the project with your Chair, researchers are encouraged to contact the IRB Office at IRB@phoenix.edu, or through IRBNet, with questions.