IRB submissions for researchers

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Presentation transcript:

IRB submissions for researchers School of Advanced Studies Dr. Andrew Maus Associate Dean – IRB and Dissertation Services

Agenda Regulations and federal-wide assurance (FWA) Where to find the IRB Guidance Documents IRB Review Process IRB Review Types IRB decisions Demonstration Contacting the IRB Office Q&A

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). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html

Where can you find the UOPX IRB? On the Research Hub: http://research.phoenix.edu/content/institutional-review-board IRBNet http://irbnet.org IRBNet is a 3rd party, web-based, software designed to conduct IRB reviews. IRBNet is used for all IRB reviews at UOPX. Researchers self-register and affiliate with the UOPX IRB.

IRBNet Guidance Documents IRBNet Forms and Templates Library All needed guidance and instructions for all IRB scenarios. The main three are: READ ME FIRST: UOPX IRB Process Guidance – IRB Application FAQs - Submissions, Revisions, and Resubmissions

IRB Review Process UOPX IRB review process Pre-Review/Administrative Review (Locking / unlocking) Content Review Exempt Expedited Full Committee

Submission Types vs. Review Types New (Initial submission) Revision (re-submission) Response (re-submission) Amendment (re-submission) Continuing (re-submission) Note: More information and guidance can be found in: GUIDANCE - IRBNet Instructions for Initial Submission and GUIDANCE - IRBNet Instructions for Resubmissions Review Types: Exempt Expedited Full Board Note: Researchers can learn more by reviewing: GUIDANCE - OHRP Decision Tree Checklists (Determining Type of IRB Review).

Decisions Regardless of review type, possible decisions are: Exempt Approved Approved with conditions Information required Modification required Note: “Exempt” can be both a review type, and a decision. A resubmission package is needed if the decision is: - Approved with conditions - Information required - Modification required Note: Explanations for ALL decisions can be found in Understanding IRB Reviews, Actions and Decision Letters in the forms and templates library.

Demonstration

Contact the IRB Office Please contact the IRB Office AFTER reviewing the guidance in the IRBNet Forms and Templates library. The IRB office email is: IRB@phoenix.edu.

Q&A