The PG Institutional Review Board (PG IRB) offers three distinct application submission pathways: (1) Human Research Determination, (2) Exempt Research, and (3) Expedited Research. This page provides guidance to investigators on the steps required to complete and submit a successful application.
Investigators should review the following guidance documents carefully to ensure the correct IRB submission pathway is selected prior to submitting materials. Confirming the appropriate pathway in advance can help prevent delays and the need for resubmission. These resources are provided for reference purposes only and are intended for individual use.
Please use the IRB-310- WORKSHEET – Human Research Determination to verify that an activity does not constitute human research. This pathway applies to non-research activities, such as quality assurance, quality improvement, or program evaluation initiatives intended for local improvement. The purpose of this pathway is to obtain a determination letter from the PG Institutional Review Board (PG IRB) confirming non-research status. Investigators should select this pathway when the primary objective of the project is to improve a specific local service or workflow, rather than to address a research question or test a hypothesis. Projects in this category are intended to benefit a single site or practice and are not designed to contribute to generalizable knowledge.
Please use the IRB-312- WORKSHEET – Exemption Determination to assess whether a research proposal qualifies for exemption from full board review. The worksheet provides detailed criteria and category descriptions to guide this determination. To be eligible for the exemption pathway, the research must present no more than minimal risk to participants, ensure equitable participant selection based on relevance rather than convenience, and include appropriate safeguards to protect participants and their personal information. The proposed research must also fall within one of the exemption categories outlined in the worksheet.
Please use the IRB-313- WORKSHEET – Expedited Review to determine whether a research proposal requires expedited review. The worksheet provides detailed guidance on the eligibility criteria and the categories of research that qualify for this level of review. Research in this pathway must present no more than minimal risk to participants (defined as risks not exceeding those ordinarily encountered in daily life), and requires a higher level of scrutiny than research eligible for exemption. Appropriate safeguards must be in place to protect participants from risks such as criminal or civil liability or damage to financial standing, as described in the worksheet. The proposed research must also fall within one of the expedited review categories outlined in the worksheet.
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The Purdue University Global Institutional Review Board (IRB) follows the terms of its Federalwide Assurance with the Office for Human Research Protections (OHRP). To support compliance and the protection of human subjects, OHRP recommends ongoing training for investigators, IRB members, staff, and other relevant personnel.
Compliance may be satisfied by completing one of the following:
Please complete the following course:
Human Research (Curriculum Group)
Group 2. SOCIAL (Course Learner Group)
1 – Basic Course (Stage)
Register through CITI Program at: https://about.citiprogram.org/
Select Purdue University Global as your affiliated institution, and use your Purdue Global email address. There is no cost to you.
Only the Basic Course in Social/Behavioral Research (SBR) will be accepted. Refresher courses, Responsible Conduct of Research courses, or other alternatives do not meet this requirement.
Available through PHRP Training at: https://phrptraining.com/
A current certificate from another institution offering comparable training may be accepted. Certificates more than 7 years old will not be accepted.
After confirming the appropriate pathway, completing the required training, and obtaining a CITI Training Certificate, investigators should download and complete all documents pertaining to their appropriate pathway for submission to the PG Institutional Review Board (PG IRB). All instructional text in red font should be deleted and replaced with study-specific information in black font.
Complete IRB-503c- PROTOCOL – Exempt Research
Prior to completing this form, investigators should ensure that all required preliminary steps have been completed and that all necessary documents are prepared for upload.
