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Office of Research & Sponsored Programs

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Research Integrity & Education

Human Subjects Research (IRB)

Research that involves the use of human subjects (through human interaction or through obtaining identifiable data or biospecimens) requires IRB review prior to beginning such a project. The Human Research Protection Program (HRPP) is responsible for the administration of the Institutional Review Board (IRB) activities and oversight of human research protections activities such as educational programs and post approval monitoring.

Our Mission Statement

The University of Denver is committed to protecting the rights and welfare of individuals participating as subjects in research. The Office of Research Integrity and Education (ORIE) is home to the Human Research Protection Program (HRPP) and the Institutional Review Board (IRB), and it is charged with reviewing and overseeing human subjects research.

for investigators forms, checklists, & templates irbnet
citi training what needs irb review? full board review

DU Human Research Protection Program and Institutional Review Board COVID-19 Recommendations

As DU continues to restart research on campus and in the community, the Office of Research Integrity & Education (ORIE) is responding and implementing procedural changes to continue to protect University of Denver investigators, research participants, and the on-going research projects that are conducted in our labs. The IRB continues to accept and process submissions while being observant of the guidelines outlined in the DU COVID-19 Protocols for Research, Scholarship, & Creative Work guidance.

Reopening or incorporating in-person interactions or interventions with research
Any PI planning to conduct in-person human subjects research is required to submit an addendum as outlined in the Addendum template to document precautions that will be taken during the COVID-19 pandemic. Provided the PI submits the addendum appropriately, the DU IRB will not require current IRB-approved projects to be modified or other new submissions to incorporate the COVID-19 restrictions and safety protocols.

This Addendum for Conducting Human Subjects Research to Incorporate the COVID-19 Restrictions may be: (1) posted as a separate document when submitting a new research project application in IRBNet; or (2) posted as a separate document within an amendment request for a currently approved project (i.e., submitted alone within an Amendment/Modification package in IRBNet). This Addendum addresses only the additional steps that PIs must incorporate into a currently approved or new human subjects research project if in-person interactions will occur during the COVID-19 pandemic. Investigators have the option to (1) adhere to this Addendum as written and submit it in IRBNet without changes; or (2) customize the document for use with a research protocol and consent documents.

Need Guidance or Information on COVID-19?
Please refer to the DU COVID-19 website for additional guidance and information.

Need to Request an IRB Consultation?
Your questions are important. If your human subjects research-related questions have not been answered in the FAQs or by your supervisor, please submit your question or request a consultation through the IRBAdmin@du.edu. We will respond directly and potentially by adding these answers to our FAQs.

Please know that the Office of Research Integrity & Education (ORIE) staff is here to provide guidance, resources, and support to assist researchers during this challenging time.

 

 


Office of Human Research Protection (OHRP)
Federalwide Assurance (FWA) Number: 00004520
Expiration Date: February 10, 2025

IRB Registration Number: IORG0000314
Expiration Date: April 17, 2021