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Research Integrity & Education

Human Subjects Research (IRB)

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

In response to the COVID-19 pandemic, all human subjects research protocols submitted to the DU IRB for review will be required to observe all the current COVID-19 restrictions that were implemented by the University of Denver on March 20, 2020. Please incorporate these requirements into your IRB application. If the current COVID-19 restrictions are not observed and implemented, the IRB will not approve the research protocol and will be placed in a database until the restrictions are lifted.

For current University information and updates on COVID-19 restrictions, please refer to the DU COVID-19 website. This website provides all of the latest information from the CDC, State Health Department, funding agencies, and University updates, including research FAQs for faculty, staff, and students.

Making Study Modifications in Response to the COVID-19 Restrictions
The DU HRPP/IRB has implemented the following procedural change to assist researchers in implementing modifications to their research projects.

If a research project is currently approved by the DU IRB and involves any in-person interactions with research participants (i.e., focus groups, interviews, screenings, recruitment, data collection, follow-up visits), the study must be modified or temporarily suspended. If the in-person interactions can be converted to using remote procedures (i.e., Zoom, Skype, telephone, or other secure electronic communication), the IRB will allow the those type of changes to a research protocol without requiring a formal amendment to be submitted through the IRBNet system and issued IRB approval prior to implementation.

If a researcher chooses to implement the use of one of these remote practices, the changes must become part of the study file in the Principal Investigator's records. To ensure the IRB maintains a record of the use of a remote practice as a substitution to in-person interaction, an email message noting the IRBNet protocol number, PI name, and a brief summary of the changes must be submitted to the IRB email account ([email protected]) within 10 business days of the implementation. The IRB office will attach this information in your research project in the IRBNet system.

New IRB Submissions (New Projects & Amendments) That Don't Comply with Current COVID-19 Restrictions
If a new research project or amendment is submitted through the IRBNet system for review and approval, the DU IRB will conduct a preliminary review. As part of the review process, reviewers will identify whether the proposed research complies with the current COVID-19 restrictions. If a project is not in compliance with the COVID-19 restrictions, the Principal Investigator will be notified by email and be given two options.

OPTION 1: Request that the proposed research study be modified to remove all in-person interactions with research participants and incorporate the use of remote alternative methods for obtaining informed consent, conducting research activities, and gathering study data (e.g., Zoom, Skype, telephone, email, etc.).

If this option is selected, investigators must send an email to the IRB at [email protected] to UNLOCK the IRBNet package so revisions can be made to the project in IRBNet to align with the COVID-19 restrictions. Please remember to include the IRBNet # for the project and the Principal Investigator's name in the email request.

After the required revisions have been made, the package must be RE-LOCKED BY THE INVESTIGATOR by clicking on the 'Revisions Complete' tab. If the package is not re-locked, the IRB will not re-review the project and the proposed modifications.

OPTION 2: If the research design cannot be altered to align with the COVID-19 restrictions (direct in-person interactions), please send an email to [email protected] to alert the IRB that your study cannot be modified. The DU IRB will SAVE AND LOCK your package, and it will be transferred to the COVID-19 database until the research restrictions have been lifted. Once the restrictions are lifted, the IRB will contact the Principal Investigator to determine if a preliminary review should be conducted or the project should be withdrawn.

IRB Questions Or Need to Schedule a Consultation?
If you have any questions or need to discuss the COVID19 restrictions, please send a consultation request to [email protected] or refer to the research FAQs section on the DU COVID-19 website.

The HRPP/IRB will continue to communicate with University leadership. For questions about the IRB review process or additional instances requiring insight on any of the topics above, please contact the DU IRB Office through [email protected] or Mary Travis, Research Integrity Director, at [email protected].

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.

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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