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Research Integrity & Education

Human Subjects Research (IRB)

Implementation of the Revised Policy for the Protection of Human Subjects (Common Rule) - January 21, 2019

The revised Federal Policy for the Protection of Human Subjects (45 CFR 46 Subpart A) known as the Common Rule has been adopted by HHS and 15 Federal Agencies.  The compliance date is January 21, 2019.  More background information can be found in the Federal Register along with the information on the transition provision and implementation timelines (NIH Notice).

In many cases, the Common Rule changes will not impact your ongoing research. The effective and general compliance date of the revised Common Rule is January 21, 2019. To review some of the key changes of the revised Common Rule, please refer to the PowerPoint program presented at the Town Hall Meetings presented during the month of January.

The DU IRB has made changes to relevant policies and procedures in accordance with the New Common Rule:

  • Revised Definitions: Research and Human Subjects
  • Informed Consent (new general requirements, new elements, changes to the waiver of informed consent and expansion of when signed informed consent is not required)
  • Changes in IRB Review
    • Continuing Review - new Extended Approval Process
    • Limited Review
    • Single IRB Review (sIRB)
  • Exempt Research

For information on how current exempt and expedited research project reviewed by the DU IRB are being modified in response to revisions to the human subject research regulations, please refer to the following documents:

Changes to Current EXEMPT Research Projects | Word

Changes to Current EXPEDITED Research Projects | Word

Exemption Categories Chart per revised Common Rule | Word

 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 is home to the Human Research Protection Program (HRPP) and the Institutional Review Board (IRB) charged with reviewing and overseeing human subjects research.

Research that involves the use of human subjects (either directly or through records or other data such as specimens) requires human subjects 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.   

overview of the process     

OVERVIEW OF PROCESS: WHAT CAN I EXPECT?             

Step 1: What Needs IRB Review: Determine if your research require IRB Review

Step 2: How to Submit:

  • If your research requires IRB Review, determine if it is exempt, expedited, or full board
  • Download checklist
  • Fill out application 
  • Complete supplemental forms for specific research topics (i.e. prisoners, children, schools, ect)
  • Create consent forms, waivers, recruitment materials, and advertisement materials

Step 3: IRBNet: Fill out application on IRBNet

Step 4: CITI: Complete required CITI training

Step 5: Sign and lock IRBNet application (if student, have faculty sponsor sign and lock application)

NEWSLETTER

Want to know the latest updates from the IRB? Want to know more about human subjects research on the DU campus? If so, please download our monthly newsletter.

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Office of Human Research Protection (OHRP)
Federalwide Assurance (FWA) Number: 00004520
Expiration Date: April 21, 2020

IRB Registration Number: IRB00000314
Expiration Date: April 17, 2021