Us
Vision
The IRB provides a high quality review of human subjects research being undertaken by Faculty, Staff and Students at the ºù«ÍÞÊÓƵ. We will be recognized for our knowledgeable and respectful guidance of clients through the submission and review process.
Mission
The mission of CU ºù«ÍÞÊÓƵ’s IRB Office is to protect the rights and welfare of subjects involved in Human Research that is conducted or supported by the University by conducting a review compliant with applicable regulations.
To achieve our Vision, we will initially focus our activities on providing timely turnaround times for protocol review; provide high quality guidance to Investigators for protocol submission requirements; a user-friendly interface for the electronic submission system (eRA).
What is the IRB?
The Institutional Review Board CU ºù«ÍÞÊÓƵ is responsible for the review of all human subject research when conducted by the university's faculty, staff, students or other affiliates and agents. The primary goal is to ensure human subjects are:
- Treated with dignity
- Adequately protected from risk of harm
- Provided informed consent so they may voluntarily and knowledgeably participate in research
The IRB seeks to create a collaborative relationship with the research community to assure that research with human subjects is conducted in accordance with legal requirements and the ethical principles of Respect for Persons, Beneficence and Justice. These principles require balancing the risks to subjects versus the scientific knowledge to be gained as well as the potential benefits to subjects and society. Specifically, the IRB follows the ethical principles found in the Belmont Report and codified in The Common Rule set out in 45 CFR 46, subpart A. It also follows subparts B-D of 45 CFR 46. Finally, the ºù«ÍÞÊÓƵ has developed its own policies and procedures to ensure that proposed and ongoing research involving human subjects complies with these laws and principles. These three documents guide the review of each proposal received by the IRB.
What is the IRB's Regulatory Authority?
The IRB is governed by the federal regulations that dictate the scope and purpose of IRB activities. The Office of Human Research Protection (OHRP) is the federal administrative agency that monitors the IRB and its activities. The Food and Drug Administration (FDA) also protects human research subjects through its investigational device and drug regulations. Both the OHRP and the FDA monitor human subject protections through educational efforts, site visits, and reporting requirements. Both have the authority to suspend research for failure to adhere to the regulations.
Who serves on the IRB?
At CU ºù«ÍÞÊÓƵ, our IRB consists of two panels: Panel 1 (Social & Behavioral Research) and Panel 2 (Biomedical Research). Each panel consists primarily of CU ºù«ÍÞÊÓƵ faculty whose expertise includes the types of research the panel reviews. In addition, each panel has at least one non-scientific member and one non-affiliated member whose roles are to represent the views of non-researchers, the community, and specialties.
What is the IRB's affiliate position within CU?
CU's IRB is assigned as part of the Office of Research Integrity or ORI, which is assigned to part of the Research & Innovation Office/Dean of Graduate School. The affiliate offices are located on the Main Campus in the Regent Administrative building.