Institutional Review Board
Institutional Review Board (IRB) is a federally mandated committee that provides oversight for all research activities with the aim to protect the rights and welfare of the human subjects recruited to participate in research. In the United States, the Food and Drug Administration (FDA) and Department of Health and Human Services (specifically Office for Human Research Protections) regulations have empowered IRBs to approve, monitor and review biomedical and behavioral research.
IRBs came into existence due to research abuses that took place earlier in the twentieth century. Two of the most notorious of these abuses were the experiments of Nazi physicians that became a focus of the post-World War II and the Tuskegee Syphilis Study by the US Public Health Service on black men in rural Alabama. The 1974 National Research Act, which established IRBs, also created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
All research involving human subjects, whether funded or unfunded, is reviewed by committee members to ensure the research is conducted in a manner that does not infringe on the subject’s safety, health, welfare or well-being and ensures institutional compliance with related Federal regulations (Code of Federal Regulations: 45 CFR 46 and 21 CFR 50). Title 45 CFR (Code of Federal Regulations) Part 46 provides a guideline for the protection of human subjects involved in research.
IRB – Frequently Asked Questions
Who must apply? Faculty, staff and students who collect data associated with human subjects in any fashion.
What kinds of data collection are covered? All types, including data gathered by survey, focus group, interview, direct contact, web survey, class assigned data collection, reanalysis of data gathered for an alternate purpose, etc.
What types of approvals are available? Three types: exempt from full board approval, expedited committee approval and full board approval.
What is the advantage of approval? Protects individual researchers from liability if there is an unexpected negative outcome; provides institutional backing for research; ensures institutional access for external funding; and meets the requirement of Federal statute.
Who do you contact for further information?
Director of Institutional Research
Colorado Mountain College
802 Grand Ave
Glenwood Springs, CO 81601
Application forms to request approval from the IRB to conduct research involving human subjects are available for downloading:
- IRB Process Flow Chart (pdf) outlines the steps needed for the IRB process
- IRB Step Definition Guide (pdf) for use with the IRB flow chart
- IRB Guidelines for Class Projects (pdf)
- Exempt Application Form (pdf)
- Expedited and Full Board Application Form (pdf)
- Informed Consent Requirements and Template (pdf)
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