Institutional Review Board (IRB)
What Is an Institutional Review Board (IRB)?
An IRB is an independent committee designated by an organization
to assure that the rights and welfare of people participating in
research studies are protected. Colorado Cancer Research Program has
designated the Colorado Community IRB (CCIRB) to review the research
studies it participates in, whether sponsored by the National Cancer
Institute or other sponsors.
Who Serves on an IRB?
An IRB consists of at least five members of varying backgrounds.
IRB members have the professional experience to provide appropriate
scientific and ethical review. An IRB must have at least one
scientist member and at least one member whose primary experience is
non-scientific. There must also be members from the community,
representing both gender and racial diversity. The members of the
Colorado Community IRB include retired physicians (cancer
specialists) and legal, educational, and research professionals, as
well as cancer patients.
Where Does an IRB Get Its Authority?
In 1974, the US Department of Health and Human Services created
regulations regarding the protection of human subjects through the
establishment of IRBs, which are overseen on the federal level by
the HHS Office for Human Research Protections (OHRP). OHRP assists
IRBs in their work and receives and investigates claims of
inappropriate research practices.
How Does an IRB Make Its Decisions?
Before a physician researcher can enroll patients in a research
study, the protocol (research procedures) is reviewed by the IRB.
The researcher provides the IRB with all the necessary materials to
conduct a review, including a full description of the proposed
project and treatment drugs, other materials to be used such as
questionnaires, a description of the manner in which subjects will
be enrolled, and a detailed consent form. The IRB examines all these
materials to determine if the research participants are adequately
informed and protected.
What Does an IRB Do after Reviewing the Project?
After examining the materials the researcher provides to the IRB,
the committee members must decide if the benefits of the research
are maximized and the risks minimized, and make a final
determination on whether the benefits justify the risks to the
participants. If the IRB finds that this is the case, they may
approve the study. Alternatively, the IRB may request that the
researcher make specific changes to the procedures or consent form
and then approve the protocol contingent on these changes. Finally,
the IRB may decide to disapprove the project. In addition to
reviewing new research protocols, IRBs also review continuing
projects or those that have changes in their procedures. Continuing
projects are reviewed yearly or more often if the IRB feels it is