Colorado Community Institutional Review Board

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. The 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 nonscientific. 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 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.

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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.

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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 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 approve the protocol contingent on these changes. Finally, the IRB may decide to disapprove of 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 necessary.

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