Research Volunteers - What is an IRB?
Understanding How a Study Gets Approved for the Public
Feb 15, 2009
The following article is the second in a series on understanding your rights as a U.S. research volunteer such as the right to privacy, confidentiality, and proper informed consent. The focus of this article is on the role of the IRB.
What Is an IRB?
The term IRB is found in the U.S. Code of Federal Regulations at 45 CFR 46, but some organizations name their IRB the Human Research Advisory Committee or the Human Studies Committee to be more descriptive. No matter the name, Institutional Review Boards must review a study for safety, privacy, confidentiality and consent before the study goes live. The committee can approve or modify studies that have the proper protections, or disapprove any study that poses excess risk to the volunteer. In a nutshell, the IRB exists to protect the rights of the volunteers, reduce their risks, and increase their benefits.
Who Serves on an IRB?
Members will typically have a background in science, medicine, nursing or psychology, and many of them will have an education at the doctoral level. An IRB is never comprised of a single gender. Many sites track the gender composition of a committee before the meeting to ensure quorum is met. An IRB must always have at least one member who is not a scientist, one who is not connected to the organization, and will make certain that a scientist on the committee cannot review his own study (45 CFR 46).
What Does an IRB Review?
In the U.S., an IRB has to review a study to make sure it presents minimal risk to the volunteer. Keep in mind that the following items are not comprehensive, and if you want to know more details about what an IRB does at your particular study site, ask for a copy of their policies. Often their polices can be found on their IRB's website. The following is only a snapshot of this very complex procedure, and the debate over these issues can last long hours.
In brief, U.S. law (45 CFR 46) requires an IRB to look at:
- Scientific design
- How big the risks are to volunteers compared to the benefits the study offers.
- Volunteers will voluntarily consent to a study and the consent will be documented.
- Data will be monitored for safety of the volunteers.
- The study has a plan for the protecting privacy of volunteers.
- The study has a plan for protecting confidentiality of volunteer data.
The best thing to do when participating in a study is to find the study site's IRB website and read their policies on approval of research. It is important, too, to see how the project site (which is usually a hospital or university) reaches out to volunteers to provide information about research projects.
As final word, please note that some study sites use a proprietary IRB or one not connected directly with the study site. It is okay to ask which IRB the site used to get a study approved, and it is okay to check the procedures before you enter the study.
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