Institutional Review Boards (IRBs) play a critical role in the clinical trial and medical research industry. However, those new to the sector may be unfamiliar with an IRB’s role in the broader landscape. Here is a deep dive into IRBs, including what they are, when they’re required, why they’re critical to the process, and more.
What Is an IRB?
An IRB is an independent group that has been formally designated to review and monitor clinical research involving human subjects. Its main purpose is to protect the welfare and rights of the subjects during the trials. In addition the IRB ensures the research is ethical, reviews any potential biases with the clinical investigators and evaluates the compliance of the protocol with regulations and local laws.
An IRB gets its authority through federal regulations focused on protecting human subjects. IRBs are administered by the Office of Human Research Protections, a part of the U.S. Department of Health and Human Services.
IRBs have the authority to approve or disapprove medical research projects or clinical trials based on their findings. Additionally, they could require project modifications, effectively withholding an approval or denial until those behind the research make the requested changes. Once the updates are in place, the IRB reevaluates the project before making a decision.
As the research is underway, the IRB can conduct periodic reviews. This ensures that the rights and welfare of the subjects are protected throughout the trial.
IRB Member Composition
According to the Code of Federal Regulations (CFR), each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities. IRB membership should include diversity of the members by having a mix of genders, races, ages, and demographics. Each member should possess the professional competence necessary to review the specific research activities
Within the IRB, at least one member must be scientifically-oriented, and at least one member must be non-scientifically-oriented. Additionally, one member must not have an affiliation with the institution performing the research.
When Are IRBs Required?
Generally speaking, IRBs are a required part of the medical research process whenever there are human subjects involved. However, there are some exceptions where IRBs are not required. For example, survey-based research that meets specific conditions for anonymity, presents no risk of civil or criminal liability, and involves no harm to social, vocational, or financial standing.
It is a good rule of thumb to always include an IRB review of your research prior to any protocol procedures beginning.
Why Are IRBs Vital in Clinical Trials?
The IRB reviews the informed consent form to assure that the researchers have complied with all applicable regulations. A signed informed consent document is needed to prove that the subject has agreed to participate in the research.
Functionally, an IRB is an objective third party. Its goal is to follow specific federal regulations to manage risk. Essentially, the IRB ensures that safety and ethics are part of the equation, preventing any undue risks for human subjects.
Local IRB vs. Central IRB: What’s the Difference?
There are two types of IRBs: local and central. Both local IRBs and central IRBs follow the same rules and regulations regarding composition, authority, and required actions. Where they differ is primarily a matter of location.
Local IRBs operate within a limited area, such as a single academic institution. Essentially, a local IRB is an onsite administrative body that limits its role to participating in medical research and clinical trials hosted by one organization.
Central IRBs provide services to multiple research centers. Typically, investigators in private practice or independent research clinic can utilize a central IRB.
Ultimately, IRBs are a critical part of the medical research and clinical trial landscape, ensuring the wellbeing and rights of human subjects are protected each step of the way. Researchers should plan time for preparing IRB submission packets as well as the time for the IRB to review the trial. Failure to obtain IRB approval before conducting a clinical research trial may result in the researcher being unable to use data and other information collected during the trial.
As part of the medical research community, Vial aims to make critical information accessible.
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