An Institutional Review Board (IRB) is an independent committee required by federal law to review, approve, and monitor biomedical research involving human participants. IRBs are one of the most important, and least understood, safeguards in clinical research.
What Is an IRB?
An IRB is typically composed of physicians, scientists, ethicists, and community members. Its primary purpose is to ensure that clinical research meets ethical standards and adequately protects participant rights.
What Does an IRB Review?
Before any study can begin enrolling participants, the IRB must review and approve:
- The study protocol (exactly what will be done)
- The informed consent document
- How participants will be recruited
- The qualifications of the research team
- Any advertisements or recruitment materials
What Authority Does an IRB Have?
An IRB can require changes to a study protocol before approving it, suspend enrollment if safety concerns emerge, and permanently shut down a study that violates ethical standards.
Ongoing Oversight
IRB oversight does not end at approval. IRBs conduct annual reviews of ongoing studies and receive reports of any adverse events or protocol deviations. They must be notified of any changes to the study design.
How Does This Protect You?
Knowing that an independent board of experts, including non-scientists and community members, has reviewed and approved a study before you can be enrolled provides a foundational layer of protection on top of FDA regulations and your own rights under informed consent.
At NuLine, all of our studies have full IRB approval. Questions? Contact our team.