What is an IRB and why is it important?

What is an IRB?

An IRB (Institutional Review Board) is an independent committee that reviews and oversees clinical research involving humans. Its job is to protect the rights, safety, and well-being of study participants.

IRBs are made up of a mix of people like medical experts, scientists, ethicists, and community members, so decisions aren’t made from one point of view but from a wide range of perspectives.

What does an IRB actually do?

Before a clinical trial can start, the IRB must review and approve things like:

The study protocol (what’s being done and why)
Informed consent forms (how risks and benefits are explained)
Recruitment materials (ads, flyers, social media posts, scripts)
Risk–benefit analysis (are risks minimized and reasonable?)
Privacy and data protection plans

Once the study is ready for activation, the IRB continues to:

Monitor adverse events
Review protocol changes
Require continuing review (usually annually)
Step in if participant safety is at risk

Why is the IRB so important?

Because clinical trials involve real people, not just data.

IRBs exist to prevent:

Exploitation or coercion of participants
Unnecessary or hidden risks
Poorly designed studies that expose people to harm
Ethical violations like lack of informed consent

Historically, IRBs came about because of serious abuses in research (think: Tuskegee Syphilis Study). They’re a safeguard to make sure “this should be studied” doesn’t override “this is safe and ethical.”

Is IRB approval required?

Yes—absolutely.

In the U.S.:

Federally funded human research must have IRB approval
FDA-regulated clinical trials must have IRB oversight
Most journals won’t publish results without IRB approval
Sponsors and CROs won’t touch a study without it

No IRB = no study. Full stop.

Why it matters to participants

For participants, IRB oversight means:

They’re fully informed before saying yes
They can withdraw at any time
Their privacy is protected
There’s accountability if something goes wrong

Why it matters to research teams

For sites, sponsors, and recruiters (this matters for your world):

Ensures ethical recruitment practices
Protects the site and company legally
Builds trust with participants and communities
Keeps the study compliant and fundable

Bottom line:
The IRB is the ethical backbone of clinical research. It exists to make sure progress in medicine never comes at the cost of human dignity or safety.

References and Sources:

Food and Drug Administration. (2023). Institutional Review Boards (IRBs) and protection of human subjects in clinical trials. U.S. Department of Health and Human Services. https://www.fda.gov/about-fda/cder-offices-and-divisions/institutional-review-boards-irbs-and-protection-human-subjects-clinical-trials

Food and Drug Administration. (2023). Protection of human subjects: Standards for institutional review boards for clinical investigations (21 CFR Part 56). U.S. Department of Health and Human Services. https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/protection-human-subjects-standards-institutional-review-boards-clinical-investigations

Office for Human Research Protections. (2018). Federal policy for the protection of human subjects (“Common Rule”). U.S. Department of Health and Human Services. https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html

University of California, San Francisco. (n.d.). IRB review process. UCSF Office of Ethics and Compliance. https://irb.ucsf.edu/irb-review

Harvard University Committee on the Use of Human Subjects. (n.d.). Do you need IRB review and why? https://cuhs.harvard.edu/do-you-need-irb-review-and-why

Resnik, D. B. (2020). Institutional review boards: Purpose and challenges. Accountability in Research, 27(6), 315–328. https://doi.org/10.1080/08989621.2020.1762719

Council for Clinical Research Professionals. (n.d.). What is an institutional review board (IRB)? https://ccrps.org/clinical-research-blog/institutional-review-board-irb