Whether you’re participating in a research study, reviewing clinical trial data, or supporting a patient who’s enrolled in a study, understanding institutional review boards (IRBs) is essential for nurses in all practice settings. IRBs help protect the rights and well-being of research participants — and by extension, help ensure ethical, responsible practice.
What is an institutional review board?
An IRB is a committee that reviews, monitors, and approves research involving human participants. The primary purpose of this board is to ensure that research is conducted ethically and that the rights, safety, and welfare of all participants are protected.
IRBs evaluate research protocols to ensure that risks to participants are minimized, informed consent is obtained appropriately, and participants are selected equitably. They also assess whether the potential benefits of the research outweigh the risks.
Why IRBs matter to nurses
Nurses are a fundamental part of patient advocacy, education, and research, and IRBs intersect with all three of these domains. Here’s why IRBs matter:
- Patient advocacy: Understanding IRB principles helps nurses advocate for patients’ rights during research participation.
- Research participation: Nurses involved in clinical trials or evidence-based practice projects are responsible for recruiting participants, collecting data, or ensuring informed consent, all of which fall under IRB oversight.
- Ethical awareness: Nurses who conduct their own research, such as in advanced practice roles or academic settings, must obtain IRB approval before involving human participants.
In short, IRB knowledge supports ethical nursing practice, protects vulnerable populations, and helps maintain public trust in healthcare research.
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Learn MoreA brief history of IRBs
The origin of IRBs is rooted in historical ethical breaches in research. Following World War II, the Nuremberg Code (1947) laid the groundwork for ethical research standards, emphasizing voluntary consent and the avoidance of unnecessary suffering.
Subsequent unethical studies, such as the Untreated Tuskegee Syphilis Study (1932–1972), in which Black men were misled and denied treatment, further highlighted the need for regulatory oversight.
In response, the National Research Act of 1974 established the requirement for IRBs in the United States. This act also led to the development of the Belmont Report (1979), which outlines three core principles that still guide IRB decisions today:
- Respect for persons: This ensures voluntary participation and informed consent.
- Beneficence: This is about maximizing benefits while minimizing risks.
- Justice: This ensures fair and equitable participant selection.
These ethical principles continue to shape IRB guidelines and decisions in modern research.
Key IRBs and guidelines nurses should know
While IRBs exist within most hospitals, universities, and research institutions, it’s important to be familiar with both local and national regulatory structures such as the following:
- Institutional IRBs: These boards are typically affiliated with healthcare organizations or academic institutions. Nurses working on research projects will most often interact with these boards directly.
- U.S. Department of Health and Human Services (HHS): Through the Office for Human Research Protections (OHRP), HHS oversees federal regulations for IRBs under the Common Rule (45 CFR 46), which provides uniform standards for IRB review and participant protections.
- Food and Drug Administration (FDA): The FDA regulates IRBs, overseeing clinical trials involving investigational drugs, biologics, or medical devices.
- National Institutes of Health (NIH) IRB: Nurses involved in federally funded research may encounter the NIH IRB, which sets standards for ethical research involving human subjects.
IRB guidelines in practice
IRBs follow a standardized process to review and approve research studies. Nurses involved in research should be aware of the following core IRB guidelines:
- Informed consent is required. Participants must voluntarily agree to participate, with full knowledge of the study’s purpose, procedures, risks, and benefits.
- Risks must be minimized. Research must be designed to avoid unnecessary harm and discomfort to participants.
- Privacy and confidentiality must be protected. This includes safeguarding health information and personal data.
- Vulnerable populations receive special protections. This includes children, prisoners, pregnant women, and individuals with cognitive impairments.
- Ongoing oversight is required. IRBs monitor approved studies regularly and can suspend or terminate studies if ethical concerns arise.
The nurse’s role in upholding research ethics
Whether you're a bedside nurse involved in research recruitment or a nurse researcher leading a study, you play a key role in upholding ethical standards. Here are a few ways nurses contribute to IRB-aligned research:
- Ensure informed consent is truly informed.
- Advocate for participants' rights and safety.
- Report ethical concerns or protocol deviations.
- Participate in IRB review as a member or consultant.
By staying informed about IRB processes and principles, nurses help safeguard the integrity of research and reinforce the trust patients place in healthcare professionals.
