All terms
Institutional Review Board
Board that reviews and approves human-subjects research at an institution.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
Definition
An IRB is a committee that reviews biomedical research involving human subjects to ensure their rights and welfare are protected, per 21 CFR Part 56. What the regulation says
The FDA, under 21 CFR Part 56, mandates Institutional Review Board (IRB) review for clinical investigations involving human subjects to protect their rights, safety, and welfare. Similarly, clinical investigations conducted in the European Union must obtain a favorable opinion from an ethics committee, as outlined in the EU MDR 2017/745, Article 58. These regulatory requirements ensure that research protocols are ethically sound and scientifically valid.What this means in practice
Both SR and NSR device studies require IRB approval. Non-U.S. trials use equivalent ethics committees.Examples
- A MedTech company developing a new cardiac stent must submit its clinical investigation plan, including the informed consent form and patient recruitment materials, to an IRB for approval before enrolling any patients.
- A medical device manufacturer conducting a post-market surveillance study involving patient surveys must obtain IRB clearance, even if the data collected is de-identified, to ensure ethical considerations are met.
- A researcher modifying a previously approved study protocol to include a new patient population or a different data collection method must submit an amendment to the IRB for review and authorization prior to implementing the changes.
Common pitfalls
- •Failing to obtain IRB approval before initiating a clinical investigation can lead to regulatory non-compliance and invalidation of study data.
- •Misinterpreting the scope of IRB review, assuming it only applies to interventional studies and not to observational studies or studies using existing de-identified data, is a common pitfall.
- •Not ensuring that all investigators and research staff have completed appropriate human subjects protection training can result in IRB findings and study delays.
- •Neglecting to submit modifications to an approved study protocol to the IRB for review and approval prior to implementation can be a serious regulatory violation.
- •Assuming that an IRB approval from one institution is automatically transferable to another without formal review and acceptance by the second institution's IRB is incorrect and can lead to unapproved research activities.
Frequently asked questions
The primary role of an IRB is to review and approve research activities involving human subjects to ensure their rights, safety, and welfare are protected according to ethical principles and regulatory requirements.
Cross-references
Uses
Related terms
Shared paths + categoryClinical & Trials
Informed Consent
Voluntary, informed agreement to participate in research after disclosure of risks and benefits.
Clinical Trials & Evidence · adjacent
Clinical & Trials
Investigational Device Exemption(IDE)
FDA authorization to use an investigational device in a clinical study.
Clinical Trials & Evidence
Clinical & Trials
IDE Annual Progress Report
Annual report sponsors must submit to FDA summarizing the progress of an approved IDE study, including enrollment, deviations, and adverse events.
Clinical Trials & Evidence · adjacent
Clinical & Trials
Adaptive Trial Design
Trial design that pre-specifies opportunities to modify aspects (sample size, arms, endpoints) based on interim data.
Clinical Trials & Evidence
Clinical & Trials
Adverse Event(AE)
Any untoward medical occurrence in a subject, whether or not related to the device.
Clinical Trials & Evidence
Clinical & Trials
Clinical Evaluation Report(CER)
Documented assessment of clinical data demonstrating EU MDR conformity for a device.
Clinical Trials & Evidence
Latest in MedTech
Primary references
3 sourcesLink health: 3 verified· last checked 2026-06-20
eCFR·1ICH·1ISO·1
- 121 CFR Part 56VerifiedeCFRecfr.gov
- 2ICH GuidelinesVerifiedICHich.org
- 3ISO 14155 Standard PageVerifiedISOiso.org
Inline markers like [1] jump to the matching reference above.