--- title: "IRB, Institutional Review Board | MedTech Terms" description: "Board that reviews and approves human-subjects research at an institution. 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Both serve the same fundamental purpose of reviewing and approving research involving human subjects to ensure ethical conduct." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Clinical & Trials](/terms?cat=Clinical%20%26%20Trials) 6. / 7. Institutional Review Board [All terms](/terms) Clinical & Trials [Clinical Evidence](/ecosystems/clinical-evidence)IRB # Institutional Review Board Board that reviews and approves human-subjects research at an institution. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last 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](/terms/mdr-reporting) 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 What is the primary role of an IRB? 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. Are all clinical studies required to have IRB review? What is the difference between an IRB and an Ethics Committee? ## Cross-references ### Uses Concepts or artefacts this term builds on. - [ Informed Consent ](/terms/informed-consent) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Clinical & Trials Informed Consent Voluntary, informed agreement to participate in research after disclosure of risks and benefits. ](/terms/informed-consent)[ Clinical & Trials Investigational Device Exemption(IDE) FDA authorization to use an investigational device in a clinical study. ](/terms/ide) ### Clinical Trials & Evidence · From this learning path [ 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. Adjacent lesson ](/terms/ide-annual-report?from=clinical-trials-and-evidence)[ Clinical & Trials Adaptive Trial Design Trial design that pre-specifies opportunities to modify aspects (sample size, arms, endpoints) based on interim data. ](/terms/adaptive-trial?from=clinical-trials-and-evidence)[ Clinical & Trials Adverse Event(AE) Any untoward medical occurrence in a subject, whether or not related to the device. ](/terms/adverse-event?from=clinical-trials-and-evidence)[ Clinical & Trials Clinical Evaluation Report(CER) Documented assessment of clinical data demonstrating EU MDR conformity for a device. ](/terms/cer?from=clinical-trials-and-evidence) ### More in Clinical & Trials · Same category [ Clinical & Trials Feasibility Study Small clinical study evaluating initial safety, usability, and design parameters of an investigational device. ](/terms/feasibility-study)[ Clinical & Trials IDE Supplement Amendment to an approved Investigational Device Exemption for protocol or device changes. ](/terms/ide-supplement) Cited by Where this term appears across MedTech Terms. Learning paths (1) - [Clinical Trials & Evidence](/paths/clinical-trials-and-evidence)Lesson 4 of 18 Ecosystems (1) - [Clinical Evidence](/ecosystems/clinical-evidence) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 eCFR· 1 ICH· 1 ISO· 1 1. [1 21 CFR Part 56 Verified eCFR · ecfr.gov ](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-56) 2. [2 ICH Guidelines Verified ICH · ich.org ](https://www.ich.org/page/ich-guidelines) 3. [3 ISO 14155 Standard Page Verified ISO · iso.org ](https://www.iso.org/standard/71690.html) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Clinical evidence intersecting with device security? We support clinical-stage MedTech teams whose investigational devices touch patient data or hospital networks. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Clinical & Trials Acronym IRB Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=irb) Learn in 60 seconds Card Lesson Quiz Board that reviews and approves human-subjects research at an institution. - · Both SR and NSR device studies require IRB approval. - · Non-U.S. - · trials use equivalent ethics committees. Remember this Watch out: Failing to obtain IRB approval before initiating a clinical investigation can lead to regulatory non-compliance and invalidation of study data. Related terms - [Investigational Device Exemption(IDE) ](/terms/ide) - [Informed Consent ](/terms/informed-consent) You may also need Auto-suggested from Clinical & Trials and shared keywords. - [Data Safety Monitoring Board(DSMB) ](/terms/dsmb) - [IDE Annual Progress Report ](/terms/ide-annual-report) - [Performance Study (IVDR) ](/terms/ivdr-performance-study) - [Unanticipated Adverse Device Effect(UADE) ](/terms/uade) - [Human Factors Engineering(HFE) ](/terms/human-factors) - [HIPAA(HIPAA) ](/terms/hipaa) [All Clinical & Trials terms](/terms?cat=Clinical%20%26%20Trials) From the Blue Goat network Related resources and services on this topic. - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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