--- title: "Informed Consent, Definition | MedTech Terms" description: "Voluntary, informed agreement to participate in research after disclosure of risks and benefits. Plain-English Clinical & Trials definition for MedTech teams, w" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/informed-consent#term", "name": "Informed Consent", "description": "Per 21 CFR Part 50, informed consent is the legally effective agreement of a subject to participate in a clinical investigation, obtained under circumstances that minimize coercion and ensure understanding of risks, benefits, and alternatives.", "url": "https://medtechterms.com/terms/informed-consent", "termCode": "informed-consent", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/informed-consent#article", "headline": "Informed Consent", "description": "Voluntary, informed agreement to participate in research after disclosure of risks and benefits.", "url": "https://medtechterms.com/terms/informed-consent", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/informed-consent" }, "about": { "@id": "https://medtechterms.com/terms/informed-consent#term" }, "articleSection": "Clinical & Trials", "inLanguage": "en", "keywords": "Informed Consent, Clinical & Trials, medical device, MedTech", "author": { "@type": "Person", "name": "Christian Espinosa", "jobTitle": "Founder, Blue Goat Cyber", "url": "https://bluegoatcyber.com" }, "publisher": { "@type": "Organization", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "isPartOf": { "@type": "WebSite", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "datePublished": "2026-05-05", "dateModified": "2026-05-05", "citation": [ { "@type": "CreativeWork", "name": "21 CFR Part 50", "url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-50", "publisher": { "@type": "Organization", "name": "eCFR" } }, { "@type": "CreativeWork", "name": "ICH Guidelines", "url": "https://www.ich.org/page/ich-guidelines", "publisher": { "@type": "Organization", "name": "ICH" } }, { "@type": "CreativeWork", "name": "ISO 14155 Standard Page", "url": "https://www.iso.org/standard/71690.html", "publisher": { "@type": "Organization", "name": "ISO" } } ], "mentions": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ide#term", "name": "Investigational Device Exemption", "alternateName": "IDE", "url": "https://medtechterms.com/terms/ide" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/irb#term", "name": "Institutional Review Board", "alternateName": "IRB", "url": "https://medtechterms.com/terms/irb" } ] }, { "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://medtechterms.com/" }, { "@type": "ListItem", "position": 2, "name": "Terms", "item": "https://medtechterms.com/terms" }, { "@type": "ListItem", "position": 3, "name": "Clinical & Trials", "item": "https://medtechterms.com/terms?cat=Clinical%20%26%20Trials" }, { "@type": "ListItem", "position": 4, "name": "Informed Consent", "item": "https://medtechterms.com/terms/informed-consent" } ] }, { "@type": "FAQPage", "@id": "https://medtechterms.com/terms/informed-consent#faq", "mainEntity": [ { "@type": "Question", "name": "What are the essential elements of informed consent?", "acceptedAnswer": { "@type": "Answer", "text": "Essential elements, as described in 21 CFR 50.25, include a statement that the study involves research, an explanation of procedures, risks, benefits, alternative treatments, and a statement regarding confidentiality and compensation for injury." } }, { "@type": "Question", "name": "When is re-consent required?", "acceptedAnswer": { "@type": "Answer", "text": "Re-consent is necessary when there are significant new findings or changes to the study protocol that may affect the participant's willingness to continue, as advised by the IRB and outlined in 21 CFR 50.25(b)(5)." } }, { "@type": "Question", "name": "Who is responsible for obtaining informed consent?", "acceptedAnswer": { "@type": "Answer", "text": "The investigator, or a person delegated by the investigator and trained to do so, is responsible for obtaining informed consent after ensuring the participant has sufficient opportunity to consider participation and ask questions." } }, { "@type": "Question", "name": "Can informed consent be waived?", "acceptedAnswer": { "@type": "Answer", "text": "In limited circumstances, an Institutional Review Board (IRB) may waive or alter informed consent requirements. The criteria for waiver are outlined in 21 CFR 50.25(d) and involve situations such as minimal risk, public benefit, or emergency research." } } ] } ] } --- [ 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. Informed Consent [All terms](/terms) Clinical & Trials [Quality System](/ecosystems/quality-system)[Clinical Evidence](/ecosystems/clinical-evidence) # Informed Consent Voluntary, informed agreement to participate in research after disclosure of risks and benefits. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition Per 21 CFR Part 50, informed consent is the legally effective agreement of a subject to participate in a clinical investigation, obtained under circumstances that minimize coercion and ensure understanding of risks, benefits, and alternatives. What the regulation says Under 21 CFR Part 50, informed consent is a fundamental ethical and regulatory requirement for clinical investigations involving human subjects. The [EU Medical Device Regulation](/terms/mdr) ( [MDR](/terms/mdr-reporting)) 2017/745, in Annex I, Section 1, also mandates that subjects provide informed consent for clinical investigations, emphasizing documentation and the right of withdrawal. ICH E6(R2) [Good Clinical Practice](/terms/gcp) guidelines further elaborate on the responsibilities of investigators and institutional review boards (IRBs) regarding the informed consent process and documentation. ## What this means in practice Informed consent documents are reviewed by IRBs. Pediatric, vulnerable population, and digital trial contexts have additional considerations. ## Examples - A medical device company conducting a clinical trial for a new implantable cardiac device must obtain informed consent from each participant using a document that outlines the device’s purpose, potential risks, and the participant’s rights, such as withdrawing at any time. - Before enrolling a patient in a study evaluating a novel diagnostic software, a researcher provides an informed consent form explaining the data collection process, privacy safeguards, and how the results will be used. - For a study involving a drug to treat a rare disease, the research team meets with potential participants and their legal representatives to thoroughly discuss the experimental nature of the treatment, possible side effects, and available standard therapies, ensuring all questions are answered before signature. Common pitfalls - • Failing to clearly explain all reasonably foreseeable risks and discomforts to the participant is a common pitfall. - • Overlooking the need for re-consent when significant new information arises during a clinical investigation can lead to non-compliance. - • Using overly technical or complex language in informed consent forms can hinder a participant's understanding, invalidating the consent. - • Not ensuring that the informed consent process is free from coercion or undue influence, especially with vulnerable populations, is a serious violation. - • Failure to document the informed consent discussion and signed form appropriately can result in regulatory deficiencies. ## Frequently asked questions What are the essential elements of informed consent? Essential elements, as described in 21 CFR 50.25, include a statement that the study involves research, an explanation of procedures, risks, benefits, alternative treatments, and a statement regarding confidentiality and compensation for injury. When is re-consent required? Who is responsible for obtaining informed consent? Can informed consent be waived? ## Cross-references ### Used by Things that build on this term. - [ Institutional Review Board(IRB) ](/terms/irb) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Clinical & Trials Institutional Review Board(IRB) Board that reviews and approves human-subjects research at an institution. ](/terms/irb)[ 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 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)[ Clinical & Trials Feasibility Study Small clinical study evaluating initial safety, usability, and design parameters of an investigational device. ](/terms/feasibility-study?from=clinical-trials-and-evidence) ### More in Clinical & Trials · Same category [ 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. ](/terms/ide-annual-report)[ 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 5 of 18 Ecosystems (2) - [Quality System](/ecosystems/quality-system) - [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 50 Verified eCFR · ecfr.gov ](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-50) 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 Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=informed-consent) Learn in 60 seconds Card Lesson Quiz Voluntary, informed agreement to participate in research after disclosure of risks and benefits. - · Informed consent documents are reviewed by IRBs. - · Pediatric, vulnerable population, and digital trial contexts have additional considerations. Remember this Watch out: Failing to clearly explain all reasonably foreseeable risks and discomforts to the participant is a common pitfall. Related terms - [Investigational Device Exemption(IDE) ](/terms/ide) - [Institutional Review Board(IRB) ](/terms/irb) You may also need Auto-suggested from Clinical & Trials and shared keywords. - [Investigator-Initiated Trial(IIT) ](/terms/investigator-initiated-trial) - [Performance Study (IVDR) ](/terms/ivdr-performance-study) - [Clinical Evaluation Plan(CEP) ](/terms/clinical-evaluation-plan) - [Real-World Data(RWD) ](/terms/rwd) - [Real-World Evidence(RWE) ](/terms/real-world-evidence) - [Trial Master File(TMF) ](/terms/trial-master-file) [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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