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Glossary:TAG-00134-Eth-kom

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Glossary > Ethics committee

Ethics committee
Tag-ID TAG-00134-Eth-kom
English Ethics committee / Independent ethics committee / Institutional review board / Research ethics committee
EN Abbr. EC / IEC / IRB
French Comité d'éthique / Comité d'éthique indépendant / Comité d'examen de l'établissement / Comité de protection des personnes / Comité d'examen éthique
FR Abbr. CE / CEI / CEE / CPP
German Ethikkommission / Unabhängige Ethikkommission / Institutional Review Board
DE Abbr. EK / IRB

References

 ScopeDocument partLanguageDocument
AUT MPG – Medizinproduktegesetz 26-May-2022 § 22MD§ 22DEAUT MPG – Medizinproduktegesetz 26-May-2022
AUT Question - BASG 11-Feb-2025 -G-DEAUT Question - BASG 11-Feb-2025
CIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016 Page 20GPage 20ENCIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 41HM§ 41DEDEU AMG - Arzneimittelgesetz 19-Jul-2023
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 41aG§ 41aDEDEU AMG - Arzneimittelgesetz 19-Jul-2023
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 41bG§ 41bDEDEU AMG - Arzneimittelgesetz 19-Jul-2023
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 41cG§ 41cDEDEU AMG - Arzneimittelgesetz 19-Jul-2023
DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 1 1.1 ; 1.3NISLeitlinie 1 1.1 ; 1.3DEDEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018
DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.7.5NIS2.7.5DEDEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022
DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 10G§ 10DEDEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022
DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 11G§ 11DEDEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022
DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 4G§ 4DEDEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022
DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 5G§ 5DEDEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022
DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 6G§ 6DEDEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022
DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 7G§ 7DEDEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 33MD§ 33DEDEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 35MD§ 35DEDEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 40MD§ 40DEDEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 41MD§ 41DEDEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 48MD§ 48DEDEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 49MD§ 49DEDEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 50MD§ 50DEDEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 55MD§ 55DEDEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 59MD§ 59DEDEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 4GArticle 4ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 Article R1123-20GArticle R1123-20FRFRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025
FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025 Article R1123-20-1GArticle R1123-20-1FRFRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025
FRA SI RIPH 2G - Website 16-May-2025 -MD-FRFRA SI RIPH 2G - Website 16-May-2025
GBR HRA - Ending your project 28-Jan-2025 -G-ENGBR HRA - Ending your project 28-Jan-2025
GBR IRAS - Integrated Research Application System 28-Jan-2025 TemplatesGTemplatesENGBR IRAS - Integrated Research Application System 28-Jan-2025
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 11 - 12HMArticle 11 - 12ENGBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 14HMArticle 14ENGBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 15 (1) - (6)HMArticle 15 (1) - (6)ENGBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 15 (5) (d)HMArticle 15 (5) (d)ENGBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 15 (5) (k)-(l)HMArticle 15 (5) (k)-(l)ENGBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 15 (7) - (10)HMArticle 15 (7) - (10)ENGBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 16HMArticle 16ENGBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 relevant ethics committeeHMArticle 2 relevant ethics committeeENGBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 25HMArticle 25ENGBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 5-6HMArticle 5-6ENGBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 7-10HMArticle 7-10ENGBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 3 Part 1 1.HMSchedule 3

Part 1

1.		ENGBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 3 Part 1 1. ; 3.HMSchedule 3

Part 1

1. ; 3.		ENGBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
ICH ICH E6 Guideline R3 (2025) GLOSSARY - Institutional Review Board (IRB)/Independent Ethics Committee (IEC)GGLOSSARY - Institutional Review Board (IRB)/Independent Ethics Committee (IEC)ENICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 1GIII. Annex 1 1ENICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.13GIII. Annex 1 2.13ENICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.4.2GIII. Annex 1 2.4.2ENICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.8GIII. Annex 1 3.8ENICH ICH E6 Guideline R3 (2025)
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.24MD3.24ENISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 3.26MD3.26ENISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 5.7MD5.7ENISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
USA 21 CFR Part 312 09-Apr-2025 § 312.3 - IECHM§ 312.3 - IECENUSA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 50 09-Apr-2025 § 50.3 (i)G§ 50.3 (i)ENUSA 21 CFR Part 50 09-Apr-2025
USA 21 CFR Part 56 09-Apr-2025 -G-ENUSA 21 CFR Part 56 09-Apr-2025
USA 21 CFR Part 56 09-Apr-2025 Subpart BGSubpart BENUSA 21 CFR Part 56 09-Apr-2025
USA 21 CFR Part 56 09-Apr-2025 Subpart CGSubpart CENUSA 21 CFR Part 56 09-Apr-2025
USA 21 CFR Part 56 09-Apr-2025 § 56.102 (m)G§ 56.102 (m)ENUSA 21 CFR Part 56 09-Apr-2025
USA 21 CFR Part 56 09-Apr-2025 § 56.103G§ 56.103ENUSA 21 CFR Part 56 09-Apr-2025
USA 21 CFR Part 56 09-Apr-2025 § 56.104G§ 56.104ENUSA 21 CFR Part 56 09-Apr-2025
USA 21 CFR Part 56 09-Apr-2025 § 56.104 (d)G§ 56.104 (d)ENUSA 21 CFR Part 56 09-Apr-2025
USA 21 CFR Part 56 09-Apr-2025 § 56.105G§ 56.105ENUSA 21 CFR Part 56 09-Apr-2025
USA 21 CFR Part 56 09-Apr-2025 § 56.109G§ 56.109ENUSA 21 CFR Part 56 09-Apr-2025
USA 21 CFR Part 56 09-Apr-2025 § 56.110 (a) - (b) (1)G§ 56.110 (a) - (b) (1)ENUSA 21 CFR Part 56 09-Apr-2025
USA 21 CFR Part 56 09-Apr-2025 § 56.110 (b) (2)G§ 56.110 (b) (2)ENUSA 21 CFR Part 56 09-Apr-2025
USA 21 CFR Part 56 09-Apr-2025 § 56.111 - §56.112G§ 56.111

-

§56.112		ENUSA 21 CFR Part 56 09-Apr-2025
USA 21 CFR Part 56 09-Apr-2025 § 56.113-001G§ 56.113ENUSA 21 CFR Part 56 09-Apr-2025
USA 21 CFR Part 56 09-Apr-2025 § 56.113-002G§ 56.113ENUSA 21 CFR Part 56 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 Subpart DMDSubpart DENUSA 21 CFR Part 812 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.3 (f)MD§ 812.3 (f)ENUSA 21 CFR Part 812 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.3 (t)MD§ 812.3 (t)ENUSA 21 CFR Part 812 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.42MD§ 812.42ENUSA 21 CFR Part 812 09-Apr-2025
USA 45 CFR Part 46 09-Apr-2025 Subpart BGSubpart BENUSA 45 CFR Part 46 09-Apr-2025
USA 45 CFR Part 46 09-Apr-2025 Subpart EGSubpart EENUSA 45 CFR Part 46 09-Apr-2025
USA 45 CFR Part 46 09-Apr-2025 § 46.104G§ 46.104ENUSA 45 CFR Part 46 09-Apr-2025
USA 45 CFR Part 46 09-Apr-2025 § 46.107 - § 46.112G§ 46.107 - § 46.112ENUSA 45 CFR Part 46 09-Apr-2025
USA 45 CFR Part 46 09-Apr-2025 § 46.113G§ 46.113ENUSA 45 CFR Part 46 09-Apr-2025
USA 45 CFR Part 46 09-Apr-2025 § 46.115G§ 46.115ENUSA 45 CFR Part 46 09-Apr-2025
USA 45 CFR Part 46 09-Apr-2025 § 46.124G§ 46.124ENUSA 45 CFR Part 46 09-Apr-2025
USA Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure 1998 -G-ENUSA Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure 1998
USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 III A. ; IV.GIII A. ; IV.ENUSA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009
USA FDA INFORMATION SHEET - Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators Jan-1998 -HM-ENUSA FDA INFORMATION SHEET - Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators Jan-1998
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.2 - ConsultationHM3.2 - ConsultationENWHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.2 - IntroductionHM3.2 - IntroductionENWHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.2 - ResponsibilityHM3.2 - ResponsibilityENWHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - ethics committeeHMGlossary - ethics committeeENWHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WMA Declaration of Helsinki 2024 Paragraph 23GParagraph 23ENWMA Declaration of Helsinki 2024
WMA Declaration of Helsinki 2024 Paragraph 23 - Amendment approvalGParagraph 23 - Amendment approvalENWMA Declaration of Helsinki 2024
WMA Declaration of Helsinki 2024 Paragraph 23 - Final reportGParagraph 23 - Final reportENWMA Declaration of Helsinki 2024
WMA Declaration of Helsinki 2024 Paragraph 23 - OversightGParagraph 23 - OversightENWMA Declaration of Helsinki 2024
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