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Glossary:TAG-00029-Inf-rte

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Glossary > Informed consent

Informed consent
Tag-ID TAG-00029-Inf-rte
English Informed consent / Consent
EN Abbr. IC
French Consentement éclairé / Consentement libre et éclairé
FR Abbr. CE
German Einwilligung nach Aufklärung / Informierte Einwilligung / Aufgeklärte Einwilligung
DE Abbr. ENA

References

 ScopeDocument partLanguageDocument
CIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016 Page 23GPage 23ENCIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 3HM§ 40b Absatz 3DEDEU AMG - Arzneimittelgesetz 19-Jul-2023
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 4HM§ 40b Absatz 4DEDEU AMG - Arzneimittelgesetz 19-Jul-2023
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 5HM§ 40b Absatz 5DEDEU AMG - Arzneimittelgesetz 19-Jul-2023
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 6-001HM§ 40b Absatz 6DEDEU AMG - Arzneimittelgesetz 19-Jul-2023
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 96 Nr. 10, 11, 21HM§ 96 Nr. 10, 11, 21DEDEU AMG - Arzneimittelgesetz 19-Jul-2023
DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 1 1.2NISLeitlinie 1 1.2DEDEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018
DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 5NISLeitlinie 5DEDEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018
DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.7.4NIS2.7.4DEDEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 28 Absatz 1 – 2MD§ 28 Absatz 1 – 2DEDEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 28 Absatz 3MD§ 28 Absatz 3DEDEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 28 Absatz 4 – 6MD§ 28 Absatz 4 – 6DEDEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022
EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022 2.9G2.9ENEU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022
EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 Annex A A5.3GAnnex A A5.3ENEU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023
EU Regulation (EU) 2016/679 (GDPR) 04-May-2016 Article 6 Paragraph 1GArticle 6 Paragraph 1ENEU Regulation (EU) 2016/679 (GDPR) 04-May-2016
EU Regulation (EU) 2016/679 (GDPR) 04-May-2016 Article 9 Paragraph 1GArticle 9 Paragraph 1ENEU Regulation (EU) 2016/679 (GDPR) 04-May-2016
EU Regulation (EU) 2016/679 (GDPR) 04-May-2016 Article 9 Paragraph 2GArticle 9 Paragraph 2ENEU Regulation (EU) 2016/679 (GDPR) 04-May-2016
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 63 Paragraph 1MDArticle 63 Paragraph 1ENEU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 63 Paragraph 2MDArticle 63 Paragraph 2ENEU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 63 Paragraph 3 – 5MDArticle 63 Paragraph 3 – 5ENEU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 63 Paragraph 6 – 7MDArticle 63 Paragraph 6 – 7ENEU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 64MDArticle 64ENEU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 65MDArticle 65ENEU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 66MDArticle 66ENEU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 68MDArticle 68ENEU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 2 Paragraph 58IVDArticle 2 Paragraph 58ENEU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 59 Paragraph 1IVDArticle 59 Paragraph 1ENEU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 59 Paragraph 2IVDArticle 59 Paragraph 2ENEU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 59 Paragraph 3 – 5IVDArticle 59 Paragraph 3 – 5ENEU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023 Article 59 Paragraph 6 – 7IVDArticle 59 Paragraph 6 – 7ENEU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 28 Paragraph 1HMArticle 28 Paragraph 1ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 28 Paragraph 2-3HMArticle 28 Paragraph 2-3ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 29 Paragraph 1HMArticle 29 Paragraph 1ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 29 Paragraph 2HMArticle 29 Paragraph 2ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 29 Paragraph 3-5HMArticle 29 Paragraph 3-5ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 29 Paragraph 6-8HMArticle 29 Paragraph 6-8ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 31 Paragraph 1HMArticle 31 Paragraph 1ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 31 Paragraph 2-3HMArticle 31 Paragraph 2-3ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 32 Paragraph 1HMArticle 32 Paragraph 1ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 32 Paragraph 2-3HMArticle 32 Paragraph 2-3ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 33HMArticle 33ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 34HMArticle 34ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 35 Paragraph 1HMArticle 35 Paragraph 1ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 35 Paragraph 2-3HMArticle 35 Paragraph 2-3ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 7GArticle 7ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
GBR Data Protection Act 2018 06-Jun-2022 Article 2GArticle 2ENGBR Data Protection Act 2018 06-Jun-2022
GBR Data Protection Act 2018 06-Jun-2022 Schedule 10GSchedule 10ENGBR Data Protection Act 2018 06-Jun-2022
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 1 Part 3-001HMSchedule 1 Part 3ENGBR 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 1 Part 3-002HMSchedule 1 Part 3ENGBR 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 1 Part 5HMSchedule 1 Part 5ENGBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
GBR UK GDPR - United Kingdom General Data Protection Regulation 31-Dec-2020 Article 6 Paragraph 1GArticle 6 Paragraph 1ENGBR UK GDPR - United Kingdom General Data Protection Regulation 31-Dec-2020
GBR UK GDPR - United Kingdom General Data Protection Regulation 31-Dec-2020 Article 9 Paragraph 1GArticle 9 Paragraph 1ENGBR UK GDPR - United Kingdom General Data Protection Regulation 31-Dec-2020
GBR UK GDPR - United Kingdom General Data Protection Regulation 31-Dec-2020 Article 9 Paragraph 2GArticle 9 Paragraph 2ENGBR UK GDPR - United Kingdom General Data Protection Regulation 31-Dec-2020
ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 2.2GAnnex 2 2.2ENICH ICH E6 Guideline - Annex 2 R3 Annex 2
ICH ICH E6 Guideline R3 (2025) GLOSSARY - Informed ConsentGGLOSSARY - Informed ConsentENICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) II 2.4GII 2.4ENICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8GIII. Annex 1 2.8ENICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8.13GIII. Annex 1 2.8.13ENICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8.8GIII. Annex 1 2.8.8ENICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8.9GIII. Annex 1 2.8.9ENICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.9.1GIII. Annex 1 2.9.1ENICH ICH E6 Guideline R3 (2025)
INT Nuremberg Code 1947 CodeGCodeENINT Nuremberg Code 1947
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 5.8.2MD5.8.2ENISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 5.8.3MD5.8.3ENISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
USA 21 CFR Part 50 09-Apr-2025 § 50.20G§ 50.20ENUSA 21 CFR Part 50 09-Apr-2025
USA 21 CFR Part 50 09-Apr-2025 § 50.22G§ 50.22ENUSA 21 CFR Part 50 09-Apr-2025
USA 21 CFR Part 50 09-Apr-2025 § 50.23G§ 50.23ENUSA 21 CFR Part 50 09-Apr-2025
USA 21 CFR Part 50 09-Apr-2025 § 50.24G§ 50.24ENUSA 21 CFR Part 50 09-Apr-2025
USA 21 CFR Part 50 09-Apr-2025 § 50.25 (a) - (b)G§ 50.25 (a) - (b)ENUSA 21 CFR Part 50 09-Apr-2025
USA 21 CFR Part 50 09-Apr-2025 § 50.25 (e)G§ 50.25 (e)ENUSA 21 CFR Part 50 09-Apr-2025
USA 21 CFR Part 50 09-Apr-2025 § 50.27G§ 50.27ENUSA 21 CFR Part 50 09-Apr-2025
USA 21 CFR Part 50 09-Apr-2025 § 50.3 (l)G§ 50.3 (l)ENUSA 21 CFR Part 50 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (5)MD§ 812.150 (a) (5)ENUSA 21 CFR Part 812 09-Apr-2025
USA 21 CFR Part 812 09-Apr-2025 § 812.150 (b) (8)MD§ 812.150 (b) (8)ENUSA 21 CFR Part 812 09-Apr-2025
USA 45 CFR Part 160 09-Apr-2025 § 164.508G§ 164.508ENUSA 45 CFR Part 160 09-Apr-2025
USA 45 CFR Part 46 09-Apr-2025 § 46.116G§ 46.116ENUSA 45 CFR Part 46 09-Apr-2025
USA 45 CFR Part 46 09-Apr-2025 § 46.117G§ 46.117ENUSA 45 CFR Part 46 09-Apr-2025
USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 II. IntroductionGII. IntroductionENUSA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023
USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 III.GIII.ENUSA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023
USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023 IV.GIV.ENUSA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023
USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024 5.2G5.2ENUSA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024
WHO WHO - Guidance for best practices for clinical trials 2024 Annex 2 2.5GAnnex 2 2.5ENWHO WHO - Guidance for best practices for clinical trials 2024
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.3 c)HM3.3 c)ENWHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.3 c) ; e) - g)HM3.3 c) ; e) - g)ENWHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.3 e) - g)HM3.3 e) - g)ENWHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.5HM4.5ENWHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - informed consentHMGlossary - informed consentENWHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 22GPage 22ENWHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005
WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Page 60-61GPage 60-61ENWHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005
WMA Declaration of Helsinki 2024 Paragraph 25 – 28GParagraph 25 – 28ENWMA Declaration of Helsinki 2024
WMA Declaration of Helsinki 2024 Paragraph 31 – 32GParagraph 31 – 32ENWMA Declaration of Helsinki 2024
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