Regulation (EU) 536/2014 and the role of ethics committees: a proposal for a review system model
Independent ethics committees play an important role in clinical trials as well as in all health-related research. Internationally, the national laws of the individual countries have guided their local development and organisation over the decades. Directive 2001/20/EC of the European Parliament and...
Uloženo v:
| Vydáno v: | BMJ open Ročník 14; číslo 11; s. e073451 |
|---|---|
| Hlavní autoři: | , |
| Médium: | Journal Article |
| Jazyk: | angličtina |
| Vydáno: |
England
British Medical Journal Publishing Group
07.11.2024
BMJ Publishing Group LTD BMJ Publishing Group |
| Témata: | |
| ISSN: | 2044-6055, 2044-6055 |
| On-line přístup: | Získat plný text |
| Tagy: |
Přidat tag
Žádné tagy, Buďte první, kdo vytvoří štítek k tomuto záznamu!
|
| Abstract | Independent ethics committees play an important role in clinical trials as well as in all health-related research. Internationally, the national laws of the individual countries have guided their local development and organisation over the decades. Directive 2001/20/EC of the European Parliament and of the Council explicitly recognised the ethics committees’ duty to protect the rights, safety and well-being of human subjects involved in trials and to provide public assurance of that protection. Regulation (EU) 536/2014, which repealed the aforesaid directive, provides that a clinical trial must be subjected to scientific and ethical review, without specifically defining what they consist in. The divide between the evaluation of the ethical value and the scientific value of a study is very faint and, for some, it may even appear a meaningless distinction. While Regulation (EU) 536/2014 requires Member States to ensure that ethics committees are involved in the assessment process within their national territory, it does not require such ethical assessment to be binding. This article proposes a possible system for interaction between ethics committees and local regulatory authorities in which the meaning and purpose of the ethical assessment are conceptually clearly defined and not narrow. |
|---|---|
| AbstractList | Independent ethics committees play an important role in clinical trials as well as in all health-related research. Internationally, the national laws of the individual countries have guided their local development and organisation over the decades. Directive 2001/20/EC of the European Parliament and of the Council explicitly recognised the ethics committees’ duty to protect the rights, safety and well-being of human subjects involved in trials and to provide public assurance of that protection. Regulation (EU) 536/2014, which repealed the aforesaid directive, provides that a clinical trial must be subjected to scientific and ethical review, without specifically defining what they consist in. The divide between the evaluation of the ethical value and the scientific value of a study is very faint and, for some, it may even appear a meaningless distinction. While Regulation (EU) 536/2014 requires Member States to ensure that ethics committees are involved in the assessment process within their national territory, it does not require such ethical assessment to be binding. This article proposes a possible system for interaction between ethics committees and local regulatory authorities in which the meaning and purpose of the ethical assessment are conceptually clearly defined and not narrow. Independent ethics committees play an important role in clinical trials as well as in all health-related research. Internationally, the national laws of the individual countries have guided their local development and organisation over the decades. Directive 2001/20/EC of the European Parliament and of the Council explicitly recognised the ethics committees' duty to protect the rights, safety and well-being of human subjects involved in trials and to provide public assurance of that protection. Regulation (EU) 536/2014, which repealed the aforesaid directive, provides that a clinical trial must be subjected to scientific and ethical review, without specifically defining what they consist in. The divide between the evaluation of the ethical value and the scientific value of a study is very faint and, for some, it may even appear a meaningless distinction. While Regulation (EU) 536/2014 requires Member States to ensure that ethics committees are involved in the assessment process within their national territory, it does not require such ethical assessment to be binding. This article proposes a possible system for interaction between ethics committees and local regulatory authorities in which the meaning and purpose of the ethical assessment are conceptually clearly defined and not narrow.Independent ethics committees play an important role in clinical trials as well as in all health-related research. Internationally, the national laws of the individual countries have guided their local development and organisation over the decades. Directive 2001/20/EC of the European Parliament and of the Council explicitly recognised the ethics committees' duty to protect the rights, safety and well-being of human subjects involved in trials and to provide public assurance of that protection. Regulation (EU) 536/2014, which repealed the aforesaid directive, provides that a clinical trial must be subjected to scientific and ethical review, without specifically defining what they consist in. The divide between the evaluation of the ethical value and the scientific value of a study is very faint and, for some, it may even appear a meaningless distinction. While Regulation (EU) 536/2014 requires Member States to ensure that ethics committees are involved in the assessment process within their national territory, it does not require such ethical assessment to be binding. This article proposes a possible system for interaction between ethics committees and local regulatory authorities in which the meaning and purpose of the ethical assessment are conceptually clearly defined and not narrow. |
| Author | Petrini, Carlo Riva, Luciana |
| Author_xml | – sequence: 1 givenname: Luciana orcidid: 0000-0003-1695-3183 surname: Riva fullname: Riva, Luciana email: luciana.riva@iss.it organization: Bioethics Unit, Istituto Superiore di Sanita, Rome, Lazio, Italy – sequence: 2 givenname: Carlo surname: Petrini fullname: Petrini, Carlo organization: Bioethics Unit, Istituto Superiore di Sanita, Rome, Lazio, Italy |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/39510791$$D View this record in MEDLINE/PubMed |
| BookMark | eNp9ks1u1TAQhS1UREvpEyAhS2zKItT_TtggVBWoVAkJ0bWxncm9uUriYDtFfXtcciktC7yxPfPN8Wh8nqODKUyA0EtK3lLK1Zkbd2GGqWKE8YpoLiR9go4YEaJSRMqDB-dDdJLSjpQlZCMle4YOeSMp0Q09Qt-_wmYZbO7DhE8vrt9gWcQZoQLbqcV5CziGAXDoMORt7xP2YRz7nAHSO2zxHMMckh1wF2K5Rrjp4SdOtynDiMfQwvACPe3skOBkvx-j648X384_V1dfPl2ef7iqnGhIrpxmXBHrwULXcdWA7nQra-q0c4qA8qLRgnXCKw8lCsAdpVoB-Fo78IIfo8tVtw12Z-bYjzbemmB78zsQ4sbYmHs_gOGd1I2uhZPMiqJb6661nLXWs9pR2xat96vWvLgRWg9TjnZ4JPo4M_Vbswk3htIyX8nqonC6V4jhxwIpm7FPHobBThCWZDgtECO1pAV9_Q-6C0ucyqwKJZQiXElVqFcPW7rv5c9PFoCvgI8hpQjdPUKJubOM2VvG3FnGrJYpVWdrVUn-ffd_Fb8AIobDBQ |
| Cites_doi | 10.1136/medethics-2012-101228 10.1186/1472-6939-13-35 10.1001/jama.2013.281053 10.1080/03007995.2018.1528214 10.1016/S0140-6736(12)60430-9 10.1097/DCC.0b013e3181de9ec5 10.1136/jme.2006.016782 10.1001/jama.283.20.2701 10.1136/bmj.313.7070.1413 10.1002/eahr.500104 10.1371/journal.pbio.2004879 10.1136/medethics-2019-106014 10.1080/17512433.2019.1680282 10.1007/s00103-019-02952-8 10.1007/s00103-017-2579-9 10.1136/jme.2007.021089 10.1111/dewb.12004 10.7326/0003-4819-141-4-200408170-00008 10.1525/jer.2011.6.1.3 10.1111/bcp.14871 10.1097/00004479-200404000-00012 10.1016/j.conctc.2018.05.014 10.1136/medethics-2018-105107 10.1186/1472-6939-9-6 10.1136/medethics-2015-103028 10.1136/medethics-2020-106757 10.1136/jme.2006.016071 10.1136/medethics-2015-102688 10.1136/bmj.g3710 |
| ContentType | Journal Article |
| Copyright | Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. 2024 Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. Copyright © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. 2024 |
| Copyright_xml | – notice: Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. – notice: 2024 Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. – notice: Copyright © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. 2024 |
| DBID | 9YT ACMMV AAYXX CITATION CGR CUY CVF ECM EIF NPM 3V. 7RV 7X7 7XB 88E 88G 8FI 8FJ 8FK ABUWG AFKRA AZQEC BENPR BTHHO CCPQU COVID DWQXO FYUFA GHDGH GNUQQ K9- K9. KB0 M0R M0S M1P M2M NAPCQ PHGZM PHGZT PIMPY PJZUB PKEHL PPXIY PQEST PQQKQ PQUKI PRINS PSYQQ Q9U 7X8 5PM DOA |
| DOI | 10.1136/bmjopen-2023-073451 |
| DatabaseName | BMJ Open Access Journals BMJ Journals:Open Access CrossRef Medline MEDLINE MEDLINE (Ovid) MEDLINE MEDLINE PubMed ProQuest Central (Corporate) Nursing & allied health premium. Health & Medical Collection ProQuest Central (purchase pre-March 2016) Medical Database (Alumni Edition) Psychology Database (Alumni) Hospital Premium Collection Hospital Premium Collection (Alumni Edition) ProQuest Central (Alumni) (purchase pre-March 2016) ProQuest Central (Alumni) ProQuest Central UK/Ireland ProQuest Central Essentials ProQuest Central BMJ Journals ProQuest One Coronavirus Research Database ProQuest Central Korea Health Research Premium Collection Health Research Premium Collection (Alumni) ProQuest Central Student Consumer Health Database ProQuest Health & Medical Complete (Alumni) Nursing & Allied Health Database (Alumni Edition) Consumer Health Database Health & Medical Collection (Alumni Edition) Medical Database ProQuest Psychology Database Nursing & Allied Health Premium ProQuest Central Premium ProQuest One Academic Publicly Available Content Database ProQuest Health & Medical Research Collection ProQuest One Academic Middle East (New) ProQuest One Health & Nursing ProQuest One Academic Eastern Edition (DO NOT USE) ProQuest One Academic (retired) ProQuest One Academic UKI Edition ProQuest Central China ProQuest One Psychology ProQuest Central Basic MEDLINE - Academic PubMed Central (Full Participant titles) DOAJ Directory of Open Access Journals |
| DatabaseTitle | CrossRef MEDLINE Medline Complete MEDLINE with Full Text PubMed MEDLINE (Ovid) Publicly Available Content Database ProQuest One Psychology ProQuest Central Student ProQuest One Academic Middle East (New) ProQuest Central Essentials ProQuest Health & Medical Complete (Alumni) ProQuest Central (Alumni Edition) ProQuest One Community College ProQuest One Health & Nursing ProQuest Family Health (Alumni Edition) ProQuest Central China ProQuest Central ProQuest Health & Medical Research Collection Health Research Premium Collection Health and Medicine Complete (Alumni Edition) ProQuest Central Korea Health & Medical Research Collection ProQuest Central (New) ProQuest Medical Library (Alumni) ProQuest Central Basic ProQuest Family Health ProQuest One Academic Eastern Edition Coronavirus Research Database ProQuest Nursing & Allied Health Source ProQuest Hospital Collection Health Research Premium Collection (Alumni) ProQuest Psychology Journals (Alumni) ProQuest Hospital Collection (Alumni) Nursing & Allied Health Premium ProQuest Health & Medical Complete ProQuest Medical Library ProQuest Psychology Journals ProQuest One Academic UKI Edition BMJ Journals ProQuest Nursing & Allied Health Source (Alumni) ProQuest One Academic ProQuest One Academic (New) ProQuest Central (Alumni) MEDLINE - Academic |
| DatabaseTitleList | CrossRef MEDLINE - Academic MEDLINE Publicly Available Content Database |
| Database_xml | – sequence: 1 dbid: DOA name: DOAJ Directory of Open Access Journals url: https://www.doaj.org/ sourceTypes: Open Website – sequence: 2 dbid: NPM name: PubMed url: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed sourceTypes: Index Database – sequence: 3 dbid: 7RV name: Nursing & allied health premium. url: https://search.proquest.com/nahs sourceTypes: Aggregation Database |
| DeliveryMethod | fulltext_linktorsrc |
| Discipline | Medicine |
| EISSN | 2044-6055 |
| ExternalDocumentID | oai_doaj_org_article_3f579784b52a449787fda32dac28b1ad PMC11552528 39510791 10_1136_bmjopen_2023_073451 bmjopen |
| Genre | Journal Article Review |
| GroupedDBID | --- 4.4 53G 5VS 7RV 7X7 7~R 88E 8FI 8FJ 9YT ABUWG ACGFS ACMMV ADBBV AENEX AFKRA ALIPV ALMA_UNASSIGNED_HOLDINGS AOIJS AZQEC BAWUL BCNDV BENPR BKNYI BPHCQ BTFSW BTHHO CCPQU DIK DWQXO EBS FYUFA GNUQQ GROUPED_DOAJ GX1 HMCUK HYE HZ~ K9- KQ8 M0R M1P M2M M48 M~E NAPCQ O9- OK1 PGMZT PHGZT PIMPY PQQKQ PROAC PSQYO PSYQQ RHI RMJ RPM UKHRP AAYXX ADRAZ AFFHD BVXVI CITATION EJD H13 PHGZM PJZUB PPXIY CGR CUY CVF ECM EIF NPM 3V. 7XB 8FK COVID K9. PKEHL PQEST PQUKI PRINS Q9U 7X8 PUEGO 5PM |
| ID | FETCH-LOGICAL-b490t-b72360aceaeff369e7f7d581b7bb60e6c49742f4c6ce81bee3b1176eec87bec43 |
| IEDL.DBID | RMJ |
| ISICitedReferencesCount | 0 |
| ISICitedReferencesURI | http://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=Summon&SrcAuth=ProQuest&DestLinkType=CitingArticles&DestApp=WOS_CPL&KeyUT=001353225400001&url=https%3A%2F%2Fcvtisr.summon.serialssolutions.com%2F%23%21%2Fsearch%3Fho%3Df%26include.ft.matches%3Dt%26l%3Dnull%26q%3D |
| ISSN | 2044-6055 |
| IngestDate | Fri Oct 03 12:51:17 EDT 2025 Tue Nov 04 02:05:23 EST 2025 Thu Oct 02 03:41:25 EDT 2025 Mon Nov 10 15:22:14 EST 2025 Mon Jul 21 05:46:11 EDT 2025 Sat Nov 29 05:32:21 EST 2025 Thu Apr 24 22:50:16 EDT 2025 |
| IsDoiOpenAccess | true |
| IsOpenAccess | true |
| IsPeerReviewed | true |
| IsScholarly | true |
| Issue | 11 |
| Keywords | Clinical Trial Law (see Medical Law) Ethics (see Medical Ethics) |
| Language | English |
| License | This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. |
| LinkModel | DirectLink |
| MergedId | FETCHMERGED-LOGICAL-b490t-b72360aceaeff369e7f7d581b7bb60e6c49742f4c6ce81bee3b1176eec87bec43 |
| Notes | Communication ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 ObjectType-Review-3 content type line 23 None declared. |
| ORCID | 0000-0003-1695-3183 |
| OpenAccessLink | https://bmjopen.bmj.com/content/14/11/e073451.full |
| PMID | 39510791 |
| PQID | 3146603656 |
| PQPubID | 2040975 |
| ParticipantIDs | doaj_primary_oai_doaj_org_article_3f579784b52a449787fda32dac28b1ad pubmedcentral_primary_oai_pubmedcentral_nih_gov_11552528 proquest_miscellaneous_3128320851 proquest_journals_3146603656 pubmed_primary_39510791 crossref_primary_10_1136_bmjopen_2023_073451 bmj_journals_10_1136_bmjopen_2023_073451 |
| PublicationCentury | 2000 |
| PublicationDate | 2024-11-07 |
| PublicationDateYYYYMMDD | 2024-11-07 |
| PublicationDate_xml | – month: 11 year: 2024 text: 2024-11-07 day: 07 |
| PublicationDecade | 2020 |
| PublicationPlace | England |
| PublicationPlace_xml | – name: England – name: London – name: BMA House, Tavistock Square, London, WC1H 9JR |
| PublicationTitle | BMJ open |
| PublicationTitleAbbrev | BMJ Open |
| PublicationTitleAlternate | BMJ Open |
| PublicationYear | 2024 |
| Publisher | British Medical Journal Publishing Group BMJ Publishing Group LTD BMJ Publishing Group |
| Publisher_xml | – name: British Medical Journal Publishing Group – name: BMJ Publishing Group LTD – name: BMJ Publishing Group |
| References | Emanuel, Wood, Fleischman (R13) 2004; 141 Bernabe, van Thiel, Breekveldt (R9) 2019; 35 Dawson, Yentis (R21) 2007; 33 Leaning (R2) 1996; 313 Trace, Kolstoe (R16) 2018; 44 (R1) 2013 Kenter, Cohen (R34) 2012; 379 (R18) 2001 Cornejo Moreno, Gómez Arteaga (R10) 2012; 13 Tenti, Simonetti, Bochicchio (R20) 2018; 11 (R19) 2014; 158 Stahl (R30) 2017; 60 Tamariz, Hendler, Wells (R8) 2021; 43 Lanzerath (R28) 2019; 62 Yarborough (R24) 2021; 47 Hunter (R22) 2007; 33 Kaur, Choy (R12) 2014; 14 Sims (R3) 2010; 29 Tusino, Furfaro (R14) 2022; 88 Moore, Donnelly (R26) 2018; 44 Emanuel, Wendler, Grady (R4) 2000; 283 Waligora (R33) 2013; 39 Westra, Bos, Cohen (R32) 2014; 348 Scavone, di Mauro, Pietropaolo (R29) 2019; 12 Abbott, Grady (R15) 2011; 6 Liberati (R25) 2004; 27 Petrini (R27) 2016; 42 Coleman, Bouësseau (R11) 2008; 9 Wieschowski, Chin, Federico (R23) 2018; 16 McGuinness (R37) 2008; 34 Lukaseviciene, Hasford, Lanzerath (R31) 2020 Wieschowski (2024121219321121000_14.11.e073451.23) 2018; 16 Scavone (2024121219321121000_14.11.e073451.29) 2019; 12 2024121219321121000_14.11.e073451.31 2024121219321121000_14.11.e073451.33 Lanzerath (2024121219321121000_14.11.e073451.28) 2019; 62 Tusino (2024121219321121000_14.11.e073451.14) 2022; 88 Stahl (2024121219321121000_14.11.e073451.30) 2017; 60 2024121219321121000_14.11.e073451.27 Kaur (2024121219321121000_14.11.e073451.12) 2014; 14 Coleman (2024121219321121000_14.11.e073451.11) 2008; 9 2024121219321121000_14.11.e073451.24 2024121219321121000_14.11.e073451.26 Bernabe (2024121219321121000_14.11.e073451.9) 2019; 35 2024121219321121000_14.11.e073451.25 Tamariz (2024121219321121000_14.11.e073451.8) 2021; 43 Tenti (2024121219321121000_14.11.e073451.20) 2018; 11 Kenter (2024121219321121000_14.11.e073451.34) 2012; 379 2024121219321121000_14.11.e073451.22 2024121219321121000_14.11.e073451.21 Cornejo Moreno (2024121219321121000_14.11.e073451.10) 2012; 13 Westra (2024121219321121000_14.11.e073451.32) 2014; 348 2024121219321121000_14.11.e073451.17 2024121219321121000_14.11.e073451.7 2024121219321121000_14.11.e073451.16 2024121219321121000_14.11.e073451.19 2024121219321121000_14.11.e073451.18 2024121219321121000_14.11.e073451.13 2024121219321121000_14.11.e073451.35 2024121219321121000_14.11.e073451.37 Abbott (2024121219321121000_14.11.e073451.15) 2011; 6 2024121219321121000_14.11.e073451.36 2024121219321121000_14.11.e073451.2 2024121219321121000_14.11.e073451.1 2024121219321121000_14.11.e073451.4 2024121219321121000_14.11.e073451.3 2024121219321121000_14.11.e073451.6 2024121219321121000_14.11.e073451.5 |
| References_xml | – start-page: 34 year: 2001 ident: R18 article-title: Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use publication-title: Off J Eur Commun – volume: 39 start-page: 408 year: 2013 ident: R33 article-title: A European consistency for functioning of RECs? We just lost our chance publication-title: J Med Ethics doi: 10.1136/medethics-2012-101228 – volume: 158 year: 2014 ident: R19 article-title: Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials in medicinal products for human use and repealing Directive 2001/20/EC publication-title: Off J Eur Union – volume: 13 year: 2012 ident: R10 article-title: Violation of ethical principles in clinical research. Influences and possible solutions for Latin America publication-title: BMC Med Ethics doi: 10.1186/1472-6939-13-35 – start-page: 2191 year: 2013 ident: R1 article-title: World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects publication-title: JAMA doi: 10.1001/jama.2013.281053 – volume: 35 start-page: 637 year: 2019 ident: R9 article-title: Ethics in clinical trial regulation: ethically relevant issues from EMA inspection reports publication-title: Curr Med Res Opin doi: 10.1080/03007995.2018.1528214 – volume: 379 start-page: 1765 year: 2012 ident: R34 article-title: Re-engineering the European Union Clinical Trials Directive publication-title: The Lancet doi: 10.1016/S0140-6736(12)60430-9 – volume: 29 start-page: 173 year: 2010 ident: R3 article-title: A brief review of the Belmont report publication-title: Dimens Crit Care Nurs doi: 10.1097/DCC.0b013e3181de9ec5 – volume: 33 start-page: 241 year: 2007 ident: R22 article-title: Proportional ethical review and the identification of ethical issues publication-title: J Med Ethics doi: 10.1136/jme.2006.016782 – volume: 283 start-page: 2701 year: 2000 ident: R4 article-title: What makes clinical research ethical? publication-title: JAMA doi: 10.1001/jama.283.20.2701 – volume: 313 start-page: 1413 year: 1996 ident: R2 article-title: War crimes and medical science publication-title: BMJ doi: 10.1136/bmj.313.7070.1413 – volume: 43 start-page: 42 year: 2021 ident: R8 article-title: A Call for Better, Not Faster, Research Ethics Committee Reviews in the Covid-19 Era publication-title: Ethics Hum Res doi: 10.1002/eahr.500104 – volume: 16 year: 2018 ident: R23 article-title: Preclinical efficacy studies in investigator brochures: Do they enable risk-benefit assessment? publication-title: PLoS Biol doi: 10.1371/journal.pbio.2004879 – volume: 47 start-page: 572 year: 2021 ident: R24 article-title: Do we really know how many clinical trials are conducted ethically? Why research ethics committee review practices need to be strengthened and initial steps we could take to strengthen them publication-title: J Med Ethics doi: 10.1136/medethics-2019-106014 – volume: 12 start-page: 1027 year: 2019 ident: R29 article-title: The European clinical trials regulation (No 536/2014): changes and challenges publication-title: Expert Rev Clin Pharmacol doi: 10.1080/17512433.2019.1680282 – volume: 62 start-page: 697 year: 2019 ident: R28 article-title: Europäische Ethikkommissionen im Wandel: Herausforderungen durch neue Rahmenbedingungen[European ethics committees in transition: challenges of new requirements] publication-title: Bundesgesundheitsbl doi: 10.1007/s00103-019-02952-8 – volume: 60 start-page: 836 year: 2017 ident: R30 article-title: Implementation status of Regulation EU 536/2014 in the member states publication-title: Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz doi: 10.1007/s00103-017-2579-9 – volume: 34 start-page: 695 year: 2008 ident: R37 article-title: Research ethics committees: the role of ethics in a regulatory authority publication-title: J Med Ethics doi: 10.1136/jme.2007.021089 – volume: 14 start-page: 20 year: 2014 ident: R12 article-title: A Critique of the ICH-GCP Guideline publication-title: Dev World Bioeth doi: 10.1111/dewb.12004 – volume: 141 start-page: 282 year: 2004 ident: R13 article-title: Oversight of human participants research: identifying problems to evaluate reform proposals publication-title: Ann Intern Med doi: 10.7326/0003-4819-141-4-200408170-00008 – volume: 6 start-page: 3 year: 2011 ident: R15 article-title: A systematic review of the empirical literature evaluating IRBs: what we know and what we still need to learn publication-title: J Empir Res Hum Res Ethics doi: 10.1525/jer.2011.6.1.3 – volume: 88 start-page: 40 year: 2022 ident: R14 article-title: Rethinking the role of Research Ethics Committees in the light of Regulation (EU) No 536/2014 on clinical trials and the COVID-19 pandemic publication-title: Br J Clin Pharmacol doi: 10.1111/bcp.14871 – volume: 27 start-page: 154 year: 2004 ident: R25 article-title: Research Ethics Committees: can they contribute to the improvement of clinical research in Europe? publication-title: J Ambul Care Manage doi: 10.1097/00004479-200404000-00012 – volume: 11 start-page: 99 year: 2018 ident: R20 article-title: Main changes in European Clinical Trials Regulation (No 536/2014) publication-title: Contemp Clin Trials Commun doi: 10.1016/j.conctc.2018.05.014 – volume: 44 start-page: 874 year: 2018 ident: R16 article-title: Reviewing code consistency is important, but research ethics committees must also make a judgement on scientific justification, methodological approach and competency of the research team publication-title: J Med Ethics doi: 10.1136/medethics-2018-105107 – volume: 9 year: 2008 ident: R11 article-title: How do we know that research ethics committees are really working? The neglected role of outcomes assessment in research ethics review publication-title: BMC Med Ethics doi: 10.1186/1472-6939-9-6 – volume: 42 start-page: 186 year: 2016 ident: R27 article-title: What is the role of ethics committees after Regulation (EU) 536/2014? publication-title: J Med Ethics doi: 10.1136/medethics-2015-103028 – year: 2020 ident: R31 article-title: Implementation of the EU clinical trial regulation transforms the ethics committee systems and endangers ethical standards publication-title: J Med Ethics doi: 10.1136/medethics-2020-106757 – volume: 33 start-page: 165 year: 2007 ident: R21 article-title: Contesting the science/ethics distinction in the review of clinical research publication-title: J Med Ethics doi: 10.1136/jme.2006.016071 – volume: 44 start-page: 481 year: 2018 ident: R26 article-title: The job of “ethics committees.” publication-title: J Med Ethics doi: 10.1136/medethics-2015-102688 – volume: 348 year: 2014 ident: R32 article-title: New EU clinical trials regulation publication-title: BMJ doi: 10.1136/bmj.g3710 – ident: 2024121219321121000_14.11.e073451.6 – volume: 348 year: 2014 ident: 2024121219321121000_14.11.e073451.32 article-title: New EU clinical trials regulation publication-title: BMJ doi: 10.1136/bmj.g3710 – ident: 2024121219321121000_14.11.e073451.3 doi: 10.1097/DCC.0b013e3181de9ec5 – volume: 62 start-page: 697 year: 2019 ident: 2024121219321121000_14.11.e073451.28 article-title: Europäische Ethikkommissionen im Wandel: Herausforderungen durch neue Rahmenbedingungen[European ethics committees in transition: challenges of new requirements] publication-title: Bundesgesundheitsbl doi: 10.1007/s00103-019-02952-8 – volume: 9 year: 2008 ident: 2024121219321121000_14.11.e073451.11 article-title: How do we know that research ethics committees are really working? The neglected role of outcomes assessment in research ethics review publication-title: BMC Med Ethics doi: 10.1186/1472-6939-9-6 – volume: 12 start-page: 1027 year: 2019 ident: 2024121219321121000_14.11.e073451.29 article-title: The European clinical trials regulation (No 536/2014): changes and challenges publication-title: Expert Rev Clin Pharmacol doi: 10.1080/17512433.2019.1680282 – volume: 16 year: 2018 ident: 2024121219321121000_14.11.e073451.23 article-title: Preclinical efficacy studies in investigator brochures: Do they enable risk-benefit assessment? publication-title: PLoS Biol doi: 10.1371/journal.pbio.2004879 – ident: 2024121219321121000_14.11.e073451.24 doi: 10.1136/medethics-2019-106014 – ident: 2024121219321121000_14.11.e073451.2 doi: 10.1136/bmj.313.7070.1413 – ident: 2024121219321121000_14.11.e073451.26 doi: 10.1136/medethics-2015-102688 – ident: 2024121219321121000_14.11.e073451.4 doi: 10.1001/jama.283.20.2701 – ident: 2024121219321121000_14.11.e073451.13 doi: 10.7326/0003-4819-141-4-200408170-00008 – ident: 2024121219321121000_14.11.e073451.36 – volume: 6 start-page: 3 year: 2011 ident: 2024121219321121000_14.11.e073451.15 article-title: A systematic review of the empirical literature evaluating IRBs: what we know and what we still need to learn publication-title: J Empir Res Hum Res Ethics doi: 10.1525/jer.2011.6.1.3 – ident: 2024121219321121000_14.11.e073451.17 – ident: 2024121219321121000_14.11.e073451.31 doi: 10.1136/medethics-2020-106757 – volume: 43 start-page: 42 year: 2021 ident: 2024121219321121000_14.11.e073451.8 article-title: A Call for Better, Not Faster, Research Ethics Committee Reviews in the Covid-19 Era publication-title: Ethics Hum Res doi: 10.1002/eahr.500104 – volume: 35 start-page: 637 year: 2019 ident: 2024121219321121000_14.11.e073451.9 article-title: Ethics in clinical trial regulation: ethically relevant issues from EMA inspection reports publication-title: Curr Med Res Opin doi: 10.1080/03007995.2018.1528214 – volume: 379 start-page: 1765 year: 2012 ident: 2024121219321121000_14.11.e073451.34 article-title: Re-engineering the European Union Clinical Trials Directive publication-title: The Lancet doi: 10.1016/S0140-6736(12)60430-9 – ident: 2024121219321121000_14.11.e073451.5 – ident: 2024121219321121000_14.11.e073451.7 – ident: 2024121219321121000_14.11.e073451.19 – ident: 2024121219321121000_14.11.e073451.33 doi: 10.1136/medethics-2012-101228 – ident: 2024121219321121000_14.11.e073451.25 doi: 10.1097/00004479-200404000-00012 – volume: 60 start-page: 836 year: 2017 ident: 2024121219321121000_14.11.e073451.30 article-title: Implementation status of Regulation EU 536/2014 in the member states publication-title: Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz doi: 10.1007/s00103-017-2579-9 – volume: 88 start-page: 40 year: 2022 ident: 2024121219321121000_14.11.e073451.14 article-title: Rethinking the role of Research Ethics Committees in the light of Regulation (EU) No 536/2014 on clinical trials and the COVID-19 pandemic publication-title: Br J Clin Pharmacol doi: 10.1111/bcp.14871 – volume: 14 start-page: 20 year: 2014 ident: 2024121219321121000_14.11.e073451.12 article-title: A Critique of the ICH-GCP Guideline publication-title: Dev World Bioeth doi: 10.1111/dewb.12004 – ident: 2024121219321121000_14.11.e073451.21 doi: 10.1136/jme.2006.016071 – volume: 13 year: 2012 ident: 2024121219321121000_14.11.e073451.10 article-title: Violation of ethical principles in clinical research. Influences and possible solutions for Latin America publication-title: BMC Med Ethics doi: 10.1186/1472-6939-13-35 – ident: 2024121219321121000_14.11.e073451.37 doi: 10.1136/jme.2007.021089 – ident: 2024121219321121000_14.11.e073451.35 – ident: 2024121219321121000_14.11.e073451.1 doi: 10.1001/jama.2013.281053 – ident: 2024121219321121000_14.11.e073451.18 – ident: 2024121219321121000_14.11.e073451.22 doi: 10.1136/jme.2006.016782 – ident: 2024121219321121000_14.11.e073451.16 doi: 10.1136/medethics-2018-105107 – ident: 2024121219321121000_14.11.e073451.27 doi: 10.1136/medethics-2015-103028 – volume: 11 start-page: 99 year: 2018 ident: 2024121219321121000_14.11.e073451.20 article-title: Main changes in European Clinical Trials Regulation (No 536/2014) publication-title: Contemp Clin Trials Commun doi: 10.1016/j.conctc.2018.05.014 |
| SSID | ssj0000459552 |
| Score | 2.3707664 |
| SecondaryResourceType | review_article |
| Snippet | Independent ethics committees play an important role in clinical trials as well as in all health-related research. Internationally, the national laws of the... |
| SourceID | doaj pubmedcentral proquest pubmed crossref bmj |
| SourceType | Open Website Open Access Repository Aggregation Database Index Database Publisher |
| StartPage | e073451 |
| SubjectTerms | Clinical medicine Clinical Trial Clinical trials Clinical Trials as Topic Committees Communication Compliance Corporate sponsorship Ethics Ethics (see Medical Ethics) Ethics Committees - ethics Ethics Committees - legislation & jurisprudence Human subjects Informed consent Law (see Medical Law) Medical research Models, Theoretical Regulation Research Design - legislation & jurisprudence Social Control, Formal Validation Studies as Topic |
| SummonAdditionalLinks | – databaseName: DOAJ Directory of Open Access Journals dbid: DOA link: http://cvtisr.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwrV3PaxUxEA5aRLyIv922SgQPFQzdzc9dbyotXiwiFnpbk-wEn9B9pW_r3-9Msn2-J6IXj5sM7OyXyc6EJN_H2EujtVcJvJDaO6FjTCJY5QUo4q8yCqKLWWzCnZy0Z2fdpw2pLzoTVuiBC3CHKhmHKx0djPSa5NBcGrySg4-yDY0f6O-LVc_GYir_g7XpjJEzzVCj7GE4_056VILkwgXGtaatyZvYupWQMm__n4rN389MbiSh43vs7lw98rfF6_vsBowP2O2P8_74Q_b1c5GWR7D5wdHpK27QJ0y-mvtx4FjrcTpNyJeJQz7nzjHezhfTBLB6wz2_IMmEFb4AK1l8LNdaeCF75lkz5xE7PT768v6DmDUURNBdPYngpLK1j-AhJWU7cMkNBmtVF4KtwUaEVMuko42ArQAqNI2zALF1OLxaPWY743KEp4xDqjuZXOubBu1xnRaD10OdTKqDG4ZYsQOEs5_nwKrPywtl-xn5npDvC_IVe32NeX9RWDX-bv6OxmVtSpTYuQEDpZ8Dpf9XoFRs_3pUf_moMFFYTOLGVuzFuhtnGG2b-BGWV2RDck5UmlbsSQmCtSeKClTXYU-7FR5brm73jItvmcW7IfI7I9vd__Fxe-wO4qXzJUm3z3amyyt4xm7FH9Nidfk8z42fYikTTw priority: 102 providerName: Directory of Open Access Journals – databaseName: Nursing & allied health premium. dbid: 7RV link: http://cvtisr.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwpV1Lb9QwELZoQagX3pRAQUbiUCSiJvEr4YIAteJChSqKegu2M4ZFarLspvx-ZhzvlkWoF46xLXmcb8Ye2-P5GHuhpLQigM0raU0uvQ-508LmICh_lRLgjY9kE-b4uD47az6lA7dlCqtczYlxou4GT2fkBwJNWuN0q_Sb-c-cWKPodjVRaGyx6yWt3ajP5uTL-owF3ZVGqSolGyqFPnDnP4iVKifS8By1W9IF5RaWbixLMXv_v1zOvyMn_1iKjm7_7yDusFvJCeVvJ625y65Bf4_d_Jiu2e-zrycTQz1ixvcPT19yhYPCNVxy23ccXUZOQYl8CBxiuDzH3s9n4wiwfM0tnxPzwhI7QIcYP6fXMXzKGc0j9c4Ddnp0-Pn9hzxRMeRONsWYO1MJXVgPFkIQugETTKfQ5TXO6QK0l7gvqYL02gOWAghXlkYD-NqglkjxkG33Qw-PGIdQNFUwtS1LbI_bPe-s7IqgQuFM1_mM7SMebTKlZRt3KUK3CbqWoGsn6DL2agVaO5-Sc1zd_B0Bu25KmbVjwbD41iZDbUVQBnfW0qnKSqLfM6Gzouqsr2pX2i5jeytoL2W8xDVjz9fVaKh0-2J7GC6oDbFCkYebsd1Ji9aSCPJzTYM19YZ-bYi6WdPPvsdk4CXl0FNV_fhquZ6wHfwTMr6iNHtse1xcwFN2w_8aZ8vFs2g2vwFLYSFO priority: 102 providerName: ProQuest |
| Title | Regulation (EU) 536/2014 and the role of ethics committees: a proposal for a review system model |
| URI | https://bmjopen.bmj.com/content/14/11/e073451.full https://www.ncbi.nlm.nih.gov/pubmed/39510791 https://www.proquest.com/docview/3146603656 https://www.proquest.com/docview/3128320851 https://pubmed.ncbi.nlm.nih.gov/PMC11552528 https://doaj.org/article/3f579784b52a449787fda32dac28b1ad |
| Volume | 14 |
| WOSCitedRecordID | wos001353225400001&url=https%3A%2F%2Fcvtisr.summon.serialssolutions.com%2F%23%21%2Fsearch%3Fho%3Df%26include.ft.matches%3Dt%26l%3Dnull%26q%3D |
| hasFullText | 1 |
| inHoldings | 1 |
| isFullTextHit | |
| isPrint | |
| journalDatabaseRights | – providerCode: PRVADZ databaseName: BMJ Journals customDbUrl: eissn: 2044-6055 dateEnd: 99991231 omitProxy: false ssIdentifier: ssj0000459552 issn: 2044-6055 databaseCode: RMJ dateStart: 20110101 isFulltext: true titleUrlDefault: http://www.bmj.com/thebmj providerName: BMJ Publishing Group Ltd – providerCode: PRVAON databaseName: DOAJ Directory of Open Access Journals customDbUrl: eissn: 2044-6055 dateEnd: 99991231 omitProxy: false ssIdentifier: ssj0000459552 issn: 2044-6055 databaseCode: DOA dateStart: 20110101 isFulltext: true titleUrlDefault: https://www.doaj.org/ providerName: Directory of Open Access Journals – providerCode: PRVHPJ databaseName: ROAD: Directory of Open Access Scholarly Resources customDbUrl: eissn: 2044-6055 dateEnd: 99991231 omitProxy: false ssIdentifier: ssj0000459552 issn: 2044-6055 databaseCode: M~E dateStart: 20110101 isFulltext: true titleUrlDefault: https://road.issn.org providerName: ISSN International Centre – providerCode: PRVPQU databaseName: Consumer Health Database customDbUrl: eissn: 2044-6055 dateEnd: 99991231 omitProxy: false ssIdentifier: ssj0000459552 issn: 2044-6055 databaseCode: M0R dateStart: 20110101 isFulltext: true titleUrlDefault: https://search.proquest.com/familyhealth providerName: ProQuest – providerCode: PRVPQU databaseName: Health & Medical Collection customDbUrl: eissn: 2044-6055 dateEnd: 99991231 omitProxy: false ssIdentifier: ssj0000459552 issn: 2044-6055 databaseCode: 7X7 dateStart: 20110101 isFulltext: true titleUrlDefault: https://search.proquest.com/healthcomplete providerName: ProQuest – providerCode: PRVPQU databaseName: Nursing & allied health premium. customDbUrl: eissn: 2044-6055 dateEnd: 99991231 omitProxy: false ssIdentifier: ssj0000459552 issn: 2044-6055 databaseCode: 7RV dateStart: 20110101 isFulltext: true titleUrlDefault: https://search.proquest.com/nahs providerName: ProQuest – providerCode: PRVPQU databaseName: ProQuest Central customDbUrl: eissn: 2044-6055 dateEnd: 99991231 omitProxy: false ssIdentifier: ssj0000459552 issn: 2044-6055 databaseCode: BENPR dateStart: 20110101 isFulltext: true titleUrlDefault: https://www.proquest.com/central providerName: ProQuest – providerCode: PRVPQU databaseName: Psychology Database customDbUrl: eissn: 2044-6055 dateEnd: 99991231 omitProxy: false ssIdentifier: ssj0000459552 issn: 2044-6055 databaseCode: M2M dateStart: 20110101 isFulltext: true titleUrlDefault: https://www.proquest.com/psychology providerName: ProQuest – providerCode: PRVPQU databaseName: Publicly Available Content Database customDbUrl: eissn: 2044-6055 dateEnd: 99991231 omitProxy: false ssIdentifier: ssj0000459552 issn: 2044-6055 databaseCode: PIMPY dateStart: 20110101 isFulltext: true titleUrlDefault: http://search.proquest.com/publiccontent providerName: ProQuest |
| link | http://cvtisr.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwnV1bb9MwFD5aNzTthfslMCoj8TAksibxLeGNoU6AlKqqGCpPwXZsKNLSqc34_Rw7aaEIIcSLc_FR4tjH8ncc-_sAnnPGFHVWxRlTMmbGuFgLqmJLPX8Vp9ZIE8Qm5GSSz-fFdA-yzV4YffnNy0ad4rHb0eA5mpp2lLJRmo4sOiTj6amfmh7AgY9tvCfPyvfbeRWEKAUPQjtZwliMaJ33ZEMpFZvHx140PO4edgSH1MOMQNM5QIOdESoQ-f8Jff6-iPKXUen81v98z2242WNQ8rpzmjuwZ5u7cFj2f9nvwedZJ1CPTUZOxhcvCMdvwiGcEdXUBBEj8WsSydIRG1bLE3zl5aJtrV2_IopceeGFNb4A8TBedptjSEcZTYLyzn24OB9_ePM27pUYYs2KpI21zKhIlLHKOkdFYaWTNUfEK7UWiRWGYViSOWaEsXjXWqrTVAprTS7RSRh9APvNsrGPgFiXFJmTuUpTtMdoz2jF6sRxl2hZ1yaCE6yrqu9J6yoEKVRUfUVWvuWqrtoieLlpqOqq4-b4u_mZb8ytqSfWDjeWqy9V308r6rjEwJppninm1fekqxXNamWyXKeqjuB44wo_y0hxuBEIBbiI4Nk2G_up__miGru89jZeFMoD3Agedp6zLcnG_yLId3xqp6i7Oc3ia-ACTz2FHs_yx_9ebU_gCK9Y2FApj2G_XV3bp3DDfG8X69UQBnL20adzGdJ8CAdn48l0NgzTFZiWiT8vsxJzpu_K6adh6IE_AIT7Jbw |
| linkProvider | BMJ Publishing Group Ltd |
| linkToHtml | http://cvtisr.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMw1V1Zb9QwELbagoAX7mOhgJFAKhJRE58JEkIcrVr1EEKttG-p7YzLIjW77G5B_Cl-IzNJdssi1Lc-8BjbSnx8nny2x_Mx9lwr5WQElwjlbKJCiIk30iUgKX6VlhBsaMQm7P5-3u8Xn5bYr9ldGHKrnNnExlBXw0B75OsSp7RBc6vN29G3hFSj6HR1JqHRwmIHfv7AJdvkzfZHHN8XQmxuHHzYSjpVgcSrIp0m3gppUhfAQYzSFGCjrTSyN-u9ScEEhRRbRBVMAEwFkD7LrAEIucUGK4nvXWaX0I5bciGzfTvf00F6VGgtuuBGmTTr_uQrqWAlJFKe4GxSdCC6jKkLv8FGLeBfFPdvT80_fn2bN_63TrvJrnckm79rZ8UttgT1bXZlr3MjuMOOPsNxJ1vG1zYOX3KNnYgcRXFXVxwpMSenSz6MHJrrABxbezKYTgEmr7njI1KWmOAHkPDjY3v7h7cxsXkjLXSXHV5I--6xlXpYwwPGIaaFiDZ3WYblcTkbvFNVGnVMva2q0GNrOP5lZyomZbMKk6bsoFISVMoWKj32agaSctQGHzm_-HsC0rwoRQ5vEobj47IzRKWM2iJyldfCKZIXtLFyUlQuiNxnruqx1RmUzup4hqMeezbPRkNEp0uuhuEplSHVK2LwPXa_Re28JpJ4vC0wJ1_A80JVF3PqwZcm2HlGMQK1yB-eX6-n7OrWwd5uubu9v_OIXcNeUc2NUbvKVqbjU3jMLofv08Fk_KSZspwdXTTcfwMkPYFV |
| linkToPdf | http://cvtisr.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMw1V1bb9MwFLZ2QRMv3GGBAUYCaUiLmviaICHEWCumQVVNTNpbZjvHo5OWlrYD8df4dRwnaUcR2tseeIxtJbbznZPP8fH5CHkphTDcg4mZMDoWzvnYKm5i4CF_leTgtKvFJnS_nx0f54MV8mt-FiaEVc59Yu2oy5EL_8g7HE1aobuVquPbsIjBXu_d-FscFKTCTutcTqOByAH8_IHLt-nb_T18168Y63W_fPgYtwoDsRV5MoutZlwlxoEB77nKQXtdSmRy2lqVgHIC6TbzwikHWArAbZpqBeAyjYMXHO-7StY1kgy0rvXdbn9wuPjDg2Qpl5K1qY5Srjr2_CxoYsVBsjxG2xJhe3QVS5c-irV2wL8I799xm398CHu3_-cpvENutfSbvm_s5S5Zgeoe2fjcBhjcJyeHcNoKmtHt7tFrKnFCkb0IaqqSIlmmIRyTjjyF-qAAxZGfD2czgOkbaug4aE5M8QG4FMDL5lwQbbJl01p06AE5upbxPSRr1aiCTULBJznzOjNpiu1xoeusEWXipU-sLksXkW3EQtE6kWlRr8-4KlrYFAE2RQObiOzMAVOMm7QkVzffDaBaNA05xeuC0eS0aF1Uwb3Uuc6ElcyIIDyofWk4K41jmU1NGZGtOawu-3iJqYi8WFSjiwr7TqaC0UVoE_SwArePyKMGwYue8MDwdY412RK2l7q6XFMNv9Zp0NOQPVCy7PHV_XpONhDlxaf9_sETchMnRdRHSfUWWZtNLuApueG-z4bTybPWfik5uW68_wYoZYt2 |
| openUrl | ctx_ver=Z39.88-2004&ctx_enc=info%3Aofi%2Fenc%3AUTF-8&rfr_id=info%3Asid%2Fsummon.serialssolutions.com&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Regulation+%28EU%29+536%2F2014+and+the+role+of+ethics+committees%3A+a+proposal+for+a+review+system+model&rft.jtitle=BMJ+open&rft.au=Riva%2C+Luciana&rft.au=Petrini%2C+Carlo&rft.date=2024-11-07&rft.pub=British+Medical+Journal+Publishing+Group&rft.issn=2044-6055&rft.eissn=2044-6055&rft.volume=14&rft.issue=11&rft_id=info:doi/10.1136%2Fbmjopen-2023-073451&rft_id=info%3Apmid%2F39510791&rft.externalDBID=bmjopen&rft.externalDocID=bmjopen |
| thumbnail_l | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/lc.gif&issn=2044-6055&client=summon |
| thumbnail_m | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/mc.gif&issn=2044-6055&client=summon |
| thumbnail_s | http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/sc.gif&issn=2044-6055&client=summon |