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Drug Regulation

Research ethics committees and post-approval activities: a qualitative study on the perspectives of European research ethics committee representatives

Shereen Coxa Centre for Medical Ethics, Institute of Health and Society, Faculty of Medicine, University of Oslo, Oslo, NorwayCorrespondence[email protected]

https://orcid.org/0000-0002-9674-8544

Jan Helge Solbakka Centre for Medical Ethics, Institute of Health and Society, Faculty of Medicine, University of Oslo, Oslo, Norway

Rosemarie D. L. C. Bernabea Centre for Medical Ethics, Institute of Health and Society, Faculty of Medicine, University of Oslo, Oslo, Norway;b The Faculty of Health and Social Sciences, University of South-Eastern Norway, Kongsberg, Norway

Pages 1897-1907 | Received 04 May 2022, Accepted 17 Aug 2022, Published online: 27 Aug 2022

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https://doi.org/10.1080/03007995.2022.2115773
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Rice TW. The historical, ethical, and legal background of human-subjects research. Respiratory Care. 2008;53(10):1325–1329.
PubMed Web of Science ®Google Scholar
Carlson R, Boyd KM, Webb DJ. The revision of the declaration of Helsinki: past, present and future. Br J Clin Pharmacol. 2004;57(6):695–713.
PubMed Web of Science ®Google Scholar
Malik AY, Foster C. The revised declaration of Helsinki: cosmetic or real change? J R Soc Med. 2016;109(5):184–189.
PubMed Web of Science ®Google Scholar
World Medical Association, “DECLARATION OF HELSINKI Ethical Principles for Medical Research Involving Human Subjects.” 2004; [cited 2021 Sep 10]. Available from: https://www.wma.net/wp-content/uploads/2018/07/DoH-Oct2004.pdf.
Google Scholar
World Medical Association, “Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects,” Oct. 2008.
Google Scholar
Cox S, Solbakk JH, Bernabe RDLC. The role of research ethics committees after the approval of clinical trial protocols in the EU and the USA: a descriptive content analysis of international and regional normative documents. Curr Med Res Opin. 2021;37(6):1061–1069.
PubMed Web of Science ®Google Scholar
ICH. E6(R2) good clinical practice: integrated addendum to ICH E6(R1) guidance for industry E6(R2) Good Clinical Practice. 2018; [cited 2019 Nov 04]. Available from: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htmand/orhttp://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
Google Scholar
Bernabe R, van Thiel G, Breekveldt N, et al. Ethics in clinical trial regulation: ethically relevant issues from EMA inspection reports. Curr Med Res Opin. 2019;35(4):637–645.
PubMed Web of Science ®Google Scholar
Bernabe R, van Thiel G, Breekveldt N, et al. Drug regulators and ethics: Which GCP issues are also ethical issues? Drug Discovery Today. 2016;21(2):217–224.
PubMed Web of Science ®Google Scholar
Braun V, Clarke V. Using thematic analysis in psychology. Qualitative Research in Psychology. 2006;3(2):77–101.
Google Scholar
Bernabe R, van Thiel G, Gispen C, et al. The ambivalent place of ethics in European regulatory documents. Drug Discovery Today. 2018;23(2):205–207.
PubMed Web of Science ®Google Scholar
OHRP, “45 CFR 46,” Rockville, Maryland, 2018; [cited 2019 Nov 10]. Available from: https://gov.ecfr.io/cgi-bin/ECFR.
Google Scholar
Berry J, Piwncess T, Hospital R, et al. Local research ethics committees can audit ethical standards in research. J Med Ethics. 1997;23(6):379–381.
PubMed Web of Science ®Google Scholar
Pickworth E. Should local research ethics committees monitor research they have approved? J Med Ethics. 2000;26(5):330–333.
PubMed Web of Science ®Google Scholar
Kon AA. The role of empirical research in bioethics. Am J Bioeth. 2009;9(6–7):59–65.
PubMed Web of Science ®Google Scholar

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