Back to WHAT? The role of research ethics in pandemic times JH Solbakk, HB Bentzen, S Holm, AKT Heggestad, B Hofmann, ... Medicine, health care and philosophy 24, 3-20, 2021 | 39 | 2021 |
The risk-benefit task of research ethics committees: An evaluation of current approaches and the need to incorporate decision studies methods RDLC Bernabe, GJMW van Thiel, JAM Raaijmakers, JJM van Delden BMC medical ethics 13, 1-9, 2012 | 37 | 2012 |
The fiduciary obligation of the physician-researcher in phase IV trials RDLC Bernabe, GJMW Van Thiel, JAM Raaijmakers, JJM Van Delden BMC Medical Ethics 15, 1-8, 2014 | 19 | 2014 |
What do international ethics guidelines say in terms of the scope of medical research ethics? RDLC Bernabe, GJMW Van Thiel, JJM van Delden BMC medical ethics 17, 1-18, 2016 | 17 | 2016 |
Decision theory and the evaluation of risks and benefits of clinical trials RDC Bernabe, GJMW van Thiel, JAM Raaijmakers, JJM van Delden Drug discovery today 17 (23-24), 1263-1269, 2012 | 14 | 2012 |
A survey in Mexico about ethics dumping in clinical research NH Germán, B Rosemarie BMC Medical Ethics 20, 1-11, 2019 | 11 | 2019 |
Ethics in clinical trial regulation: ethically relevant issues from EMA inspection reports R Bernabe, G van Thiel, NS Breekveldt, CC Gispen-de Wied, ... Current Medical Research and Opinion 35 (4), 637-645, 2019 | 11 | 2019 |
Drug regulators and ethics: which GCP issues are also ethical issues? RDLC Bernabe, GJMW van Thiel, NS Breekveldt, JJM van Delden Drug Discovery Today 21 (2), 217-224, 2016 | 9 | 2016 |
Patient representatives' contributions to the benefit–risk assessment tasks of the European Medicines Agency scientific committees RDLC Bernabe, GJMW van Thiel, J van Delden British Journal of Clinical Pharmacology 78 (6), 1248-1256, 2014 | 9 | 2014 |
Phase IV non-inferiority trials and additional claims of benefit RDLC Bernabe, G Wangge, MJ Knol, OH Klungel, JJM Van Delden, ... BMC Medical Research Methodology 13, 1-5, 2013 | 9 | 2013 |
Informed consent and phase IV non-interventional drug research RDC Bernabe, GJMW van Thiel, JJM van Delden, JAM Raaijmakers Current medical research and opinion 27 (3), 513-518, 2011 | 9 | 2011 |
Consent in psychiatric biobanks for pharmacogenetic research FH van der Baan, RDC Bernabe, AL Bredenoord, JG Gregoor, G Meynen, ... International Journal of Neuropsychopharmacology 16 (3), 677-682, 2013 | 8 | 2013 |
Exportation of unethical practices to low and middle income countries in biomedical research G Novoa-Heckel, R Bernabe, J Linares Rev. Bioetica & Derecho 40, 167, 2017 | 7 | 2017 |
The need to explicate the ethical evaluation tools to avoid ethical inflation RDC Bernabe, GJMW van Thiel, JAM Raaijmakers, JJM van Delden The American Journal of Bioethics 9 (11), 56-58, 2009 | 7 | 2009 |
Post-trial provisions in the Declaration of Helsinki: a watered-down principle that needs to be strengthened F Hellmann, RLC Bernabe, N Homedes Journal of the Royal Society of Medicine 115 (11), 420-423, 2022 | 6 | 2022 |
Extended Reality—New Opportunity for People With Disability? Practical and Ethical Considerations K Stendal, RDLC Bernabe Journal of Medical Internet Research 26, e41670, 2024 | 5 | 2024 |
Composition and capacity of Institutional Review Boards, and challenges experienced by members in ethics review processes in Addis Ababa, Ethiopia: An exploratory qualitative study YZ Seralegne, CK Wangamati, RDLC Bernabe, B Farsides, A Aseffa, ... Developing world bioethics 23 (1), 50-58, 2023 | 5 | 2023 |
Research ethics committees and post-approval activities: a qualitative study on the perspectives of European research ethics committee representatives S Cox, JH Solbakk, RDLC Bernabe Current Medical Research and Opinion 38 (11), 1897-1907, 2022 | 5 | 2022 |
Regulatory sanctions for ethically relevant GCP violations R Bernabe, G van Thiel, N Breekveldt, C Gispen, J van Delden Drug Discovery Today, 2019 | 4* | 2019 |
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 … S Cox, JH Solbakk, RDLC Bernabe Current Medical Research and Opinion 37 (6), 1061-1069, 2021 | 3 | 2021 |