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  1. Participants’ Awareness of Ethical Compliance, Safety and Protection During Participation in Pharmaceutical Industry Clinical Trials: A Controlled Survey.Gerardo González-Saldivar, René Rodríguez-Gutiérrez, Jose Luis Viramontes-Madrid, Alejandro Salcido-Montenegro, Neri Alejandro Álvarez-Villalobos, Victoria González-Nava & José Gerardo González-González - 2019 - BMC Medical Ethics 20 (1):2.
    The rapid increase of industry-sponsored clinical research towards developing countries has led to potentially complex ethical issues to assess. There is scarce evidence about the perception of these participants about the ethical compliance, security, and protection. We sought to evaluate and contrast the awareness and perception of participants and non-participants of industry-sponsored research trials on ethical, safety, and protection topics. A Cases-control survey conducted at twelve research sites in México. Previous and current participants of ISRT as well as non-participants with (...)
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  • Research approvals iceberg: helping it melt away.Simon E. Kolstoe & David Carpenter - 2019 - BMC Medical Ethics 20 (1):1-4.
    In their paper “Research approvals iceberg: how a ‘low-key’ study in England needed 89 professionals to approve it and how we can do better” Petrova and Barclay highlight concerns with the health research regulatory environment in the UK. As long-standing chairs of NHS research ethics committees, researchers, and also academics in research ethics, we are also often frustrated with the regulatory process in the UK. However, we think that Petrova and Barclay’s analysis is misleading because it conflates research ethics with (...)
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  • Research Approvals Iceberg: Helping It Melt Away.Simon E. Kolstoe & David Carpenter - 2019 - BMC Medical Ethics 20 (1):1-4.
    In their paper “Research approvals iceberg: how a ‘low-key’ study in England needed 89 professionals to approve it and how we can do better” Petrova and Barclay highlight concerns with the health research regulatory environment in the UK. As long-standing chairs of NHS research ethics committees, researchers, and also academics in research ethics, we are also often frustrated with the regulatory process in the UK. However, we think that Petrova and Barclay’s analysis is misleading because it conflates research ethics with (...)
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  • 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.Samantha Trace & Simon Kolstoe - 2018 - Journal of Medical Ethics 44 (12):874-875.
    We have followed with interest the commentaries arising from Moore and Donnellys1 argument that authorities in charge of research ethics committees should focus primarily on establishing code-consistent reviews.1 We broadly agree with Savulescu’s2 argument that ethics committees should become more expert, but in a different way and for a different reason. We have recently been working with the UK Health Research Authority analysing the outcomes of their ‘Shared Ethical Debate’ exercises.3 Each ShED exercise involves the circulation of a single research (...)
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  • Data and Tissue Research Without Patient Consent: A Qualitative Study of the Views of Research Ethics Committees in New Zealand.Angela Ballantyne & Andrew Moore - 2018 - Ajob Empirical Bioethics 9 (3):143-153.
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