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Start Over Author "Peter Kleist" Topic declaration of helsinki
3 results on '"Peter Kleist"'

1. Corrigendum: Linking the Declarations of Helsinki and of Taipei: Critical Challenges of Future-Oriented Research Ethics

Author

Chieko Kurihara, Varvara Baroutsou, Sander Becker, Johan Brun, Brigitte Franke-Bray, Roberto Carlesi, Anthony Chan, Luis Francisco Collia, Peter Kleist, Luís Filipe Laranjeira, Kotone Matsuyama, Shehla Naseem, Johanna Schenk, Honorio Silva, Sandor Kerpel-Fronius, and on behalf of Working Group on Ethics of the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine

Subjects
research ethics, data science, medicines development, privacy protection, data sharing, declaration of Helsinki, Therapeutics. Pharmacology, RM1-950
Published
2021
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2. Linking the Declarations of Helsinki and of Taipei: Critical Challenges of Future-Oriented Research Ethics

Author

Chieko Kurihara, Varvara Baroutsou, Sander Becker, Johan Brun, Brigitte Franke-Bray, Roberto Carlesi, Anthony Chan, Luis Francisco Collia, Peter Kleist, Luís Filipe Laranjeira, Kotone Matsuyama, Shehla Naseem, Johanna Schenk, Honorio Silva, Sandor Kerpel-Fronius, and on behalf of Working Group on Ethics of the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine

Subjects
research ethics, data science, medicines development, privacy protection, data sharing, Declaration of Helsinki, Therapeutics. Pharmacology, RM1-950
Abstract

Expansion of data-driven research in the 21st century has posed challenges in the evolution of the international agreed framework of research ethics. The World Medical Association (WMA)’s Declaration of Helsinki (DoH) has provided ethical principles for medical research involving humans since 1964, with the last update in 2013. To complement the DoH, WMA issued the Declaration of Taipei (DoT) in 2016 to provide additional principles for health databases and biobanks. However, the ethical principles for secondary use of data or material obtained in research remain unclear. With such a perspective, the Working Group on Ethics (WGE) of the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP) suggests a closer scientific linkage in the DoH to the DoT focusing specifically on areas that will facilitate data-driven research, and to further strengthen the protection of research participants.

Published
2020
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3. The Shared Ethical Responsibility of Medically and Non-medically Qualified Experts in Human Drug Development Teams

Author

Chieko Kurihara, David Dubois, Jane Barrett, Luís Filipe Laranjeira, Greg Koski, Luis Francisco Collia, Roberto Carlesi, Sandor Kerpel-Fronius, Anthony A.W. Chan, Peter Kleist, Honorio Silva, Johan Brun, Sander Becker, and Johanna Schenk

Subjects
0301 basic medicine, Ethics committee, media_common.quotation_subject, education, Specialty, Pharmacologie, medicines development, 03 medical and health sciences, Medicines development, Pharmacology (medical), multidisciplinary research, Justice (ethics), media_common, Ethical code, Ethics, Multidisciplinary research, Pharmacology, ethics committee, International ethics, lcsh:RM1-950, Pharmaceutical medicine, Beneficence, ethics, lcsh:Therapeutics. Pharmacology, 030104 developmental biology, pharmaceutical medicine, Engineering ethics, Psychology, Autonomy, Declaration of Helsinki
Abstract

The complexity of developing and applying increasingly sophisticated new medicinal products has led to the participation of many non-medically qualified scientists in multi-disciplinary non-clinical and clinical drug development teams world-wide. In this introductory paper to the "IFAPP International Ethics Framework for Pharmaceutical Physicians and Medicines Development Scientists" it is argued that all members of such multidisciplinary teams must share the scientific and ethical responsibilities since they all influence directly or indirectly both the outcome of the various phases of the medicines development projects and the safety of the research subjects involved. The participating medical practitioner retains the overriding responsibility and the final decision to stop a trial if the well-being of the research subjects is seriously endangered. All the team members should follow the main ethical principles governing human research, the respect for autonomy, justice, beneficence and non-maleficence. Nevertheless, the weighing of these principles might be different under various conditions according to the specialty of the members., SCOPUS: ar.j, info:eu-repo/semantics/published

Published
2018
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