Informed consent in clinical studies involving human participants: ethical insights of medical researchers in Germany and Poland

  • Background The internationalization of clinical studies requires a shared understanding of the fundamental ethical values guiding clinical studies. It is important that these values are not only embraced at the legal level but also adopted by clinicians themselves during clinical studies. Objective Our goal is to provide an insight on how clinicians in Germany and Poland perceive and identify the different ethical issues regarding informed consent in clinical studies. Methods To gain an understanding of how clinicians view clinical studies in the countries they work in, we carried out semi-structured problem-centered interviews per telephone in Poland (n = 6) and Germany (n = 6). Our interviewees concentrated on three main topics: an appraisal of the normative framework, challenges in the information process and the protection of all participants in clinical studies. Results Clinicians generally supported the normative framework, even though they considered it quiteBackground The internationalization of clinical studies requires a shared understanding of the fundamental ethical values guiding clinical studies. It is important that these values are not only embraced at the legal level but also adopted by clinicians themselves during clinical studies. Objective Our goal is to provide an insight on how clinicians in Germany and Poland perceive and identify the different ethical issues regarding informed consent in clinical studies. Methods To gain an understanding of how clinicians view clinical studies in the countries they work in, we carried out semi-structured problem-centered interviews per telephone in Poland (n = 6) and Germany (n = 6). Our interviewees concentrated on three main topics: an appraisal of the normative framework, challenges in the information process and the protection of all participants in clinical studies. Results Clinicians generally supported the normative framework, even though they considered it quite complex. In the two study countries, a widely noted dilemma in the information process was whether to overburden participants with extensive information or risking leaving out important facts. Clinicians were ready to exclude larger population groups from participating in clinical studies when the information process could not be carried out with standard procedures or when their inclusion was ethically sensitive. Conclusion Clinicians need to gain a better understanding of the consequences of excluding larger population groups form participating in clinical studies. They should seek assistance in improving the information process for the inclusion of underrepresented groups in clinical studies.zeige mehrzeige weniger

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Verfasserangaben:Cristian TimmermannORCiDGND, Marcin OrzechowskiORCiD, Oxana KosenkoORCiD, Katarzyna WoniakORCiD, Florian StegerORCiD
URN:urn:nbn:de:bvb:384-opus4-958708
Frontdoor-URLhttps://opus.bibliothek.uni-augsburg.de/opus4/95870
ISSN:2296-858XOPAC
Titel des übergeordneten Werkes (Englisch):Frontiers in Medicine
Verlag:Frontiers Media S.A.
Typ:Wissenschaftlicher Artikel
Sprache:Englisch
Datum der Erstveröffentlichung:19.05.2022
Veröffentlichende Institution:Universität Augsburg
Datum der Freischaltung in OPUS:14.06.2022
Freies Schlagwort / Tag:Central and Eastern Europe; clinical trials; informed consent; medical ethics; research ethics
Jahrgang:9
Erste Seite:901059
DOI:https://doi.org/10.3389/fmed.2022.901059
Einrichtungen der Universität:Medizinische Fakultät
Medizinische Fakultät / Professur für Ethik der Medizin
DDC-Klassifikation:6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit
Lizenz (Deutsch):License LogoCC-BY 4.0: Creative Commons: Namensnennung (mit Print on Demand)