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Researchers’ views on, and experiences with, the requirement to obtain informed consent in research involving human participants: a qualitative study

Antonia Xu, Melissa Therese Baysari, Sophie Lena Stocker, Liang Joo Leow, Richard Osborne Day & Jane Ellen Carland

BMC Medical Ethics 21 (1):1-11 (2020)

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The participant’s voice: crowdsourced and undergraduate participants’ views toward ethics consent guidelines.Nadine S. J. Stirling & Melanie K. T. Takarangi - forthcoming - Ethics and Behavior.details The informed consent process presents challenges for psychological trauma research (e.g. Institutional Review Board [IRB] apprehension). While previous research documents researcher and IRB-member perspectives on these challenges, participant views remain absent. Thus, using a mixed-methods approach, we investigated participant views on consent guidelines in two convenience samples: crowdsourced (N = 268) and undergraduate (N = 265) participants. We also examined whether trauma-exposure influenced participant views. Overall, participants were satisfied with current guidelines, providing minor feedback and ethical reminders for researchers. Moreover, (...) Download Export citation Bookmark
Participants’ Right to Withdraw from Research: Researchers’ Lived Experiences on Ethics of Withdrawal.Bibek Dahal - 2024 - Journal of Academic Ethics 22 (1):191-209.details Ethics in research can be broadly divided into two epistemic dimensions. One dimension focuses on bureaucratic procedures (i.e., procedural ethics), while the other focuses on contextually and culturally contested practice of ethics in research (i.e., ethics in practice). Researchers experience both dimensions distinctly in their qualitative research. The review of ethics in prospective research through bureaucratic procedures aims to measure compliance with documented requirements relating to research participants, data management, consent, and ensure researchers can demonstrate their ethical competence before they (...) Download Export citation Bookmark 1 citation
Normative framework of informed consent in clinical research in Germany, Poland, and Russia.Marcin Orzechowski, Katarzyna Woniak, Cristian Timmermann & Florian Steger - 2021 - BMC Medical Ethics 22 (1):1-10.details Background: Biomedical research nowadays is increasingly carried out in multinational and multicenter settings. Due to disparate national regulations on various ethical aspects, such as informed consent, there is the risk of ethical compromises when involving human subjects in research. Although the Declaration of Helsinki is the point of reference for ethical conduct of research on humans, national normative requirements may diverge from its provisions. The aim of this research is to examine requirements on informed consent in biomedical research in Germany, (...) Download Export citation Bookmark
Exploring the Decision-Making Process of People Living with HIV Enrolled in Antiretroviral Clinical Trials: A Qualitative Study of Decisions Guided by Trust and Emotions.Maria Feijoo-Cid, Antonia Arreciado Marañón, Ariadna Huertas, Amado Rivero-Santana, Carina Cesar, Valeria Fink, María Isabel Fernández-Cano & Omar Sued - 2023 - Health Care Analysis 31 (3):135-155.details The informed consent is an ethical and legal requirement for potential participants to enroll in a study. There is ample of evidence that understanding consent information and enrollment is challenging for participants in clinical trials. On the other hand, the reasoning process behind decision-making in HIV clinical trials remains mostly unexplored. This study aims to examine the decision-making process of people living with HIV currently participating in antiretroviral clinical trials and their understanding of informed consent. We conducted a qualitative socio-constructivist (...) Download Export citation Bookmark

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