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  1. Accessing health services through the back door: a qualitative interview study investigating reasons why people participate in health research in Canada. [REVIEW]Anne Townsend & Susan M. Cox - 2013 - BMC Medical Ethics 14 (1):40.
    Although there is extensive information about why people participate in clinical trials, studies are largely based on quantitative evidence and typically focus on single conditions. Over the last decade investigations into why people volunteer for health research have become increasingly prominent across diverse research settings, offering variable based explanations of participation patterns driven primarily by recruitment concerns. Therapeutic misconception and altruism have emerged as predominant themes in this literature on motivations to participate in health research. This paper contributes to more (...)
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  • An audit of questions asked by participants during the informed consent process for regulatory studies at a tertiary referral centre – An analysis of consent narratives.Unnati Saxena, Debdipta Bose, Mitesh Kumar Maurya, Nithya Jaideep Gogtay & Urmila Mukund Thatte - 2021 - Clinical Ethics 16 (2):144-150.
    Objective To evaluate the questions asked during the informed consent process by adult and adolescent participants as well as their parents in five interventional regulatory studies conducted at our center from 2018 to 2019. Methods The study protocol was approved by Institutional Ethics Committee [EC/OA-116/2019]. Consent narratives in the source documents for the studies were evaluated. Questions asked were classified as per Indian Council of Medical Research’s guidelines. We evaluated total number of questions, nature of questions and whether there was (...)
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  • An evaluation of reporting of consent declines in three high impact factor journals.B. H. Figer, S. J. Thaker, M. Boob, N. J. Gogtay & U. M. Thatte - 2018 - Clinical Ethics 13 (4):189-193.
    Background Informed consent confers upon participants the right to decline or accept participation in a study in equal measure. Consent declines can be used as a potential metric to assess the adequacy of the informed consent process. Limited literature is available on the reporting of consent declines in Clinical Research. We evaluated randomized controlled trials published in three high-impact factor journals for consent declines to assess the extent of exertion of autonomy by research participants. Methods CONSORT flow charts in RCTs (...)
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  • Questionable informed consent of vulnerable pregnant research participants in South India – What a staff reminder poster does not say.Wendy A. Cook - 2015 - Nursing Ethics 22 (2):264-272.
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  • Healthy Volunteers for Clinical Trials in Resource-Poor Settings: National Registries Can Address Ethical and Safety Concerns.Francois Bompart - 2019 - Cambridge Quarterly of Healthcare Ethics 28 (1):134-143.
    Healthy Volunteers (HVs) who participate in clinical trials are a vulnerable group that deserves specific protection. We assessed the number and types of studies that involve HVs around the world and outline the methodological barriers to their analysis. We found that tens of thousands of HVs are involved every year in clinical trials in a large variety of countries and that the overwhelming majority of studies are not “first-in-human” but pharmacokinetic studies. The two cornerstones for both ethical and safe participation (...)
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