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Valid consent requires the potential research participant understands the information provided. We examined current practice in 50 proposed Clinical Trials of Investigational Medicinal Products to determine how this understanding is checked. The majority of the proposals ( n = 44) indicated confirmation of understanding would take place during an interactive conversation between the researcher and potential participant, containing questions to assess and establish understanding. Yet up until now, research design and review have not focussed upon this, concentrating more on written (...) |
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Research consent processes must provide potential participants with the necessary information to help them decide if they wish to join a study. On the Oxford ‘A’ Research Ethics Committee we’ve found that current research proposals mostly provide adequate detail (even if not in an easily comprehensible format), but often fail to support decision making, a view supported by published evidence. In a previous paper, we described how consent might be structured, and here we develop the concept of an Information and (...) |
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Volume 20, Issue 5, June 2020, Page 28-30. |
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In the 60+ years that the modern concept of informed consent has been around, researchers in various fields of practice, especially medical ethics, have developed new models to overcome theoretical and practical problems. While (systematic) literature reviews of such models exist within given fields (e.g., genetic screening), this article breaks ground by analyzing academic literature on consent models across fields. Three electronic research databases (Scopus, Google Scholar, and Web of Science) were searched for publications mentioning informed consent models. The titles, (...) |
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Decentralized clinical trials (DCTs) have the potential to advance the conduct of clinical trials, but raise several ethical issues, including obtaining valid informed consent. The debate on the ethical issues resulting from digitalization is predominantly focused on direct risks relating to for example data protection, safety, and data quality. We submit however, that a broader view on ethical aspects of DCTs is needed to touch upon the new challenges that come with the DCT practice. Digitalization has impacts that go beyond (...) |
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Background Informed consent procedures for large population-based cohort studies should be comprehensive and easy-to-use. This is particularly challenging when participants from different socio-economic groups and multicultural ethnic backgrounds are involved. Recently, more and more studies have tried to use multimedia in informed consent procedures. We describe the development and testing of a digital informed consent app and elaborate on whether this may contribute to a comprehensive and practical procedure to obtain informed consent for public health research. Methods In a sample (...) |
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Background Standard interpretations of the ethical principle of respect for persons have not incorporated the views and values of patients, especially patients from groups underrepresented in research. This limits the ability of research ethics scholarship, guidance, and oversight to support inclusive, patient-centered research. This study aimed to identify the practical approaches that patients in community-based settings value most for conveying respect in genomics research. Methods We conducted a 3-round, web-based survey using the modified Delphi technique to identify areas of agreement (...) |
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BackgroundAlthough patient advocates have developed templates for standard consent forms, evaluating patient preferences for first in human (FIH) and window of opportunity (Window) trial consent forms is critical due to their unique risks. FIH trials are the initial use of a novel compound in study participants. In contrast, Window trials give an investigational agent over a fixed duration to treatment naïve patients in the time between diagnosis and standard of care (SOC) surgery. Our goal was to determine the patient-preferred presentation (...) |
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Background There is little dispute that the ideal moral standard for surgical informed consent calls for surgeons to carry out a disclosure dialogue with patients before they sign the informed consent form. This narrative study is the first to link patient experiences regarding the disclosure dialogue with patient-surgeon trust, central to effective recuperation and higher adherence. Methods Informants were 12 Israelis, aged 29–81, who underwent life-saving surgeries. A snowball sampling was used to locate participants in their initial recovery process upon (...) |
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