Informed Consent: Patient Autonomy and Clinician Beneficence within Health Care, Second Edition (Cli

Informed Consent: Patient Autonomy and Clinician Beneficence within Health Care (2nd ed). Reviewed by J. Pasek. Copyright and License information ▻.
Table of contents

Beyond Vulnerability, Toward Inclusion: Politics, Ethics, Epistemology Mary L.

Gray, PhD, and co-authors discuss the political and social implications of big data. Gray, PhD, discusses the ethical considerations behind recent social media research. This report is the basis for this plenary session. A New Regulatory Framework for the 21st Century report. Joffe outlines the criticisms of the system of human subjects research oversight and provides solutions.

Informed Consent: Patient Autonomy and Clinician Beneficence within Health Care (2nd ed)

The Academies cited concern with the clarity of the proposed changes and proposed that the government create an independent commission to develop new rules for the research community Panel I: Beecher published five notable articles on human subjects research issues. Wilfond, MD, et al. However, most patients held the opposite view and preferred to speak about consent with their doctors.

Patient Perspectives on the Learning Health System: Patients tended to believe that being informed about research was more important than the actual mechanism of consent, and most were content with being able to opt out from participating. Weinfurt, PhD, analyzed the results of 12 focus groups looking at comparative effectiveness research. Participants were given hypothetical research studies to discuss, and common discussion themes included notification, authorization, and research design and conduct.

Children between the ages of 10 and 15 years old are much closer, but not quite at the level of adult comprehension on research rights. Bruzzese and Fisher discuss how these results may impact informed consent practices in research. Children's Competence for Assent and Consent: Recommendations are made to address these dilemmas for future research with children. They also discover that financial compensation is an important factor in the decision process.

Communication of Randomization in Childhood Leukemia Trials Panelist Eric Kodish, MD, and co-authors conducted a multisite study examining the informed consent process in randomized clinical trials for childhood leukemia.

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The main objective of the study was to determine the understanding of parents after attending a conference specifically around the concept of randomization. They discovered that even after explanation, about half of the parents still did not understand randomization, leading to a problem in the informed consent process. Fisher, PhD, conducted a project to look at how sexual and gender minority youth viewed the practice of guardian permission for a pre-exposure prophylaxis PrEP adherence trial.

Brody, PhD, and co-authors looked at how family and physician-investigators influence participation of adolescents in asthma clinical research studies. She learned from researchers that such donations are invaluable and describes her efforts to work with researchers to bring more attention to this critical area. She also shares the moving stories of other donor families.

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