دورية أكاديمية
The ethical value of consulting community members in non-emergency trials conducted with waivers of informed consent for research.
| العنوان: | The ethical value of consulting community members in non-emergency trials conducted with waivers of informed consent for research. |
|---|---|
| المؤلفون: | Largent EA; Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA., Joffe S; Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA., Dickert NW; Department of Medicine, Division of Cardiology, Emory University School of Medicine, Atlanta, GA, USA., Morain SR; Berman Institute of Bioethics, Johns Hopkins University, Baltimore, MD, USA. |
| المصدر: | Clinical trials (London, England) [Clin Trials] 2024 Jun 25, pp. 17407745241259360. Date of Electronic Publication: 2024 Jun 25. |
| Publication Model: | Ahead of Print |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: SAGE Publications Country of Publication: England NLM ID: 101197451 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1740-7753 (Electronic) Linking ISSN: 17407745 NLM ISO Abbreviation: Clin Trials Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: London : SAGE Publications Original Publication: London : Arnold, c2004- |
| مستخلص: | There is growing interest in using embedded research methods, particularly pragmatic clinical trials, to address well-known evidentiary shortcomings afflicting the health care system. Reviews of pragmatic clinical trials published between 2014 and 2019 found that 8.8% were conducted with waivers of informed consent; furthermore, the number of trials where consent is not obtained is increasing with time. From a regulatory perspective, waivers of informed consent are permissible when certain conditions are met, including that the study involves no more than minimal risk, that it could not practicably be carried out without a waiver, and that waiving consent does not violate participants' rights and welfare. Nevertheless, when research is conducted with a waiver of consent, several ethical challenges arise. We must consider how to: address empirical evidence showing that patients and members of the public generally prefer prospective consent, demonstrate respect for persons using tools other than consent, promote public trust and investigator integrity, and ensure an adequate level of participant protections. In this article, we use examples drawn from real pragmatic clinical trials to argue that prospective consultation with representatives of the target study population can address, or at least mitigate, many of the ethical challenges posed by waivers of informed consent. We also consider what consultation might involve to illustrate its feasibility and address potential objections. Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. |
| معلومات مُعتمدة: | U54 AG063546 United States AG NIA NIH HHS |
| فهرسة مساهمة: | Keywords: Consent; ethics; pragmatic trials; waivers |
| تواريخ الأحداث: | Date Created: 20240625 Latest Revision: 20240626 |
| رمز التحديث: | 20240626 |
| DOI: | 10.1177/17407745241259360 |
| PMID: | 38916109 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1740-7753 |
|---|---|
| DOI: | 10.1177/17407745241259360 |