دورية أكاديمية
Ethics challenges in sharing data from pragmatic clinical trials.
| العنوان: | Ethics challenges in sharing data from pragmatic clinical trials. |
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| المؤلفون: | Morain SR; Johns Hopkins Berman Institute of Bioethics, Baltimore, MD, USA.; Department of Health Policy & Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA., Bollinger J; Johns Hopkins Berman Institute of Bioethics, Baltimore, MD, USA., Weinfurt K; Department of Population Health Sciences, School of Medicine, Duke University Medical Center, Durham, NC, USA., Sugarman J; Johns Hopkins Berman Institute of Bioethics, Baltimore, MD, USA. |
| المصدر: | Clinical trials (London, England) [Clin Trials] 2022 Dec; Vol. 19 (6), pp. 681-689. Date of Electronic Publication: 2022 Sep 07. |
| نوع المنشور: | Journal Article; Research Support, N.I.H., Extramural |
| 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- |
| مواضيع طبية MeSH: | Ethics, Research* , Information Dissemination*, Humans ; Informed Consent ; Electronic Health Records ; Research Personnel |
| مستخلص: | Numerous arguments have been advanced for broadly sharing de-identified, participant-level clinical trials data, and trial sponsors and journals are increasingly requiring it. However, data sharing in pragmatic clinical trials presents ethical challenges related to the use of waivers or alterations of informed consent for some pragmatic clinical trials and corresponding limitations of informed consent to guide sharing decisions; the potential for data sharing in pragmatic clinical trials to present risks not only for individual patient-subjects, but also for health systems and the clinicians within them; sharing of data from electronic health records instead of data newly collected for research purposes; and researchers' limited capacity to control sensitive data within an electronic health record and potential implications of such limits for meeting obligations inherent to Certificates of Confidentiality. These challenges raise questions about the extent to which traditional research ethics governance structures are capable of guiding decisions about pragmatic clinical trial data sharing. This article identifies and examines these ethical challenges for pragmatic clinical trial data sharing. We suggest several areas for future empirical scholarship, including the need to identify patient and public attitudes regarding pragmatic clinical trial data sharing as well as to assess the demand for pragmatic clinical trial data and the correspondingly likely benefit of such sharing. Further conceptual work is also needed to explore how requirements to respect patient-subjects about whom data are shared in the context of pragmatic clinical trials should be understood, particularly in the absence of informed consent for initial research activities, and the appropriate balance between promoting the generation of socially valuable knowledge and respecting autonomy. |
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| معلومات مُعتمدة: | U24 AT009676 United States AT NCCIH NIH HHS; U24 AT010961 United States AT NCCIH NIH HHS |
| فهرسة مساهمة: | Keywords: Pragmatic clinical trials; data sharing; ethics; individual participant data |
| تواريخ الأحداث: | Date Created: 20220908 Date Completed: 20221122 Latest Revision: 20230616 |
| رمز التحديث: | 20230616 |
| مُعرف محوري في PubMed: | PMC10267884 |
| DOI: | 10.1177/17407745221110881 |
| PMID: | 36071689 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1740-7753 |
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| DOI: | 10.1177/17407745221110881 |