Think Pragmatically: Investigators' Obligations to Patient-Subjects When Research is Embedded in Care.
Growing interest in embedded research approaches—where research is incorporated into clinical care—has spurred numerous studies to generate knowledge relevant to the real-world needs of patients and other stakeholders. However, it also has presented ethical challenges. An emerging challenge is how t...
| Published in: | American Journal of Bioethics Vol. 23; no. 8; pp. 10 - 22 |
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| Main Authors: | , |
| Format: | Journal Article |
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Taylor & Francis Ltd
Aug2023
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| Online Access: | View this record in EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=165049961&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 165049961 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 15265161 FKZ jtl: American Journal of Bioethics issn: 15265161 maglogo: N pubinfo: dt: Aug2023 vid: 23 iid: 8 pid: 377 pub: Taylor & Francis Ltd place: Philadelphia, Pennsylvania artinfo: ui: 165049961 156377383 10.1080/15265161.2022.2063435 165049961 ppf: 10 ppct: 12 formats: fmt: – @attributes: type: T – @attributes: type: P tig: atl: Think Pragmatically: Investigators' Obligations to Patient-Subjects When Research is Embedded in Care. aug: au: Morain, Stephanie Largent, Emily affil: Johns Hopkins University sug: subj: Research Subjects Research Ethics Ethics, Professional Health Services Research Clinical Trials Case Studies Osteoporosis Atrial Fibrillation Emergency Care ab: Growing interest in embedded research approaches—where research is incorporated into clinical care—has spurred numerous studies to generate knowledge relevant to the real-world needs of patients and other stakeholders. However, it also has presented ethical challenges. An emerging challenge is how to understand the nature and extent of investigators' obligations to patient-subjects. Prior scholarship on investigator duties has generally been grounded upon the premise that research and clinical care are distinct activities, bearing distinct duties. Yet this premise—and its corresponding implications—are challenged when research and clinical care are deliberately integrated. After presenting three case studies from recent pragmatic clinical trials, we identify six differences between explanatory trials and embedded research that limit the application of existing scholarship for ascertaining investigator duties. We suggest that these limitations indicate a need to account for the implications of usual care and to move beyond a narrow focus on the investigator-subject dyad, one that better reflects the team- and institution-based nature of contemporary health systems. pubtype: Academic Journal doctype: Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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