دورية أكاديمية
أعرض في EDS

Physician-Investigator, Research Coordinator, and Patient Perspectives on Dual-Role Consent in Oncology: A Qualitative Study.

التفاصيل البيبلوغرافية
العنوان: Physician-Investigator, Research Coordinator, and Patient Perspectives on Dual-Role Consent in Oncology: A Qualitative Study.
المؤلفون: Morain SR; Johns Hopkins Berman Institute of Bioethics and the Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland., Barlevy D; Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, Texas., Joffe S; Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia., Largent EA; Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia.; Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia.
المصدر: JAMA network open [JAMA Netw Open] 2023 Jul 03; Vol. 6 (7), pp. e2325477. Date of Electronic Publication: 2023 Jul 03.
نوع المنشور: Journal Article; Research Support, N.I.H., Extramural
اللغة: English
بيانات الدورية: Publisher: American Medical Association Country of Publication: United States NLM ID: 101729235 Publication Model: Electronic Cited Medium: Internet ISSN: 2574-3805 (Electronic) Linking ISSN: 25743805 NLM ISO Abbreviation: JAMA Netw Open Subsets: MEDLINE
أسماء مطبوعة: Original Publication: Chicago, IL : American Medical Association, [2018]-
مواضيع طبية MeSH: Neoplasms* , Physicians*, Humans ; Female ; Male ; Prospective Studies ; Medical Oncology ; Informed Consent
مستخلص: Importance: Classic statements of research ethics generally advise against dual-role consent in which physician-investigators seek consent for research participation from patients with whom they have preexisting treatment relationships. Yet dual-role consent is common in clinical oncology research, as studies are often conducted in close relationship with clinical care.
Objective: To explore key stakeholders' perspectives on dual-role consent in clinical oncology trials.
Design, Setting, and Participants: This qualitative study with 43 participants was conducted at a National Cancer Institute-designated comprehensive cancer center from 2018 to 2022. Semistructured qualitative interviews of physician-investigators, research coordinators, and patients were performed. Respondents were recruited from 3 populations: (1) physician-investigators engaged in clinical oncology research; (2) research coordinators engaged in clinical oncology research; and (3) patients, with and without prior clinical trial experience, who had received a new cancer diagnosis at least 2 months prior to enrollment in this study.
Main Outcomes and Measures: Interviews were audio recorded and professionally transcribed. A thematic analysis approach was used to develop a codebook that included both theory-driven, a priori codes and emergent, inductive codes. Two authors double-coded all transcripts and met regularly to compare coding, discuss discrepancies, refine the codebook, and draft memos describing relevant themes and their frequency.
Results: Among the 43 respondents, 28 (65.1%) were female; 9 (20.9%) were African American, 8 (18.6%) were Asian, 6 (14.0%) were Hispanic, and 21 (48.8%) were White; 15 were physician-investigators (6 [40.0%] with 6-10 years of experience, 4 [26.7%] with at least 20 years of experience), 13 were research coordinators (5 [38.5%] with 0-5 years of experience, 5 [38.5%] with 6-10 years of experience), and 15 were patients (9 [60.0%] aged 46-64 years). Four main themes were found: interviewees (1) perceived greater potential for role synergy than for role conflict; (2) reported dual-role consent as having mixed effects on the consent process, increasing prospective participants' understanding and likelihood of agreement while also challenging voluntariness; (3) preferred a team-based approach to the consent process in which physician-investigators and research coordinators share responsibility for communicating with prospective participants and safeguarding voluntariness; and (4) offered strategies for managing tensions in dual-role consent.
Conclusions and Relevance: This qualitative study found that concerns about dual-role consent in clinical oncology, while valid, may be outweighed by corresponding advantages, particularly if appropriate mitigation strategies are in place. These findings support a team-based approach to informed consent, in which physician-investigators and research coordinators promote both the understanding and voluntariness of prospective participants.
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معلومات مُعتمدة: P30 CA125123 United States CA NCI NIH HHS
تواريخ الأحداث: Date Created: 20230725 Date Completed: 20230726 Latest Revision: 20230728
رمز التحديث: 20230729
مُعرف محوري في PubMed: PMC10369198
DOI: 10.1001/jamanetworkopen.2023.25477
PMID: 37490290
قاعدة البيانات: MEDLINE
الوصف
تدمد:2574-3805
DOI:10.1001/jamanetworkopen.2023.25477