Getting into Their Heads: When the Investigator is also the Treating Physician

Morain, Stephanie R.; Largent, Emily A.; Wexler, Anna

doi:10.1080/21507740.2020.1866103

Cited by 2 publications

(2 citation statements)

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“…Controversy exists, however, around who can permissibly seek informed consent. What role, if any, can a prospective participant’s treating physician play in the consent process when that physician leads or collaborates in said research? Previously, we have used the term dual-role consent to describe the practice of physician-investigators seeking consent for research participation from individuals with whom they have preexisting treatment relationships …”

Section: Introductionmentioning

confidence: 99%

“…What role, if any, can a prospective participant's treating physician play in the consent process when that physician leads or collaborates in said research? [2][3][4][5][6][7][8] Previously, we have used the term dual-role consent to describe the practice of physician-investigators seeking consent for research participation from individuals with whom they have preexisting treatment relationships. 2 Classic statements of research ethics advise against dual-role consent, based on the view that distinct normative commitments govern physician-patient and investigator-participant relationships.…”

Section: Introductionmentioning

confidence: 99%

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Physician-Investigator, Research Coordinator, and Patient Perspectives on Dual-Role Consent in Oncology

Morain,

Barlevy,

Joffe

et al. 2023

JAMA Netw Open

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ImportanceClassic 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.ObjectiveTo explore key stakeholders’ perspectives on dual-role consent in clinical oncology trials.Design, Setting, and ParticipantsThis 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 MeasuresInterviews 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.ResultsAmong 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 RelevanceThis 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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Section: Introductionmentioning

confidence: 99%