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Adhering to Ethical Benchmarks in Neurology Clinical Trials Using iPSCs.

ABSTRACT: We examine the ethics of using induced pluripotent stem cells (iPSCs) in cell transplantation treatment of neurologic diseases and the essential types of ethical benchmarks required in clinical trials in neurology using iPSCs, including embryonic pluripotent stem cells. We focus on two issues: (1) comparison and (2) criticism of the two types of neuro-hype (neuro-purism and neuro-essentialism). In order to ensure that the dialog on ethical benchmarks continues to develop in a manner that promotes trust with society and research subjects, concerns about the clinical use of pluripotent stem cells (particularly iPSCs) in neurology must be at the forefront of any ethics discussion.

SUBMITTER: Akabayashi A

PROVIDER: S-EPMC7283412 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Adhering to Ethical Benchmarks in Neurology Clinical Trials Using iPSCs.

Akabayashi Akira A Nakazawa Eisuke E Jecker Nancy S NS

Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics 20200401 2

We examine the ethics of using induced pluripotent stem cells (iPSCs) in cell transplantation treatment of neurologic diseases and the essential types of ethical benchmarks required in clinical trials in neurology using iPSCs, including embryonic pluripotent stem cells. We focus on two issues: (1) comparison and (2) criticism of the two types of neuro-hype (neuro-purism and neuro-essentialism). In order to ensure that the dialog on ethical benchmarks continues to develop in a manner that promote ...[more]

PMID: 30924090

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Project description:ImportancePragmatic clinical trials that seek informed consent after randomization (ie, postrandomization consent) are increasingly used, but debate on ethics persists because control arm patients are not specifically informed about the trials and randomization occurs before consent for the trials. The public's attitude toward postrandomization consent trials is unknown, but the way the trials are described could bias people's views.ObjectivesTo assess the attitudes of the US general public toward postrandomization informed consent for pragmatic trials and to measure potential framing and other factors associated with those attitudes.Design, setting, and participantsAn online, 2 × 2 experimental survey (fielded between February 23 and April 3, 2018) portraying 4 scenarios of postrandomization informed consent (with prior broad consent for medical record use) was conducted. These scenarios included traditional randomized clinical trial language framing vs alternative framing in a high-stakes trial (ie, survival in leukemia) or low-stakes trial (ie, blood glucose level in diabetes). A total of 3793 individuals invited to participate were part of an existing panel representative of the US general public (GfK KnowledgePanel).Main outcomes and measuresThe proportion of participants who would recommend that an ethics review board approve a postrandomization consent pragmatic trial.ResultsA total of 2042 of 3739 invitees (54.6%) responded; after exclusion of 38 incomplete surveys, 2004 participants were included in the analysis. Of these, 997 (49.8%) were women, 1440 (71.9%) were white non-Hispanic, 199 (9.9%) were black non-Hispanic, and 233 (11.6%) were Hispanic. Mean (SD) age was 47.5 (17.4) years. Across scenarios, weighted data showed that 75.4% of the participants would recommend approval of the postrandomization consent pragmatic trial, 20.4% would probably not recommend approval, and 4.2% would definitely not recommend approval. Approval was not sensitive to framing language (traditional vs new framing in high-stakes scenario, 74.3% vs 76.8%, P = .40; in low-stakes scenario, 77.7% vs 72.9%, P = .10) or to the stakes (low vs high stakes in traditional framing, 77.7% vs 74.3%, P = .25; in new framing, 72.9% vs 76.8%, P = .18). Better understanding of the postrandomization consent design was associated with higher rate of approval (78.1% vs 65.0%, P = .002 for high-stakes scenario; 77.2% vs 64.9%, P = .004 for low-stakes scenario), especially among those with less education. However, opinions about personal involvement in the control arm were more cautious (range depending on scenario, 45.6%-59.7%) and sensitive to stakes but not to framing.Conclusions and relevanceThe public's generally high rate of approval of the ethics of postrandomization informed consent for pragmatic trial designs does not appear to be affected by whether postrandomization consent design is framed using traditional randomized clinical trial terminology, regardless of the stakes of the trial. Promoting better understanding of the design may increase its acceptance by the public.

Dataset Information

Adhering to Ethical Benchmarks in Neurology Clinical Trials Using iPSCs.

Publications

Adhering to Ethical Benchmarks in Neurology Clinical Trials Using iPSCs.

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