Ethical issues in implementation science: perspectives from a National Heart, Lung, and Blood Institute workshop.

Autor: Dickert NW; Department of Medicine and Emory Health Services Research Center, Emory University School of Medicine, 1750 Haygood Drive #250-N, Atlanta, GA, USA. njr@emory.edu., Spiegelman D; Center for Methods On Implementation and Prevention Science, Department of Biostatistics, Yale School of Public Health, New Haven, CT, USA., Blumenthal-Barby JS; Baylor College of Medicine, Center for Medical Ethics and Health Policy, Houston, TX, USA., Graham G; Healthcare and Public Health at Google/YouTube, New Haven, CT, USA., Joffe S; Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA., Kahn JM; Department of Critical Care Medicine and Department of Health Policy & Management, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA., Kass NE; Johns Hopkins Berman Institute of Bioethics and Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA., Kim SYH; Department of Bioethics, National Institutes of Health Clinical Center, Bethesda, MD, USA., Kerlin MP; Department of Medicine, Division of Pulmonary, Allergy and Critical Care, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA., Langford AT; Department of Family Medicine and Public Health Sciences, Wayne State University School of Medicine, Detroit, MI, USA., Lavery JV; Hubert Department of Global Health, Rollins School of Public Health, Center for Ethics, Emory University, Atlanta, GA, USA., Matlock DD; Division of Geriatric Medicine, Department of Medicine, University of Colorado School of Medicine, Aurora; VA Eastern Colorado Geriatric Research Education and Clinical Center, Denver, CO, USA., Fenton KN; Advanced Technologies and Surgery Branch, Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, and Department of Bioethics, National Institutes of Health Clinical Center, National Institutes of Health, Bethesda, MD, USA., Mensah GA; Center for Translation Research and Implementation Science, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, USA.
Jazyk: angličtina
Zdroj: Implementation science : IS [Implement Sci] 2024 Nov 19; Vol. 19 (1), pp. 77. Date of Electronic Publication: 2024 Nov 19.
DOI: 10.1186/s13012-024-01403-6
Abstrakt: Ethical issues arise in the context of implementation science that may differ from those encountered in other research settings. This report, developed out of a workshop convened by the Center for Translation Research and Implementation Science within the United States National Heart, Lung, and Blood Institute, identifies six key themes that are important to the assessment of ethical dimensions of implementation science. First, addressing ethical challenges in implementation science does not require new ethical principles, commitments, or regulations. However, it does require understanding of the specific contexts arising in implementation research related to both study design and the intervention being implemented. Second, implementation research involves many different types of people in research, including patients, clinicians, administrators, the social networks of any of these, and the general population. These individuals play different roles that may entail different ethical considerations, obligations, and vulnerabilities. Third, the appropriateness of and need for informed consent in implementation research is connected to the role of the subject/participant, the nature of the intervention, and the design of the study. Even where traditional "full" consent processes are unnecessary or inappropriate, communication and engagement are critical. Similarly, even when research is exempt and informed consent unnecessary, Data Safety and Monitoring Board oversight of implementation studies may be advisable to ensure quality, address unexpected consequences, and identify overwhelming evidence of benefit. Fourth, implementation science is often explicitly designed to encourage specific behaviors and discourage others. There is a need for clarity regarding when efforts at behavioral change enhance or threaten autonomy and how to protect participants whose autonomy is threatened. Fifth, there is significant overlap between implementation science and quality improvement, and the ideal regulatory oversight structure for implementation science remains unclear. It is critical to encourage learning and growth while assuring appropriate protections. Sixth, implementation research takes place across a range of social and cultural contexts. Engagement and collaboration with stakeholders in designing and executing implementation trials and studies- especially when vulnerabilities exist- is essential. Attention to these themes will help ensure that implementation science fulfills its goal of advancing the practice of health care within a sound ethical framework.
Competing Interests: Declarations Ethics approval and consent to participate Not Applicable. Consent for publication Not Applicable. Competing interests Dr. Dickert reports receiving research support from NCATS, AHRQ, the American Heart Association, Abiomed, and Merck, service on Data Safety Monitoring Boards for NIH and PCORI, and consulting activity for Abiomed, Inc. Dr. Joffe is a paid member of a data safety and monitoring committee for CSL Behring.
(© 2024. The Author(s).)
Databáze: MEDLINE
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