Clinical Research Ethics: Critical and Qualitative Analysis of Facilitators and Barriers
Keywords:
Clinical Research Ethics, Clinical Ethics, Principialism, Bioethics, Health Justice
Abstract
To analyze the ethical challenges dealing with clinical research, we carried out a systematic review of the literature and qualitative research, determining facilitators, barriers, and ethical paradigms perceived by Chilean clinical researchers. Through the analysis of the literature, we identified the main ethical challenges involved “in” clinical research (hic et nunc) and those that arise “from” clinical research itself (ex post). Semi-structured interviews showed four critical knots associated with clinical research (founding, legislation, multi-center research, and the relationship with regulatory entities), together with facilitating aspects and barriers when implementing researches.
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References
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Beauchamp, Tom L., James F. Childress (1979). Principles of Biomedical Ethics. Oxford: Oxford University Press.
Borgerson, Kirstin (2016). «An Argument for Fewer Clinical Trials». Hastings Center Report 46: pp. 25–35. doi:10.1002/hast.637.
Borracci, Raúl A. (2016). «Fallibility of the Ethics Committees in Medical Research». Revista Argentina de Cardiología 84(6), 605–609. doi: 10.7775/rac.v84.i6.9991.
Boutin-Foster, Carla, Ebony Scott, Jennifer Melendez, Anna Rodriguez, Rosio Ramos, Balavenkatesh Kanna, Walid Michelen (2013). «Ethical Considerations for Conducting Health Disparities Research in Community Health Centers: A Social-Ecological Perspective». American Journal of Public Health 103, no. 12: pp. 2179–2184. doi: 10.2105/AJPH.2013.301599.
Davis, Dena S. (2017). «Ethical Issues in Alzheimer’s Disease Research Involving Human Subjects». Journal of Medical Ethics 43 no. 12: pp. 852–856. doi:10.1136/medethics-2016-103392.
Emanuel, Ezekiel J., David Wendler, Christine Grady (2000). «What makes clinical research ethical?». JAMA 283, no. 20: pp. 2701–2711. doi:10.1001/jama.283.20.2701.
Estella, Ángel (2018). «Ethics Research in Critically Ill Patients». Medicina Intensiva 42: pp. 247–254. doi: 10.1016/j.medine.2017.11.001.
Gajardo Jáuregui, Jean, José M. Aravena (2017). «Tensiones en torno a la inclusión de personas con diagnóstico de demencia en investigación científica». Acta Bioethica 23, no. 2: pp. 253–258.
Gelfand, Scott D. (2013). «Clinical equipoise: Actual or hypothetical disagreement?». The Journal of Medicine and Philosophy 38, no. 6: pp. 590–604. doi:10.1093/jmp/jht023.
Kottow, Miguel H. (2005). «Conflictos en ética de investigación con seres humanos». Cadernos de Saúde Pública 21, no. 3: pp. 862–869. doi:10.1590/S0102-311X2005000300020.
Lange, Margaret M., Wendy Rogers, Susan Dodds (2013). «Vulnerability in research ethics: A way forward». Bioethics 27, no. 6: pp. 333–340. doi:10.1111/bioe.12032.
Mackay, Douglas (2016). «Fair subject selection in clinical research: formal equality of opportunity». Journal of Medical Ethics 42: pp. 672–677. doi: 10.1136/medethics-2015-103311.
Marouf, Fatma E., Bryn S. Esplin (2015). «Setting a Minimum Standard of Care in Clinical Trials: Human Rights and Bioethics as Complementary Frameworks». Health and Human Rights 17, no. 1: pp. 31–42.
Martínez Picabea de Giorgiutti, Elba (2013). «Regulaciones bioéticas en investigaciones con seres humanos». Journal of Basic & Applied Genetics 24, no. 1: pp. 5–12.
McKinney, Ross E., Laura M. Beskow, Daniel E. Ford, John D. Lantos, Jonathan McCall, Bray Patrick-Lake, et al. (2015). «Use of Altered Informed Consent in Pragmatic Clinical Research». Clinical Trials 12, no. 5: pp. 494–502. doi:10.1177/1740774515597688.
Miller, Franklin (2014). «Clinical Research before Informed Consent». Kennedy Institute of Ethics 24, no. 2: pp. 141–157.
Napier, Stephen (2013). «Challenging research on human subjects: Justice and uncompensated harms». Theoretical Medicine & Bioethics 34: pp. 29–51. doi:10.1007/s11017-013-9241-9.
Prah Ruger, Jennifer (2010). «Health Capability: Conceptualization and Operationalization». American Journal of Public Health 100, no. 1: 41–49. doi: 10.2105/AJPH.2008.143651.
Pratt, Bridget, Adnan A. Hyder (2015). «Global Justice and Health Systems Research in Low- and Middle- Income Countries». Journal of law, medicine & ethics 43, no. 1: pp. 143–161. doi: 10.1111/jlme.12202.
Quesada Rodríguez, Francisco (2013). «La Bioética y los Derechos Humanos. Una perspectiva filosófica sobre la justicia en la investigación científica y experimentación clínica con seres humanos». Medicina Legal de Costa Rica 30, no. 2: pp. 24–34.
Stapleton, Greg, Greg Schröder-Bäck, Ulrich Laaser, Agnes Meershoek, Daniela Popa (2014). «Global health ethics: An introduction to prominent theories and relevant topics». Global Health Action 7. doi: 10.3402/gha.v7.23569.
Van Campen, Luann E., Donald G. Therasse, Mitchell Klopfenstein, Robert J. Levine (2015). «Eli Lilly and Company’s bioethics framework for human biomedical research». Current Medical Research & Opinion 31, no. 11: pp. 2081–2093. doi:10.1185/03007995.2015.1087987.
Welch, Mary J., Rachel Lally, Jennifer E. Miller, Stephanie Pittman, Lynda Brodsky, Arthur L. Caplan, et al. (2015). «The ethics and regulatory landscape of including vulnerable populations in pragmatic clinical trials». Clinical Trials 12, no. 5: pp. 503–510. doi: 10.1177/1740774515597701.
Wendler, David, Annette Rid (2107). «In Defense of a Social Value Requirement for Clinical Research». Bioethics 31, no. 2: pp. 77–86. doi:10.1111/bioe.12325.
Wenner, Danielle M. (2016). «Against Permitted Exploitation in Developing World Research Agreements». Developing World Bioethics 16, no. 1: pp. 36–44. doi: 10.1111/dewb.12081.
Woods, Simon, Pauline Mccormack (2013). «Disputing the ethics of research: the challenge from bioethics and patient activism to the interpretation of the Declaration of Helsinki in clinical trials». Bioethics 27, no. 5: pp. 243–250. doi: 10.1111/j.1467-8519.2011.01945.x.
Published
2020-12-31
How to Cite
[1]
Valera, L., González, K., Ramos, P. and Altermatt, F. 2020. Clinical Research Ethics: Critical and Qualitative Analysis of Facilitators and Barriers. Analysis. Claves de Pensamiento Contemporáneo. 27, (Dec. 2020), no. 2: pp. 1-. DOI:https://doi.org/10.5281/zenodo.4592011.
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Section
Humanities
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