Characterization of a Group of Research Ethics Committees in Colombia
DOI:
https://doi.org/10.5294/pebi.2018.22.2.8Keywords:
Research Ethics Committees, research, ethical review, clinical protocolsAbstract
In the last decades, controlled clinical trials sponsored by the pharmaceutical industry have increased considerably. This has led to the need for greater control and assistance by regulators and ethics committees to ensure appropriate compliance with established ethical standards and good clinical practices in general. In Colombia, the National Food and Drug Surveillance Institute (INVIMA), the regulator in the country, controls and monitors the operation of clinical research with drugs. In 2008, this entity issued Resolution 2378, which provides and regulates research actors in Colombia, including ethics committees. After being in force for several years, it is necessary to know whether research ethics committees in Colombia operate in accordance with this regulation and to determine the status of implementation of the requirements therein. For this purpose, a survey was designed to be voluntarily answered and a response was obtained from 25 of the 69 certified committees in Colombia. Twenty-two of them could be analyzed because their information was complete. Compared with previous studies, favorable changes in development and organization were observed in accordance with the current proposed regulation.
Downloads
References
Buxton M, Hanney S, Jones T. Estimating the economic value to societies of the impact of health research: a critical review. Bull World Health Organ. 2004;82(10):733-9. Disponible en: http://www.who.int/bulletin/volumes/82/10/733.pdf?ua=1
Health Economics Research Group (HERG) Brunel University. Office of Health Economics (OHE) RAND Europe. Medical Research: What’s it worth? Estimating the economic benefi ts from medical research in the UK London; 2008.
Shen LJ, Chou H, Huang CF, Chou GM, Chan WK, Wu FL. Economic benefits of sponsored clinical trials on pharmaceutical expenditures at a medical center in Taiwan. Contemp Clin Trials. 2011;32(4):485-91. doi: 10.1016/j.cct.2011.04.003
Kaló Z, Antal J, Pénzes M, Pozsgay C, Szepezdi Z, Nagyjánosi L. Contribution of clinical trials to gross domestic product in Hungary. Croat Med J. 2014;55(5):446-51. doi: 10.3325/cmj.2014.55.446
Jara-Navarro M. El reto de la investigación y la producción científica en salud. Rev Gerenc Polit Salud.11(22):5-10. Disponible en: http://www.redalyc.org/articulo.oa?id=54523558001
Palacios M. Las Buenas Prácticas Clínicas en Colombia. 2009;39(4). Disponible en: http://colombiamedica.univalle.edu.co/index.php/comedica/article/view/612/862
Molina DI, Giraldo GC. Impacto de la investigación clínica en el desarrollo de un país. Acta Med Colom. 2012;37(4):215-9. Disponible en: http://www.scielo.org.co/pdf/amc/v37n4/v37n4a09.pdf
Carreño A. Situación de los estudios clínicos en Colombia. Med (Bogotá). 2013;35(2):123-9. Disponible en: https://revistamedicina.net/ojsanm/index.php/Medicina/article/download/37/87/
Jácome-Roca A. Investigación clínica en Colombia. Medicina (Bogotá). 2013;35(2):101-3. Disponible en: http://revistamedicina.net/ojsanm/index.php/Medicina/article/download/34/85/
República de Colombia. Ministerio de Protección Social. Resolución 2378 de 2008. Por la cual se adoptan las Buenas Prácticas Clínicas para las instituciones que conducen investigación con medicamentos en seres humanos; 2008.
Gamboa G. Regulación de la ética de investigación en Colombia. En: Lolas F, Rodriguez E, editores. Ethics of biomedical and psychosocial research program, Interdisciplinary Center for Studies on Bioethics, University of Chile, Grant Fogarty International Center R25TWOO6056. Lima: Acta bioeth; 2011. pp. 273-5.
Sharp RR, Taylor HA, Brinich MA, Boyle MM, Cho M, Coors M, et al. Research ethics consultation: Ethical and professional practice challenges and recommendations. Acad Med. 2015;90(5):615-20. doi: 10.1097/ACM.0000000000000640
Grady C. Institutional review boards: Purpose and challenges. Chest. 2015;148(5):1148-55. doi: 10.1378/chest.15-0706
Wolf LE, Croughan M, Lo B. The challenges of IRB review and human subjects protections in practice-based research. Med Care. 2002;40(6):521-9. Disponible en: https://journals.lww.com/lww-medicalcare/Abstract/2002/06000/The_Challenges_of_IRB_Review_and_Human_Subjects.9.aspx
Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical industry sponsorship and research outcome and quality: Systematic review. BMJ. 2003;326(7400):1167-70. doi: 10.1136/bmj.326.7400.1167
Klitzman RL. US IRBs confronting research in the developing world. Dev World Bioeth. 2012;12(2):63-73. doi: 10.1111/j.1471-8847.2012.00324.x
Graham DG, Spano MS, Manning B. The IRB challenge for practice-based research: Strategies of the American Academy of Family Physicians National Research Network (AAFP NRN). J Am Board Fam Med. 2007;20(2):181-7. doi: 10.3122/jabfm.2007.02.060110
Alterio MG, Alvarado R, Cifuentes E, Garzón F, Ortegon M. Estructura y organización de los comités de ética de la investigación en Colombia (2001-2002). Rev Latinoam Bioet. 2008;8(1):96-115. doi: 10.18359/rlbi.1121
Miranda MC. Comités de ética de investigación en humanos: una experiencia colombiana. Rev Col Bioética. 2006;1(1):141-8. Disponible en: http://www.bioeticaunbosque.edu.co/publicaciones/Revista/Revista1/Articulo_Miranda.pdf
Miranda MC, Palma G, Jaramillo E. Comités de ética de investigación en humanos: el desafío de su fortalecimiento en Colombia. Biomédica. 2006;26(1):138-44. doi: 10.7705/biomedica.v26i1.1402
Green LA, Lowery JC, Kowalski CP, Wyszewianski L. Impact of institutional review board practice variation on observational health services research. Health Serv Res. 2006;41(1):214-30. doi: 10.1111/j.1475-6773.2005.00458.x
Taylor HA, Chaisson L, Sugarman J. Enhancing communication among data monitoring committees and institutional review boards. Clin Trials. 2008;5(3):277-82. doi: 10.1177/1740774508091262
Coleman CH, Bouesseau MC. How do we know that research ethics committees are really working? The neglected role of outcomes assessment in research ethics review. BMC Med Ethics. 2008;9:6. doi: 10.1186/1472-6939-9-6
Wagner TH, Bhandari A, Chadwick GL, Nelson DK. The cost of operating institutional review boards (IRBs). Acad Med. 2003;78(6):638-44. Disponible en: https://journals.lww.com/academicmedicine/Fulltext/2003/06000/The_Cost_of_Operating_Institutional_Review_Boards.19.aspx
Wagner TH, Cruz AM, Chadwick GL. Economies of scale in institutional review boards. Med Care. 2004;42(8):817-23. Disponible en: https://www.jstor.org/stable/4640821
Hood MN, Gugerty B, Levine R, Ho VB. Computerized information management for institutional review boards. Comput Inform Nurs. 2005;23(4):190-8; quiz 9-200. Disponible en: https://journals.lww.com/cinjournal/Fulltext/2005/07000/Computerized_Information_Management_for.5.aspx
Blustein J, Regenstein M, Siegel B, Billings J. Notes from the field: Jumpstarting the IRB approval process in multicenter studies. Health Serv Res. 2007;42(4):1773-82. doi: 10.1111/j.1475-6773.2006.00687.x
Alfano SL, Piedrahita LE, Uscinski KT, Palma GI. Strengthening capacity for human research protections: A joint initiative of Yale University, CIDEIM, and UniValle. IRB. 2012;34(5):16-20. Disponible en: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3632282/
He S, Botkin JR, Hurdle JF. An analysis of information technology adoption by IRBs of Large Academic Medical Centers in the United States. J Empir Res Hum Res Ethics. 2015;10(1):31-6. doi: 10.1177/1556264614560146
Rey Lozano E. El representante de la comunidad en los comités de ética en investigación biomédica de instituciones de salud de Bogotá, Colombia. Revista Latinoamericana de Bioética. 2014;14:130-7. doi: 10.18359/rlbi.502
National Council on Ethics in Human Research. Community representation: Broadening the perspective and value base of research ethics boards. NCEHR Commun. 2001;11(1):11-4. Disponible en: http://www.ncehr-cnerh.org/english/code_2/sec01.html
Klitzman R. Institutional review board community members: Who are they, what do they do, and whom do they represent? Acad Med. 2012;87(7):975-81. doi: 10.1097/ACM.0b013e3182578b54
Enfield KB, Truwit JD. The purpose, composition, and function of an institutional review board: Balancing priorities. Respir Care. 2008;53(10):1330-6.
Barchi F, Kasimatis Singleton M, Merz JF. Fostering IRB collaboration for review of international research. Am J Bioeth. 2014;14(5):3-8. doi: 10.1080/15265161.2014.892168
República de Colombia. Ley 23 de 1981. Por la cual se dictan normas en materia de ética médica; 1981.
República de Colombia. Ministerio de Salud. Resolución 8430 de 1993. Por la cual se establecen las normas científicas, técnicas y administrativas para la investigación en salud; 1993.
Sinclair M, O’Toole J, Malawaraarachchi M, Leder K. Comparison of response rates and cost-effectiveness for a community-based survey: Postal, internet and telephone modes with generic or personalised recruitment approaches. BMC Medical Research Methodology. 2012;12(1):1-8. doi: 10.1186/1471-2288-12-132
Silverman H, Sleem H, Moodley K, Kumar N, Naidoo S, Subramanian T, et al. Results of a self-assessment tool to assess the operational characteristics of research ethics committees in low- and middle-income countries. J Med Ethics. 2015;41(4):332-7. doi: 10.1136/medethics-2013-101587
Sleem H, Abdelhai RA, Al-Abdallat I, Al-Naif M, Gabr HM, Kehil ET, et al. Development of an accessible self-assessment tool for research ethics committees in developing countries. J Empir Res Hum Res Ethics. 2010;5(3):85-96; quiz 7-8. doi: 10.1525/jer.2010.5.3.85
Hemminki E. Research ethics committees in the regulation of clinical research: Comparison of Finland to England, Canada, and the United States. Health Res Policy Syst. 2016;14:5. doi: 10.1186/s12961-016-0078-3
Saunders J. Research ethics committees—Time for change? Clin Med (Lond). 2002;2(6):534-8.
Al-Shahi R. Research ethics committees in the UK—The pressure is now on research and development departments. J R Soc Med. 2005;98(10):444-7. doi: 10.1258/jrsm.98.10.444
Kass NE, Hyder AA, Ajuwon A, Appiah-Poku J, Barsdorf N, Elsayed DE, et al. The structure and function of research ethics committees in Africa: A case study. PLoS Med. 2007;4(1):e3. doi: 10.1371/journal.pmed.0040003
Published
How to Cite
Issue
Section
License
Copyright (c) 2018 Persona y Bioética
This work is licensed under a Creative Commons Attribution 4.0 International License.
Authors who publish with this journal agree to the following terms:
This journal and its papers are published with the Creative Commons License Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0). You are free to share copy and redistribute the material in any medium or format if you: give appropriate credit, provide a link to the license, and indicate if changes were made; don’t use our material for commercial purposes; don’t remix, transform, or build upon the material.
