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2019, Number 1

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Rev Med MD 2019; 10.11 (1)

Approval by ethics committee in abstracts presented at the “CIAM XIX”

Colunga-Lozano LE, Davizon-López CA

Language: Spanish
References: 18
Page: 10-14
PDF size: 530.33 Kb.


ABSTRACT

Introduction. Ethic is a fundamental process during research development. Ethics review board (ERB) approval should be reported in the research synthesis (abstract), to guarantee methodological and statistical third parties assessment and participants wellbeing. In Jalisco, the Congreso Internacional Avances en Medicina (CIAM) is the most important academic event related to health sciences. In order to understand the scientific behavior related to the ethics description, we decided to review the research projects published in the “CIAM” manuscript. Our objective was to determine the ERB approval and participants informed consent in the research projects published at the XIX “CIAM”.
Methods. We identified eligible trials published in the “Archivos de Ciencia” XIX CIAM magazine. We included trials if they were identified to perform research in humans. Two review authors independently extracted data (ERB approval and IC) and disagreements were solved by discussion. Results were expressed as percentages.
Results. A total of 679 trials were evaluated, of which 617 (90.9%) were classified as human research. 33 (5.3%) corresponded to basic sciences, 151 (24.5%) clinical research, 236 (38.2%) case reports, 81 (13.1%) epidemiological research, 36 (5.8%) educational research, 24 (3.9%) quality management in health services and 56 (9.1%) in mental health. The EBR was present in 6 abstracts (1%) and the participant's IC was present in 66 abstracts (10.7%).
Discussion. Currently, an international effort is been made to increase the transparency in research development, and medical conferences are not an exception. The presence of ERB approval and participant´s IC might improve the research quality and guarantee the participants wellbeing.
Conclusion: We showed that the ERB approval and participant´s IC were reported in very few occasions. This situation might encourage the conference organizers to use the templates available to report the research projects (equator network).


REFERENCES

  1. World Medical Association. World Medical Association Declaration of Helsinki. JAMA [Internet]. 2013 Nov 27 [cited 2018 May 18]; 310 (20): 2191. Available from: http://www.ncbi.nlm.nih.gov/pubmed/24141714

  2. 2.Ioannidis JP, Caplan AL, Dal-Re R. Outcome reporting bias in clinical trials: why monitoring matters. Bmj. 2017;356:j408.

  3. Ruiz-Canela M, Martínez-González MÁ, Gómez- Gracia E, Fernández-Crehuet J. Informed Consent and Approval by Institutional Review Boards in Published Reports on Clinical Trials. N Engl J Med [ Internet ]. 1999 Apr 8 [ cited 2018 May 16 ]; 340 (14): 1114–5. Available from: http://www.ncbi.nlm.nih.gov/pubmed/10206829

  4. Schroter S, Plowman R, Hutchings A, Gonzalez A. Reporting ethics committee approval and patient consent by study design in five general medical journals. J Med Ethics [Internet]. 2006 Dec 1 [cited 2018 May 16];32(12):718–23. Available from: http://www.ncbi.nlm.nih.gov/pubmed/17145913

  5. Finlay KA, Fernandez C V. Failure to report and provide commentary on research ethics board approval and informed consent in medical journals. J Med Ethics [Internet]. 2008 Oct 1 [cited 2018 May 16]; 34(10): 761–4. Available from: http://www.ncbi.nlm.nih.gov/pubmed/18827111

  6. Yank V, Rennie D. Reporting of informed consent and ethics committee approval in clinical trials. JAMA [Internet]. 2002 Jun 5 [cited 2018 May 16]; 287 (21): 2 8 3 5 – 8 . Available from: http://www.ncbi.nlm.nih.gov/pubmed/12038927

  7. McConnell P, Kaufman N, De Hert S, Samama CM, Molnar Z, Einav S. Research ethics committee approval as reported for abstracts submitted to the annual Euroanaesthesia meeting. Eur J Anaesthesiol [Internet]. 2017 Dec [cited 2018 May 16];34(12): 824–30. Available from: http://insights.ovid.com/crossref ?an=00003643- 201712000-00006

  8. López-de-la-Peña XA. [Informed consent and the approval of evaluation committees in Mexican medical research]. Rev Invest Clin [Internet]. [cited 2018 May 16];47(5):399–404. Available from: http://www.ncbi.nlm.nih.gov/pubmed/8584811

  9. Emanuel EJ, Wendler D, Grady C. What Makes Clinical Research Ethical? JAMA [Internet]. 2000 May 24 [cited 2018 Aug 6];283(20):2701. Available from: http://jama.jamanetwork.com/article.aspx?doi=1 0.1001/jama.283.20.2701

  10. Borracci RA, Calderón G, Seoane MR, Perez AC, Doval HC. Ethical review and informed consent in cardiovascular research reports in Argentina. Arq Bras Cardiol [Internet]. 2008 May [cited 2018 Aug 5]; 90 (5): 290–3. Available from: http://www.ncbi.nlm.nih.gov/pubmed/18516396

  11. Gagnier JJ, Kienle G, Altman DG, Moher D, Sox H, Riley D, et al. The CARE guidelines: consensusbased clinical case report guideline development. J Clin Epidemiol [Internet]. 2014 Jan [cited 2018 Aug 7]; 67 (1): 46–51. Available from: http://www.ncbi.nlm.nih.gov/pubmed/24035173

  12. Kim DT, Spivey WH. A retrospective analysis of institutional review board and informed consent practices in EMS research. Ann Emerg Med [Internet]. 1994 Jan [cited 2018 Aug 7];23(1):70–4. Available f r o m : http://www.ncbi.nlm.nih.gov/pubmed/8273962

  13. Matot I, Pizov R, Sprung CL. Evaluation of Institutional Review Board review and informed consent in publications of human research in critical care medicine. Crit Care Med [Internet]. 1998 Sep [cited 2018 Aug 7];26(9):1596–602. Available from: http://www.ncbi.nlm.nih.gov/pubmed/9751600

  14. Karlawish JH, Hougham GW, Stocking CB, Sachs GA. What is the quality of the reporting of research ethics in publications of nursing home research? J Am Geriatr Soc [Internet]. 1999 Jan [cited 2018 Aug 7]; 47(1): 76–81. Available from: http://www.ncbi.nlm.nih.gov/pubmed/9920233

  15. Roggin KK, Chwals WJ, Tracy TF. Institutional Review Board approval for prospective experimental studies on infants and children. J Pediatr Surg [Internet]. 2001 Jan [cited 2018 Aug 7];36(1):205–8. Available from: http://www.ncbi.nlm.nih.gov/pubmed/11150466

  16. Dingemann J, Dingemann C, Ure B. Failure to Report Ethical Approval and Informed Consent in Paediatric Surgical Publications. Eur J Pediatr Surg [Internet]. 2011 Aug 17 [cited 2018 Aug 5]; 21 (04): 215–9. Available from: http://www.ncbi.nlm.nih.gov/pubmed/21590657

  17. Amdur RJ, Biddle C. Institutional review board approval and publication of human research results. JAMA [Internet]. 1997 Mar 19 [cited 2018 Aug 5]; 277 (11): 909–14. Available from: http://www.ncbi.nlm.nih.gov/pubmed/9062330

  18. Rowan-Legg A, Weijer C, Gao J, Fernandez C. A comparison of journal instructions regarding institutional review board approval and conflict-ofinterest disclosure between 1995 and 2005. J Med Ethics [Internet]. 2009 Jan 1 [cited 2018 Aug 5]; 35 (1): 74– 8. Available from: http://www.ncbi.nlm.nih.gov/pubmed/19103950




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