Literature DB >> 28548197

[Differentiated review of biomedical research projects by ethics committees].

María Bernardita Portales1, Patricio Michaud2, Sofía P Salas3, Juan Pablo Beca1.   

Abstract

Ten years after the approval of the Chilean bill that regulates scientific research in humans (Law Nº 20.120), and considering the current status of accreditation and training of many Research Ethics Committee (REC), it is necessary to analyze their performance. We analyzed the Chilean experience with REC aiming to propose a differential type of review, considering the risks to research participants. To improve the quality of the review and the efficiency of these committees, we propose to differentiate the revisions depending on the type of project, its methods and its risks. Initially, the types of review should be classified as exempt from review, expedited review and full review by the committee. In this proposal the type of review is confirmed or can be modified by a designated member of the committee after an initial review of the project. Thus, the deliberation and review times of the committee could be optimized avoiding delays in their revision.

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Year:  2017        PMID: 28548197      PMCID: PMC8083817          DOI: 10.4067/S0034-98872017000300014

Source DB:  PubMed          Journal:  Rev Med Chil        ISSN: 0034-9887            Impact factor:   0.553


  4 in total

1.  What makes clinical research ethical?

Authors:  E J Emanuel; D Wendler; C Grady
Journal:  JAMA       Date:  2000 May 24-31       Impact factor: 56.272

2.  Reform of Clinical Research Regulations, Finally.

Authors:  Ezekiel J Emanuel
Journal:  N Engl J Med       Date:  2015-11-04       Impact factor: 91.245

3.  Ethics and clinical research.

Authors:  H K Beecher
Journal:  N Engl J Med       Date:  1966-06-16       Impact factor: 91.245

4.  World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects.

Authors: 
Journal:  JAMA       Date:  2013-11-27       Impact factor: 56.272

  4 in total

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