Literature DB >> 29373777

Commented review of the Colombian legislation regarding the ethics of health research.

Mónica María Lopera1.   

Abstract

The scope of ethics in health research transcends its legal framework and the regulations established in Resolution 8430 of 1993. These norms represent a fundamental tool to determine the minimum protection standards for research subjects, and, therefore, they should be known, applied properly, and reflect upon by all researchers in the field.Here I present and discuss from an analytical point of view the regulations that guide research in health. In this framework, health is understood as a multidimensional process, and research in health as a multidisciplinary exercise involving basic, clinical and public health research, collective health, and other related sciences.The main analytical categories are related to the principles and actors involved in research (regulatory authorities, ethical committees, and special or vulnerable subjects and populations), and to professional ethics codes, in addition to informed consents and data management.Despite the contribution of this legislation to the qualification of health research, my conclusion is that the national legislation in ethics for health research requires updating regarding technological and scientific developments, as well as specifications from the multiple types of health studies.

Entities:  

Keywords:  Research ethics committees; codes of ethics; ethics, clinical; ethics, professional; legislation; principle-based ethics

Mesh:

Year:  2017        PMID: 29373777      PMCID: PMC8100973          DOI: 10.7705/biomedica.v37i4.3333

Source DB:  PubMed          Journal:  Biomedica        ISSN: 0120-4157            Impact factor:   0.935


  4 in total

1.  The interface between assisted reproductive technologies and genetics: technical, social, ethical and legal issues.

Authors:  Sirpa Soini; Dolores Ibarreta; Violetta Anastasiadou; Ségolène Aymé; Suzanne Braga; Martina Cornel; Domenico A Coviello; Gerry Evers-Kiebooms; Joep Geraedts; Luca Gianaroli; Joyce Harper; György Kosztolanyi; Kersti Lundin; Emilio Rodrigues-Cerezo; Karen Sermon; Jorge Sequeiros; Lisbeth Tranebjaerg; Helena Kääriäinen
Journal:  Eur J Hum Genet       Date:  2006-05       Impact factor: 4.246

Review 2.  The social and ethical issues of post-genomic human biobanks.

Authors:  Anne Cambon-Thomsen
Journal:  Nat Rev Genet       Date:  2004-11       Impact factor: 53.242

3.  Council of Europe adopts additional protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine, on the prohibition of cloning human beings.

Authors: 
Journal:  Int Dig Health Legis       Date:  1998

4.  The Belmont Report. Ethical principles and guidelines for the protection of human subjects of research.

Authors: 
Journal:  J Am Coll Dent       Date:  2014
  4 in total
  2 in total

1.  Implementing a Redcap-based research data collection system for mental health.

Authors:  Arturo Marroquin Rivera; Juan Camilo Rosas-Romero; Sergio Mario Castro; Fernando Suárez-Obando; Jeny Aguilera-Cruz; Sophia Marie Bartels; Sena Park; William Chandler Torrey; Carlos Gómez-Restrepo
Journal:  Rev Colomb Psiquiatr (Engl Ed)       Date:  2021-07-10

2.  Does Resolution 8430 of 1993 respond to the current needs of ethics in health research with human beings in Colombia?

Authors:  Julio Cesar Mateus; María Teresa Varela; Diana María Caicedo; Nhora Lucía Arias; Cruz Deisy Jaramillo; Liliana Cristina Morales; Gloria Inés Palma
Journal:  Biomedica       Date:  2019-09-01       Impact factor: 0.935

  2 in total

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