Literature DB >> 32105428

[List of Ethical Principles for Medical Research Involving Human Subjects].

Marcela Perez-Rodriguez1, Ricardo Berea-Baltierra, Ivonne Analí Roy-García, Lino Palacios-Cruz, Rodolfo Rivas-Ruiz.   

Abstract

The ethical principles of a research proposal are not contained only in a paragraph or in the informed consent form; actually, they are an essential part of the whole protocol from the beginning to the end. In a complementary manner to the regulatory and educative documents, our objective in this article is to propose a checklist of questions so researches can ensure they have included the necessary information and precautions to meet the ethical considerations that are required for every research with human beings, which shall be called List of Ethical Principles for Medical Research Involving Human Subjects. We propose questions that researchers must ask themselves when they compose the background, justification, objectives, research question, hypothesis, selection criteria, sample size calculation, sampling, research design, statistical analysis plan, ethical aspects, publication plan, and references.

Entities:  

Keywords:  Informed consent; Research ethics; Research protocol

Mesh:

Year:  2019        PMID: 32105428      PMCID: PMC8054480          DOI: 10.29262/ram.v66i4.706

Source DB:  PubMed          Journal:  Rev Alerg Mex        ISSN: 0002-5151


  9 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.  To Enroll or Not to Enroll?: A Researcher Struggles with the Decision to Involve Study Participants in a Clinical Trial That Could Save Their Lives.

Authors:  Roberto Abadie
Journal:  Narrat Inq Bioeth       Date:  2017

3.  Equipoise and the ethics of clinical research.

Authors:  B Freedman
Journal:  N Engl J Med       Date:  1987-07-16       Impact factor: 91.245

4.  [The research protocol VI: How to choose the appropriate statistical test. Inferential statistics].

Authors:  Eric Flores-Ruiz; María Guadalupe Miranda-Novales; Miguel Ángel Villasís-Keever
Journal:  Rev Alerg Mex       Date:  2017 Jul-Sep

5.  [The research protocol III. Study population].

Authors:  Jesús Arias-Gómez; Miguel Ángel Villasís-Keever; María Guadalupe Miranda-Novales
Journal:  Rev Alerg Mex       Date:  2016 Apr-Jun

6.  Research protocol VIII. The ethics of research on human subjects.

Authors:  María Guadalupe Miranda-Novales; Miguel Ángel Villasís-Keever
Journal:  Rev Alerg Mex       Date:  2019 Jan-Mar

Review 7.  De vuelta a la clínica: sin justificación no existe pregunta de investigación que valga.

Authors:  Juan O Talavera; Rodolfo Rivas-Ruiz; Marcela Pérez-Rodríguez; Ivonne Analí Roy-Garcia; Lino Palacios-Cruz
Journal:  Gac Med Mex       Date:  2019       Impact factor: 0.302

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

Authors: 
Journal:  J Am Coll Dent       Date:  2014

9.  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

  9 in total

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