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Open Access Highly Accessed Debate

Violation of ethical principles in clinical research. Influences and possible solutions for Latin America

Borys Alberto Cornejo Moreno1* and Gress Marissell Gómez Arteaga2

Author affiliations

1 Research Coordinator Medical Associate, Planning and Institutional Liaison Coordination, Healthcare Services Management, The Mexican Institute of Social Security, Hidalgo Delegation, Delegación Hidalgo, Boulevard Luis Donaldo Colosio n° 516, Pachuca de Soto, Hidalgo, CP 42070, Mexico

2 Planning and Institutional Liaison Coordinator, Healthcare Services Management, The Mexican Institute of Social Security, Hidalgo Delegation, Boulevard Luis Donaldo Colosio n° 516, Canutillo, Pachuca de Soto, Hidalgo, CP 42070, Mexico

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Citation and License

BMC Medical Ethics 2012, 13:35  doi:10.1186/1472-6939-13-35

Published: 16 December 2012

Abstract

Background

Even though we are now well into the 21st century and notwithstanding all the abuse to individuals involved in clinical studies that has been documented throughout History, fundamental ethical principles continue to be violated in one way or another.

Discussion

Here are some of the main factors that contribute to the abuse of subjects participating in clinical trials: paternalism, improper use of informed consent, lack of strict ethical supervision, pressure exerted by health institutions to increase the production of scientific material, and the absence of legislation regarding ethics in terms of health care and research. Are researchers ready to respect fundamental ethical principles in light of the ample window of information provided by individual genomes, while defending the rights of the subjects participating in clinical studies as a major priority?

Summary

As one of the possible solutions to this problem, education regarding fundamental ethical principles is suggested for participants in research studies as an initial method of cognitive training in ethics, together with the promotion of ethical behavior in order to encourage the adoption of reasonable policies in the field of values, attitudes and behavior.

Keywords:
Informed consent; Autonomy; Genomics; Ethical; Justice; Nonmaleficence; Beneficence