Research Ethics


Photo: Ibrahim Abed | Translated by Claudia Gómez | Last updated: 26/01/2022

 

Policies on conflicts of interest, research with human and animal subjects, and informed consent

International guidelines

Argentine legislation

Recommendations and reports

 

 


Policies on conflicts of interest, research with human and animal subjects, and informed consent

 

Conflict of Interest

 

According to the International Committee of Medical Journal Editors (ICMJE) in its recommendations on the  Disclosure of Financial and Non-Financial Relationships and Activities, and Conflicts of Interest, the credibility of published articles depends, to a large extent, on the transparency with which the relationships and practices of authors and editors, directly or topically related to the work, are managed. These practices include study design, data collection and writing of the research, as well as peer review, editing and publication of scientific work.

According to the ICMJE definition, possible conflict of interest and bias exists when professional judgment about a primary interest may be influenced by a secondary interest (for example, financial benefit). As the perception of conflicts of interest is as important as actual conflicts, any existing or potential conflict of interest, any commitment to the funding sources, or any type of relationship or rivalry that could be understood as a conflict of interest should be clearly expressed. The absence of conflict of interest must also be manifested. If authors and/or editors consider it relevant, this information will be published in the corresponding section of the article.

In order to encourage authors to declare any relationship that could be understood as a conflict of interest, they are asked to submit along with their article the "Declaration of Ethical Aspects and Conflicts of Interest," in which  they must declare the existence of "any commitment of those who are named as authors, including the sources of funding or any other type of relationship that could be understood as a conflict of interest."

However, cases of “undeclared” conflicts of interest may be identified by the editorial team or by external reviewers. In such cases, the journal will follow guidelines proposed by the Committee on Publication Ethics (COPE) regarding "What to do if a reviewer suspects undisclosed conflict of interest (Col) in a submitted manuscript" or "What to do if a reader suspects undisclosed conflict of interest (Col) in a published article."

Research involving human subjects and informed consent

 

Articles submitted to Salud Colectiva must follow ethical principles expressed in the WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects adopted by the 64th General Assembly of 2013 of the World Medical Association (WMA), recommendations on Protection of Research Participants of the International Committee of Medical Journal Editors (ICMJE), the International Ethical Guidelines for Epidemiological Studies of the Council for International Organizations of Medical Sciences (CIOMS) and specific legislation – if any – of the country in which the research was carried out.

In alignment with these international guidelines on the protection of human beings, there should be a paragraph in the Methodology section specifying the informed consent obtained from research participants and the approval of the research protocol by an Ethics Committee.

Considering the multidisciplinary and multisectorial nature of the research submitted to Salud Colectiva, we hold to the principle that the "interpretation and application of the ethical principles should not be rigid or dogmatic, but must be the result of a consensus among the different agents of the research with their respective approaches" (see Decree No. 1480/2011).

Salud Colectiva adopts the guidelines expressed in Section "A3. Informed consent" in Decree No. 1480/2011 of the Argentine Ministry of Health, in relation to exceptions to the application of informed consent.

In order to ensure that authors explicitly comply with ethical principles, in the case of  research involving humans (including ethnographic work with in-depth interviews, or any type of research involving human participants), the journal requests authors to submit in addition to their article a "Declaration of Ethical Aspects and Conflicts of Interest." In the document,  they must state whether the article provides a clear explanation regarding the informed consent obtained from those involved in the research and the approval of the research project by an Ethics Committee.

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International guidelines

 

International Ethical Guidelines for Health-related Research Involving Humans
Council for International Organizations of Medical Sciences (CIOMS), World Health Organization (WHO)
Geneva 2002

International Ethical Guidelines for Biomedical Research Involving Human Subjects
Council for International Organizations of Medical Sciences (CIOMS), World Health Organization (WHO)
Geneva 2002

International Ethical Guidelines for Epidemiological Studies
Council for International Organizations of Medical Sciences (CIOMS), World Health Organization (WHO)
Geneva 1991

International Ethical Guidelines for Epidemiological Studies
Council for International Organizations of Medical Sciences (CIOMS), World Health Organization (WHO)
Last revised: 2009

WMA Declaration of Helinksi - Ethical Principles for Medical Research Involving Human Subjects
World Medical Association (WMA)
Last revised: 59th General Assembly, Seoul, Korea, October 2008

Universal Declaration on Bioethics and Human Rights
United Nations Educational, Scientific and Cultural Organization (UNESCO)
Date of adoption: October 19, 2005

United Nations Declaration on the Rights of Indigenous Peoples
United Nations Educational, Scientific and Cultural Organization (UNESCO)
Date approved: September 13, 2007

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Argentine legislation

 

Decree No. 1480/2011 Guide for Research on Humans
Repeals Decree No. 1490/07 and No. 102/09. 
Ministry of Health
Jurisdiction: National
Date of approval: September 13, 2011

Act No. 26.742 Amends Act No. 26.529 which stated patient´s rights in their relationship with health professionals and institutions
Jurisdiction: National
Date of ratification: May 9, 2012
Date of enactment: May 24, 2012

Act No. 26.529 Patient's Rights in their Relationship with Health Professionals and Institutions
Jurisdiction: National
Date of ratification: October 21, 2009
Date of enactment: November 19, 2009

Act No. 25.467 Science, Technology and Innovation National System
Jurisdiction: National
Date of ratification: August 29, 2001
Date of enactment: September 20, 2001

Act No. 3301 on Protection of Human Rights in Health Research
Jurisdiction: City of Buenos Aires
Date of ratification: November 26, 2009
Date of enactment: January 20, 2010

Act No. 11044 Public Health. Health Research
Jurisdiction: Province of Buenos Aires
Sanction date: December 6, 1990
Promulgation date: December 26, 1990

National Executive Order No. 3385/2008. Medical services. Health Research. Ethical aspects of research on humans. Minors or mentally disabled people. Act No. 11.044 enforcement.
Jurisdiction: Province of Buenos Aires
Date: December 30, 2008

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Recommendations and Reports

 

CONICET: Guidelines for Ethical Behavior in Social Sciences and Humanities
National Council for Scientific and Technological Research (CONICET)
Buenos Aires: December 11, 2006

CONICET: Ethical Principles for the Behavior of Scientific and Technological Researchers
National Council for Scientific and Technological Research (CONICET)
Buenos Aires: March 22, 2006

Referential Ethical Framework for Medical Research in Humans
National Council of Scientific and Technical Research (CONICET)
Buenos Aires: July 1, 2005

Proposals for a socially responsible science and technology
National Committee of Ethics in Science and Technology (CECTE)
Ministry of Science, Technology and Productive Innovation
Buenos Aires: n.d.

Informative text on GT - Research on Social and Human Sciences
National Commission on Ethics in Research (CONEP)
Brazilia: July 3, 2014

CSIC Code of Good Scientific Practice
Scientific Research Council (CSIC)
Madrid: 2011

Argentine Committee on Ethics in Science and Technology (CECTE)
Ministry of Science, Technology and Productive Innovation (MINCYT)

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