Research Article | OPEN ACCESS DOI: 10.23937/2469-5793/1510104

How to Establish a Medical Ethics or Bioethics Committee?

Angel Velarde, MD, MSCE1,2* and Erwin Calgua, MD, MSCE3,4

1School of Medicine, University of San Carlos de Guatemala, Guatemala

2Director of Research, Hospital of Oncology in Guatemala, Guatemala

3General Directorate of Research, University of San Carlos de Guatemala, Guatemala

4Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, USA

Summary

Background

As humanity increases in quantity and science advances, every day the need arises to understand the principles that govern human behavior; therefore, our objective is to establish a frame of reference about how a Medical Ethics or Bioethics Committee is established.

Methodology

A review of the literature was carried out in MEDLINE, LILACS, COCHRANE, on ethics, bioethics, bioethics committees, and administrative functioning of the ethics committees.

Results

From the review of the literature, it was found that the ethics committees must be composed of at least 5 members, who are nominated by the director of the institution, with at least one member in the scientific area, a member in an area not scientific and a member not affiliated with the institution and each member must conduct ethics courses. The duration of the period will be for 3 years, and continuity may be given when so determined. Of the conflicts of interest, it was found that the last update of the year 2011 establishes $ 5,000 or 5% as a baseline to assess conflict of interest.

Conclusion

It is recommended to carry out a descriptive study on the form and structure of operation of ethics committees, and to run a descriptive study of what physicians know about it.

Keywords

Bioethics, Ethics, Guatemala, History, Committee

Introduction

As humanity increases in quantity and science advances, every day the need arises to understand the principles that govern human behavior at the time of conducting studies where the human is subjected to procedures to obtain information that will serve to advance knowledge in the field of medical application, being bioethics responsible for governing behavior in this context. Bioethics considered as science has little time to be conceived as such; one of his predecessors is the Dutch oncologist Rensselaer Van Potter who is credited with the first use of the word bioethics. In his work Bioethics: Bridge to the future published in 1971, he establishes the way in which he visualized a close relationship between the world of science that we know today about life, its facts and the ethical values, both in human life and in its environment. ecological and environment: Potter conceived this concept as "Global Bioethics" [1].

The concept of bioethics joins efforts that other authors have made to establish their relationship with medicine and society, the environment, life in situations of illness and public health [2-10].

The definition of bioethics is re-structured in the year of 1978 when it was published in the first journal of bioethics, and comes to be defined as the systematic study of human behavior in the context of medical sciences to analyze the moral principles that govern the human task when carrying out research and applying bioethical evaluation to any research project that includes the participation of human beings [11,12].

In its original conception, bioethics was conceived to be a bridge between science and humanity, involving the global connotation of multiple meanings [1,11,13], that led me to establish a level of minimum standards in which different traditions and cultures agree; At another, more complete level, efforts are being made to articulate more specific standards of bioethics in the context of religion and cultural traditions, to change the meaning and evolution of life itself [14].

UNESCO created a bioethics program in 1993 to promote and define standards that states could use in the development of their own bioethics policies, achieving in 1997 that the general conference of UNESCO adopts the universal declaration of human rights and the genome [15-17].

In Guatemala, in 2009, through the Ministry of Public Health and Social Assistance (MSPAS) and the Pan American Health Organization (PAHO), the ministerial agreement was made public that formalizes the creation and functioning of the National Committee of Ethics in Health [18], and access is obtained so that by means of subscription education in ethics is provided [19].

Methodology

A review of the literature was carried out in MEDLINE, LILACS, COCHRANE, on ethics, bioethics, bioethics committees, and administrative functioning of the ethics committees.

Ethics or bioethics?

Ethics

The field of ethics studies the principles of right and wrong [20,21] in the field of medicine refers to the ethics between the doctor-patient relationship, including all general responsibilities towards the patient [22]. Medical ethics includes four principles: Respect for autonomy, beneficence, non-maleficence, and justice [23].

Bioethics

It is the systematic, pluralistic and interdisciplinary study and the resolution of the ethical questions posed by the sciences of medicine, life and society, as applied to human beings and their relationship with the biosphere, including questions related to the Availability and accessibility of scientific and technological development and its application [24].

Investigation

Any systematic research designed to develop or contribute to the generalization of knowledge [25].

How to establish an Institutional Review Board of medical ethics or ethics/bioethics committee?

The board must be composed of at least five members, who must have knowledge in scientific and non-scientific areas, and must include at least one member with a scientific area, a member with a non-scientific area, a member who is not affiliated to the institution; being able to invite in additional situations individuals with domain in specific areas, as long as there is no conflict of interests; [25] Each member must complete ethics courses every three years [19].

Conflict of Interest

Different institutions have adopted the amount of 5% ownership in any company, [26] and in 2011 the amount of $ 5,000 dollars for providing services in non-public entities was established as the final standard as the baseline to establish a conflict of interest. Establishing 60 days to notify new conflicts of interest when appropriate [27].

How long does it take to review the request for approval by the medical ethics or bioethics committee?

The average time of approval of simple protocols in 2008 was 18-24 days, and for complex protocols it was 63 days, [28] and it is considered a prolonged time when it exceeds three months [29].

How long the period of functions of each member of the committee lasts

The duration will be three years and may be reappointed by the director of the institution when appropriate [30].

Results

From the review of the literature, it was found that the ethics committees must be composed of at least 5 members, who are nominated by the director of the institution; Each member must take ethics courses. The duration of the period will be for 3 years, and continuity may be given when so determined.

Conclusions

It is recommended to carry out a descriptive study on the form and structure of operation of ethics committees, and to run a descriptive study of what physicians know about it.

Conflicts of Interest

None to declare.

Sponsorship

None.

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Citation

Velarde A, Calgua E (2019) How to Establish a Medical Ethics or Bioethics Committee?. J Fam Med Dis Prev 5:104. doi.org/10.23937/2469-5793/1510104