Bioethics Committee

The main goal of Bioethics Committee for human subject research is to ensure compliance with existing and current fundamental ethical standards. All this in view of including people of various ages, races, and socioeconomic and cultural conditions in investigations that seek to gain new knowledge or strengthen already existing knowledge related to health and well-being.

These regulations and precepts are part of international consensus and have been published in various sources such as:

• The International Standards for Research

• Resolution 0008430 of 1993 of National Ministry of Health

• The Helsinki Declaration

• The Belmont Report

• The Nuremberg Code

• The Universal Declaration of Human Rights

• The International Code of Medical Ethics in Human Beings

Functions

• Evaluate research protocols, which are suggested by Institute of Medical Research or other centers related to healthcare, with respect to compliance with ethical standards enacted in local and universal current agreements.

• Protect both the personal and the social dignity of each research participant.

• Review aspects related to the validity and value of research protocols in terms of the importance of the subject to be investigated, its relevance, applicability of results, and its novelty.

• Analyze the proposal development in relation to its methodological quality and coherence of its components: research question, hypotheses, objectives, theoretical framework, and statistical methodology. All these components must be addressed to fulfil the objectives.

• Ensure the quality and suitability of each researcher involved in the project.

• Assess the researcher’s participation within the project in order to determine their relevance as co-investigator.

• Balance benefits and risks. The former are expected to be greater than the latter. In addition, the evaluation of short and long term benefits for community and participants is intended.

• Establish standards for the design of informed consents.

• Evaluate documents submitted for consideration by potential participants or research subjects in each investigation.

• Ensure that every human subject research meets the basic requirements of charity, respect for human beings, and equitable justice.

• Ensure that human subject research is replaced by animal research when possible. However, the ethical principles of the research must be respected.

• Ensure that each research is financially supported in order to allow the researcher to compensate any damage when necessary.

• Promote continuing education through talks, articles, forums, seminars, and undergraduate and graduate training.

• Create policies that ensure compliance with the fundamental principles of ethics by the research community.

• Establish guidelines on appropriate research behavior concerning to the participants and the research.

• Evaluate the benefit-risk balance for participants.

• Assess the social impact of research projects.

• Keep correspondence with other ethics committees of the university and other institutions.

Bioethics Committee Responsibilities

• Strictly review of research protocols with regard to:

• Methodological design of the proposal

• Research question

• Working hypothesis

• Objectives

• Data collection methodology

• Statistical methodology

• Evaluation and implementation of results (comments and conclusions)

• Design of informed consent

• Participant recruitment process validity

• Information provided to everyone involved in the research

• Information about payments and compensations

• Researchers’ curriculum and suitability

• Presentation of civil liability insurance

• Evaluation of periodic reports submitted throughout the research