Are you looking into biomedical research in Costa Rica? Research in biomedicine turns out to be an inevitable and essential activity for the human race. Years, centuries, and even millennia of analysis, observation and gathering of information on human “cellular repair” prove this statement, modernizing clinical processes more and more to give human beings greater hope in terms of quality and quantity of life.

It is for this reason that it is important to unify, in this article, such medical development with another great invention: the law, specifically the regulation of biomedical research in the country, and what are the requirements that every scientist in this field must comply to carry out any investigation in the country.

Firstly, as a fundamental basis that supports medical intellectual development in Costa Rica, Article 21 of the Political Constitution of Costa Rica protects the right to life (also interpreted by the Constitutional Chamber as the right to health) with the concept “Human life is inviolable.”

Universal Declaration of Human Rights

There are also international instruments that Costa Rica has signed that not only authorize but also promote this scientific activity, such as the Universal Declaration of Human Rights, International Ethical Guidelines for Biomedical Research in Human Beings, and especially the Universal Declaration on the Human Genome and Human Rights in its article 12 that deals with:

Every person must have access to the progress of biology, genetics and medicine in the field of the human genome, respecting their dignity and rights.

The freedom of investigation, which is necessary for the progress of knowledge, comes from the freedom of thought. The applications of research on the human genome, particularly in the field of biology, genetics and medicine, must be aimed at alleviating suffering and improving the health of the individual and all humanity.”

However, all these rules, as mentioned, are programmatic and only establish the basis of the regulation of each signatory State. But what is the legislation in Costa Rica regarding biomedical research?

Biomedical Research Costa Rica

In the legal rank, the most specific regulation is the “Biomedical Research Regulatory Law”, which aims to “regulate biomedical research with human beings in health matters, in the public and private sectors.”

One of the most notable aspects of this law is the creation of the National Council for Health Research (CONIS by its Spanish initials), which has a wide range of authorization, supervision and control powers over all biomedical research that sets foot in the country.

This includes routine inspections to legal actions for breach of the law, all at any stage, whether observational, experimental, up to clinical tests, including, if applicable, the commercialization of therapeutic products originating from the investigation.

Ensuring Ethical Standards

Biomedical research plays a crucial role in advancing medical knowledge and improving human health. In order to ensure that such research is conducted in a responsible and ethical manner, it is necessary to have compliance regulations in place.

In Costa Rica, these regulations aim to protect the rights and welfare of research participants and to ensure that the results of the research are reliable and valid.

One of the key aspects of compliance in biomedical research in Costa Rica is obtaining informed consent from research participants. This involves providing individuals with information about the study, including its purpose, procedures, and potential risks and benefits, and obtaining their agreement to participate.

Researchers must also adhere to strict rules regarding confidentiality and data protection, as well as ethical standards for the use of human subjects and animals in research.

Key Regulatory Bodies Overseeing Biomedical Research in Costa Rica

Another important aspect of compliance is ensuring that research projects are approved by the relevant ethics committees and regulatory bodies. This helps to ensure that research proposals are thoroughly reviewed and evaluated before they are approved and that the study is conducted in accordance with the highest ethical standards.

Compliance with ethical and regulatory standards is essential for the credibility and reputation of biomedical research. By following these guidelines, researchers in Costa Rica can ensure that their work is conducted in a responsible and ethical manner and that the results they obtain are trustworthy and useful to the scientific community and to society as a whole.

Scientific Ethics Committees

Another core aspect of this law is the creation of the Scientific Ethics Committees (CECs), which are ad hoc committees (meaning that they exist for a specific purpose)

that will supervise the investigations of private entities and their actions for them to be in line with Costa Rican regulations.

Regarding the obligations of the researcher set forth by the law, the most important are:

● Strictly respect life, health and human dignity and meet the requirements and criteria of scientific rigour, as well as the ethical norms that regulate the matter and the requirements established in this law.

● Have academic background, training, and experience to assume responsibility for the proper conduct of biomedical research.

● Submit the research protocol to the duly accredited CEC and, before starting any activity related to the research, have the respective approval.

● Comply with the provisions of the research protocol approved by the CEC.

● Guarantee the obtaining of informed consent in a correct and timely manner by the participant or their legal representative, when the corresponding CEC has not exempted them from said requirement.

● Inform the CEC, within a maximum period of twenty-four hours, of all serious adverse events or unexpected problems that occur in biomedical research under their responsibility.

● Keep in a file all the documentation of each investigation, for a period of fifteen years after the conclusion of the investigation.

Clarify that informed consent

It is necessary to clarify that informed consent is required as long as patients or human beings are needed to carry out the test of the research product.

It is necessary that researchers fully review their informed consent documents since failure to comply with any of these requirements can result in major civil, administrative and even criminal consequences, depending on the situation, it could be seen in a trial where it is discussed the violation of the fundamental right to life or health of any patient participating in the research.

Biomedical Research in Costa Rica

Depending on the type of research, the application of one or the other standard varies concerning the nature of the analyses and studies to be carried out.

For example, there are regulations added to research with stem cells, or, if it is the case that it is necessary to export, import and manipulate human or animal organic tissue, compliance with the Human Organ and Tissue Donation and Transplant Law must be monitored as well as the Regulation for the Registration, Classification, Importation and Control of Biomedical Equipment and Material.

In conclusion, Costa Rica has a relatively appropriate regulatory framework to carry out research in the field of medicine in any of the phases in which they are. However, it is far from having a clear regulation, with legal concepts correctly delimited and condensed as those of other countries. Therefore, it is always necessary to consult with a lawyer with knowledge and experience in the field.

Author: Jaime Rivera A.