A biomedical research study is an activity designed to develop or support knowledge about health in human beings. This type of research involves the participation of volunteers. There are two main types of biomedical research: clinical research (also known as experimental or interventional) and observational research (also known as epidemiological or non-interventional research).

Clinical Research
During clinical trials, subjects receive specific preventive, diagnostic or therapeutic interventions based on a research protocol. These interventions may include drugs, vaccines, medical devices, clinical procedures or behavioral changes, for example, diet modifications. Research is most common for new interventions that are currently in development, which when studied there is uncertainty if they will produce benefits, damages or any differences regarding currently used therapies. Researchers determine the safety and efficacy of these interventions by analyzing the results obtained by the subjects. For example, when administering a new drug to patients with high blood pressure, the researcher can evaluate if the pressure decreases or not. Clinical research must be conducted before these new interventions are made available to the general public.

Observational research
Unlike clinical research, observational research subjects do not receive any interventions from the investigator and they are not subjected to controlled conditions. The investigator obtains the results by observing a group of subjects. For example, the investigator observes a group of adults in order to analyze the effects of physical activity on their health.

Biomedical research is vital in the development of new methods for the prevention, detection, diagnosis and treatment of diseases that affect human beings. Research allows us to determine if new products and procedures are safe and effective and if they provide any additional benefits when compared to currently available interventions. By participating in a biomedical study, the person is contributing to the gathering of valuable information about their disease and its treatment.

Biomedical research must be conducted by a principal investigator who is generally a specialist in the area being studied. The principal investigator employs a research team that may be made up by other physicians, nurses, pharmacists, microbiologists, social workers and other healthcare professionals, they may also use administrative support staff.

Biomedical research is generally sponsored, meaning that an organization or person provides the necessary economic resources to conduct it. Sponsors may be public or private entities such as pharmaceutical companies, medical device development companies, universities, governments, medical centers, the investigator, among others.

Places where the research is conducted include hospitals, universities, medical offices, healthcare centers, among others.

Biomedical research is conducted according to the instructions of a research plan, which is known as the protocol. The protocol is a document that describes the following information:

• The justification or importance of conducting the research.
• Objectives or questions that the research wishes to respond to.
• Characteristics and conditions that must be met for subjects to participate.
• The number of subjects needed for the investigation.
• Description of the necessary methods, procedures and materials.
• Description of the intervention, if any, and the information that will be gathered from subjects.
• Methods for protecting the health and wellbeing of the subjects.
• All information relevant for conducting the research according to the applicable local laws.

For research to be conducted in Costa Rica, the trial must first be approved by an Institutional Review Board (Comité Ético Científico) which is duly accredited by the National Healthcare Research Council [Consejo Nacional de Investigación en Salud (CONIS)] from the Ministry of Health.

There are several mechanisms by which the welfare, safety and health of the subjects who volunteer for biomedical research is protected in the country.

Informed consent
Participation in research is strictly voluntary. For every study in which the subject decides to enroll, an informed consent process should be performed. During this process, the investigator together with the subject reads and explains an informed consent document. This document must provide all the necessary trial information in order for the subject to make a decision. It must also be redacted in an adequate language so it can be comprehended. When this process is finished, it is signed by both parties and a witness, this will serve as proof that the subject wishes to participate voluntarily. The subject may withdraw from the trial at any time he/she wishes, even if he/she has signed the informed consent document.

Institutional Review Board(Comité Ético Científico) Approval
In order to conduct a trial which needs the participation of human beings, it must be previously approved by an Institutional Review Board (Comité Ético Científico) which is duly accredited by the National Healthcare Research Council [Consejo Nacional de Investigación en Salud (CONIS)] from the Ministry of Health. The purpose of these committees is to protect the rights, safety, freedom, dignity and wellbeing of subjects participating in clinical trials. They are also in charge of ensuring that trials meet the necessary scientific requirements and criteria, as well as all ethical rules that must be met, such as the informed consent, suitability and experience of researchers and the requirements of national laws. Institutional Review Boards are made up by several professionals in healthcare, social sciences, legal and research fields and community representatives.

Regulating laws and international regulations
All biomedical research conducted in Costa Rica must meet the requirements in Law N° 9234, specifically, the Biomedical Research Regulating Law (Ley Reguladora de investigación biomédica), which was published in the Official Newspaper on April 25th, 2014, and the Bylaws of the Biomedical Research Regulating Law (Reglamento de la Ley Reguladora de investigación biomédica), published on July 17th, 2015. Aside from complying with national regulations, research must abide by international regulations established for these activities. Complying with these regulations ensures that research respects the rights and wellbeing of subjects, as well as the scientific quality of the research.

As with all medical interventions, there are risks related to participation in clinical trials. When risks are evaluated, it is important to focus on two aspects: the severity of the damage that may result from participation in this trial and the probability of any damages. Most of the risks related to clinical trials are mild and transient, however, there are occasions when subjects may suffer complications requiring medical attention. The specific risks associated to the research and the intervention are described in detail by the informed consent document which must be read and accepted by the subject before participating in any research activities. Additionally, the risks are explained to the subject by the researcher or any member of the research team, members of the research team must also answer any and all questions regarding the trial.

Through participation in biomedical research activities, you may receive the following benefits:

• Gain access to new clinical therapies or procedures that are not yet available to the general public.
• Gain access to medical services from expert staff at a specialized facility.
• Free treatment and care.
• The opportunity to help society through medical knowledge contributions and improvement of treatments for future patients.

Before agreeing to participate in a biomedical research activity, the person must inform himself/herself in the best way possible regarding the trial and must feel confident enough to clarify all doubts with the researcher and his/her team. The following list shows some of the aspects that the interested party may consider discussing in order to make an informed decision. It should be noted that most answers will be available in the informed consent document.

• What is the purpose of the trial?
• Why do investigators think that this treatment may be effective and beneficial for my health condition?
• Which treatments, tests and procedures will I be submitted to?
• Which are the risks and possible side effects that I may experience due to my participation?
• How can my participation affect my daily life?
• Who will be in charge of my treatment, how do I get in touch in case of emergency?
• Will my participation cost me anything?
• How will I know if the treatment is working, will I receive the final results of the trial?
• Is this research approved by a CONIS-approved Institutional Review Board?

Subjects in biomedical research are entitled to:

• To have the informed consent document shown and explained to them.
• To have all doubts regarding the trial explained.
• Denying to participate in the research.
• Withdraw from the research at any time without any explanation.
• Receive updated information regarding the trial.
• To maintain their identity, personal and health information confidential.
• Enjoy the benefits obtained by the research.
• Healthcare services.
• Compensation for damages.
• Be covered by a policy which protects them from damages produced by the research.
• The rights of the subjects are:
  • Comply with the indications and instructions.
  • Notify the investigators about discomforts, side effects and health changes in a timely manner.
  • Notify the treating physician regarding their participation in clinical trial.
  • If the subject needs independent medical attention, he/she must report any treatments being received to the investigator.
  • Provide truthful and timely information regarding prior diseases and preexisting medical conditions.

The Active Trials section shows a listing of all trials that ICIMED is currently conducting. If you are interested in taking part in a biomedical research trial, you may contact ICIMED staff at 2296-0100 or at informacion@icimed.cr.

The staff may ask you some basic questions regarding your health in order to determine which trial is more appropriate for you and if your condition complies with some of the main requirements established in the trial you are interested in. You may request an appointment with the physicians in charge in order to explain all details regarding the trial.