Methodological note 1. Ethics committee: when, how and, why? Content in Spanish.

2023-05-28

Ethics committee: when, how and, why? Content in Spanish.

Fanny Petermann-Rochaa, Alberto Pérez-Lópezb,*

a Centro de Investigación Biomédica, Facultad de Medicina, Universidad Diego Portales, Santiago, Chile. b Departamento de Ciencias Biomédicas, Facultad de Medicina y Ciencias de la Salud, Universidad de Alcalá, España

* alberto_perez-lopez@hotmail.com

From a bio-psycho-social perspective, research involving humans and animals is understood as any activity that entails the systematic collection or analysis of data with the intention of generating new knowledge. In this context, research ethics committees, or bioethics committees, are responsible for evaluating the ethical, methodological, and legal rigor of research designs and protocols—whether in vivo, in vitro, or ex vivo—conducted on humans, animal models, or cellular models. This evaluation must be carried out before any project is undertaken.

It is important to highlight that, concerning research specifically involving humans, international standards emphasize two key areas:

  1. Research: Any activity that involves the systematic collection or analysis of data with the primary aim of developing or contributing to generalizable knowledge.
  2. Human subjects: Individuals who (i) become personally identifiable through the collection, preparation, or use of biological or medical material or other records by the researcher; or (ii) are exposed to intervention, observation, or other interactions with researchers.

From a historical perspective, the evaluation of research ethics began to gain prominence during the Nuremberg Trials at the end of World War II, particularly in the International Military Tribunal, as a consequence of the acts committed by Nazi doctors between the 1930s and 1940s. These doctors conducted experiments that pushed the limits of human survival. As a result of this process, the Nuremberg Code1 was developed, outlining ten key principles to ensure respect for individuals participating in research. Among these principles, the most notable are voluntary informed consent, minimal harm, a greater benefit than risk, and the participant’s ability to withdraw at any time.

Subsequently, in June 1964, the first declaration of ethical principles for medical research involving human subjects was incorporated during the 18th World Medical Association meeting in Helsinki, Finland. In this assembly, the main ethical principles required in human research were established to promote and ensure the protection of participants' health and rights (more information can be found at the following link).

Other significant events include the Belmont Report (1974), which was the first to formally establish three fundamental ethical principles: beneficence, respect, and justice.

These and other milestones have ensured that, today, research must comply with a set of minimum ethical guidelines. These guidelines ensure that participants fully understand all relevant information about the research study and, once this is achieved, make the decision to participate freely, without coercion, undue influence, manipulation, or intimidation.

The widespread use of digital platforms has led to an increase in remote research conducted via the internet (e.g., web-based surveys). In this context, an essential question arises: Should these studies require ethical approval?

While open-ended questions in public online environments may not require informed consent, research conducted in private online settings—where written, oral, or visual data is collected—must obtain approval from an ethics committee. Additionally, informed consent must be included at the beginning of the survey, clearly stating that all collected data will remain anonymous and confidential. Sensitive information, such as exact addresses, should be avoided.

Whether conducted online or in person, a research protocol must include the following elements for evaluation by an ethics committee:

  1. Background and justification for the research proposal.
  2. Objectives and expected outcomes of the study, with a brief statement on its relevance.
  3. Methodology, procedures, analysis plan, sampling strategy, and sample size calculations.
  4. Study limitations and an assessment of risks versus benefits for participants and communities involved.
  5. Budget and timeline.
  6. References.
  7. Informed consent documentation.
  8. Data collection instruments (e.g., surveys, sample collection methods, etc.).

Ethics and bioethics committees ensure compliance with universal and fundamental ethical principles regulating research involving human subjects. These principles uphold respect for persons, beneficence, and justice.

For further information on specific situations, it is recommended to consult the international guidelines of the Council for International Organizations of Medical Sciences (CIOMS).

References: 

PAHO. PAHO Ethics Review Committee (PAHOERC). Retrieved from https://www.paho.org/en/paho-ethics-review-committee-pahoerc

Shuster, E. (1997). Fifty Years Later: The Significance of the Nuremberg Code. New England Journal of Medicine, 337(20), 1436-1440. doi:10.1056/nejm199711133372006

WHO. Promoting compliance, risk management and ethics. Retrieved from https://www.who.int/about/ethics

WMA. (2022). WMA DECLARATION OF HELSINKI – ETHICAL PRINCIPLES FOR MEDICAL RESEARCH INVOLVING HUMAN SUBJECTS. Retrieved from https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/