Medical research involving human participants always requires special attention to ethical aspects. International organizations have developed a range of standards and recommendations that regulate such research, ensuring proper protection of participants' rights and scientific integrity. In this article, we will review the main international documents defining ethical principles in medical research.
Ethical standards for medical research involving human participants are based on a series of international documents that have formulated modern principles for protecting participants' rights. These documents are used by research institutions, ethics committees, and regulatory bodies worldwide to ensure proper practices and integrity in research.
Declaration of Helsinki
The Declaration of Helsinki is one of the main ethical standards for conducting medical research involving human participants. It was adopted in 1964 and has been revised several times since, with the latest edition being approved in 2024. The Declaration establishes the fundamental principles for research aimed at evaluating new treatment or prevention methods, as well as safeguarding the rights and well-being of participants. The World Medical Association (WMA) oversees the adherence to its key principles, which include the following:
- Prioritising the well-being of the participant. The core principle is that the well-being of the individual should always take precedence over scientific or societal interests.
- Informed consent. Participants must be clearly informed about the nature of the research, potential risks, and their rights.
- Professional qualification of researchers. Those conducting the research must have the appropriate qualifications and experience.
- Transparency and accountability. Researchers must ensure the transparency of their work and be prepared for their activities to be scrutinised.
This document serves as the foundation for many ethical standards used in different countries and is a crucial element in the development of national laws and regulations for research involving human participants.
Belmont Report
Belmont Report was published in 1979 and is an important document for understanding the basic ethical principles in medical research in the United States. It also has international significance with compliance overseen by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (USA). The main principles include:
- Respect for persons. Researchers must ensure the autonomy of participants, respecting their rights to make independent decisions.
- Beneficence. Maximising benefits for participants and minimising any potential risks.
- Justice. Equal and fair access to the research and distribution of risks and benefits.
The Belmont Report has become the foundation for national ethical standards and influenced the development of ethics committees in the United States and other countries worldwide.
CIOMS ethical guidelines
The Council for International Organizations of Medical Sciences (CIOMS), in collaboration with the WHO, has developed ethical guidelines for biomedical research involving human participants. These guidelines help to practically apply general ethical principles to specific cases, especially when working with vulnerable groups of participants such as children or patients with disabilities. Key recommendations include:
Informed participation. Participants must clearly understand how their data will be used and must give consent to participate.
Protection of vulnerable groups. Special attention must be given to the rights of vulnerable participants, such as minors or socially disadvantaged groups.
Clarity of procedures and data protection. Clear procedures must be defined for collecting, storing, and using participants' data.
COPE
The Committee on Publication Ethics (COPE) has developed guidelines concerning ethical norms in academic publications, as well as determining how to handle issues such as authorship, plagiarism, conflicts of interest, and peer review. A significant aspect is the guidance for reviewers, editors, and authors on proper conduct during the publication process.
Key principles include:
- Authorship. Clear requirements for determining authorship and contributions to the work, to avoid “pseudo-authorship” or “scientific plagiarism”.
- Conflicts of interest. Requirements to declare conflicts of interest at all stages of publication.
- Plagiarism detection. Creating mechanisms to detect plagiarism and protect authors' intellectual property.
- Peer review process. Supporting transparent and ethical peer review of scientific articles.
COPE provides editors and reviewers with clear instructions to ensure publication ethics and resolve ethical issues that arise during the peer review and publication of medical research.
The importance of international ethical standards
International ethical documents are not just declarations of the highest level but also practical guidelines for anyone involved in medical research. They establish requirements for protecting the rights and safety of research participants, informed consent, autonomy, and ethical evaluation of scientific value. These documents influence national laws, ethics committee requirements, regulatory body rules, and international project standards. Adhering to their provisions is essential for ensuring trust in research results and respect for participants' dignity.
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