Guidelines on Research Ethics

Guidelines on Research Ethics

The rapid pace of modern scientific and technological development and the magnitude of the associated challenges require active consolidation of Russian scientists and the international expert community in developing tools for effective research ethics regulation in various fields of science and their implementation into practice both at the level of individual countries and on a global scale.

The sphere of influence of ethics has expanded: increasingly, ethical issues encompass diverse areas of science, which is becoming anthropocentric. The core values and principles of ethics, laid down by the philosophers of antiquity, have been reinterpreted in light of the lessons of history enshrined in the Nuremberg Code, as well as in connection with the development of research ethics.

Decree of the President of the Russian Federation Vladimir Putin No. 145 of February 28, 2024, and subsequent regulatory acts define the strategy for the country's scientific and technological development. The document identifies priority areas such as artificial intelligence, genetic technologies, new materials, environmentally friendly energy, as well as issues related to security, healthcare, and the digitalization of society. The strategy emphasizes the need to consider ethical aspects in the development of science and technology.

This is reflected in the following directions: assessment of the consequences of technology implementation: the importance of analyzing potential risks and benefits for society, including possible harm to humans and the environment; particular attention is paid to issues of bioethics, the protection of personal data in medical and genetic research; national interests and ethical standards: Russia is developing its own approaches to the ethical review of scientific projects, taking into account both international norms (e.g., the Declaration of Helsinki) and national values.

The Presidential Decree on the scientific and technological development of the Russian Federation is closely linked to ethical issues, because under modern conditions scientific progress is impossible without considering the moral, legal, and social consequences of implementing new technologies. Ethical norms are becoming an integral part of state policy in the field of science and technology, and their observance is an important condition for the sustainable and safe development of society.

Work is underway to further improve the system of independent ethical review of technological activities, especially in medicine and biotechnology. The Russian Academy of Sciences (RAS) has announced the creation of a Council on the Ethics of Scientific Research under the RAS Presidium. The goals of the Council are: to consider draft national and international documents concerning research ethics; to develop and review recommendations, standards, and norms in the field of research ethics; to carry out independent ethical assessment for the issuance of an opinion on the ethical validity of conducting scientific research, scientific technical, and innovative activities.

A key role in responding to the global challenges of ethics in these processes belongs to UNESCO and the World Health Organization. The tasks of international institutions within the UNESCO structure are to formulate ethical standards and international declarations in various fields of scientific development, to support educational and awareness raising projects, and to ensure the functioning and interaction of expert and advisory bodies.

At the center of discussion for the global community are issues of the ethics of artificial intelligence, neurotechnologies, quantum computing, space exploration, mobile communication systems, reproductive technologies, genetics, biotechnology, and synthetic biology.

At UNESCO's initiative, the international community has adopted a number of fundamental documents establishing bioethical standards for scientific development and the application of biotechnologies, ensuring the protection of human rights in research and medical practice. These include the Universal Declaration on the Human Genome and Human Rights (1997), the International Declaration on Human Genetic Data (2003), and the Universal Declaration on Bioethics and Human Rights (2005).

UNESCO organizes international forums, supports discussion and advisory projects on current bioethical issues, including modern challenges related to the active development of neurotechnologies and the integration of artificial intelligence into research procedures and practical healthcare, progress in genetic and biosynthetic developments, and issues of bioeconomics. The result of discussions on neuroethics conducted in 2023–2025 with the participation of Russian experts was the development of draft recommendations on the ethics of neurotechnologies.

At one of the sessions of the St. Petersburg Economic Forum in 2025, the term "neoethics" emerged, reflecting the essence of the evolution of ideas about ethics associated with a fundamentally new range of challenges concerning human rights and freedoms due to the development of neurotechnologies.

UNESCO's educational projects play a significant role in these processes. The development and implementation into international educational practice of a basic curriculum in bioethics, and the establishment of bioethical standards in specialist training, normalize bioethical discourse and enhance the intellectual potential of bioethics research. UNESCO supports initiatives to establish chairs in bioethics, promotes the popularization of bioethical knowledge, and encourages public organizations to engage in discussions on current bioethical issues.

UNESCO responds rapidly to urgent problems arising from significant challenges in science and practical healthcare, such as the need to implement ethical standards during the spread of Ebola virus disease in 2014 and the COVID 19 pandemic in 2020.

UNESCO's bioethical initiatives are most visibly implemented in the creation and support of bioethics committees. The International Bioethics Committee, composed of 36 independent experts, the Intergovernmental Bioethics Committee, which includes representatives from 36 member states, and the World Commission on the Ethics of Scientific Knowledge and Technology initiate discussions on the most pressing bioethical issues and develop international documents defining the principles of bioethics in various directions of the "human sciences" and related spheres of life. UNESCO actively supports the activities of National Bioethics Committees, including in the Russian Federation.

The role of Bioethics Committees has been defined in connection with the increase in anthropological risks and moral ethical problems arising from the development of biology and medicine, problems that cannot be solved by the methods of science alone. Ethics committees ensure the protection of the rights and safety of patients and research participants, initiate and conduct preliminary reviews of scientific developments in accordance with ethical standards.

The multi level organization of the infrastructure of ethics committees — from local committees to state and interstate structures — ensures a comprehensive procedure for public and professional expert discussion, optimizes the process of making competent decisions on the most complex issues of technological development, taking into account interdisciplinary and social aspects, and also contributes to regulatory initiatives for the systematic protection of the rights and dignity of patients and participants in biomedical research.

In addressing bioethical challenges, UNESCO acts as the international coordinator of initiatives from expert, educational, and public groups and associations, as well as interstate structures, whose tasks include bioethical regulation and the implementation of ethical standards in research and medical practice.

The World Health Organization's (WHO) activities in the formation and development of bioethics at the international level are aimed at developing and implementing standards for the protection of human rights in biomedical research, establishing norms for the responsible use of biomedical technologies, preventing risks, and ensuring the safety of dual use developments.

The structure of WHO regional offices and expert centers ensures the review and approval of national and international ethical guidelines for conducting research involving human participants. WHO also initiates and supports educational programs and awareness raising projects, facilitates global and regional dialogue on sharing best practices in bioethics, and promotes the adoption of international documents in the field of ethical regulation of healthcare.

The goal of WHO's activities is to protect the rights and human dignity of patients and participants in biomedical research, to ensure conditions and procedures for compliance with the principles of voluntary informed consent, to eliminate unjustified risks, and to prevent any form of discrimination, abuse, and inequity in access to technological innovations, both at the national and global levels.

To achieve this goal, in 2022 the WHO developed and proposed for practical application the Global guidance for the responsible use of biomedical research involving human participants.

The WHO works closely with the World Medical Association (WMA). The concept of the new version of the WMA's Declaration of Helsinki (2024)—the key document defining ethical principles for medical research involving human participants—is actively used by the WHO in preparing its documents.

One of the most significant innovations is the strengthened protection of vulnerable populations. Unlike previous versions, which addressed the inclusion of such groups more generally, paragraph 19 now clearly stipulates the need to carefully weigh the risks of excluding them from research against the potential benefits of participation. Special attention is paid to persons unable to give informed consent: additional safeguards are provided for them, and their inclusion in research is permissible only under conditions of minimal risk or direct benefit to themselves.

For the first time in the Declaration's history, a paragraph on environmental sustainability (paragraph 11) has been included, reflecting growing global concern about the impact of scientific activities on the environment. Researchers are now required to minimize environmental harm and consider principles of sustainable development when planning and conducting experiments.

The principles of informed consent have also undergone significant clarification. Whereas earlier the main focus was on the mere fact of obtaining consent, it is now emphasized that information must be provided in a language that is understandable, taking into account the individual needs of participants. Furthermore, participants are granted the right to be informed about the overall results of the research, thereby increasing the transparency of scientific work. Issues related to the collection and storage of biological materials, as well as the secondary use of data, are separately regulated, providing stricter control over the handling of personal information.

An important step forward is the tightening of requirements for post trial provisions. Sponsors and researchers are obliged to arrange in advance how participants who require effective interventions identified during the research will gain access to them after its conclusion. This rule, enshrined in paragraph 34, aims to prevent situations where patients who participated in research are deprived of access to life saving medicines or treatments.

The role of Research Ethics Committees (RECs) has also been revised. The new version emphasizes that such committees must be fully independent, transparent, and possess sufficient resources for the quality assessment of research. At the same time, they are required to take into account local circumstances, but without compromising the basic principles of participant protection set forth in the Declaration.

The 2024 revision continues the WMA's efforts, begun in 2013, to broaden the application of the Declaration: from covering only physicians to covering all researchers, research teams, institutions, authors, editors, and publishers involved in biomedical research. It is also emphasized that RECs should have the authority to monitor ongoing research. The researcher is obliged to provide the REC with the information necessary for such monitoring, in particular information about any serious adverse events.

Contemporary challenges, such as pandemics, the digitalization of medicine, and the globalization of scientific research, are also reflected in the updated text. For example, paragraph 8 specifically states that even in emergency situations, ethical norms must be strictly observed.

The rules for using placebos have been clarified: their use is now permissible only when no proven interventions exist or when it is necessary for methodological reasons, provided it does not expose participants to additional risk.

Thus, the 2024 Declaration of Helsinki retains its core mission — the protection of the rights and dignity of participants in medical research — while becoming better adapted to contemporary realities. These changes demonstrate how ethical principles evolve in response to new scientific, technological, and social challenges, remaining a reliable guide for researchers worldwide.

The WHO Guidance on the ethics of health research priority setting (2025) formulates four key ethical principles, developed on the basis of best practices, agreed bioethical values, and principles of fair resource allocation.

The first principle is maximizing social value. The primary goal of any health research is to improve human well being and reduce social inequalities. The social value of a study is determined by three main factors: the likelihood of its successful completion, the scale of potential benefits to society, and the impact on reducing existing inequalities in access to health care.

The second principle is respect for special obligations. When setting priorities, it is necessary to consider the ethical duties of organizations and researchers towards specific groups, such as patients with particular diseases, residents of specific regions, or those funding the research.

The third principle involves careful assessment of possible risks. Particular attention should be paid to minimizing and justifying potential harm to research participants (including animals), as well as risks to third parties, such as the possibility of "dual use" of research results.

The fourth principle concerns fair procedures. The priority setting process should be accountable (with a clear definition of who makes decisions and to whom they are accountable), transparent (ensuring that information about methods and results is accessible to all stakeholders), and inclusive (involving all groups affected by the decisions being made).

The joint efforts of UNESCO and WHO, supported by state and interstate organizations, form the basis for international cooperation and global solutions in implementing unified approaches to addressing the ethical issues of science and society.

The importance of the international institutions UNESCO and WHO in the development of research ethics is increasing with the acceleration of technological progress. The global community's interest in expanding ethical discourse is also growing. This publication (the Guide for Ethics Committees) is one step towards achieving the goal of ethical regulation of scientific and technological advancement, ensuring the rights and dignity of patients and participants in biomedical research.

Thus, the widespread exchange of knowledge and best practices in this context contributes to the prevention of risks of inequality and discrimination and ensures the principle of fairness in access to scientific achievements. Approaches to transitioning from closed, citation oriented systems to open, transparent, interoperable sources and resources, and the creation of mechanisms for continuous dialogue and iterative refinement of research evaluation systems using digital tools, are actively being discussed.

A special role belongs to scientists and researchers who undertake complex tasks related to human well being. Amid all the diversity of technological solutions, the human factor remains key in both the creation and application of the products of scientific progress. The effectiveness and safety of new technologies depend on the qualifications and knowledge of researchers; this is the foundation of scientific integrity, the importance of which is emphasized in all international documents.

We hope that this Guide will be useful for making confident decisions in addressing both simple and complex challenges of scientific inquiry.

Academician of the Russian Academy of Sciences,

Doctor of Medical Sciences,

Professor Alexander Khokhlov