Understanding of the terms in their semantic and teleological context is a precondition for the correct application of regulations. The challenge in understanding the terms is even more significant in cases of specific terms in various industries.
The subject of this article is to address the meaning of the terms „medical research“ and „health-related scientific research“, as those terms are seemingly synonyms, but we are in fact dealing with two completely different types of research. There are differences in terms of the manner of conducting these two types of research and the goals to be achieved through conducting of the respective research. Absence of clear rules and non-existence of court practice in this area lead to difficulties in the work of researchers and healthcare workers, as well as in the determination of competencies of the authorities and bodies, when it comes to performing control over such research.
- Documents of international organizations and bodies
Item 1 of the Preamble of the Helsinki Declaration of the World Medical Association – Ethical Principles of Medical Research on Humans states that the purpose of this document is to establish ethical principles of medical research on humans, including research that uses recognisable human materials and data. From the subject formulation, it follows that there are, on the one hand, medical research on humans that encompasses the application of certain medical protocols in providing healthcare protection to people and, on the other hand, other types of research that encompass research on biological materials and data on the patients’ health status.
In the introduction, on the 3rd page of the 2016 Guidelines of the Council for International Organizations of Medical Sciences (CIOMS), headquartered in Geneva ("CIOMS Guidelines"), it is stated that health-related scientific research includes biomedical, epidemiological, experiential, and social science research involving humans.
Guideline 10 of the respective document (Research involving biological materials and related data) covers research that uses human samples and data, which, however, does not involve the provision of healthcare protection to participants of the research.
Guidelines for collecting and reporting on data in research and experimental development of the Organisation for Economic Co-operation and Development (OECD Frascati Manual) of 2015 envisage in Chapter 2.7.1. – Field of research and development (FORD) that medical and health science encompass clinical medicine, health science, medical biotechnology, and other related fields.
The OECD Frascati Manual (2015) clearly distinguishes between:
- basic research: aimed at acquiring new knowledge without direct application;
- applied research: directed towards a specific objective or practical application, including the understanding of diseases, identification of biomarkers, development of diagnostic methods, etc.;
- experimental development: involves the use of existing knowledge to create new products, processes, or services.
Within the field of health, the Frascati Manual states that R&D activities (research and development) may be conducted in higher education institutions, research institutes, and even in hospitals, but do not necessarily include the provision of healthcare services.
- National Regulations
Article 16 of the Law on the Ratification of the Convention on Human Rights and Biomedicine ("Official Gazette of the RS – International Treaties", No. 12/2010) (Protection of persons undergoing research) stipulates that research involving a person is considered an intervention, which indicates that it does not necessarily include the provision of healthcare services.
Article 1 of the Law on Patients’ Rights ("Official Gazette of the RS", No. 45/2013 and 25/2019 – other law) prescribes that this law governs the rights of patients when using healthcare services, the manner in which such rights are exercised and protected, as well as other matters relating to the rights and obligations of patients.
Given that the subject matter of this law is the regulation of patient rights in the context of healthcare service delivery, Article 25 of the law regulates medical research. However, this law does not govern health-related scientific research.
Health-related scientific research is governed by the Article 59 of the Law on Higher Education ("Official Gazette of the RS", No. 88/2017, 73/2018, 27/2018 – other law, 67/2019, 6/2020 – other law, 11/2021 – authentic interpretation, 67/2021, 67/2021 – other law, 76/2023 and 19/2025), as well as the Law on Science and Research ("Official Gazette of the RS", No. 49/2019).
- Medical Research
International documents and national regulations clearly distinguish between medical research and health-related scientific research.
Medical research is conducted in healthcare institutions, and within the scope of such research, healthcare services are provided to participants. These research activities are directly aimed at improving individual health and involve monitoring of health status, diagnostics, disease prognosis, and the application of new therapeutic procedures.
A typical example of medical research includes clinical trials of medicinal products and medical devices, where patients are under continuous medical supervision throughout the entire research process, and healthcare services are provided for the purpose of determining the safety and efficiency of the therapy. The same applies to research involving experimental therapies, as well as to studies that involve ongoing monitoring of patients’ health status for the purpose of improving diagnostics and disease prognosis.
- Health-related scientific research
Health-related scientific research is conducted within accredited research organizations (such as higher education health institutions, scientific institutes, and healthcare institutions, accredited to conduct scientific research). The subject of such research encompasses understanding of biological, genetic, experiential, and social components of health and disease, with the aim of advancing medical knowledge, which, if successful (which is not guaranteed in the case of scientific research), may later be applied in clinical practice.
- e) Oversight over the Conduct of Research
Oversight over the conduct of medical research is conducted by the competent health inspections and the ethics committees of the relevant healthcare institutions.
Oversight over the conduct of health-related scientific research is conducted by the ethics committees of higher education institutions and scientific institutes in which such research is performed.
- f) Challenges in the Conducting of Research
Since the national legislation does not define the meaning of the terms medical research and health-related scientific research or the responsibilities of participants in such research, numerous issues arise in practice.
One of the fundamental issues is the criterion for determining the venue where health-related scientific research is to be conducted. Starting from the standpoint that such research may only be conducted by institutions accredited for this type of research, that only such institutions may conclude contracts with funding entities and that the research is conducted in the laboratories of those institutions, it logically follows that such research is to be carried out within those institutions, and that the researchers and professional bodies of those institutions are responsible for both its conduct and oversight.
The responsibility of the professional bodies of such institutions also includes issuing approvals for conducting the research. The fact that biological material used for this type of research is obtained from patients in healthcare institutions does not mean that the research itself is conducted in healthcare institutions.
On the contrary, this type of research differs from medical research precisely in the fact that the involvement of health professionals within healthcare institutions does not include the provision of healthcare services as part of the research. It is common practice for biological material used for research purposes to be collected during surgical treatment of patients, or for research to use biological material that was already generated during such procedures. Therefore, the responsibility of healthcare professionals in conducting this type of research is limited to obtaining informed consent in accordance with the provisions of the aforementioned Oviedo Convention. The responsibilities of participants in the research are regulated by a contract between the research organization and the healthcare institution, which also includes the research protocol as an integral part. By signing this contract, the head of the healthcare institution declares that he is familiar with the research and provides consent to the participation of the institution’s healthcare professionals in the research.
Another problematic issue concerns the provisions of the Law on Healthcare.
In the section defining the scope of public concern for health at the national level, the Law on Healthcare refers to the "development of research activity in the field of healthcare."
The term public concern for health refers to economic, health, and social policies through which conditions are created for the implementation of healthcare, the preservation and improvement of public health, as well as measures aimed at coordinating the functioning and development of the healthcare system.
Healthcare includes implementation of measures and activities for the preservation and improvement of the health of citizens of the Republic of Serbia (hereinafter: citizen), the prevention, control, and early detection of diseases, injuries, and other health disorders, and timely, effective, and efficient treatment, healthcare, and rehabilitation.
This law defines healthcare activity as the activity through which healthcare for citizens is provided, and which is implemented through the healthcare system.
The healthcare system in the Republic of Serbia consists of healthcare institutions, higher education institutions that implement accredited study programs for acquiring the necessary knowledge and skills to perform tasks in the field of healthcare (hereinafter: higher education institutions of the health profession) and other legal entities for which it is stipulated by special law that they perform healthcare activities, private practice, healthcare professionals and health associates, as well as the organization and financing of healthcare.
Given that healthcare for citizens is provided through the healthcare system, which consists of healthcare institutions, other legal entities authorized by special law to perform healthcare activities, and private practice — where healthcare professionals and health associates perform healthcare activities — as well as higher education institutions of the health profession that deliver accredited study programs to acquire the necessary knowledge and skills to perform tasks in the field of healthcare, it follows that research activity in the field of healthcare inevitably includes also the provision of healthcare activities. Accordingly, research in the field of healthcare is limited to medical research and health-related scientific research, for which the responsibility lies with the healthcare institution accredited to conduct such research.
Medical research is directly aimed at improving individual health and encompasses the monitoring of health status, diagnostics, disease prognosis, and the application of new therapeutic procedures. All these components of medical research imply the provision of healthcare services to patients participating in the research by the healthcare institutions themselves.
Starting from the standpoint that researchers and professional bodies of institutions in which scientific research is conducted are responsible for the implementation and oversight of such research, the provision in the Law on Healthcare defining that the ethics committee shall give approval for the conduct of health-related scientific research, medical research, and public health research, as well as monitor their implementation, is unclear.
Specifically, it is unclear whether the ethics committee of a healthcare institution is competent to grant approval for the conduct of health-related research accredited to conduct such research, or whether it is also competent to grant approval for the conduct of such research in higher education institutions of the health profession and scientific institutes.
Furthermore, if it is indeed competent in both cases, the question arises whether the competence of ethics committees of higher education institutions and scientific institutes to give approval for the conduct of such research—in accordance with Article 59, paragraph 6 of the Law on Higher Education—is thereby questionable or unnecessary, or whether it is merely about “overlapping” of competences and the need to achieve consensus of the society regarding the interpretation of the aforementioned terms and the responsibilities related to the conduct of scientific research.
By Ivan Milosevic, Partner, and Janez Voncina, Senior Associate, JPM & Partners
