RECs in non-health-related sciences in Estonia
Apart from health-related research, national regulations in Estonia also cover non-health-related research, but only in two cases. First, research projects involving the processing of special categories of personal data without the consent of the data subject. According to the Estonian Personal Data Protection Act section 6(4), processing special categories of personal data for research purposes without the consent of the data subject requires REC review. Second, according to the Organisation of Research and Development and Innovation Act section 28(4), which specifies situations when a person under 18 years of age can give informed consent independently, without the consent of their legal representative. Namely, a person aged 15–17 may independently give informed consent to participate in research and for related data processing if they understand the research, it is not physically invasive, and a research ethics committee has confirmed that any mentally invasive research meets ethical standards. Other non-health-related research falls outside the scope of national-level legal regulation.
At the national level, the Estonian Research Council initiated a working group that drafted the document “Code of Conduct for Human Subject Research”. The document outlines the circumstances under which REC approval is required if there are no clear requirements (e.g., legal, from funders and publishers) in place, specifying the following conditions:
- Human subject research that is likely to harm people or has other expected harmful effects requires an assessment by an independent ethics committee before the research activities begin.
- Human subject research that meets at least one of the following conditions requires approval by an ethics committee:
- The human subject research is physically invasive;
- Participation in the human subject research involves significant mental strain or a risk of harm to (mental) health;
- Participation in the human subject research may place the persons involved in the research or their relatives in a vulnerable state;
- The human subject research may endanger the participants in the research, their relatives or the researchers conducting the research;
- The participation of the person in the research is not based on prior informed consent or significantly deviates from the principles of informed consent;
- The collection or further processing of personal data may, by its nature, scope, novelty or context, harm the rights and interests of the person.
- Human subject research that uses biological material derived from humans requires approval by an ethics committee.
- The need for approval by an ethics committee may arise from legislation. In this case, the approval must be based on the requirements set out in legislation.
Apart from national regulations, only very general ethical guidance exists for non-health-related research. For instance, the ethics code of the Estonian Association of Sociologists offers general guidance on conducting research, but it does not cover ethics review. However, when a project receives funding from the Estonian Research Council, the Council assesses the ethical aspects of research proposals. Following this assessment, it may impose an additional requirement in the grant agreement: that the specific project must be approved by a REC, even if such approval is not mandated by national regulations. This assessment is typically conducted by a group of experts, some of whom are also members of RECs.
Additionally, researchers may choose to seek REC approval for publication or at the request of funders, even if it's not required by national regulations or the Estonian Research Council.
Until the end of 2025, non-health-related research regulated under national regulations is reviewed at the regional level by either the University of Tartu REC or the Research Ethics Committee of the National Institute for Health Development (NIHD REC) and at the institutional level by the Ethics Committee of Tallinn University. From 2026, the system will change. The most notable difference will be the establishment of the national-level ethics committees, created and office-supported by the Estonian Research Council (ETAg), which will assess all types of research - health-related (excluding clinical drug trials and medical devices), as well as non-health-related research. There will be one REC for biomedical research, another for SSH research, and a third that functions as a data access committee for the national health information system, the Estonian Biobank, and several national registries and databases. At the same time, research institutions (e.g., universities) may continue to maintain their own institutional ethics committees for reviewing in-house applications. As a result, non-health-related research may be reviewed either by an institutional ethics committee, if one exists, or otherwise by the ETAg national committee.
For instance, the University of Tartu REC (UT REC) comprises diverse experts nominated by university faculties, ensuring representation across research fields. Additionally, external experts can be involved when needed. UT REC organizes the review process of non-health-related research in the same way as for health-related research; for instance, the application form and deadlines are the same for both. UT REC is supported by a secretary and the university's central document system. In 2024, UT REC reviewed approximately 260 protocols in 11 meetings, with a bit more than half involving health-related research and the rest spanning various non-health-related fields. The review process typically takes around a month, adhering to the committee's 60-day statutory deadline. The UT REC will continue as an institutional committee from 2026 onwards.
Report contributor and national contact: Kristi Louk
