Approval can be considered an additional protective measure that helps ensure that research is carried out ethically. In some cases, the ethics committee’s approval may be a legal obligation; in others, the approval may be necessary to meet a funding provider’s or publisher’s requirements, and in some cases, for ethical reasons.

In most cases, asking for approval from the ethics committee depends on whether the researcher wants to conduct human research. Human research involves processing personal data and studying the participant’s physical or mental health. Some human research in Estonia is specifically regulated by law, such as clinical trials on medicinal products and devices and human genetic research.

NB! Please note that amendments to the Organisation of Research and Development and Innovation Act (TAIKS) have also brought changes to the organisation of ethics committees as of 1 January 2026.


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2.14.1. Statutory obligation

The Personal Data Protection Act stipulates that an ethics committee assesses both research ethics and data protection standards. In Estonia, the approval of an ethics committee is required by law if

  • special categories of personal data, such as health data or biometric data, are processed without the person’s consent (section 6 (4));
  • genetic data is processed in human genetic research under the Human Genes Research Act (HGRA), including genetic data obtained from the Estonian Biobank (section 27 of the HGRA) or from other sources (section 32 of the HGRA);
  • personal data are issued from the health information system (section 59 of the Health Services Organisation Act);
  • a clinical trial of a medicinal product is carried out (section 992 of the Medicinal Products Act);
  • a clinical investigation of a medical device is carried out (section 213 of the Medical Devices Act).

In many cases, the law specifies which ethics committee to consult. For example, studies involving the disclosure of data from the Estonian Biobank and the Health Information System are approved by the Estonian Research ethics committee, while clinical trials of medicinal products and clinical investigations of medical devices are approved by the ethics committee for medical research established under the  Republic of Estonia Agency of Medicines.

In cases not specified by law, the Estonian Research ethics committee or the University of Tartu Research Ethics Committee should be approached, depending on the rules described on the website of the University of Tartu Research Ethics Committee.

2.14.2. Requirements of funders and publishers

Also, the project funder or the publishing house where the researcher plans to publish the study may require approval. For example, if the lead partner in an international project decides that approval from national ethics committees is required for the research, Estonian researchers need to obtain the approval.

Example

A medical researcher carried out a study for which he did not consider it necessary to seek the ethics committee’s approval because it did not involve special categories of data. After the study was completed, the researcher wanted to publish an article on the subject in an international journal. The publisher required the researcher to obtain approval from the ethics committee. The ethics committee does not grant approvals retroactively, and so the article was not published in an international journal. Thus, while approval is not always mandatory, the lack of approval may reduce the researcher’s chances to publish.

2.14.3. Ethical considerations

A researcher may also ask for the ethics committee’s approval on ethical grounds, as this helps ensure that the planned research does not harm people. Consent is usually necessary when the study is carried out using a very different method from the usual one (for example, when people are misled or deceived), involves vulnerable people, or a higher risk than usual. If you have any questions regarding research ethics, you can contact the University of Tartu's research integrity counsellors. Each faculty of the university has at least one research integrity counsellor whose contact information you cand find here.

In addition, a researcher may always voluntarily seek the ethics committee’s approval.




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