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Approval can be seen as an additional safeguard to help 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.

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2.13.1.      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 (subsection 6 (4));
  • the data are processed by the biobank (section 29 of the Human Genes Research Act), including cases when the gene donor’s data are de-pseudonymised (section 24 of the Human Genes Research Act);
  • personal data are issued from the health information system (section 594 of the Health Services Organisation Act);
  • a clinical trial of a medicinal product is carried out (section 93 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. The Estonian Bioethics and Human Research Council coordinates research related to the release of data from the Estonian Biobank and the Health Information System; the Ethics Committee for Medicinal Products of the Republic of Estonia Agency of Medicines coordinates the clinical trials of medicinal products; the Research Ethics Committee of the University of Tartu and the Research Ethics Committee of the National Institute for Health Development coordinate clinical investigations of medical devices. In some cases, it is necessary to consult several ethics committees to combine data from the Health Information System and other sources.

However, in some cases, it is not specified which ethics committee should be consulted according to subsection 6 (4) of the Personal Data Protection Act. In these cases, any ethics committee recognised in the field is suitable.

2.13.2.      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.

2.13.3.      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.

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

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