Human Genetic Research Act

(1) This Act regulates

1) the maintenance of the Estonian Biobank and the processing of tissue samples and personal data necessary therefor, while ensuring the voluntary nature of gene donation and the protection of the rights of gene donors;

2) the requirements for the processing of tissue samples and genetic data upon conducting scientific research, including human genetic research, and the procedure for exercising oversight over compliance with such requirements.

(2) The Health Services Organisation Act is applied to the collection of tissue samples under this Act.

(3) This Act does not regulate the rights and obligations of donors as established in the Blood Act, the Procurement, Handling and Transplantation of Cells, Tissues and Organs Act, and the Artificial Insemination and Embryo Protection Act, nor does it regulate the use of biological material in the manufacture of advanced therapy medicinal products.

(4) This Act does not apply to the processing of genetic data for other purposes, including the provision of health services or offence proceedings.

(5) The Personal Data Protection Act applies to the processing of personal data on the basis of this Act, taking into account the specifications provided for in this Act.

(1) For the purposes of this Act, a gene donor is a person who, on the basis of Chapter 2 of this Act, provides a tissue sample to the Estonian Biobank and whose personal data are processed.

(2) For the purposes of this Act, health data means the data specified in clause 15 of Article 4 of the Regulation (EU) No 2016/679 of the European Parliament and of the Council on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 04.05.2016, p 1–88).

(3) For the purposes of this Act, genetic data means the data specified in clause 13 of Article 4 of the Regulation (EU) No 2016/679.

(4) For the purposes of this Act, DNA means a molecule of deoxyribonucleic acid which contains the genetic information of a human being.

(5) For the purposes of this Act, tissue sample means cells, intercellular substance and body fluids taken from a human being for the purposes of human genetic research;

(6) For the purposes of this Act, genealogical data means information in the Estonian Biobank concerning the names, dates of birth and biological relationships of the gene donor’s biological relatives.

(1) For the purposes of this Act, scientific research means scientific study carried out for the purposes of research and development, human genetic research, innovation or policy-making.

(2) For the purposes of this Act, human genetic research means scientific research to study and describe human DNA, other constituents of tissue samples, personal data and genealogical data, and to determine the links between them with the purpose of obtaining data on the genes and hereditary characteristics of human beings.

(1) For the purposes of this Act, pseudonymisation means the replacement with a unique identification code of such data of a tissue sample, personal data, or genealogical data which enables the identification of the person.

(2) For the purposes of this Act, depseudonymisation means the re-association of a tissue sample, personal data and genealogical data replaced by a unique identification code with data which enables the identification of a person.

(1) The Estonian Biobank (hereinafter the Biobank) is a database of tissue samples and data from gene donors, including genealogical data, genetic data, and health data, which forms part of the state information system and is maintained for the following purposes

1) collect data on the health and genetic information of the Estonian population;

2) compile statistics based on the data collected;

3) conduct and promote scientific research, including human genetic research, based on the data collected;

4) apply the results of scientific research related to the Biobank to improve public health and make information in the Biobank and information on the results of scientific research available to gene donors.

(2) Scientific research, including human genetic research, based on tissue samples and data from the Biobank is permitted for studying and describing the links between human genes, the living environment and lifestyle, finding medicinal products or methods of treatment, assessing individual health risks, and preventing diseases.

(3) Tissue samples are released or made available for use from the Biobank in accordance with the provisions of § 13 of this Act.

The controller of the Biobank is the University of Tartu.

(1) The constitutive regulations of the Biobank are established by the minister in charge of the policy sector by a regulation which provides

1) the functions of the controller and the processor and the requirements for the agreement to be entered into between the controller and the processor;

2) a detailed composition of data to be collected in the Biobank, including the composition of data received from the data providers and the procedure for the transmission of such data, and the procedure for notification of the removal of tissue samples from Estonia;

3) the procedure of ensuring the correctness of data;

4) requirements for the collection and processing of declarations of intention;

5) the detailed procedures for the exchange of data, including access to and release of data, and the requirements for the release record;

6) requirements for the collection of tissue samples;

7) requirements for the storage of tissue samples and personal data of gene donors, including requirements for the information system and the storage facilities of tissue samples;

8) requirements for the destruction of tissue samples and personal data of gene donors, including requirements for the destruction record;

9) other organisational issues.

(2) The controller of the Biobank establishes a detailed description of the composition of data of the declaration of intention of a gene donor and the guidelines for completing the declaration of intention, and publishes them on its website.

(1) The following data are processed in the Biobank

1) general data, nationality, education, place of birth, period of stay in Estonia, marital status, time and place of death or data on the person being missing and declarations of intention of the gene donor;

2) if there is a representative, general data about the representative of the gene donor and the declarations of intention made on behalf of the person represented through them;

3) health data of the gene donor and other data on health services, health behaviour and personal characteristics, data on tissue samples, and data obtained from the analysis of the tissue samples of the gene donor, including genetic data;

4) information regarding a gene donor or the health and health behaviour of their biological relatives as disclosed by a gene donor;

5) data related to the fact of being a gene donor, including data on invitations, notifications and enquiries;

6) data processing protocol data;

7) pseudonymisation and depseudonymisation data;

8) log data.

(2) The personal data of a gene donor is deemed to have been submitted to the Biobank as of the first pseudonymisation of the data in accordance with the procedure set forth in § 24 of this Act.

(1) The following databases, which are part of the state information system, serve as the Biobank data providers for the collection, verification and supplementing the general data and health data of a gene donor

1) health information system;

2) population register;

3) digital prescription centre;

4) Estonian myocardial infarction registry;

5) Health Insurance Fund database;

6) Estonian cancer registry;

7) pregnancy information system;

8) Estonian cancer screening registry;

9) causes of death registry;

10) Estonian tuberculosis registry.

(2) In addition to the data providers referred to in subsection 1 of this section, health care providers who have entered into a data transfer agreement with the controller of the Biobank submit data to the Biobank to supplement the health data of gene donors.

(3) If tissue samples and personal data of gene donors are used for conducting scientific research, the controller of the research transfers the data received as a result of the scientific research to the controller of the Biobank for submission to the Biobank in the following cases

1) specific data are included in the composition of data of the Biobank database as of the transfer date;

2) The controller of the Biobank has assessed that specific data are necessary in order to achieve the objectives of the Biobank and has provided in its decision for the transfer of such data to the Biobank for processing.

(4) If the controller of the Biobank has decided on the transfer of data to the Biobank on the basis of subsection 3 of this section, the requirements for the transfer, including the exact composition of data, the time and manner of transfer, are agreed upon in the data access agreement to be entered into between the controller of the Biobank and the controller of scientific research.

(1) Data exchange with the data providers specified in subsection 1 of § 9 of this Act takes place once a year. Data exchange with the data providers specified in subsection 2 of § 9 of this Act takes place in accordance with the provisions of the agreement.

(2) The restriction on data exchange referred to in subsection 1 of this section does not apply to

1) a separate request made in the course of conducting scientific research;

2) data exchange with the health information system concerning being a gene donor, declarations of intention, and the provision of services.

(3) The controller of the Biobank ensures the exchange of data with the health information system on the basis of a corresponding written declaration of intention of the gene donor. Data is disclosed on a request-by-request basis to fulfil the objectives provided for in the Health Services Organisation Act.

(4) The data obtained pursuant to subsection 1 of this section is verified, organized, and submitted to the Biobank.

(1) The tissue samples of gene donors and the data specified in clauses 1–7 of subsection 1 of § 8 of this Act are retained in the Biobank for an indefinite term, except in the cases provided for in subsections 1–3 of § 18 of this Act.

(2) The controller of the Biobank destroys the source data received in the data exchange within 30 calendar days as of the submission of the data to the Biobank.

(3) After the performance of a processing operation, the logs of the Biobank specified in clause 8 of subsection 1 of § 8 of this Act are retained as follows

1) logs of data release, pseudonymisation and depseudonymisation for 10 years;

2) the technical logs of data processing operations for one year.

(4) Logs that have exceeded the retention period are deleted by calendar year, no later than December 31 of the year following the expiry of the retention period.

(1) The controller of the Biobank

1) organises the collection of tissue samples from gene donors and ensures compliance with the requirements for processing the tissue samples of gene donors;

2) ensures that the personal data of gene donors are collected and supplemented in the Biobank;

3) ensures the protection of the rights of gene donors in the data processing of the Biobank;

4) ensures the pseudonymisation and depseudonymisation of the personal data of gene donors;

5) ensures the retention, deletion, and destruction of data and logs;

6) ensures the organisation of data exchange, data release and data access;

7) establishes a secure processing environment for the processing of Biobank data in scientific research;

8) is responsible for the lawfulness of the requirements for processing of personal data and data processing operations, including the ongoing analysis of information related to data security, the identification of security risks, and the implementation of appropriate measures;

9) ensures the functioning of the application software necessary for the management of the Biobank;

10) ensures the handling of incidents arising from data processing in the Biobank and user support;

11) keeps records of the data collected and released and the services provided through the Biobank, and prepares concise analyses to manage such records;

12) ensures the backup of the data held in the Biobank;

13) ensures the development and improvement of the Biobank;

14) performs scientific research, including human genetic research, on the basis of the Biobank data.

(2) The controller of the Biobank may, under the conditions provided for in this Act and in the cases provided for in its implementing legislation, grant the right to process the Biobank data to the processor, except for the right to pseudonymise and depseudonymise the personal data of a gene donor.

(3) The specific tasks, competence and liability of the processor of the Biobank is provided for in a written agreement entered into between the controller and the processor of the Biobank.

(4) The controller designates by name the persons who are authorised to pseudonymise or depseudonymise data, who have access to the tissue samples and personal data of gene donors, and who issue pseudonymised tissue samples, genealogical data, and personal data, as well as depseudonymised personal data.

(1) The controller of the Biobank may process the data of the Biobank only for the purposes provided for in § 5 of this Act.

(2) The use of data of the Biobank for other purposes, including the collection of evidence in civil or offence proceedings or for surveillance activities, is prohibited, except in the cases provided for in this section.

(3) On the basis of a request from the Estonian Forensic Science Institute, the controller of the Biobank compares the genetic data of an unidentified deceased person with the genetic data in the Biobank database to determine whether the unidentified deceased person was a gene donor, and, if a match is found, provides the Estonian Forensic Science Institute with the name and personal identification code of that gene donor for the purpose of identifying the individual, if the Estonian Forensic Science Institute has been unable to identify the unidentified deceased person by other means.

(4) The purposes specified in this section do not restrict the right of the controller of the Biobank to release the data of a gene donor for other purposes on the basis of their declaration of intention.

(5) The controller of the Biobank grants access to or releases pseudonymised tissue samples and pseudonymised personal data for the purpose specified in subsection 2 of § 5 of this Act after assessing the following conditions

1) if tissue samples are to be used, the requested quantity of tissue samples, the quantity of tissue samples stored in the Biobank and the scientific value of the data obtained as a result of the analysis of tissue samples;

2) burden on gene donors;

3) associated resource costs for the Biobank;

4) the conditions specified in subsection 6 of this section.

(6) The controller of the scientific research is required to

1) have the necessary expert knowledge and resources;

2) strictly comply with the legislation governing the conduct of scientific research, good research practice, and ethical standards;

3) ensure compliance with the requirements for the protection of personal data.

(7) The controller of the Biobank makes a discretionary decision in writing on the basis of the provisions of subsections 5 and 6 of this section.

(8) If the controller of the Biobank finds, in accordance with subsection 3 of § 9 of this Act, that, in order to achieve the goals of the Biobank, it is necessary to process within the Biobank data obtained as a result of scientific research using the tissue samples and data from the Biobank, or the tissue samples and data collected in the course of such scientific research, the controller prescribes a corresponding condition and other conditions specified in subsection 4 of § 9 in its discretionary decision.

(9) Before the use or release of tissue samples, the approval of the research ethics committee is required in the cases specified in § 27 of this Act.

(1) Genealogical data may be used solely within the Biobank to structure the tissue samples and personal data from gene donors based on biological relationships, including in the case referred to in clause 5 of subsection 1 of § 26 of this Act.

(2) The controller of the Biobank may allow the use or release of genealogical data in pseudonymised form for the purpose of conducting scientific research.

(1) Becoming a gene donor and taking a tissue sample takes place on the basis of the individual’s informed and voluntary declaration of intention, which complies at least with the requirements provided for in § 20 of this Act.

(2) Influencing a person’s decision to become a gene donor, including by threatening with negative consequences, offering payment or material benefits, or providing speculative information, is prohibited.

A person of limited active legal capacity cannot be a gene donor in the Biobank, unless the following conditions are met

1) at least the information provided for in subsection 4 of § 20 of this Act has been provided to the person of limited active legal capacity and their legal representative;

2) the legal representative has signed the declaration of intention provided for in subsection 1 of § 15 of this Act, provided the Biobank with their contact details and established their authority of representation;

3) the person of limited active legal capacity does not object to the collection of a tissue sample from them and the processing of their personal data.

(1) The data in the Biobank are subject to restriction on access for an indefinite term in order to ensure the voluntary nature of gene donation and the protection of the privacy of gene donors. The controller of the Biobank is permitted to disclose general information about scientific research related to the Biobank.

(2) A gene donor alone has the right to disclose and make public the fact of being or not being a gene donor and the related circumstances.

(3) The controller of the Biobank may disclose the fact of someone being or not being a gene donor in the course of the data exchange provided for in § 10 of this Act, including upon forwarding personal identification codes of gene donors to data providers, upon release of data to the gene donor themselves or a third person designated by them or in the framework of release of other data permitted on the basis of this Act.

(1) Gene donors have the right to withdraw from becoming a gene donor before the first pseudonymisation of their tissue samples and personal data. In such case, the controller of the Biobank destroys the tissue sample and the declaration of intention of the gene donor and the data provided by the gene donor without delay upon receipt of the declaration of intention of withdrawal.

(2) After the tissue sample and personal data are pseudonymised for the first time, the gene donor has the right to request the destruction of the depseudonymisation data only. In such case, the controller of the Biobank destroys the depseudonymisation data of the gene donor within one month as of becoming aware of the request, but does not destroy the gene donor’s tissue sample or other data with scientific value.

(3) If the identity of a gene donor has been disclosed or made public unlawfully or the person has become a gene donor unlawfully, the person has the right to request that the controller of the Biobank destroy their tissue sample and personal data. The controller destroys, without delay, the tissue sample and declarations of intention of the gene donor and other personal data of the gene donor as of the establishment of unlawfulness, unless the controller proves that the identity of the gene donor has been made public as a result of the conduct of the gene donor themselves or the person has not become a gene donor unlawfully.

(4) In order to exercise the rights specified in subsections 1–3 of this section, a gene donor submits a written declaration of intention to the controller of the Biobank.

(5) In the case specified in subsection 2 of this section, the controller of the Biobank has the right to refuse to accept a person as a gene donor again.

(1) Gene donors have the right not to know their genetic data and health data.

(2) Gene donors have the right to access personally their data retained in the Biobank and obtain a copy thereof. Gene donors do not have the right to access their genealogical data.

(3) A gene donor may not be charged a fee for accessing the data held about them in the Biobank or for the release of such data to them, taking into account the specifications specified in subsection 3 of Article 15 of Regulation (EU) 2016/679 of the European Parliament and of the Council.

(4) A gene donor has the right to counselling upon accessing the data held about them in the Biobank.

(5) Gene donors have the right to submit additional data on themselves to the controller.

(6) A gene donor has the right to submit a written declaration of intention via the health information system for the transfer of their genetic data from the Biobank to the health information system.

(7) A gene donor may, at any time, through the health information system, prohibit the additional transfer of their genetic data from the Biobank to the health information system. In such case, the controller of the Biobank suspends further data transmission.

(1) A person’s tissue sample and personal data, including health data and genetic data, are submitted to the Biobank if the person has submitted to the Biobank a declaration of intention to become a gene donor specified in subsection 4 of this section.

(2) The declaration of intention to become a gene donor is made in writing and signed by the person becoming a gene donor or their legal representative.

(3) A partial or conditional declaration of intention is not valid.

(4) A declaration of intention to become a gene donor is valid if the controller or processor of the Biobank has provided to the person becoming a gene donor in writing, before making the declaration of intention, at least the information provided for in §§ 13–19 of this Act concerning the permissibility of the use of the data of the gene donor and the rights of the gene donor and the declaration of intention clearly states that by signing the declaration the person wishing to become a gene donor confirms that they have understood and consent to the following

1) they provide a tissue sample;

2) their personal data, including health data and genetic data, tissue sample data and genealogical data, are collected and submitted to the Biobank;

3) their personal data are further processed in the Biobank, including personal data being depseudonymised, updated, made available and released in order to fulfil the purposes laid down in this Act.

(5) The controller or processor of the Biobank to whom a person who wishes to become a gene donor submits a corresponding declaration of intention is required to immediately provide the gene donor with a copy of their declaration of intention or make it available to them electronically after the submission of the declaration of intention.

(6) The controller of the Biobank has the right to refuse to accept a declaration of intention to become a gene donor if the Biobank lacks the capacity to process tissue samples and personal data of new gene donors, if the person does not belong to the research sample approved by the controller of the Biobank or if the person has previously requested the destruction of depseudonymisation data.

(1) A declaration of intention to become a gene donor is retained until the expiry of the period specified in subsection 1 of § 11 of this Act, provided that the relevant data is submitted to the Biobank.

(2) Declarations of intention that have not been submitted to the Biobank are destroyed immediately if the gene donor has submitted a written declaration of intention to withdraw from gene donation prior to the submission of the data to the Biobank.

(3) Declarations of intention that have not been submitted to the Biobank are destroyed if the person who submitted the declaration of intention has not provided a tissue sample within at least one year after submitting the declaration of intention.

(1) The declaration of intention of a gene donor is valid for an indefinite term even after the death of the gene donor, unless a shorter period of validity has been specified.

(2) After the death of a gene donor, their tissue sample and personal data are processed until the expiry of the period specified in subsection 1 of § 11 of this Act. A successor of a gene donor may not withdraw from gene donor status on behalf of a gene donor or submit other declarations of intention specified in this Act on behalf of a deceased gene donor.

(1) Before submitting the declaration of intention specified in § 20 of this Act and taking a tissue sample, the identity of the person who wishes to become a gene donor must be verified.

(2) Procedures related to the collection of a tissue sample from a gene donor, which are medical procedures, are performed by a health care provider on the conditions and in accordance with the procedure provided for in legislation. A health care provider with whom the controller of the Biobank has entered into a tissue sampling agreement ensures the confidentiality and security of the tissue sample and personal data of the gene donor upon collection and transmission of the data of the gene donor and transmits the tissue sample and personal data in accordance with the agreement entered into with the controller of the Biobank.

(3) Based on the information provided by the gene donor themselves, only data on the health status of the gene donor themselves may be collected.

(4) Gene donors may be asked questions about the health data of their biological relatives. Such data may not be used to directly identify a specific person.

(5) The controller may compile the genealogical data of a gene donor on the basis of interviews with the gene donor and the results of human genetic research.

(1) Upon submission to the Biobank, the controller assigns unique pseudonyms to the tissue sample and personal data of gene donors.

(2) In order to verify the accuracy of the personal data of gene donors to be submitted to the Biobank, the controller has the right, prior to pseudonymising the personal data, to compare it with the personal data retained in the databases referred to in subsection 1 of § 9 and with personal data received from the data providers referred to in subsection 2 of § 9 of this Act, and, where necessary, to correct or supplement the data.

(3) The controller replaces all data in the tissue sample and personal data that would allow the gene donor to be directly identified with a pseudonym.

(4) The controller and processor of the Biobank and the controller of scientific research are required to label the tissue sample and personal data, including the genealogical data, with the pseudonym assigned by the controller of the Biobank.

Tissue samples and related data of gene donors are stored on the territory of the Republic of Estonia. The senate of the University of Tartu may, with the permission of the research ethics committee specified in § 27 of this Act and where compelling reasons become evident, grant permission to store a tissue sample and related data and to conduct scientific research outside the territory of the Republic of Estonia, provided that the tissue sample is released in a pseudonymised form and the controller ensures effective control over the use of the tissue sample and compliance of further processing with legislation.

(1) The controller of the Biobank may depseudonymise the personal data of a gene donor without the assessment of the research ethics committee only in the following cases

1) to update, supplement or verify the personal data of a gene donor, either by contacting the gene donor or without contacting the gene donor;

2) to enable access to data kept in the Biobank regarding a gene donor in accordance with the declaration of intention of the gene donor, except for the right to access a genealogical data;

3) to destroy the gene donor’s tissue sample, personal data or data allowing depseudonymisation;

4) in order to identify a gene donor and, with the gene donor’s written declaration of intention, to collect a new tissue sample if a tissue sample has been destroyed or does not contain a sufficient amount of DNA;

5) in order to identify a gene donor within the Biobank and make additions to or amend their genealogical data if the results of genetic research contradict the previously known genealogical data or provide new information concerning the genealogical data;

6) for the transmission of gene donor data to the health information system pursuant to subsection 3 of § 10 of this Act;

7) for the transmission of gene donor data pursuant to subsection 3 of § 13 of this Act;

(2) Depseudonymisation of gene donor data in order to supplement the Biobank with data obtained as a result of scientific research is permitted subject to the prior approval of the research ethics committee specified in § 27 of this Act.

(3) On the basis of the approval of the research ethics committee, the controller of the Biobank may depseudonymise the personal data of a gene donor to contact the gene donor in order to invite them to participate in further scientific research.

(1) The ethics and justification of the use or release of tissue samples and data from the Biobank for research purposes are assessed by an independent research ethics committee consisting of scientists and representatives of various fields referred to in § 26 of the Organisation of Research and Development and Innovation Act.

(2) The research ethics committee gives an assessment in the following cases

1) the activities of the controller of the Biobank in the cases specified in clause 3 of subsection 1 of § 5, § 25 and subsections 2 and 3 of § 26 of this Act;

2) for the release of or access to data in the Biobank in the case specified in subsection 5 of § 13 of this Act.

(1) Unless otherwise provided by law, the applicant pays a cost-based fee for the processing of an application for the use or release of tissue samples and data from the Biobank.

(2) The controller of the Biobank establishes and publishes on its website

1) the procedure for processing applications for the use or release of tissue samples and data from the Biobank;

2) the procedure for the use and release of tissue samples and data from the Biobank;

3) the procedure for the release of a gene donor’s data for participation in scientific research, on the basis of the gene donor’s additional consent;

4) fees for the processing of applications and for the use and release of tissue samples and data.

(3) The controller of the Biobank may grant the right to use the intellectual property of the Biobank for scientific research purposes for a fee determined in an agreement with the controller. The controller of the Biobank compiles and publishes a list of intellectual property on its website.

(4) The controller of the Biobank may establish a fee reduced from the fees specified in subsections 2 and 3 of this section for the following applicants related to scientific research located in the European Union who are performing a public function, provided that the purpose of the scientific research is not aimed at obtaining economic benefit

1) public legal persons and public bodies and institutions entrusted with tasks in the field of public health;

2) evaluated research and education institutions.

(5) The fees specified in this section are paid on the basis of the established rates and procedure to the controller of the Biobank.

(1) The activities of the controller of the Biobank in the administration and maintenance of the Biobank are financed from the state budget through the budget of the Ministry of Social Affairs.

(2) The activities of the controller of the Biobank in the collection of tissue samples, collecting personal data, further processing thereof and conducting scientific research are financed from the state budget and other funds.

(3) The activities of the controller of the Biobank in developing and improving the Biobank are financed from the state budget and other funds, including the fees specified in § 28 of this Act.

(4) The submission of the personal data of a gene donor in the health information system and the activities of the controller of the Biobank which are justified and necessary for this purpose are financed from the state budget and other funds.

(1) The data of the Biobank in the possession of the controller of the Biobank, including tissue samples in the ownership of the controller, are not transferable, except in the case provided for in this Act. Upon the cessation or termination of the activities of the controller of the Biobank, the tissue samples in its possession, the data related to the tissue samples, personal data, genealogical data, and other data processed by the Biobank, as well as the right to process such data, is transferred to the Republic of Estonia.

(2) Before the transfer of the rights specified in subsection 1 of this section, the controller of the Biobank notifies the gene donor of the new controller by using the contact information of the gene donor or by publishing a corresponding notice in the Ametlikud Teadaanded or a nationwide publication.

(1) The provisions of this Chapter apply to the controller of scientific research processing genetic data in human genetic research conducted for the purpose of carrying out scientific research in the Republic of Estonia, for which data are collected or processed in Estonia.

(2) Scientific research means both scientific research carried out without the consent of a person within the meaning of § 6 of the Personal Data Protection Act, and scientific research carried out on the basis of the consent of a person.

(1) Before the processing of genetic data begins, the procedure of the research ethics committee specified in § 26 of the Organisation of Research and Development and Innovation Act must be completed and the approval of the committee must be obtained.

(2) The ethics committee specified in subsection 1 of this section does not give an assessment of the clinical investigation of a medicinal product for human use, the clinical investigation of a medical device and the performance study of an in vitro diagnostic medical device. In the case of such studies, the assessment is carried out by the ethics committee referred to in § 992 of the Medicines Act and § 213 of the Medical Devices Act.

(1) The person specified in subsection 1 of § 31 of this Act must determine in the application for research submitted to the research ethics committee which genetic data are used in human genetic research and appoint the person responsible for data protection and ensure that such a person is available throughout the research.

(2) The research ethics committee publishes in the Estonian Research Information System a list of controllers of human genetic research that have received a favourable assessment, together with the title and short description of the scientific research.

Oversight over compliance with the requirements for the management of public information and processing of personal data provided for in this Act is exercised by the Data Protection Inspectorate.

Data collected in the Biobank before 1 April 2026 are part of the composition of data of the Biobank and form the Biobank dataset which is processed in accordance with the provisions of this Act and the constituent regulations of the Biobank database.

Consent given by a gene donor prior to 1 April 2026 is governed by the provisions regarding consent in effect until that date. The provisions of this Act apply to declarations of intention submitted by gene donors after 1 April 2026.

If the research ethics committee has not made a decision on the application for the use or release of tissue samples and data from the Biobank for the purposes of scientific research by 1 April 2026, the application and the processing fee paid is returned to the applicant.

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[Provisions amending other Acts have been omitted from this text.]

Human Genes Research Act (RT I 2000, 104, 685) is repealed.

(1) This Act enters into force on 1 April 2026.

(2) Clause 17 of § 45 of this Act enters into force on 1 October 2026.