REPUBLIC OF LITHUANIA
LAW
ON ETHICS OF BIOMEDICAL RESEARCH
11 May 2000 No VIII-1679
(As last amended on 21 May 2020 – No XIII-2953)
Vilnius
CHAPTER I
GENERAL PROVISIONS
Article 1. Purpose of the Law
1. This Law shall establish ethical requirements for biomedical research, terms and conditions of processing of human biological samples and processing personal health information for the purposes of biomedical research and activities of biobanks, terms and conditions of issuance of approvals to conduct biomedical research, supervision of the conduct of biomedical research and liability of sponsors and investigators of biomedical research for damage resulting from the subject’s health impairment or death.
2. Paragraphs 4, 6, 7, 9, 10, 13 to 16 and 26 of Article 2, points 3 and 4 of Article 4, points 1, 2, 4, 5, 7 of paragraph 1 and paragraphs 3 and 4 of Article 6, paragraphs 3 and 4 of Article 7, Article 11(5), paragraphs 31 and 4 of Article 12, paragraph 1, point 13 of paragraph 2 and paragraphs 3 to 7 of Article 21, paragraphs 1 to 4, point 3 of paragraph 5 of Article 22, Article 241, Article 25(6) and Article 26 of this Law and the requirements of Regulation (EU) 2017/745 shall apply to the conduct of clinical investigations on medical devices.
3. Paragraphs 4, 6, 7, 9, 10, 111, 13 to 16 and 26 of Article 2, Article 3(8), points 1, 2, 4, 5, 7 of paragraph 1, paragraph 3 of Article 6, paragraphs 3 and 4 of Article 7, Article 11(4), Article 111, paragraphs 1, 2, 32, 33 and 4 of Article 12, paragraph 1, point 3 of paragraph 2 and paragraphs 3 to 7 of Article 21, paragraphs 1 to 4 and point 3 of paragraph 5 of Article 22, Article 242, Article 25(6) and Article 26 of this Law and the requirements of Regulation (EU) 536/2014 shall apply to the conduct of clinical trials on medicinal products.
4. The provisions of this Law have been harmonised with the legal acts of the European Union referred to in the Annex to this Law.
Article 2. Definitions
1. 'Personal health information' (hereinafter: ‘health information’) means data on a person’s health, diseases and health disorders, causes thereof, external factors, diagnosis, course, prognosis, medical treatment, outcome, death, heritability or any other information related to the person's health.
2. 'Provision of personal health information' (hereinafter: ‘provision of health information’) means disclosure of personal health information by transmitting it or making it otherwise available, except for publication thereof in the media.
3. 'Processing of personal health information' (hereinafter: ‘processing of health information’) means any operation which is performed with personal health information such as collection, recording, accumulation, storage, classification, grouping, combining, alteration (supplementation or correction), biomedical research, provision, publication, use, logical and/or arithmetic operations, search, dissemination, destruction or any other action or actions.
4. 'Person who because of the state of his health may not be considered as being capable of reasonably assessing his interests' means an adult adjudged as being incapacitated in the area of health care or of limited legal capacity in the area of health care, or an adult or a married minor, or a minor adjudged as being of full legal capacity (emancipated) whose state of health does not allow him to assess his interests or hinders reasonable assessment thereof.
5. 'Biobank' means a public legal person acting in the capacity of a budgetary or public establishment and holding a licence for personal health care services, including the right to process human biological samples and health information for the purposes specified in this Law and conducting of biomedical research (hereinafter: a ‘licence for biobanking’).
6. 'Bioethical requirements' means the ethical requirements stipulated in legal acts of the Republic of Lithuania and international legal acts and codes of ethics and applicable to the provision of health care services and conducting of biomedical research.
7. 'Biomedical research' means verification of hypotheses of biomedical sciences by means of methods of scientific research pursuing the aim of developing scientific knowledge about human health, diseases, diagnosis, medical treatment or prevention thereof. This term as used in the Articles of this Law, their paragraphs and points specified in Article 1(2) of this Law shall correspond to the term ‘clinical investigation on a medical device’ and have the meanings defined in this paragraph and in point 45 of Article 2 of Regulation (EU) 2017/745. This term as used in the Articles of this Law, their paragraphs and points specified in Article 1(3) of this Law shall correspond to the term ‘clinical trial’ and have the meanings defined in this paragraph and in Article 2(2)(2) of Regulation (EU) 536/2014.
8. 'Biomedical research site' (hereinafter: a 'research site') means a legal person whereat biomedical research is conducted.
9. 'Sponsor of biomedical research' means a natural or a legal person or any other organisation or a branch thereof which takes responsibility for the initiation, for the management and setting up of the financing of biomedical research (except for a clinical trial on a medicinal product and a clinical investigation on a medical device). This term as used in the Articles of this Law, their paragraphs and points specified in Article 1(2) of this Law shall correspond to the term ‘sponsor’ and have the meanings defined in this paragraph and in point 49 of Article 2 of Regulation (EU) 2017/745 while this term as used in the Articles of this Law, their paragraphs and points specified in Article 1(3) of this Law shall correspond to the term ‘sponsor’ and have the meanings defined in this paragraph and in Article 2(2)(14) of Regulation (EU) 536/2014.
10. 'Ethical requirements for biomedical research' means bioethical requirements as established by this Law and applicable to the conducting of biomedical research.
11. 'Ethical supervision of biomedical research' means activities carried out by the Lithuanian Bioethics Committee and/or a regional biomedical research ethics committee and having the purpose of controlling compliance of sponsors and investigators of biomedical research with ethical requirements for biomedical research.
111. ‘Substantial modification of a clinical trial on a medicinal product’ shall correspond to the term 'substantial modification' and have the same meaning as defined in Articles 2(2)(13) of Regulation (EU) 536/2014.
12. 'Informed consent to biobanking' (hereinafter: ‘person’s consent to biobanking’) means a voluntary, explicit and knowing written consent by a person or, in the cases and in accordance with the procedure provided for by this Law, by another person empowered to give the person's consent to biobanking, by the surviving spouse of the deceased person (hereinafter: a 'surviving person') or, where the person is not married, the marriage has been dissolved, the spouse has been declared missing or the spouses have been living separately, by a close relative to process a human biological sample and health information for the purposes specified in this Law.
13. 'Informed consent to participate in biomedical research' (hereinafter: ‘person’s consent to participate in research’) means a voluntary, explicit and knowing written consent to participate in biomedical research, except for a clinical trial on a medicinal product and a clinical investigation on a medical device, signed by a person or, in the cases and in accordance with the procedure provided for by this Law, by another person empowered to give the person’s consent to participate in biomedical research, by the surviving spouse or, where the person is not married, the marriage has been dissolved, the spouse has been declared missing or the spouses have been living separately, by a close relative. This term as used in the Articles of this Law, their paragraphs and points specified in Article 1(2) of this Law shall correspond to the term ‘informed consent' and have the meanings defined in this paragraph and in point 55 of Article 2 of Regulation (EU) 2017/745 while this term as used in the Articles of this Law, their paragraphs and points specified in Article 1(3) of this Law shall correspond to the term ‘informed consent’ and have the meanings defined in this paragraph and in Article 2(2)(21) of Regulation (EU) 536/2014.
14. 'Clinical research' means biomedical research on living human subjects, except for a clinical trial on a medicinal product and a clinical investigation on a medical device. This term as used in the Articles of this Law, their paragraphs and points specified in Article 1(2) of this Law shall have the meanings defined in this paragraph and in point 45 of Article 2 of Regulation (EU) 2017/745 while this term as used in the Articles of this Law, their paragraphs and points specified in Article 1(3) of this Law shall have the meanings defined in this paragraph and in Article 2(2)(2) of Regulation (EU) 536/2014.
141. ‘Clinical investigation on a medical device’ shall correspond to the term 'clinical investigation' and have the same meaning as defined in point 45 of Article 2 of Regulation (EU) 2017/745.
142. ‘Clinical trial on a medicinal product’ shall correspond to the term 'clinical trial' and have the same meaning as defined in Article 2(2)(2) of Regulation (EU) 536/2014.
143. 'Clinical trial site' means a personal health care institution satisfying the requirements established in this Law whereat clinical trials on medicinal products are conducted.
144. ‘Low-intervention clinical trial on a medicinal product’ shall correspond to the term 'low-intervention clinical trial' and have the same meaning as defined in Article 2(2)(3) of Regulation (EU) 536/2014.
15. 'Investigator' means a natural person conducting biomedical research, except for a clinical trial on a medicinal product and a clinical investigation on a medical device, and meeting the requirements established by this Law. This term as used in the Articles of this Law, their paragraphs and points specified in Article 1(2) of this Law shall have the meanings defined in this paragraph and in point 54 of Article 2 of Regulation (EU) 2017/745 while this term as used in the Articles of this Law, their paragraphs and points specified in Article 1(3) of this Law shall have the meanings defined in this paragraph and in Article 2(2)(15) of Regulation (EU) 536/2014.
16. 'Subject' means a person who participates in a biomedical research, except for a clinical trial on a medicinal product or a clinical investigation on a medical product. This term as used in the Articles of this Law, their paragraphs and points specified in Article 1(2) of this Law shall correspond to the term ‘subject’ and have the meanings defined in this paragraph and in point 50 of Article 2 of Regulation (EU) 2017/745 while this term as used in the Articles of this Law, their paragraphs and points specified in Article 1(3) of this Law shall correspond to the term ‘subject’ and have the meanings defined in this paragraph and in Article 2(2)(17) of Regulation (EU) 536/2014.
17. 'Human biological sample' means biological material taken from a living or dead human organism.
18. 'Provision of human biological samples' means transfer of human biological samples or making them otherwise available.
19. 'Processing of human biological samples' means any action performed with human biological samples: procurement, treatment, conservation, collection, storage, identification, assessment, biomedical research, classification, grouping, combining, alteration (supplementation or correction), provision, search, destruction or any other action or actions.
20. 'Human embryo' means the stage of development of a human organism from the moment of impregnation (formation of a zygote) until the end of the eighth week of pregnancy.
21. 'Human embryonic stem cells' means the cells of a human embryo which can divide in vitro and/or can develop into specialised types of cells.
22. 'Human embryonic stem cell line' means the stem cells of a human embryo which can be grown in vitro and divide without differentiating into other types of cells for a long period of time.
23. 'Human stem cells' means the unspecialised cells present during the period of development of a human embryo and a human foetus as well as in tissues of an adult person which are capable to differentiating into specialised cells of different tissue types and renew at the same time.
24. 'Human stem cell line' means the human stem cells which are grown in vitro ensuring their long-term division without differentiation.
25. 'Human foetus' means the stage of development of a human organism from the ninth week of pregnancy until birth.
26. Other terms used in this Law shall be interpreted as they are defined in the Civil Code of the Republic of Lithuania, the Law of the Republic of Lithuania on Insurance, the Law of the Republic of Lithuania on Pharmacy, the Law of the Republic of Lithuania on Equal Treatment, the Law of the Republic of Lithuania on the Rights of Patients and Compensation for the Damage to Their Health, the Law of the Republic of Lithuania on Health Care Institutions, the Law of the Republic of Lithuania on the Health System, the Law of the Republic of Lithuania on Fundamentals of Protection of the Rights of the Child, the Law of the Republic of Lithuania on Donation and Transplantation of Human Tissues, Cells and Organs, the Law of the Republic of Lithuania on the Establishment of Death of a Human Being and on Critical Conditions, Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 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 2016 L 119, p. 1), Regulation (EU) 2017/745 and Regulation (EU) 536/2014.
Article 3. Objects of biomedical research
1. Biomedical research may be undertaken on living or deceased human subjects or their groups, a human embryo, a human foetus, a human biological sample and health information.
2. The creation of human embryos for the purposes of biomedical research shall be prohibited.
3. A human embryo and a human foetus may be subject only of such biomedical research where the potential benefit to the human embryo and human foetus under investigation exceeds risks.
4. It shall be prohibited to undertake biomedical research on a human embryo and a human foetus who died after an abortion at a woman's request, in the absence of medical indications.
5. Cloning of a human being shall be prohibited.
6. Biomedical research on human embryos or human foetuses during which or after which a human embryo or a human foetus is destroyed or a human embryo is not placed into a woman's uterus shall be prohibited.
7. Biomedical research involving modifications of the human genome may only be carried out for preventive, diagnostic or therapeutic purposes and only in the cases when it is not intended to modify the genome of descendants.
8. Import into the territory of the Republic of Lithuania and export therefrom of tissues of a human embryo, embryonic stem cells and lines thereof or tissues of a foetus and the stem cells taken therefrom and lines thereof shall be prohibited. This prohibition shall not apply to the import into the territory of the Republic of Lithuania and export therefrom of the stem cells taken from umbilical cord or placenta after the birth of a child and the samples taken for genetic research in accordance with requirements of paragraph 3 of this Article. Transit through the territory of the Republic of Lithuania of tissues of a human embryo, embryonic stem cells and lines thereof or tissues of a human foetus and the stem cells taken therefrom and lines thereof shall be possible only subject to an authorisation by the Minister of Health. The Description of the Procedure for Issuing Authorisations for the Transit through the Territory of the Republic of Lithuania of Tissues of Human Embryos, Embryonic Stem Cells and Lines Thereof or Tissues of a Human Foetus and the Stem Cells Taken Therefrom and Lines Thereof as well as the Description of the Procedure for Importing into the Territory of the Republic of Lithuania and Exporting Therefrom of the Human Stem Cells Taken from the Umbilical Cord or Placenta after the Birth of a Child and the Human Biological Samples Taken for Genetic Research shall be approved by the Minister of Health.
Article 4. Prohibition of discrimination
It shall be prohibited to discriminate against a person, restrict his rights or legitimate interests:
1) by virtue of processing or non-processing of human biological samples and health information by a biobank;
2) on grounds of human biological samples and health information processed by a biobank;
3) by virtue of the person's participation or non-participation in biomedical research;
4) on grounds of biomedical research results.
CHAPTER II
ETHICAL REQUIREMENTS FOR BIOMEDICAL RESEARCH
Article 5. Ethical requirements for biomedical research
1. Biomedical research must be conducted according to the principle that the interests of a human being prevail over the interests of society and science.
2. Biomedical research may be conducted only if all of the following conditions are fulfilled:
1) biomedical research has scientific and practical merit;
2) biomedical research may not be replaced by another research without the involvement of human beings;
3) protection of interests of the subject and confidentiality of his health information are ensured;
4) the person's consent to participate in research (except for the cases referred to in Article 7(5) and (11) of this Law) has been obtained or, when biomedical research is conducted on the human biological samples and health information processed in a biobank, the person's consent to biobanking has been obtained;
5) having refused to give his consent to participate in research or his consent to biobanking or having withdrawn it, the person will retain the right to adequate personal health care;
6) comprehensive data of relevant pre-clinical tests are available (applies only to clinical research);
7) risks and inconveniences that the subject may suffer are not greater than the benefits of biomedical research. In the case of clinical research, it shall be possible not to provide the subject with personal health care applicable according to normal clinical practice only in a situation where the effectiveness of personal health care applicable according to normal clinical practice has not been proven and the risks and inconveniences that the subject may suffer are not greater than the benefits of biomedical research, or where non-provision of such personal health care does not pose a threat to the health of the subject;
8) the principal investigator and the sponsor of biomedical research are covered, in the cases specified by Article 12(2) of this Law, by the third-party insurance for compensation to the subject of the possible pecuniary and non-pecuniary damage caused in the course of biomedical research;
9) the documents of the institutions indicated in Article 20 of this Law granting the right to conduct biomedical research have been obtained;
10) there are no prohibitions against it in other laws.
Article 6. Vulnerable subjects and protection of their interests
1. The following subjects shall be regarded as vulnerable subjects whose consent to participate in biomedical research may be influenced by external factors or who are wholly or in part incapable of defending their interests:
1) persons who because of the state of their health may not be considered as being capable of reasonably assessing their interests;
2) minors;
3) students, where their participation in biomedical research is related to their studies;
4) persons in social nursing homes;
5) servicemen in the active military service;
6) personnel of health care institutions where biomedical research is being conducted who are subordinate to the investigator;
7) persons in imprisonment institutions or other places of detention.
2. Other groups of persons may be recognised as vulnerable subjects by a reasoned decision of the Lithuanian Bioethics Committee or a regional biomedical research ethics committee when considering documents for the issue of an approval to conduct biomedical research or by a reasoned decision of the Lithuanian Bioethics Committee when considering documents for the issue of a favourable opinion to conduct a clinical trial on a medicinal product.
3. Clinical research may be conducted on vulnerable subjects only in the following cases:
1) when clinical research is possible only with vulnerable subjects and there is a scientific basis for believing that participation in clinical research will yield direct benefit to the subject, which will be greater than the risks and inconveniences associated with the clinical research;
2) when clinical research is only possible with vulnerable subjects and clinical research is directly related to the state of health of the subject and there is a scientific basis for believing that participation in clinical research will be useful for the group of persons not participating in research whereto the subject belongs, and the interventional research methods applicable to the subject for the purposes of clinical research have minor and temporary undesirable effects on the health of the subject;
3) when clinical research is directly related to a state of health posing a threat to or having a debilitating impact on the subject in the case whereof there is no adequate personal health care, and there is a scientific basis for believing that participation in clinical research will yield direct benefit to the subject, which will be greater than the risks and inconveniences associated with clinical research.
4. It shall be allowed to conduct clinical investigations on a medical device with persons specified in points 4, 5 and 7 of paragraph 1 of this Article in the cases referred to in paragraph 3 of this Article.
Article 7. Person's consent to participate in research
1. Before involving a person in biomedical research, except for biomedical research which is undertaken on the human biological samples and/or health information processed in a biobank with his consent to biobanking, the person's consent to participate in research must be obtained. The person's consent to participate in research must meet all of the following conditions:
1) the consent to participate in research has been given by the person capable of expressing his will;
2) the consent to participate in research has been given upon receipt by the person of adequate and clear information in accordance with the procedure laid down in paragraph 8 of this Article;
3) the consent to participate in research has been given freely by the person (in the cases and in accordance with the procedure laid down by this Law, by another person empowered to give a person's consent to participate in research, the surviving spouse or, where the person is not married, the marriage has been dissolved, the spouse has been declared missing or the spouses have been living separately, by a close relative referred to in paragraph 5 of this Article in the order of priority);
4) the consent to participate in research meets detailed requirements for the person's consent to participate in research as established by the Minister of Health.
2. If a person, due to a physical handicap, illness or for other reasons, is unable to sign the person's consent to participate in research, the person's consent to participate in research shall be signed in accordance with the procedure laid down by the Civil Code.
3. A minor must be provided with the information referred to in paragraph 8 of this Article according to his age and capacity of understanding, With regard to a minor’s participation in biomedical research, the person’s consent to participate in research shall be given by the minor’s statutory representatives, however if the minor who is capable of understanding the information provided to him expresses his wish not to participate in the biomedical research or, if the minor is already involved in such a biomedical research, to discontinue his participation therein, the minor's participation in the research shall not commence or shall be terminated, unless this is contrary to the interests of the minor. The issue of whether a minor’s wish not to participate in the research is contrary to the minor’s interests shall be decided by the minor’s statutory representatives having regard to the investigator’s opinion. Where a decision on the participation of a minor in biomedical research involves a conflict of interests between the minor and the minor's statutory representatives or between the minor's statutory representatives, the decision on the participation of the minor in biomedical research shall be made in accordance with the procedure laid down in Article 3.163 of the Civil Code. Where minors are involved in biomedical research, a representative of the Child Rights Protection and Adoption Service under the Ministry of Social Security and Labour shall attend a meeting of the Lithuanian Bioethics Committee when taking a decision on the conclusion of the ethical review of an application for a clinical trial on a medicinal product with regard to the aspects covered in Articles 6 and/or 7 of Regulation (EU) No 536/2014 (hereinafter: the 'conclusion of the ethical review of an application for a clinical trial on a medicinal product'), the conclusion of the ethical review of an application for the substantial modification of a clinical trial on a medicinal product with regard to the aspects covered in Article 6 and/or Article 7 of Regulation (EU) No 536/2014 (hereinafter: the 'conclusion of the ethical review of an application for the substantial modification of a clinical trial on a medicinal product') or the conclusion of the ethical review of an application for a clinical investigation on a medical device concerning the compliance of the clinical investigation on the medical device with the requirements established in Regulation (EU) 2017/745 and in this Law. The procedure for a minor’s participation in biomedical research shall be laid down by the Minister of Health and the Minister of Social Security and Labour.
4. With regard to the participation in biomedical research of an adult or a married minor or a minor recognised by a court as being of full legal capacity (emancipated) whose state of health does not allow him to assess his interests or prevents him from making a reasonable assessment of his interests, the person's consent to participate in biomedical research shall be given by the person's spouse,or, where the person is not married or the marriage has been dissolved, or the person's spouse has been declared missing or the spouses have been living separately, by one of the person's parents/adoptive parents or one of the person's adult children/adopted children, unless one of the person's parents/adoptive parents has expressed his objection to the person's participation in biomedical research (in this case, it is prohibited to undertake biomedical research on the person), or, if the person has designated an appointed representative in accordance with the procedure laid down in the Law on the Rights of Patients and Compensation for the Damage to Their Health, by the appointed representative. With regard to a person who has been adjudged as being incapacitated in the area of health care, the person's consent to participate in biomedical research shall be given by his guardian and with regard to a person who has been adjudged as being of limited legal capacity in the area of health care, such consent shall be given by the person's curator and the said person himself. The subject must be provided with the information referred to in paragraph 8 of this Article according to his capacity of understanding. The investigator shall take into account the wish of the subject capable of assessing the information provided to him not to participate in biomedical research or, if the subject is already involved in such biomedical research, the wish to withdraw from it.
5. Where prior to his death a person did not give his consent to participate in research or did not withdraw it, the person's consent that biomedical research on a human biological sample/samples and health information of the deceased be conducted shall be given by the surviving spouse or, where the person was not married, the marriage was dissolved, the spouse was declared missing or the spouses lived separately, by one of his close relatives in the following order of priority: parents/adoptive parents, adult children/adopted children, brothers/sisters, grandparents, grandchildren. If the consent is given by one of the above-mentioned persons in the order of priority, the consent of other close relatives of the deceased shall not be asked for. If one of the above-mentioned persons expresses his objection in the order of priority, it shall be prohibited to conduct biomedical research on a human biological sample/samples and health information of the deceased.
6. A person and any other person who is referred to in paragraphs 3 and 4 of this Article and who is empowered to give the person's consent to participate in research (hereinafter: 'any other person empowered to give the person's consent to participate in research') may be informed and the person's consent to participate in research may be obtained after the inclusion of the person in biomedical research, provided that all of the following conditions are fulfilled:
1) due to a critical condition or another medical condition which requires urgent aid, the person is unable to receive the information referred to in paragraph 8 of this Article and give the person's consent to participate in research, and a person who because of the state of his health may not be considered as capable of reasonably assessing his interests or the minor is unable to receive the information referred to in paragraph 8 of this Article and to express his willingness or unwillingness to participate in biomedical research;
2) there are scientific grounds to expect that the participation of the person in biomedical research will produce a direct and significant benefit to his health, that is, his suffering will be alleviated and/or health will improve, or conditions will be provided to diagnose an illness or predict the course thereof;
3) the person must without delay undergo a biomedical research diagnostic or medical procedure (hereinafter: a 'procedure'), which precludes the provision of the information referred to in paragraph 8 of this Article and obtaining of the person's consent to participate in research from another person empowered to give the person's consent to participate in research;
4) the investigator certifies that he is not aware of any objections to participate in biomedical research previously expressed by the person concerned;
5) biomedical research relates directly to the person's medical condition which requires undertaking an urgent procedure, which precludes the provision of the information referred to in paragraph 8 of this Article and obtaining the person's consent to participate in research from the person or another person empowered to give the person's consent to participate in research, and biomedical research is of such a nature that it can be conducted exclusively in the presence of acute life-threatening or other acute serious medical conditions;
6) biomedical research poses a minimal risk to, and imposes a minimal burden on, the person’s health in comparison with personal health care treatment of the subject’s condition according to standard clinical practice.
7. A person involved in biomedical research under the conditions referred to in paragraph 6 of this Article may continue to participate in the biomedical research after he is provided the information referred to in paragraph 8 of this Article, also information about the right to object to further use for the purpose of biomedical research of the health information obtained in the course of the biomedical research, when the person objects to continuing participation in the research, and the consent to participate in the research is obtained from the following persons:
1) a minor’s statutory representatives, when the subject is a minor, or another person empowered to give a person’s consent to participate in research, when the subject is a person who because of the state of his health may not be considered as being capable of reasonably assessing their interests – without delay, as soon as it becomes possible to provide them with the information referred to in paragraph 8 of this Article and to obtain from them a person’s consent to participate in research;
2) the subject – without delay, as soon as the subject becomes capable of reasonably assessing his interests.
8. Before giving his consent to participate in research, a person or, in the cases provided for by this Law, another person empowered to give the person’s consent to participate in research, the surviving spouse or, where the person is not married, the marriage has been dissolved, the spouse has been declared missing or the spouses have been living separately, a close relative referred to in paragraph 5 of this Article in the order of priority, having regard to the age and state of health of the person giving the consent to participate in research, must be informed in a comprehensible manner, by explaining specific medical terms, about:
1) the purpose of biomedical research;
2) the design of biomedical research;
3) the methods applicable in the course of biomedical research;
4) an approval to conduct biomedical research issued by the Lithuanian Bioethics Committee or a regional biomedical research ethics committee as indicated in Article 20 of this Law;
5) foreseeable benefits of biomedical research to the subject;
6) rights of the subject;
7) risks and inconveniences of biomedical research for the subject;
8) the procedure for compensating for the damage which could be caused in the course of biomedical research;
9) the right to withdraw his consent to participate in research at any time, providing to him information about the consequences of such withdrawal;
10) guarantees of confidentiality of health information.
9. The investigator shall provide a person or, in the cases provided for by this Law, any other person empowered to give the person’s consent to participate in research or the surviving spouse or, where the person is not married, the marriage has been dissolved, the spouse has been declared missing or the spouses have been living separately, a close relative referred to in paragraph 5 of this Article in the order of priority with a clear, free-of-charge and practicable possibility of withdrawing, at a written request, the person’s consent to participate in research. The results of biomedical research obtained through conducting biomedical research before receipt of the person’s request to withdraw the person’s consent to participate in research shall not be destroyed.
10. Detailed requirements for the content of the person’s consent to participate in biomedical research and information indicated in paragraph 8 of this Article as well as a procedure for giving and withdrawing the consent shall be lay down by the Minister of Health.
11. A decision on whether a person’s consent to participate in research is necessary for conducting biomedical research on a person’s biological sample and/or health information which has been obtained for the purpose of provision of personal health care, statistical or other purposes before applying for undertaking research on this person shall be taken by the Lithuanian Bioethics Committee or a regional biomedical research ethics committee issuing an approval to conduct biomedical research.
Article 8. Person's consent to biobanking
1. Human biological samples and health information shall be processed for the purposes specified in Article 16(1) of this Law only subject to obtaining a person's consent to biobanking. The person's consent to biobanking must meet all of the following conditions:
1) the person's consent to biobanking has been given by a person capable of expressing his will;
2) the person's consent to biobanking has been given upon receipt by the person of adequate and clear information in accordance with the procedure laid down in paragraph 6 of this Article;
3) the person's consent to biobanking has been given freely by the person (in the cases and in accordance with the procedure laid down by this Law - another person empowered to give the person's consent to participate in research, the surviving spouse or, where the person is not married, the marriage has been dissolved, the spouse has been declared missing or the spouses have been living separately, a close relative referred to in paragraph 5 of this Article in the order of priority);
4) the person's consent to biobanking meets detailed requirements for the content of person's consent to biobanking as established by the Minister of Health.
2. If a person, due to a physical handicap, illness or for other reasons, is unable to sign a person's consent to biobanking, the person's consent to biobanking shall be signed in accordance with the procedure laid down by the Civil Code.
3. A person's consent to biobanking in respect of the processing of a minor's biological sample and health information for the purposes specified in Article 16(1) of this Law shall be given by the minor's statutory representatives.
4. With regard to the processing of human biological samples and health information of an adult or a married minor or a minor recognised by a court as being of full legal capacity (emancipated) whose state of health does not allow him to assess his interests or prevents him from making a reasonable assessment of his interests, the person's consent to participate in biobanking shall be given by the person's spouse or, where the person is not married or the marriage has been dissolved, or the person's spouse has been declared missing or the spouses have been living separately, by one of the person's parents/adoptive parents, or one of the person's adult children/adopted children, unless one of the person's parents/adoptive parents or one of the person's adult children/adopted children has expressed his objection to the person's participation in biobanking (in this case, it is prohibited to involve the person in biobanking), or, if the person has designated an appointed representative in accordance with the procedure laid down in the Law on the Rights of Patients and Compensation for the Damage to Their Health, by the appointed representative. With regard to a person who has been adjudged as being incapacitated in the area of health care, the person's consent to biobanking shall be given by his guardian and with regard to a person who has been adjudged as being of limited legal capacity in the area of health care, such consent shall be given by the person's curator and the said person himself.
5. A person's consent to biobanking in respect of the processing of a human biological sample of a deceased person and his health information for the purposes specified in Article 16(1) of this Law shall be given by the surviving spouse or, where the person was not married, marriage was dissolved, the spouse has been declared missing or the spouses lived separately, by one of his close relatives in the following order of priority: parents/adoptive parents, adult children/adopted children, brothers/sisters, grandparents, grandchildren. If the consent is given by one of the above-mentioned persons in the order of priority, the consent of other close relatives of the deceased shall not be asked for. If one of these persons objects in the order of priority, it shall be prohibited to use the deceased person's human biological sample and health information in biobanking.
6. Before giving his consent to biobanking, a person, any other person who is specified in paragraphs 3 and 4 of this Article and who is empowered to give the person's consent to biobanking (herainafter: 'any other person empowered to give the person's consent to biobanking), the surviving spouse or, where the person is not married , a close relative referred to in paragraph 5 of this Article in the order of priority, having regard to the age and the state of health of the person giving the consent to biobanking, must be informed in a manner comprehensible to him, by explaining specific medical terms, about:
1) the meaning of the person's consent to biobanking, potential benefits, inconveniences and risks to the person;
2) the objectives and means of processing of a biological sample and health information, including obtaining of health information from health care institutions, registers and/or state information systems, and the fact that the objectives and means of specific biomedical research on the human biological sample and health information concerned at the moment of giving a person's consent to biobanking may be unknown due to the insufficient level of development of science or technology or for other objective reasons;
3) a possibility to access information contained in the biobank regarding the use of his (or deceased person's) human biological sample and health information and the objectives pursued by such a use;
4) guarantees of the confidentiality of health information and the statement that the biobank provides human biological samples and/or health information or the biomedical research results obtained from the use thereof or a part thereof enabling the identification of the person only by a reasoned decision of the court, where it is necessary for the hearing of a case in court;
5) the right to withdraw the person's consent to biobanking.
7. A minor or a person who because of the state of his health may not be considered as capable of reasonably assessing his interests must be provided with the information referred to in paragraph 6 of this Article according to his capacity of understanding and his wish not to grant to a biobank a permission to process his biological sample and health information for the purposes specified in Article 16(1) of this Law, and where a person's consent to biobanking has already been given, to withdraw this consent must be respected.
8. A biobank may process human biological samples remaining after surgery, invasive and/or interventional procedures and health information for the processing of which a person has not given the person's consent to biobanking in accordance with the procedure laid down in this Article, but only to the extent necessary for the preservation of these human biological samples and, where the person would give the person's consent to biobanking within one month after a surgery, an invasive and/or interventional procedure, for the processing of the samples in the biobank, while health information may be processed by a biobank only to the extent necessary for the assessment of the suitability of such human biological samples for the purposes set out in Article 16(1) of this Law. Where the person or, in the cases specified by this Law, any other person empowered to give the person's consent to biobanking does not give the person's consent to biobanking within the time limit laid down in this paragraph, the biobank must forthwith destroy a human biological sample and health information stored in the biobank. Information that human biological samples and health information may be processed in the biobank in accordance with the procedure laid down in this paragraph must be available to patients at personal health care institutions.
9. Any invasive and/or interventional procedure whose sole purpose is receipt and further processing of a human biological sample/samples in a biobank and undertaking of biomedical research on it/them rather than a person's medical treatment or diagnosis shall be permitted only if a person's consent to biobanking contains a consent to procure a human biological sample for this purpose.
10. A biobank shall provide a person or, in the cases provided for by this Law, any other person empowered to give the person's consent to biobanking or the surviving spouse or a close relative with a clear, free-of-charge and practicable possibility of withdrawing, at a written request, the person's consent to biobanking. At the person's written request to withdraw the person's consent to biobanking, the human biological sample and health information stored in the biobank may not be processed, and the human biological sample and health information transferred to the persons indicated in Article 17 of this Law may not be used and must be destroyed in accordance with the procedure laid down by the Minister of Health, and the person must be notified thereof. The biomedical research results obtained through biomedical research on human biological samples and health information before receipt of the person's request to withdraw the person's consent to biobanking shall not be destroyed.
11. Detailed requirements for the content of the person's consent to biobanking and information indicated in paragraph 6 of this Article shall be set out and a procedure for giving and withdrawing the person's consent to biobanking shall be laid down by the Minister of Health.
Article 9. Confidentiality of health information
1. The health information obtained in the course of biomedical research and enabling a person's identification shall be confidential and may be provided solely in accordance with the procedure laid down by the Law on the Rights of Patients and Compensation for the Damage to Their Health.
2. The health information obtained in the course of biomedical research shall not be considered as confidential and may be published without the subject's consent, where the publication of such health information will not enable the person's identification.
Article 10. Compensation for expenses
Subjects shall be entitled to compensation for the expenses incurred due to participation in biomedical research and the time spent. The procedure for calculating and paying compensation shall be laid down by the Government of the Republic of Lithuania (hereinafter: the 'Government') or an institution authorised by it.
Article 11. Sponsor and investigator of biomedical research
1. A sponsor of biomedical research shall be responsible for the initiation, management and funding of the biomedical research.
2. An investigator shall be responsible for the conduct of a biomedical research at a research site. Where the investigator himself conducts the biomedical research or leads a team of individuals conducting the biomedical research at the research centre and is responsible for the activities of this team, he shall be referred to as the principal investigator.
3. An investigator, except for an investigator conducting biomedical research indicated in paragraphs 4 and 5 of this Article, must possess a higher education qualification and experience conforming to the nature of the biomedical research. When conducting a biomedical research involving the interventional biomedical research methods which pose a risk to the subject's health, an investigator must also hold a relevant licence of a personal health care professional, have experience in patient care and be employed at a research site. Specific requirements for the higher education qualification and experience of the investigator who applies an interventional biomedical research method posing a risk to the subject's health shall be established by the Minister of Health.
4. In the case of a clinical trial on a medicinal product, an investigator must possess a higher education qualification conforming to the nature of the clinical trial on the medicinal product, the right to practise medicine or dentistry, as appropriate, at least one year's experience in patient care, and should have completed the good clinical practice courses within the last five years or should have acted, during that period, as an investigator in a clinical trial of a medicinal product, and should have been employed at a clinical trial site. The procedure for organising good clinical practice courses and the requirements for the development of good clinical practice training programmes shall be approved and the specific requirements for the higher education qualification of an investigator conducting a clinical trial on a medicinal product shall be adopted by the Minister for Health. When conducting the biomedical research indicated in this paragraph, the principal investigator must have also experience in the area of clinical trials of a medicinal product. A person may be employed as the principal investigator only at one site conducting the same research.
5. When a clinical investigation on a medical device is conducted, investigators who perform actions assigned to the competence of personal health care professionals in accordance with laws and other legal acts of the Republic of Lithuania on the subjects must possess a higher education qualification conforming to the nature of the clinical investigation on the medical device, and the right to engage in the relevant practice of personal health care. In the case of investigations referred to in this paragraph, the principal investigator must also have experience in the clinical investigation on the medical device conforming to the nature of such investigations. The specific experience requirements for the principal investigator shall be established by the Minister for Health. Other investigators involved in conducting the clinical investigation on the medical device must possess a higher education qualification conforming to the nature of the clinical investigation on the medical device. The clinical investigation with the medical device must be conducted in the clinical investigation site which must be authorised to provide personal health care services required for the clinical investigation of the medical device.
Article 111. Clinical trial site
A clinical trial site must be authorised to provide personal health care services required for a clinical trial on a medicinal product.
Article 12. Compensation for pecuniary and non-pecuniary damage suffered by a subject
1. The sponsor of biomedical research and the investigator shall be liable for the pecuniary and non-pecuniary damage suffered by the subject, except for the pecuniary and non-pecuniary damage resulting from causes unrelated to biomedical research or from deliberate acts of the subject. The sponsor of biomedical research and the investigator shall assume solidary liability for the pecuniary and non-pecuniary damage indicated in this paragraph and suffered by the subject, unless the sponsor and the investigator of biomedical research agree otherwise in writing. The pecuniary and non-pecuniary damage caused to the subject's health by the sponsor and the investigator of biomedical research shall be compensated for in accordance with the procedure laid down by the Civil Code, the Law on Insurance and other legal acts.
2. The sponsor of biomedical research (other than a clinical investigation on a medical device) in which the interventional research methods applied to the subject for the purpose of research pose a risk to the subject's health, as well as the sponsor and the principal investigator of a clinical trial on a medicinal product must insure themselves against civil liability for the possible pecuniary and non-pecuniary damage resulting from the subject’s health injury or death by concluding compulsory insurance contracts with insurers for the civil liability of the sponsor and the principal investigator of biomedical research, except for the cases referred to in paragraph 3 of this Article, where biomedical research is permitted even without compulsory insurance against the civil liability of the sponsor of the biomedical research and the principal investigator. Whether the interventional research methods used for the purpose of biomedical research (other than a clinical trial on a medical device) pose a risk to the subject's health shall be assessed by the Lithuanian Bioethics Committee or by a regional biomedical research ethics committee, which authorises the conduct of a biomedical research.
3. A low-intervention clinical trial on a medicinal product as well as other biomedical research (other than a clinical investigation on a medical device) in which the interventional biomedical research methods applied to the subject have only a slightly detrimental and temporary impact on his health shall be permitted to be conducted by a personal health care institution which itself or its employee is the sponsor of, or whose employee is the principal investigator of, such a biomedical research, even without concluding a compulsory insurance against civil liability on the part of the sponsor and the principal investigator of biomedical research. In the case referred to in this paragraph, the pecuniary and non-pecuniary damage caused to the subject's health by the sponsor and the investigator of biomedical research shall be compensated for in accordance with the procedure laid down in the Law on the Rights of Patients and Compensation for the Damage to Their Health, with the funds of an account managed by an institution authorised by the Government, where such an account accumulates the contributions made by health care institutions to compensate for the damage to the health of patients (pecuniary and non-pecuniary).
31. In the case of a clinical investigation on a medical device in which the research methods used for the purpose of research pose a risk to the health of a subject, the sponsor of the investigation and the principal investigator must be covered by the insurance against civil liability for the possible pecuniary and non-pecuniary damage resulting from injury to the health of the subject or the death of the subject, by concluding with an insurer a contract of compulsory insurance against civil liability on the part of the sponsor and the principal investigator of biomedical research. A low-intervention clinical investigation on a medical device in which the biomedical research methods applied to a subject have only a slightly detrimental and temporary impact on his health shall be permitted to be conducted by a personal health care institution which itself or its employee is the sponsor of, or whose employee is the principal investigator of, such biomedical research, even without concluding a compulsory insurance against civil liability on the part of the sponsor and the principal investigator of biomedical research. In the case referred to in this paragraph, the pecuniary and non-pecuniary damage caused to the subject's health by the sponsor and the investigator of biomedical research shall be compensated in accordance with the procedure laid down in the Law on the Rights of Patients and Compensation for the Damage to Their Health, with the funds of an account managed by an institution authorised by the Government, where such an account accumulates the contributions made by health care institutions to compensate for the damage to the health of patients (pecuniary and non-pecuniary). When assessing an application for a clinical investigation on a medical device and an application for the substantial modification of a clinical investigation pursuant to the List of Biomedical Research Methods Causing a Slightly Detrimental and Temporary Impact on the Subject’s Health as approved by the Minister of Health, the State Health Care Accreditation Agency under the Ministry of Health and the Lithuanian Bioethics Committee shall assess whether the research methods used for the purposes of the clinical investigation on the medical device pose a risk to the subject's health and whether the research methods used for the purposes of the clinical investigation on the medical device have a slightly detrimental and temporary impact on the subject's health. The State Health Care Accreditation Agency under the Ministry of Health and the Lithuanian Bioethics Committee may, by a reasoned decision, recognise as causing a slightly detrimental and temporary impact on the subject’s health also other methods of a clinical investigation on a medical device which are not included in the List of Interventional Biomedical Research Methods Causing a Slightly Detrimental and Temporary Impact on the Subject’s Health, pursuant to the criteria set out by the Minister of Health.
32. When assessing a request for authorisation of a clinical trial on a medicinal product as well as accompanying documents (hereinafter: an 'application for a clinical trial on a medicinal product') or a request for authorisation of the substantial modification of a clinical trial on a medicinal product as well as accompanying documents (hereinafter: an 'application for the substantial modification of a clinical trial on a medicinal product'), the Lithuanian Bioethics Committee and the State Medicines Control Agency of Lithuania (hereinafter: the 'State Medicines Control Agency') shall assess whether the clinical trial on the medicinal product is a low-intervention clinical trial.
33. The Lithuanian Bioethics Committee or a regional biomedical research ethics committee issuing an approval to conduct biomedical research shall assess pursuant to the List of Interventional Biomedical Research Methods Causing a Slightly Detrimental and Temporary Impact on the Subject’s Health, as approved by the Minister of Health, whether interventional research methods applied for the purposes of biomedical research, except for a clinical trial on a medicinal product and clinical investigations on medical devices, have a slightly detrimental and temporary impact on the subject's health. The Lithuanian Bioethics Committee or the regional biomedical research ethics committee may, by a reasoned decision, recognise as causing a slightly detrimental and temporary impact on the subject’s health also other interventional biomedical research methods which are not included in the List of Interventional Biomedical Research Methods Causing a Slightly Detrimental and Temporary Impact on the Subject’s Health, pursuant to the criteria set out by the Minister of Health.
4. The amount of compulsory insurance against civil liability of the sponsor of biomedical research and the principal investigator may not be less than EUR 29 000 as regards compensation for pecuniary and non-pecuniary damage caused to a single subject. The compulsory insurance cover against civil liability of the sponsor of biomedical research and the principal investigator must be effective from the commencement of biomedical research until completion thereof and for not less than five years from the completion of biomedical research. Rules for compulsory insurance against civil liability of the sponsor of biomedical research and the principal investigator, which stipulate other terms and conditions of the contract of compulsory insurance against civil liability of the sponsor of biomedical research and the principal investigator the procedure for calculating and paying the amount of compensation for pecuniary and non-pecuniary damage caused to the subject's health shall be established by the Government or an institution authorised by it.
CHAPTER III
TERMS OF BIOBANKING
Article 13. Biobanking
1. Biobanks shall carry out their activity in compliance with the requirements of this Law, the Law on Legal Protection of Personal Data and the Law on Health Care Institutions, while respecting the rights and freedoms of individuals and observing the principles of transparency, reliability, data security and openness.
2. Biobanks shall process human biological samples and health information for the purposes specified in Article 16(1) of this Law.
3. Biobanks shall be entitled:
1) to be sponsors of biomedical research and to conduct biomedical research;
2) to cooperate, in accordance with the procedure laid down by legal acts, with biobanks of the European Union Member States, other states of the European Economic Area and third countries and international organisations and to participate in activities thereof;
3) to obtain health information in accordance with the procedure laid down in Article 15 of this Law.
Article 14. Licensing of biobanks
1. A public legal person acting in the capacity of a budgetary or public establishment and seeking to be issued and having been issued a licence to engage in biobanking must meet the requirements established in the Law on Heath Care Institutions for the issue of a licence to engage in healthcare and the following requirements:
1) ensure that the requirements established in the Description of Requirements for Biobanking as approved by the Minister of Health for the purpose of ensuring the traceability, security, quality and availability to investigators of human biological samples and health information are met by:
a) premises, equipment and material used for human biological samples and processing of health information;
b) the system of organisation, management and processing as regards the processing of human biological samples and health information;
2) appoint an employee responsible for conformity of the processing of human biological samples and health information to requirements of legal acts.
2. A licence to engage in biobanking shall be issued, suspended, suspension thereof shall be lifted and the licence shall be revoked in accordance with the procedure laid down by the Law on Health Care Institutions.
Article 15. Right of a biobank to obtain health information
1. Upon receipt of a person’s consent to biobanking, a biobank shall have the right to obtain the health information of a person whose human biological sample and health information are processed in the biobank from health care institutions, registers and/or state information systems in accordance with the procedure laid down by law.
2. A biobank shall have the right to obtain health information from other legal persons indicated in a person’s consent to biobanking, where such health information is not available in registers and/or state information systems and to health care institutions or its provision would require from the health care institutions unreasonably high material costs and/or time.
3. A biobank shall exercise the rights indicated in this Article at its own discretion or at the request of the sponsor of biomedical research, his authorised representative or the principal investigator.
Article 16. Processing of human biological samples and health information
1. The processing of human biological samples and health information in a biobank shall pursue the following goals:
1) provision, in accordance with the procedure laid down by this Law, of human biological samples and health information to the persons referred to in Article 17 of this Law;
2) use, in accordance with the procedure laid down by this Law, of human biological samples and health information for the purposes of biomedical research;
3) improvement of the quality of stored biological samples or their suitability for future biomedical research, use of the biological samples which are unsuitable for biomedical research for the purposes of improvement of preparation of such samples for storage, storage technologies and quality control procedures and carrying out of other actions of improvement of the biobanking process.
2. Biobanks shall ensure the processing traceability, security, quality and availability to investigators of human biological samples and health information in accordance with the procedure laid down in the Description of Requirements for Biobanking.
3. The health information processed in a biobank shall be confidential and be processed in accordance with the procedure laid down by law. The confidentiality of the health information processed in the biobank shall be ensured by all natural and legal persons using such health information, also the entities referred to in Article 15(1) and (2) of this Law.
4. The health information processed by a biobank shall not be considered as confidential and may be published without the consent of a person who has given a person's consent to biobanking, where the publication of such health information will not enable the person's identification.
5. A biobank shall encode a human biological sample and/or health information received and shall process separately the personal data enabling identification of a person whose biological samples and/or health information is processed in the biobank, while providing a possibility to identify a specific person.
Article 17. Provision of human biological samples and/or health information as well as of information which is important for a person's health
1. The human biological samples and health information processed in a biobank may be provided to the sponsor of biomedical research, his authorised representative or the principal investigator upon receipt of an approval to conduct biomedical research by the institutions provided for in Article 20 of this Law.
2. The human biological samples and health information processed in a biobank may be provided to other biobanks of the Republic of Lithuania, the European Union Member States and other states of the European Economic Area and third countries, to the sponsor of biomedical research, his authorised representative or the principal investigator conducting biomedical research outside the Republic of Lithuania where the biobank providing the human biological samples and health information obtains an approval of the Lithuanian Bioethics Committee for the provision of the human biological samples and/or health information processed in the biobank.
3. An approval for the provision of the human biological samples and/or health information processed in a biobank shall be issued where the Lithuanian Bioethics Committee decides that:
1) objectives of the provision of the human biological samples and health information correspond to the scope of a person's consent to biobanking given by the person concerned;
2) the persons referred to in paragraph 2 of this Article are in possession of the authorisations issued by the ethics committee of their country of operation and/or other institutions and granting the right to process the human biological samples and/or health information for the purposes of biomedical research.
4. A procedure for issuing an approval for the provision of the human biological samples and/or health information processed in a biobank shall be laid down by the Minister of Health.
5. A biobank shall provide human biological samples and health information or the results of biomedical research obtained from their use or a part of such results, where they enable the person's identification, only by a reasoned decision of a court, where it is necessary for the hearing of a case in court.
6. The sponsor of biomedical research, his authorised representative or the principal investigator shall notify a biobank of information which emerged in the course of biomedical research on the person's biological sample and health information and which is important for the person's health. The biobank shall assess the notified information based on the criteria for the information of importance for a person's health which must be notified and, upon establishing that such information must be provided, shall notify it to the person concerned, another person empowered to give a person's consent to biobanking or the person's treating physician. Criteria for the information of importance for a person's health which must be notified in accordance with the procedure laid down in this Article and the procedure for notifying it shall be laid down by the Minister of Health.
Article 18. State supervision of biobanking
The state supervision of biobanking shall be carried out within the respective remit by the Lithuanian Bioethics Committee and the State Health Care Accreditation Agency under the Ministry of Health.
Article 19. Publicity of biobanking
Biobanks shall publish information on their activity in accordance with the procedure laid down by the Minister of Health.
CHAPTER IV
SUPERVISION OF CONDUCT OF BIOMEDICAL RESEARCH
Article 20. Institutions authorising the conduct of biomedical research (except for clinical trial on medicinal products and clinical investigations on medical devices)
Approvals to conduct biomedical research, except for clinical trials on medicinal products and clinical investigations on medical devices, shall be issued by the Lithuanian Bioethics Committee in the case provided for in Article 21(2)(2) of this Law or a regional biomedical research ethics committee in the case provided for in Article 22(5)(1) of this Law.
Article 21. Lithuanian Bioethics Committee
1. The Lithuanian Bioethics Committee shall be a budgetary institution financed from the state budget and other state monetary funds. The rights and duties of the owner of the Lithuanian Bioethics Committee shall be exercised by the Ministry of Health of the Republic of Lithuania (hereinafter: the 'Ministry of Health').
2. The Lithuanian Bioethics Committee shall:
1) analyse challenges of bioethics and consult state and municipal institutions, agencies and organisations on the issues of bioethics, submit conclusions and proposals relating to the draft laws and other legal acts regulating these issues;
2) issue approvals to conduct biomedical research, except for clinical trials on medicinal products and clinical investigations on medical devices, where the biomedical research is planned to be conducted at the research sites located within the territory attributed to activities of more than one regional biomedical research ethics committee, and carry out ethical supervision of such research;
3) perform the ethical review of an application for a clinical trial on a medicinal product and an application for the substantial modification of a clinical trial on a medicinal product with regard to the aspects covered in Articles 6 and/or 7 of Regulation (EU) No 536/2014 and submit the conclusion of the ethical review of the application for the clinical trial on the medicinal product and the conclusion of the ethical review of the application for the substantial modification of the clinical trial on the medicinal product in accordance with the procedure laid down in Article 242 of this Law;
4) issue authorisations to provide the human biological samples and/or health information processed in biobanks to the persons referred to in Article 17(2) of this Law;
5) in accordance with the procedure laid down by the Minister of Health, keep a registry of biomedical research, accumulate, store and provide information thereon while ensuring protection of confidential information;
6) prepare and approve sample forms of the documents issued by the Lithuanian Bioethics Committee and regional biomedical research ethics committees and submitted to the Lithuanian Bioethics Committee and the regional biomedical research ethics committees;
7) supervise activities of regional biomedical research ethics committees;
8) annually report to the Ministry of Health about its own activities and make proposals to address challenges of bioethics;
9) supervise compliance with bioethical requirements by health care institutions and the institutions providing personal and public healthcare services;
10) provide methodological assistance and consult medical ethics commissions of health care institutions and other institutions on the issues of bioethics;
11) represent the Republic of Lithuania at international organisations within its remit;
12) perform the ethical review of an application for a clinical investigation on a medical device and an application for the substantial modification of a clinical investigation on a medical device with regard to the aspects covered in Regulation (EU) No 2017/745 and this Law as well as submit the conclusion of the ethical review of the application for the clinical investigation on the medical device and the conclusion of the ethic review of the application for the substantial modification of the clinical investigation on the medical device in accordance with the procedure laid down in Article 241 of this Law;
13) perform other functions as prescribed in this Law, other laws and the regulations of the Lithuanian Bioethics Committee.
3. The Lithuanian Bioethics Committee shall issue approvals to conduct biomedical research, submit conclusions of the ethical review of applications for clinical trials on medicinal products and conclusions of the ethical review of applications for the substantial modification of clinical trials on medicinal products regarding the conformity of the clinical trial on the medicinal product or the substantial modification of the clinical trial on the medicinal product, respectively, to requirements established in Regulation (EU) No 536/2014 and submit conclusions of the ethical review of applications for clinical investigations on medical devices and conclusions of the ethical review of applications for the substantial modification of clinical investigations on medical devices regarding the conformity of the clinical investigation on the medical device or the substantial modification of the clinical investigation on the medical device, respectively, to requirements established in Regulation (EU) 2017/745 and in this Law, subject to the approval of the Group of Biomedical Research Experts of the Lithuanian Bioethics Committee. The Group of Biomedical Research Experts of the Lithuanian Bioethics Committee shall take a decision in the cases referred to in points 2 and 3 of paragraph 5 of Article 22 of this Law upon the evaluation of proposals by regional biomedical research ethics committees.
4. The Group of Biomedical Research Experts of the Lithuanian Bioethics Committee shall consist of nine members, of whom five experts are professionals of biomedical sciences, three are professionals holding a degree in the area of social sciences or humanities and one representative of a patients' organisation. Professionals of biomedical sciences shall, within the time limit and in accordance with the procedure laid down by the Minister of Health, be nominated to the Group of Biomedical Research Experts of the Lithuanian Bioethics Committee by associations of personal health care professionals, professionals of social sciences or humanities shall be nominated by the universities teaching bioethics or health law subjects, whereas a representative of the patients' organisation shall be nominated by patients' organisations. The composition of the Group of Biomedical Research Experts of the Lithuanian Bioethics Committee shall be approved by the Minister of Health acting in compliance with the principles of impartiality and transparency and having regard to the professional qualifications and competence of candidates and their experience in the area of ethics of biomedical research. The operating arrangements of this Group shall be set out by the Minister of Health.
5. The term of office of a member of the Group of Biomedical Research Experts of the Lithuanian Bioethics Committee shall be four years. A person may serve as a member of the Group of Biomedical Research Experts of the Lithuanian Bioethics Committee for no longer than two terms in succession.
6. The mandate of a member of the Group of Biomedical Research Experts of the Lithuanian Bioethics Committee shall expire with the expiry of his term of office, when he resigns or when he is recalled by the Minister of Health on the recommendation of an association or institution which nominated him or in the cases when he no longer can perform the duties of a member of the Group of Biomedical Research Experts of the Lithuanian Bioethics Committee due to an illness or when he dies. In such cases, where the term of office of the Group of Biomedical Research Experts of the Lithuanian Bioethics Committee is not expired, a new candidate for a member of the Group of Biomedical Research Experts of the Lithuanian Bioethics Committee shall be nominated, and the new member of this Group shall be approved in accordance with the procedure laid down by this Law.
7. The work of the members of the Group of Biomedical Research Experts of the Lithuanian Bioethics Committee shall be remunerated in accordance with the procedure laid down by the Law of the Republic of Lithuania on Remuneration of Employees of State and Municipal Agencies and Members of Commissions.
Article 22. Establishment of regional biomedical research ethics committees and remit thereof
1. Regional biomedical research ethics committees shall be established under universities offering three-cycle medical studies. Funds shall be provided for activities of the regional biomedical research ethics committees in the state budget appropriations allocated to the Ministry of Health.
2. The procedure for establishing regional biomedical research committees, carrying out activities thereof and addressing the issues falling within their remit shall be laid down by regulations of regional biomedical research committees which shall be approved by the rector of a university in agreement with the Minister of Health. The territorial jurisdiction of the regional biomedical research ethics committees shall be specified by the Minister of Health.
3. Regional biomedical research ethics committees shall be established in accordance with the procedure laid down by regulations of the regional biomedical research ethics committees and consist of nine members:
1) two professionals of biomedical sciences holding a scientific degree and two professionals of social sciences or humanities holding a scientific degree shall be appointed by a university under which a regional biomedical research ethics committee has been established;
2) three health care professionals from the health care institutions operating in the area and a professional of social sciences or humanities shall be appointed by the Minister of Health;
3) one member shall be appointed by patients' organisations.
4. The composition of a regional biomedical research ethics committee shall be approved by a university rector in agreement with the Minister of Health. The term of office of a member of the regional biomedical research ethics committee shall be four years. A person may serve on the regional biomedical research ethics committee for no longer than two terms in succession.
5. A regional biomedical research ethics committee shall:
1) issue approvals to conduct biomedical research, except for clinical trials on medicinal products, and clinical investigations on medical devices, where the biomedical research is planned to be conducted at the research sites located solely within the territory attributed to activities of an appropriate regional biomedical research ethics committee;
2) make proposals to the Lithuanian Bioethics Committee where the biomedical research, except for clinical trials on medicinal products and clinical investigations on medical devices, is planned to be conducted at the research sites located within the territory attributed to activities of more than one regional biomedical research ethics committee;
3) make proposals to the Lithuanian Bioethics Committee regarding the ethical review of an application for a clinical trial on a medicinal product with regard to the aspects covered in Article 7 of Regulation (EU) No 536/2014 as well as make proposals to the Lithuanian Bioethics Committee regarding the ethical review of an application for a clinical investigation on a medical device with regard to the aspects covered in Regulation (EU) No 2017/745 and this Law, where the clinical trial on the medicinal product and the clinical investigation on the medical device are planned to be conducted within the territory attributed to their activities;
4) carry out ethical supervision of the biomedical research for which it has issued the approval;
5) keep a registry of issued approvals;
6) report to the Lithuanian Bioethics Committee in accordance with the procedure laid down by it.
Article 23. Receipt and consideration of documents and issuance of approvals
1. In order to obtain an approval to conduct biomedical research, the sponsor, an authorised representative thereof and/or the principal investigator shall submit to the Lithuanian Bioethics Committee or to a regional biomedical research ethics committee the documents a list whereof shall be approved by the Minister of Health. The documents must be considered and the approval to conduct biomedical research must be issued or a reasoned refusal to issue it must be given not later than within 45 calendar days of receipt of all duly executed documents.
2. The procedure for issuing approvals to conduct biomedical research shall be laid down by the Minister of Health.
3. The Lithuanian Bioethics Committee or a regional biomedical research ethics committee shall take a decision not to issue an approval to conduct biomedical research where, based on the submitted documents, it is established that the biomedical research contradicts the requirements for biomedical research ethics established in Chapter II of this Law, incomplete and/or false documentation and/or information has been submitted, and the instruction to eliminate these shortcomings has not been complied with.
4. A state fee of the established amount shall be paid for expert examination of the documents submitted for the issuance of an approval to conduct biomedical research and for the issuance of approvals.
Article 24. Suspension of an approval to conduct biomedical research, lifting of the suspension and revocation of the approval to conduct biomedical research
1. An approval to conduct biomedical research shall be suspended in the following cases:
1) violations of the requirements for biomedical research ethics established in Chapter II of this Law have been identified, which could significantly undermine subjects' rights, security, health and/or the quality and/or integrity of biomedical research data, or information on possible violations of this kind is available;
2) when requested by the sponsor of a biomedical research, his authorised representative or the principal investigator;
3) repealed as of 26 May 2021.
2. Upon adopting a decision on suspension of an approval to conduct biomedical research on the ground indicated in point 1 of paragraph 1 of this Article, a notice thereof shall be given not later than within three calendar days from the adoption of the decision to the sponsor of biomedical research, the principal investigator and the head of a research site and a time limit for eliminating the violations identified shall be laid down. This time limit may not exceed 30 calendar days, except for the cases when, for objective reasons, elimination of the violations requires a longer period of time or when an approval to conduct biomedical research is suspended at the request of the sponsor of biomedical research or the principal investigator on grounds other than violations. The sponsor of biomedical research, the principal investigator and the head of the research site must ensure that biomedical research is immediately discontinued.
3. A decision to lift the suspension of an approval shall be adopted where no violations are identified or upon eliminating the violations or, where the approval to conduct biomedical research is suspended at the request of the sponsor of biomedical research, his authorised representative or the principal investigator on grounds other than violations, when the sponsor of biomedical research, his authorised representative or the principal investigator file an application for annulling the decision on suspension of the approval to conduct biomedical research.
4. An approval to conduct biomedical research shall be revoked in the following cases:
1) violations of the requirements for biomedical research ethics established in Chapter II of this Law have been identified, which could significantly undermine subjects' rights, security, health and/or the quality and integrity of biomedical research data and which may not be eliminated upon suspending the biomedical research;
2) violations of the requirements for biomedical research ethics established in Chapter II of this Law have been identified, which could significantly undermine subjects' rights, security, health and/or the quality and integrity of biomedical research data, on the basis of which the approval to conduct biomedical research has been suspended and which have not been eliminated within the specified time limit;
3) when requested by the sponsor of a biomedical research, his authorised representative or the principal investigator;
4) where the sponsor of biomedical research, his authorised representative or the principal investigator fail to file an application for lifting the suspension of the approval within two years from the adoption of a decision to suspend the approval to conduct biomedical research on the ground indicated in point 2 of paragraph 1 of this Article;
5) repealed as of 26 May 2021.
5. Upon taking a decision to revoke an approval to conduct biomedical research, the sponsor of a biomedical research, his authorised representative or the principal investigator as well as the head of a research centre shall be notified thereof in writing not later than within three calendar days from the taking of the decision and must ensure that biomedical research is immediately terminated.
6. Powers to suspend an approval to conduct biomedical research, to lift the suspension of the approval and to revoke the approval to conduct biomedical research shall be vested in an institution which has issued such an approval.
Article 241. Institutions authorising and supervising clinical investigations on medical devices
1. The State Health Care Accreditation Agency under the Ministry of Health shall carry out an assessment of an application for a clinical investigation on a medical device with regard to the aspects covered in Article 71 of Regulation (EU) 2017/745 and shall issue an approval to conduct the clinical investigation on the medical device, provided that, on the basis of the assessment as well as on the basis of the conclusion of the ethical review of the application for the clinical investigation on the medical device submitted by the Lithuanian Bioethics Committee, the clinical investigation on the medical device complies with the requirements established by Regulation (EU) 2017/745.
2. An approval to conduct a clinical investigation on a medical device shall be issued within the time limits set out in Article 70(7)(b) of Regulation (EU) 2017/745.
3. The State Health Care Accreditation Agency under the Ministry of Health shall carry out an assessment of an application for the substantial modification of a clinical investigation on a medical device with regard to the aspects covered in Article 71 of Regulation (EU) 2017/745 and shall issue an approval to undertake the substantial modification of the clinical investigation on the medical device, provided that, on the basis of the assessment as well as on the basis of the conclusion of the ethical review of the application for the clinical investigation on the medical device submitted by the Lithuanian Bioethics Committee, the modification of the clinical investigation on the medical device complies with the requirements established by Regulation (EU) 2017/745.
4. An approval to undertake the substantial modification of a clinical investigation on a medical device shall be issued within the time limits set out in paragraphs 3 and 4 of Article 75 of Regulation (EU) 2017/745.
5. Applications for a clinical investigation on a medical device and applications for the substantial modification of a clinical investigation on a medical device shall be submitted and assessed in accordance with the procedure laid down in Regulation (EU) 2017/745 and the procedure laid down by the Minister of Health.
6. The State Health Care Accreditation Agency under the Ministry of Health shall perform the functions of a Member State referred to in Chapter VI of Regulation (EU) 2017/745 and ensure, in accordance with the procedure laid down by the Minister of Health, that the information of the electronic system on clinical investigations referred to in Article 73 of Regulation (EU) 2017/745 is accessible to the Lithuanian Bioethics Committee and regional biomedical research ethics committees.
7. The Lithuanian Bioethics Committee shall participate in the assessment of the information referred to in Article 80 of Regulation (EU) 2017/745 in accordance with the procedure laid down in Article 80 of Regulation (EU) 2017/745.
8. The State Health Care Accreditation Agency under the Ministry of Health and the Lithuanian Bioethics Committee shall supervise within the remit referred to in this Article whether clinical investigations on medical devices are in compliance with the requirements of Regulation (EU) 2017/745 and of this Law.
9. The Lithuanian Bioethics Committee requests the State Health Care Accreditation Agency under the Ministry of Health to take the measures provided for in Article 76 of Regulation (EU) 2017/745 when the Committee has grounds for considering that the requirements established in Regulation (EU) 2017/745 are not met.
10. The State Health Care Accreditation Agency under the Ministry of Health shall apply measures provided for in Article 76 of Regulation (EU) 2017/745 when it has grounds for considering that the requirements established in Regulation (EU) 2017/745 are not met.
11. Decisions of the State Health Care Accreditation Agency under the Ministry of Health to refuse to issue an approval to conduct a clinical investigation on a medical device, to refuse to issue an approval to undertake the substantial modification of a clinical investigation on a medical device, as well as decisions on the application of the measures referred to in Article 76(1) of Regulation (EU) 2017/745 may be appealed against in accordance with the procedure laid down in the Law of the Republic of Lithuania on Administrative Proceedings.
Article 242. Institutions authorising and supervising clinical trials on medicinal products
1. The State Medicines Control Agency shall perform scientific assessment of an application for a clinical trial on a medicinal product with regard to the aspects covered in Articles 6 and/or 7 of Regulation (EU) 536/2014 and shall issue an approval to conduct the clinical trial on the medicinal product, provided that, on the basis of this assessment as well as on the basis of the conclusion of the ethical review of the application for the clinical trial on the medicinal product submitted by the Lithuanian Bioethics Committee, the clinical trial on the medicinal product complies with the requirements established out in Regulation (EU) 536/2014.
2. The State Medicines Control Agency shall perform scientific assessment of an application for the substantial modification of a clinical trial on a medicinal product with regard to the aspects covered in Articles 6 and/or 7 of Regulation (EU) 536/2014 and shall issue an approval to undertake the substantial modification of the clinical trial on the medicinal product, provided that, on the basis of this assessment as well as on the basis of the conclusion of the ethical review of the application for the substantial modification of the clinical trial on the medicinal product submitted by the Lithuanian Bioethics Committee, the modification of the clinical trial on the medicinal product complies with the requirements established in Regulation (EU) 536/2014.
3. The Lithuanian Bioethics Committee shall submit the conclusion referred to in paragraphs 1 and 2 of this Article to the State Medicines Control Agency at the latest two working days before the expiry of the time limit for the assessment of a relevant application as set out in Article 8(1), Article 14(3), Article 19(1), Article 20(5) or Article 23(1) of Regulation (EU) No 536/2014.
4. The State Medicines Control Agency shall perform the functions, as indicated in Chapters II, III and XIII of Regulation (EU) No 536/2014, of the national contact point specified in Article 83 of Regulation (EU) No 536/2014 in accordance with the procedure laid down by a reporting Member State or, where the Republic of Lithuania is a reporting Member State pursuant to Regulation (EU) No 536/2014, in accordance with the procedure laid down by a Member State concerned and the Minister of Health. The Agency shall ensure that the Lithuanian Bioethics Committee and regional biomedical research ethics committees have access to the EU portal referred to in Article 80 of Regulation (EU) No 536/2014.
5. The Lithuanian Bioethics Committee shall participate in the assessment of the information referred in Articles 42 and 43 of Regulation (EU) 536/2014 in accordance with the procedure laid down in Article 44 of Regulation (EU) 536/42.
6. The Lithuanian Bioethics Committee shall requests the State Medicines Control Agency to take the measures provided for in Article 77 of Regulation (EU) 536/2014 when the Committee has justified grounds for considering that the requirements established in Regulation (EU) 536/2014 are not met.
Article 25. Procedure for examining complaints
1. The sponsor of biomedical research, his authorised representative and/or the principal investigator shall have the right to appeal against a decision of a regional biomedical research ethics committee to refuse the issuance of an approval or to revoke or suspend the approval to the Lithuanian Bioethics Committee within 15 calendar days from receipt of such a decision. The Lithuanian Bioethics Committee must examine this appeal and take a decision within 30 calendar days from its receipt.
2. Filing of an appeal shall not suspend the execution of a decision to revoke or suspend an approval to undertake biomedical research.
3. Upon examining an appeal by the sponsor of a biomedical research, his authorised representative or the principal investigator against a decision of a regional biomedical research ethics committee decision to refuse the issuance of an approval to conduct biomedical research or to revoke or suspend the approval to conduct biomedical research, the Lithuanian Bioethics Committee shall take a decision:
1) to dismiss the appeal by the sponsor of biomedical research, his authorised representative and/or the principal investigator and to uphold the decision of the regional biomedical research ethics committee or
2) to uphold the appeal of the sponsor of biomedical research, his authorised representative or the principal investigator and to issue the approval or to take a decision to annul the decision to revoke or suspend the approval to undertake biomedical research.
4. A decision of the Lithuanian Bioethics Committee shall, not later than within five working days from the taking thereof, be dispatched to a person who has filed an appeal and to a regional biomedical research ethics committee which has taken a decision appealed against.
5. Repealed as of 31 January 2022.
6. The subjects or other persons empowered to give a person’s consent to participate in research in the cases specified in this Law shall have the right to appeal to an institution which has issued an approval or to court in accordance with the procedure laid down by law and other legal acts against actions of the sponsor of biomedical research, his authorised representative, the principal investigator and other persons conducting biomedical research.
7. The persons whose biological sample and/or health information is processed by a biobank shall have the right to appeal against actions of the biobank in accordance with the procedure laid down by laws and other legal acts.
CHAPTER V
FINAL PROVISIONS
Article 26. Liability for infringements of ethical requirements for biomedical research
1. Persons in breach of requirements of this Law shall be held liable under law.
2. The fact of undertaking biomedical research without an authorisation or not in compliance with the requirements established by this Law and other legal acts, provided the research has not caused either pecuniary or non-pecuniary damage to the subject’s health, shall be held equivalent to an act of malpractice.
I promulgate this Law passed by the Seimas of the Republic of Lithuania.
PRESIDENT OF THE REPUBLIC VALDAS ADAMKUS
Annex to
the Republic of Lithuania Law
on Ethics of Biomedical Research
LEGAL ACTS OF THE EUROPEAN UNION IMPLEMENTED BY THIS LAW
1. Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ 2014 L 158, p. 1).
2. Regulation (EU) No 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ 2017 L 117, p. 1).