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REPUBLIC OF LITHUANIA

REPUBLIC OF LITHUANIA Official translation REPUBLIC OF LITHUANIA LAW ON ETHICS OF BIOMEDICAL RESEARCH 11 May, 2000 No. VIII-1679 Vilnius CHAPTER ONE GENERAL PROVISIONS Article

  1. Purpose of the Law
  2. This Law shall set forth requirements and principles for ethics of biomedical research, the procedure for giving approval to conduct biomedical research, the procedure for control of conducting biomedical research and liability for infringement of the provisions of this Law.
  3. Biomedical research must be conducted according to the principle whereby the interests of the human being prevail over the interests of society and science. Article
  4. Definitions
  5. Biomedical research means verification of hypotheses of biomedicine by methods of scientific investigation and development of knowledge about characteristics of human health.
  6. Ethics of biomedical research means adherence to the ethical requirements and principles in the conduct of biomedical research provided for in this Law.
  7. Principal investigator means a scientist having contractual relations with the sponsor of biomedical research and health care institutions where biomedical research is conducted. Where biomedical research is performed by a team of individuals, its members shall be called investigators for whom the requirements are set by the responsible leader - the principal investigator. In the case of research involving medical documents, the principal investigator shall be a scientist or a licensed medical doctor having contractual relations with the sponsor of biomedical research and health care establishments where biomedical research is conducted.
  8. Sponsor of biomedical research means a natural or a legal person, or an enterprise without the status of a legal person, which initiates, finances, supervises biomedical research and takes responsibility for its conduct, consequences and publication of the research findings.
  9. Research subject means an individual who participates in biomedical research.
  10. Representative of the trial subject means a legally acceptable representative or an appointed representative. The authorisation of the appointed representative must be executed in the manner prescribed by laws of the Republic of Lithuania.
  11. Informed consent (hereinafter consent) means an express written agreement given with full consciousness of the consequences by the research subject to participate in the research.
  12. Approval means an authorisation granted by the Lithuanian Bioethics Committee or the Regional Biomedical Research Ethics Committee to conduct biomedical research.
  13. Clinical research means biomedical research involving human subjects.
  14. Non-clinical research means biomedical research not involving human subjects.
  15. Confidentiality of information means prevention of disclosure of information about the state of health of the research subject, diagnosis, prognosis, treatment and other personal data related to the subject’s health.
  16. Moral harm means harm resulting from the activities of the principal investigator and other individuals conducting biomedical research which do not conform to the requirements of medical ethics. These requirements of medical ethics shall be established by the Lithuanian Bioethics Committee. Article
  17. Objectives, Subjects and Characteristics of Biomedical Research
  18. Biomedical research may be carried out with individuals or their groups, a foetus, tissues, organs, cells and genetic material, cadavers and medical documents. Individuals or their groups and a foetus may be subjects of biomedical research only where comprehensive data about appropriate non-clinical research is available. Non-clinical research must be carried out in conformity with the Guidelines for Good Laboratory Practice approved by the Ministry of Health. Clinical research must be conducted in accordance with the Guidelines for Good Clinical Practice approved by the Ministry of Health.
  19. Human embryos may be subjects only of clinical observations (non-invasion investigations). Other clinical investigations involving human embryos and their creation for purposes of biomedical research shall be prohibited. Human embryos may be subjected to such biomedical research where the medical risks for the embryo are not disproportionate to the potential benefits.
  20. Cloning of a human being shall be prohibited.
  21. The character of biomedical research involving cadavers and research involving medical documents shall be defined by law and by the Lithuanian Bioethics Committee. CHAPTER TWO REQUIREMENTS FOR ETHICS OF BIOMEDICAL RESEARCH Article
  22. Requirements for Ethics of Biomedical Research Biomedical research may only be undertaken if the following requirements are met: 1) biomedical research has scientific and practical merit; 2) protection of the interests of the research subject and confidentiality of information about him has been ensured; 3) free and informed consent of the research subject has been obtained; 4) the investigator and the sponsor of biomedical research are covered by the third party insurance against any harm to the research subject; 5) an approval has been given by the Lithuanian Bioethics Committee or the Regional Biomedical Research Ethics Committee; 6) there are no prohibitions against it in other laws. Article
  23. Vulnerable Subjects
  24. Vulnerable subjects shall be individuals whose willingness to volunteer in biomedical research may be unduly influenced by external circumstances. The following subjects shall be regarded as vulnerable: 1) persons with mental disorders but able to give their consent to take part in biomedical research; 2) minors; 3) students if their participation in biomedical research is related to their studies; 4) persons in nursing homes; 5) soldiers in the active military service; 6) personnel of health care institutions where biomedical research is being conducted who are subordinate to the investigator.
  25. Biomedical research may not be performed on persons kept in prisons or other places of detention.
  26. Other groups of persons may be recognised as/ attributed to vulnerable persons by a reasoned decision of the Lithuanian Bioethics Committee.
  27. Additional measures for the protection of their interests specified in Article 7 of this Law shall be applicable to vulnerable persons. Article
  28. Protection of the Interests of the Research Subject With a view to protecting the interests of the research subject, biomedical research shall be undertaken if the following conditions are met: 1) biomedical research may not be replaced by any another research without the involvement of human beings; 2) free and informed consent of the subject has been obtained; 3) the subject who does not give his consent to participate in biomedical research or who withdraws his consent shall not be deprived of his right to be provided adequate health care; 4) the risks that may be incurred by the research subject must not be disproportionate to the potential benefits he derives from participation in the research. As a rule, the expected treatment may not be administered to the research subject only when its efficacy has not been proved or when not administering it does not pose a risk to the health of the research subject; 5) the principal investigator and the sponsor of biomedical research are covered by the third party insurance for compensation of damage caused to the research subject’s health and death resulting from biomedical research. Article
  29. Protection of Vulnerable Persons
  30. Biomedical research involving vulnerable persons shall be permitted if all the following conditions are met: 1) this kind of biomedical research may be carried out only on vulnerable persons; 2) the results of biomedical research have the potential to produce real and direct benefit to the health of research subjects; 3) a biomedical research shall not pose a risk to the health or life of a research subject.
  31. If the subject is a minor, consent to undertake a biomedical research shall be given by both parents or legally acceptable representatives of the minor, and the children’s rights protection agency of a district or a city. If the parents of a minor are separated, consent of one of the parents or of the legally acceptable representative and of the district or city children’s rights protection agency must be obtained.
  32. The consent of a person who has a mental disorder but may give his free and informed consent to take part in a biomedical research must be attested by two witnesses and the head of a health care establishment where a biomedical research is being conducted. Approval of the Medical Ethics Commission must also be obtained. The procedure of forming the Medical Ethics Commission and conducting its activities shall be laid down in the model regulations of the Medical Ethics Commission of a health care establishment approved by the Ministry of Health. Article
  33. Consent of the Research Subject
  34. Biomedical research shall be carried out after the research subject has given his written consent. Before giving his consent, the research subject shall be provided information understandable to him and attested by his signature about the aims, plan of the research and methods to be applied, decisions of the Lithuanian Bioethics Committee or an appropriate Regional Biomedical Research Ethics Committee as well as about the following: 1) benefits of the prospective biomedical research for the subject; 2) the rights, foreseeable risks and inconveniences which biomedical research may cause to the subject as well as the compensation available to the subject in the event of a research related injury; 3) the right of the research subject to withdraw in writing his consent to participate in biomedical research at any time, and providing to him information about the consequences of discontinuing biomedical research; 4) guarantees of confidentiality of the information.
  35. Whether the subject’s informed consent is necessary for carrying out biomedical research on tissues, organs, a foetus, cell or genetic material which had been obtained from the person for other purposes during medical interventions before requesting the subject to give his consent, also when biomedical research involves medical documents, shall be decided by the Lithuanian Bioethics Committee or the Regional Biomedical Research Ethics Committee giving their approval. Article
  36. Confidentiality of Information
  37. Information obtained in the course of biomedical research about the research subject’s health, diagnosis, prognosis, treatment and other health related personal information shall be kept confidential and may be made publicly available only in the manner set forth in the Law on Patients’ Rights and Compensation for Damage to Health.
  38. The information obtained in the course of biomedical research about the subject’s health, diagnosis, prognosis, treatment and other health related facts of a personal character shall not be regarded as confidential and may be made publicly available without the consent of the subject if the subject’s identity remains undisclosed when such information is made available. Article
  39. Reimbursement of Expenses Research subjects shall be entitled to reimbursement of expenses for participating in biomedical research. The procedure of calculation of the expenses and their payment shall be determined by the Government or a body authorised by it. Article
  40. Civil Liability of the Sponsor and the Principal Investigator of Medical Research and its Insurance
  41. The sponsor and the principal investigator of biomedical research shall be liable for damage resulting from injury to the health of a research subject or his death as well as for research-related non-pecuniary (moral) damage, if they fail to prove that damage has resulted from causes unrelated to biomedical research or from deliberate acts of the research subject. In the event of death of a research subject caused by biomedical research or by the consequences of such research, the sponsor and the principal investigator of biomedical research must compensate for damage to persons referred to in Article 88 of the Law on Health System.
  42. The extent of moral damage in its monetary expression, with account of the gravity of the offence, its consequences and other circumstances, may not exceed LTL 10,
  44. The sponsor and the principal investigator of biomedical research must be covered by the third party insurance against research-related damage under Compulsory Third Party Insurance Contracts of the Principal Investigator and the Sponsor of Biomedical Research concluded with insurance companies having an authorisation of the State Insurance Supervisory Authority at the Ministry of Finance to provide this type of insurance. This requirement shall be applicable only where biomedical research is carried out on human subjects.
  45. The Regulations of Compulsory Third Party Insurance of Principal Investigators and Sponsors of Medical Research establishing the extent of health damage to a research subject and the manner of compensation for it shall be approved by the Government or a body authorised by it. CHAPTER THREE REVIEW OF BIOMEDICAL RESEARCH Article
  46. Institutions Issuing Approvals
  47. Biomedical research in Lithuania may be performed only subject to an approval obtained from the Lithuanian Bioethics Committee or the Regional Biomedical Research Ethics Committee. Conduct of biomedical research without a prior approval shall be unlawful.
  48. Approvals shall be granted by the Lithuanian Bioethics Committee which shall have the right to mandate the Regional Biomedical Research Ethics Committee to perform these functions. If the Regional Biomedical Research Ethics Committee fails to perform these functions in the appropriate manner, his right to issue approvals may be suspended by a reasoned decision of the Lithuanian Bioethics Committee.
  49. Approvals for clinical trials of medicinal products shall be issued on the recommendation of the State Medicines Control Agency. Article
  50. Establishment of the Lithuanian Bioethics Committee and its Competence
  51. The Lithuanian Bioethics Committee shall be established and its composition and regulations shall be approved by the Ministry of Health. The Lithuanian Bioethics Committee shall be a legal person. Its activities shall be financed from the state budget.
  52. The Lithuanian Bioethics Committee shall : 1) analyse problems of bioethics and consult central and local authorities, agencies and organisations on these issues, submit conclusions and proposals relating to laws and other legal acts regulating problems of bioethics; 2) issue approvals for conducting biomedical research and undertake ethical review of research and monitoring of the activities of Regional Biomedical Research Ethics committees; 3) annually report to the Ministry of Health about its own activities and make proposals on how to address bioethical problems; 4) review whether individual and public health care is in conformity with the requirements of medical ethics and monitor compliance of legal persons with the requirements of bioethics; 5) provide methodological assistance and consult medical ethics committees of health care establishments on the issues relating to their activities; 6) within the scope of their competence represent Lithuania in international organisations; 7) perform other functions provided for in its regulations.
  53. The Lithuanian Bioethics Committee, according to the procedure determined by the Ministry of Health, shall keep a record of biomedical research, gather, store and provide information about the research, ensuring protection of confidential information; it shall also design and approve model document forms.
  54. To address specific problems of bioethics ad hoc commissions may be formed by the Government. Article
  55. Formation of Regional Biomedical Research Ethics Committees and their Competence
  56. Regional Biomedical Research Ethics Committees shall be formed in the counties having universities and shall be composed proportionally of representatives of the degree-holding academic community, health care specialists and the general public. The quotas of representation in the committees, the number of committee members and composition of the committees, the territory of their jurisdiction shall be established by the Lithuanian Bioethics Committee which shall also approve model operating procedures of the committees
  57. Regional Biomedical Research Ethics Committees shall: 1) grant approvals when mandated this function by the Lithuanian Bioethics Committee; 2) monitor biomedical research for which they have given their approval; 3) keep a record of biomedical research for which they have given their approval and communicate information from the record to the Lithuanian Bioethics Committee; 4) make an annual report about their activities to the Lithuanian Bioethics Committee; 5) perform other functions mandated to them by the Lithuanian Bioethics Committee. Article
  58. Receipt and Examination of Applications and Issue of Approvals
  59. The sponsor and/or the principal investigator of biomedical research who seek an approval shall submit to the Lithuanian Bioethics Committee or the Regional Biomedical Research Ethics Committee an application and a list of documents determined by the Ministry of Health. The application and documents must be examined and an approval must be issued or a reasoned refusal to grant it must be given within 45 calendar days from the registration of the application and all the documents, and after payment of all the fees for biomedical research expert examination.
  60. The Lithuanian Ethics Committee or the Regional Biomedical Research Ethics Committee shall make a cost estimate for expert examination of biomedical research, communicate it to the sponsor and/or the principal investigator of biomedical research who have filed an application and documents, and shall set the deadline for payment of the expenses. When the Lithuanian Bioethics Committee or the Regional Biomedical Research Ethics Committee make a decision to refuse to issue an approval, the amount paid for expert examination of biomedical research shall not be refunded to the sponsor and/or the principal investigator of biomedical research. Where sponsors of research are state institutions of higher education, state scientific institutions or state and municipal health care institutions, or where biomedical research involves medical documents, expert examination shall be provided free of charge.
  61. The procedure for issuing approvals shall be determined by a body authorised by the Government.
  62. The Lithuanian Bioethics Committee or the Regional Biomedical Research Ethics Committee shall have the right to make a decision not to issue an approval if the information provided in the application and the documents does not conform to the requirements of ethics of biomedical research laid down in this Law, or if the application and documents filed are not properly executed. Article
  63. Invalidation of an Approval
  64. The Lithuanian Bioethics Committee or the Regional Biomedical Research Ethics Committee shall have the right to invalidate an approval where there is evidence of non-compliance with the requirements of ethics of biomedical research laid down in this Law or when such is the request of the principal investigator. The evidence of non-compliance shall be ascertained by the Lithuanian Bioethics Committee or the Regional Biomedical Research Ethics Committee within the scope of their competence.
  65. The Lithuanian Bioethics Committee or the Regional Biomedical Research Ethics Committee, upon making a decision to invalidate an approval, within 45 calendar days from the day when the decision was made, shall notify in writing the sponsor and/or the principal investigator of a biomedical research, and heads of health care institutions where biomedical research is being conducted. The sponsor and/or the principal investigator of biomedical research and heads of health care institutions where biomedical research is being conducted must ensure that biomedical research is promptly terminated. Article
  66. Investigation of Complaints
  67. The sponsor and/or its principal investigator of a biomedical research shall have the right to appeal a decision of the Regional Biomedical Research Ethics Committee to refuse issue of an approval or to invalidate an approval to the Lithuanian Bioethics Committee within 15 calendar days from the receipt of such a decision. The Lithuanian Bioethics Committee must investigate this appeal within 30 calendar days from its receipt.
  68. Filing of an appeal shall not suspend the enforcement of the decision to invalidate an approval.
  69. After examining the complaint by the sponsor and/or its principal investigator of biomedical research against the decision of the Regional Biomedical Research Ethics Committee to refuse issue of an approval or to invalidate an approval, the Lithuanian Bioethics Committee shall have the right: 1) to uphold the decision of the Regional Biomedical Research Ethics Committee and to dismiss the appeal of the sponsor and/or the chief investigator of biomedical research; 2) to uphold the appeal of the sponsor and/or the principal investigator of biomedical research and issue an approval or make a decision to overrule the decision on the invalidation of an approval.
  70. If a decision on the refusal to issue an approval or on the invalidation of an approval is adopted by the Lithuanian Bioethics Committee within the scope of its competence, the sponsor and/or the principal investigator of biomedical research shall have the right to appeal such a decision to court in the manner provided by law within 30 calendar days from the receipt of such a decision.
  71. The research subjects or their representatives shall have the right to appeal the actions of the sponsor, the principal investigator and other persons involved in carrying out of biomedical research to an institution which has issued an approval and to court in the manner prescribed by law and other legal acts. CHAPTER FOUR FINAL PROVISIONS Article
  72. Liability for Violations of the Requirements of Biomedical Research Ethics
  73. Persons in breach of the requirements of this Law shall be held liable in the manner provided for by law.
  74. Carrying out of biomedical research without an approval or not in conformity with the requirements of this Law and other legal acts provided the research has not damaged the research subject’s health shall be treated as an act of malpractice. Article
  75. Entry into Force This Law shall enter into force on 1 January
  76. Article
  77. Proposals to the Government or a Body Authorised by it, to the State Insurance Supervisory Authority at the Ministry of Finance and to the Ministry of Health
  78. By 1 November 2000, the Government or a body authorised by it shall draw up and approve the Regulations for Compulsory Third Party Insurance of Principal Investigators and Sponsors of Biomedical Research.
  79. By 1 October 2000, the State Insurance Supervisory Authority at the Ministry of Finance shall approve the Procedure for Granting Authorisations for Compulsory Third Party Insurance of Principal Investigators and Sponsors of Biomedical Research.
  80. By 1 November 2000, the Government or a body authorised by it shall draft and approve legal acts relating to this Law. I promulgate this Law passed by the Seimas of the Republic of Lithuania PRESIDENT OF THE REPUBLIC VALDAS ADAMKUS

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