79C3C34C52B45572883A05D425EB0F82
Law on Ethics of Biomedical Research
https://leaux.net/URLS/General/Lithuania__Law_on_Ethics_of_Biomedical_Research_2016.pdf
http://leaux.net/URLS/ConvertAPI Text Files/AEAEB2D2452EBF3B8BA3DE2F023541BF.en.txt
Examining the file media/Synopses/AEAEB2D2452EBF3B8BA3DE2F023541BF.html:
This file was generated: 2020-12-01 07:01:29
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / vulnerable
Searching for indicator vulnerable:
(return to top)
p.000004: 5) has not given the person's consent to participate in the research or the person's consent to participate in the activities of the biobank or has revoked it,
p.000004: the person will not lose the right to receive adequate personal health care;
p.000006: 6
p.000006: 6) details of the relevant pre - clinical study are provided (for clinical use only)
p.000006: research);
p.000006: 7) the risks and inconveniences to which the subject may be exposed do not exceed
p.000006: benefits of biomedical research. In the case of a clinical trial, the subject may not receive a routine clinical trial
p.000006: practice, personal health care shall only be applied if it is in accordance with normal clinical practice
p.000006: the effectiveness of the personal health care provided has not been demonstrated and the risks and inconveniences to which it may be exposed
p.000006: subject, do not outweigh the benefits of biomedical research, or when such personal health care
p.000006: the non-application does not endanger the health of the subject;
p.000006: 8) in the cases specified in Paragraphs 2 and 3 of Article 12 of this Law, the principal investigator and the biomedical
p.000006: the research client or the health care institution is insured against civil liability for possible
p.000006: compensation for pecuniary and non-pecuniary damage caused during the biomedical research to the research subject;
p.000006: 9) documents conferring the right to perform have been obtained from the instituteijiț referred to in Article 20 of this Law
p.000006: biomedical research;
p.000006: 10) this is not prohibited by other laws.
p.000006: Article 6. Vulnerable persons and protection of interest
p.000006: 1. Vulnerable persons whose consent to participate in a biomedical study may be affected by external
p.000006: circumstances or who are unable, in whole or in part, to defend their interest shall be deemed to be:
p.000006: 1) persons who, due to their state of health, cannot be considered capable of reasonably assessing their interests;
p.000006: 2) children;
p.000006: 3) students, if their participation in biomedical research is related to studies;
p.000006: 4) persons living in social care institutions;
p.000006: 5) soldiers during the actual military retreat;
p.000006: 6) employees of the health care institution where the biomedical research is performed, subordinate to the researcher;
p.000006: 7) persons in prisons or other places of deprivation of liberty.
p.000006: 2. Lithuanian Bioethics Committee or Regional Biomedical Research Ethics Committee when evaluating documents
p.000006: on the issuance of a permit for a biomedical research, the Lithuanian Bioethics Committee, when evaluating the documents
p.000006: approval of a clinical trial of a medicinal product, a reasoned decision may be taken
p.000006: to recognize other groups of persons as vulnerable persons.
p.000006: 3. Clinical trials on vulnerable persons shall be permitted only in the following cases:
p.000007: 7
p.000007: (1) where a clinical trial can only be performed on vulnerable individuals and there is scientific reason to believe that
p.000007: participation in a clinical trial will provide a direct benefit to the subject that is greater than that associated with the clinical trial.
p.000007: associated risks and inconveniences;
p.000007: 2) when the clinical trial can only be performed on vulnerable individuals and the clinical trial is directly
p.000007: is related to the health status of the subject and there is scientific reason to expect that participation in the clinical trial will occur
p.000007: beneficial to the non-study group to which the subject belongs and to the subject for the purpose of the clinical trial
p.000007: the intervention methods used in the study have a minor adverse effect on the health of the subject;
p.000007: 3) when the clinical trial is directly related to the life-threatening or debilitating subject of the subject
p.000007: a medical condition for which there is no adequate personal health care and there is a scientific basis
p.000007: it is expected that participation in the clinical trial will provide a direct benefit to the subject that is greater than
p.000007: risks and inconveniences associated with the clinical trial.
p.000007: Article 7. Individual consent to participate in the study
p.000007: 1. Before including a person in a biomedical research, other than a biomedical research carried out with
p.000007: Human biological samples and / or health information processed in the biobank with the consent of the person to participate
p.000007: biobaiilco, the consent of the individual to participate in the study must be obtained. A person's consent to participate in the study must
p.000007: meet all of the following conditions:
p.000007: 1) the person's consent to participate in the investigation is given by a person who can express his or her will;
...
Health / Mentally Disabled
Searching for indicator disability:
(return to top)
p.000007: biobaiilco, the consent of the individual to participate in the study must be obtained. A person's consent to participate in the study must
p.000007: meet all of the following conditions:
p.000007: 1) the person's consent to participate in the investigation is given by a person who can express his or her will;
p.000007: 2) the consent of the person to participate in the investigation has been given in accordance with the procedure established in Paragraph 8 of this Article when the person has received sufficient information
p.000007: and clear information;
p.000007: 3) the consent of a person to participate in the investigation is given by a person (in the cases and according to the procedure provided for in this Law - by another person).
p.000007: the consent of the person entitled to participate in the investigation to the surviving spouse, if the person was unmarried,
p.000007: the marriage has ended, the spouse is recognized as not knowing where he or she is or whether the spouses have lived apart,
p.000007: free priority of a close relative referred to in Article 5 (5);
p.000007: 4) The person's consent to participate in the study is in accordance with the detailed consent of the person established by the Ministry of Health
p.000007: participate in the study of content reilcalavimus.
p.000007: 2. If, due to a physical disability, illness or other reason, a person is unable to sign the person's consent
p.000007: to participate in the investigation, the person's consent to participate in the investigation shall be signed in accordance with the procedure established by the Civil Code.
p.000007: 3. The child shall be given the age specified in paragraph 8 of this article, according to his or her age and ability to understand
p.000007: information. Due to vailco's participation in a biomedical research, the consent of the person to participate in the research is given by the child
p.000007: representatives in accordance with the law, but if the child, who is able to understand the information provided to him, expresses a wish
p.000007: not to participate in a biomedical study or, if vailcas
p.000007: already participates in such a biomedical study, does not participate in it, the child does not participate in the study, or
p.000007: terminated unless this is contrary to the best interests of the child. Is the child's desire not to participate in the study
p.000007: does not contradict the interests of the child, the child's representatives shall decide in accordance with the law, taking into account the opinion of the researcher.
p.000007: When children are involved in a biomedical study, the decision to approve a clinical trial
p.000007: Participation in the meeting of the Lithuanian Bioethics Committee for the issuance of a study certificate
p.000007: Representative of the Ministry of Social Security and Labor. Child
p.000007: the procedure for participation in biomedical research shall be established by the health care minisoas and the Republic of Lithuania
p.000007: Minister of Social Security and Labor.
p.000007: 4. A person who, because of his state of health, cannot be considered to be able to promote his interests prudently,
p.000007: the consent of a person to participate in a biomedical research is given by the spouse of the person, if the person is
p.000007: unmarried, the marriage is over, the spouse is recognized as unknown or the spouses live
p.000007: - one of the person’s parents (¡tėvip) or one of the adult children (łvaikiq), or
p.000007: incapacitated, - his guardian or, in the case of a disability, his carer (hereinafter
p.000007: consent to participate in the study). The subject must be able to understand according to his / her ability to understand
p.000007: the information referred to in paragraph 8 of this Article has been provided. The researcher takes into account the subject who can understand
p.000007: the information provided to him, the wish not to participate in a biomedical study or, if the subject is in such a study
p.000007: already involved in the blomedical study, the desire not to participate in it. Upon receipt of the consent of one of these persons
p.000007: priority, to perform a biomedical examination with a person who, due to a medical condition, is unable to
p.000007: considered to be able to reasonably assess their interests is prohibited.
p.000007: 5. If, before death, the person has not given his or her consent to participate in the investigation or has not withdrawn his or her consent,
p.000007: perform biomedical treatment with the biological sample (s) of the deceased and health information
p.000007: given by the surviving spouse, if the person was not married, the marriage has ended, the spouse
p.000007: is recognized as unknown where the spouses were living apart, - one of the next of kin
p.000007: the following order of precedence: parents (grandparents), adult children (grandchildren), brothers (sisters), grandparents, grandchildren.
p.000007: With the consent of one of these persons, the next of kin's next of kin
...
p.000010: to participate in the activities of the biobank must meet all of the following conditions:
p.000010: 1) the consent of a person to participate in the activities of a biobank is given by a person who can express his or her will;
p.000010: 2) the consent of the person to participate in the activities of the biobank has been given to the person in accordance with the procedure established in Paragraph 6 of this Article
p.000010: upon receipt of sufficient and clear information;
p.000010: 3) the consent of the person to participate in the activities of the biobank has been given by the person (in the cases provided for in this Law and
p.000010: procedure - the consent of another person entitled to participate in the investigation to the surviving spouse, if the person
p.000010: was unmarried, the marriage has ended, the spouse is recognized as unknown or the spouses
p.000010: - the free will of a close relative referred to in paragraph 5 of this section);
p.000010: 4) the consent of the person to participate in the activities of the biobank complies with the detailed requirements established by the Minister of Health
p.000010: the content requirements of the person's consent to participate in the activities of the biobank.
p.000010: 2. If, due to a physical disability, illness or other reasons, a person is unable to sign the person's consent
p.000010: to participate in the activities of the biobank, the consent of the person to participate in the activities of the biobank shall be signed by the Civil Code
p.000010: in accordance with the procedure laid down.
p.000010: 3. The consent of a person to participate in a biobank for the processing of a child’s biological sample and health information
p.000010: for the purposes set out in Article 16 (1) of the Law shall be provided by the child's representatives in accordance with the Law.
p.000010: 4. The consent of a person to participate in the activities of the biobank due to a person who, due to his / her health condition, cannot be considered
p.000010: able to reasonably assess their interests in the processing of human biological sample and health information
p.000010: for the purposes set out in Article 16 (1) of this Law shall be provided by the spouse of the person if the person is
p.000010: unmarried, the marriage is over, the spouse is recognized as unknown or the spouses live
p.000010: divorce, one of the person’s parents (jtêviq) acba one of the adult child (} child) or when the person is in court
...
Health / Physically Disabled
Searching for indicator illness:
(return to top)
p.000007: meet all of the following conditions:
p.000007: 1) the person's consent to participate in the investigation is given by a person who can express his or her will;
p.000007: 2) the consent of the person to participate in the investigation has been given in accordance with the procedure established in Paragraph 8 of this Article when the person has received sufficient information
p.000007: and clear information;
p.000007: 3) the consent of a person to participate in the investigation is given by a person (in the cases and according to the procedure provided for in this Law - by another person).
p.000007: the consent of the person entitled to participate in the investigation to the surviving spouse, if the person was unmarried,
p.000007: the marriage has ended, the spouse is recognized as not knowing where he or she is or whether the spouses have lived apart,
p.000007: free priority of a close relative referred to in Article 5 (5);
p.000007: 4) The person's consent to participate in the study is in accordance with the detailed consent of the person established by the Ministry of Health
p.000007: participate in the study of content reilcalavimus.
p.000007: 2. If, due to a physical disability, illness or other reason, a person is unable to sign the person's consent
p.000007: to participate in the investigation, the person's consent to participate in the investigation shall be signed in accordance with the procedure established by the Civil Code.
p.000007: 3. The child shall be given the age specified in paragraph 8 of this article, according to his or her age and ability to understand
p.000007: information. Due to vailco's participation in a biomedical research, the consent of the person to participate in the research is given by the child
p.000007: representatives in accordance with the law, but if the child, who is able to understand the information provided to him, expresses a wish
p.000007: not to participate in a biomedical study or, if vailcas
p.000007: already participates in such a biomedical study, does not participate in it, the child does not participate in the study, or
p.000007: terminated unless this is contrary to the best interests of the child. Is the child's desire not to participate in the study
...
p.000010: to participate in the activities of the biobank must meet all of the following conditions:
p.000010: 1) the consent of a person to participate in the activities of a biobank is given by a person who can express his or her will;
p.000010: 2) the consent of the person to participate in the activities of the biobank has been given to the person in accordance with the procedure established in Paragraph 6 of this Article
p.000010: upon receipt of sufficient and clear information;
p.000010: 3) the consent of the person to participate in the activities of the biobank has been given by the person (in the cases provided for in this Law and
p.000010: procedure - the consent of another person entitled to participate in the investigation to the surviving spouse, if the person
p.000010: was unmarried, the marriage has ended, the spouse is recognized as unknown or the spouses
p.000010: - the free will of a close relative referred to in paragraph 5 of this section);
p.000010: 4) the consent of the person to participate in the activities of the biobank complies with the detailed requirements established by the Minister of Health
p.000010: the content requirements of the person's consent to participate in the activities of the biobank.
p.000010: 2. If, due to a physical disability, illness or other reasons, a person is unable to sign the person's consent
p.000010: to participate in the activities of the biobank, the consent of the person to participate in the activities of the biobank shall be signed by the Civil Code
p.000010: in accordance with the procedure laid down.
p.000010: 3. The consent of a person to participate in a biobank for the processing of a child’s biological sample and health information
p.000010: for the purposes set out in Article 16 (1) of the Law shall be provided by the child's representatives in accordance with the Law.
p.000010: 4. The consent of a person to participate in the activities of the biobank due to a person who, due to his / her health condition, cannot be considered
p.000010: able to reasonably assess their interests in the processing of human biological sample and health information
p.000010: for the purposes set out in Article 16 (1) of this Law shall be provided by the spouse of the person if the person is
p.000010: unmarried, the marriage is over, the spouse is recognized as unknown or the spouses live
p.000010: divorce, one of the person’s parents (jtêviq) acba one of the adult child (} child) or when the person is in court
...
p.000021: the term established by the Minister of Defense and specialists in the field of biomedical science in accordance with the procedure established by him or her i
p.000021: The biomedical study of the Lithuanian Bioethics Committee is proposed by a group of experts in personal health care
p.000021: associations of specialists, and specialists in the field of social sciences or humanities are offered by universities,
p.000021: in which subjects of bioethics or health law are taught. Biomedical9 of the Lithuanian Bioethics Committee
p.000021: The personal composition of the research expert group shall be approved by the Minister of Health in accordance with
p.000021: the principles of impartiality and transparency, taking into account the professional qualifications and competences of the candidates; and
p.000021: experience in the field of ethics in biomedical research. Remuneration of this group's activities and expert work
p.000021: determined by the Minister of Health.
p.000021: 5. The term of office of the biomedical research expert group of the Lithuanian Bioethics Committee is 4 years. Same
p.000021: a person may be a member of the biomedical research expedition group of the Lithuanian Bioethics Committee for no more than two
p.000021: consecutive terms.
p.000021: 6. The term of office of a member of the Biomedical Research Expert Group of the Lithuanian Bioethics Committee shall expire when:
p.000021: his term of office ends, he resigns, he is revoked by the health minisoas of his
p.000022: 22
p.000022: on the proposal of the association or institution that has submitted the candidature or he / she can no longer pursue Lithuanian bioethics
p.000022: Committee on Biomedical Research on the Duties of a Member of the Expert Group on Illness as well as When He Dies. In such cases,
p.000022: if the term of office of the biomedical research expert group of the Lithuanian Bioethics Committee has not expired, until it
p.000022: A new candidate for a member of the Biomedical Research Expert Group of the Lithuanian Bioethics Committee is proposed by the end of
p.000022: a new member of this group shall be approved in accordance with the procedure established by this Law.
p.000022: Article 22. Establishment and competence of regional ethics committees for biomedical research
p.000022: 1. Regional biomedical research ethics committees shall be established at the university where the conduct is conducted
p.000022: three-stage medical studies. Funds are provided for the activities of the Ethics Committee for Regional Biomedical Research
p.000022: from the state budget appropriations allocated to the Ministry of Health.
p.000022: 2. Regional biomedicininip research ethics set up, activities, jp competence issues
p.000022: The procedure is governed by the provisions of the Regional Biomedical Research Ethics Committee, which, in agreement with the
p.000022: Minister of Health, approves the rector of the university. Regional Biomedical Research Ethics Committee
p.000022: the territorial boundaries of the activity are determined by the Minister of Health.
p.000022: 3. Regional biomedical research ethics committees shall be established for regional biomedical
...
Health / stem cells
Searching for indicator stem cells:
(return to top)
p.000002: signed the consent of the person or another person to participate in the investigation in the cases and in accordance with the procedure provided for in this Law
p.000002: entitled to grant the marriage of a surviving spouse if the person was unmarried
p.000002: expires, the spouse is recognized as not knowing where he or she is or the spouses have lived apart, - a close relative.
p.000002: 14. "Clinical trials" means bioinedicological trials in living humans.
p.000002: 15. Researcher - a natural person performing biomedical research who complies with the requirements established in this Law.
p.000002: 16. Research subject - a person participating in a biomedical research.
p.000002: 17. "Human biological sample" means a biological material taken from a living or dead human body.
p.000002: 18. “Provision of human biological samples” means the transfer or making available of human biological samples
p.000002: biidu.
p.000002: ! 9. "Handling of human biological samples" means any operation performed on human biological samples
p.000002: action: collection, processing, preservation, accumulation, storage, identification, evaluation,
p.000002: biomedical research, classification, refining, aggregation, modification (addition or correction), provision,
p.000002: search, destruction or any other act or actions.
p.000002: 20. Human embryo - a developing human body from the moment of fertilization (zygote formation) to the eighth
p.000002: end of the week of pregnancy.
p.000002: 21. ‘human embryonic stem cells’ means human embryonic stem cells which are capable of
p.000002: to divide and / or develop specialized cell types in vitro.
p.000002: 22. Human embryonic stem cell line means a human embryonic stem cell which may be
p.000002: grown in vitro and divided without long-term differentiation into other cell types.
p.000002: 23. Human stem cells - during the development of the human embryo and human fetus and the
p.000002: non-specialized cells in human tissues that can differentiate} specialized
p.000002: țvairiq audiniq tips cells and regenerate at the same time.
p.000002: 24. Human stem cell line Human stem cells grown in vitro
p.000002: conditions, ensuring their long-term sharing without differentiation.
p.000004: 4
p.000004: 25. "Human fetus" means the developing human body from the beginning of the ninth week of pregnancy until birth.
p.000004: 26. Other terms used in this Law shall be understood as they are defined in the Republic of Lithuania
p.000004: Civil Code (hereinafter - the Civil Code), the Law on Insurance of the Republic of Lithuania (hereinafter - the Insurance Code)
p.000004: Law on Pharmacy), the Law on Equal Opportunities of the Republic of Lithuania, the Law on Equal Opportunities of the Republic of Lithuania
p.000004: The Law on Compensation and Damage to Health of the Republic of Lithuania (hereinafter referred to as the
p.000004: Law on Remuneration of Health Care), the Law on Health Care Institutions of the Republic of Lithuania
p.000004: maintenance ¡staigq
p.000004: Law of the Republic of Lithuania on the Protection of the Rights of the Child
p.000004: the Law of the Republic of Lithuania on Human Tissues, Cell Cells, Organ Donation and Transplantation,
p.000004: Republic of human death detection and critical condition
p.000004: and the Law on the Legal Protection of Personal Data of the Republic of Lithuania (hereinafter - the Law on the Legal Protection of Personal Data)
p.000004: protection law).
p.000004: Article 3. Biomedical research objects
p.000004: 1. In a biomedical research, the objects may be living or dead humans or groups of humans, human embryos, human
p.000004: fruit, Human Biological Sample and Health Information.
p.000004: 2. The establishment of a human embryo for the purposes of biomedical research is prohibited.
p.000004: 3. Biomedical research shall only be carried out on a human embryo and human fetus if it is intended to:
p.000004: the benefits to the human embryo and human fetus under consideration outweigh the risks.
p.000004: 4. Biomedical research on human embryos and fetuses
p.000004: after termination of pregnancy at the request of a woman in the absence of medical indications.
p.000004: 5. Human cloning is prohibited.
p.000004: 6. Biomedical research on a human embryo or human fetus during or after which a human
p.000004: an embryo or human fetus is destroyed or a human embryo is not transferred} to a woman’s uterus is prohibited.
p.000004: 7. Biomedical research that modifies the human genome may only be performed for prophylactic,
p.000004: for diagnostic or therapeutic purposes and only if they are not intended to modify the genome of the offspring.
p.000004: 8. Human embryonic audinip, embryonic stem cell and its line or fetal audinip and derived from it
p.000004: the entry into and exit from the territory of the Republic of Lithuania of stem cells and their lines is prohibited.
p.000004: This prohibition does not apply to stem cells extracted from the umbilical cord or placenta after the birth of a child,
p.000004: and samples taken for genetic testing in accordance with the requirements of Paragraph 3 of this Article for export to Lithuania
p.000004: Territory of the Republic and for exit from
p.000004: jos. Human embryonic tissue, embryonic stem cells and their lines or human fetal tissues and from
p.000004: Transit through the territory of the Republic of Lithuania of the stem cell and their line is possible only
p.000004: with the permission of the Minister of Health. Permission for human embryonic tissue, embryonic stem cells, etc.
p.000004: human fetal tissue and stem cells derived therefrom and
p.000004: The territory of the Republic of Lithuania and the Human stem cell extract obtained from the umbilical cord or
p.000004: placenta after the birth of a child, and genetic testing of a human biological sample for transportation Î Lithuanian
p.000004: The Minister of Health shall approve the Republic and the description of the procedure for removal from it.
p.000004: Article 4. Prohibition of discrimination
p.000004: It is prohibited to discriminate against a person, restrict his or her rights or legitimate interests:
p.000004: 1) due to the fact that the biobank handles or does not manage human biological samples and health information;
p.000004: 2) on the basis of human biological samples and health information processed in the biobank;
p.000004: 3) due to the fact that the person participates or does not participate in the biomedical research;
p.000004: 4) based on the results of biomedical research.
p.000004: CHAPTER II
p.000004: ETHICAL REQUIREMENTS FOR BIOMEDICAL RESEARCH
p.000004: Article 5. Ethical requirements in biomedical research
p.000004: 1. Biomedical research shall be conducted in accordance with the principle that the best interests of the human person shall be paramount
p.000004: the interests of society and science.
p.000004: 2. Biomedical research may be performed only under all of the following conditions:
p.000004: 1) is a scientific and practical development of biomedical research;
p.000004: 2) biomedical research cannot be replaced by other research performed by human nebiitq
p.000004: researched;
p.000004: 3) u ”the protection of the interest of the researcher and the confidentiality of his / her health information is ensured;
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.000012: health information is prohibited in the activities of the biobank.
p.000012: 6. Before giving a person's consent to participate in the activities of a biobank, a person, in the cases provided for in this Law -
p.000012: another person entitled to give consent to participate in the activities of the biobank, the surviving spouse, if
p.000012: was unmarried, - a close relative in the order of priority referred to in paragraph 5,
p.000012: taking into account the age and health status of the person giving consent to participate in the biobank,
p.000012: in a way that he understands, explaining the specific medical terms, informed of:
p.000012: 1) the essence of the person's consent to participate in the activities of the biobank, the possible benefits, inconveniences and risks to the person;
p.000012: (2) the objectives and results of the processing of the biological sample and health information, including health
p.000012: obtaining information from healthcare from institutions, the registry and / or the state infor-
p.000012: systems and the fact that a specific biomedical study with this human biological sample and health
p.000012: information goals and ways at the time of giving a person's consent to participate in biobank activities may be unknown due to
p.000012: insufficient level of scientific or technological development or other objelctyviqip;
p.000012: 3) access to biobanlco information on his (or deceased person's) human biological sample
p.000012: and the use of health information and the purposes of that use;
p.000012: 4) guarantees of confidentiality of health information and the fact that the biobank provides human biological samples and / or
p.000012: health information or results of biomedical research obtained using them, or parts thereof, which allow
p.000012: to establish the identity of a person shall be provided only by a reasoned court decision, if this is necessary for the case in court
p.000012: to examine;
p.000012: 5) the right to revoke a person's consent to participate in the activities of a biobank.
p.000012: 7. A child or a person who, due to a medical condition, cannot be considered capable of reasonably assessing his or her own interests,
p.000012: in accordance with his ability to understand, the information referred to in paragraph 6 of this Article shall be provided and shall be
p.000012: taking into account ț its wish not to grant the biobank the right to process its biological sample and health information
p.000012: for the purposes set out in Paragraph 1 of Article 16 of this Law, and if the consent of the person to participate in the activities of the biobank
p.000012: already given, - šț withdraw the consent.
p.000012: 8. The biobank may handle human biological samples remaining after surgery9,
p.000012: invasive and / or interventional procedures and health information for which the person has not
p.000012: consent to participate in the activities of the biobank in accordance with the procedure established in this Article,
p.000013: 13
...
Social / Age
Searching for indicator age:
(return to top)
p.000007: and clear information;
p.000007: 3) the consent of a person to participate in the investigation is given by a person (in the cases and according to the procedure provided for in this Law - by another person).
p.000007: the consent of the person entitled to participate in the investigation to the surviving spouse, if the person was unmarried,
p.000007: the marriage has ended, the spouse is recognized as not knowing where he or she is or whether the spouses have lived apart,
p.000007: free priority of a close relative referred to in Article 5 (5);
p.000007: 4) The person's consent to participate in the study is in accordance with the detailed consent of the person established by the Ministry of Health
p.000007: participate in the study of content reilcalavimus.
p.000007: 2. If, due to a physical disability, illness or other reason, a person is unable to sign the person's consent
p.000007: to participate in the investigation, the person's consent to participate in the investigation shall be signed in accordance with the procedure established by the Civil Code.
p.000007: 3. The child shall be given the age specified in paragraph 8 of this article, according to his or her age and ability to understand
p.000007: information. Due to vailco's participation in a biomedical research, the consent of the person to participate in the research is given by the child
p.000007: representatives in accordance with the law, but if the child, who is able to understand the information provided to him, expresses a wish
p.000007: not to participate in a biomedical study or, if vailcas
p.000007: already participates in such a biomedical study, does not participate in it, the child does not participate in the study, or
p.000007: terminated unless this is contrary to the best interests of the child. Is the child's desire not to participate in the study
p.000007: does not contradict the interests of the child, the child's representatives shall decide in accordance with the law, taking into account the opinion of the researcher.
p.000007: When children are involved in a biomedical study, the decision to approve a clinical trial
p.000007: Participation in the meeting of the Lithuanian Bioethics Committee for the issuance of a study certificate
p.000007: Representative of the Ministry of Social Security and Labor. Child
p.000007: the procedure for participation in biomedical research shall be established by the health care minisoas and the Republic of Lithuania
...
p.000009: obtained during a biomedical study, when the person refuses to continue to participate in the study, and the consent of the person is obtained
p.000009: participate in the survey from the person of the chip:
p.000009: 1) the child's representation under the law when the subject is a child or the consent of another person to participate in the investigation
p.000009: entitled to give when the subject is a person who, due to a medical condition, cannot be considered capable of
p.000009: to assess its interests prudently, as soon as it becomes possible to submit them to paragraph 8 of this Article
p.000009: the specified information and obtain the consent of the person to participate in the investigation;
p.000009: 2) subject - immediately when the subject becomes able to reasonably assess his / her interests.
p.000010: 10
p.000010: 8. Before giving a person's consent to participate in the investigation, the person or, in the cases provided for in this Law, another person
p.000010: the person entitled to give consent to participate in the investigation, the surviving spouse, if the person was
p.000010: unmarried, the marriage is over, the spouse is recognized as unknown or the spouses are separated,
p.000010: - a close relative as referred to in paragraph 5, in order of priority, with the consent of the person
p.000010: to participate in the study on the age and state of health of the person giving the study, in a comprehensible
p.000010: medical terms must be informed of:
p.000010: 1) the purpose of the biomedical research;
p.000010: 2) a biomedical research plan;
p.000010: 3) methods used in biomedical research;
p.000010: 4) specified in Article 20 of this Law in the Lithuanian Bioethics Committee or regional biomedical research
p.000010: permission of the Ethics Committee to conduct a biomedical research or approval of the Lletuva Bioethics Committee
p.000010: to conduct a clinical) examination of the medicinal product and the certificate of the State Agency of Medicines
p.000010: Permission of the Ministry of Health of the Republic;
p.000010: 5) the expected benefits of the biomedical research for the research subject;
p.000010: 6) the rights of the research subject;
p.000010: 7) the possible risks and inconveniences that the subject may cause to the subject by biomedical research;
p.000010: 8) the procedure for compensation for possible damage caused by a biomedical research;
p.000010: 9) the right to revoke a person's consent to participate in the study at any time by providing information about the biomedical study
p.000010: the consequences of termination;
p.000010: 10) guarantees of confidentiality of health information.
p.000010: 9. The investigator shall give the consent of the person or, in the cases provided for in this Law, to another person to participate in the investigation.
p.000010: entitled to give to a person or to a surviving spouse, if the person was unmarried, the marriage is
p.000010: expires, the spouse is deemed not to know where he or she is or whether the spouses have lived apart,
...
p.000010: processing for the purposes set out in Article 16 (1) of this Law shall be provided by the surviving spouse, if the person
p.000010: was unmarried, the marriage is over, the spouse is
p.000012: 12
p.000012: - it is not known where the spouses were or whether the spouses lived apart, - one of the close relatives
p.000012: priority: parents ({parents), adult children (} children), brothers (sisters), grandparents, grandchildren. Gavus
p.000012: the consent of one of these9 persons is established in order of priority, the consent of the deceased close relative is not sought.
p.000012: In the event of the disagreement of one of these9 persons, use the biological samples of the deceased and
p.000012: health information is prohibited in the activities of the biobank.
p.000012: 6. Before giving a person's consent to participate in the activities of a biobank, a person, in the cases provided for in this Law -
p.000012: another person entitled to give consent to participate in the activities of the biobank, the surviving spouse, if
p.000012: was unmarried, - a close relative in the order of priority referred to in paragraph 5,
p.000012: taking into account the age and health status of the person giving consent to participate in the biobank,
p.000012: in a way that he understands, explaining the specific medical terms, informed of:
p.000012: 1) the essence of the person's consent to participate in the activities of the biobank, the possible benefits, inconveniences and risks to the person;
p.000012: (2) the objectives and results of the processing of the biological sample and health information, including health
p.000012: obtaining information from healthcare from institutions, the registry and / or the state infor-
p.000012: systems and the fact that a specific biomedical study with this human biological sample and health
p.000012: information goals and ways at the time of giving a person's consent to participate in biobank activities may be unknown due to
p.000012: insufficient level of scientific or technological development or other objelctyviqip;
p.000012: 3) access to biobanlco information on his (or deceased person's) human biological sample
p.000012: and the use of health information and the purposes of that use;
p.000012: 4) guarantees of confidentiality of health information and the fact that the biobank provides human biological samples and / or
p.000012: health information or results of biomedical research obtained using them, or parts thereof, which allow
p.000012: to establish the identity of a person shall be provided only by a reasoned court decision, if this is necessary for the case in court
p.000012: to examine;
p.000012: 5) the right to revoke a person's consent to participate in the activities of a biobank.
...
Social / Child
Searching for indicator child:
(return to top)
p.000002: 22. Human embryonic stem cell line means a human embryonic stem cell which may be
p.000002: grown in vitro and divided without long-term differentiation into other cell types.
p.000002: 23. Human stem cells - during the development of the human embryo and human fetus and the
p.000002: non-specialized cells in human tissues that can differentiate} specialized
p.000002: țvairiq audiniq tips cells and regenerate at the same time.
p.000002: 24. Human stem cell line Human stem cells grown in vitro
p.000002: conditions, ensuring their long-term sharing without differentiation.
p.000004: 4
p.000004: 25. "Human fetus" means the developing human body from the beginning of the ninth week of pregnancy until birth.
p.000004: 26. Other terms used in this Law shall be understood as they are defined in the Republic of Lithuania
p.000004: Civil Code (hereinafter - the Civil Code), the Law on Insurance of the Republic of Lithuania (hereinafter - the Insurance Code)
p.000004: Law on Pharmacy), the Law on Equal Opportunities of the Republic of Lithuania, the Law on Equal Opportunities of the Republic of Lithuania
p.000004: The Law on Compensation and Damage to Health of the Republic of Lithuania (hereinafter referred to as the
p.000004: Law on Remuneration of Health Care), the Law on Health Care Institutions of the Republic of Lithuania
p.000004: maintenance ¡staigq
p.000004: Law of the Republic of Lithuania on the Protection of the Rights of the Child
p.000004: the Law of the Republic of Lithuania on Human Tissues, Cell Cells, Organ Donation and Transplantation,
p.000004: Republic of human death detection and critical condition
p.000004: and the Law on the Legal Protection of Personal Data of the Republic of Lithuania (hereinafter - the Law on the Legal Protection of Personal Data)
p.000004: protection law).
p.000004: Article 3. Biomedical research objects
p.000004: 1. In a biomedical research, the objects may be living or dead humans or groups of humans, human embryos, human
p.000004: fruit, Human Biological Sample and Health Information.
p.000004: 2. The establishment of a human embryo for the purposes of biomedical research is prohibited.
p.000004: 3. Biomedical research shall only be carried out on a human embryo and human fetus if it is intended to:
p.000004: the benefits to the human embryo and human fetus under consideration outweigh the risks.
p.000004: 4. Biomedical research on human embryos and fetuses
p.000004: after termination of pregnancy at the request of a woman in the absence of medical indications.
p.000004: 5. Human cloning is prohibited.
p.000004: 6. Biomedical research on a human embryo or human fetus during or after which a human
p.000004: an embryo or human fetus is destroyed or a human embryo is not transferred} to a woman’s uterus is prohibited.
p.000004: 7. Biomedical research that modifies the human genome may only be performed for prophylactic,
p.000004: for diagnostic or therapeutic purposes and only if they are not intended to modify the genome of the offspring.
p.000004: 8. Human embryonic audinip, embryonic stem cell and its line or fetal audinip and derived from it
p.000004: the entry into and exit from the territory of the Republic of Lithuania of stem cells and their lines is prohibited.
p.000004: This prohibition does not apply to stem cells extracted from the umbilical cord or placenta after the birth of a child,
p.000004: and samples taken for genetic testing in accordance with the requirements of Paragraph 3 of this Article for export to Lithuania
p.000004: Territory of the Republic and for exit from
p.000004: jos. Human embryonic tissue, embryonic stem cells and their lines or human fetal tissues and from
p.000004: Transit through the territory of the Republic of Lithuania of the stem cell and their line is possible only
p.000004: with the permission of the Minister of Health. Permission for human embryonic tissue, embryonic stem cells, etc.
p.000004: human fetal tissue and stem cells derived therefrom and
p.000004: The territory of the Republic of Lithuania and the Human stem cell extract obtained from the umbilical cord or
p.000004: placenta after the birth of a child, and genetic testing of a human biological sample for transportation Î Lithuanian
p.000004: The Minister of Health shall approve the Republic and the description of the procedure for removal from it.
p.000004: Article 4. Prohibition of discrimination
p.000004: It is prohibited to discriminate against a person, restrict his or her rights or legitimate interests:
p.000004: 1) due to the fact that the biobank handles or does not manage human biological samples and health information;
p.000004: 2) on the basis of human biological samples and health information processed in the biobank;
p.000004: 3) due to the fact that the person participates or does not participate in the biomedical research;
p.000004: 4) based on the results of biomedical research.
p.000004: CHAPTER II
p.000004: ETHICAL REQUIREMENTS FOR BIOMEDICAL RESEARCH
p.000004: Article 5. Ethical requirements in biomedical research
p.000004: 1. Biomedical research shall be conducted in accordance with the principle that the best interests of the human person shall be paramount
p.000004: the interests of society and science.
p.000004: 2. Biomedical research may be performed only under all of the following conditions:
p.000004: 1) is a scientific and practical development of biomedical research;
p.000004: 2) biomedical research cannot be replaced by other research performed by human nebiitq
p.000004: researched;
p.000004: 3) u ”the protection of the interest of the researcher and the confidentiality of his / her health information is ensured;
p.000004: 4) the consent of the person to participate in the investigation has been obtained (except for Article 7 (5) and
p.000004: Cases referred to in paragraph 11) or where the biomedical research is performed with human biologicals managed by a biobank
...
p.000007: 2) the consent of the person to participate in the investigation has been given in accordance with the procedure established in Paragraph 8 of this Article when the person has received sufficient information
p.000007: and clear information;
p.000007: 3) the consent of a person to participate in the investigation is given by a person (in the cases and according to the procedure provided for in this Law - by another person).
p.000007: the consent of the person entitled to participate in the investigation to the surviving spouse, if the person was unmarried,
p.000007: the marriage has ended, the spouse is recognized as not knowing where he or she is or whether the spouses have lived apart,
p.000007: free priority of a close relative referred to in Article 5 (5);
p.000007: 4) The person's consent to participate in the study is in accordance with the detailed consent of the person established by the Ministry of Health
p.000007: participate in the study of content reilcalavimus.
p.000007: 2. If, due to a physical disability, illness or other reason, a person is unable to sign the person's consent
p.000007: to participate in the investigation, the person's consent to participate in the investigation shall be signed in accordance with the procedure established by the Civil Code.
p.000007: 3. The child shall be given the age specified in paragraph 8 of this article, according to his or her age and ability to understand
p.000007: information. Due to vailco's participation in a biomedical research, the consent of the person to participate in the research is given by the child
p.000007: representatives in accordance with the law, but if the child, who is able to understand the information provided to him, expresses a wish
p.000007: not to participate in a biomedical study or, if vailcas
p.000007: already participates in such a biomedical study, does not participate in it, the child does not participate in the study, or
p.000007: terminated unless this is contrary to the best interests of the child. Is the child's desire not to participate in the study
p.000007: does not contradict the interests of the child, the child's representatives shall decide in accordance with the law, taking into account the opinion of the researcher.
p.000007: When children are involved in a biomedical study, the decision to approve a clinical trial
p.000007: Participation in the meeting of the Lithuanian Bioethics Committee for the issuance of a study certificate
p.000007: Representative of the Ministry of Social Security and Labor. Child
p.000007: the procedure for participation in biomedical research shall be established by the health care minisoas and the Republic of Lithuania
p.000007: Minister of Social Security and Labor.
p.000007: 4. A person who, because of his state of health, cannot be considered to be able to promote his interests prudently,
p.000007: the consent of a person to participate in a biomedical research is given by the spouse of the person, if the person is
p.000007: unmarried, the marriage is over, the spouse is recognized as unknown or the spouses live
p.000007: - one of the person’s parents (¡tėvip) or one of the adult children (łvaikiq), or
p.000007: incapacitated, - his guardian or, in the case of a disability, his carer (hereinafter
p.000007: consent to participate in the study). The subject must be able to understand according to his / her ability to understand
p.000007: the information referred to in paragraph 8 of this Article has been provided. The researcher takes into account the subject who can understand
p.000007: the information provided to him, the wish not to participate in a biomedical study or, if the subject is in such a study
p.000007: already involved in the blomedical study, the desire not to participate in it. Upon receipt of the consent of one of these persons
p.000007: priority, to perform a biomedical examination with a person who, due to a medical condition, is unable to
...
p.000007: is recognized as unknown where the spouses were living apart, - one of the next of kin
p.000007: the following order of precedence: parents (grandparents), adult children (grandchildren), brothers (sisters), grandparents, grandchildren.
p.000007: With the consent of one of these persons, the next of kin's next of kin
p.000007: consent is not sought. In case of disagreement of one of these persons, priority shall be given to perform
p.000007: biomedical examination with a biological sample (s) of the deceased and health information is prohibited.
p.000007: 6. The person and any other person entitled to consent to the investigation may be informed
p.000007: the consent of a person to participate in a study may be obtained from a person receiving a biomedical study when
p.000007: all of the following conditions are met:
p.000009: 9
p.000009: 1) due to the condition of the ingot or other health condition, for which the necessary assistance is required, the person may not:
p.000009: to obtain the information referred to in paragraph 8 of this Article and to give the consent of the person to participate in the investigation, and the person
p.000009: who, because of his or her state of health, cannot be considered capable of reasonably assessing his or her own interests, whether the child
p.000009: cannot receive the information referred to in paragraph 8 of this Article and may not express a wish or unwillingness to participate
p.000009: biomedical research;
p.000009: 2) there is a scientific basis for expecting that a person’s participation in biomedical research will benefit his or her health
p.000009: direct significant benefits, such as alleviating his suffering and / or improving his health, or
p.000009: conditions for diagnosing or predicting the course of the disease;
p.000009: 3) the person must undergo an immediate diagnostic or treatment procedure for a biomedical examination (hereinafter -
p.000009: the information referred to in paragraph 8 and the consent of the individual cannot be obtained
p.000009: to participate in the investigation from another person entitled to give consent to participate in the investigation;
p.000009: 4) the investigator confirms that he / she is not aware that the person has previously filed any objection to participation
p.000009: biomedical research;
p.000009: 5) the biomedical research is directly related to the condition of the person's hygiene, which requires him to have immediate
p.000009: the information referred to in paragraph 8 of this Article cannot be provided and obtained
p.000009: the consent of the person to participate in the investigation from the person or other person entitled to give consent to participate in the investigation
p.000009: and the biomedical research is of such a nature that it can only be performed in a life-threatening or other
p.000009: ümiit sunkiiț health cases;
p.000009: 6) the risk to human health and inconvenience posed by the biomedical research is minimal compared to the
p.000009: clinical practice in the case of the subject's medical condition.
p.000009: 7. Under the conditions set out in paragraph 6 of this Article, a person included in a biomedical research may continue to participate
p.000009: in a biomedical study when provided with the information referred to in paragraph 8 of this Article, and
p.000009: information on the right to object to the continued use of health information for the purpose of biomedical research,
p.000009: obtained during a biomedical study, when the person refuses to continue to participate in the study, and the consent of the person is obtained
p.000009: participate in the survey from the person of the chip:
p.000009: 1) the child's representation under the law when the subject is a child or the consent of another person to participate in the investigation
p.000009: entitled to give when the subject is a person who, due to a medical condition, cannot be considered capable of
p.000009: to assess its interests prudently, as soon as it becomes possible to submit them to paragraph 8 of this Article
p.000009: the specified information and obtain the consent of the person to participate in the investigation;
p.000009: 2) subject - immediately when the subject becomes able to reasonably assess his / her interests.
p.000010: 10
p.000010: 8. Before giving a person's consent to participate in the investigation, the person or, in the cases provided for in this Law, another person
p.000010: the person entitled to give consent to participate in the investigation, the surviving spouse, if the person was
p.000010: unmarried, the marriage is over, the spouse is recognized as unknown or the spouses are separated,
p.000010: - a close relative as referred to in paragraph 5, in order of priority, with the consent of the person
p.000010: to participate in the study on the age and state of health of the person giving the study, in a comprehensible
p.000010: medical terms must be informed of:
p.000010: 1) the purpose of the biomedical research;
p.000010: 2) a biomedical research plan;
p.000010: 3) methods used in biomedical research;
p.000010: 4) specified in Article 20 of this Law in the Lithuanian Bioethics Committee or regional biomedical research
...
p.000010: upon receipt of sufficient and clear information;
p.000010: 3) the consent of the person to participate in the activities of the biobank has been given by the person (in the cases provided for in this Law and
p.000010: procedure - the consent of another person entitled to participate in the investigation to the surviving spouse, if the person
p.000010: was unmarried, the marriage has ended, the spouse is recognized as unknown or the spouses
p.000010: - the free will of a close relative referred to in paragraph 5 of this section);
p.000010: 4) the consent of the person to participate in the activities of the biobank complies with the detailed requirements established by the Minister of Health
p.000010: the content requirements of the person's consent to participate in the activities of the biobank.
p.000010: 2. If, due to a physical disability, illness or other reasons, a person is unable to sign the person's consent
p.000010: to participate in the activities of the biobank, the consent of the person to participate in the activities of the biobank shall be signed by the Civil Code
p.000010: in accordance with the procedure laid down.
p.000010: 3. The consent of a person to participate in a biobank for the processing of a child’s biological sample and health information
p.000010: for the purposes set out in Article 16 (1) of the Law shall be provided by the child's representatives in accordance with the Law.
p.000010: 4. The consent of a person to participate in the activities of the biobank due to a person who, due to his / her health condition, cannot be considered
p.000010: able to reasonably assess their interests in the processing of human biological sample and health information
p.000010: for the purposes set out in Article 16 (1) of this Law shall be provided by the spouse of the person if the person is
p.000010: unmarried, the marriage is over, the spouse is recognized as unknown or the spouses live
p.000010: divorce, one of the person’s parents (jtêviq) acba one of the adult child (} child) or when the person is in court
p.000010: incapacitated, his guardian or, in the event of a person’s incapacity, his caregiver (hereinafter referred to as
p.000010: the person entitled to give consent to participate in the activities of the biobank).
p.000010: 5. The consent of the person to participate in the activities of the biobank regarding the biological sample and health information of the deceased
p.000010: processing for the purposes set out in Article 16 (1) of this Law shall be provided by the surviving spouse, if the person
p.000010: was unmarried, the marriage is over, the spouse is
p.000012: 12
p.000012: - it is not known where the spouses were or whether the spouses lived apart, - one of the close relatives
p.000012: priority: parents ({parents), adult children (} children), brothers (sisters), grandparents, grandchildren. Gavus
p.000012: the consent of one of these9 persons is established in order of priority, the consent of the deceased close relative is not sought.
p.000012: In the event of the disagreement of one of these9 persons, use the biological samples of the deceased and
p.000012: health information is prohibited in the activities of the biobank.
...
p.000012: in a way that he understands, explaining the specific medical terms, informed of:
p.000012: 1) the essence of the person's consent to participate in the activities of the biobank, the possible benefits, inconveniences and risks to the person;
p.000012: (2) the objectives and results of the processing of the biological sample and health information, including health
p.000012: obtaining information from healthcare from institutions, the registry and / or the state infor-
p.000012: systems and the fact that a specific biomedical study with this human biological sample and health
p.000012: information goals and ways at the time of giving a person's consent to participate in biobank activities may be unknown due to
p.000012: insufficient level of scientific or technological development or other objelctyviqip;
p.000012: 3) access to biobanlco information on his (or deceased person's) human biological sample
p.000012: and the use of health information and the purposes of that use;
p.000012: 4) guarantees of confidentiality of health information and the fact that the biobank provides human biological samples and / or
p.000012: health information or results of biomedical research obtained using them, or parts thereof, which allow
p.000012: to establish the identity of a person shall be provided only by a reasoned court decision, if this is necessary for the case in court
p.000012: to examine;
p.000012: 5) the right to revoke a person's consent to participate in the activities of a biobank.
p.000012: 7. A child or a person who, due to a medical condition, cannot be considered capable of reasonably assessing his or her own interests,
p.000012: in accordance with his ability to understand, the information referred to in paragraph 6 of this Article shall be provided and shall be
p.000012: taking into account ț its wish not to grant the biobank the right to process its biological sample and health information
p.000012: for the purposes set out in Paragraph 1 of Article 16 of this Law, and if the consent of the person to participate in the activities of the biobank
p.000012: already given, - šț withdraw the consent.
p.000012: 8. The biobank may handle human biological samples remaining after surgery9,
p.000012: invasive and / or interventional procedures and health information for which the person has not
p.000012: consent to participate in the activities of the biobank in accordance with the procedure established in this Article,
p.000013: 13
p.000013: but only to the extent necessary to preserve these human biological births and if the person within one month after
p.000013: consent of a person to perform a surgical, invasive and / or interventional procedure
p.000013: biobank, which may be processed in the biobank, and health information only to the extent necessary,
p.000013: that birth is assessed as such The suitability of a human biological êminip in Article 16 (1) of this Law
p.000013: for the purposes set. If a person or, in the cases specified in this Law, another person's consent to participate
...
Searching for indicator children:
(return to top)
p.000006: benefits of biomedical research. In the case of a clinical trial, the subject may not receive a routine clinical trial
p.000006: practice, personal health care shall only be applied if it is in accordance with normal clinical practice
p.000006: the effectiveness of the personal health care provided has not been demonstrated and the risks and inconveniences to which it may be exposed
p.000006: subject, do not outweigh the benefits of biomedical research, or when such personal health care
p.000006: the non-application does not endanger the health of the subject;
p.000006: 8) in the cases specified in Paragraphs 2 and 3 of Article 12 of this Law, the principal investigator and the biomedical
p.000006: the research client or the health care institution is insured against civil liability for possible
p.000006: compensation for pecuniary and non-pecuniary damage caused during the biomedical research to the research subject;
p.000006: 9) documents conferring the right to perform have been obtained from the instituteijiț referred to in Article 20 of this Law
p.000006: biomedical research;
p.000006: 10) this is not prohibited by other laws.
p.000006: Article 6. Vulnerable persons and protection of interest
p.000006: 1. Vulnerable persons whose consent to participate in a biomedical study may be affected by external
p.000006: circumstances or who are unable, in whole or in part, to defend their interest shall be deemed to be:
p.000006: 1) persons who, due to their state of health, cannot be considered capable of reasonably assessing their interests;
p.000006: 2) children;
p.000006: 3) students, if their participation in biomedical research is related to studies;
p.000006: 4) persons living in social care institutions;
p.000006: 5) soldiers during the actual military retreat;
p.000006: 6) employees of the health care institution where the biomedical research is performed, subordinate to the researcher;
p.000006: 7) persons in prisons or other places of deprivation of liberty.
p.000006: 2. Lithuanian Bioethics Committee or Regional Biomedical Research Ethics Committee when evaluating documents
p.000006: on the issuance of a permit for a biomedical research, the Lithuanian Bioethics Committee, when evaluating the documents
p.000006: approval of a clinical trial of a medicinal product, a reasoned decision may be taken
p.000006: to recognize other groups of persons as vulnerable persons.
p.000006: 3. Clinical trials on vulnerable persons shall be permitted only in the following cases:
p.000007: 7
p.000007: (1) where a clinical trial can only be performed on vulnerable individuals and there is scientific reason to believe that
p.000007: participation in a clinical trial will provide a direct benefit to the subject that is greater than that associated with the clinical trial.
p.000007: associated risks and inconveniences;
p.000007: 2) when the clinical trial can only be performed on vulnerable individuals and the clinical trial is directly
...
p.000007: information. Due to vailco's participation in a biomedical research, the consent of the person to participate in the research is given by the child
p.000007: representatives in accordance with the law, but if the child, who is able to understand the information provided to him, expresses a wish
p.000007: not to participate in a biomedical study or, if vailcas
p.000007: already participates in such a biomedical study, does not participate in it, the child does not participate in the study, or
p.000007: terminated unless this is contrary to the best interests of the child. Is the child's desire not to participate in the study
p.000007: does not contradict the interests of the child, the child's representatives shall decide in accordance with the law, taking into account the opinion of the researcher.
p.000007: When children are involved in a biomedical study, the decision to approve a clinical trial
p.000007: Participation in the meeting of the Lithuanian Bioethics Committee for the issuance of a study certificate
p.000007: Representative of the Ministry of Social Security and Labor. Child
p.000007: the procedure for participation in biomedical research shall be established by the health care minisoas and the Republic of Lithuania
p.000007: Minister of Social Security and Labor.
p.000007: 4. A person who, because of his state of health, cannot be considered to be able to promote his interests prudently,
p.000007: the consent of a person to participate in a biomedical research is given by the spouse of the person, if the person is
p.000007: unmarried, the marriage is over, the spouse is recognized as unknown or the spouses live
p.000007: - one of the person’s parents (¡tėvip) or one of the adult children (łvaikiq), or
p.000007: incapacitated, - his guardian or, in the case of a disability, his carer (hereinafter
p.000007: consent to participate in the study). The subject must be able to understand according to his / her ability to understand
p.000007: the information referred to in paragraph 8 of this Article has been provided. The researcher takes into account the subject who can understand
p.000007: the information provided to him, the wish not to participate in a biomedical study or, if the subject is in such a study
p.000007: already involved in the blomedical study, the desire not to participate in it. Upon receipt of the consent of one of these persons
p.000007: priority, to perform a biomedical examination with a person who, due to a medical condition, is unable to
p.000007: considered to be able to reasonably assess their interests is prohibited.
p.000007: 5. If, before death, the person has not given his or her consent to participate in the investigation or has not withdrawn his or her consent,
p.000007: perform biomedical treatment with the biological sample (s) of the deceased and health information
p.000007: given by the surviving spouse, if the person was not married, the marriage has ended, the spouse
p.000007: is recognized as unknown where the spouses were living apart, - one of the next of kin
p.000007: the following order of precedence: parents (grandparents), adult children (grandchildren), brothers (sisters), grandparents, grandchildren.
p.000007: With the consent of one of these persons, the next of kin's next of kin
p.000007: consent is not sought. In case of disagreement of one of these persons, priority shall be given to perform
p.000007: biomedical examination with a biological sample (s) of the deceased and health information is prohibited.
p.000007: 6. The person and any other person entitled to consent to the investigation may be informed
p.000007: the consent of a person to participate in a study may be obtained from a person receiving a biomedical study when
p.000007: all of the following conditions are met:
p.000009: 9
p.000009: 1) due to the condition of the ingot or other health condition, for which the necessary assistance is required, the person may not:
p.000009: to obtain the information referred to in paragraph 8 of this Article and to give the consent of the person to participate in the investigation, and the person
p.000009: who, because of his or her state of health, cannot be considered capable of reasonably assessing his or her own interests, whether the child
p.000009: cannot receive the information referred to in paragraph 8 of this Article and may not express a wish or unwillingness to participate
p.000009: biomedical research;
p.000009: 2) there is a scientific basis for expecting that a person’s participation in biomedical research will benefit his or her health
p.000009: direct significant benefits, such as alleviating his suffering and / or improving his health, or
...
p.000010: for the purposes set out in Article 16 (1) of this Law shall be provided by the spouse of the person if the person is
p.000010: unmarried, the marriage is over, the spouse is recognized as unknown or the spouses live
p.000010: divorce, one of the person’s parents (jtêviq) acba one of the adult child (} child) or when the person is in court
p.000010: incapacitated, his guardian or, in the event of a person’s incapacity, his caregiver (hereinafter referred to as
p.000010: the person entitled to give consent to participate in the activities of the biobank).
p.000010: 5. The consent of the person to participate in the activities of the biobank regarding the biological sample and health information of the deceased
p.000010: processing for the purposes set out in Article 16 (1) of this Law shall be provided by the surviving spouse, if the person
p.000010: was unmarried, the marriage is over, the spouse is
p.000012: 12
p.000012: - it is not known where the spouses were or whether the spouses lived apart, - one of the close relatives
p.000012: priority: parents ({parents), adult children (} children), brothers (sisters), grandparents, grandchildren. Gavus
p.000012: the consent of one of these9 persons is established in order of priority, the consent of the deceased close relative is not sought.
p.000012: In the event of the disagreement of one of these9 persons, use the biological samples of the deceased and
p.000012: health information is prohibited in the activities of the biobank.
p.000012: 6. Before giving a person's consent to participate in the activities of a biobank, a person, in the cases provided for in this Law -
p.000012: another person entitled to give consent to participate in the activities of the biobank, the surviving spouse, if
p.000012: was unmarried, - a close relative in the order of priority referred to in paragraph 5,
p.000012: taking into account the age and health status of the person giving consent to participate in the biobank,
p.000012: in a way that he understands, explaining the specific medical terms, informed of:
p.000012: 1) the essence of the person's consent to participate in the activities of the biobank, the possible benefits, inconveniences and risks to the person;
p.000012: (2) the objectives and results of the processing of the biological sample and health information, including health
p.000012: obtaining information from healthcare from institutions, the registry and / or the state infor-
p.000012: systems and the fact that a specific biomedical study with this human biological sample and health
...
Social / Fetus/Neonate
Searching for indicator fetus:
(return to top)
p.000002: 14. "Clinical trials" means bioinedicological trials in living humans.
p.000002: 15. Researcher - a natural person performing biomedical research who complies with the requirements established in this Law.
p.000002: 16. Research subject - a person participating in a biomedical research.
p.000002: 17. "Human biological sample" means a biological material taken from a living or dead human body.
p.000002: 18. “Provision of human biological samples” means the transfer or making available of human biological samples
p.000002: biidu.
p.000002: ! 9. "Handling of human biological samples" means any operation performed on human biological samples
p.000002: action: collection, processing, preservation, accumulation, storage, identification, evaluation,
p.000002: biomedical research, classification, refining, aggregation, modification (addition or correction), provision,
p.000002: search, destruction or any other act or actions.
p.000002: 20. Human embryo - a developing human body from the moment of fertilization (zygote formation) to the eighth
p.000002: end of the week of pregnancy.
p.000002: 21. ‘human embryonic stem cells’ means human embryonic stem cells which are capable of
p.000002: to divide and / or develop specialized cell types in vitro.
p.000002: 22. Human embryonic stem cell line means a human embryonic stem cell which may be
p.000002: grown in vitro and divided without long-term differentiation into other cell types.
p.000002: 23. Human stem cells - during the development of the human embryo and human fetus and the
p.000002: non-specialized cells in human tissues that can differentiate} specialized
p.000002: țvairiq audiniq tips cells and regenerate at the same time.
p.000002: 24. Human stem cell line Human stem cells grown in vitro
p.000002: conditions, ensuring their long-term sharing without differentiation.
p.000004: 4
p.000004: 25. "Human fetus" means the developing human body from the beginning of the ninth week of pregnancy until birth.
p.000004: 26. Other terms used in this Law shall be understood as they are defined in the Republic of Lithuania
p.000004: Civil Code (hereinafter - the Civil Code), the Law on Insurance of the Republic of Lithuania (hereinafter - the Insurance Code)
p.000004: Law on Pharmacy), the Law on Equal Opportunities of the Republic of Lithuania, the Law on Equal Opportunities of the Republic of Lithuania
p.000004: The Law on Compensation and Damage to Health of the Republic of Lithuania (hereinafter referred to as the
p.000004: Law on Remuneration of Health Care), the Law on Health Care Institutions of the Republic of Lithuania
p.000004: maintenance ¡staigq
p.000004: Law of the Republic of Lithuania on the Protection of the Rights of the Child
p.000004: the Law of the Republic of Lithuania on Human Tissues, Cell Cells, Organ Donation and Transplantation,
p.000004: Republic of human death detection and critical condition
p.000004: and the Law on the Legal Protection of Personal Data of the Republic of Lithuania (hereinafter - the Law on the Legal Protection of Personal Data)
p.000004: protection law).
p.000004: Article 3. Biomedical research objects
p.000004: 1. In a biomedical research, the objects may be living or dead humans or groups of humans, human embryos, human
p.000004: fruit, Human Biological Sample and Health Information.
p.000004: 2. The establishment of a human embryo for the purposes of biomedical research is prohibited.
p.000004: 3. Biomedical research shall only be carried out on a human embryo and human fetus if it is intended to:
p.000004: the benefits to the human embryo and human fetus under consideration outweigh the risks.
p.000004: 4. Biomedical research on human embryos and fetuses
p.000004: after termination of pregnancy at the request of a woman in the absence of medical indications.
p.000004: 5. Human cloning is prohibited.
p.000004: 6. Biomedical research on a human embryo or human fetus during or after which a human
p.000004: an embryo or human fetus is destroyed or a human embryo is not transferred} to a woman’s uterus is prohibited.
p.000004: 7. Biomedical research that modifies the human genome may only be performed for prophylactic,
p.000004: for diagnostic or therapeutic purposes and only if they are not intended to modify the genome of the offspring.
p.000004: 8. Human embryonic audinip, embryonic stem cell and its line or fetal audinip and derived from it
p.000004: the entry into and exit from the territory of the Republic of Lithuania of stem cells and their lines is prohibited.
p.000004: This prohibition does not apply to stem cells extracted from the umbilical cord or placenta after the birth of a child,
p.000004: and samples taken for genetic testing in accordance with the requirements of Paragraph 3 of this Article for export to Lithuania
p.000004: Territory of the Republic and for exit from
p.000004: jos. Human embryonic tissue, embryonic stem cells and their lines or human fetal tissues and from
p.000004: Transit through the territory of the Republic of Lithuania of the stem cell and their line is possible only
p.000004: with the permission of the Minister of Health. Permission for human embryonic tissue, embryonic stem cells, etc.
p.000004: human fetal tissue and stem cells derived therefrom and
p.000004: The territory of the Republic of Lithuania and the Human stem cell extract obtained from the umbilical cord or
...
Social / Incarcerated
Searching for indicator liberty:
(return to top)
p.000006: 8) in the cases specified in Paragraphs 2 and 3 of Article 12 of this Law, the principal investigator and the biomedical
p.000006: the research client or the health care institution is insured against civil liability for possible
p.000006: compensation for pecuniary and non-pecuniary damage caused during the biomedical research to the research subject;
p.000006: 9) documents conferring the right to perform have been obtained from the instituteijiț referred to in Article 20 of this Law
p.000006: biomedical research;
p.000006: 10) this is not prohibited by other laws.
p.000006: Article 6. Vulnerable persons and protection of interest
p.000006: 1. Vulnerable persons whose consent to participate in a biomedical study may be affected by external
p.000006: circumstances or who are unable, in whole or in part, to defend their interest shall be deemed to be:
p.000006: 1) persons who, due to their state of health, cannot be considered capable of reasonably assessing their interests;
p.000006: 2) children;
p.000006: 3) students, if their participation in biomedical research is related to studies;
p.000006: 4) persons living in social care institutions;
p.000006: 5) soldiers during the actual military retreat;
p.000006: 6) employees of the health care institution where the biomedical research is performed, subordinate to the researcher;
p.000006: 7) persons in prisons or other places of deprivation of liberty.
p.000006: 2. Lithuanian Bioethics Committee or Regional Biomedical Research Ethics Committee when evaluating documents
p.000006: on the issuance of a permit for a biomedical research, the Lithuanian Bioethics Committee, when evaluating the documents
p.000006: approval of a clinical trial of a medicinal product, a reasoned decision may be taken
p.000006: to recognize other groups of persons as vulnerable persons.
p.000006: 3. Clinical trials on vulnerable persons shall be permitted only in the following cases:
p.000007: 7
p.000007: (1) where a clinical trial can only be performed on vulnerable individuals and there is scientific reason to believe that
p.000007: participation in a clinical trial will provide a direct benefit to the subject that is greater than that associated with the clinical trial.
p.000007: associated risks and inconveniences;
p.000007: 2) when the clinical trial can only be performed on vulnerable individuals and the clinical trial is directly
p.000007: is related to the health status of the subject and there is scientific reason to expect that participation in the clinical trial will occur
p.000007: beneficial to the non-study group to which the subject belongs and to the subject for the purpose of the clinical trial
p.000007: the intervention methods used in the study have a minor adverse effect on the health of the subject;
p.000007: 3) when the clinical trial is directly related to the life-threatening or debilitating subject of the subject
p.000007: a medical condition for which there is no adequate personal health care and there is a scientific basis
...
Social / Marital Status
Searching for indicator married:
(return to top)
p.000007: - one of the person’s parents (¡tėvip) or one of the adult children (łvaikiq), or
p.000007: incapacitated, - his guardian or, in the case of a disability, his carer (hereinafter
p.000007: consent to participate in the study). The subject must be able to understand according to his / her ability to understand
p.000007: the information referred to in paragraph 8 of this Article has been provided. The researcher takes into account the subject who can understand
p.000007: the information provided to him, the wish not to participate in a biomedical study or, if the subject is in such a study
p.000007: already involved in the blomedical study, the desire not to participate in it. Upon receipt of the consent of one of these persons
p.000007: priority, to perform a biomedical examination with a person who, due to a medical condition, is unable to
p.000007: considered to be able to reasonably assess their interests is prohibited.
p.000007: 5. If, before death, the person has not given his or her consent to participate in the investigation or has not withdrawn his or her consent,
p.000007: perform biomedical treatment with the biological sample (s) of the deceased and health information
p.000007: given by the surviving spouse, if the person was not married, the marriage has ended, the spouse
p.000007: is recognized as unknown where the spouses were living apart, - one of the next of kin
p.000007: the following order of precedence: parents (grandparents), adult children (grandchildren), brothers (sisters), grandparents, grandchildren.
p.000007: With the consent of one of these persons, the next of kin's next of kin
p.000007: consent is not sought. In case of disagreement of one of these persons, priority shall be given to perform
p.000007: biomedical examination with a biological sample (s) of the deceased and health information is prohibited.
p.000007: 6. The person and any other person entitled to consent to the investigation may be informed
p.000007: the consent of a person to participate in a study may be obtained from a person receiving a biomedical study when
p.000007: all of the following conditions are met:
p.000009: 9
p.000009: 1) due to the condition of the ingot or other health condition, for which the necessary assistance is required, the person may not:
p.000009: to obtain the information referred to in paragraph 8 of this Article and to give the consent of the person to participate in the investigation, and the person
p.000009: who, because of his or her state of health, cannot be considered capable of reasonably assessing his or her own interests, whether the child
p.000009: cannot receive the information referred to in paragraph 8 of this Article and may not express a wish or unwillingness to participate
...
Searching for indicator unmarried:
(return to top)
p.000002: 7. Biomedical research - testing of hypotheses of biomedical science by scientific research methods,
p.000002: aimed at developing scientific knowledge about human health, diseases, their diagnosis, treatment or prevention.
p.000002: 8. Biomedical Research Center (hereinafter referred to as the Research Center) - a legal entity where a biomedical
p.000002: research.
p.000002: 9. Biomedical research participant - a natural or legal person, other organization or a division thereof,
p.000002: initiating, managing biomedical research and ensuring its funding.
p.000002: 10. Ethical requirements for biomedical research - bioethical requirements established in this Law shall apply
p.000002: in biomedical research.
p.000002: 11. Ethical supervision of biomedical research - Lithuanian Bioethics Committee and (or) regional
p.000002: Activities of the Committee of the Committee on Biomedical Research in Supervision as Clients and Researchers in Biomedical Research
p.000002: adheres to the ethical requirements of biomedical research.
p.000002: 12. Consent of an informed person to participate in the activities of a biobank (hereinafter consent of a person to participate in
p.000002: biobank) is a voluntary, explicit, informed written consent signed by a person or a member of this
p.000002: in the cases and according to the procedure provided for, the person entitled to give the consent of another person to participate in the activities of the biobank,
p.000002: the surviving spouse, if the person was
p.000002: unmarried, the marriage is over, the spouse is declared to be unknown or
p.000002: the spouses have lived apart, - a close relative who, for the purposes laid down in this Law, is authorized to
p.000002: personal biological sample and health information.
p.000002: 13. Consent of an informed person to participate in a biomedical research (hereinafter - consent of a person to participate in
p.000002: voluntary, explicit, informed written consent to participate in a biomedical study,
p.000002: signed the consent of the person or another person to participate in the investigation in the cases and in accordance with the procedure provided for in this Law
p.000002: entitled to grant the marriage of a surviving spouse if the person was unmarried
p.000002: expires, the spouse is recognized as not knowing where he or she is or the spouses have lived apart, - a close relative.
p.000002: 14. "Clinical trials" means bioinedicological trials in living humans.
p.000002: 15. Researcher - a natural person performing biomedical research who complies with the requirements established in this Law.
p.000002: 16. Research subject - a person participating in a biomedical research.
p.000002: 17. "Human biological sample" means a biological material taken from a living or dead human body.
p.000002: 18. “Provision of human biological samples” means the transfer or making available of human biological samples
p.000002: biidu.
p.000002: ! 9. "Handling of human biological samples" means any operation performed on human biological samples
p.000002: action: collection, processing, preservation, accumulation, storage, identification, evaluation,
p.000002: biomedical research, classification, refining, aggregation, modification (addition or correction), provision,
p.000002: search, destruction or any other act or actions.
p.000002: 20. Human embryo - a developing human body from the moment of fertilization (zygote formation) to the eighth
p.000002: end of the week of pregnancy.
p.000002: 21. ‘human embryonic stem cells’ means human embryonic stem cells which are capable of
p.000002: to divide and / or develop specialized cell types in vitro.
p.000002: 22. Human embryonic stem cell line means a human embryonic stem cell which may be
p.000002: grown in vitro and divided without long-term differentiation into other cell types.
...
p.000007: it is expected that participation in the clinical trial will provide a direct benefit to the subject that is greater than
p.000007: risks and inconveniences associated with the clinical trial.
p.000007: Article 7. Individual consent to participate in the study
p.000007: 1. Before including a person in a biomedical research, other than a biomedical research carried out with
p.000007: Human biological samples and / or health information processed in the biobank with the consent of the person to participate
p.000007: biobaiilco, the consent of the individual to participate in the study must be obtained. A person's consent to participate in the study must
p.000007: meet all of the following conditions:
p.000007: 1) the person's consent to participate in the investigation is given by a person who can express his or her will;
p.000007: 2) the consent of the person to participate in the investigation has been given in accordance with the procedure established in Paragraph 8 of this Article when the person has received sufficient information
p.000007: and clear information;
p.000007: 3) the consent of a person to participate in the investigation is given by a person (in the cases and according to the procedure provided for in this Law - by another person).
p.000007: the consent of the person entitled to participate in the investigation to the surviving spouse, if the person was unmarried,
p.000007: the marriage has ended, the spouse is recognized as not knowing where he or she is or whether the spouses have lived apart,
p.000007: free priority of a close relative referred to in Article 5 (5);
p.000007: 4) The person's consent to participate in the study is in accordance with the detailed consent of the person established by the Ministry of Health
p.000007: participate in the study of content reilcalavimus.
p.000007: 2. If, due to a physical disability, illness or other reason, a person is unable to sign the person's consent
p.000007: to participate in the investigation, the person's consent to participate in the investigation shall be signed in accordance with the procedure established by the Civil Code.
p.000007: 3. The child shall be given the age specified in paragraph 8 of this article, according to his or her age and ability to understand
p.000007: information. Due to vailco's participation in a biomedical research, the consent of the person to participate in the research is given by the child
p.000007: representatives in accordance with the law, but if the child, who is able to understand the information provided to him, expresses a wish
p.000007: not to participate in a biomedical study or, if vailcas
p.000007: already participates in such a biomedical study, does not participate in it, the child does not participate in the study, or
p.000007: terminated unless this is contrary to the best interests of the child. Is the child's desire not to participate in the study
p.000007: does not contradict the interests of the child, the child's representatives shall decide in accordance with the law, taking into account the opinion of the researcher.
p.000007: When children are involved in a biomedical study, the decision to approve a clinical trial
p.000007: Participation in the meeting of the Lithuanian Bioethics Committee for the issuance of a study certificate
p.000007: Representative of the Ministry of Social Security and Labor. Child
p.000007: the procedure for participation in biomedical research shall be established by the health care minisoas and the Republic of Lithuania
p.000007: Minister of Social Security and Labor.
p.000007: 4. A person who, because of his state of health, cannot be considered to be able to promote his interests prudently,
p.000007: the consent of a person to participate in a biomedical research is given by the spouse of the person, if the person is
p.000007: unmarried, the marriage is over, the spouse is recognized as unknown or the spouses live
p.000007: - one of the person’s parents (¡tėvip) or one of the adult children (łvaikiq), or
p.000007: incapacitated, - his guardian or, in the case of a disability, his carer (hereinafter
p.000007: consent to participate in the study). The subject must be able to understand according to his / her ability to understand
p.000007: the information referred to in paragraph 8 of this Article has been provided. The researcher takes into account the subject who can understand
p.000007: the information provided to him, the wish not to participate in a biomedical study or, if the subject is in such a study
p.000007: already involved in the blomedical study, the desire not to participate in it. Upon receipt of the consent of one of these persons
p.000007: priority, to perform a biomedical examination with a person who, due to a medical condition, is unable to
p.000007: considered to be able to reasonably assess their interests is prohibited.
p.000007: 5. If, before death, the person has not given his or her consent to participate in the investigation or has not withdrawn his or her consent,
p.000007: perform biomedical treatment with the biological sample (s) of the deceased and health information
p.000007: given by the surviving spouse, if the person was not married, the marriage has ended, the spouse
...
p.000009: in a biomedical study when provided with the information referred to in paragraph 8 of this Article, and
p.000009: information on the right to object to the continued use of health information for the purpose of biomedical research,
p.000009: obtained during a biomedical study, when the person refuses to continue to participate in the study, and the consent of the person is obtained
p.000009: participate in the survey from the person of the chip:
p.000009: 1) the child's representation under the law when the subject is a child or the consent of another person to participate in the investigation
p.000009: entitled to give when the subject is a person who, due to a medical condition, cannot be considered capable of
p.000009: to assess its interests prudently, as soon as it becomes possible to submit them to paragraph 8 of this Article
p.000009: the specified information and obtain the consent of the person to participate in the investigation;
p.000009: 2) subject - immediately when the subject becomes able to reasonably assess his / her interests.
p.000010: 10
p.000010: 8. Before giving a person's consent to participate in the investigation, the person or, in the cases provided for in this Law, another person
p.000010: the person entitled to give consent to participate in the investigation, the surviving spouse, if the person was
p.000010: unmarried, the marriage is over, the spouse is recognized as unknown or the spouses are separated,
p.000010: - a close relative as referred to in paragraph 5, in order of priority, with the consent of the person
p.000010: to participate in the study on the age and state of health of the person giving the study, in a comprehensible
p.000010: medical terms must be informed of:
p.000010: 1) the purpose of the biomedical research;
p.000010: 2) a biomedical research plan;
p.000010: 3) methods used in biomedical research;
p.000010: 4) specified in Article 20 of this Law in the Lithuanian Bioethics Committee or regional biomedical research
p.000010: permission of the Ethics Committee to conduct a biomedical research or approval of the Lletuva Bioethics Committee
p.000010: to conduct a clinical) examination of the medicinal product and the certificate of the State Agency of Medicines
p.000010: Permission of the Ministry of Health of the Republic;
p.000010: 5) the expected benefits of the biomedical research for the research subject;
p.000010: 6) the rights of the research subject;
p.000010: 7) the possible risks and inconveniences that the subject may cause to the subject by biomedical research;
p.000010: 8) the procedure for compensation for possible damage caused by a biomedical research;
p.000010: 9) the right to revoke a person's consent to participate in the study at any time by providing information about the biomedical study
p.000010: the consequences of termination;
p.000010: 10) guarantees of confidentiality of health information.
p.000010: 9. The investigator shall give the consent of the person or, in the cases provided for in this Law, to another person to participate in the investigation.
p.000010: entitled to give to a person or to a surviving spouse, if the person was unmarried, the marriage is
p.000010: expires, the spouse is deemed not to know where he or she is or whether the spouses have lived apart,
p.000010: A clear, free and easy-to-implement priority for a close relative referred to in paragraph 5
p.000010: the possibility to withdraw the person's consent to participate in the investigation upon written request. Biomedical research
p.000010: the results of the biomedical research prior to the person's request to withdraw the person's consent to participate
p.000010: study receipt are not destroyed.
p.000010: 10. Details of the content of the person's consent to participate in the investigation and of the information referred to in paragraph 8 of this Article shall be provided.
p.000010: the requirements and the procedure for granting and revoking consent shall be established by the Minister of Health.
p.000010: 11. In the case of biomedical research, the object of which is prior to the request for biomedical
p.000010: a biological sample of the individual for health, statistical or other purposes at the time of the study; and
p.000010: (or) health information, Lithuanian Bioethics Committee or
p.000010: the Regional Ethics Committee for Biomedical Research, which authorizes blomedicininț research,
p.000010: decide whether the consent of the person to participate in the investigation is necessary.
p.000010: Article 8. Individual consent to participate in biobank activities
p.000010: 1. Human biological samples and health information shall be processed in accordance with Article 16 (1) of this Law
p.000010: for the purposes set out in paragraph 1 only with the consent of the individual to participate in the biobank. Personal consent
p.000010: to participate in the activities of the biobank must meet all of the following conditions:
p.000010: 1) the consent of a person to participate in the activities of a biobank is given by a person who can express his or her will;
p.000010: 2) the consent of the person to participate in the activities of the biobank has been given to the person in accordance with the procedure established in Paragraph 6 of this Article
p.000010: upon receipt of sufficient and clear information;
p.000010: 3) the consent of the person to participate in the activities of the biobank has been given by the person (in the cases provided for in this Law and
p.000010: procedure - the consent of another person entitled to participate in the investigation to the surviving spouse, if the person
p.000010: was unmarried, the marriage has ended, the spouse is recognized as unknown or the spouses
p.000010: - the free will of a close relative referred to in paragraph 5 of this section);
p.000010: 4) the consent of the person to participate in the activities of the biobank complies with the detailed requirements established by the Minister of Health
p.000010: the content requirements of the person's consent to participate in the activities of the biobank.
p.000010: 2. If, due to a physical disability, illness or other reasons, a person is unable to sign the person's consent
p.000010: to participate in the activities of the biobank, the consent of the person to participate in the activities of the biobank shall be signed by the Civil Code
p.000010: in accordance with the procedure laid down.
p.000010: 3. The consent of a person to participate in a biobank for the processing of a child’s biological sample and health information
p.000010: for the purposes set out in Article 16 (1) of the Law shall be provided by the child's representatives in accordance with the Law.
p.000010: 4. The consent of a person to participate in the activities of the biobank due to a person who, due to his / her health condition, cannot be considered
p.000010: able to reasonably assess their interests in the processing of human biological sample and health information
p.000010: for the purposes set out in Article 16 (1) of this Law shall be provided by the spouse of the person if the person is
p.000010: unmarried, the marriage is over, the spouse is recognized as unknown or the spouses live
p.000010: divorce, one of the person’s parents (jtêviq) acba one of the adult child (} child) or when the person is in court
p.000010: incapacitated, his guardian or, in the event of a person’s incapacity, his caregiver (hereinafter referred to as
p.000010: the person entitled to give consent to participate in the activities of the biobank).
p.000010: 5. The consent of the person to participate in the activities of the biobank regarding the biological sample and health information of the deceased
p.000010: processing for the purposes set out in Article 16 (1) of this Law shall be provided by the surviving spouse, if the person
p.000010: was unmarried, the marriage is over, the spouse is
p.000012: 12
p.000012: - it is not known where the spouses were or whether the spouses lived apart, - one of the close relatives
p.000012: priority: parents ({parents), adult children (} children), brothers (sisters), grandparents, grandchildren. Gavus
p.000012: the consent of one of these9 persons is established in order of priority, the consent of the deceased close relative is not sought.
p.000012: In the event of the disagreement of one of these9 persons, use the biological samples of the deceased and
p.000012: health information is prohibited in the activities of the biobank.
p.000012: 6. Before giving a person's consent to participate in the activities of a biobank, a person, in the cases provided for in this Law -
p.000012: another person entitled to give consent to participate in the activities of the biobank, the surviving spouse, if
p.000012: was unmarried, - a close relative in the order of priority referred to in paragraph 5,
p.000012: taking into account the age and health status of the person giving consent to participate in the biobank,
p.000012: in a way that he understands, explaining the specific medical terms, informed of:
p.000012: 1) the essence of the person's consent to participate in the activities of the biobank, the possible benefits, inconveniences and risks to the person;
p.000012: (2) the objectives and results of the processing of the biological sample and health information, including health
p.000012: obtaining information from healthcare from institutions, the registry and / or the state infor-
p.000012: systems and the fact that a specific biomedical study with this human biological sample and health
p.000012: information goals and ways at the time of giving a person's consent to participate in biobank activities may be unknown due to
p.000012: insufficient level of scientific or technological development or other objelctyviqip;
p.000012: 3) access to biobanlco information on his (or deceased person's) human biological sample
p.000012: and the use of health information and the purposes of that use;
p.000012: 4) guarantees of confidentiality of health information and the fact that the biobank provides human biological samples and / or
p.000012: health information or results of biomedical research obtained using them, or parts thereof, which allow
p.000012: to establish the identity of a person shall be provided only by a reasoned court decision, if this is necessary for the case in court
p.000012: to examine;
...
Social / Property Ownership
Searching for indicator property:
(return to top)
p.000014: 4. When a clinical trial of a medicinal product is being conducted, the investigator must have a clinical pharmacy
p.000014: preparation research pobiid) corresponding to a higher education qualification relevant to medical practice
p.000014: or dental practice license, have experience in patient care, have completed good clinical practice
p.000014: practice training and employed at a research center. When performing the biomedical research referred to in this
p.000014: the principal investigator must also have experience in clinical trials of the medicinal product. Specific
p.000014: higher education qualifications of a researcher conducting a clinical trial, good clinical practice
p.000014: The requirements for practical training9 and experience are set by the Minister of Health. A person can work
p.000014: the principal investigator is only one in the same study center.
p.000015: 15
p.000015: Article 12. Civil liability of the client and researcher of biomedical research and its insurance
p.000015: 1. The client and researcher of a biomedical research shall be liable for pecuniary and non-pecuniary damage caused to the research subject, except
p.000015: pecuniary and non-pecuniary damage caused by causes other than biomedical research,
p.000015: or dê1 intentional act of the subject. The sponsor of the biomedical research and the investigator shall be jointly and severally liable for this part
p.000015: specified pecuniary and non-pecuniary damage caused to the subject, except in the case of biomedical research
p.000015: the sponsor and the investigator agree otherwise in writing. Property made by the client and researcher of the biomedical research
p.000015: and non-pecuniary damage to the health of the subject shall be compensated in accordance with the provisions of the Civil Code, the Law on Insurance and other legal acts.
p.000015: order.
p.000015: 2. The principal investigator of the biomedical research must insure his civil liability in respect of
p.000015: possible pecuniary and non-pecuniary damage caused by the health injury of the subject or the
p.000015: death, remuneration, civil liability of the client of the biomedical research and the principal investigator
p.000015: compulsory insurance contracts with insurers. This requirement is considered only when it is met
p.000015: a clinical trial of a medicinal product or any other biomedical trial in which a person is involved
p.000015: interventional research methods used for biomedical research pose a risk to the health of the subject.
p.000015: Whether interventional research methods used for biomedical research pose a risk to the subject
p.000015: health, is assessed by the Lithuanian Bioethics Committee, which issues a clinical trial approval
p.000015: research certificate or authorization for a biomedical research, or a regional biomedical research
p.000015: ethylcos committee authorizing biomedical research.
p.000015: 3. A clinical trial of a medicinal product or any other biomedical trial in which the participating
p.000015: interventional biomedical research methods have only a minor adverse effect on the individual.
p.000015: health is also permitted in the case of a personal health care institution which itself or
p.000015: its employee is the client of such biomedical research or its employee is the sponsor of such biomedical research
p.000015: researcher, the contract of civil liability for damage to patients provides for property and non-property
p.000015: compensation for damage that may occur during such biomedical research. Whether they apply
p.000015: Interventional biomedical research methods have a small undesirable temporary effect on the subject
p.000015: health, is assessed by the Lithuanian Bioethics Committee, which issues a clinical trial approval
p.000015: research certificate or authorization for biomedicininț research, or regional biomedicininip
p.000015: Research Ethics Committee, which authorizes biomedical research based on health
p.000015: approved by the Minister of Defense Minor adverse temporary effects on the health of the subject
p.000015: list of interventional biomedical research methods. Lithuanian Bioethics Committee or regional
p.000015: the ethics committee may, by reasoned decision, declare a minor
p.000015: temporary effects on the subject's health
p.000016: 16
p.000016: and other Minor adverse adverse effects on the health of the subject through biomedical intervention.
p.000016: research method interventional biomedical research methods not listed.
p.000016: 4. Compulsory civil liability insurance of the client of the biomedical research and the principal investigator
p.000016: the amount may not be less than 29 000 eunț for pecuniary and non-pecuniary damage caused to one subject,
p.000016: offset. Compulsory civil liability insurance for the client of the biomedical research and the principal investigator
p.000016: protection must be valid from the beginning to the end of the biomedical examination and for at least 5 years from
p.000016: end of biomedical research. Civilian of the client and principal investigator of the biomedical research
p.000016: the rules on compulsory liability insurance laid down by the other sponsor of the biomedical research and
p.000016: the terms and conditions of the principal investigator 's compulsory civil liability insurance contract, property and
p.000016: the procedure for calculating and reimbursing the amount of non-proprietary health research shall be established by the Government or its authorized
p.000016: authority.
p.000016: CHAPTER III BIOBANKS, OPERATING CONDITIONS
p.000016: Article 13. Biobank activities
p.000016: 1. The activities of the Biobank shall be carried out in accordance with this Law, the Law on Legal Protection of Personal Data and the Law on Health.
p.000016: requirements of the law, respecting the rights and freedoms of the individual and
p.000016: the principles of reliability, security and openness.
p.000016: 2. Biobanks shall process human biological samples and health information in accordance with the procedures specified in Paragraph 1 of Article 16 of this Law.
p.000016: purposes.
p.000016: 3. Biobanks have the right to:
p.000016: 1) be clients of biomedical research and perform biomedical research;
p.000016: 2) to co-operate with the Member States of the European Union in accordance with the procedure established by legal acts
p.000016: biobanks, international organizations of third countries and third countries, to participate in them
p.000016: activities;
p.000016: 3) to receive health information in accordance with the procedure established in Article 15 of this Law.
p.000016: Article 14. Biobankq pouring
p.000016: 1. A public legal entity acting as a budgetary or public body for the purpose of obtaining and obtaining a license
p.000016: to engage in the activities of a biobank must meet the requirements set out in the Law on Health Care
p.000016: the following requirements for obtaining a health care license:
p.000017: 17
p.000017: 1) to ensure that the requirement for the operation of the Biobank approved by the Minister of Health
...
Social / Soldier
Searching for indicator military:
(return to top)
p.000006: the effectiveness of the personal health care provided has not been demonstrated and the risks and inconveniences to which it may be exposed
p.000006: subject, do not outweigh the benefits of biomedical research, or when such personal health care
p.000006: the non-application does not endanger the health of the subject;
p.000006: 8) in the cases specified in Paragraphs 2 and 3 of Article 12 of this Law, the principal investigator and the biomedical
p.000006: the research client or the health care institution is insured against civil liability for possible
p.000006: compensation for pecuniary and non-pecuniary damage caused during the biomedical research to the research subject;
p.000006: 9) documents conferring the right to perform have been obtained from the instituteijiț referred to in Article 20 of this Law
p.000006: biomedical research;
p.000006: 10) this is not prohibited by other laws.
p.000006: Article 6. Vulnerable persons and protection of interest
p.000006: 1. Vulnerable persons whose consent to participate in a biomedical study may be affected by external
p.000006: circumstances or who are unable, in whole or in part, to defend their interest shall be deemed to be:
p.000006: 1) persons who, due to their state of health, cannot be considered capable of reasonably assessing their interests;
p.000006: 2) children;
p.000006: 3) students, if their participation in biomedical research is related to studies;
p.000006: 4) persons living in social care institutions;
p.000006: 5) soldiers during the actual military retreat;
p.000006: 6) employees of the health care institution where the biomedical research is performed, subordinate to the researcher;
p.000006: 7) persons in prisons or other places of deprivation of liberty.
p.000006: 2. Lithuanian Bioethics Committee or Regional Biomedical Research Ethics Committee when evaluating documents
p.000006: on the issuance of a permit for a biomedical research, the Lithuanian Bioethics Committee, when evaluating the documents
p.000006: approval of a clinical trial of a medicinal product, a reasoned decision may be taken
p.000006: to recognize other groups of persons as vulnerable persons.
p.000006: 3. Clinical trials on vulnerable persons shall be permitted only in the following cases:
p.000007: 7
p.000007: (1) where a clinical trial can only be performed on vulnerable individuals and there is scientific reason to believe that
p.000007: participation in a clinical trial will provide a direct benefit to the subject that is greater than that associated with the clinical trial.
p.000007: associated risks and inconveniences;
p.000007: 2) when the clinical trial can only be performed on vulnerable individuals and the clinical trial is directly
p.000007: is related to the health status of the subject and there is scientific reason to expect that participation in the clinical trial will occur
p.000007: beneficial to the non-study group to which the subject belongs and to the subject for the purpose of the clinical trial
...
Social / Trade Union Membership
Searching for indicator union:
(return to top)
p.000002: THE REPUBLIC OF LITHUANIA
p.000002: BIOMEDICAL, J STUDY ETHICS {CONSTRUCTION NO. VIII-1679 AMENDMENT CONSTRUCTION
p.000002: 2015 September 17 No. XB-1938 Vilnius
p.000002: Article 1. Law of the Republic of Lithuania on Ethics of Biomedical Research No. VIII-1679 new
p.000002: wording
p.000002: To amend the Law of the Republic of Lithuania on Ethics of Biomedical Research No. VIII-1679 ii jj is worded as follows:
p.000002: “BIOMEDICAL RESEARCH ETHICS OF THE REPUBLIC OF LITHUANIA
p.000002: ]BUILDING
p.000002: I SKYBIUS
p.000002: GENERAL PROVISIONS
p.000002: Article 1. Purpose of the law
p.000002: 1. This Law lays down the ethical requirements for biomedical research, human biological and personal
p.000002: the sustainability of health information for biomedical research purposes and biobankq activities
p.000002: conditions for the authorization of biomedical research, the supervision of the performance of biomedical research
p.000002: and biomedical research and the liability for damage caused by the subject.
p.000002: health consent or death.
p.000002: 2. The provisions of this Law are harmonized with the legal acts of the European Union specified in this Law
p.000002: in the Annex to the Law.
p.000002: Article 2. The main concepts of this law
p.000002: 1. Personal health information (hereinafter health information) - data on a person's health, diseases
p.000002: and health disorders, causes, external factors, diagnosis, course, prognosis, treatment, outcome, death,
p.000002: heredity or any other information related to a person’s health.
p.000002: 2
p.000002: 2. Provision of personal health information (hereinafter - provision of health information) - personal health
p.000002: disclosure of information by transmission or otherwise making it available, other than by making it available to the public
p.000002: in the media.
p.000002: 3. Processing of personal health information (hereinafter referred to as "health information processing") - any
p.000002: which action is taken on personal health information: collection, recording, storage, storage,
p.000002: classification, grouping, merging, modification (addition or correction), biomedical research, provision,
p.000002: publication, use, logical and / or arithmetic operations, search, dissemination, destruction or other
p.000002: action or actions.
p.000002: 4. A person who, because of a medical condition, cannot be considered to be able to reasonably assess his or her interests is an adult
p.000002: a person declared incapacitated or of limited breeding by a court, or an adult or recognized by a court
p.000002: a full-fledged (emancipated) minor whose state of health does not allow him to assess his interest or
p.000002: tightens to judge them wisely.
p.000002: 5. Biobank - a public legal entity acting as a budgetary or public body, holding a personal
p.000002: a health care license to engage in activities involving human biological êminiq and health information
...
p.000016: offset. Compulsory civil liability insurance for the client of the biomedical research and the principal investigator
p.000016: protection must be valid from the beginning to the end of the biomedical examination and for at least 5 years from
p.000016: end of biomedical research. Civilian of the client and principal investigator of the biomedical research
p.000016: the rules on compulsory liability insurance laid down by the other sponsor of the biomedical research and
p.000016: the terms and conditions of the principal investigator 's compulsory civil liability insurance contract, property and
p.000016: the procedure for calculating and reimbursing the amount of non-proprietary health research shall be established by the Government or its authorized
p.000016: authority.
p.000016: CHAPTER III BIOBANKS, OPERATING CONDITIONS
p.000016: Article 13. Biobank activities
p.000016: 1. The activities of the Biobank shall be carried out in accordance with this Law, the Law on Legal Protection of Personal Data and the Law on Health.
p.000016: requirements of the law, respecting the rights and freedoms of the individual and
p.000016: the principles of reliability, security and openness.
p.000016: 2. Biobanks shall process human biological samples and health information in accordance with the procedures specified in Paragraph 1 of Article 16 of this Law.
p.000016: purposes.
p.000016: 3. Biobanks have the right to:
p.000016: 1) be clients of biomedical research and perform biomedical research;
p.000016: 2) to co-operate with the Member States of the European Union in accordance with the procedure established by legal acts
p.000016: biobanks, international organizations of third countries and third countries, to participate in them
p.000016: activities;
p.000016: 3) to receive health information in accordance with the procedure established in Article 15 of this Law.
p.000016: Article 14. Biobankq pouring
p.000016: 1. A public legal entity acting as a budgetary or public body for the purpose of obtaining and obtaining a license
p.000016: to engage in the activities of a biobank must meet the requirements set out in the Law on Health Care
p.000016: the following requirements for obtaining a health care license:
p.000017: 17
p.000017: 1) to ensure that the requirement for the operation of the Biobank approved by the Minister of Health
p.000017: requirements set out in the inventory to ensure human biological êminip and health
p.000017: traceability, security, quality and availability of information to researchers, in accordance with:
p.000017: (a) premises, materials and materials used for human biological samples and health information
p.000017: handling;
p.000017: (b) the organization, management and administration of the processing of human biological samples and health information
p.000017: system;
p.000017: 2) appoint an employee responsible for the management of human biological resources and health information in accordance with the law;
p.000017: requirements of the act.
p.000017: 2. A license to engage in the activities of a biobank shall be issued, its validity shall be suspended, suspension of the license
p.000017: revoked, the validity of the license shall be revoked in accordance with the procedure established by the Law on Health Care Institutions.
p.000017: Article 15. Biobank's right to receive health information
...
p.000017: The confidentiality of health information processed in the Biobank shall be ensured by all natural and legal persons
p.000017: who use this health information, as well as those referred to in Article 15 (1) and (2) of this Law
p.000017: subjects.
p.000017: 4. The information processed by the biobank is not considered confidential and may be published without
p.000017: the consent of the person who has given the consent of the person to participate in the activities of the biobank, if after the publication of such health
p.000017: the information will not be identifiable.
p.000017: 5. The biobank shall assign a code to the human biological sample and / or health information received and
p.000017: allowing the identification of the person whose biological samples and / or health information is being processed
p.000017: in the biobank, the identity is managed separately, ensuring the possibility to identify the konlnetq person.
p.000017: Article 17. Human biological samples and / or health information and personal health are relevant
p.000017: provision of information
p.000017: 1. Human biological samples and health information processed in a biobank may be provided for biomedical purposes
p.000017: the sponsor of the study, his authorized representative or the principal investigator when issued in accordance with Article 20 of this Law.
p.000017: permits for biomedical research by the designated authority.
p.000017: 2. Human biological samples and health information processed in the Biobank may be shared
p.000017: Republic of Lithuania, a member state of the European Union, another state of the European Economic Area and
p.000017: biobanks, a biomedical research client, his authorized representative or a principal investigator in a third country,
p.000017: performing biomedical research outside the Republic of Lithuania, human biological samples and health information
p.000017: after obtaining the permission of the Lithuanian Bioethics Committee regarding the human biological materials processed in the biobank
p.000017: èminip and / or provision of health information.
p.000017: 3. Authorization for the provision of Human Biological Samples and / or Health Information processed in a biobank
p.000017: issued after the Lithuanian Bioethics Committee has decided that:
p.000017: 1) the purposes of the provision of human biological êminiq and health information are consistent with the consent given by the person
p.000017: to participate in the activities of the biobank;
p.000019: 19
p.000019: 2) the persons referred to in Paragraph 2 of this Article have the certificates issued by the State Ethics Committee and / or the institution
p.000019: permits authorizing the processing of human biological samples and / or skeletal information for biomedical research
p.000019: purposes.
p.000019: 4. The authorization of a biobanlce shall be subject to the processing of human biological samples and / or health information
p.000019: the procedure for issuance shall be established by the Minister of Health.
p.000019: 5. Biobank Human biological samples and health information or biomedical data obtained from their use
p.000019: the results of the investigation, or the part thereof which allows the identification of the person, shall be provided only by a reasoned court decision, if it is
p.000019: is necessary for the trial of the case.
...
p.000026: the decision of the ethics committee to leave the sponsor of the biomedical research, its authorized representative or
p.000026: the principal investigator shall exercise the right to appeal to a court in accordance with the procedure established by law.
p.000026: 6. Subjects or, in cases established by this Law, others with the right to consent to participate in the investigation
p.000026: the right to appeal against the biomedical research client, his authorized representative, the principal investigator
p.000026: and the activities of persons performing biomedical research to the licensing authority, the court tstatymp and
p.000026: another legal act in accordance with the established procedure.
p.000026: 7. Persons whose biological sample and / or health information is processed in the biobank have the right to appeal against the biobank.
p.000026: actions in accordance with the procedure established by law and other legal acts.
p.000026: CHAPTER V
p.000026: FINAL PROVISIONS
p.000026: Article 26. Liability for breaches of ethical requirements in biomedical research
p.000026: 1. Persons who have violated the requirements of this Law shall be liable in accordance with the procedure established by law.
p.000026: 2. Carrying out a biomedical test without authorization or in breach of this statute and other legislation
p.000026: requirement9, without causing pecuniary or non-pecuniary damage to the health of the subject, shall be
p.000026: for the performance of professional duties.
p.000027: 27
p.000027: Annex to the Law on Ethics of Biomedical Research of the Republic of Lithuania
p.000027: {IMPLEMENTING EUROPEAN UNION LEGISLATION
p.000027: 1. 2001 April 4 Directive 2001/20 / EC of the European Parliament and of the Council on the approximation of the laws of the Member States
p.000027: and amend legislation relating to the implementation of good clinical practice in the field of medicinal products for human use.
p.000027: clinical trials (OJ 2004 in. special order, Chapter 13, Volume 26, p. 299). "
p.000027: Article 2. Entry into force, implementation and application of the law
p.000027: 1. This Law, with the exception of paragraph 2 of this Article, shall enter into force on 1 January 2016. January 1
p.000027: 2. The Government of the Republic of Lithuania or an institution authorized by it, the Ministry of Health of the Republic of Lithuania
p.000027: Minister and Minister of Social Security and Labor of the Republic of Lithuania until 2015 rrr. December 31 accepts this
p.000027: implementing legislation.
p.000027: 3. Documents submitted before the entry into force of this Law for the authorization of a biomedical research or for
p.000027: a certificate of consent to conduct a clinical trial of a medicinal product and an authorization to conduct a clinical trial of a medicinal product
p.000027: studies (hereinafter referred to as ‘authorization’) and biomedical studies
p.000027: issued before the entry into force of this Law shall be carried out in accordance with the biomedical research of the Republic of Lithuania.
p.000027: provisions of the Code of Ethics in force until now
p.000027: {entry into force of the Act, except as provided in paragraphs 4 and 5 of this Article.
p.000027: 4. Documents concerning the issue of a permit, submitted and not examined before the entry into force of this Law,
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000002: and biomedical research and the liability for damage caused by the subject.
p.000002: health consent or death.
p.000002: 2. The provisions of this Law are harmonized with the legal acts of the European Union specified in this Law
p.000002: in the Annex to the Law.
p.000002: Article 2. The main concepts of this law
p.000002: 1. Personal health information (hereinafter health information) - data on a person's health, diseases
p.000002: and health disorders, causes, external factors, diagnosis, course, prognosis, treatment, outcome, death,
p.000002: heredity or any other information related to a person’s health.
p.000002: 2
p.000002: 2. Provision of personal health information (hereinafter - provision of health information) - personal health
p.000002: disclosure of information by transmission or otherwise making it available, other than by making it available to the public
p.000002: in the media.
p.000002: 3. Processing of personal health information (hereinafter referred to as "health information processing") - any
p.000002: which action is taken on personal health information: collection, recording, storage, storage,
p.000002: classification, grouping, merging, modification (addition or correction), biomedical research, provision,
p.000002: publication, use, logical and / or arithmetic operations, search, dissemination, destruction or other
p.000002: action or actions.
p.000002: 4. A person who, because of a medical condition, cannot be considered to be able to reasonably assess his or her interests is an adult
p.000002: a person declared incapacitated or of limited breeding by a court, or an adult or recognized by a court
p.000002: a full-fledged (emancipated) minor whose state of health does not allow him to assess his interest or
p.000002: tightens to judge them wisely.
p.000002: 5. Biobank - a public legal entity acting as a budgetary or public body, holding a personal
p.000002: a health care license to engage in activities involving human biological êminiq and health information
p.000002: for the purposes set out in this Law and the performance of biomedical research (hereinafter referred to as
p.000002: biobank activities).
p.000002: 6. Bioethical requirements - in the Republic of Lithuania and international legal acts and codes of ethics
p.000002: ethical requirements for the provision of health care and biomedical research have been established.
p.000002: 7. Biomedical research - testing of hypotheses of biomedical science by scientific research methods,
p.000002: aimed at developing scientific knowledge about human health, diseases, their diagnosis, treatment or prevention.
p.000002: 8. Biomedical Research Center (hereinafter referred to as the Research Center) - a legal entity where a biomedical
p.000002: research.
p.000002: 9. Biomedical research participant - a natural or legal person, other organization or a division thereof,
p.000002: initiating, managing biomedical research and ensuring its funding.
p.000002: 10. Ethical requirements for biomedical research - bioethical requirements established in this Law shall apply
p.000002: in biomedical research.
p.000002: 11. Ethical supervision of biomedical research - Lithuanian Bioethics Committee and (or) regional
p.000002: Activities of the Committee of the Committee on Biomedical Research in Supervision as Clients and Researchers in Biomedical Research
p.000002: adheres to the ethical requirements of biomedical research.
...
p.000006: 7) persons in prisons or other places of deprivation of liberty.
p.000006: 2. Lithuanian Bioethics Committee or Regional Biomedical Research Ethics Committee when evaluating documents
p.000006: on the issuance of a permit for a biomedical research, the Lithuanian Bioethics Committee, when evaluating the documents
p.000006: approval of a clinical trial of a medicinal product, a reasoned decision may be taken
p.000006: to recognize other groups of persons as vulnerable persons.
p.000006: 3. Clinical trials on vulnerable persons shall be permitted only in the following cases:
p.000007: 7
p.000007: (1) where a clinical trial can only be performed on vulnerable individuals and there is scientific reason to believe that
p.000007: participation in a clinical trial will provide a direct benefit to the subject that is greater than that associated with the clinical trial.
p.000007: associated risks and inconveniences;
p.000007: 2) when the clinical trial can only be performed on vulnerable individuals and the clinical trial is directly
p.000007: is related to the health status of the subject and there is scientific reason to expect that participation in the clinical trial will occur
p.000007: beneficial to the non-study group to which the subject belongs and to the subject for the purpose of the clinical trial
p.000007: the intervention methods used in the study have a minor adverse effect on the health of the subject;
p.000007: 3) when the clinical trial is directly related to the life-threatening or debilitating subject of the subject
p.000007: a medical condition for which there is no adequate personal health care and there is a scientific basis
p.000007: it is expected that participation in the clinical trial will provide a direct benefit to the subject that is greater than
p.000007: risks and inconveniences associated with the clinical trial.
p.000007: Article 7. Individual consent to participate in the study
p.000007: 1. Before including a person in a biomedical research, other than a biomedical research carried out with
p.000007: Human biological samples and / or health information processed in the biobank with the consent of the person to participate
p.000007: biobaiilco, the consent of the individual to participate in the study must be obtained. A person's consent to participate in the study must
p.000007: meet all of the following conditions:
p.000007: 1) the person's consent to participate in the investigation is given by a person who can express his or her will;
p.000007: 2) the consent of the person to participate in the investigation has been given in accordance with the procedure established in Paragraph 8 of this Article when the person has received sufficient information
p.000007: and clear information;
p.000007: 3) the consent of a person to participate in the investigation is given by a person (in the cases and according to the procedure provided for in this Law - by another person).
...
p.000015: specified pecuniary and non-pecuniary damage caused to the subject, except in the case of biomedical research
p.000015: the sponsor and the investigator agree otherwise in writing. Property made by the client and researcher of the biomedical research
p.000015: and non-pecuniary damage to the health of the subject shall be compensated in accordance with the provisions of the Civil Code, the Law on Insurance and other legal acts.
p.000015: order.
p.000015: 2. The principal investigator of the biomedical research must insure his civil liability in respect of
p.000015: possible pecuniary and non-pecuniary damage caused by the health injury of the subject or the
p.000015: death, remuneration, civil liability of the client of the biomedical research and the principal investigator
p.000015: compulsory insurance contracts with insurers. This requirement is considered only when it is met
p.000015: a clinical trial of a medicinal product or any other biomedical trial in which a person is involved
p.000015: interventional research methods used for biomedical research pose a risk to the health of the subject.
p.000015: Whether interventional research methods used for biomedical research pose a risk to the subject
p.000015: health, is assessed by the Lithuanian Bioethics Committee, which issues a clinical trial approval
p.000015: research certificate or authorization for a biomedical research, or a regional biomedical research
p.000015: ethylcos committee authorizing biomedical research.
p.000015: 3. A clinical trial of a medicinal product or any other biomedical trial in which the participating
p.000015: interventional biomedical research methods have only a minor adverse effect on the individual.
p.000015: health is also permitted in the case of a personal health care institution which itself or
p.000015: its employee is the client of such biomedical research or its employee is the sponsor of such biomedical research
p.000015: researcher, the contract of civil liability for damage to patients provides for property and non-property
p.000015: compensation for damage that may occur during such biomedical research. Whether they apply
p.000015: Interventional biomedical research methods have a small undesirable temporary effect on the subject
p.000015: health, is assessed by the Lithuanian Bioethics Committee, which issues a clinical trial approval
p.000015: research certificate or authorization for biomedicininț research, or regional biomedicininip
p.000015: Research Ethics Committee, which authorizes biomedical research based on health
p.000015: approved by the Minister of Defense Minor adverse temporary effects on the health of the subject
p.000015: list of interventional biomedical research methods. Lithuanian Bioethics Committee or regional
p.000015: the ethics committee may, by reasoned decision, declare a minor
p.000015: temporary effects on the subject's health
p.000016: 16
p.000016: and other Minor adverse adverse effects on the health of the subject through biomedical intervention.
p.000016: research method interventional biomedical research methods not listed.
p.000016: 4. Compulsory civil liability insurance of the client of the biomedical research and the principal investigator
p.000016: the amount may not be less than 29 000 eunț for pecuniary and non-pecuniary damage caused to one subject,
p.000016: offset. Compulsory civil liability insurance for the client of the biomedical research and the principal investigator
p.000016: protection must be valid from the beginning to the end of the biomedical examination and for at least 5 years from
p.000016: end of biomedical research. Civilian of the client and principal investigator of the biomedical research
p.000016: the rules on compulsory liability insurance laid down by the other sponsor of the biomedical research and
p.000016: the terms and conditions of the principal investigator 's compulsory civil liability insurance contract, property and
p.000016: the procedure for calculating and reimbursing the amount of non-proprietary health research shall be established by the Government or its authorized
p.000016: authority.
p.000016: CHAPTER III BIOBANKS, OPERATING CONDITIONS
p.000016: Article 13. Biobank activities
p.000016: 1. The activities of the Biobank shall be carried out in accordance with this Law, the Law on Legal Protection of Personal Data and the Law on Health.
p.000016: requirements of the law, respecting the rights and freedoms of the individual and
p.000016: the principles of reliability, security and openness.
...
Social / education
Searching for indicator education:
(return to top)
p.000013: confidential and may be provided only in accordance with the procedure established by the Law on Patients' Rights and Compensation for Health Damage.
p.000014: 14
p.000014: 2. Health information obtained from biomedical research shall not be considered confidential and may be published without delay
p.000014: the consent of the subject if the publication of such health information will not lead to the identification of the person.
p.000014: Article 10. Islaidq salary
p.000014: Subjects shall be entitled to compensation for the costs incurred in sharing the biomedical research.
p.000014: wasted time. The procedure for calculation and payment of compensation shall be established by the Government of the Republic of Lithuania (hereinafter -
p.000014: Government) or a body authorized by it.
p.000014: Article 11. Biomedical research client and researcher
p.000014: 1. The sponsor of a biomedical research shall be responsible for the initiation, management and administration of the biomedical research
p.000014: securing funding for biomedical research.
p.000014: 2. The researcher shall be responsible for the biomedical research carried out at the research center. If the biomedical research is performed by a researcher
p.000014: one or the research center leads a group of biomedical researchers and is responsible for this
p.000014: group activities, he is called the principal investigator.
p.000014: 3. When conducting biomedical research involving interventional biomedical
p.000014: the test methods pose a risk to the health of the subject (with the exception of the biomedical tests referred to in paragraph 4 of this Article)
p.000014: research), the researcher must have a higher education degree appropriate to the nature of such biomedical research
p.000014: a qualification, an appropriate license to practice medicine or a dental practice, to have a patient
p.000014: supervisory experience and other staff at the research center, and the principal investigator must also
p.000014: have biomedical research, where the interventional biomedical research methods used pose
p.000014: risk to the subject's health. The specific investigator performing the task referred to in this paragraph
p.000014: biomedical research, higher education qualification and experience requirements are set by the Minister of Health.
p.000014: 4. When a clinical trial of a medicinal product is being conducted, the investigator must have a clinical pharmacy
p.000014: preparation research pobiid) corresponding to a higher education qualification relevant to medical practice
p.000014: or dental practice license, have experience in patient care, have completed good clinical practice
p.000014: practice training and employed at a research center. When performing the biomedical research referred to in this
p.000014: the principal investigator must also have experience in clinical trials of the medicinal product. Specific
p.000014: higher education qualifications of a researcher conducting a clinical trial, good clinical practice
p.000014: The requirements for practical training9 and experience are set by the Minister of Health. A person can work
p.000014: the principal investigator is only one in the same study center.
p.000015: 15
p.000015: Article 12. Civil liability of the client and researcher of biomedical research and its insurance
p.000015: 1. The client and researcher of a biomedical research shall be liable for pecuniary and non-pecuniary damage caused to the research subject, except
p.000015: pecuniary and non-pecuniary damage caused by causes other than biomedical research,
p.000015: or dê1 intentional act of the subject. The sponsor of the biomedical research and the investigator shall be jointly and severally liable for this part
p.000015: specified pecuniary and non-pecuniary damage caused to the subject, except in the case of biomedical research
p.000015: the sponsor and the investigator agree otherwise in writing. Property made by the client and researcher of the biomedical research
p.000015: and non-pecuniary damage to the health of the subject shall be compensated in accordance with the provisions of the Civil Code, the Law on Insurance and other legal acts.
p.000015: order.
p.000015: 2. The principal investigator of the biomedical research must insure his civil liability in respect of
p.000015: possible pecuniary and non-pecuniary damage caused by the health injury of the subject or the
p.000015: death, remuneration, civil liability of the client of the biomedical research and the principal investigator
p.000015: compulsory insurance contracts with insurers. This requirement is considered only when it is met
p.000015: a clinical trial of a medicinal product or any other biomedical trial in which a person is involved
...
Social / embryo
Searching for indicator embryo:
(return to top)
p.000002: 13. Consent of an informed person to participate in a biomedical research (hereinafter - consent of a person to participate in
p.000002: voluntary, explicit, informed written consent to participate in a biomedical study,
p.000002: signed the consent of the person or another person to participate in the investigation in the cases and in accordance with the procedure provided for in this Law
p.000002: entitled to grant the marriage of a surviving spouse if the person was unmarried
p.000002: expires, the spouse is recognized as not knowing where he or she is or the spouses have lived apart, - a close relative.
p.000002: 14. "Clinical trials" means bioinedicological trials in living humans.
p.000002: 15. Researcher - a natural person performing biomedical research who complies with the requirements established in this Law.
p.000002: 16. Research subject - a person participating in a biomedical research.
p.000002: 17. "Human biological sample" means a biological material taken from a living or dead human body.
p.000002: 18. “Provision of human biological samples” means the transfer or making available of human biological samples
p.000002: biidu.
p.000002: ! 9. "Handling of human biological samples" means any operation performed on human biological samples
p.000002: action: collection, processing, preservation, accumulation, storage, identification, evaluation,
p.000002: biomedical research, classification, refining, aggregation, modification (addition or correction), provision,
p.000002: search, destruction or any other act or actions.
p.000002: 20. Human embryo - a developing human body from the moment of fertilization (zygote formation) to the eighth
p.000002: end of the week of pregnancy.
p.000002: 21. ‘human embryonic stem cells’ means human embryonic stem cells which are capable of
p.000002: to divide and / or develop specialized cell types in vitro.
p.000002: 22. Human embryonic stem cell line means a human embryonic stem cell which may be
p.000002: grown in vitro and divided without long-term differentiation into other cell types.
p.000002: 23. Human stem cells - during the development of the human embryo and human fetus and the
p.000002: non-specialized cells in human tissues that can differentiate} specialized
p.000002: țvairiq audiniq tips cells and regenerate at the same time.
p.000002: 24. Human stem cell line Human stem cells grown in vitro
p.000002: conditions, ensuring their long-term sharing without differentiation.
p.000004: 4
p.000004: 25. "Human fetus" means the developing human body from the beginning of the ninth week of pregnancy until birth.
p.000004: 26. Other terms used in this Law shall be understood as they are defined in the Republic of Lithuania
p.000004: Civil Code (hereinafter - the Civil Code), the Law on Insurance of the Republic of Lithuania (hereinafter - the Insurance Code)
p.000004: Law on Pharmacy), the Law on Equal Opportunities of the Republic of Lithuania, the Law on Equal Opportunities of the Republic of Lithuania
p.000004: The Law on Compensation and Damage to Health of the Republic of Lithuania (hereinafter referred to as the
p.000004: Law on Remuneration of Health Care), the Law on Health Care Institutions of the Republic of Lithuania
p.000004: maintenance ¡staigq
p.000004: Law of the Republic of Lithuania on the Protection of the Rights of the Child
p.000004: the Law of the Republic of Lithuania on Human Tissues, Cell Cells, Organ Donation and Transplantation,
p.000004: Republic of human death detection and critical condition
p.000004: and the Law on the Legal Protection of Personal Data of the Republic of Lithuania (hereinafter - the Law on the Legal Protection of Personal Data)
p.000004: protection law).
p.000004: Article 3. Biomedical research objects
p.000004: 1. In a biomedical research, the objects may be living or dead humans or groups of humans, human embryos, human
p.000004: fruit, Human Biological Sample and Health Information.
p.000004: 2. The establishment of a human embryo for the purposes of biomedical research is prohibited.
p.000004: 3. Biomedical research shall only be carried out on a human embryo and human fetus if it is intended to:
p.000004: the benefits to the human embryo and human fetus under consideration outweigh the risks.
p.000004: 4. Biomedical research on human embryos and fetuses
p.000004: after termination of pregnancy at the request of a woman in the absence of medical indications.
p.000004: 5. Human cloning is prohibited.
p.000004: 6. Biomedical research on a human embryo or human fetus during or after which a human
p.000004: an embryo or human fetus is destroyed or a human embryo is not transferred} to a woman’s uterus is prohibited.
p.000004: 7. Biomedical research that modifies the human genome may only be performed for prophylactic,
p.000004: for diagnostic or therapeutic purposes and only if they are not intended to modify the genome of the offspring.
p.000004: 8. Human embryonic audinip, embryonic stem cell and its line or fetal audinip and derived from it
p.000004: the entry into and exit from the territory of the Republic of Lithuania of stem cells and their lines is prohibited.
p.000004: This prohibition does not apply to stem cells extracted from the umbilical cord or placenta after the birth of a child,
p.000004: and samples taken for genetic testing in accordance with the requirements of Paragraph 3 of this Article for export to Lithuania
p.000004: Territory of the Republic and for exit from
p.000004: jos. Human embryonic tissue, embryonic stem cells and their lines or human fetal tissues and from
p.000004: Transit through the territory of the Republic of Lithuania of the stem cell and their line is possible only
p.000004: with the permission of the Minister of Health. Permission for human embryonic tissue, embryonic stem cells, etc.
p.000004: human fetal tissue and stem cells derived therefrom and
p.000004: The territory of the Republic of Lithuania and the Human stem cell extract obtained from the umbilical cord or
p.000004: placenta after the birth of a child, and genetic testing of a human biological sample for transportation Î Lithuanian
...
Social / employees
Searching for indicator employees:
(return to top)
p.000006: subject, do not outweigh the benefits of biomedical research, or when such personal health care
p.000006: the non-application does not endanger the health of the subject;
p.000006: 8) in the cases specified in Paragraphs 2 and 3 of Article 12 of this Law, the principal investigator and the biomedical
p.000006: the research client or the health care institution is insured against civil liability for possible
p.000006: compensation for pecuniary and non-pecuniary damage caused during the biomedical research to the research subject;
p.000006: 9) documents conferring the right to perform have been obtained from the instituteijiț referred to in Article 20 of this Law
p.000006: biomedical research;
p.000006: 10) this is not prohibited by other laws.
p.000006: Article 6. Vulnerable persons and protection of interest
p.000006: 1. Vulnerable persons whose consent to participate in a biomedical study may be affected by external
p.000006: circumstances or who are unable, in whole or in part, to defend their interest shall be deemed to be:
p.000006: 1) persons who, due to their state of health, cannot be considered capable of reasonably assessing their interests;
p.000006: 2) children;
p.000006: 3) students, if their participation in biomedical research is related to studies;
p.000006: 4) persons living in social care institutions;
p.000006: 5) soldiers during the actual military retreat;
p.000006: 6) employees of the health care institution where the biomedical research is performed, subordinate to the researcher;
p.000006: 7) persons in prisons or other places of deprivation of liberty.
p.000006: 2. Lithuanian Bioethics Committee or Regional Biomedical Research Ethics Committee when evaluating documents
p.000006: on the issuance of a permit for a biomedical research, the Lithuanian Bioethics Committee, when evaluating the documents
p.000006: approval of a clinical trial of a medicinal product, a reasoned decision may be taken
p.000006: to recognize other groups of persons as vulnerable persons.
p.000006: 3. Clinical trials on vulnerable persons shall be permitted only in the following cases:
p.000007: 7
p.000007: (1) where a clinical trial can only be performed on vulnerable individuals and there is scientific reason to believe that
p.000007: participation in a clinical trial will provide a direct benefit to the subject that is greater than that associated with the clinical trial.
p.000007: associated risks and inconveniences;
p.000007: 2) when the clinical trial can only be performed on vulnerable individuals and the clinical trial is directly
p.000007: is related to the health status of the subject and there is scientific reason to expect that participation in the clinical trial will occur
p.000007: beneficial to the non-study group to which the subject belongs and to the subject for the purpose of the clinical trial
p.000007: the intervention methods used in the study have a minor adverse effect on the health of the subject;
...
Social / parents
Searching for indicator parents:
(return to top)
p.000007: already participates in such a biomedical study, does not participate in it, the child does not participate in the study, or
p.000007: terminated unless this is contrary to the best interests of the child. Is the child's desire not to participate in the study
p.000007: does not contradict the interests of the child, the child's representatives shall decide in accordance with the law, taking into account the opinion of the researcher.
p.000007: When children are involved in a biomedical study, the decision to approve a clinical trial
p.000007: Participation in the meeting of the Lithuanian Bioethics Committee for the issuance of a study certificate
p.000007: Representative of the Ministry of Social Security and Labor. Child
p.000007: the procedure for participation in biomedical research shall be established by the health care minisoas and the Republic of Lithuania
p.000007: Minister of Social Security and Labor.
p.000007: 4. A person who, because of his state of health, cannot be considered to be able to promote his interests prudently,
p.000007: the consent of a person to participate in a biomedical research is given by the spouse of the person, if the person is
p.000007: unmarried, the marriage is over, the spouse is recognized as unknown or the spouses live
p.000007: - one of the person’s parents (¡tėvip) or one of the adult children (łvaikiq), or
p.000007: incapacitated, - his guardian or, in the case of a disability, his carer (hereinafter
p.000007: consent to participate in the study). The subject must be able to understand according to his / her ability to understand
p.000007: the information referred to in paragraph 8 of this Article has been provided. The researcher takes into account the subject who can understand
p.000007: the information provided to him, the wish not to participate in a biomedical study or, if the subject is in such a study
p.000007: already involved in the blomedical study, the desire not to participate in it. Upon receipt of the consent of one of these persons
p.000007: priority, to perform a biomedical examination with a person who, due to a medical condition, is unable to
p.000007: considered to be able to reasonably assess their interests is prohibited.
p.000007: 5. If, before death, the person has not given his or her consent to participate in the investigation or has not withdrawn his or her consent,
p.000007: perform biomedical treatment with the biological sample (s) of the deceased and health information
p.000007: given by the surviving spouse, if the person was not married, the marriage has ended, the spouse
p.000007: is recognized as unknown where the spouses were living apart, - one of the next of kin
p.000007: the following order of precedence: parents (grandparents), adult children (grandchildren), brothers (sisters), grandparents, grandchildren.
p.000007: With the consent of one of these persons, the next of kin's next of kin
p.000007: consent is not sought. In case of disagreement of one of these persons, priority shall be given to perform
p.000007: biomedical examination with a biological sample (s) of the deceased and health information is prohibited.
p.000007: 6. The person and any other person entitled to consent to the investigation may be informed
p.000007: the consent of a person to participate in a study may be obtained from a person receiving a biomedical study when
p.000007: all of the following conditions are met:
p.000009: 9
p.000009: 1) due to the condition of the ingot or other health condition, for which the necessary assistance is required, the person may not:
p.000009: to obtain the information referred to in paragraph 8 of this Article and to give the consent of the person to participate in the investigation, and the person
p.000009: who, because of his or her state of health, cannot be considered capable of reasonably assessing his or her own interests, whether the child
p.000009: cannot receive the information referred to in paragraph 8 of this Article and may not express a wish or unwillingness to participate
p.000009: biomedical research;
p.000009: 2) there is a scientific basis for expecting that a person’s participation in biomedical research will benefit his or her health
...
p.000010: the content requirements of the person's consent to participate in the activities of the biobank.
p.000010: 2. If, due to a physical disability, illness or other reasons, a person is unable to sign the person's consent
p.000010: to participate in the activities of the biobank, the consent of the person to participate in the activities of the biobank shall be signed by the Civil Code
p.000010: in accordance with the procedure laid down.
p.000010: 3. The consent of a person to participate in a biobank for the processing of a child’s biological sample and health information
p.000010: for the purposes set out in Article 16 (1) of the Law shall be provided by the child's representatives in accordance with the Law.
p.000010: 4. The consent of a person to participate in the activities of the biobank due to a person who, due to his / her health condition, cannot be considered
p.000010: able to reasonably assess their interests in the processing of human biological sample and health information
p.000010: for the purposes set out in Article 16 (1) of this Law shall be provided by the spouse of the person if the person is
p.000010: unmarried, the marriage is over, the spouse is recognized as unknown or the spouses live
p.000010: divorce, one of the person’s parents (jtêviq) acba one of the adult child (} child) or when the person is in court
p.000010: incapacitated, his guardian or, in the event of a person’s incapacity, his caregiver (hereinafter referred to as
p.000010: the person entitled to give consent to participate in the activities of the biobank).
p.000010: 5. The consent of the person to participate in the activities of the biobank regarding the biological sample and health information of the deceased
p.000010: processing for the purposes set out in Article 16 (1) of this Law shall be provided by the surviving spouse, if the person
p.000010: was unmarried, the marriage is over, the spouse is
p.000012: 12
p.000012: - it is not known where the spouses were or whether the spouses lived apart, - one of the close relatives
p.000012: priority: parents ({parents), adult children (} children), brothers (sisters), grandparents, grandchildren. Gavus
p.000012: the consent of one of these9 persons is established in order of priority, the consent of the deceased close relative is not sought.
p.000012: In the event of the disagreement of one of these9 persons, use the biological samples of the deceased and
p.000012: health information is prohibited in the activities of the biobank.
p.000012: 6. Before giving a person's consent to participate in the activities of a biobank, a person, in the cases provided for in this Law -
p.000012: another person entitled to give consent to participate in the activities of the biobank, the surviving spouse, if
p.000012: was unmarried, - a close relative in the order of priority referred to in paragraph 5,
p.000012: taking into account the age and health status of the person giving consent to participate in the biobank,
p.000012: in a way that he understands, explaining the specific medical terms, informed of:
p.000012: 1) the essence of the person's consent to participate in the activities of the biobank, the possible benefits, inconveniences and risks to the person;
p.000012: (2) the objectives and results of the processing of the biological sample and health information, including health
p.000012: obtaining information from healthcare from institutions, the registry and / or the state infor-
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.000007: to participate in the investigation, the person's consent to participate in the investigation shall be signed in accordance with the procedure established by the Civil Code.
p.000007: 3. The child shall be given the age specified in paragraph 8 of this article, according to his or her age and ability to understand
p.000007: information. Due to vailco's participation in a biomedical research, the consent of the person to participate in the research is given by the child
p.000007: representatives in accordance with the law, but if the child, who is able to understand the information provided to him, expresses a wish
p.000007: not to participate in a biomedical study or, if vailcas
p.000007: already participates in such a biomedical study, does not participate in it, the child does not participate in the study, or
p.000007: terminated unless this is contrary to the best interests of the child. Is the child's desire not to participate in the study
p.000007: does not contradict the interests of the child, the child's representatives shall decide in accordance with the law, taking into account the opinion of the researcher.
p.000007: When children are involved in a biomedical study, the decision to approve a clinical trial
p.000007: Participation in the meeting of the Lithuanian Bioethics Committee for the issuance of a study certificate
p.000007: Representative of the Ministry of Social Security and Labor. Child
p.000007: the procedure for participation in biomedical research shall be established by the health care minisoas and the Republic of Lithuania
p.000007: Minister of Social Security and Labor.
p.000007: 4. A person who, because of his state of health, cannot be considered to be able to promote his interests prudently,
p.000007: the consent of a person to participate in a biomedical research is given by the spouse of the person, if the person is
p.000007: unmarried, the marriage is over, the spouse is recognized as unknown or the spouses live
p.000007: - one of the person’s parents (¡tėvip) or one of the adult children (łvaikiq), or
p.000007: incapacitated, - his guardian or, in the case of a disability, his carer (hereinafter
p.000007: consent to participate in the study). The subject must be able to understand according to his / her ability to understand
p.000007: the information referred to in paragraph 8 of this Article has been provided. The researcher takes into account the subject who can understand
...
General/Other / Incapacitated
Searching for indicator incapacitated:
(return to top)
p.000002: conditions for the authorization of biomedical research, the supervision of the performance of biomedical research
p.000002: and biomedical research and the liability for damage caused by the subject.
p.000002: health consent or death.
p.000002: 2. The provisions of this Law are harmonized with the legal acts of the European Union specified in this Law
p.000002: in the Annex to the Law.
p.000002: Article 2. The main concepts of this law
p.000002: 1. Personal health information (hereinafter health information) - data on a person's health, diseases
p.000002: and health disorders, causes, external factors, diagnosis, course, prognosis, treatment, outcome, death,
p.000002: heredity or any other information related to a person’s health.
p.000002: 2
p.000002: 2. Provision of personal health information (hereinafter - provision of health information) - personal health
p.000002: disclosure of information by transmission or otherwise making it available, other than by making it available to the public
p.000002: in the media.
p.000002: 3. Processing of personal health information (hereinafter referred to as "health information processing") - any
p.000002: which action is taken on personal health information: collection, recording, storage, storage,
p.000002: classification, grouping, merging, modification (addition or correction), biomedical research, provision,
p.000002: publication, use, logical and / or arithmetic operations, search, dissemination, destruction or other
p.000002: action or actions.
p.000002: 4. A person who, because of a medical condition, cannot be considered to be able to reasonably assess his or her interests is an adult
p.000002: a person declared incapacitated or of limited breeding by a court, or an adult or recognized by a court
p.000002: a full-fledged (emancipated) minor whose state of health does not allow him to assess his interest or
p.000002: tightens to judge them wisely.
p.000002: 5. Biobank - a public legal entity acting as a budgetary or public body, holding a personal
p.000002: a health care license to engage in activities involving human biological êminiq and health information
p.000002: for the purposes set out in this Law and the performance of biomedical research (hereinafter referred to as
p.000002: biobank activities).
p.000002: 6. Bioethical requirements - in the Republic of Lithuania and international legal acts and codes of ethics
p.000002: ethical requirements for the provision of health care and biomedical research have been established.
p.000002: 7. Biomedical research - testing of hypotheses of biomedical science by scientific research methods,
p.000002: aimed at developing scientific knowledge about human health, diseases, their diagnosis, treatment or prevention.
p.000002: 8. Biomedical Research Center (hereinafter referred to as the Research Center) - a legal entity where a biomedical
p.000002: research.
p.000002: 9. Biomedical research participant - a natural or legal person, other organization or a division thereof,
p.000002: initiating, managing biomedical research and ensuring its funding.
p.000002: 10. Ethical requirements for biomedical research - bioethical requirements established in this Law shall apply
p.000002: in biomedical research.
p.000002: 11. Ethical supervision of biomedical research - Lithuanian Bioethics Committee and (or) regional
...
p.000007: terminated unless this is contrary to the best interests of the child. Is the child's desire not to participate in the study
p.000007: does not contradict the interests of the child, the child's representatives shall decide in accordance with the law, taking into account the opinion of the researcher.
p.000007: When children are involved in a biomedical study, the decision to approve a clinical trial
p.000007: Participation in the meeting of the Lithuanian Bioethics Committee for the issuance of a study certificate
p.000007: Representative of the Ministry of Social Security and Labor. Child
p.000007: the procedure for participation in biomedical research shall be established by the health care minisoas and the Republic of Lithuania
p.000007: Minister of Social Security and Labor.
p.000007: 4. A person who, because of his state of health, cannot be considered to be able to promote his interests prudently,
p.000007: the consent of a person to participate in a biomedical research is given by the spouse of the person, if the person is
p.000007: unmarried, the marriage is over, the spouse is recognized as unknown or the spouses live
p.000007: - one of the person’s parents (¡tėvip) or one of the adult children (łvaikiq), or
p.000007: incapacitated, - his guardian or, in the case of a disability, his carer (hereinafter
p.000007: consent to participate in the study). The subject must be able to understand according to his / her ability to understand
p.000007: the information referred to in paragraph 8 of this Article has been provided. The researcher takes into account the subject who can understand
p.000007: the information provided to him, the wish not to participate in a biomedical study or, if the subject is in such a study
p.000007: already involved in the blomedical study, the desire not to participate in it. Upon receipt of the consent of one of these persons
p.000007: priority, to perform a biomedical examination with a person who, due to a medical condition, is unable to
p.000007: considered to be able to reasonably assess their interests is prohibited.
p.000007: 5. If, before death, the person has not given his or her consent to participate in the investigation or has not withdrawn his or her consent,
p.000007: perform biomedical treatment with the biological sample (s) of the deceased and health information
p.000007: given by the surviving spouse, if the person was not married, the marriage has ended, the spouse
p.000007: is recognized as unknown where the spouses were living apart, - one of the next of kin
p.000007: the following order of precedence: parents (grandparents), adult children (grandchildren), brothers (sisters), grandparents, grandchildren.
...
p.000010: to participate in the activities of the biobank, the consent of the person to participate in the activities of the biobank shall be signed by the Civil Code
p.000010: in accordance with the procedure laid down.
p.000010: 3. The consent of a person to participate in a biobank for the processing of a child’s biological sample and health information
p.000010: for the purposes set out in Article 16 (1) of the Law shall be provided by the child's representatives in accordance with the Law.
p.000010: 4. The consent of a person to participate in the activities of the biobank due to a person who, due to his / her health condition, cannot be considered
p.000010: able to reasonably assess their interests in the processing of human biological sample and health information
p.000010: for the purposes set out in Article 16 (1) of this Law shall be provided by the spouse of the person if the person is
p.000010: unmarried, the marriage is over, the spouse is recognized as unknown or the spouses live
p.000010: divorce, one of the person’s parents (jtêviq) acba one of the adult child (} child) or when the person is in court
p.000010: incapacitated, his guardian or, in the event of a person’s incapacity, his caregiver (hereinafter referred to as
p.000010: the person entitled to give consent to participate in the activities of the biobank).
p.000010: 5. The consent of the person to participate in the activities of the biobank regarding the biological sample and health information of the deceased
p.000010: processing for the purposes set out in Article 16 (1) of this Law shall be provided by the surviving spouse, if the person
p.000010: was unmarried, the marriage is over, the spouse is
p.000012: 12
p.000012: - it is not known where the spouses were or whether the spouses lived apart, - one of the close relatives
p.000012: priority: parents ({parents), adult children (} children), brothers (sisters), grandparents, grandchildren. Gavus
p.000012: the consent of one of these9 persons is established in order of priority, the consent of the deceased close relative is not sought.
p.000012: In the event of the disagreement of one of these9 persons, use the biological samples of the deceased and
p.000012: health information is prohibited in the activities of the biobank.
p.000012: 6. Before giving a person's consent to participate in the activities of a biobank, a person, in the cases provided for in this Law -
...
Searching for indicator incapacity:
(return to top)
p.000010: to participate in the activities of the biobank, the consent of the person to participate in the activities of the biobank shall be signed by the Civil Code
p.000010: in accordance with the procedure laid down.
p.000010: 3. The consent of a person to participate in a biobank for the processing of a child’s biological sample and health information
p.000010: for the purposes set out in Article 16 (1) of the Law shall be provided by the child's representatives in accordance with the Law.
p.000010: 4. The consent of a person to participate in the activities of the biobank due to a person who, due to his / her health condition, cannot be considered
p.000010: able to reasonably assess their interests in the processing of human biological sample and health information
p.000010: for the purposes set out in Article 16 (1) of this Law shall be provided by the spouse of the person if the person is
p.000010: unmarried, the marriage is over, the spouse is recognized as unknown or the spouses live
p.000010: divorce, one of the person’s parents (jtêviq) acba one of the adult child (} child) or when the person is in court
p.000010: incapacitated, his guardian or, in the event of a person’s incapacity, his caregiver (hereinafter referred to as
p.000010: the person entitled to give consent to participate in the activities of the biobank).
p.000010: 5. The consent of the person to participate in the activities of the biobank regarding the biological sample and health information of the deceased
p.000010: processing for the purposes set out in Article 16 (1) of this Law shall be provided by the surviving spouse, if the person
p.000010: was unmarried, the marriage is over, the spouse is
p.000012: 12
p.000012: - it is not known where the spouses were or whether the spouses lived apart, - one of the close relatives
p.000012: priority: parents ({parents), adult children (} children), brothers (sisters), grandparents, grandchildren. Gavus
p.000012: the consent of one of these9 persons is established in order of priority, the consent of the deceased close relative is not sought.
p.000012: In the event of the disagreement of one of these9 persons, use the biological samples of the deceased and
p.000012: health information is prohibited in the activities of the biobank.
p.000012: 6. Before giving a person's consent to participate in the activities of a biobank, a person, in the cases provided for in this Law -
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000015: list of interventional biomedical research methods. Lithuanian Bioethics Committee or regional
p.000015: the ethics committee may, by reasoned decision, declare a minor
p.000015: temporary effects on the subject's health
p.000016: 16
p.000016: and other Minor adverse adverse effects on the health of the subject through biomedical intervention.
p.000016: research method interventional biomedical research methods not listed.
p.000016: 4. Compulsory civil liability insurance of the client of the biomedical research and the principal investigator
p.000016: the amount may not be less than 29 000 eunț for pecuniary and non-pecuniary damage caused to one subject,
p.000016: offset. Compulsory civil liability insurance for the client of the biomedical research and the principal investigator
p.000016: protection must be valid from the beginning to the end of the biomedical examination and for at least 5 years from
p.000016: end of biomedical research. Civilian of the client and principal investigator of the biomedical research
p.000016: the rules on compulsory liability insurance laid down by the other sponsor of the biomedical research and
p.000016: the terms and conditions of the principal investigator 's compulsory civil liability insurance contract, property and
p.000016: the procedure for calculating and reimbursing the amount of non-proprietary health research shall be established by the Government or its authorized
p.000016: authority.
p.000016: CHAPTER III BIOBANKS, OPERATING CONDITIONS
p.000016: Article 13. Biobank activities
p.000016: 1. The activities of the Biobank shall be carried out in accordance with this Law, the Law on Legal Protection of Personal Data and the Law on Health.
p.000016: requirements of the law, respecting the rights and freedoms of the individual and
p.000016: the principles of reliability, security and openness.
p.000016: 2. Biobanks shall process human biological samples and health information in accordance with the procedures specified in Paragraph 1 of Article 16 of this Law.
p.000016: purposes.
p.000016: 3. Biobanks have the right to:
p.000016: 1) be clients of biomedical research and perform biomedical research;
p.000016: 2) to co-operate with the Member States of the European Union in accordance with the procedure established by legal acts
p.000016: biobanks, international organizations of third countries and third countries, to participate in them
p.000016: activities;
p.000016: 3) to receive health information in accordance with the procedure established in Article 15 of this Law.
p.000016: Article 14. Biobankq pouring
p.000016: 1. A public legal entity acting as a budgetary or public body for the purpose of obtaining and obtaining a license
p.000016: to engage in the activities of a biobank must meet the requirements set out in the Law on Health Care
p.000016: the following requirements for obtaining a health care license:
p.000017: 17
p.000017: 1) to ensure that the requirement for the operation of the Biobank approved by the Minister of Health
p.000017: requirements set out in the inventory to ensure human biological êminip and health
p.000017: traceability, security, quality and availability of information to researchers, in accordance with:
...
p.000017: 2. Biobanks shall ensure the traceability, security,
p.000017: quality and availability to researchers in accordance with the procedure set out in the description of Biobank's operational requirements.
p.000017: 3. Health information processed in the Biobank is confidential and handled in accordance with the procedure established by law.
p.000017: The confidentiality of health information processed in the Biobank shall be ensured by all natural and legal persons
p.000017: who use this health information, as well as those referred to in Article 15 (1) and (2) of this Law
p.000017: subjects.
p.000017: 4. The information processed by the biobank is not considered confidential and may be published without
p.000017: the consent of the person who has given the consent of the person to participate in the activities of the biobank, if after the publication of such health
p.000017: the information will not be identifiable.
p.000017: 5. The biobank shall assign a code to the human biological sample and / or health information received and
p.000017: allowing the identification of the person whose biological samples and / or health information is being processed
p.000017: in the biobank, the identity is managed separately, ensuring the possibility to identify the konlnetq person.
p.000017: Article 17. Human biological samples and / or health information and personal health are relevant
p.000017: provision of information
p.000017: 1. Human biological samples and health information processed in a biobank may be provided for biomedical purposes
p.000017: the sponsor of the study, his authorized representative or the principal investigator when issued in accordance with Article 20 of this Law.
p.000017: permits for biomedical research by the designated authority.
p.000017: 2. Human biological samples and health information processed in the Biobank may be shared
p.000017: Republic of Lithuania, a member state of the European Union, another state of the European Economic Area and
p.000017: biobanks, a biomedical research client, his authorized representative or a principal investigator in a third country,
p.000017: performing biomedical research outside the Republic of Lithuania, human biological samples and health information
p.000017: after obtaining the permission of the Lithuanian Bioethics Committee regarding the human biological materials processed in the biobank
p.000017: èminip and / or provision of health information.
p.000017: 3. Authorization for the provision of Human Biological Samples and / or Health Information processed in a biobank
p.000017: issued after the Lithuanian Bioethics Committee has decided that:
p.000017: 1) the purposes of the provision of human biological êminiq and health information are consistent with the consent given by the person
p.000017: to participate in the activities of the biobank;
p.000019: 19
p.000019: 2) the persons referred to in Paragraph 2 of this Article have the certificates issued by the State Ethics Committee and / or the institution
p.000019: permits authorizing the processing of human biological samples and / or skeletal information for biomedical research
p.000019: purposes.
p.000019: 4. The authorization of a biobanlce shall be subject to the processing of human biological samples and / or health information
p.000019: the procedure for issuance shall be established by the Minister of Health.
p.000019: 5. Biobank Human biological samples and health information or biomedical data obtained from their use
...
p.000025: the quality and integrity of the data which led to the suspension of the biomedical research authorization and which
p.000025: the deadline has not been eliminated;
p.000025: 3) when requested by the client of the biomedical research, his / her authorized representative or the principal
p.000025: tyrants;
p.000025: 4) when the sponsor of the biomedical research, his authorized representative or the principal investigator through
p.000025: two years after the decision to suspend the authorization of a biomedical research in accordance with paragraph 1 2
p.000025: does not submit a request for revocation of the suspension of the permit on the basis of the point of acceptance;
p.000025: 5) to establish requirements approved by the Minister of Health for medical devices intended for clinical use
p.000025: investigations, infringements which may significantly harm the rights, safety, health and / or
p.000025: the quality and / or integrity of biomedical research data and which cannot be eliminated by suspending biomedical
p.000025: study or for which the authorization for a biomedical study has been suspended and which have not been
p.000025: remove.
p.000025: 5. Following a decision to withdraw the authorization of a biomedical research, no later than 3 calendar days
p.000025: days from the day of making the decision, the client of the biomedical research shall be informed thereof in writing
p.000025: } an authorized representative or principal investigator, the head of the research center, who must ensure that
p.000025: the biomedical study was terminated immediately.
p.000025: 6. Powers to suspend a biomedical research authorization, to revoke an authorization
p.000025: suspension, the authorization of the biomedical research shall be revoked by the authority which transferred the authorization
p.000025: betrayed.
p.000025: Article 25 Complaints procedure
p.000025: 1. The decision of the Regional Ethics Committee for Biomedical Research to refuse to authorize biomedical research
p.000025: revocation or suspension of the authorization by the sponsor of the biomedical study, his authorized representative or
p.000025: the principal investigator shall have the right to appeal within 15 calendar days of receiving such a decision
p.000025: Lithuanian Bioethics Committee. The Lithuanian Bioethics Committee must examine this complaint and make a decision through
p.000025: 30 calendar days from the date of its receipt.
p.000025: 2. The lodging of an appeal shall not suspend the decision to revoke or suspend the authorization of the biomedical research
p.000025: validity of enforcement.
p.000025: 3. After examining a complaint from a biomedical research client, his authorized representative or the principal investigator concerning a regional
p.000025: decision of the Committee for Biomedical Research to refuse to issue
p.000026: 26
p.000026: authorization for biomedical research, revocation or suspension of authorization for biomedical research,
p.000026: The Lithuanian Bioethics Committee makes a decision:
p.000026: 1) reject the complaint of the sponsor of the biomedical research, his authorized representative or the principal investigator and
p.000026: the decision of the Biomedical Research Ethics Committee to remain unchanged, or
p.000026: 2) to satisfy and issue a complaint of the client of the biomedical research, his authorized representative or the main intention
p.000026: authorization to conduct a biomedical research or to take a decision to revoke or suspend an authorization
p.000026: to carry out the revocation of the validity of a biomedical study.
p.000026: 4. The decision adopted by the Lithuanian Bioethics Committee no later than within 5 working days from the day of its adoption
p.000026: sent to the complainant and to the regional biomedical
p.000026: investigation to the ethics committee.
p.000026: 5. The decision of the Lithuanian Bioethics Committee to refuse to issue a permit to perform a biomedical research, to revoke or
p.000026: to suspend the authorization of the biomedical research, as well as the decision of the Lletuva Bioethics Committee to reject
p.000026: the complaint of the sponsor of the biomedical research, his authorized representative or the principal investigator and the regional biomedical research
p.000026: the decision of the ethics committee to leave the sponsor of the biomedical research, its authorized representative or
p.000026: the principal investigator shall exercise the right to appeal to a court in accordance with the procedure established by law.
p.000026: 6. Subjects or, in cases established by this Law, others with the right to consent to participate in the investigation
p.000026: the right to appeal against the biomedical research client, his authorized representative, the principal investigator
p.000026: and the activities of persons performing biomedical research to the licensing authority, the court tstatymp and
p.000026: another legal act in accordance with the established procedure.
p.000026: 7. Persons whose biological sample and / or health information is processed in the biobank have the right to appeal against the biobank.
p.000026: actions in accordance with the procedure established by law and other legal acts.
p.000026: CHAPTER V
p.000026: FINAL PROVISIONS
p.000026: Article 26. Liability for breaches of ethical requirements in biomedical research
p.000026: 1. Persons who have violated the requirements of this Law shall be liable in accordance with the procedure established by law.
p.000026: 2. Carrying out a biomedical test without authorization or in breach of this statute and other legislation
p.000026: requirement9, without causing pecuniary or non-pecuniary damage to the health of the subject, shall be
p.000026: for the performance of professional duties.
p.000027: 27
p.000027: Annex to the Law on Ethics of Biomedical Research of the Republic of Lithuania
p.000027: {IMPLEMENTING EUROPEAN UNION LEGISLATION
p.000027: 1. 2001 April 4 Directive 2001/20 / EC of the European Parliament and of the Council on the approximation of the laws of the Member States
p.000027: and amend legislation relating to the implementation of good clinical practice in the field of medicinal products for human use.
p.000027: clinical trials (OJ 2004 in. special order, Chapter 13, Volume 26, p. 299). "
p.000027: Article 2. Entry into force, implementation and application of the law
p.000027: 1. This Law, with the exception of paragraph 2 of this Article, shall enter into force on 1 January 2016. January 1
p.000027: 2. The Government of the Republic of Lithuania or an institution authorized by it, the Ministry of Health of the Republic of Lithuania
...
Orphaned Trigger Words
p.000012: invasive and / or interventional procedures and health information for which the person has not
p.000012: consent to participate in the activities of the biobank in accordance with the procedure established in this Article,
p.000013: 13
p.000013: but only to the extent necessary to preserve these human biological births and if the person within one month after
p.000013: consent of a person to perform a surgical, invasive and / or interventional procedure
p.000013: biobank, which may be processed in the biobank, and health information only to the extent necessary,
p.000013: that birth is assessed as such The suitability of a human biological êminip in Article 16 (1) of this Law
p.000013: for the purposes set. If a person or, in the cases specified in this Law, another person's consent to participate
p.000013: the person entitled to grant in the activities of the biobank shall not give the consent of the person within the term specified in this Part
p.000013: to participate in the activities of the biobank, the biobank must immediately destroy the human biological sample stored in the biobank.
p.000013: and health information. Information on human biological samples and health information
p.000013: biobanlce may be processed in accordance with the procedures set out in this paragraph, shall be made publicly available to patients for personal health
p.000013: in care facilities.
p.000013: 9. Any invasive and / or interventional procedure the sole purpose of which is to obtain and further process human
p.000013: biological sample (s) in a biobank and to carry out biomedical research with it (jars) and not to treat or
p.000013: diagnosis is permitted only if the person’s consent to participate in the biobank
p.000013: consent to take a human biological sample for that purpose.
p.000013: 10. A biobank shall give the consent of a person or, in the cases provided for in this Law, another person to participate
p.000013: to a person entitled to operate in a biobank, or to a surviving spouse or close relative
p.000013: a clear, free and easy-to-use opportunity for a relative to withdraw their consent in writing
p.000013: to participate in the activities of the biobank. Upon receipt of a written request from a person to revoke the person's consent to participate in the biobank
p.000013: the human biological sample stored in the biobank and the health information can no longer be processed and
p.000013: to transmit a human biological sample and health information to the persons specified in Article 17 of the Law
p.000013: can no longer be used and must be destroyed and reported in accordance with the procedure established by the Minister of Health
p.000013: notified to the person. Biomedical research results obtained from biomedical research with Human Biologicals
p.000013: samples, and health information prior to receipt of a person’s request to revoke a person’s consent to participate in a biobank
p.000013: indestructible.
p.000013: 11. Detailed content of the person's consent to participate in the biobank's activities and information specified in this
p.000013: requirements and the procedure for granting and revoking a person's consent to participate in the activities of the biobank
p.000013: determined by the Minister of Health.
p.000013: Article 9. Confidentiality of health information
p.000013: 1. Health information obtained from a biomedical research shall be identifiable
p.000013: confidential and may be provided only in accordance with the procedure established by the Law on Patients' Rights and Compensation for Health Damage.
p.000014: 14
p.000014: 2. Health information obtained from biomedical research shall not be considered confidential and may be published without delay
p.000014: the consent of the subject if the publication of such health information will not lead to the identification of the person.
p.000014: Article 10. Islaidq salary
p.000014: Subjects shall be entitled to compensation for the costs incurred in sharing the biomedical research.
p.000014: wasted time. The procedure for calculation and payment of compensation shall be established by the Government of the Republic of Lithuania (hereinafter -
p.000014: Government) or a body authorized by it.
p.000014: Article 11. Biomedical research client and researcher
p.000014: 1. The sponsor of a biomedical research shall be responsible for the initiation, management and administration of the biomedical research
p.000014: securing funding for biomedical research.
p.000014: 2. The researcher shall be responsible for the biomedical research carried out at the research center. If the biomedical research is performed by a researcher
p.000014: one or the research center leads a group of biomedical researchers and is responsible for this
p.000014: group activities, he is called the principal investigator.
p.000014: 3. When conducting biomedical research involving interventional biomedical
...
p.000016: to engage in the activities of a biobank must meet the requirements set out in the Law on Health Care
p.000016: the following requirements for obtaining a health care license:
p.000017: 17
p.000017: 1) to ensure that the requirement for the operation of the Biobank approved by the Minister of Health
p.000017: requirements set out in the inventory to ensure human biological êminip and health
p.000017: traceability, security, quality and availability of information to researchers, in accordance with:
p.000017: (a) premises, materials and materials used for human biological samples and health information
p.000017: handling;
p.000017: (b) the organization, management and administration of the processing of human biological samples and health information
p.000017: system;
p.000017: 2) appoint an employee responsible for the management of human biological resources and health information in accordance with the law;
p.000017: requirements of the act.
p.000017: 2. A license to engage in the activities of a biobank shall be issued, its validity shall be suspended, suspension of the license
p.000017: revoked, the validity of the license shall be revoked in accordance with the procedure established by the Law on Health Care Institutions.
p.000017: Article 15. Biobank's right to receive health information
p.000017: 1. With the consent of a person to participate in the activities of a biobank, the biobank shall be entitled to receive
p.000017: The sample and health information are processed in the biobank, health information from health care
p.000017: lstaigq, registry and / or state information system in accordance with the procedure established by law.
p.000017: 2. The biobank also has the right to receive health information from another legal entity specified by the person
p.000017: in the consent of the person to participate in the activities of the biobank, if this health information is not available in the registers and / or the state
p.000017: information systems and do not have a health care facility or its provision from health
p.000017: would require an unreasonably high material and / or time cost for the care institution.
p.000017: 3. The biobank shall exercise the rights referred to in this Article on its own initiative or in the context of biomedical research
p.000017: at the request of the client, his authorized representative or the principal investigator.
p.000017: Article 16. Management of human biological samples and health information
p.000017: 1. The objectives of the processing of human biological samples and health information in the biobank are:
p.000017: 1) to provide human biological samples and health information in accordance with the procedure established by this Law
p.000017: persons referred to in Article 17 of the Law;
p.000017: 2) to use human biological samples and health information in accordance with the procedure established by this Law
p.000017: biomedical research;
p.000017: 3) to improve the protected biological quality of the sample and its suitability for future biomedical research, unsuitable
p.000017: to use biological samples for biomedical research
p.000017: preparation for storage, improvement of storage technologies or quality control procedures and other biobank
p.000017: actions to improve the operational process.
p.000017: 2. Biobanks shall ensure the traceability, security,
p.000017: quality and availability to researchers in accordance with the procedure set out in the description of Biobank's operational requirements.
p.000017: 3. Health information processed in the Biobank is confidential and handled in accordance with the procedure established by law.
...
p.000017: 3. Authorization for the provision of Human Biological Samples and / or Health Information processed in a biobank
p.000017: issued after the Lithuanian Bioethics Committee has decided that:
p.000017: 1) the purposes of the provision of human biological êminiq and health information are consistent with the consent given by the person
p.000017: to participate in the activities of the biobank;
p.000019: 19
p.000019: 2) the persons referred to in Paragraph 2 of this Article have the certificates issued by the State Ethics Committee and / or the institution
p.000019: permits authorizing the processing of human biological samples and / or skeletal information for biomedical research
p.000019: purposes.
p.000019: 4. The authorization of a biobanlce shall be subject to the processing of human biological samples and / or health information
p.000019: the procedure for issuance shall be established by the Minister of Health.
p.000019: 5. Biobank Human biological samples and health information or biomedical data obtained from their use
p.000019: the results of the investigation, or the part thereof which allows the identification of the person, shall be provided only by a reasoned court decision, if it is
p.000019: is necessary for the trial of the case.
p.000019: 6. The sponsor of the biomedical research, its authorized representative or the principal investigator shall notify the
p.000019: health-relevant information obtained from a biomedical examination of that person's biological sample and
p.000019: health information. Biobank evaluates this information in accordance with the importance of personal health
p.000019: criteria for notifiable information and determining that the information must be provided
p.000019: shall notify the person to whom the person’s consent to participate in the biobank is entitled to give
...
p.000020: Ministry (hereinafter referred to as the Ministry of Health).
p.000020: 2. Lithuanian Bioethics Committee:
p.000020: 1) analyzes bioethical problems and consults state and local government institutions, institutions,
p.000020: organizations on bioethics issues, provide conclusions and suggestions on how to regulate these issues
p.000020: jstatymtț and other draft legal acts;
p.000020: 2) issue permits for the performance of biomedical research, except for clinical trials of medicinal products,
p.000020: when biomedical research is planned to be performed in research centers located in more than one regional
p.000020: biomedical research in the area assigned to the activities of the ethics committee, and shall carry out this research ethically
p.000020: maintenance;
p.000020: 3) issue certificates of approval for the conduct of clinical trials of a medicinal product and perform this biomedical trial
p.000020: ethical supervision;
p.000020: 4) issue permits for the provision of human biological samples and (or) health information processed in biobanks
p.000020: the persons referred to in Article 17 (2) of this Law;
p.000021: 21
p.000021: 5) in accordance with the procedure established by the Minister of Health, perform the accounting, storage, storage and distribution of biomedical research
p.000021: provide information about them, ensuring the protection of confidential information;
p.000021: 6) prepares and approves model ethics of the Lithuanian Bioethics Committee, regional biomedical research
p.000021: Committee to the Lithuanian Bioethics Committee, regional biomedical research ethics committees
p.000021: document forms;
p.000021: 7) supervise the activities of the ethics committee for biomedical research in the regioninitț;
p.000021: 8) report annually to the Ministry of Health on its activities and submit proposals on
p.000021: bioethical problem solving;
p.000021: 9) supervision as health professionals and institutions providing personal and public
p.000021: health care services, complies with the requirement of bioethics9;
p.000021: 10) provide methodological support and advise health care țstaigq medical ethics commissions and others
p.000021: institutions on bioethics;
p.000021: 11) represent the Republic of Lithuania in international organizations according to its competence;
p.000021: 12) perform other tasks specified in this Law, other laws and regulations of the Lithuanian Bioethics Committee
p.000021: functions.
p.000021: 3. Authorizations for biomedical studies and consent to conduct clinical trials on a medicinal product
p.000021: Certificates are issued by the Lithuanian Bioethics Committee when the biomedical certificate of the Lithuanian Bioethics Committee is positive
p.000021: study expert group conclusion.
p.000021: 4. The biomedical research group of the Lithuanian Bioethics Committee consists of 9 members, of which 5 are biomedical
p.000021: science, 4 - specialists in the field of social sciences or humanities with a scientific degree. Through health
p.000021: the term established by the Minister of Defense and specialists in the field of biomedical science in accordance with the procedure established by him or her i
p.000021: The biomedical study of the Lithuanian Bioethics Committee is proposed by a group of experts in personal health care
p.000021: associations of specialists, and specialists in the field of social sciences or humanities are offered by universities,
p.000021: in which subjects of bioethics or health law are taught. Biomedical9 of the Lithuanian Bioethics Committee
p.000021: The personal composition of the research expert group shall be approved by the Minister of Health in accordance with
p.000021: the principles of impartiality and transparency, taking into account the professional qualifications and competences of the candidates; and
p.000021: experience in the field of ethics in biomedical research. Remuneration of this group's activities and expert work
p.000021: determined by the Minister of Health.
p.000021: 5. The term of office of the biomedical research expert group of the Lithuanian Bioethics Committee is 4 years. Same
p.000021: a person may be a member of the biomedical research expedition group of the Lithuanian Bioethics Committee for no more than two
p.000021: consecutive terms.
...
p.000022: a new member of this group shall be approved in accordance with the procedure established by this Law.
p.000022: Article 22. Establishment and competence of regional ethics committees for biomedical research
p.000022: 1. Regional biomedical research ethics committees shall be established at the university where the conduct is conducted
p.000022: three-stage medical studies. Funds are provided for the activities of the Ethics Committee for Regional Biomedical Research
p.000022: from the state budget appropriations allocated to the Ministry of Health.
p.000022: 2. Regional biomedicininip research ethics set up, activities, jp competence issues
p.000022: The procedure is governed by the provisions of the Regional Biomedical Research Ethics Committee, which, in agreement with the
p.000022: Minister of Health, approves the rector of the university. Regional Biomedical Research Ethics Committee
p.000022: the territorial boundaries of the activity are determined by the Minister of Health.
p.000022: 3. Regional biomedical research ethics committees shall be established for regional biomedical
p.000022: an ethics committee of 9 members in accordance with the procedure laid down in the regulations:
p.000022: 1) two specialists in the field of biomedical sciences with a scientific degree and two with a scientific degree
p.000022: Specialists in the field of social sciences or humanities are appointed by a university with a regional association
p.000022: Biomedical Research Ethics Committee;
p.000022: 2) three health professionals from a health care institution operating in the region and one
p.000022: a specialist in the field of social sciences or humanities is appointed by the Ministry of Health;
p.000022: 3) one member is appointed by patient organizations.
p.000022: 4. Regional biomedicininip research ethics committee staff composition, in coordination with health care
p.000022: Minister, approved by the Rector of the University. The term of office of a member of the Regional Biomedical Research Ethics Committee
p.000022: 4 years. A member of the Regional Biomedical Research Ethics Committee may serve a maximum of two terms from
p.000022: queues.
p.000022: 5. Regional Biomedical Research Ethics Committee:
p.000022: 1) issue authorizations for the performance of biomedical research, except for clinical trials of a medicinal product,
p.000022: when biomedical research is planned to be performed in research centers located only in the relevant regional
p.000022: biomedicininip research in the area assigned to the ethylcos committee veilil;
p.000023: 23
p.000023: 2) submit conclusions to the Lithuanian Bioethics Committee when biomedical research is planned to be performed in research centers,
p.000023: located in the territory assigned to more than one regional biomedical research ethics committee;
p.000023: 3) submit to the Commander of the Lithuanian Bioethics Committee when clinical trials of a medicinal product are planned
p.000023: in the territory assigned to the activity;
p.000023: 4) performs biomedical research for which it has been authorized and a clinical trial of the medicinal product,
p.000023: who perform the findings, ethical oversight;
p.000023: 5) keep records of the issued permits;
p.000023: 6) submit activity reports to the Lithuanian Bioethics Committee in accordance with the procedure established by it.
p.000023: Article 23. Acceptance of documents, their consideration and issuance of permits
p.000023: 1. The sponsor of a biomedical study, his authorized representative or the principal investigator in order to obtain
p.000023: biomedical research, the Lithuanian Bioethics Committee or the regional biomedical research ethics committee
p.000023: submit documents, the list of which shall be approved by the Minister of Health. The documents must be examined
p.000023: and a biomedical research permit has been issued or refused with a reasoned submission no later than 45
p.000023: calendar days from the date of receipt of all duly completed documents. The documents must be examined and the permit issued
p.000023: to carry out a biomedical examination with a medical device issued or refused on the basis of a reasoned
p.000023: as within 60 calendar days from the date of receipt of all duly executed documents.
p.000023: 2. The procedure for the issue of a permit to perform a biomedical examination shall be established by the Minister of Health.
p.000023: 3. The Lithuanian Bioethics Committee or the Regional Biomedical Research Ethics Committee shall make a decision
p.000023: not to authorize a biomedical research if it is established from the submitted documents that the biomedical
p.000023: the research contradicts the ethical requirements for biomedical research set out in Chapter II of this Law,
p.000023: not all and / or incorrect documents and / or information have been provided and the requirement to correct
p.000023: shortcomings and the decision not to authorize a biomedical research with a medical device
p.000023: in the case of the State Accreditation Service for Health Care Activities under the Health Protection
p.000023: the ministries submit a conclusion that the medical device does not comply with the established by the Minister of Health
p.000023: requirements for non-medical devices for clinical trials.
p.000023: 4. For documents submitted for authorization of biomedical research, examination and authorization
p.000023: a fixed state fee is paid for the issuance.
p.000024: 24
p.000024: Article 24. Suspension, revocation of suspension of biomedical research authorization and
p.000024: withdrawal of authorization to conduct a biomedical research
p.000024: 1. The authorization of a biomedical research shall be suspended in the following cases:
p.000024: 1) a violation of the ethical requirements for biomedical research referred to in Chapter II of this Law has been established, as a result of which
p.000024: be significantly infringed on the rights, safety, health and / or biomedical data of the subject.
p.000024: quality and / or integrity, or information is available on possible such breaches;
p.000024: 2) the client of the biomedical research, its authorized representative or the principal investigator so requests;
p.000024: 3) a requirement for medical devices intended for clinical use approved by the Minister of Health has been established
p.000024: investigations, infringements which may significantly prejudice the rights, safety, health and / or
p.000024: the quality and / or integrity of biomedical research data.
p.000024: 2. Where a decision has been taken to suspend the authorization of a biomedical research in accordance with paragraph 1
p.000024: On the basis of Item 1, no later than within 3 calendar days from the date of the decision in writing
p.000024: the client of the biomedical research, the principal investigator, the head of the research center shall be informed and indicated
p.000024: deadline for rectifying the specified irregularities. This period may not exceed 30 calendar days
p.000024: Except for objective reasons, a longer period is required to remedy the irregularities, or
p.000024: when the authorization for a biomedical study is suspended by the sponsor of the biomedical study or the principal
p.000024: at the request of the investigator for reasons other than violations. Client of biomedical research, principal
p.000024: the researcher and the head of the research center must ensure that the biomedical research is stopped immediately.
p.000024: 3. The decision to lift the suspension shall be taken in the absence of an infringement or infringements
p.000024: and when the authorization for a biomedical study is suspended by the sponsor of the biomedical study,
p.000024: at the request of his / her authorized representative or principal investigator, for reasons other than
p.000024: the sponsor, his authorized representative or the principal investigator shall submit a request for annulment of the decision
p.000024: suspend the authorization to carry out a biomedical examination.
p.000024: 4. The authorization for a biomedical research shall be revoked in the following cases:
p.000024: 1) a violation of the ethical requirements of biomedical research set forth in Chapter II of this Law, which may
p.000024: significantly harm the rights, safety, health and / or quality of biomedical research data
p.000024: and integrity and which cannot be eliminated by suspending biomedical research;
p.000025: 25
p.000025: 2) violations of the ethical requirements for biomedical research established in Chapter II of this Law have been identified, which
p.000025: may significantly harm the subject’s rights, safety, health and / or biomedical research
p.000025: the quality and integrity of the data which led to the suspension of the biomedical research authorization and which
p.000025: the deadline has not been eliminated;
p.000025: 3) when requested by the client of the biomedical research, his / her authorized representative or the principal
p.000025: tyrants;
p.000025: 4) when the sponsor of the biomedical research, his authorized representative or the principal investigator through
p.000025: two years after the decision to suspend the authorization of a biomedical research in accordance with paragraph 1 2
p.000025: does not submit a request for revocation of the suspension of the permit on the basis of the point of acceptance;
p.000025: 5) to establish requirements approved by the Minister of Health for medical devices intended for clinical use
p.000025: investigations, infringements which may significantly harm the rights, safety, health and / or
p.000025: the quality and / or integrity of biomedical research data and which cannot be eliminated by suspending biomedical
p.000025: study or for which the authorization for a biomedical study has been suspended and which have not been
p.000025: remove.
p.000025: 5. Following a decision to withdraw the authorization of a biomedical research, no later than 3 calendar days
p.000025: days from the day of making the decision, the client of the biomedical research shall be informed thereof in writing
...
p.000027: and amend legislation relating to the implementation of good clinical practice in the field of medicinal products for human use.
p.000027: clinical trials (OJ 2004 in. special order, Chapter 13, Volume 26, p. 299). "
p.000027: Article 2. Entry into force, implementation and application of the law
p.000027: 1. This Law, with the exception of paragraph 2 of this Article, shall enter into force on 1 January 2016. January 1
p.000027: 2. The Government of the Republic of Lithuania or an institution authorized by it, the Ministry of Health of the Republic of Lithuania
p.000027: Minister and Minister of Social Security and Labor of the Republic of Lithuania until 2015 rrr. December 31 accepts this
p.000027: implementing legislation.
p.000027: 3. Documents submitted before the entry into force of this Law for the authorization of a biomedical research or for
p.000027: a certificate of consent to conduct a clinical trial of a medicinal product and an authorization to conduct a clinical trial of a medicinal product
p.000027: studies (hereinafter referred to as ‘authorization’) and biomedical studies
p.000027: issued before the entry into force of this Law shall be carried out in accordance with the biomedical research of the Republic of Lithuania.
p.000027: provisions of the Code of Ethics in force until now
p.000027: {entry into force of the Act, except as provided in paragraphs 4 and 5 of this Article.
p.000027: 4. Documents concerning the issue of a permit, submitted and not examined before the entry into force of this Law,
p.000027: after the entry into force of this Law shall be examined in accordance with the Law of the Republic of Lithuania set out in Article 1 of this Law.
p.000027: biomedical research ethics.
p.000027: 5. This Law shall apply to biomedical research authorized before the entry into force of this Law.
p.000027: shall apply 3 years after the date of entry into force of this Law. This law is referred to in this paragraph
p.000027: biomedical research may be tailcomas before the deadline specified in this paragraph, if Lithuanian
p.000027: Issuance of a permit for biomedical research approved by the Minister of Health of the Republic
p.000027: description of the procedure or the Certificate of Authorization and Authorization to conduct a clinical trial of the medicinal product
...
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| age | Age |
| authority | Relationship to Authority |
| child | Child |
| children | Child |
| disability | Mentally Disabled |
| education | education |
| embryo | embryo |
| employees | employees |
| fetus | Fetus/Neonate |
| illness | Physically Disabled |
| incapacitated | Incapacitated |
| incapacity | Incapacitated |
| liberty | Incarcerated |
| married | Marital Status |
| military | Soldier |
| minor | Youth/Minors |
| opinion | philosophical differences/differences of opinion |
| parents | parents |
| property | Property Ownership |
| stem cells | stem cells |
| union | Trade Union Membership |
| unmarried | Marital Status |
| vulnerable | vulnerable |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| child | ['children'] |
| children | ['child'] |
| incapacitated | ['incapacity'] |
| incapacity | ['incapacitated'] |
| married | ['unmarried'] |
| unmarried | ['married'] |
Trigger Words
consent
developing
ethics
harm
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input