79C3C34C52B45572883A05D425EB0F82

Changes of the Law on Ethics of Biomedical Research No. 536/2014 (2017)

https://leaux.net/URLS/General/Lithuania_Changes_of_Law_on_Ethics_of_Biomedical_Research_No._5362014_2017.pdf

http://leaux.net/URLS/ConvertAPI Text Files/55159713C11E070925F2E303EED87B08.en.txt

Examining the file media/Synopses/55159713C11E070925F2E303EED87B08.html:

This file was generated: 2020-12-01 07:02:02

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

Vulnerability Type	Vulnerability	Indicator	# Matches
Political	political affiliation	party	1
Political	vulnerable	vulnerable	1
Health	Drug Usage	drug	1
Social	Access to Social Goods	access	1
Social	Age	age	2
Social	Child	child	17
Social	Child	children	5
Social	Marital Status	married	3
Social	Marital Status	unmarried	5
Social	Trade Union Membership	union	5
Social	Youth/Minors	minor	9
Social	education	education	2
Social	employees	employees	1
Social	parents	parents	8
Social	philosophical differences/differences of opinion	opinion	1
General/Other	Incapacitated	incapacitated	3
General/Other	Public Emergency	emergency	1

Political / political affiliation

Searching for indicator party:

(return to top)
p.000006: clinical trial of the medicinal product and employed at the research center. Organization of good clinical practice training
p.000006: procedures and requirements for the development of good clinical practice curricula shall also be approved by the investigator-in-charge
p.000006: clinical trial of a medicinal product, the requirements for higher education qualifications shall be established by health care
p.000006: Minister. When performing the biomedical research referred to in this Part, the principal investigator must also
p.000006: have experience in clinical trials of the medicinal product. A person can work as a principal investigator in only one of the same
p.000006: research center. "
p.000006: Article 7. Supplementation of the Law with Article 111
p.000006: To supplement the Law with Article 111:
p.000006: “Article 111. Clinical Drug Research Center
p.000006: The clinical trial center must have the right to provide personal health care services,
p.000006: required for the clinical investigation of the medicinal product. "
p.000006: Article 8. Amendment of Article 12
p.000006: 1. Article 12 (2) is amended to read as follows:
p.000007: 7
p.000007: „2. A biomedical study in which a participant undergoes interventional research for research purposes
p.000007: the methods pose a risk to the health of the subject as well as to the sponsor of the clinical trial and
p.000007: the principal investigator must insure his civil liability against possible pecuniary and non-pecuniary damage,
p.000007: caused by an injury to the subject or death of the subject by concluding a biomedical examination
p.000007: Compulsory third party liability insurance contracts between the client and the principal investigator with insurers
p.000007: unless the pecuniary and non-pecuniary damage which may result from the biomedical research referred to in
p.000007: Article 3 (3), the remuneration is provided for in the civil service of the personal health care institution
p.000007: liability insurance for patients. Whether applicable for biomedical research purposes
p.000007: interventional research methods pose a risk to the subject's health, according to the Lithuanian Bioethics Committee
p.000007: or the Regional Ethics Committee for Biomedical Research, which authorizes the biomedical research. "
p.000007: 2. Article 12 (3) is amended to read as follows:
p.000007: „3. A low - intervention clinical trial, as well as another biomedical trial in which
p.000007: interventional biomedical research methods applied to the participant pose only a minor adverse event
p.000007: temporary effects on his health are also permitted in the case of a personal health care institution which
p.000007: itself or its employee is the client of such biomedical research or its employee is such
p.000007: biomedical research researcher, is provided for in the civil liability insurance contract
p.000007: compensation for pecuniary and non-pecuniary damage which may arise in the course of such biomedical research. "
p.000007: 3. The following paragraph 31 is added to Article 12:
p.000007: „31. Whether a clinical trial of a medicinal product is a small intervention is assessed by Lithuanian bioethics
p.000007: Committee and the State Medicines Control Service under the Ministry of Health of the Republic of Lithuania
...

Political / vulnerable

Searching for indicator vulnerable:

(return to top)
p.000003: the term "subject" and used in this paragraph and in Regulation (EU) No 182/2011. Article 2 (2) (17) of Regulation (EU) No 536/2014
p.000003: defined values. "
p.000003: 13. Amend Article 2 (26) to read as follows:
p.000003: „26. Other terms used in this Law shall be understood as they are defined in the Republic of Lithuania
p.000003: Civil Code, the Law on Insurance of the Republic of Lithuania, the Law on Pharmacy of the Republic of Lithuania, the Law on Pharmacy of the Republic of Lithuania
p.000003: Law on Equal Opportunities of the Republic of Lithuania, Compensation of Patients' Rights and Damage to Health of the Republic of Lithuania
p.000003: the Law on Health Care Institutions of the Republic of Lithuania, the Law on Health of the Republic of Lithuania
p.000003: the Law on the System, the Law on the Fundamentals of the Protection of the Rights of the Child of the Republic of Lithuania, the
p.000003: in the Law on Donation and Transplantation of Tissues, Cells, Organs, Determination of Human Death in the Republic of Lithuania, and
p.000003: the Law on Emergency Situations, the Law on the Legal Protection of Personal Data of the Republic of Lithuania and Regulation (EU) No.
p.000003: 536/2014. "
p.000004: 4
p.000004: Article 3. Amendment of Article 6
p.000004: Amend Article 6 (2) to read as follows:
p.000004: „2. Lithuanian Bioethics Committee or Regional Biomedical Research Ethics Committee, evaluating
p.000004: documents regarding the issuance of a permit to conduct a biomedical research, by reasoned decision of vulnerable persons
p.000004: may recognize other groups of persons. "
p.000004: Article 4. Amendment of Article 7
p.000004: 1. Article 7 (3) is amended to read as follows:
p.000004: „3. The child shall be provided with the information referred to in paragraph 8 of this Article according to his or her age and ability to understand
p.000004: information. Due to the child's participation in the biomedical research, the person's consent to participate in the research is given by the child
p.000004: representatives under the law, but if the child, who is able to understand the information provided to him, expresses a wish
p.000004: not participate in a biomedical study or, if the child is already participating in such a biomedical study,
p.000004: cease to participate, the child's participation in the study shall not begin or end unless
p.000004: contrary to the best interests of the child. Whether the child's desire not to participate in the investigation is not against the child's interests is decided
p.000004: the child's legal representatives, taking into account the investigator's opinion. If the decision on the child's participation
...

Health / Drug Usage

Searching for indicator drug:

(return to top)
p.000006: to participate in the activities of the biobank by explaining the age and health condition of the donor in a way that he or she understands
p.000006: special medical terms informed of: '.
p.000006: Article 6. Amendment of Article 11
p.000006: Amend Article 11 (4) to read as follows:
p.000006: „4. When a clinical trial of a medicinal product is performed, the investigator must have the clinical medicinal product
p.000006: a higher education qualification corresponding to the nature of the research, the right to practice medicine accordingly
p.000006: or dental practice, have at least one year of patient care experience and in the last
p.000006: have completed five years of training in good clinical practice or have been a researcher during that period
p.000006: clinical trial of the medicinal product and employed at the research center. Organization of good clinical practice training
p.000006: procedures and requirements for the development of good clinical practice curricula shall also be approved by the investigator-in-charge
p.000006: clinical trial of a medicinal product, the requirements for higher education qualifications shall be established by health care
p.000006: Minister. When performing the biomedical research referred to in this Part, the principal investigator must also
p.000006: have experience in clinical trials of the medicinal product. A person can work as a principal investigator in only one of the same
p.000006: research center. "
p.000006: Article 7. Supplementation of the Law with Article 111
p.000006: To supplement the Law with Article 111:
p.000006: “Article 111. Clinical Drug Research Center
p.000006: The clinical trial center must have the right to provide personal health care services,
p.000006: required for the clinical investigation of the medicinal product. "
p.000006: Article 8. Amendment of Article 12
p.000006: 1. Article 12 (2) is amended to read as follows:
p.000007: 7
p.000007: „2. A biomedical study in which a participant undergoes interventional research for research purposes
p.000007: the methods pose a risk to the health of the subject as well as to the sponsor of the clinical trial and
p.000007: the principal investigator must insure his civil liability against possible pecuniary and non-pecuniary damage,
p.000007: caused by an injury to the subject or death of the subject by concluding a biomedical examination
p.000007: Compulsory third party liability insurance contracts between the client and the principal investigator with insurers
p.000007: unless the pecuniary and non-pecuniary damage which may result from the biomedical research referred to in
p.000007: Article 3 (3), the remuneration is provided for in the civil service of the personal health care institution
p.000007: liability insurance for patients. Whether applicable for biomedical research purposes
p.000007: interventional research methods pose a risk to the subject's health, according to the Lithuanian Bioethics Committee
p.000007: or the Regional Ethics Committee for Biomedical Research, which authorizes the biomedical research. "
p.000007: 2. Article 12 (3) is amended to read as follows:
p.000007: „3. A low - intervention clinical trial, as well as another biomedical trial in which
...

Searching for indicator access:

(return to top)
p.000010: No. 536/2014.
p.000010: 2. The State Medicines Control Agency shall perform a substantial change in the clinical trial of a medicinal product
p.000010: applications under Regulation (EU) No The scientific evaluation of the aspects referred to in Articles 6 and / or 7 of Regulation (EU) No 536/2014; and
p.000010: authorize a substantial change in the testing of a medicinal product if, in the light of that assessment and
p.000010: Ethical evaluation of the Lithuanian Bioethics Committee's application for a substantial change in a clinical trial
p.000010: The conclusion of the amendment to the clinical trial is in accordance with Regulation (EU) No 182/2011. 536/2014
p.000010: requirements.
p.000010: 3. The Lithuanian Bioethics Committee shall submit the conclusions referred to in Paragraphs 1 and 2 of this Article to the State Medicines Control Agency
p.000010: not later than 2 working days before the entry into force of Regulation (EU) No Article 8 (1) of Regulation (EU) No
p.000010: Article 19 (3), Article 19 (1), Article 20 (5) or Article 23 (1)
p.000010: the end of the application evaluation period.
p.000010: 4. The State Medicines Control Agency shall carry out the tasks provided for in Regulation (EU) No. 1907/2006. Chapters II, III and XIII of Regulation (EU) No 536/2014
p.000010: the reporting Member State when the Republic of Lithuania, in accordance with Regulation (EU) No 536/2014 is
p.000010: the rapporteur Member State, the Member States concerned and the Minister for Health
p.000010: the national contact point referred to in Article 4 of Regulation (EU) No 182/2011. Article 83 of Regulation (EU) No 536/2014
p.000010: Lithuanian Bioethics Committee and Regional Biomedical Research Ethics Committees access to
p.000010: Regulation (EU) No The portal of the European Union referred to in Article 80 of Regulation (EU) No 536/2014.
p.000010: 5. Lithuanian Bioethics Committee Regulation (EU) No. Shall participate in the evaluation in accordance with the procedure laid down in Article 44 of Regulation (EU) No 536/2014
p.000010: Regulation (EU) No The information referred to in Articles 42 and 43 of Regulation (EU) No 536/2014.
p.000011: 11
p.000011: 6. The Lithuanian Bioethics Committee shall apply to the State Medicines Control Agency for a sample
p.000011: Regulation (EU) No Measures provided for in Article 77 of Regulation (EU) No 536/2014 where there is evidence of non-compliance with the Regulation
p.000011: (ES) No Requirements laid down in Regulation (EU) No 536/2014. "
p.000011: Article 13. Amendment of Article 25
p.000011: Repeal Article 25 (5).
p.000011: Article 14. Amendment of the Annex to the Law
p.000011: To amend the Annex to the Law and set it forth as follows:
p.000011: “Annex to the Law on Ethics of Biomedical Research of the Republic of Lithuania
p.000011: IMPLEMENTING LEGISLATION OF THE EUROPEAN UNION
p.000011: 1. Regulation (EU) No 182/2011 of the European Parliament and of the Council 536/2014 on clinical trials on medicinal products for human use,
p.000011: repealing Directive 2001/20 / EC (OJ 2014 L 158, p. 1). "
p.000011: Article 15. Entry into force and implementation of the law
p.000011: 1. This Law, with the exception of Paragraph 3 of Article 10 and Paragraph 3 of this Article, shall enter into force after 6
p.000011: months after the European Commission announced that in 2014 April 16 Regulation (EU) of the European Parliament and of the Council
...

Searching for indicator age:

(return to top)
p.000003: Law on Equal Opportunities of the Republic of Lithuania, Compensation of Patients' Rights and Damage to Health of the Republic of Lithuania
p.000003: the Law on Health Care Institutions of the Republic of Lithuania, the Law on Health of the Republic of Lithuania
p.000003: the Law on the System, the Law on the Fundamentals of the Protection of the Rights of the Child of the Republic of Lithuania, the
p.000003: in the Law on Donation and Transplantation of Tissues, Cells, Organs, Determination of Human Death in the Republic of Lithuania, and
p.000003: the Law on Emergency Situations, the Law on the Legal Protection of Personal Data of the Republic of Lithuania and Regulation (EU) No.
p.000003: 536/2014. "
p.000004: 4
p.000004: Article 3. Amendment of Article 6
p.000004: Amend Article 6 (2) to read as follows:
p.000004: „2. Lithuanian Bioethics Committee or Regional Biomedical Research Ethics Committee, evaluating
p.000004: documents regarding the issuance of a permit to conduct a biomedical research, by reasoned decision of vulnerable persons
p.000004: may recognize other groups of persons. "
p.000004: Article 4. Amendment of Article 7
p.000004: 1. Article 7 (3) is amended to read as follows:
p.000004: „3. The child shall be provided with the information referred to in paragraph 8 of this Article according to his or her age and ability to understand
p.000004: information. Due to the child's participation in the biomedical research, the person's consent to participate in the research is given by the child
p.000004: representatives under the law, but if the child, who is able to understand the information provided to him, expresses a wish
p.000004: not participate in a biomedical study or, if the child is already participating in such a biomedical study,
p.000004: cease to participate, the child's participation in the study shall not begin or end unless
p.000004: contrary to the best interests of the child. Whether the child's desire not to participate in the investigation is not against the child's interests is decided
p.000004: the child's legal representatives, taking into account the investigator's opinion. If the decision on the child's participation
p.000004: in a biomedical research, there is a conflict of interest between the child and his or her legal representatives or the child 's legal representatives
p.000004: conflict of interest, decision on the child's participation in biomedical research
...

p.000005: (adopted) objected to the person’s participation in the biobank (in this case, to include the person in the
p.000005: biobank activities are prohibited), and if a person is entitled to the Law on Patients' Rights and Compensation for Health Damage
p.000005: has appointed a representative in accordance with the established procedure,
p.000006: 6
p.000006: transfer. The participation of a person who has been declared incapacitated by a court in the field of health care
p.000006: the consent of a person to participate in the activities of the biobank is given by his guardian, in respect of a person who is a court
p.000006: recognized as a limited factor in the field of health care, - its carer and the court itself
p.000006: factor in the field of health care. "
p.000006: 2. Article 8 (6), first subparagraph, is replaced by the following:
p.000006: „6. Before giving a person 's consent to participate in the activities of the biobank, the person referred to in paragraphs 3 and 4 of this Article
p.000006: the person entitled to give consent to participate in the activities of the biobank (hereinafter - another person 's consent to participate
p.000006: biobank), the surviving spouse, if unmarried,
p.000006: a close relative referred to in paragraph 5 of this Article in order of priority, taking into account the consent of the person
p.000006: to participate in the activities of the biobank by explaining the age and health condition of the donor in a way that he or she understands
p.000006: special medical terms informed of: '.
p.000006: Article 6. Amendment of Article 11
p.000006: Amend Article 11 (4) to read as follows:
p.000006: „4. When a clinical trial of a medicinal product is performed, the investigator must have the clinical medicinal product
p.000006: a higher education qualification corresponding to the nature of the research, the right to practice medicine accordingly
p.000006: or dental practice, have at least one year of patient care experience and in the last
p.000006: have completed five years of training in good clinical practice or have been a researcher during that period
p.000006: clinical trial of the medicinal product and employed at the research center. Organization of good clinical practice training
p.000006: procedures and requirements for the development of good clinical practice curricula shall also be approved by the investigator-in-charge
p.000006: clinical trial of a medicinal product, the requirements for higher education qualifications shall be established by health care
p.000006: Minister. When performing the biomedical research referred to in this Part, the principal investigator must also
p.000006: have experience in clinical trials of the medicinal product. A person can work as a principal investigator in only one of the same
p.000006: research center. "
p.000006: Article 7. Supplementation of the Law with Article 111
p.000006: To supplement the Law with Article 111:
p.000006: “Article 111. Clinical Drug Research Center
p.000006: The clinical trial center must have the right to provide personal health care services,
p.000006: required for the clinical investigation of the medicinal product. "
...

Searching for indicator child:

(return to top)
p.000003: 3 points. "
p.000003: 11. Amend Article 2 (15) to read as follows:
p.000003: „15. "Investigator" means a physician performing a biomedical study, other than a clinical trial of a medicinal product
p.000003: a person who meets the requirements established in this Law. This term in Article 1 (2) of this law
p.000003: referred to in the articles, parts and paragraphs of this Law referred to in this Part and in Regulation (EU)
p.000003: No. Within the meaning of Article 2 (2) (15) of Regulation (EU) No 536/2014. "
p.000003: 12. Amend Article 2 (16) to read as follows:
p.000003: „16. Subject - a person participating in a biomedical study, except for a clinical trial of a medicinal product.
p.000003: This term corresponds to the articles, their parts and points referred to in Article 1 (2) of this Law
p.000003: the term "subject" and used in this paragraph and in Regulation (EU) No 182/2011. Article 2 (2) (17) of Regulation (EU) No 536/2014
p.000003: defined values. "
p.000003: 13. Amend Article 2 (26) to read as follows:
p.000003: „26. Other terms used in this Law shall be understood as they are defined in the Republic of Lithuania
p.000003: Civil Code, the Law on Insurance of the Republic of Lithuania, the Law on Pharmacy of the Republic of Lithuania, the Law on Pharmacy of the Republic of Lithuania
p.000003: Law on Equal Opportunities of the Republic of Lithuania, Compensation of Patients' Rights and Damage to Health of the Republic of Lithuania
p.000003: the Law on Health Care Institutions of the Republic of Lithuania, the Law on Health of the Republic of Lithuania
p.000003: the Law on the System, the Law on the Fundamentals of the Protection of the Rights of the Child of the Republic of Lithuania, the
p.000003: in the Law on Donation and Transplantation of Tissues, Cells, Organs, Determination of Human Death in the Republic of Lithuania, and
p.000003: the Law on Emergency Situations, the Law on the Legal Protection of Personal Data of the Republic of Lithuania and Regulation (EU) No.
p.000003: 536/2014. "
p.000004: 4
p.000004: Article 3. Amendment of Article 6
p.000004: Amend Article 6 (2) to read as follows:
p.000004: „2. Lithuanian Bioethics Committee or Regional Biomedical Research Ethics Committee, evaluating
p.000004: documents regarding the issuance of a permit to conduct a biomedical research, by reasoned decision of vulnerable persons
p.000004: may recognize other groups of persons. "
p.000004: Article 4. Amendment of Article 7
p.000004: 1. Article 7 (3) is amended to read as follows:
p.000004: „3. The child shall be provided with the information referred to in paragraph 8 of this Article according to his or her age and ability to understand
p.000004: information. Due to the child's participation in the biomedical research, the person's consent to participate in the research is given by the child
p.000004: representatives under the law, but if the child, who is able to understand the information provided to him, expresses a wish
p.000004: not participate in a biomedical study or, if the child is already participating in such a biomedical study,
p.000004: cease to participate, the child's participation in the study shall not begin or end unless
p.000004: contrary to the best interests of the child. Whether the child's desire not to participate in the investigation is not against the child's interests is decided
p.000004: the child's legal representatives, taking into account the investigator's opinion. If the decision on the child's participation
p.000004: in a biomedical research, there is a conflict of interest between the child and his or her legal representatives or the child 's legal representatives
p.000004: conflict of interest, decision on the child's participation in biomedical research
p.000004: shall be adopted in accordance with the procedure established in Article 3.163 of the Civil Code. When involved in biomedical research
p.000004: children when deciding on an application for a clinical trial in accordance with Regulation (EU) No 182/2011.
p.000004: Conclusions of the ethical evaluation of the aspects referred to in Articles 6 and / or 7 of Regulation (EU) No 536/2014
p.000004: conclusion of the ethical evaluation of the investigational application for the medicinal product) and the essential clinical trial of the medicinal product
p.000004: amendments to Regulation (EU) No Aspects referred to in Articles 6 and / or 7 of Regulation (EU) No 536/2014
p.000004: the conclusions of the evaluation (hereinafter referred to as the "ethical review of the application for a major change to a clinical trial")
p.000004: evaluation), the State Committee for the Protection of the Rights of the Child and Adoption participates in the meeting of the Lithuanian Bioethics Committee
p.000004: a representative of the service under the Ministry of Social Security and Labor. Procedures for child participation in biomedical research
p.000004: determined by the Minister of Health and the Minister of Social Security and Labor. "
p.000004: 2. Article 7 (4) is amended to read as follows:
p.000004: „4. For an adult or a married minor, or recognized by the court as a full factor
p.000004: (emancipated) minors whose state of health does not allow them to assess their interests or hinders them
p.000004: judged intelligently, the consent of a person participating in a biomedical study to participate in the study is given by the individual
p.000004: spouse or, if the person is
p.000005: 5
p.000005: unmarried, the marriage is over, the spouse is recognized as unknown or the spouses are
p.000005: living apart, - one of the person's parents (adoptive parents) or one of the adult children (adopted children), unless
p.000005: when one of the person’s parents (adoptive parents) has expressed a disagreement with the person’s participation in a biomedical study
p.000005: biomedical examination with a person is prohibited) and if the person is entitled to Patients' Rights and Injuries
p.000005: has appointed a representative by appointment in accordance with the procedure established by the Law on Remuneration for Health, - a representative by appointment.
...

Searching for indicator children:

(return to top)
p.000004: cease to participate, the child's participation in the study shall not begin or end unless
p.000004: contrary to the best interests of the child. Whether the child's desire not to participate in the investigation is not against the child's interests is decided
p.000004: the child's legal representatives, taking into account the investigator's opinion. If the decision on the child's participation
p.000004: in a biomedical research, there is a conflict of interest between the child and his or her legal representatives or the child 's legal representatives
p.000004: conflict of interest, decision on the child's participation in biomedical research
p.000004: shall be adopted in accordance with the procedure established in Article 3.163 of the Civil Code. When involved in biomedical research
p.000004: children when deciding on an application for a clinical trial in accordance with Regulation (EU) No 182/2011.
p.000004: Conclusions of the ethical evaluation of the aspects referred to in Articles 6 and / or 7 of Regulation (EU) No 536/2014
p.000004: conclusion of the ethical evaluation of the investigational application for the medicinal product) and the essential clinical trial of the medicinal product
p.000004: amendments to Regulation (EU) No Aspects referred to in Articles 6 and / or 7 of Regulation (EU) No 536/2014
p.000004: the conclusions of the evaluation (hereinafter referred to as the "ethical review of the application for a major change to a clinical trial")
p.000004: evaluation), the State Committee for the Protection of the Rights of the Child and Adoption participates in the meeting of the Lithuanian Bioethics Committee
p.000004: a representative of the service under the Ministry of Social Security and Labor. Procedures for child participation in biomedical research
p.000004: determined by the Minister of Health and the Minister of Social Security and Labor. "
p.000004: 2. Article 7 (4) is amended to read as follows:
p.000004: „4. For an adult or a married minor, or recognized by the court as a full factor
p.000004: (emancipated) minors whose state of health does not allow them to assess their interests or hinders them
p.000004: judged intelligently, the consent of a person participating in a biomedical study to participate in the study is given by the individual
p.000004: spouse or, if the person is
p.000005: 5
p.000005: unmarried, the marriage is over, the spouse is recognized as unknown or the spouses are
p.000005: living apart, - one of the person's parents (adoptive parents) or one of the adult children (adopted children), unless
p.000005: when one of the person’s parents (adoptive parents) has expressed a disagreement with the person’s participation in a biomedical study
p.000005: biomedical examination with a person is prohibited) and if the person is entitled to Patients' Rights and Injuries
p.000005: has appointed a representative by appointment in accordance with the procedure established by the Law on Remuneration for Health, - a representative by appointment.
p.000005: The participation in a biomedical investigation of a person who has been declared incapacitated by a court in the field of health care
p.000005: the consent of a person to participate in the investigation is given by his or her guardian, for a person who is recognized by the court on a limited basis
p.000005: factor in the field of health care, - his carer and himself recognized by the court as a limited factor
p.000005: a person in the field of health care. The subject should be given this article according to his / her ability to understand
p.000005: Information referred to in paragraph 8. The researcher takes into account the subject who can understand what is presented to him
p.000005: information, a wish not to participate in a biomedical study or, if the subject is in such a biomedical study
p.000005: already participating in the study, the wish not to participate in it. "
p.000005: 3. Article 7 (6), first subparagraph, is replaced by the following:
p.000005: „6. The person and other person referred to in paragraphs 3 and 4 of this Article who is entitled to give consent to participate in the investigation
...

p.000005: consent to participate in a study may be obtained by including a person in a biomedical study when all of the following conditions are met:
p.000005: conditions: ".
p.000005: 4. Article 7 (8) (4) is amended to read as follows:
p.000005: „4) the Lithuanian Bioethics Committee or the Regional Biomedical Research Committee referred to in Article 20 of this Law
p.000005: the authorization of the ethics committee to carry out a biomedical study; ".
p.000005: Article 5. Amendment of Article 8
p.000005: 1. Article 8 (4) is amended to read as follows:
p.000005: „4. Consent of a person to participate in the activities of the biobank in respect of an adult or a married minor
p.000005: a person, or a court-recognized full-fledged (emancipated) minor, whose health
p.000005: condition does not allow them to evaluate their interests or evaluate them intelligently, human biological sample and
p.000005: the processing of health information for the purposes specified in Paragraph 1 of Article 16 of this Law is provided by a person
p.000005: spouse or, if the person is unmarried, the marriage has ended, the spouse is recognized as
p.000005: do not know where they are or if the spouses live apart, - one of the person's parents (adoptive parents) or one of the adults
p.000005: children (adopted), unless one of the person’s parents (adoptive parents) or one of the adult children
p.000005: (adopted) objected to the person’s participation in the biobank (in this case, to include the person in the
p.000005: biobank activities are prohibited), and if a person is entitled to the Law on Patients' Rights and Compensation for Health Damage
p.000005: has appointed a representative in accordance with the established procedure,
p.000006: 6
p.000006: transfer. The participation of a person who has been declared incapacitated by a court in the field of health care
p.000006: the consent of a person to participate in the activities of the biobank is given by his guardian, in respect of a person who is a court
p.000006: recognized as a limited factor in the field of health care, - its carer and the court itself
p.000006: factor in the field of health care. "
p.000006: 2. Article 8 (6), first subparagraph, is replaced by the following:
p.000006: „6. Before giving a person 's consent to participate in the activities of the biobank, the person referred to in paragraphs 3 and 4 of this Article
p.000006: the person entitled to give consent to participate in the activities of the biobank (hereinafter - another person 's consent to participate
p.000006: biobank), the surviving spouse, if unmarried,
p.000006: a close relative referred to in paragraph 5 of this Article in order of priority, taking into account the consent of the person
...

Searching for indicator married:

Searching for indicator unmarried:

(return to top)
p.000002: Within the meaning of point 2 of paragraph 2. "
p.000002: 3. Article 2 (9) is amended to read as follows:
p.000002: „9. Biomedical research client - a natural or legal person, other organization or their subdivision, initiating,
p.000002: managing a biomedical study (other than a clinical trial of a medicinal product) providing its funding. This
p.000002: the term in the articles, their parts and points referred to in Article 1 (2) of this Law corresponds to
p.000002: the term "customer" and used in this paragraph and in Regulation (EU) No Article 2 (2) of Regulation (EU) No 536/2014
p.000002: Within the meaning of point 14. "
p.000002: 4. The following paragraph 111 is added to Article 2:
p.000002: „111. Substantial change in the clinical trial of a medicinal product - this concept corresponds to the concept of “substantial
p.000002: and shall have the same meaning as in Regulation (EU) No Article 2 (2) of Regulation (EU) No 536/2014
p.000002: paragraph 13. "
p.000002: 5. Article 2 (12) is amended to read as follows:
p.000002: „12. Informed person 's consent to participate in the activities of the biobank (hereinafter - the person' s consent to participate in the biobank
p.000002: voluntary, explicit, informed written consent, signed by a person or in accordance with the provisions of this law.
p.000002: in cases and procedures, the consent of another person to participate in the activities of the biobank to give the deceased person
p.000002: surviving spouse (hereinafter referred to as ‘surviving spouse’), if the person was unmarried, the marriage is
p.000002: the spouse is recognized as unknown or the spouses have lived apart, - a close relative,
p.000002: to allow the processing of a person's biological sample and health information for the purposes set out in this Law. "
p.000002: 6. Amend Article 2 (13) to read as follows:
p.000002: „13. Consent of an informed person to participate in a biomedical research (hereinafter referred to as "informed consent")
p.000002: voluntary, explicit, informed written consent to participate in a biomedical
p.000002: a clinical trial of a medicinal product, signed by a person or another in the cases and in accordance with the procedure provided for by this Law
p.000002: the consent of the person entitled to participate in the investigation to the person who survived the spouse, if the person was
p.000002: unmarried, the marriage has ended, the spouse is declared unknown or the spouses have lived apart,
p.000002: - a close relative. This concept in the articles of this law referred to in Article 1 (2) of this Law,
p.000002: in their paragraphs and paragraphs, the term ‘informed consent’ and used in this paragraph and in Regulation (EU)
p.000002: No. Within the meaning of Article 2 (2) (21) of Regulation (EU) No 536/2014. "
p.000002: 7. Article 2 (14) is amended to read as follows:
p.000002: „14. Clinical trial means a biomedical trial, other than a clinical trial of medicinal products, with live
p.000002: people. This term is defined in Article 1 (2) of this Law
p.000003: 3
p.000003: Articles, parts and paragraphs of this Act shall be used in this Part and in Regulation (EU) No 536/2014 2
p.000003: within the meaning of point (2) of paragraph 2 of this Article. "
p.000003: 8. The following paragraph 141 is added to Article 2:
p.000003: „141. Clinical trial of a medicinal product - this term corresponds to the term "clinical trial" and is used
p.000003: with the same meaning as defined in Regulation (EU) No Article 2 (2) (2) of Regulation (EU) No 536/2014. "
p.000003: 9. The following paragraph 142 is added to Article 2:
p.000003: „142. A clinical medicinal product research center shall comply with the requirements established in this Law
p.000003: the personal health care facility where the clinical trial of the medicinal product is performed. "
p.000003: 10. The following paragraph 143 is added to Article 2:
p.000003: „143. Low-intervention clinical trial of a medicinal product - this term corresponds to the term “low-intervention
p.000003: clinical trial ’and shall have the same meaning as defined in Regulation (EU) No 182/2011. Article 2 (2) of Regulation (EU) No 536/2014
p.000003: 3 points. "
p.000003: 11. Amend Article 2 (15) to read as follows:
...

p.000004: Conclusions of the ethical evaluation of the aspects referred to in Articles 6 and / or 7 of Regulation (EU) No 536/2014
p.000004: conclusion of the ethical evaluation of the investigational application for the medicinal product) and the essential clinical trial of the medicinal product
p.000004: amendments to Regulation (EU) No Aspects referred to in Articles 6 and / or 7 of Regulation (EU) No 536/2014
p.000004: the conclusions of the evaluation (hereinafter referred to as the "ethical review of the application for a major change to a clinical trial")
p.000004: evaluation), the State Committee for the Protection of the Rights of the Child and Adoption participates in the meeting of the Lithuanian Bioethics Committee
p.000004: a representative of the service under the Ministry of Social Security and Labor. Procedures for child participation in biomedical research
p.000004: determined by the Minister of Health and the Minister of Social Security and Labor. "
p.000004: 2. Article 7 (4) is amended to read as follows:
p.000004: „4. For an adult or a married minor, or recognized by the court as a full factor
p.000004: (emancipated) minors whose state of health does not allow them to assess their interests or hinders them
p.000004: judged intelligently, the consent of a person participating in a biomedical study to participate in the study is given by the individual
p.000004: spouse or, if the person is
p.000005: 5
p.000005: unmarried, the marriage is over, the spouse is recognized as unknown or the spouses are
p.000005: living apart, - one of the person's parents (adoptive parents) or one of the adult children (adopted children), unless
p.000005: when one of the person’s parents (adoptive parents) has expressed a disagreement with the person’s participation in a biomedical study
p.000005: biomedical examination with a person is prohibited) and if the person is entitled to Patients' Rights and Injuries
p.000005: has appointed a representative by appointment in accordance with the procedure established by the Law on Remuneration for Health, - a representative by appointment.
p.000005: The participation in a biomedical investigation of a person who has been declared incapacitated by a court in the field of health care
p.000005: the consent of a person to participate in the investigation is given by his or her guardian, for a person who is recognized by the court on a limited basis
p.000005: factor in the field of health care, - his carer and himself recognized by the court as a limited factor
p.000005: a person in the field of health care. The subject should be given this article according to his / her ability to understand
p.000005: Information referred to in paragraph 8. The researcher takes into account the subject who can understand what is presented to him
p.000005: information, a wish not to participate in a biomedical study or, if the subject is in such a biomedical study
...

p.000005: „6. The person and other person referred to in paragraphs 3 and 4 of this Article who is entitled to give consent to participate in the investigation
p.000005: (hereinafter - another person entitled to give consent to participate in the investigation) may also be informed by the person
p.000005: consent to participate in a study may be obtained by including a person in a biomedical study when all of the following conditions are met:
p.000005: conditions: ".
p.000005: 4. Article 7 (8) (4) is amended to read as follows:
p.000005: „4) the Lithuanian Bioethics Committee or the Regional Biomedical Research Committee referred to in Article 20 of this Law
p.000005: the authorization of the ethics committee to carry out a biomedical study; ".
p.000005: Article 5. Amendment of Article 8
p.000005: 1. Article 8 (4) is amended to read as follows:
p.000005: „4. Consent of a person to participate in the activities of the biobank in respect of an adult or a married minor
p.000005: a person, or a court-recognized full-fledged (emancipated) minor, whose health
p.000005: condition does not allow them to evaluate their interests or evaluate them intelligently, human biological sample and
p.000005: the processing of health information for the purposes specified in Paragraph 1 of Article 16 of this Law is provided by a person
p.000005: spouse or, if the person is unmarried, the marriage has ended, the spouse is recognized as
p.000005: do not know where they are or if the spouses live apart, - one of the person's parents (adoptive parents) or one of the adults
p.000005: children (adopted), unless one of the person’s parents (adoptive parents) or one of the adult children
p.000005: (adopted) objected to the person’s participation in the biobank (in this case, to include the person in the
p.000005: biobank activities are prohibited), and if a person is entitled to the Law on Patients' Rights and Compensation for Health Damage
p.000005: has appointed a representative in accordance with the established procedure,
p.000006: 6
p.000006: transfer. The participation of a person who has been declared incapacitated by a court in the field of health care
p.000006: the consent of a person to participate in the activities of the biobank is given by his guardian, in respect of a person who is a court
p.000006: recognized as a limited factor in the field of health care, - its carer and the court itself
p.000006: factor in the field of health care. "
p.000006: 2. Article 8 (6), first subparagraph, is replaced by the following:
p.000006: „6. Before giving a person 's consent to participate in the activities of the biobank, the person referred to in paragraphs 3 and 4 of this Article
p.000006: the person entitled to give consent to participate in the activities of the biobank (hereinafter - another person 's consent to participate
p.000006: biobank), the surviving spouse, if unmarried,
p.000006: a close relative referred to in paragraph 5 of this Article in order of priority, taking into account the consent of the person
p.000006: to participate in the activities of the biobank by explaining the age and health condition of the donor in a way that he or she understands
p.000006: special medical terms informed of: '.
p.000006: Article 6. Amendment of Article 11
p.000006: Amend Article 11 (4) to read as follows:
p.000006: „4. When a clinical trial of a medicinal product is performed, the investigator must have the clinical medicinal product
p.000006: a higher education qualification corresponding to the nature of the research, the right to practice medicine accordingly
p.000006: or dental practice, have at least one year of patient care experience and in the last
p.000006: have completed five years of training in good clinical practice or have been a researcher during that period
p.000006: clinical trial of the medicinal product and employed at the research center. Organization of good clinical practice training
p.000006: procedures and requirements for the development of good clinical practice curricula shall also be approved by the investigator-in-charge
p.000006: clinical trial of a medicinal product, the requirements for higher education qualifications shall be established by health care
p.000006: Minister. When performing the biomedical research referred to in this Part, the principal investigator must also
p.000006: have experience in clinical trials of the medicinal product. A person can work as a principal investigator in only one of the same
p.000006: research center. "
p.000006: Article 7. Supplementation of the Law with Article 111
...

Searching for indicator union:

(return to top)
p.000010: applications under Regulation (EU) No The scientific evaluation of the aspects referred to in Articles 6 and / or 7 of Regulation (EU) No 536/2014; and
p.000010: authorize a substantial change in the testing of a medicinal product if, in the light of that assessment and
p.000010: Ethical evaluation of the Lithuanian Bioethics Committee's application for a substantial change in a clinical trial
p.000010: The conclusion of the amendment to the clinical trial is in accordance with Regulation (EU) No 182/2011. 536/2014
p.000010: requirements.
p.000010: 3. The Lithuanian Bioethics Committee shall submit the conclusions referred to in Paragraphs 1 and 2 of this Article to the State Medicines Control Agency
p.000010: not later than 2 working days before the entry into force of Regulation (EU) No Article 8 (1) of Regulation (EU) No
p.000010: Article 19 (3), Article 19 (1), Article 20 (5) or Article 23 (1)
p.000010: the end of the application evaluation period.
p.000010: 4. The State Medicines Control Agency shall carry out the tasks provided for in Regulation (EU) No. 1907/2006. Chapters II, III and XIII of Regulation (EU) No 536/2014
p.000010: the reporting Member State when the Republic of Lithuania, in accordance with Regulation (EU) No 536/2014 is
p.000010: the rapporteur Member State, the Member States concerned and the Minister for Health
p.000010: the national contact point referred to in Article 4 of Regulation (EU) No 182/2011. Article 83 of Regulation (EU) No 536/2014
p.000010: Lithuanian Bioethics Committee and Regional Biomedical Research Ethics Committees access to
p.000010: Regulation (EU) No The portal of the European Union referred to in Article 80 of Regulation (EU) No 536/2014.
p.000010: 5. Lithuanian Bioethics Committee Regulation (EU) No. Shall participate in the evaluation in accordance with the procedure laid down in Article 44 of Regulation (EU) No 536/2014
p.000010: Regulation (EU) No The information referred to in Articles 42 and 43 of Regulation (EU) No 536/2014.
p.000011: 11
p.000011: 6. The Lithuanian Bioethics Committee shall apply to the State Medicines Control Agency for a sample
p.000011: Regulation (EU) No Measures provided for in Article 77 of Regulation (EU) No 536/2014 where there is evidence of non-compliance with the Regulation
p.000011: (ES) No Requirements laid down in Regulation (EU) No 536/2014. "
p.000011: Article 13. Amendment of Article 25
p.000011: Repeal Article 25 (5).
p.000011: Article 14. Amendment of the Annex to the Law
p.000011: To amend the Annex to the Law and set it forth as follows:
p.000011: “Annex to the Law on Ethics of Biomedical Research of the Republic of Lithuania
p.000011: IMPLEMENTING LEGISLATION OF THE EUROPEAN UNION
p.000011: 1. Regulation (EU) No 182/2011 of the European Parliament and of the Council 536/2014 on clinical trials on medicinal products for human use,
p.000011: repealing Directive 2001/20 / EC (OJ 2014 L 158, p. 1). "
p.000011: Article 15. Entry into force and implementation of the law
p.000011: 1. This Law, with the exception of Paragraph 3 of Article 10 and Paragraph 3 of this Article, shall enter into force after 6
p.000011: months after the European Commission announced that in 2014 April 16 Regulation (EU) of the European Parliament and of the Council
p.000011: No. Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use and repealing Directive 2001/20 / EC (OJ
p.000011: L 158, p. 1), the portal of the European Union referred to in Article 80 and Article 81 of this Regulation
p.000011: The European Union database referred to in paragraph 1 shall perform its function in full and comply with Article 82 (1) of this Regulation
p.000011: (hereinafter referred to as the notification), the publication in the Official Journal of the European Union
p.000011: in the Official Journal (hereinafter referred to as "publication").
p.000011: 2. Paragraph 3 of Article 10 of this Law shall enter into force in 2019. January 1
p.000011: 3. The Government of the Republic of Lithuania, the Minister of Health of the Republic of Lithuania, the Minister of Social Affairs of the Republic of Lithuania
p.000011: Minister of Health and Labor, State Medicines Control Service under the Health Care of the Republic of Lithuania
p.000011: The Bioethics Committee of the Ministry and Lithuania shall adopt the implementing legislation of this Law before the entry into force of this Law
p.000011: acts.
p.000012: 12
p.000012: 4. The Ministry of Health of the Republic of Lithuania shall inform the manager of the Register of Legal Acts about this
p.000012: the date of entry into force of the law after the publication of the notice referred to in paragraph 1 of this Article.
p.000012: I promulgate this law adopted by the Seimas of the Republic of Lithuania.
p.000012: President of the Republic Dalia
...

Searching for indicator minor:

(return to top)
p.000002: THE REPUBLIC OF LITHUANIA
p.000002: BIOMEDICAL RESEARCH ETHICS LAW NO. VIII-1679 1, 2, 6, 7, 8, 11, 12, 20,
p.000002: AMENDMENTS TO ARTICLES 21, 22, 25 AND THE ANNEX AND SUPPLEMENT TO THE LAW 111,
p.000002: ARTICLE 241 OF THE LAW
p.000002: 2017 November 16 No. XIII-735 Vilnius
p.000002: Article 1. Amendment of Article 1
p.000002: 1. The following paragraph 2 is added to Article 1:
p.000002: „2. For the clinical trials of medicinal products, Article 2 (4), (7), (9),
p.000002: 111, 13 to 16 and 26, Article 3 (8), Article 6 (1), points 1, 2, 4, 5, 7 and paragraph 3,
p.000002: Article 7 (3) and (4), Article 11 (4), Article 111, Article 12 (1) to (31) and (4),
p.000002: Article 21 (1), (2) (3) and (3) to (7), Article 22 (1) to (4), (5) (3),
p.000002: Article 241, Article 25 (6) and Article 26. "
p.000002: 2. Former Article 1 (2) shall become paragraph 3.
p.000002: Article 2. Amendment of Article 2
p.000002: 1. Article 2 (4) is amended to read as follows:
p.000002: „4. A person who, because of his state of health, cannot be regarded as being able to assess his interests reasonably,
p.000002: an adult recognized by a court as incapacitated for health care or a person with limited health care
p.000002: or an adult or a married minor, or recognized by a court as a full factor
p.000002: (emancipated) a minor whose state of health does not allow him or her to assess his or her interests or prevents them from assessing them
p.000002: wisely. "
p.000002: 2. Article 2 (7) is amended to read as follows:
p.000002: „7. Biomedical research - testing of hypotheses in biomedical sciences by research methods,
p.000002: aimed at developing scientific knowledge about human health, diseases, their diagnosis, treatment or prevention. This
p.000002: the term in the articles, their parts and points referred to in Article 1 (2) of this Law corresponds to
p.000002: the term “clinical trial” and used in this Part and in 2014. April 16 European Parliament and of the Council
p.000002: Council Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use
p.000002: Directive
p.000002: 2
p.000002: 2001/20 / EC (OJ 2014 L 158, p. 1) (hereinafter referred to as Regulation (EU) No 536/2014), Article 2
p.000002: Within the meaning of point 2 of paragraph 2. "
p.000002: 3. Article 2 (9) is amended to read as follows:
p.000002: „9. Biomedical research client - a natural or legal person, other organization or their subdivision, initiating,
p.000002: managing a biomedical study (other than a clinical trial of a medicinal product) providing its funding. This
p.000002: the term in the articles, their parts and points referred to in Article 1 (2) of this Law corresponds to
p.000002: the term "customer" and used in this paragraph and in Regulation (EU) No Article 2 (2) of Regulation (EU) No 536/2014
p.000002: Within the meaning of point 14. "
p.000002: 4. The following paragraph 111 is added to Article 2:
p.000002: „111. Substantial change in the clinical trial of a medicinal product - this concept corresponds to the concept of “substantial
p.000002: and shall have the same meaning as in Regulation (EU) No Article 2 (2) of Regulation (EU) No 536/2014
p.000002: paragraph 13. "
...

p.000004: conflict of interest, decision on the child's participation in biomedical research
p.000004: shall be adopted in accordance with the procedure established in Article 3.163 of the Civil Code. When involved in biomedical research
p.000004: children when deciding on an application for a clinical trial in accordance with Regulation (EU) No 182/2011.
p.000004: Conclusions of the ethical evaluation of the aspects referred to in Articles 6 and / or 7 of Regulation (EU) No 536/2014
p.000004: conclusion of the ethical evaluation of the investigational application for the medicinal product) and the essential clinical trial of the medicinal product
p.000004: amendments to Regulation (EU) No Aspects referred to in Articles 6 and / or 7 of Regulation (EU) No 536/2014
p.000004: the conclusions of the evaluation (hereinafter referred to as the "ethical review of the application for a major change to a clinical trial")
p.000004: evaluation), the State Committee for the Protection of the Rights of the Child and Adoption participates in the meeting of the Lithuanian Bioethics Committee
p.000004: a representative of the service under the Ministry of Social Security and Labor. Procedures for child participation in biomedical research
p.000004: determined by the Minister of Health and the Minister of Social Security and Labor. "
p.000004: 2. Article 7 (4) is amended to read as follows:
p.000004: „4. For an adult or a married minor, or recognized by the court as a full factor
p.000004: (emancipated) minors whose state of health does not allow them to assess their interests or hinders them
p.000004: judged intelligently, the consent of a person participating in a biomedical study to participate in the study is given by the individual
p.000004: spouse or, if the person is
p.000005: 5
p.000005: unmarried, the marriage is over, the spouse is recognized as unknown or the spouses are
p.000005: living apart, - one of the person's parents (adoptive parents) or one of the adult children (adopted children), unless
p.000005: when one of the person’s parents (adoptive parents) has expressed a disagreement with the person’s participation in a biomedical study
p.000005: biomedical examination with a person is prohibited) and if the person is entitled to Patients' Rights and Injuries
p.000005: has appointed a representative by appointment in accordance with the procedure established by the Law on Remuneration for Health, - a representative by appointment.
p.000005: The participation in a biomedical investigation of a person who has been declared incapacitated by a court in the field of health care
p.000005: the consent of a person to participate in the investigation is given by his or her guardian, for a person who is recognized by the court on a limited basis
...

p.000005: a person in the field of health care. The subject should be given this article according to his / her ability to understand
p.000005: Information referred to in paragraph 8. The researcher takes into account the subject who can understand what is presented to him
p.000005: information, a wish not to participate in a biomedical study or, if the subject is in such a biomedical study
p.000005: already participating in the study, the wish not to participate in it. "
p.000005: 3. Article 7 (6), first subparagraph, is replaced by the following:
p.000005: „6. The person and other person referred to in paragraphs 3 and 4 of this Article who is entitled to give consent to participate in the investigation
p.000005: (hereinafter - another person entitled to give consent to participate in the investigation) may also be informed by the person
p.000005: consent to participate in a study may be obtained by including a person in a biomedical study when all of the following conditions are met:
p.000005: conditions: ".
p.000005: 4. Article 7 (8) (4) is amended to read as follows:
p.000005: „4) the Lithuanian Bioethics Committee or the Regional Biomedical Research Committee referred to in Article 20 of this Law
p.000005: the authorization of the ethics committee to carry out a biomedical study; ".
p.000005: Article 5. Amendment of Article 8
p.000005: 1. Article 8 (4) is amended to read as follows:
p.000005: „4. Consent of a person to participate in the activities of the biobank in respect of an adult or a married minor
p.000005: a person, or a court-recognized full-fledged (emancipated) minor, whose health
p.000005: condition does not allow them to evaluate their interests or evaluate them intelligently, human biological sample and
p.000005: the processing of health information for the purposes specified in Paragraph 1 of Article 16 of this Law is provided by a person
p.000005: spouse or, if the person is unmarried, the marriage has ended, the spouse is recognized as
p.000005: do not know where they are or if the spouses live apart, - one of the person's parents (adoptive parents) or one of the adults
p.000005: children (adopted), unless one of the person’s parents (adoptive parents) or one of the adult children
p.000005: (adopted) objected to the person’s participation in the biobank (in this case, to include the person in the
p.000005: biobank activities are prohibited), and if a person is entitled to the Law on Patients' Rights and Compensation for Health Damage
p.000005: has appointed a representative in accordance with the established procedure,
p.000006: 6
p.000006: transfer. The participation of a person who has been declared incapacitated by a court in the field of health care
p.000006: the consent of a person to participate in the activities of the biobank is given by his guardian, in respect of a person who is a court
p.000006: recognized as a limited factor in the field of health care, - its carer and the court itself
p.000006: factor in the field of health care. "
...

p.000006: required for the clinical investigation of the medicinal product. "
p.000006: Article 8. Amendment of Article 12
p.000006: 1. Article 12 (2) is amended to read as follows:
p.000007: 7
p.000007: „2. A biomedical study in which a participant undergoes interventional research for research purposes
p.000007: the methods pose a risk to the health of the subject as well as to the sponsor of the clinical trial and
p.000007: the principal investigator must insure his civil liability against possible pecuniary and non-pecuniary damage,
p.000007: caused by an injury to the subject or death of the subject by concluding a biomedical examination
p.000007: Compulsory third party liability insurance contracts between the client and the principal investigator with insurers
p.000007: unless the pecuniary and non-pecuniary damage which may result from the biomedical research referred to in
p.000007: Article 3 (3), the remuneration is provided for in the civil service of the personal health care institution
p.000007: liability insurance for patients. Whether applicable for biomedical research purposes
p.000007: interventional research methods pose a risk to the subject's health, according to the Lithuanian Bioethics Committee
p.000007: or the Regional Ethics Committee for Biomedical Research, which authorizes the biomedical research. "
p.000007: 2. Article 12 (3) is amended to read as follows:
p.000007: „3. A low - intervention clinical trial, as well as another biomedical trial in which
p.000007: interventional biomedical research methods applied to the participant pose only a minor adverse event
p.000007: temporary effects on his health are also permitted in the case of a personal health care institution which
p.000007: itself or its employee is the client of such biomedical research or its employee is such
p.000007: biomedical research researcher, is provided for in the civil liability insurance contract
p.000007: compensation for pecuniary and non-pecuniary damage which may arise in the course of such biomedical research. "
p.000007: 3. The following paragraph 31 is added to Article 12:
p.000007: „31. Whether a clinical trial of a medicinal product is a small intervention is assessed by Lithuanian bioethics
p.000007: Committee and the State Medicines Control Service under the Ministry of Health of the Republic of Lithuania
p.000007: (hereinafter referred to as the State Medicines Control Agency) in assessing the application for a clinical trial authorization
p.000007: the study of the medicinal product and the accompanying documents (hereinafter referred to as the clinical trial of the medicinal product)
p.000007: application) or an application for an authorization to make a substantial change to a clinical trial of a medicinal product and at the same time
p.000007: (hereinafter referred to as “application for a major change to a clinical trial of a medicinal product”). ”
p.000007: 4. The following paragraph 32 is added to Article 12:
p.000007: „32. Whether intervention is used for biomedical research other than a clinical trial of a medicinal product
p.000007: research methods cause a small undesirable temporary effect on the subject's health, evaluates Lithuanian bioethics
p.000007: Committee or the Regional Committee for the Ethics of Biomedical Research, which authorizes biomedical research
p.000007: study in accordance with a minor adverse temporary effect approved by the Minister of Health
p.000007: a list of research interventional biomedical research methods. Lithuanian Bioethics Committee
p.000007: or regional
p.000008: 8
p.000008: the Ethics Committee for Biomedical Research may, by reasoned decision, declare a minor adverse
p.000008: health effects of the subject and other minor adverse temporary effects on the health of the subject
p.000008: interventional biomedical research methods not included in the list of interventional biomedical research methods
p.000008: research methods in accordance with criteria laid down by the Minister for Health. "
p.000008: Article 9. Amendment of Article 20
p.000008: Amend Article 20 to read as follows:
p.000008: “Article 20. Authorities authorizing biomedical research (excluding clinical trials)
p.000008: research on medicinal products)
p.000008: Permits to perform biomedical research, except for clinical trial of a medicinal product, are issued by Lithuania
p.000008: the Bioethics Committee in the case provided for in Article 21 (2) (2) of this Law or regional
p.000008: the Ethics Committee for Biomedical Research in the case provided for in Item 1 of Paragraph 5 of Article 22 of this Law. Permits to perform
p.000008: biomedical research with medical devices (hereinafter referred to as medical devices) in this Article
p.000008: issued by the institutions referred to in paragraph 1 only after receiving the State Accreditation Service for Health Care Activities under
p.000008: The conclusion of the Ministry of Health is that medical devices for use in biomedical research
p.000008: meets the requirements set by the Minister of Health. "
p.000008: Article 10. Amendment of Article 21
p.000008: 1. Article 21 (2) (3) is amended to read as follows:
p.000008: "(3) perform applications for a clinical trial of a medicinal product and an essential clinical trial of the medicinal product
p.000008: amendments to Regulation (EU) No Ethical aspects referred to in Articles 6 and / or 7 of Regulation (EU) No 536/2014
p.000008: evaluation and provide the conclusion of the ethical evaluation of the clinical trial application and the substantive clinical evaluation
...

Searching for indicator education:

(return to top)
p.000006: transfer. The participation of a person who has been declared incapacitated by a court in the field of health care
p.000006: the consent of a person to participate in the activities of the biobank is given by his guardian, in respect of a person who is a court
p.000006: recognized as a limited factor in the field of health care, - its carer and the court itself
p.000006: factor in the field of health care. "
p.000006: 2. Article 8 (6), first subparagraph, is replaced by the following:
p.000006: „6. Before giving a person 's consent to participate in the activities of the biobank, the person referred to in paragraphs 3 and 4 of this Article
p.000006: the person entitled to give consent to participate in the activities of the biobank (hereinafter - another person 's consent to participate
p.000006: biobank), the surviving spouse, if unmarried,
p.000006: a close relative referred to in paragraph 5 of this Article in order of priority, taking into account the consent of the person
p.000006: to participate in the activities of the biobank by explaining the age and health condition of the donor in a way that he or she understands
p.000006: special medical terms informed of: '.
p.000006: Article 6. Amendment of Article 11
p.000006: Amend Article 11 (4) to read as follows:
p.000006: „4. When a clinical trial of a medicinal product is performed, the investigator must have the clinical medicinal product
p.000006: a higher education qualification corresponding to the nature of the research, the right to practice medicine accordingly
p.000006: or dental practice, have at least one year of patient care experience and in the last
p.000006: have completed five years of training in good clinical practice or have been a researcher during that period
p.000006: clinical trial of the medicinal product and employed at the research center. Organization of good clinical practice training
p.000006: procedures and requirements for the development of good clinical practice curricula shall also be approved by the investigator-in-charge
p.000006: clinical trial of a medicinal product, the requirements for higher education qualifications shall be established by health care
p.000006: Minister. When performing the biomedical research referred to in this Part, the principal investigator must also
p.000006: have experience in clinical trials of the medicinal product. A person can work as a principal investigator in only one of the same
p.000006: research center. "
p.000006: Article 7. Supplementation of the Law with Article 111
p.000006: To supplement the Law with Article 111:
p.000006: “Article 111. Clinical Drug Research Center
p.000006: The clinical trial center must have the right to provide personal health care services,
p.000006: required for the clinical investigation of the medicinal product. "
p.000006: Article 8. Amendment of Article 12
p.000006: 1. Article 12 (2) is amended to read as follows:
p.000007: 7
p.000007: „2. A biomedical study in which a participant undergoes interventional research for research purposes
p.000007: the methods pose a risk to the health of the subject as well as to the sponsor of the clinical trial and
p.000007: the principal investigator must insure his civil liability against possible pecuniary and non-pecuniary damage,
p.000007: caused by an injury to the subject or death of the subject by concluding a biomedical examination
p.000007: Compulsory third party liability insurance contracts between the client and the principal investigator with insurers
p.000007: unless the pecuniary and non-pecuniary damage which may result from the biomedical research referred to in
p.000007: Article 3 (3), the remuneration is provided for in the civil service of the personal health care institution
p.000007: liability insurance for patients. Whether applicable for biomedical research purposes
...

Searching for indicator employees:

(return to top)
p.000008: after evaluating the proposals of the regional ethics committees for biomedical research. "
p.000009: 9
p.000009: 3. Article 21 (4) is amended to read as follows:
p.000009: „4. The biomedical research expert group of the Lithuanian Bioethics Committee consists of 9 members, 5 of whom are members of the biomedical sciences.
p.000009: specialists, 3 - specialists in the field of social sciences or humanities with a scientific degree and one
p.000009: a representative of the patient organization. Within the term and in accordance with the procedure established by the Minister of Health
p.000009: specialists in the field of biomedical sciences to the biomedical research expert group of the Lithuanian Bioethics Committee
p.000009: offers associations of personal health professionals in the social sciences or humanities
p.000009: Specialists are offered by universities that teach bioethics or health law, and
p.000009: a representative of the patient organization is nominated by the patient organization. Lithuanian Bioethics Committee for Biomedical Research
p.000009: the staff of the expert group shall be approved by the Minister of Health on the basis of impartiality and transparency
p.000009: taking into account the professional qualifications and competences of the candidates and their experience in biomedical research
p.000009: ethics. The procedure for the activities of this group shall be determined by the Minister of Health. "
p.000009: 4. The following paragraph 7 is added to Article 21:
p.000009: „7. A member of the biomedical research expert group of the Lithuanian Bioethics Committee is paid 0.33 of the basic salary
p.000009: the amount established in the Law on Remuneration of Employees of State and Municipal Institutions of the Republic of Lithuania
p.000009: in accordance with the established procedure (hereinafter - the basic amount of the official salary), remuneration for the performance of a clinical medicinal product
p.000009: examination of the research application (review), 0.22 basic salary of the official salary for the next biomedical research
p.000009: examination of documents (review), 0.11 base salary of the official salary for the essential clinical pharmacy
p.000009: examination (review) of the application for change of the study of the preparation and 0.14 basic salary of the official salary for
p.000009: every hour of participation in the meeting of the biomedical research expert group of the Lithuanian Bioethics Committee.
p.000009: Remuneration for participation in the activities of the biomedical research expert group of the Lithuanian Bioethics Committee
p.000009: paid from the state budget appropriations approved by the Ministry of Health. "
p.000009: Article 11. Amendment of Article 22
p.000009: 1. Article 22 (5) (2) is amended to read as follows:
p.000009: “2) submit proposals to the Lithuanian Bioethics Committee when biomedical research is planned to be performed
p.000009: research centers located in more than one regional biomedical research ethics committee
p.000009: in the designated area; ".
p.000009: 2. Article 22 (5) (3) is amended to read as follows:
p.000009: "3) submit proposals to the Lithuanian Bioethics Committee regarding the application for a clinical trial of a medicinal product in accordance with Regulation (EU)
p.000009: No. Aspects of the ethical evaluation of clinical trials on a medicinal product referred to in Article 7 of Regulation (EU) No 536/2014
p.000009: planned to take place in the area assigned to their activities; ".
p.000010: 10
...

Searching for indicator parents:

(return to top)
p.000004: conclusion of the ethical evaluation of the investigational application for the medicinal product) and the essential clinical trial of the medicinal product
p.000004: amendments to Regulation (EU) No Aspects referred to in Articles 6 and / or 7 of Regulation (EU) No 536/2014
p.000004: the conclusions of the evaluation (hereinafter referred to as the "ethical review of the application for a major change to a clinical trial")
p.000004: evaluation), the State Committee for the Protection of the Rights of the Child and Adoption participates in the meeting of the Lithuanian Bioethics Committee
p.000004: a representative of the service under the Ministry of Social Security and Labor. Procedures for child participation in biomedical research
p.000004: determined by the Minister of Health and the Minister of Social Security and Labor. "
p.000004: 2. Article 7 (4) is amended to read as follows:
p.000004: „4. For an adult or a married minor, or recognized by the court as a full factor
p.000004: (emancipated) minors whose state of health does not allow them to assess their interests or hinders them
p.000004: judged intelligently, the consent of a person participating in a biomedical study to participate in the study is given by the individual
p.000004: spouse or, if the person is
p.000005: 5
p.000005: unmarried, the marriage is over, the spouse is recognized as unknown or the spouses are
p.000005: living apart, - one of the person's parents (adoptive parents) or one of the adult children (adopted children), unless
p.000005: when one of the person’s parents (adoptive parents) has expressed a disagreement with the person’s participation in a biomedical study
p.000005: biomedical examination with a person is prohibited) and if the person is entitled to Patients' Rights and Injuries
p.000005: has appointed a representative by appointment in accordance with the procedure established by the Law on Remuneration for Health, - a representative by appointment.
p.000005: The participation in a biomedical investigation of a person who has been declared incapacitated by a court in the field of health care
p.000005: the consent of a person to participate in the investigation is given by his or her guardian, for a person who is recognized by the court on a limited basis
p.000005: factor in the field of health care, - his carer and himself recognized by the court as a limited factor
p.000005: a person in the field of health care. The subject should be given this article according to his / her ability to understand
p.000005: Information referred to in paragraph 8. The researcher takes into account the subject who can understand what is presented to him
p.000005: information, a wish not to participate in a biomedical study or, if the subject is in such a biomedical study
p.000005: already participating in the study, the wish not to participate in it. "
p.000005: 3. Article 7 (6), first subparagraph, is replaced by the following:
p.000005: „6. The person and other person referred to in paragraphs 3 and 4 of this Article who is entitled to give consent to participate in the investigation
p.000005: (hereinafter - another person entitled to give consent to participate in the investigation) may also be informed by the person
p.000005: consent to participate in a study may be obtained by including a person in a biomedical study when all of the following conditions are met:
p.000005: conditions: ".
p.000005: 4. Article 7 (8) (4) is amended to read as follows:
p.000005: „4) the Lithuanian Bioethics Committee or the Regional Biomedical Research Committee referred to in Article 20 of this Law
p.000005: the authorization of the ethics committee to carry out a biomedical study; ".
p.000005: Article 5. Amendment of Article 8
p.000005: 1. Article 8 (4) is amended to read as follows:
p.000005: „4. Consent of a person to participate in the activities of the biobank in respect of an adult or a married minor
p.000005: a person, or a court-recognized full-fledged (emancipated) minor, whose health
p.000005: condition does not allow them to evaluate their interests or evaluate them intelligently, human biological sample and
p.000005: the processing of health information for the purposes specified in Paragraph 1 of Article 16 of this Law is provided by a person
p.000005: spouse or, if the person is unmarried, the marriage has ended, the spouse is recognized as
p.000005: do not know where they are or if the spouses live apart, - one of the person's parents (adoptive parents) or one of the adults
p.000005: children (adopted), unless one of the person’s parents (adoptive parents) or one of the adult children
p.000005: (adopted) objected to the person’s participation in the biobank (in this case, to include the person in the
p.000005: biobank activities are prohibited), and if a person is entitled to the Law on Patients' Rights and Compensation for Health Damage
p.000005: has appointed a representative in accordance with the established procedure,
p.000006: 6
p.000006: transfer. The participation of a person who has been declared incapacitated by a court in the field of health care
p.000006: the consent of a person to participate in the activities of the biobank is given by his guardian, in respect of a person who is a court
p.000006: recognized as a limited factor in the field of health care, - its carer and the court itself
p.000006: factor in the field of health care. "
p.000006: 2. Article 8 (6), first subparagraph, is replaced by the following:
p.000006: „6. Before giving a person 's consent to participate in the activities of the biobank, the person referred to in paragraphs 3 and 4 of this Article
p.000006: the person entitled to give consent to participate in the activities of the biobank (hereinafter - another person 's consent to participate
p.000006: biobank), the surviving spouse, if unmarried,
p.000006: a close relative referred to in paragraph 5 of this Article in order of priority, taking into account the consent of the person
...

Searching for indicator opinion:

(return to top)
p.000004: may recognize other groups of persons. "
p.000004: Article 4. Amendment of Article 7
p.000004: 1. Article 7 (3) is amended to read as follows:
p.000004: „3. The child shall be provided with the information referred to in paragraph 8 of this Article according to his or her age and ability to understand
p.000004: information. Due to the child's participation in the biomedical research, the person's consent to participate in the research is given by the child
p.000004: representatives under the law, but if the child, who is able to understand the information provided to him, expresses a wish
p.000004: not participate in a biomedical study or, if the child is already participating in such a biomedical study,
p.000004: cease to participate, the child's participation in the study shall not begin or end unless
p.000004: contrary to the best interests of the child. Whether the child's desire not to participate in the investigation is not against the child's interests is decided
p.000004: the child's legal representatives, taking into account the investigator's opinion. If the decision on the child's participation
p.000004: in a biomedical research, there is a conflict of interest between the child and his or her legal representatives or the child 's legal representatives
p.000004: conflict of interest, decision on the child's participation in biomedical research
p.000004: shall be adopted in accordance with the procedure established in Article 3.163 of the Civil Code. When involved in biomedical research
p.000004: children when deciding on an application for a clinical trial in accordance with Regulation (EU) No 182/2011.
p.000004: Conclusions of the ethical evaluation of the aspects referred to in Articles 6 and / or 7 of Regulation (EU) No 536/2014
p.000004: conclusion of the ethical evaluation of the investigational application for the medicinal product) and the essential clinical trial of the medicinal product
p.000004: amendments to Regulation (EU) No Aspects referred to in Articles 6 and / or 7 of Regulation (EU) No 536/2014
p.000004: the conclusions of the evaluation (hereinafter referred to as the "ethical review of the application for a major change to a clinical trial")
p.000004: evaluation), the State Committee for the Protection of the Rights of the Child and Adoption participates in the meeting of the Lithuanian Bioethics Committee
p.000004: a representative of the service under the Ministry of Social Security and Labor. Procedures for child participation in biomedical research
...

General/Other / Incapacitated

Searching for indicator incapacitated:

General/Other / Public Emergency

Searching for indicator emergency:

(return to top)
p.000003: a person who meets the requirements established in this Law. This term in Article 1 (2) of this law
p.000003: referred to in the articles, parts and paragraphs of this Law referred to in this Part and in Regulation (EU)
p.000003: No. Within the meaning of Article 2 (2) (15) of Regulation (EU) No 536/2014. "
p.000003: 12. Amend Article 2 (16) to read as follows:
p.000003: „16. Subject - a person participating in a biomedical study, except for a clinical trial of a medicinal product.
p.000003: This term corresponds to the articles, their parts and points referred to in Article 1 (2) of this Law
p.000003: the term "subject" and used in this paragraph and in Regulation (EU) No 182/2011. Article 2 (2) (17) of Regulation (EU) No 536/2014
p.000003: defined values. "
p.000003: 13. Amend Article 2 (26) to read as follows:
p.000003: „26. Other terms used in this Law shall be understood as they are defined in the Republic of Lithuania
p.000003: Civil Code, the Law on Insurance of the Republic of Lithuania, the Law on Pharmacy of the Republic of Lithuania, the Law on Pharmacy of the Republic of Lithuania
p.000003: Law on Equal Opportunities of the Republic of Lithuania, Compensation of Patients' Rights and Damage to Health of the Republic of Lithuania
p.000003: the Law on Health Care Institutions of the Republic of Lithuania, the Law on Health of the Republic of Lithuania
p.000003: the Law on the System, the Law on the Fundamentals of the Protection of the Rights of the Child of the Republic of Lithuania, the
p.000003: in the Law on Donation and Transplantation of Tissues, Cells, Organs, Determination of Human Death in the Republic of Lithuania, and
p.000003: the Law on Emergency Situations, the Law on the Legal Protection of Personal Data of the Republic of Lithuania and Regulation (EU) No.
p.000003: 536/2014. "
p.000004: 4
p.000004: Article 3. Amendment of Article 6
p.000004: Amend Article 6 (2) to read as follows:
p.000004: „2. Lithuanian Bioethics Committee or Regional Biomedical Research Ethics Committee, evaluating
p.000004: documents regarding the issuance of a permit to conduct a biomedical research, by reasoned decision of vulnerable persons
p.000004: may recognize other groups of persons. "
p.000004: Article 4. Amendment of Article 7
p.000004: 1. Article 7 (3) is amended to read as follows:
p.000004: „3. The child shall be provided with the information referred to in paragraph 8 of this Article according to his or her age and ability to understand
p.000004: information. Due to the child's participation in the biomedical research, the person's consent to participate in the research is given by the child
p.000004: representatives under the law, but if the child, who is able to understand the information provided to him, expresses a wish
p.000004: not participate in a biomedical study or, if the child is already participating in such a biomedical study,
p.000004: cease to participate, the child's participation in the study shall not begin or end unless
...

Orphaned Trigger Words

Appendix

Indicator List

Indicator	Vulnerability
access	Access to Social Goods
age	Age
child	Child
children	Child
drug	Drug Usage
education	education
emergency	Public Emergency
employees	employees
incapacitated	Incapacitated
married	Marital Status
minor	Youth/Minors
opinion	philosophical differences/differences of opinion
parents	parents
party	political affiliation
union	Trade Union Membership
unmarried	Marital Status
vulnerable	vulnerable

Indicator Peers (Indicators in Same Vulnerability)

Indicator	Peers
child	['children']
children	['child']
married	['unmarried']
unmarried	['married']

Trigger Words

consent

developing

ethics

protection

risk

Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability Type	Vulnerability	Indicator	# Matches
Political	political affiliation	party	1
Political	vulnerable	vulnerable	1
Health	Drug Usage	drug	1
Social	Access to Social Goods	access	1
Social	Age	age	2
Social	Child	child	17
Social	Child	children	5
Social	Marital Status	married	3
Social	Marital Status	unmarried	5
Social	Trade Union Membership	union	5
Social	Youth/Minors	minor	9
Social	education	education	2
Social	employees	employees	1
Social	parents	parents	8
Social	philosophical differences/differences of opinion	opinion	1
General/Other	Incapacitated	incapacitated	3
General/Other	Public Emergency	emergency	1

Changes of the Law on Ethics of Biomedical Research No. 536/2014 (2017)

Applicable Type / Vulnerability / Indicator Overlay for this Input

Political / political affiliation

Political / vulnerable

Health / Drug Usage

Social / Access to Social Goods

Social / Age

Social / Child

Social / Marital Status

Social / Trade Union Membership

Social / Youth/Minors

Social / education

Social / employees

Social / parents

Social / philosophical differences/differences of opinion

General/Other / Incapacitated

General/Other / Public Emergency

Orphaned Trigger Words

Appendix

Indicator List

Indicator Peers (Indicators in Same Vulnerability)

Trigger Words

Applicable Type / Vulnerability / Indicator Overlay for this Input