THE REPUBLIC OF LITHUANIA
BIOMEDICAL, J STUDY ETHICS {CONSTRUCTION NO. VIII-1679 AMENDMENT CONSTRUCTION
2015 September 17 No. XB-1938 Vilnius
Article 1. Law of the Republic of Lithuania on Ethics of Biomedical Research No. VIII-1679 new
wording
To amend the Law of the Republic of Lithuania on Ethics of Biomedical Research No. VIII-1679 ii jj is worded as follows:
“BIOMEDICAL RESEARCH ETHICS OF THE REPUBLIC OF LITHUANIA
]BUILDING
I SKYBIUS
GENERAL PROVISIONS
Article 1. Purpose of the law
1. This Law lays down the ethical requirements for biomedical research, human biological and personal
the sustainability of health information for biomedical research purposes and biobankq activities
conditions for the authorization of biomedical research, the supervision of the performance of biomedical research
and biomedical research and the liability for damage caused by the subject.
health consent or death.
2. The provisions of this Law are harmonized with the legal acts of the European Union specified in this Law
in the Annex to the Law.
Article 2. The main concepts of this law
1. Personal health information (hereinafter health information) - data on a person's health, diseases
and health disorders, causes, external factors, diagnosis, course, prognosis, treatment, outcome, death,
heredity or any other information related to a person’s health.
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2. Provision of personal health information (hereinafter - provision of health information) - personal health
disclosure of information by transmission or otherwise making it available, other than by making it available to the public
in the media.
3. Processing of personal health information (hereinafter referred to as "health information processing") - any
which action is taken on personal health information: collection, recording, storage, storage,
classification, grouping, merging, modification (addition or correction), biomedical research, provision,
publication, use, logical and / or arithmetic operations, search, dissemination, destruction or other
action or actions.
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
a person declared incapacitated or of limited breeding by a court, or an adult or recognized by a court
a full-fledged (emancipated) minor whose state of health does not allow him to assess his interest or
tightens to judge them wisely.
5. Biobank - a public legal entity acting as a budgetary or public body, holding a personal
a health care license to engage in activities involving human biological êminiq and health information
for the purposes set out in this Law and the performance of biomedical research (hereinafter referred to as
biobank activities).
6. Bioethical requirements - in the Republic of Lithuania and international legal acts and codes of ethics
ethical requirements for the provision of health care and biomedical research have been established.
7. Biomedical research - testing of hypotheses of biomedical science by scientific research methods,
aimed at developing scientific knowledge about human health, diseases, their diagnosis, treatment or prevention.
8. Biomedical Research Center (hereinafter referred to as the Research Center) - a legal entity where a biomedical
research.
9. Biomedical research participant - a natural or legal person, other organization or a division thereof,
initiating, managing biomedical research and ensuring its funding.
10. Ethical requirements for biomedical research - bioethical requirements established in this Law shall apply
in biomedical research.
11. Ethical supervision of biomedical research - Lithuanian Bioethics Committee and (or) regional
Activities of the Committee of the Committee on Biomedical Research in Supervision as Clients and Researchers in Biomedical Research
adheres to the ethical requirements of biomedical research.
12. Consent of an informed person to participate in the activities of a biobank (hereinafter consent of a person to participate in
biobank) is a voluntary, explicit, informed written consent signed by a person or a member of this
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,
the surviving spouse, if the person was
unmarried, the marriage is over, the spouse is declared to be unknown or
the spouses have lived apart, - a close relative who, for the purposes laid down in this Law, is authorized to
personal biological sample and health information.
13. Consent of an informed person to participate in a biomedical research (hereinafter - consent of a person to participate in
voluntary, explicit, informed written consent to participate in a biomedical study,
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
entitled to grant the marriage of a surviving spouse if the person was unmarried
expires, the spouse is recognized as not knowing where he or she is or the spouses have lived apart, - a close relative.
14. "Clinical trials" means bioinedicological trials in living humans.
15. Researcher - a natural person performing biomedical research who complies with the requirements established in this Law.
16. Research subject - a person participating in a biomedical research.
17. "Human biological sample" means a biological material taken from a living or dead human body.
18. “Provision of human biological samples” means the transfer or making available of human biological samples
biidu.
! 9. "Handling of human biological samples" means any operation performed on human biological samples
action: collection, processing, preservation, accumulation, storage, identification, evaluation,
biomedical research, classification, refining, aggregation, modification (addition or correction), provision,
search, destruction or any other act or actions.
20. Human embryo - a developing human body from the moment of fertilization (zygote formation) to the eighth
end of the week of pregnancy.
21. ‘human embryonic stem cells’ means human embryonic stem cells which are capable of
to divide and / or develop specialized cell types in vitro.
22. Human embryonic stem cell line means a human embryonic stem cell which may be
grown in vitro and divided without long-term differentiation into other cell types.
23. Human stem cells - during the development of the human embryo and human fetus and the
non-specialized cells in human tissues that can differentiate} specialized
țvairiq audiniq tips cells and regenerate at the same time.
24. Human stem cell line Human stem cells grown in vitro
conditions, ensuring their long-term sharing without differentiation.
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25. "Human fetus" means the developing human body from the beginning of the ninth week of pregnancy until birth.
26. Other terms used in this Law shall be understood as they are defined in the Republic of Lithuania
Civil Code (hereinafter - the Civil Code), the Law on Insurance of the Republic of Lithuania (hereinafter - the Insurance Code)
Law on Pharmacy), the Law on Equal Opportunities of the Republic of Lithuania, the Law on Equal Opportunities of the Republic of Lithuania
The Law on Compensation and Damage to Health of the Republic of Lithuania (hereinafter referred to as the
Law on Remuneration of Health Care), the Law on Health Care Institutions of the Republic of Lithuania
maintenance ¡staigq
Law of the Republic of Lithuania on the Protection of the Rights of the Child
the Law of the Republic of Lithuania on Human Tissues, Cell Cells, Organ Donation and Transplantation,
Republic of human death detection and critical condition
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)
protection law).
Article 3. Biomedical research objects
1. In a biomedical research, the objects may be living or dead humans or groups of humans, human embryos, human
fruit, Human Biological Sample and Health Information.
2. The establishment of a human embryo for the purposes of biomedical research is prohibited.
3. Biomedical research shall only be carried out on a human embryo and human fetus if it is intended to:
the benefits to the human embryo and human fetus under consideration outweigh the risks.
4. Biomedical research on human embryos and fetuses
after termination of pregnancy at the request of a woman in the absence of medical indications.
5. Human cloning is prohibited.
6. Biomedical research on a human embryo or human fetus during or after which a human
an embryo or human fetus is destroyed or a human embryo is not transferred} to a woman’s uterus is prohibited.
7. Biomedical research that modifies the human genome may only be performed for prophylactic,
for diagnostic or therapeutic purposes and only if they are not intended to modify the genome of the offspring.
8. Human embryonic audinip, embryonic stem cell and its line or fetal audinip and derived from it
the entry into and exit from the territory of the Republic of Lithuania of stem cells and their lines is prohibited.
This prohibition does not apply to stem cells extracted from the umbilical cord or placenta after the birth of a child,
and samples taken for genetic testing in accordance with the requirements of Paragraph 3 of this Article for export to Lithuania
Territory of the Republic and for exit from
jos. Human embryonic tissue, embryonic stem cells and their lines or human fetal tissues and from
Transit through the territory of the Republic of Lithuania of the stem cell and their line is possible only
with the permission of the Minister of Health. Permission for human embryonic tissue, embryonic stem cells, etc.
human fetal tissue and stem cells derived therefrom and
The territory of the Republic of Lithuania and the Human stem cell extract obtained from the umbilical cord or
placenta after the birth of a child, and genetic testing of a human biological sample for transportation Î Lithuanian
The Minister of Health shall approve the Republic and the description of the procedure for removal from it.
Article 4. Prohibition of discrimination
It is prohibited to discriminate against a person, restrict his or her rights or legitimate interests:
1) due to the fact that the biobank handles or does not manage human biological samples and health information;
2) on the basis of human biological samples and health information processed in the biobank;
3) due to the fact that the person participates or does not participate in the biomedical research;
4) based on the results of biomedical research.
CHAPTER II
ETHICAL REQUIREMENTS FOR BIOMEDICAL RESEARCH
Article 5. Ethical requirements in biomedical research
1. Biomedical research shall be conducted in accordance with the principle that the best interests of the human person shall be paramount
the interests of society and science.
2. Biomedical research may be performed only under all of the following conditions:
1) is a scientific and practical development of biomedical research;
2) biomedical research cannot be replaced by other research performed by human nebiitq
researched;
3) u ”the protection of the interest of the researcher and the confidentiality of his / her health information is ensured;
4) the consent of the person to participate in the investigation has been obtained (except for Article 7 (5) and
Cases referred to in paragraph 11) or where the biomedical research is performed with human biologicals managed by a biobank
samples and health information, - the consent of the person to participate in the activities of the biobank has been obtained;
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,
the person will not lose the right to receive adequate personal health care;
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6) details of the relevant pre - clinical study are provided (for clinical use only)
research);
7) the risks and inconveniences to which the subject may be exposed do not exceed
benefits of biomedical research. In the case of a clinical trial, the subject may not receive a routine clinical trial
practice, personal health care shall only be applied if it is in accordance with normal clinical practice
the effectiveness of the personal health care provided has not been demonstrated and the risks and inconveniences to which it may be exposed
subject, do not outweigh the benefits of biomedical research, or when such personal health care
the non-application does not endanger the health of the subject;
8) in the cases specified in Paragraphs 2 and 3 of Article 12 of this Law, the principal investigator and the biomedical
the research client or the health care institution is insured against civil liability for possible
compensation for pecuniary and non-pecuniary damage caused during the biomedical research to the research subject;
9) documents conferring the right to perform have been obtained from the instituteijiț referred to in Article 20 of this Law
biomedical research;
10) this is not prohibited by other laws.
Article 6. Vulnerable persons and protection of interest
1. Vulnerable persons whose consent to participate in a biomedical study may be affected by external
circumstances or who are unable, in whole or in part, to defend their interest shall be deemed to be:
1) persons who, due to their state of health, cannot be considered capable of reasonably assessing their interests;
2) children;
3) students, if their participation in biomedical research is related to studies;
4) persons living in social care institutions;
5) soldiers during the actual military retreat;
6) employees of the health care institution where the biomedical research is performed, subordinate to the researcher;
7) persons in prisons or other places of deprivation of liberty.
2. Lithuanian Bioethics Committee or Regional Biomedical Research Ethics Committee when evaluating documents
on the issuance of a permit for a biomedical research, the Lithuanian Bioethics Committee, when evaluating the documents
approval of a clinical trial of a medicinal product, a reasoned decision may be taken
to recognize other groups of persons as vulnerable persons.
3. Clinical trials on vulnerable persons shall be permitted only in the following cases:
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(1) where a clinical trial can only be performed on vulnerable individuals and there is scientific reason to believe that
participation in a clinical trial will provide a direct benefit to the subject that is greater than that associated with the clinical trial.
associated risks and inconveniences;
2) when the clinical trial can only be performed on vulnerable individuals and the clinical trial is directly
is related to the health status of the subject and there is scientific reason to expect that participation in the clinical trial will occur
beneficial to the non-study group to which the subject belongs and to the subject for the purpose of the clinical trial
the intervention methods used in the study have a minor adverse effect on the health of the subject;
3) when the clinical trial is directly related to the life-threatening or debilitating subject of the subject
a medical condition for which there is no adequate personal health care and there is a scientific basis
it is expected that participation in the clinical trial will provide a direct benefit to the subject that is greater than
risks and inconveniences associated with the clinical trial.
Article 7. Individual consent to participate in the study
1. Before including a person in a biomedical research, other than a biomedical research carried out with
Human biological samples and / or health information processed in the biobank with the consent of the person to participate
biobaiilco, the consent of the individual to participate in the study must be obtained. A person's consent to participate in the study must
meet all of the following conditions:
1) the person's consent to participate in the investigation is given by a person who can express his or her will;
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
and clear information;
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).
the consent of the person entitled to participate in the investigation to the surviving spouse, if the person was unmarried,
the marriage has ended, the spouse is recognized as not knowing where he or she is or whether the spouses have lived apart,
free priority of a close relative referred to in Article 5 (5);
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
participate in the study of content reilcalavimus.
2. If, due to a physical disability, illness or other reason, a person is unable to sign the person's consent
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.
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
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
representatives in accordance with the law, but if the child, who is able to understand the information provided to him, expresses a wish
not to participate in a biomedical study or, if vailcas
already participates in such a biomedical study, does not participate in it, the child does not participate in the study, or
terminated unless this is contrary to the best interests of the child. Is the child's desire not to participate in the study
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.
When children are involved in a biomedical study, the decision to approve a clinical trial
Participation in the meeting of the Lithuanian Bioethics Committee for the issuance of a study certificate
Representative of the Ministry of Social Security and Labor. Child
the procedure for participation in biomedical research shall be established by the health care minisoas and the Republic of Lithuania
Minister of Social Security and Labor.
4. A person who, because of his state of health, cannot be considered to be able to promote his interests prudently,
the consent of a person to participate in a biomedical research is given by the spouse of the person, if the person is
unmarried, the marriage is over, the spouse is recognized as unknown or the spouses live
- one of the person’s parents (¡tėvip) or one of the adult children (łvaikiq), or
incapacitated, - his guardian or, in the case of a disability, his carer (hereinafter
consent to participate in the study). The subject must be able to understand according to his / her ability to understand
the information referred to in paragraph 8 of this Article has been provided. The researcher takes into account the subject who can understand
the information provided to him, the wish not to participate in a biomedical study or, if the subject is in such a study
already involved in the blomedical study, the desire not to participate in it. Upon receipt of the consent of one of these persons
priority, to perform a biomedical examination with a person who, due to a medical condition, is unable to
considered to be able to reasonably assess their interests is prohibited.
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,
perform biomedical treatment with the biological sample (s) of the deceased and health information
given by the surviving spouse, if the person was not married, the marriage has ended, the spouse
is recognized as unknown where the spouses were living apart, - one of the next of kin
the following order of precedence: parents (grandparents), adult children (grandchildren), brothers (sisters), grandparents, grandchildren.
With the consent of one of these persons, the next of kin's next of kin
consent is not sought. In case of disagreement of one of these persons, priority shall be given to perform
biomedical examination with a biological sample (s) of the deceased and health information is prohibited.
6. The person and any other person entitled to consent to the investigation may be informed
the consent of a person to participate in a study may be obtained from a person receiving a biomedical study when
all of the following conditions are met:
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1) due to the condition of the ingot or other health condition, for which the necessary assistance is required, the person may not:
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
who, because of his or her state of health, cannot be considered capable of reasonably assessing his or her own interests, whether the child
cannot receive the information referred to in paragraph 8 of this Article and may not express a wish or unwillingness to participate
biomedical research;
2) there is a scientific basis for expecting that a person’s participation in biomedical research will benefit his or her health
direct significant benefits, such as alleviating his suffering and / or improving his health, or
conditions for diagnosing or predicting the course of the disease;
3) the person must undergo an immediate diagnostic or treatment procedure for a biomedical examination (hereinafter -
the information referred to in paragraph 8 and the consent of the individual cannot be obtained
to participate in the investigation from another person entitled to give consent to participate in the investigation;
4) the investigator confirms that he / she is not aware that the person has previously filed any objection to participation
biomedical research;
5) the biomedical research is directly related to the condition of the person's hygiene, which requires him to have immediate
the information referred to in paragraph 8 of this Article cannot be provided and obtained
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
and the biomedical research is of such a nature that it can only be performed in a life-threatening or other
ümiit sunkiiț health cases;
6) the risk to human health and inconvenience posed by the biomedical research is minimal compared to the
clinical practice in the case of the subject's medical condition.
7. Under the conditions set out in paragraph 6 of this Article, a person included in a biomedical research may continue to participate
in a biomedical study when provided with the information referred to in paragraph 8 of this Article, and
information on the right to object to the continued use of health information for the purpose of biomedical research,
obtained during a biomedical study, when the person refuses to continue to participate in the study, and the consent of the person is obtained
participate in the survey from the person of the chip:
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
entitled to give when the subject is a person who, due to a medical condition, cannot be considered capable of
to assess its interests prudently, as soon as it becomes possible to submit them to paragraph 8 of this Article
the specified information and obtain the consent of the person to participate in the investigation;
2) subject - immediately when the subject becomes able to reasonably assess his / her interests.
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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
the person entitled to give consent to participate in the investigation, the surviving spouse, if the person was
unmarried, the marriage is over, the spouse is recognized as unknown or the spouses are separated,
- a close relative as referred to in paragraph 5, in order of priority, with the consent of the person
to participate in the study on the age and state of health of the person giving the study, in a comprehensible
medical terms must be informed of:
1) the purpose of the biomedical research;
2) a biomedical research plan;
3) methods used in biomedical research;
4) specified in Article 20 of this Law in the Lithuanian Bioethics Committee or regional biomedical research
permission of the Ethics Committee to conduct a biomedical research or approval of the Lletuva Bioethics Committee
to conduct a clinical) examination of the medicinal product and the certificate of the State Agency of Medicines
Permission of the Ministry of Health of the Republic;
5) the expected benefits of the biomedical research for the research subject;
6) the rights of the research subject;
7) the possible risks and inconveniences that the subject may cause to the subject by biomedical research;
8) the procedure for compensation for possible damage caused by a biomedical research;
9) the right to revoke a person's consent to participate in the study at any time by providing information about the biomedical study
the consequences of termination;
10) guarantees of confidentiality of health information.
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.
entitled to give to a person or to a surviving spouse, if the person was unmarried, the marriage is
expires, the spouse is deemed not to know where he or she is or whether the spouses have lived apart,
A clear, free and easy-to-implement priority for a close relative referred to in paragraph 5
the possibility to withdraw the person's consent to participate in the investigation upon written request. Biomedical research
the results of the biomedical research prior to the person's request to withdraw the person's consent to participate
study receipt are not destroyed.
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.
the requirements and the procedure for granting and revoking consent shall be established by the Minister of Health.
11. In the case of biomedical research, the object of which is prior to the request for biomedical
a biological sample of the individual for health, statistical or other purposes at the time of the study; and
(or) health information, Lithuanian Bioethics Committee or
the Regional Ethics Committee for Biomedical Research, which authorizes blomedicininț research,
decide whether the consent of the person to participate in the investigation is necessary.
Article 8. Individual consent to participate in biobank activities
1. Human biological samples and health information shall be processed in accordance with Article 16 (1) of this Law
for the purposes set out in paragraph 1 only with the consent of the individual to participate in the biobank. Personal consent
to participate in the activities of the biobank must meet all of the following conditions:
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;
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
upon receipt of sufficient and clear information;
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
procedure - the consent of another person entitled to participate in the investigation to the surviving spouse, if the person
was unmarried, the marriage has ended, the spouse is recognized as unknown or the spouses
- the free will of a close relative referred to in paragraph 5 of this section);
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
the content requirements of the person's consent to participate in the activities of the biobank.
2. If, due to a physical disability, illness or other reasons, a person is unable to sign the person's consent
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
in accordance with the procedure laid down.
3. The consent of a person to participate in a biobank for the processing of a child’s biological sample and health information
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.
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
able to reasonably assess their interests in the processing of human biological sample and health information
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
unmarried, the marriage is over, the spouse is recognized as unknown or the spouses live
divorce, one of the person’s parents (jtêviq) acba one of the adult child (} child) or when the person is in court
incapacitated, his guardian or, in the event of a person’s incapacity, his caregiver (hereinafter referred to as
the person entitled to give consent to participate in the activities of the biobank).
5. The consent of the person to participate in the activities of the biobank regarding the biological sample and health information of the deceased
processing for the purposes set out in Article 16 (1) of this Law shall be provided by the surviving spouse, if the person
was unmarried, the marriage is over, the spouse is
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- it is not known where the spouses were or whether the spouses lived apart, - one of the close relatives
priority: parents ({parents), adult children (} children), brothers (sisters), grandparents, grandchildren. Gavus
the consent of one of these9 persons is established in order of priority, the consent of the deceased close relative is not sought.
In the event of the disagreement of one of these9 persons, use the biological samples of the deceased and
health information is prohibited in the activities of the biobank.
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 -
another person entitled to give consent to participate in the activities of the biobank, the surviving spouse, if
was unmarried, - a close relative in the order of priority referred to in paragraph 5,
taking into account the age and health status of the person giving consent to participate in the biobank,
in a way that he understands, explaining the specific medical terms, informed of:
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;
(2) the objectives and results of the processing of the biological sample and health information, including health
obtaining information from healthcare from institutions, the registry and / or the state infor-
systems and the fact that a specific biomedical study with this human biological sample and health
information goals and ways at the time of giving a person's consent to participate in biobank activities may be unknown due to
insufficient level of scientific or technological development or other objelctyviqip;
3) access to biobanlco information on his (or deceased person's) human biological sample
and the use of health information and the purposes of that use;
4) guarantees of confidentiality of health information and the fact that the biobank provides human biological samples and / or
health information or results of biomedical research obtained using them, or parts thereof, which allow
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
to examine;
5) the right to revoke a person's consent to participate in the activities of a biobank.
7. A child or a person who, due to a medical condition, cannot be considered capable of reasonably assessing his or her own interests,
in accordance with his ability to understand, the information referred to in paragraph 6 of this Article shall be provided and shall be
taking into account ț its wish not to grant the biobank the right to process its biological sample and health information
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
already given, - šț withdraw the consent.
8. The biobank may handle human biological samples remaining after surgery9,
invasive and / or interventional procedures and health information for which the person has not
consent to participate in the activities of the biobank in accordance with the procedure established in this Article,
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but only to the extent necessary to preserve these human biological births and if the person within one month after
consent of a person to perform a surgical, invasive and / or interventional procedure
biobank, which may be processed in the biobank, and health information only to the extent necessary,
that birth is assessed as such The suitability of a human biological êminip in Article 16 (1) of this Law
for the purposes set. If a person or, in the cases specified in this Law, another person's consent to participate
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
to participate in the activities of the biobank, the biobank must immediately destroy the human biological sample stored in the biobank.
and health information. Information on human biological samples and health information
biobanlce may be processed in accordance with the procedures set out in this paragraph, shall be made publicly available to patients for personal health
in care facilities.
9. Any invasive and / or interventional procedure the sole purpose of which is to obtain and further process human
biological sample (s) in a biobank and to carry out biomedical research with it (jars) and not to treat or
diagnosis is permitted only if the person’s consent to participate in the biobank
consent to take a human biological sample for that purpose.
10. A biobank shall give the consent of a person or, in the cases provided for in this Law, another person to participate
to a person entitled to operate in a biobank, or to a surviving spouse or close relative
a clear, free and easy-to-use opportunity for a relative to withdraw their consent in writing
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
the human biological sample stored in the biobank and the health information can no longer be processed and
to transmit a human biological sample and health information to the persons specified in Article 17 of the Law
can no longer be used and must be destroyed and reported in accordance with the procedure established by the Minister of Health
notified to the person. Biomedical research results obtained from biomedical research with Human Biologicals
samples, and health information prior to receipt of a person’s request to revoke a person’s consent to participate in a biobank
indestructible.
11. Detailed content of the person's consent to participate in the biobank's activities and information specified in this
requirements and the procedure for granting and revoking a person's consent to participate in the activities of the biobank
determined by the Minister of Health.
Article 9. Confidentiality of health information
1. Health information obtained from a biomedical research shall be identifiable
confidential and may be provided only in accordance with the procedure established by the Law on Patients' Rights and Compensation for Health Damage.
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2. Health information obtained from biomedical research shall not be considered confidential and may be published without delay
the consent of the subject if the publication of such health information will not lead to the identification of the person.
Article 10. Islaidq salary
Subjects shall be entitled to compensation for the costs incurred in sharing the biomedical research.
wasted time. The procedure for calculation and payment of compensation shall be established by the Government of the Republic of Lithuania (hereinafter -
Government) or a body authorized by it.
Article 11. Biomedical research client and researcher
1. The sponsor of a biomedical research shall be responsible for the initiation, management and administration of the biomedical research
securing funding for biomedical research.
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
one or the research center leads a group of biomedical researchers and is responsible for this
group activities, he is called the principal investigator.
3. When conducting biomedical research involving interventional biomedical
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)
research), the researcher must have a higher education degree appropriate to the nature of such biomedical research
a qualification, an appropriate license to practice medicine or a dental practice, to have a patient
supervisory experience and other staff at the research center, and the principal investigator must also
have biomedical research, where the interventional biomedical research methods used pose
risk to the subject's health. The specific investigator performing the task referred to in this paragraph
biomedical research, higher education qualification and experience requirements are set by the Minister of Health.
4. When a clinical trial of a medicinal product is being conducted, the investigator must have a clinical pharmacy
preparation research pobiid) corresponding to a higher education qualification relevant to medical practice
or dental practice license, have experience in patient care, have completed good clinical practice
practice training and employed at a research center. When performing the biomedical research referred to in this
the principal investigator must also have experience in clinical trials of the medicinal product. Specific
higher education qualifications of a researcher conducting a clinical trial, good clinical practice
The requirements for practical training9 and experience are set by the Minister of Health. A person can work
the principal investigator is only one in the same study center.
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Article 12. Civil liability of the client and researcher of biomedical research and its insurance
1. The client and researcher of a biomedical research shall be liable for pecuniary and non-pecuniary damage caused to the research subject, except
pecuniary and non-pecuniary damage caused by causes other than biomedical research,
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
specified pecuniary and non-pecuniary damage caused to the subject, except in the case of biomedical research
the sponsor and the investigator agree otherwise in writing. Property made by the client and researcher of the biomedical research
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.
order.
2. The principal investigator of the biomedical research must insure his civil liability in respect of
possible pecuniary and non-pecuniary damage caused by the health injury of the subject or the
death, remuneration, civil liability of the client of the biomedical research and the principal investigator
compulsory insurance contracts with insurers. This requirement is considered only when it is met
a clinical trial of a medicinal product or any other biomedical trial in which a person is involved
interventional research methods used for biomedical research pose a risk to the health of the subject.
Whether interventional research methods used for biomedical research pose a risk to the subject
health, is assessed by the Lithuanian Bioethics Committee, which issues a clinical trial approval
research certificate or authorization for a biomedical research, or a regional biomedical research
ethylcos committee authorizing biomedical research.
3. A clinical trial of a medicinal product or any other biomedical trial in which the participating
interventional biomedical research methods have only a minor adverse effect on the individual.
health is also permitted in the case of a personal health care institution which itself or
its employee is the client of such biomedical research or its employee is the sponsor of such biomedical research
researcher, the contract of civil liability for damage to patients provides for property and non-property
compensation for damage that may occur during such biomedical research. Whether they apply
Interventional biomedical research methods have a small undesirable temporary effect on the subject
health, is assessed by the Lithuanian Bioethics Committee, which issues a clinical trial approval
research certificate or authorization for biomedicininț research, or regional biomedicininip
Research Ethics Committee, which authorizes biomedical research based on health
approved by the Minister of Defense Minor adverse temporary effects on the health of the subject
list of interventional biomedical research methods. Lithuanian Bioethics Committee or regional
the ethics committee may, by reasoned decision, declare a minor
temporary effects on the subject's health
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and other Minor adverse adverse effects on the health of the subject through biomedical intervention.
research method interventional biomedical research methods not listed.
4. Compulsory civil liability insurance of the client of the biomedical research and the principal investigator
the amount may not be less than 29 000 eunț for pecuniary and non-pecuniary damage caused to one subject,
offset. Compulsory civil liability insurance for the client of the biomedical research and the principal investigator
protection must be valid from the beginning to the end of the biomedical examination and for at least 5 years from
end of biomedical research. Civilian of the client and principal investigator of the biomedical research
the rules on compulsory liability insurance laid down by the other sponsor of the biomedical research and
the terms and conditions of the principal investigator 's compulsory civil liability insurance contract, property and
the procedure for calculating and reimbursing the amount of non-proprietary health research shall be established by the Government or its authorized
authority.
CHAPTER III BIOBANKS, OPERATING CONDITIONS
Article 13. Biobank activities
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.
requirements of the law, respecting the rights and freedoms of the individual and
the principles of reliability, security and openness.
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.
purposes.
3. Biobanks have the right to:
1) be clients of biomedical research and perform biomedical research;
2) to co-operate with the Member States of the European Union in accordance with the procedure established by legal acts
biobanks, international organizations of third countries and third countries, to participate in them
activities;
3) to receive health information in accordance with the procedure established in Article 15 of this Law.
Article 14. Biobankq pouring
1. A public legal entity acting as a budgetary or public body for the purpose of obtaining and obtaining a license
to engage in the activities of a biobank must meet the requirements set out in the Law on Health Care
the following requirements for obtaining a health care license:
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1) to ensure that the requirement for the operation of the Biobank approved by the Minister of Health
requirements set out in the inventory to ensure human biological êminip and health
traceability, security, quality and availability of information to researchers, in accordance with:
(a) premises, materials and materials used for human biological samples and health information
handling;
(b) the organization, management and administration of the processing of human biological samples and health information
system;
2) appoint an employee responsible for the management of human biological resources and health information in accordance with the law;
requirements of the act.
2. A license to engage in the activities of a biobank shall be issued, its validity shall be suspended, suspension of the license
revoked, the validity of the license shall be revoked in accordance with the procedure established by the Law on Health Care Institutions.
Article 15. Biobank's right to receive health information
1. With the consent of a person to participate in the activities of a biobank, the biobank shall be entitled to receive
The sample and health information are processed in the biobank, health information from health care
lstaigq, registry and / or state information system in accordance with the procedure established by law.
2. The biobank also has the right to receive health information from another legal entity specified by the person
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
information systems and do not have a health care facility or its provision from health
would require an unreasonably high material and / or time cost for the care institution.
3. The biobank shall exercise the rights referred to in this Article on its own initiative or in the context of biomedical research
at the request of the client, his authorized representative or the principal investigator.
Article 16. Management of human biological samples and health information
1. The objectives of the processing of human biological samples and health information in the biobank are:
1) to provide human biological samples and health information in accordance with the procedure established by this Law
persons referred to in Article 17 of the Law;
2) to use human biological samples and health information in accordance with the procedure established by this Law
biomedical research;
3) to improve the protected biological quality of the sample and its suitability for future biomedical research, unsuitable
to use biological samples for biomedical research
preparation for storage, improvement of storage technologies or quality control procedures and other biobank
actions to improve the operational process.
2. Biobanks shall ensure the traceability, security,
quality and availability to researchers in accordance with the procedure set out in the description of Biobank's operational requirements.
3. Health information processed in the Biobank is confidential and handled in accordance with the procedure established by law.
The confidentiality of health information processed in the Biobank shall be ensured by all natural and legal persons
who use this health information, as well as those referred to in Article 15 (1) and (2) of this Law
subjects.
4. The information processed by the biobank is not considered confidential and may be published without
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
the information will not be identifiable.
5. The biobank shall assign a code to the human biological sample and / or health information received and
allowing the identification of the person whose biological samples and / or health information is being processed
in the biobank, the identity is managed separately, ensuring the possibility to identify the konlnetq person.
Article 17. Human biological samples and / or health information and personal health are relevant
provision of information
1. Human biological samples and health information processed in a biobank may be provided for biomedical purposes
the sponsor of the study, his authorized representative or the principal investigator when issued in accordance with Article 20 of this Law.
permits for biomedical research by the designated authority.
2. Human biological samples and health information processed in the Biobank may be shared
Republic of Lithuania, a member state of the European Union, another state of the European Economic Area and
biobanks, a biomedical research client, his authorized representative or a principal investigator in a third country,
performing biomedical research outside the Republic of Lithuania, human biological samples and health information
after obtaining the permission of the Lithuanian Bioethics Committee regarding the human biological materials processed in the biobank
èminip and / or provision of health information.
3. Authorization for the provision of Human Biological Samples and / or Health Information processed in a biobank
issued after the Lithuanian Bioethics Committee has decided that:
1) the purposes of the provision of human biological êminiq and health information are consistent with the consent given by the person
to participate in the activities of the biobank;
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2) the persons referred to in Paragraph 2 of this Article have the certificates issued by the State Ethics Committee and / or the institution
permits authorizing the processing of human biological samples and / or skeletal information for biomedical research
purposes.
4. The authorization of a biobanlce shall be subject to the processing of human biological samples and / or health information
the procedure for issuance shall be established by the Minister of Health.
5. Biobank Human biological samples and health information or biomedical data obtained from their use
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
is necessary for the trial of the case.
6. The sponsor of the biomedical research, its authorized representative or the principal investigator shall notify the
health-relevant information obtained from a biomedical examination of that person's biological sample and
health information. Biobank evaluates this information in accordance with the importance of personal health
criteria for notifiable information and determining that the information must be provided
shall notify the person to whom the person’s consent to participate in the biobank is entitled to give
person or the doctor treating the person. Mandatory information relevant to personal health
the procedure, criteria and procedure for notification shall be established by the Minister of Health.
Article 18. State supervision of Biobank activities
The state supervision of the activities of the Biobank is performed by the Lithuanian Bioethics Committee and the State
alneditation for health care activities under the Ministry of Health.
Article 19. Publicity of Biobankq activities
Biobanks shall make public information about their activities in accordance with the procedure established by the Minister of Health.
CHAPTER IV
SUPERVISION OF PERFORMANCE OF BIOMEDICAL INVESTIGATION
Article 20. Institutions granting the right to conduct biomedical research
1. Biomedical research in the Republic of Lithuania may be performed only with the permission of paragraphs 2 and 3 of this Article
to the authorities referred to in
2. Authorizations for biomedical research, except for clinical trials of medicinal products, shall be issued by Lithuania
bioethics committee or regional biomedicininip research ethics committee. Regional biomedicininitt study
the ethics committee issues permits to delay biomedical
20
research where biomedical research is planned to be carried out in research centers located only in the relevant
regional biomedical research in the area assigned to the activities of the ethics committee. Permits to perform
biomedical research planned at research centers located in more than one
regional biomedical research in the territory assigned to the activities of the ethics committee, issued by Lithuania
the Bioethics Committee, having received the conclusions of the Ethics Committee for the regional biomedical research. Permits to perform
biomedical research involving medical devices shall be issued by the authorities referred to in this Part only upon receipt
Conclusion of the State Accreditation Service for Health Care Activities under the Ministry of Health dê1
compliance of the medical device with the requirements established by the Minister of Health
measures for clinical trials.
3. Clinical trials of a medicinal product may be performed only with the approval of the Lithuanian Bioethics Committee
to carry out a clinical trial certificate of the medicinal product and the State Pharmacopoeia Service under the
Permission of the Ministry of Health of the Republic. Lithuanian Bioethics Committee approves the postponement of clinical trials
the study certificate of the medicinal product after obtaining the conclusions of the regional ethics committees for biomedical research, where
a clinical trial of the medicinal product is planned to be performed at study centers located in the relevant regional
biomedical research in the area assigned to the activities of the ethics committee.
Article 21. Lithuanian Bioethics Committee
1. The Lithuanian Bioethics Committee is a budgetary institution maintained from the state budget and the state budget.
fondp. The rights and obligations of the owner of the Lithuanian Bioethics Committee are exercised by the Health Care of the Republic of Lithuania
Ministry (hereinafter referred to as the Ministry of Health).
2. Lithuanian Bioethics Committee:
1) analyzes bioethical problems and consults state and local government institutions, institutions,
organizations on bioethics issues, provide conclusions and suggestions on how to regulate these issues
jstatymtț and other draft legal acts;
2) issue permits for the performance of biomedical research, except for clinical trials of medicinal products,
when biomedical research is planned to be performed in research centers located in more than one regional
biomedical research in the area assigned to the activities of the ethics committee, and shall carry out this research ethically
maintenance;
3) issue certificates of approval for the conduct of clinical trials of a medicinal product and perform this biomedical trial
ethical supervision;
4) issue permits for the provision of human biological samples and (or) health information processed in biobanks
the persons referred to in Article 17 (2) of this Law;
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5) in accordance with the procedure established by the Minister of Health, perform the accounting, storage, storage and distribution of biomedical research
provide information about them, ensuring the protection of confidential information;
6) prepares and approves model ethics of the Lithuanian Bioethics Committee, regional biomedical research
Committee to the Lithuanian Bioethics Committee, regional biomedical research ethics committees
document forms;
7) supervise the activities of the ethics committee for biomedical research in the regioninitț;
8) report annually to the Ministry of Health on its activities and submit proposals on
bioethical problem solving;
9) supervision as health professionals and institutions providing personal and public
health care services, complies with the requirement of bioethics9;
10) provide methodological support and advise health care țstaigq medical ethics commissions and others
institutions on bioethics;
11) represent the Republic of Lithuania in international organizations according to its competence;
12) perform other tasks specified in this Law, other laws and regulations of the Lithuanian Bioethics Committee
functions.
3. Authorizations for biomedical studies and consent to conduct clinical trials on a medicinal product
Certificates are issued by the Lithuanian Bioethics Committee when the biomedical certificate of the Lithuanian Bioethics Committee is positive
study expert group conclusion.
4. The biomedical research group of the Lithuanian Bioethics Committee consists of 9 members, of which 5 are biomedical
science, 4 - specialists in the field of social sciences or humanities with a scientific degree. Through health
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
The biomedical study of the Lithuanian Bioethics Committee is proposed by a group of experts in personal health care
associations of specialists, and specialists in the field of social sciences or humanities are offered by universities,
in which subjects of bioethics or health law are taught. Biomedical9 of the Lithuanian Bioethics Committee
The personal composition of the research expert group shall be approved by the Minister of Health in accordance with
the principles of impartiality and transparency, taking into account the professional qualifications and competences of the candidates; and
experience in the field of ethics in biomedical research. Remuneration of this group's activities and expert work
determined by the Minister of Health.
5. The term of office of the biomedical research expert group of the Lithuanian Bioethics Committee is 4 years. Same
a person may be a member of the biomedical research expedition group of the Lithuanian Bioethics Committee for no more than two
consecutive terms.
6. The term of office of a member of the Biomedical Research Expert Group of the Lithuanian Bioethics Committee shall expire when:
his term of office ends, he resigns, he is revoked by the health minisoas of his
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on the proposal of the association or institution that has submitted the candidature or he / she can no longer pursue Lithuanian bioethics
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,
if the term of office of the biomedical research expert group of the Lithuanian Bioethics Committee has not expired, until it
A new candidate for a member of the Biomedical Research Expert Group of the Lithuanian Bioethics Committee is proposed by the end of
a new member of this group shall be approved in accordance with the procedure established by this Law.
Article 22. Establishment and competence of regional ethics committees for biomedical research
1. Regional biomedical research ethics committees shall be established at the university where the conduct is conducted
three-stage medical studies. Funds are provided for the activities of the Ethics Committee for Regional Biomedical Research
from the state budget appropriations allocated to the Ministry of Health.
2. Regional biomedicininip research ethics set up, activities, jp competence issues
The procedure is governed by the provisions of the Regional Biomedical Research Ethics Committee, which, in agreement with the
Minister of Health, approves the rector of the university. Regional Biomedical Research Ethics Committee
the territorial boundaries of the activity are determined by the Minister of Health.
3. Regional biomedical research ethics committees shall be established for regional biomedical
an ethics committee of 9 members in accordance with the procedure laid down in the regulations:
1) two specialists in the field of biomedical sciences with a scientific degree and two with a scientific degree
Specialists in the field of social sciences or humanities are appointed by a university with a regional association
Biomedical Research Ethics Committee;
2) three health professionals from a health care institution operating in the region and one
a specialist in the field of social sciences or humanities is appointed by the Ministry of Health;
3) one member is appointed by patient organizations.
4. Regional biomedicininip research ethics committee staff composition, in coordination with health care
Minister, approved by the Rector of the University. The term of office of a member of the Regional Biomedical Research Ethics Committee
4 years. A member of the Regional Biomedical Research Ethics Committee may serve a maximum of two terms from
queues.
5. Regional Biomedical Research Ethics Committee:
1) issue authorizations for the performance of biomedical research, except for clinical trials of a medicinal product,
when biomedical research is planned to be performed in research centers located only in the relevant regional
biomedicininip research in the area assigned to the ethylcos committee veilil;
23
2) submit conclusions to the Lithuanian Bioethics Committee when biomedical research is planned to be performed in research centers,
located in the territory assigned to more than one regional biomedical research ethics committee;
3) submit to the Commander of the Lithuanian Bioethics Committee when clinical trials of a medicinal product are planned
in the territory assigned to the activity;
4) performs biomedical research for which it has been authorized and a clinical trial of the medicinal product,
who perform the findings, ethical oversight;
5) keep records of the issued permits;
6) submit activity reports to the Lithuanian Bioethics Committee in accordance with the procedure established by it.
Article 23. Acceptance of documents, their consideration and issuance of permits
1. The sponsor of a biomedical study, his authorized representative or the principal investigator in order to obtain
biomedical research, the Lithuanian Bioethics Committee or the regional biomedical research ethics committee
submit documents, the list of which shall be approved by the Minister of Health. The documents must be examined
and a biomedical research permit has been issued or refused with a reasoned submission no later than 45
calendar days from the date of receipt of all duly completed documents. The documents must be examined and the permit issued
to carry out a biomedical examination with a medical device issued or refused on the basis of a reasoned
as within 60 calendar days from the date of receipt of all duly executed documents.
2. The procedure for the issue of a permit to perform a biomedical examination shall be established by the Minister of Health.
3. The Lithuanian Bioethics Committee or the Regional Biomedical Research Ethics Committee shall make a decision
not to authorize a biomedical research if it is established from the submitted documents that the biomedical
the research contradicts the ethical requirements for biomedical research set out in Chapter II of this Law,
not all and / or incorrect documents and / or information have been provided and the requirement to correct
shortcomings and the decision not to authorize a biomedical research with a medical device
in the case of the State Accreditation Service for Health Care Activities under the Health Protection
the ministries submit a conclusion that the medical device does not comply with the established by the Minister of Health
requirements for non-medical devices for clinical trials.
4. For documents submitted for authorization of biomedical research, examination and authorization
a fixed state fee is paid for the issuance.
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Article 24. Suspension, revocation of suspension of biomedical research authorization and
withdrawal of authorization to conduct a biomedical research
1. The authorization of a biomedical research shall be suspended in the following cases:
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
be significantly infringed on the rights, safety, health and / or biomedical data of the subject.
quality and / or integrity, or information is available on possible such breaches;
2) the client of the biomedical research, its authorized representative or the principal investigator so requests;
3) a requirement for medical devices intended for clinical use approved by the Minister of Health has been established
investigations, infringements which may significantly prejudice the rights, safety, health and / or
the quality and / or integrity of biomedical research data.
2. Where a decision has been taken to suspend the authorization of a biomedical research in accordance with paragraph 1
On the basis of Item 1, no later than within 3 calendar days from the date of the decision in writing
the client of the biomedical research, the principal investigator, the head of the research center shall be informed and indicated
deadline for rectifying the specified irregularities. This period may not exceed 30 calendar days
Except for objective reasons, a longer period is required to remedy the irregularities, or
when the authorization for a biomedical study is suspended by the sponsor of the biomedical study or the principal
at the request of the investigator for reasons other than violations. Client of biomedical research, principal
the researcher and the head of the research center must ensure that the biomedical research is stopped immediately.
3. The decision to lift the suspension shall be taken in the absence of an infringement or infringements
and when the authorization for a biomedical study is suspended by the sponsor of the biomedical study,
at the request of his / her authorized representative or principal investigator, for reasons other than
the sponsor, his authorized representative or the principal investigator shall submit a request for annulment of the decision
suspend the authorization to carry out a biomedical examination.
4. The authorization for a biomedical research shall be revoked in the following cases:
1) a violation of the ethical requirements of biomedical research set forth in Chapter II of this Law, which may
significantly harm the rights, safety, health and / or quality of biomedical research data
and integrity and which cannot be eliminated by suspending biomedical research;
25
2) violations of the ethical requirements for biomedical research established in Chapter II of this Law have been identified, which
may significantly harm the subject’s rights, safety, health and / or biomedical research
the quality and integrity of the data which led to the suspension of the biomedical research authorization and which
the deadline has not been eliminated;
3) when requested by the client of the biomedical research, his / her authorized representative or the principal
tyrants;
4) when the sponsor of the biomedical research, his authorized representative or the principal investigator through
two years after the decision to suspend the authorization of a biomedical research in accordance with paragraph 1 2
does not submit a request for revocation of the suspension of the permit on the basis of the point of acceptance;
5) to establish requirements approved by the Minister of Health for medical devices intended for clinical use
investigations, infringements which may significantly harm the rights, safety, health and / or
the quality and / or integrity of biomedical research data and which cannot be eliminated by suspending biomedical
study or for which the authorization for a biomedical study has been suspended and which have not been
remove.
5. Following a decision to withdraw the authorization of a biomedical research, no later than 3 calendar days
days from the day of making the decision, the client of the biomedical research shall be informed thereof in writing
} an authorized representative or principal investigator, the head of the research center, who must ensure that
the biomedical study was terminated immediately.
6. Powers to suspend a biomedical research authorization, to revoke an authorization
suspension, the authorization of the biomedical research shall be revoked by the authority which transferred the authorization
betrayed.
Article 25 Complaints procedure
1. The decision of the Regional Ethics Committee for Biomedical Research to refuse to authorize biomedical research
revocation or suspension of the authorization by the sponsor of the biomedical study, his authorized representative or
the principal investigator shall have the right to appeal within 15 calendar days of receiving such a decision
Lithuanian Bioethics Committee. The Lithuanian Bioethics Committee must examine this complaint and make a decision through
30 calendar days from the date of its receipt.
2. The lodging of an appeal shall not suspend the decision to revoke or suspend the authorization of the biomedical research
validity of enforcement.
3. After examining a complaint from a biomedical research client, his authorized representative or the principal investigator concerning a regional
decision of the Committee for Biomedical Research to refuse to issue
26
authorization for biomedical research, revocation or suspension of authorization for biomedical research,
The Lithuanian Bioethics Committee makes a decision:
1) reject the complaint of the sponsor of the biomedical research, his authorized representative or the principal investigator and
the decision of the Biomedical Research Ethics Committee to remain unchanged, or
2) to satisfy and issue a complaint of the client of the biomedical research, his authorized representative or the main intention
authorization to conduct a biomedical research or to take a decision to revoke or suspend an authorization
to carry out the revocation of the validity of a biomedical study.
4. The decision adopted by the Lithuanian Bioethics Committee no later than within 5 working days from the day of its adoption
sent to the complainant and to the regional biomedical
investigation to the ethics committee.
5. The decision of the Lithuanian Bioethics Committee to refuse to issue a permit to perform a biomedical research, to revoke or
to suspend the authorization of the biomedical research, as well as the decision of the Lletuva Bioethics Committee to reject
the complaint of the sponsor of the biomedical research, his authorized representative or the principal investigator and the regional biomedical research
the decision of the ethics committee to leave the sponsor of the biomedical research, its authorized representative or
the principal investigator shall exercise the right to appeal to a court in accordance with the procedure established by law.
6. Subjects or, in cases established by this Law, others with the right to consent to participate in the investigation
the right to appeal against the biomedical research client, his authorized representative, the principal investigator
and the activities of persons performing biomedical research to the licensing authority, the court tstatymp and
another legal act in accordance with the established procedure.
7. Persons whose biological sample and / or health information is processed in the biobank have the right to appeal against the biobank.
actions in accordance with the procedure established by law and other legal acts.
CHAPTER V
FINAL PROVISIONS
Article 26. Liability for breaches of ethical requirements in biomedical research
1. Persons who have violated the requirements of this Law shall be liable in accordance with the procedure established by law.
2. Carrying out a biomedical test without authorization or in breach of this statute and other legislation
requirement9, without causing pecuniary or non-pecuniary damage to the health of the subject, shall be
for the performance of professional duties.
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Annex to the Law on Ethics of Biomedical Research of the Republic of Lithuania
{IMPLEMENTING EUROPEAN UNION LEGISLATION
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
and amend legislation relating to the implementation of good clinical practice in the field of medicinal products for human use.
clinical trials (OJ 2004 in. special order, Chapter 13, Volume 26, p. 299). "
Article 2. Entry into force, implementation and application of the law
1. This Law, with the exception of paragraph 2 of this Article, shall enter into force on 1 January 2016. January 1
2. The Government of the Republic of Lithuania or an institution authorized by it, the Ministry of Health of the Republic of Lithuania
Minister and Minister of Social Security and Labor of the Republic of Lithuania until 2015 rrr. December 31 accepts this
implementing legislation.
3. Documents submitted before the entry into force of this Law for the authorization of a biomedical research or for
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
studies (hereinafter referred to as ‘authorization’) and biomedical studies
issued before the entry into force of this Law shall be carried out in accordance with the biomedical research of the Republic of Lithuania.
provisions of the Code of Ethics in force until now
{entry into force of the Act, except as provided in paragraphs 4 and 5 of this Article.
4. Documents concerning the issue of a permit, submitted and not examined before the entry into force of this Law,
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.
biomedical research ethics.
5. This Law shall apply to biomedical research authorized before the entry into force of this Law.
shall apply 3 years after the date of entry into force of this Law. This law is referred to in this paragraph
biomedical research may be tailcomas before the deadline specified in this paragraph, if Lithuanian
Issuance of a permit for biomedical research approved by the Minister of Health of the Republic
description of the procedure or the Certificate of Authorization and Authorization to conduct a clinical trial of the medicinal product
description of the procedure for the issuance, conduct and control of clinical trials of the medicinal product
Amendments to the documents related to the respective investigation were made in accordance with Article 1 of this Law
the provisions of the Law on the Ethics of Biomedical Research of the Republic of Lithuania.
28
6. If a legal person holding personal health care issued before the entry into force of this Law
license, the biomedical research of the Republic of Lithuania set out in Article 1 of this Law in accordance with the
the right to engage in the activities of the biobank in accordance with the established procedure, his / her personal health care license shall be supplemented by
new licensed activities.
7. A legal person who has personal health care issued before the entry into force of this Law
license and established a biobank before the date of entry into force of this Law, without suspending the
calendar days from the date of entry into force of this Law, the obligation set out in Article 1 of this Law
To acquire the right to engage in a biobank in accordance with the procedure established by the Law on Ethics of Biomedical Research of the Republic of Lithuania
activities. In this case, the legal person's health care license is supplemented by writing a new licensee
activities.
8. The biobank referred to in paragraph 7 must, within 90 calendar days of the entry into force of this Law, receive
the person whose biological material samples and / or health information have been processed in the biobanlce until
the entry into force of this Law, consent to participate in the activities of the biobank. If the person's consent to participate in the activities of the biobank
not obtained, the biological sample and health information of that person 90 calendar days after the
effective date in the biobank cannot be processed.
9. The biobank referred to in paragraph 7 of this Article shall, within 90 calendar days from the date of entry into force of this Law:
must keep records of the human biological sample processed before the entry into force of this Act and
to submit to the Lithuanian Bioethics Committee and to make this law public
Law on the Ethics of Biomedical Research of the Republic of Lithuania set out in Article 1 19
in accordance with the procedure laid down in Article
I promulgate this law adopted by the Seimas of the Republic of Lithuania.
President of the Republic Dalia
Grybauskaitê