79C3C34C52B45572883A05D425EB0F82
V-28, Decree on the Detailed Requirements for the Content of a Person’s Consent to Participate in Biomedical Research and for the Information about the Biomedical Research as well as a Procedure for Giving and Withdrawing the Consent (2016)
https://leaux.net/URLS/General/Lithuania_V-28_Decree_on_the_Detailed_Requirements_for_the_Content_of_a_Persons_Consent_to_Participate_in_Biomedical_Research_and_for_the_Information_about_the_Biomedical_Research_as_well_as_a_Procedure_for_Giving_and_Withdrawing_the_Co_eg1Gugh.pdf
http://leaux.net/URLS/ConvertAPI Text Files/A3A547969FAA9E09323BDD0A45F8ED43.en.txt
Examining the file media/Synopses/A3A547969FAA9E09323BDD0A45F8ED43.html:
This file was generated: 2020-12-01 07:03:37
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Indigenous
Searching for indicator native:
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p.000004: CHAPTER IV CONSENT PROCEDURE
p.000004: 9. Before giving consent to a person or other person entitled to consent, the investigator or other person
p.000004: an authorized biomedical researcher in accordance with the requirements set out in Chapter II of the Description,
p.000004: provides him with information on biomedical research.
p.000004: 10. The investigator or another person performing biomedical research authorized by him shall ensure that the person or other person
p.000004: the person entitled to give consent would be given sufficient time to decide on his / her participation in the biomedical system
p.000004: in the study, taking into account the nature of the biomedical study as well as other circumstances that may have an impact
p.000004: decision-making (eg uncertainty, doubt, lack of experience, cultural, linguistic aspects, etc.).
p.000004: 11. The investigator or any other person authorized by the biomedical researcher who has provided the information shall encourage the person or other person
p.000004: consent to give the person to ask questions.
p.000004: 12. If consent is requested from a person or another person with the right to consent who does not understand
p.000004: Lithuanian, he must be provided with a form of consent to participate in the biomedical research in his native or other form
p.000004: in understandable language.
p.000004: 13. If a person agrees to participate in an investigation or another person entitled to give consent consents to the person's participation
p.000004: in the investigation, he shall sign the Informed Person Consent Form, indicating the name, date and time.
p.000004: 14. The informed consent form for participation in a biomedical study must also be signed by the name, date and
p.000004: the researcher or another person performing biomedical research authorized by him or her.
p.000005: 5
p.000005: 15. The informed consent form shall be drawn up in duplicate, one of which shall be served on the investigation
p.000005: to the person involved or to another person entitled to give consent, and the other shall be kept at the research center.
p.000005: 16. The information referred to in item 3 of the description shall be discussed with the person or other person entitled to give consent
p.000005: person orally and in writing with the informed consent of the person to participate in the biomedical study
p.000005: form.
p.000005: CHAPTER V PROCEDURE FOR WITHDRAWAL OF CONSENT
p.000005: 17. A person or other person entitled to give consent to withdraw consent to participate
...
Social / Access to Social Goods
Searching for indicator access:
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p.000002: 3.5. The expected benefits of biomedical research for the subject, explaining whether and how biomedical
p.000002: the study may be beneficial to the subject.
p.000002: 3.6. Potential risks and inconveniences to the subject from the biomedical examination:
p.000002: 3.6.1. possible undesirable effects of the procedures specified in section 3.4.1 of the Description or of the investigational medicinal product
p.000002: reactions and / or phenomena, discomfort or pain;
p.000002: 3.6.2. inconveniences that participation in biomedical research may cause, such as time costs, normal
p.000002: changes in the rhythm of life, psychological discomfort, etc .;
p.000002: 3.6.3. the risk of processing health information (for example, due to unforeseen circumstances
p.000002: confidential information may become available to third parties to whom the person has not given his or her consent).
p.000002: 3.7. Procedure for compensation for possible damage caused by biomedical research:
p.000002: 3.7.1. compulsory civil liability insurance for the principal investigator and the sponsor of the biomedical research
p.000002: or a personal health care facility which itself or its employee is undergoing a biomedical examination in which
p.000002: interventional biomedical research methods applied to the participant pose only a minor adverse event
p.000002: temporary effects on his health, the sponsor or his employee is a researcher of such biomedical research, civil
p.000002: liability insurance for patients, covering pecuniary and non-pecuniary damage,
p.000002: remuneration that may arise in the course of such biomedical research;
p.000002: 3.7.2. access to the civil liability insurance contract referred to in point 3.7.1 of the Description, and
p.000002: where to turn in case of injury.
p.000002: 3.8. Subject rights:
p.000002: 3.8.1. the right of a person to refuse to participate in a biomedical research and the consequences and right of such refusal
p.000002: withdraw the written consent to participate in the investigation at any time without giving reasons and reasons;
p.000002: 3.8.2. the right of a person to receive routine health care if the person refuses to participate in biomedical care
p.000002: study or withdraw consent to participate in a biomedical study;
p.000002: 3.8.3. the procedure for the withdrawal of consent to participate in a biomedical study, including information that the biomedical research
p.000002: research results, i. y. in the biomedical research documents before agreeing to participate in the biomedical research
p.000002: data recorded in the cancellation are not deleted;
p.000002: 3.8.4. persons who have the right to withdraw their consent if the subject is declared incapacitated, if his
p.000002: he cannot, because of his state of health, be regarded as capable of reasonably assessing his own interests and the fact that he will
p.000002: is taken into account when the incapacitated person is incapacitated, has incapacity or is unable to do so due to a medical condition
...
p.000003: confidential and may be provided only by the Law of the Republic of Lithuania on Patients' Rights and Compensation for Damage to Health
p.000003: and in accordance with the procedure established by the Law on the Legal Protection of Personal Data of the Republic of Lithuania;
p.000003: 3.9.2. the fact that the health information obtained from the biomedical research is not considered confidential
p.000003: and may be published without the consent of the subject if such publication would not make it possible to do so
p.000003: directly or indirectly identify a person;
p.000003: 3.9.3. the name, legal entity code and registered office of the controller (this information must be provided
p.000003: where the sponsor of the biomedical research and the controller are not the same legal entity, such as
p.000003: in the case of a controller which is the healthcare institution where the investigation takes place);
p.000003: 3.9.4. the specific measures to be taken by the sponsor of the biomedical research, the representative of the sponsor of the biomedical research, and
p.000003: persons carrying out biomedical research in order to preserve the number of persons participating in biomedical research,
p.000003: confidentiality;
p.000003: 3.9.5. where the personal data will come from, i. y. only from the subject himself, from health care
p.000003: his medical records or other sources in the institution (s) (specifying them);
p.000003: 3.9.6. what data about the person will be collected (finite from the person himself and the medical documents collected
p.000003: data list);
p.000003: 3.9.7. who and for what purpose will have access to the data allowing direct identification of the subject
p.000003: (unencrypted data) (eg persons authorized by the customer, control authorities,
p.000003: researchers participating in the study) and to whom and for what purpose only data that do not directly
p.000003: to determine the identity of the subject (coded data). If the data will be provided not only biomedical
p.000003: to the sponsor (or his representative) but also to other recipients in other parts of the European Union
p.000003: Member States, European Economic Area countries and third countries, a person or other consent
p.000003: the person entitled to grant information must be informed of the groups of recipients of the data (for example,
p.000003: laboratories) and access to the data subject’s name (name and registered office address),
p.000003: indicating that he should contact the researcher for this;
p.000003: 3.9.8. how long will the personal data of the subjects collected during the biomedical research be kept and who will be behind it
p.000003: it is responsible (e.g. researcher, biomedical research center);
p.000003: 3.9.9. the individual's right of access to his or her personal data and the right to have inaccuracies rectified,
p.000003: incomplete, inaccurate personal data;
p.000003: 3.10. Permission of the Lithuanian Bioethics Committee and / or the Regional Ethics Committee for Biomedical Research
p.000003: biomedical research or the approval of the Lithuanian Bioethics Committee to conduct a clinical trial of the medicinal product
p.000003: examination certificate and the State Medicines Control Service under the Health of the Republic of Lithuania
p.000003: permission of the Ministry of Defense to conduct a clinical trial of a medicinal product, State Data Protection
p.000003: the permission of the Inspectorate for the data controller to perform personal data processing actions and these institutions
p.000003: contact information (telephone number, e-mail address, home address).
p.000003: 3.11. Information on how to contact the investigator-in-charge, the research center, the biomedical research client and / or
p.000003: the customer's representative (telephone number, e-mail address, home address).
p.000003: 3.12. Other circumstances that may affect a person’s decision to accept or refuse to participate
p.000003: in biomedical research.
p.000003: CHAPTER III
p.000003: CONTENT REQUIREMENTS
p.000004: 4
p.000004: 4. The informed consent form shall contain the information specified in item 3 of the Description and that
p.000004: the person or other person entitled to give consent:
p.000004: 4.1. understood the information provided to him;
...
Social / Child
Searching for indicator child:
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p.000002: t v i r t i n u Informed person's consent to participate in biomedical research and information
p.000002: the requirements for biomedical research and the informed consent of a person to participate in biomedical research; and
p.000002: a description of the revocation procedure (attached).
p.000002: Minister of Health Rimante
p.000002: Šalaševičiūtė
p.000002: APPROVED
p.000002: Minister of Health of the Republic of Lithuania 2016 January 8 by order no. V-28
p.000002: REQUIREMENTS FOR THE CONSENT OF AN INFORMED PERSON TO PARTICIPATE IN A BIOMEDICAL INVESTIGATION AND INFORMATION ON A BIOMEDICAL INVESTIGATION
p.000002: DESCRIPTION OF THE PROCEDURE FOR GRANTING AND WITHDRAWING THE INFORMED PERSON'S CONSENT TO PARTICIPATE IN A BIOMEDICAL INVESTIGATION
p.000002: CHAPTER I GENERAL PROVISIONS
p.000002: 1. Informed person's consent to participate in a biomedical research and information on the biomedical research
p.000002: requirements and procedures for granting and withdrawing informed consent to participate in biomedical research
p.000002: Description (hereinafter - the Description) establishes detailed ethics of biomedical research of the Republic of Lithuania
p.000002: the information referred to in Article 7 (8) of the Law on the Ethics of Biomedical Research,
p.000002: provided to the person, the child's representatives in accordance with the law and Article 7 (4) and (5) of the Law on Ethics in Biomedical Research
p.000002: (hereinafter referred to as “biomedical research information”) before giving them an informed person
p.000002: consent to participate in a biomedical study (hereinafter - consent), requirements, detailed content of the consent
p.000002: requirements and procedures for granting and withdrawing consent.
p.000002: 2. The terms used in the description comply with the Law on Ethics of Biomedical Research, the person of the Republic of Lithuania
p.000002: the Law on Legal Protection of Data, the Law on Patients' Rights and Compensation for Damage to Health of the Republic of Lithuania, and
p.000002: terms used in other legislation.
p.000002: CHAPTER II
p.000002: INFORMATION REQUIREMENTS FOR BIOMEDICAL RESEARCH
p.000002: 3. Before giving consent, the person or other person entitled to give consent referred to in item 1 of the Description (hereinafter referred to as
p.000002: other person entitled to give consent) must be informed of:
p.000002: 3.1. The purpose of the informed consent form.
p.000002: 3.2. The purpose of biomedical research:
p.000002: 3.2.1. the research goal of biomedical research;
...
p.000002: 3.8. Subject rights:
p.000002: 3.8.1. the right of a person to refuse to participate in a biomedical research and the consequences and right of such refusal
p.000002: withdraw the written consent to participate in the investigation at any time without giving reasons and reasons;
p.000002: 3.8.2. the right of a person to receive routine health care if the person refuses to participate in biomedical care
p.000002: study or withdraw consent to participate in a biomedical study;
p.000002: 3.8.3. the procedure for the withdrawal of consent to participate in a biomedical study, including information that the biomedical research
p.000002: research results, i. y. in the biomedical research documents before agreeing to participate in the biomedical research
p.000002: data recorded in the cancellation are not deleted;
p.000002: 3.8.4. persons who have the right to withdraw their consent if the subject is declared incapacitated, if his
p.000002: he cannot, because of his state of health, be regarded as capable of reasonably assessing his own interests and the fact that he will
p.000002: is taken into account when the incapacitated person is incapacitated, has incapacity or is unable to do so due to a medical condition
p.000002: be considered able to reasonably assess their interests, willingness to withdraw consent;
p.000002: 3.8.5. the right of a child who no longer wishes to participate in a biomedical study to terminate its participation in the study, unless
p.000002: when it is against the best interests of the child;
p.000002: 3.8.6. the right to be informed of possible treatments in the event of a person refusing or withdrawing consent to participate in a study
p.000002: (alternatives to participation in the study);
p.000002: 3.8.7. the right to be reimbursed for the costs and time spent participating in the biomedical research,
p.000002: the person paying the compensation, the procedure and conditions for the calculation and payment of the compensation;
p.000003: 3
p.000003: 3.8.8. the right to object to the continued use of health information obtained for the purpose of biomedical research
p.000003: biomedical research to which he is referred to in Article 7 (6) of the Law on Ethics of Biomedical Research
p.000003: was included without consent in accordance with the established procedure, at the time when the person refuses to continue to participate in the biomedical research.
p.000003: 3.9. Guarantees of confidentiality of health information:
p.000003: 3.9.1. the fact that the health information obtained from the biomedical research enables the identification of the person is
p.000003: confidential and may be provided only by the Law of the Republic of Lithuania on Patients' Rights and Compensation for Damage to Health
p.000003: and in accordance with the procedure established by the Law on the Legal Protection of Personal Data of the Republic of Lithuania;
p.000003: 3.9.2. the fact that the health information obtained from the biomedical research is not considered confidential
p.000003: and may be published without the consent of the subject if such publication would not make it possible to do so
p.000003: directly or indirectly identify a person;
...
p.000005: the consent form shall be provided to the person or the person giving the consent and his or her consent shall be obtained. In the amended
p.000005: Changes must be clearly visible in the informed consent form.
p.000005: 23. If the information on the processing of personal data is changed in the informed consent form, it may be
p.000005: submitted to a person or other person entitled to give consent to obtain their consent only upon receipt of the Person
p.000005: the data inspectorate's permission for the data controller to perform personal data processing actions.
p.000005: 24. If, respectively, the Lithuanian Bioethics Committee issuing a permit to perform a biomedical research or
p.000005: Regional Committee for the Ethics of Biomedical Research and approval of a clinical trial of a medicinal product
p.000005: The Lithuanian Bioethics Committee issuing the study certificate approves the biomedical research during which
p.000005: interventional biomedical research methods are not used, in which cases the information may be provided to the individual
p.000005: in writing or by distance communication using the informed consent form. In this case, Describe 9-11 and
p.000005: Points 16 do not apply.
p.000005: 25. When the consent of a child to participate in a biomedical research is given by the child's legal representatives, as well as
p.000005: the description of the procedure for the child's participation in biomedical research approved by the Republic of Lithuania shall be followed
...
Social / Linguistic Proficiency
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p.000004: an authorized biomedical researcher in accordance with the requirements set out in Chapter II of the Description,
p.000004: provides him with information on biomedical research.
p.000004: 10. The investigator or another person performing biomedical research authorized by him shall ensure that the person or other person
p.000004: the person entitled to give consent would be given sufficient time to decide on his / her participation in the biomedical system
p.000004: in the study, taking into account the nature of the biomedical study as well as other circumstances that may have an impact
p.000004: decision-making (eg uncertainty, doubt, lack of experience, cultural, linguistic aspects, etc.).
p.000004: 11. The investigator or any other person authorized by the biomedical researcher who has provided the information shall encourage the person or other person
p.000004: consent to give the person to ask questions.
p.000004: 12. If consent is requested from a person or another person with the right to consent who does not understand
p.000004: Lithuanian, he must be provided with a form of consent to participate in the biomedical research in his native or other form
p.000004: in understandable language.
p.000004: 13. If a person agrees to participate in an investigation or another person entitled to give consent consents to the person's participation
p.000004: in the investigation, he shall sign the Informed Person Consent Form, indicating the name, date and time.
p.000004: 14. The informed consent form for participation in a biomedical study must also be signed by the name, date and
p.000004: the researcher or another person performing biomedical research authorized by him or her.
p.000005: 5
p.000005: 15. The informed consent form shall be drawn up in duplicate, one of which shall be served on the investigation
p.000005: to the person involved or to another person entitled to give consent, and the other shall be kept at the research center.
p.000005: 16. The information referred to in item 3 of the description shall be discussed with the person or other person entitled to give consent
p.000005: person orally and in writing with the informed consent of the person to participate in the biomedical study
p.000005: form.
p.000005: CHAPTER V PROCEDURE FOR WITHDRAWAL OF CONSENT
p.000005: 17. A person or other person entitled to give consent to withdraw consent to participate
p.000005: biomedical research, submit a written request to withdraw the consent of the researcher or another authorized biomedical
p.000005: the person conducting the investigation.
p.000005: 18. Upon receipt of a person's written request to withdraw consent, the investigator shall immediately terminate the information on
p.000005: the collection of a person and perform other actions related to the termination of a person's participation in a biomedical research,
p.000005: provided for in the biomedical research protocol.
p.000005: 19. If a request to withdraw consent to participate in a biomedical study is sent by post or courier, the investigator or his
p.000005: the authorized person shall acknowledge receipt of the request in writing within 3 working days.
p.000005: CHAPTER VI FINAL PROVISIONS
p.000005: 20. The form of the informed person's consent shall be approved by the issuer of the permit to perform the biomedical research
p.000005: Lithuanian Bioethics Committee or Regional Biomedical Research Ethics Committee and approval to conduct a clinical trial
p.000005: Lithuanian Bioethics Committee issuing a study certificate for a medicinal product.
p.000005: 21. If it is planned to use the Informed Person's consent form in a biomedical research in a language other than Lithuanian,
p.000005: A translation must be submitted to the Lithuanian Bioethics Committee or the Regional Biomedical Research Ethics Committee
p.000005: confirmation of the translator on the compliance of the translation with the Informed Person's Consent Form in Lithuanian.
p.000005: 22. Any changes to the informed consent form shall be consistent with the authorization of the biomedical study
p.000005: the Lithuanian Bioethics Committee or the Regional Biomedical Research Ethics Committee or the approval to perform
p.000005: the Lithuanian Bioethics Committee that issued the certificate for the clinical trial of the medicinal product. Changed Informed Person
p.000005: the consent form shall be provided to the person or the person giving the consent and his or her consent shall be obtained. In the amended
p.000005: Changes must be clearly visible in the informed consent form.
p.000005: 23. If the information on the processing of personal data is changed in the informed consent form, it may be
p.000005: submitted to a person or other person entitled to give consent to obtain their consent only upon receipt of the Person
p.000005: the data inspectorate's permission for the data controller to perform personal data processing actions.
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Searching for indicator linguistic:
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p.000004: the consent form must also include a place to indicate the basis for his representation.
p.000004: 7. The informed consent form shall state the date on which it was drawn up and / or any other identifying mark
p.000004: (version, number, etc.).
p.000004: 8. The form of the informed person's consent must be in Lithuanian, written in a comprehensible manner, without use
p.000004: special medical or other scientific terms, rarely used international words.
p.000004: CHAPTER IV CONSENT PROCEDURE
p.000004: 9. Before giving consent to a person or other person entitled to consent, the investigator or other person
p.000004: an authorized biomedical researcher in accordance with the requirements set out in Chapter II of the Description,
p.000004: provides him with information on biomedical research.
p.000004: 10. The investigator or another person performing biomedical research authorized by him shall ensure that the person or other person
p.000004: the person entitled to give consent would be given sufficient time to decide on his / her participation in the biomedical system
p.000004: in the study, taking into account the nature of the biomedical study as well as other circumstances that may have an impact
p.000004: decision-making (eg uncertainty, doubt, lack of experience, cultural, linguistic aspects, etc.).
p.000004: 11. The investigator or any other person authorized by the biomedical researcher who has provided the information shall encourage the person or other person
p.000004: consent to give the person to ask questions.
p.000004: 12. If consent is requested from a person or another person with the right to consent who does not understand
p.000004: Lithuanian, he must be provided with a form of consent to participate in the biomedical research in his native or other form
p.000004: in understandable language.
p.000004: 13. If a person agrees to participate in an investigation or another person entitled to give consent consents to the person's participation
p.000004: in the investigation, he shall sign the Informed Person Consent Form, indicating the name, date and time.
p.000004: 14. The informed consent form for participation in a biomedical study must also be signed by the name, date and
p.000004: the researcher or another person performing biomedical research authorized by him or her.
p.000005: 5
p.000005: 15. The informed consent form shall be drawn up in duplicate, one of which shall be served on the investigation
p.000005: to the person involved or to another person entitled to give consent, and the other shall be kept at the research center.
...
Social / Property Ownership
Searching for indicator home:
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p.000003: to the sponsor (or his representative) but also to other recipients in other parts of the European Union
p.000003: Member States, European Economic Area countries and third countries, a person or other consent
p.000003: the person entitled to grant information must be informed of the groups of recipients of the data (for example,
p.000003: laboratories) and access to the data subject’s name (name and registered office address),
p.000003: indicating that he should contact the researcher for this;
p.000003: 3.9.8. how long will the personal data of the subjects collected during the biomedical research be kept and who will be behind it
p.000003: it is responsible (e.g. researcher, biomedical research center);
p.000003: 3.9.9. the individual's right of access to his or her personal data and the right to have inaccuracies rectified,
p.000003: incomplete, inaccurate personal data;
p.000003: 3.10. Permission of the Lithuanian Bioethics Committee and / or the Regional Ethics Committee for Biomedical Research
p.000003: biomedical research or the approval of the Lithuanian Bioethics Committee to conduct a clinical trial of the medicinal product
p.000003: examination certificate and the State Medicines Control Service under the Health of the Republic of Lithuania
p.000003: permission of the Ministry of Defense to conduct a clinical trial of a medicinal product, State Data Protection
p.000003: the permission of the Inspectorate for the data controller to perform personal data processing actions and these institutions
p.000003: contact information (telephone number, e-mail address, home address).
p.000003: 3.11. Information on how to contact the investigator-in-charge, the research center, the biomedical research client and / or
p.000003: the customer's representative (telephone number, e-mail address, home address).
p.000003: 3.12. Other circumstances that may affect a person’s decision to accept or refuse to participate
p.000003: in biomedical research.
p.000003: CHAPTER III
p.000003: CONTENT REQUIREMENTS
p.000004: 4
p.000004: 4. The informed consent form shall contain the information specified in item 3 of the Description and that
p.000004: the person or other person entitled to give consent:
p.000004: 4.1. understood the information provided to him;
p.000004: 4.2. he was given the opportunity to ask questions and he received satisfactory answers;
p.000004: 4.3. understood that he or, in the case of consent, another person entitled to give consent, the biomedical
p.000004: a person participating in the investigation for whom he or she consents may withdraw from the investigation at any time
p.000004: without giving reasons;
p.000004: 4.4. understood that in order to withdraw consent to participate in a biomedical study, he must inform the researcher in writing
p.000004: or another person performing biomedical research authorized by him;
p.000004: 4.5. had sufficient time to consider the information provided to him on the biomedical study;
p.000004: 4.6. realized that participation in the study was voluntary;
p.000004: 4.7. confirms that consent is given voluntarily;
p.000004: 4.8. allows the use of personal data to the extent and in the manner specified in the Informed Person's consent form;
...
Social / Youth/Minors
Searching for indicator minor:
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p.000002: the planned duration and frequency of visits to the biomedical research center and other circumstances differ from
p.000002: personal clinical care provided in accordance with normal clinical practice (for example, how many procedures will be performed
p.000002: during the study and how many would be performed if the subject did not participate in the biomedical study).
p.000002: 3.5. The expected benefits of biomedical research for the subject, explaining whether and how biomedical
p.000002: the study may be beneficial to the subject.
p.000002: 3.6. Potential risks and inconveniences to the subject from the biomedical examination:
p.000002: 3.6.1. possible undesirable effects of the procedures specified in section 3.4.1 of the Description or of the investigational medicinal product
p.000002: reactions and / or phenomena, discomfort or pain;
p.000002: 3.6.2. inconveniences that participation in biomedical research may cause, such as time costs, normal
p.000002: changes in the rhythm of life, psychological discomfort, etc .;
p.000002: 3.6.3. the risk of processing health information (for example, due to unforeseen circumstances
p.000002: confidential information may become available to third parties to whom the person has not given his or her consent).
p.000002: 3.7. Procedure for compensation for possible damage caused by biomedical research:
p.000002: 3.7.1. compulsory civil liability insurance for the principal investigator and the sponsor of the biomedical research
p.000002: or a personal health care facility which itself or its employee is undergoing a biomedical examination in which
p.000002: interventional biomedical research methods applied to the participant pose only a minor adverse event
p.000002: temporary effects on his health, the sponsor or his employee is a researcher of such biomedical research, civil
p.000002: liability insurance for patients, covering pecuniary and non-pecuniary damage,
p.000002: remuneration that may arise in the course of such biomedical research;
p.000002: 3.7.2. access to the civil liability insurance contract referred to in point 3.7.1 of the Description, and
p.000002: where to turn in case of injury.
p.000002: 3.8. Subject rights:
p.000002: 3.8.1. the right of a person to refuse to participate in a biomedical research and the consequences and right of such refusal
p.000002: withdraw the written consent to participate in the investigation at any time without giving reasons and reasons;
p.000002: 3.8.2. the right of a person to receive routine health care if the person refuses to participate in biomedical care
p.000002: study or withdraw consent to participate in a biomedical study;
p.000002: 3.8.3. the procedure for the withdrawal of consent to participate in a biomedical study, including information that the biomedical research
p.000002: research results, i. y. in the biomedical research documents before agreeing to participate in the biomedical research
p.000002: data recorded in the cancellation are not deleted;
p.000002: 3.8.4. persons who have the right to withdraw their consent if the subject is declared incapacitated, if his
p.000002: he cannot, because of his state of health, be regarded as capable of reasonably assessing his own interests and the fact that he will
...
General/Other / Incapacitated
Searching for indicator incapacitated:
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p.000002: interventional biomedical research methods applied to the participant pose only a minor adverse event
p.000002: temporary effects on his health, the sponsor or his employee is a researcher of such biomedical research, civil
p.000002: liability insurance for patients, covering pecuniary and non-pecuniary damage,
p.000002: remuneration that may arise in the course of such biomedical research;
p.000002: 3.7.2. access to the civil liability insurance contract referred to in point 3.7.1 of the Description, and
p.000002: where to turn in case of injury.
p.000002: 3.8. Subject rights:
p.000002: 3.8.1. the right of a person to refuse to participate in a biomedical research and the consequences and right of such refusal
p.000002: withdraw the written consent to participate in the investigation at any time without giving reasons and reasons;
p.000002: 3.8.2. the right of a person to receive routine health care if the person refuses to participate in biomedical care
p.000002: study or withdraw consent to participate in a biomedical study;
p.000002: 3.8.3. the procedure for the withdrawal of consent to participate in a biomedical study, including information that the biomedical research
p.000002: research results, i. y. in the biomedical research documents before agreeing to participate in the biomedical research
p.000002: data recorded in the cancellation are not deleted;
p.000002: 3.8.4. persons who have the right to withdraw their consent if the subject is declared incapacitated, if his
p.000002: he cannot, because of his state of health, be regarded as capable of reasonably assessing his own interests and the fact that he will
p.000002: is taken into account when the incapacitated person is incapacitated, has incapacity or is unable to do so due to a medical condition
p.000002: be considered able to reasonably assess their interests, willingness to withdraw consent;
p.000002: 3.8.5. the right of a child who no longer wishes to participate in a biomedical study to terminate its participation in the study, unless
p.000002: when it is against the best interests of the child;
p.000002: 3.8.6. the right to be informed of possible treatments in the event of a person refusing or withdrawing consent to participate in a study
p.000002: (alternatives to participation in the study);
p.000002: 3.8.7. the right to be reimbursed for the costs and time spent participating in the biomedical research,
p.000002: the person paying the compensation, the procedure and conditions for the calculation and payment of the compensation;
p.000003: 3
p.000003: 3.8.8. the right to object to the continued use of health information obtained for the purpose of biomedical research
p.000003: biomedical research to which he is referred to in Article 7 (6) of the Law on Ethics of Biomedical Research
p.000003: was included without consent in accordance with the established procedure, at the time when the person refuses to continue to participate in the biomedical research.
p.000003: 3.9. Guarantees of confidentiality of health information:
p.000003: 3.9.1. the fact that the health information obtained from the biomedical research enables the identification of the person is
...
Searching for indicator incapacity:
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p.000002: where to turn in case of injury.
p.000002: 3.8. Subject rights:
p.000002: 3.8.1. the right of a person to refuse to participate in a biomedical research and the consequences and right of such refusal
p.000002: withdraw the written consent to participate in the investigation at any time without giving reasons and reasons;
p.000002: 3.8.2. the right of a person to receive routine health care if the person refuses to participate in biomedical care
p.000002: study or withdraw consent to participate in a biomedical study;
p.000002: 3.8.3. the procedure for the withdrawal of consent to participate in a biomedical study, including information that the biomedical research
p.000002: research results, i. y. in the biomedical research documents before agreeing to participate in the biomedical research
p.000002: data recorded in the cancellation are not deleted;
p.000002: 3.8.4. persons who have the right to withdraw their consent if the subject is declared incapacitated, if his
p.000002: he cannot, because of his state of health, be regarded as capable of reasonably assessing his own interests and the fact that he will
p.000002: is taken into account when the incapacitated person is incapacitated, has incapacity or is unable to do so due to a medical condition
p.000002: be considered able to reasonably assess their interests, willingness to withdraw consent;
p.000002: 3.8.5. the right of a child who no longer wishes to participate in a biomedical study to terminate its participation in the study, unless
p.000002: when it is against the best interests of the child;
p.000002: 3.8.6. the right to be informed of possible treatments in the event of a person refusing or withdrawing consent to participate in a study
p.000002: (alternatives to participation in the study);
p.000002: 3.8.7. the right to be reimbursed for the costs and time spent participating in the biomedical research,
p.000002: the person paying the compensation, the procedure and conditions for the calculation and payment of the compensation;
p.000003: 3
p.000003: 3.8.8. the right to object to the continued use of health information obtained for the purpose of biomedical research
p.000003: biomedical research to which he is referred to in Article 7 (6) of the Law on Ethics of Biomedical Research
p.000003: was included without consent in accordance with the established procedure, at the time when the person refuses to continue to participate in the biomedical research.
p.000003: 3.9. Guarantees of confidentiality of health information:
p.000003: 3.9.1. the fact that the health information obtained from the biomedical research enables the identification of the person is
p.000003: confidential and may be provided only by the Law of the Republic of Lithuania on Patients' Rights and Compensation for Damage to Health
...
General/Other / participants in a control group
Searching for indicator placebo:
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p.000002: the Law on Legal Protection of Data, the Law on Patients' Rights and Compensation for Damage to Health of the Republic of Lithuania, and
p.000002: terms used in other legislation.
p.000002: CHAPTER II
p.000002: INFORMATION REQUIREMENTS FOR BIOMEDICAL RESEARCH
p.000002: 3. Before giving consent, the person or other person entitled to give consent referred to in item 1 of the Description (hereinafter referred to as
p.000002: other person entitled to give consent) must be informed of:
p.000002: 3.1. The purpose of the informed consent form.
p.000002: 3.2. The purpose of biomedical research:
p.000002: 3.2.1. the research goal of biomedical research;
p.000002: 3.2.2. the scope of the planned biomedical research and the justification for the need for biomedical research, what
p.000002: investigated.
p.000002: 3.3. Biomedical research plan:
p.000002: 3.3.1. which persons are selected to participate in biomedical research;
p.000002: 3.3.2. the identity of the sponsor of the biomedical research and, if any, the representative of the sponsor (if the sponsor or
p.000002: his representative is a natural person) or name (if the customer or his representative is a legal person);
p.000002: 3.3.3. the likelihood of entering different study and / or control groups and the characteristics of participation in these groups (if
p.000002: biomedical research is performed with the participation of different study and / or control groups);
p.000002: 3.3.4. the essence of the use of placebo (non-active substances) (if the biomedical study is performed with placebo);
p.000002: 3.3.5. justification for not providing routine health care (if subjects are no longer covered by the study at the time of participation in the study)
p.000002: conventional treatment);
p.000002: 3.3.6. the circumstances and criteria for exclusion from the investigation;
p.000002: 3.3.7. the duration of the study (how long the biomedical study will take place and how long the subject will need to participate in the study);
p.000002: 2
p.000002: 3.3.8. the number of subjects;
p.000002: 3.3.9. countries where biomedical research is planned.
p.000002: 3.4. Methods used in biomedical research:
p.000002: 3.4.1. methods of information gathering (survey), treatment, diagnosis or other methods used in biomedical research
p.000002: procedures, frequency of visits to the biomedical research center;
p.000002: 3.4.2. an explanation of the application of the procedures specified in Section 3.4.1 of the Description in the biomedical research,
p.000002: the planned duration and frequency of visits to the biomedical research center and other circumstances differ from
p.000002: personal clinical care provided in accordance with normal clinical practice (for example, how many procedures will be performed
p.000002: during the study and how many would be performed if the subject did not participate in the biomedical study).
p.000002: 3.5. The expected benefits of biomedical research for the subject, explaining whether and how biomedical
p.000002: the study may be beneficial to the subject.
p.000002: 3.6. Potential risks and inconveniences to the subject from the biomedical examination:
p.000002: 3.6.1. possible undesirable effects of the procedures specified in section 3.4.1 of the Description or of the investigational medicinal product
p.000002: reactions and / or phenomena, discomfort or pain;
p.000002: 3.6.2. inconveniences that participation in biomedical research may cause, such as time costs, normal
...
Orphaned Trigger Words
p.000002: provided to the person, the child's representatives in accordance with the law and Article 7 (4) and (5) of the Law on Ethics in Biomedical Research
p.000002: (hereinafter referred to as “biomedical research information”) before giving them an informed person
p.000002: consent to participate in a biomedical study (hereinafter - consent), requirements, detailed content of the consent
p.000002: requirements and procedures for granting and withdrawing consent.
p.000002: 2. The terms used in the description comply with the Law on Ethics of Biomedical Research, the person of the Republic of Lithuania
p.000002: the Law on Legal Protection of Data, the Law on Patients' Rights and Compensation for Damage to Health of the Republic of Lithuania, and
p.000002: terms used in other legislation.
p.000002: CHAPTER II
p.000002: INFORMATION REQUIREMENTS FOR BIOMEDICAL RESEARCH
p.000002: 3. Before giving consent, the person or other person entitled to give consent referred to in item 1 of the Description (hereinafter referred to as
p.000002: other person entitled to give consent) must be informed of:
p.000002: 3.1. The purpose of the informed consent form.
p.000002: 3.2. The purpose of biomedical research:
p.000002: 3.2.1. the research goal of biomedical research;
p.000002: 3.2.2. the scope of the planned biomedical research and the justification for the need for biomedical research, what
p.000002: investigated.
p.000002: 3.3. Biomedical research plan:
p.000002: 3.3.1. which persons are selected to participate in biomedical research;
p.000002: 3.3.2. the identity of the sponsor of the biomedical research and, if any, the representative of the sponsor (if the sponsor or
p.000002: his representative is a natural person) or name (if the customer or his representative is a legal person);
p.000002: 3.3.3. the likelihood of entering different study and / or control groups and the characteristics of participation in these groups (if
p.000002: biomedical research is performed with the participation of different study and / or control groups);
p.000002: 3.3.4. the essence of the use of placebo (non-active substances) (if the biomedical study is performed with placebo);
p.000002: 3.3.5. justification for not providing routine health care (if subjects are no longer covered by the study at the time of participation in the study)
p.000002: conventional treatment);
p.000002: 3.3.6. the circumstances and criteria for exclusion from the investigation;
p.000002: 3.3.7. the duration of the study (how long the biomedical study will take place and how long the subject will need to participate in the study);
p.000002: 2
p.000002: 3.3.8. the number of subjects;
p.000002: 3.3.9. countries where biomedical research is planned.
p.000002: 3.4. Methods used in biomedical research:
p.000002: 3.4.1. methods of information gathering (survey), treatment, diagnosis or other methods used in biomedical research
p.000002: procedures, frequency of visits to the biomedical research center;
p.000002: 3.4.2. an explanation of the application of the procedures specified in Section 3.4.1 of the Description in the biomedical research,
p.000002: the planned duration and frequency of visits to the biomedical research center and other circumstances differ from
p.000002: personal clinical care provided in accordance with normal clinical practice (for example, how many procedures will be performed
p.000002: during the study and how many would be performed if the subject did not participate in the biomedical study).
p.000002: 3.5. The expected benefits of biomedical research for the subject, explaining whether and how biomedical
p.000002: the study may be beneficial to the subject.
p.000002: 3.6. Potential risks and inconveniences to the subject from the biomedical examination:
p.000002: 3.6.1. possible undesirable effects of the procedures specified in section 3.4.1 of the Description or of the investigational medicinal product
p.000002: reactions and / or phenomena, discomfort or pain;
p.000002: 3.6.2. inconveniences that participation in biomedical research may cause, such as time costs, normal
p.000002: changes in the rhythm of life, psychological discomfort, etc .;
p.000002: 3.6.3. the risk of processing health information (for example, due to unforeseen circumstances
p.000002: confidential information may become available to third parties to whom the person has not given his or her consent).
p.000002: 3.7. Procedure for compensation for possible damage caused by biomedical research:
p.000002: 3.7.1. compulsory civil liability insurance for the principal investigator and the sponsor of the biomedical research
p.000002: or a personal health care facility which itself or its employee is undergoing a biomedical examination in which
p.000002: interventional biomedical research methods applied to the participant pose only a minor adverse event
p.000002: temporary effects on his health, the sponsor or his employee is a researcher of such biomedical research, civil
p.000002: liability insurance for patients, covering pecuniary and non-pecuniary damage,
p.000002: remuneration that may arise in the course of such biomedical research;
p.000002: 3.7.2. access to the civil liability insurance contract referred to in point 3.7.1 of the Description, and
p.000002: where to turn in case of injury.
p.000002: 3.8. Subject rights:
p.000002: 3.8.1. the right of a person to refuse to participate in a biomedical research and the consequences and right of such refusal
p.000002: withdraw the written consent to participate in the investigation at any time without giving reasons and reasons;
p.000002: 3.8.2. the right of a person to receive routine health care if the person refuses to participate in biomedical care
p.000002: study or withdraw consent to participate in a biomedical study;
p.000002: 3.8.3. the procedure for the withdrawal of consent to participate in a biomedical study, including information that the biomedical research
p.000002: research results, i. y. in the biomedical research documents before agreeing to participate in the biomedical research
p.000002: data recorded in the cancellation are not deleted;
p.000002: 3.8.4. persons who have the right to withdraw their consent if the subject is declared incapacitated, if his
p.000002: he cannot, because of his state of health, be regarded as capable of reasonably assessing his own interests and the fact that he will
p.000002: is taken into account when the incapacitated person is incapacitated, has incapacity or is unable to do so due to a medical condition
p.000002: be considered able to reasonably assess their interests, willingness to withdraw consent;
p.000002: 3.8.5. the right of a child who no longer wishes to participate in a biomedical study to terminate its participation in the study, unless
p.000002: when it is against the best interests of the child;
p.000002: 3.8.6. the right to be informed of possible treatments in the event of a person refusing or withdrawing consent to participate in a study
p.000002: (alternatives to participation in the study);
p.000002: 3.8.7. the right to be reimbursed for the costs and time spent participating in the biomedical research,
p.000002: the person paying the compensation, the procedure and conditions for the calculation and payment of the compensation;
p.000003: 3
p.000003: 3.8.8. the right to object to the continued use of health information obtained for the purpose of biomedical research
p.000003: biomedical research to which he is referred to in Article 7 (6) of the Law on Ethics of Biomedical Research
p.000003: was included without consent in accordance with the established procedure, at the time when the person refuses to continue to participate in the biomedical research.
p.000003: 3.9. Guarantees of confidentiality of health information:
p.000003: 3.9.1. the fact that the health information obtained from the biomedical research enables the identification of the person is
p.000003: confidential and may be provided only by the Law of the Republic of Lithuania on Patients' Rights and Compensation for Damage to Health
p.000003: and in accordance with the procedure established by the Law on the Legal Protection of Personal Data of the Republic of Lithuania;
p.000003: 3.9.2. the fact that the health information obtained from the biomedical research is not considered confidential
p.000003: and may be published without the consent of the subject if such publication would not make it possible to do so
p.000003: directly or indirectly identify a person;
p.000003: 3.9.3. the name, legal entity code and registered office of the controller (this information must be provided
p.000003: where the sponsor of the biomedical research and the controller are not the same legal entity, such as
p.000003: in the case of a controller which is the healthcare institution where the investigation takes place);
p.000003: 3.9.4. the specific measures to be taken by the sponsor of the biomedical research, the representative of the sponsor of the biomedical research, and
p.000003: persons carrying out biomedical research in order to preserve the number of persons participating in biomedical research,
p.000003: confidentiality;
p.000003: 3.9.5. where the personal data will come from, i. y. only from the subject himself, from health care
p.000003: his medical records or other sources in the institution (s) (specifying them);
p.000003: 3.9.6. what data about the person will be collected (finite from the person himself and the medical documents collected
p.000003: data list);
p.000003: 3.9.7. who and for what purpose will have access to the data allowing direct identification of the subject
p.000003: (unencrypted data) (eg persons authorized by the customer, control authorities,
p.000003: researchers participating in the study) and to whom and for what purpose only data that do not directly
p.000003: to determine the identity of the subject (coded data). If the data will be provided not only biomedical
p.000003: to the sponsor (or his representative) but also to other recipients in other parts of the European Union
p.000003: Member States, European Economic Area countries and third countries, a person or other consent
p.000003: the person entitled to grant information must be informed of the groups of recipients of the data (for example,
p.000003: laboratories) and access to the data subject’s name (name and registered office address),
p.000003: indicating that he should contact the researcher for this;
p.000003: 3.9.8. how long will the personal data of the subjects collected during the biomedical research be kept and who will be behind it
p.000003: it is responsible (e.g. researcher, biomedical research center);
p.000003: 3.9.9. the individual's right of access to his or her personal data and the right to have inaccuracies rectified,
p.000003: incomplete, inaccurate personal data;
p.000003: 3.10. Permission of the Lithuanian Bioethics Committee and / or the Regional Ethics Committee for Biomedical Research
p.000003: biomedical research or the approval of the Lithuanian Bioethics Committee to conduct a clinical trial of the medicinal product
p.000003: examination certificate and the State Medicines Control Service under the Health of the Republic of Lithuania
p.000003: permission of the Ministry of Defense to conduct a clinical trial of a medicinal product, State Data Protection
p.000003: the permission of the Inspectorate for the data controller to perform personal data processing actions and these institutions
p.000003: contact information (telephone number, e-mail address, home address).
p.000003: 3.11. Information on how to contact the investigator-in-charge, the research center, the biomedical research client and / or
p.000003: the customer's representative (telephone number, e-mail address, home address).
p.000003: 3.12. Other circumstances that may affect a person’s decision to accept or refuse to participate
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| child | Child |
| home | Property Ownership |
| incapacitated | Incapacitated |
| incapacity | Incapacitated |
| language | Linguistic Proficiency |
| linguistic | Linguistic Proficiency |
| minor | Youth/Minors |
| native | Indigenous |
| placebo | participants in a control group |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| incapacitated | ['incapacity'] |
| incapacity | ['incapacitated'] |
| language | ['linguistic'] |
| linguistic | ['language'] |
Trigger Words
consent
cultural
ethics
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input