MINISTER OF HEALTH OF THE REPUBLIC OF LITHUANIA ORDER ON THE CONSENT OF AN INFORMED PERSON TO PARTICIPATE IN A BIOMEDICAL INVESTIGATION AND INFORMATION REQUIREMENTS ON BIOMEDICAL INVESTIGATION AND APPROVAL OF THE DESCRIPTION OF THE PROCEDURE FOR GRANTING AND WITHDRAWING THE CONSENT OF A CONSENT TO PARTICIPATE IN A BIOMEDICAL INVESTIGATION 2016 January 8 No. V-28 Vilnius in part, Pursuant to Article 7 of the Law on Ethics of Biomedical Research of the Republic of Lithuania 10 t v i r t i n u Informed person's consent to participate in biomedical research and information the requirements for biomedical research and the informed consent of a person to participate in biomedical research; and a description of the revocation procedure (attached). Minister of Health Rimante Šalaševičiūtė APPROVED Minister of Health of the Republic of Lithuania 2016 January 8 by order no. V-28 REQUIREMENTS FOR THE CONSENT OF AN INFORMED PERSON TO PARTICIPATE IN A BIOMEDICAL INVESTIGATION AND INFORMATION ON A BIOMEDICAL INVESTIGATION DESCRIPTION OF THE PROCEDURE FOR GRANTING AND WITHDRAWING THE INFORMED PERSON'S CONSENT TO PARTICIPATE IN A BIOMEDICAL INVESTIGATION CHAPTER I GENERAL PROVISIONS 1. Informed person's consent to participate in a biomedical research and information on the biomedical research requirements and procedures for granting and withdrawing informed consent to participate in biomedical research Description (hereinafter - the Description) establishes detailed ethics of biomedical research of the Republic of Lithuania the information referred to in Article 7 (8) of the Law on the Ethics of Biomedical Research, 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 (hereinafter referred to as “biomedical research information”) before giving them an informed person consent to participate in a biomedical study (hereinafter - consent), requirements, detailed content of the consent requirements and procedures for granting and withdrawing consent. 2. The terms used in the description comply with the Law on Ethics of Biomedical Research, the person of the Republic of Lithuania the Law on Legal Protection of Data, the Law on Patients' Rights and Compensation for Damage to Health of the Republic of Lithuania, and terms used in other legislation. CHAPTER II INFORMATION REQUIREMENTS FOR BIOMEDICAL RESEARCH 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 other person entitled to give consent) must be informed of: 3.1. The purpose of the informed consent form. 3.2. The purpose of biomedical research: 3.2.1. the research goal of biomedical research; 3.2.2. the scope of the planned biomedical research and the justification for the need for biomedical research, what investigated. 3.3. Biomedical research plan: 3.3.1. which persons are selected to participate in biomedical research; 3.3.2. the identity of the sponsor of the biomedical research and, if any, the representative of the sponsor (if the sponsor or his representative is a natural person) or name (if the customer or his representative is a legal person); 3.3.3. the likelihood of entering different study and / or control groups and the characteristics of participation in these groups (if biomedical research is performed with the participation of different study and / or control groups); 3.3.4. the essence of the use of placebo (non-active substances) (if the biomedical study is performed with placebo); 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) conventional treatment); 3.3.6. the circumstances and criteria for exclusion from the investigation; 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); 2 3.3.8. the number of subjects; 3.3.9. countries where biomedical research is planned. 3.4. Methods used in biomedical research: 3.4.1. methods of information gathering (survey), treatment, diagnosis or other methods used in biomedical research procedures, frequency of visits to the biomedical research center; 3.4.2. an explanation of the application of the procedures specified in Section 3.4.1 of the Description in the biomedical research, the planned duration and frequency of visits to the biomedical research center and other circumstances differ from personal clinical care provided in accordance with normal clinical practice (for example, how many procedures will be performed during the study and how many would be performed if the subject did not participate in the biomedical study). 3.5. The expected benefits of biomedical research for the subject, explaining whether and how biomedical the study may be beneficial to the subject. 3.6. Potential risks and inconveniences to the subject from the biomedical examination: 3.6.1. possible undesirable effects of the procedures specified in section 3.4.1 of the Description or of the investigational medicinal product reactions and / or phenomena, discomfort or pain; 3.6.2. inconveniences that participation in biomedical research may cause, such as time costs, normal changes in the rhythm of life, psychological discomfort, etc .; 3.6.3. the risk of processing health information (for example, due to unforeseen circumstances confidential information may become available to third parties to whom the person has not given his or her consent). 3.7. Procedure for compensation for possible damage caused by biomedical research: 3.7.1. compulsory civil liability insurance for the principal investigator and the sponsor of the biomedical research or a personal health care facility which itself or its employee is undergoing a biomedical examination in which interventional biomedical research methods applied to the participant pose only a minor adverse event temporary effects on his health, the sponsor or his employee is a researcher of such biomedical research, civil liability insurance for patients, covering pecuniary and non-pecuniary damage, remuneration that may arise in the course of such biomedical research; 3.7.2. access to the civil liability insurance contract referred to in point 3.7.1 of the Description, and where to turn in case of injury. 3.8. Subject rights: 3.8.1. the right of a person to refuse to participate in a biomedical research and the consequences and right of such refusal withdraw the written consent to participate in the investigation at any time without giving reasons and reasons; 3.8.2. the right of a person to receive routine health care if the person refuses to participate in biomedical care study or withdraw consent to participate in a biomedical study; 3.8.3. the procedure for the withdrawal of consent to participate in a biomedical study, including information that the biomedical research research results, i. y. in the biomedical research documents before agreeing to participate in the biomedical research data recorded in the cancellation are not deleted; 3.8.4. persons who have the right to withdraw their consent if the subject is declared incapacitated, if his he cannot, because of his state of health, be regarded as capable of reasonably assessing his own interests and the fact that he will is taken into account when the incapacitated person is incapacitated, has incapacity or is unable to do so due to a medical condition be considered able to reasonably assess their interests, willingness to withdraw consent; 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 when it is against the best interests of the child; 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 (alternatives to participation in the study); 3.8.7. the right to be reimbursed for the costs and time spent participating in the biomedical research, the person paying the compensation, the procedure and conditions for the calculation and payment of the compensation; 3 3.8.8. the right to object to the continued use of health information obtained for the purpose of biomedical research biomedical research to which he is referred to in Article 7 (6) of the Law on Ethics of Biomedical Research 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. 3.9. Guarantees of confidentiality of health information: 3.9.1. the fact that the health information obtained from the biomedical research enables the identification of the person is confidential and may be provided only by the Law of the Republic of Lithuania on Patients' Rights and Compensation for Damage to Health and in accordance with the procedure established by the Law on the Legal Protection of Personal Data of the Republic of Lithuania; 3.9.2. the fact that the health information obtained from the biomedical research is not considered confidential and may be published without the consent of the subject if such publication would not make it possible to do so directly or indirectly identify a person; 3.9.3. the name, legal entity code and registered office of the controller (this information must be provided where the sponsor of the biomedical research and the controller are not the same legal entity, such as in the case of a controller which is the healthcare institution where the investigation takes place); 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 persons carrying out biomedical research in order to preserve the number of persons participating in biomedical research, confidentiality; 3.9.5. where the personal data will come from, i. y. only from the subject himself, from health care his medical records or other sources in the institution (s) (specifying them); 3.9.6. what data about the person will be collected (finite from the person himself and the medical documents collected data list); 3.9.7. who and for what purpose will have access to the data allowing direct identification of the subject (unencrypted data) (eg persons authorized by the customer, control authorities, researchers participating in the study) and to whom and for what purpose only data that do not directly to determine the identity of the subject (coded data). If the data will be provided not only biomedical to the sponsor (or his representative) but also to other recipients in other parts of the European Union Member States, European Economic Area countries and third countries, a person or other consent the person entitled to grant information must be informed of the groups of recipients of the data (for example, laboratories) and access to the data subject’s name (name and registered office address), indicating that he should contact the researcher for this; 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 it is responsible (e.g. researcher, biomedical research center); 3.9.9. the individual's right of access to his or her personal data and the right to have inaccuracies rectified, incomplete, inaccurate personal data; 3.10. Permission of the Lithuanian Bioethics Committee and / or the Regional Ethics Committee for Biomedical Research biomedical research or the approval of the Lithuanian Bioethics Committee to conduct a clinical trial of the medicinal product examination certificate and the State Medicines Control Service under the Health of the Republic of Lithuania permission of the Ministry of Defense to conduct a clinical trial of a medicinal product, State Data Protection the permission of the Inspectorate for the data controller to perform personal data processing actions and these institutions contact information (telephone number, e-mail address, home address). 3.11. Information on how to contact the investigator-in-charge, the research center, the biomedical research client and / or the customer's representative (telephone number, e-mail address, home address). 3.12. Other circumstances that may affect a person’s decision to accept or refuse to participate in biomedical research. CHAPTER III CONTENT REQUIREMENTS 4 4. The informed consent form shall contain the information specified in item 3 of the Description and that the person or other person entitled to give consent: 4.1. understood the information provided to him; 4.2. he was given the opportunity to ask questions and he received satisfactory answers; 4.3. understood that he or, in the case of consent, another person entitled to give consent, the biomedical a person participating in the investigation for whom he or she consents may withdraw from the investigation at any time without giving reasons; 4.4. understood that in order to withdraw consent to participate in a biomedical study, he must inform the researcher in writing or another person performing biomedical research authorized by him; 4.5. had sufficient time to consider the information provided to him on the biomedical study; 4.6. realized that participation in the study was voluntary; 4.7. confirms that consent is given voluntarily; 4.8. allows the use of personal data to the extent and in the manner specified in the Informed Person's consent form; 4.9. acknowledge receipt of a copy of the informed consent form signed by the investigator or another person authorized by him. a person performing a biomedical research. 5. The informed consent form may also contain other information relevant to the investigation. 6. The informed consent form shall specify the location of the person or other person with the consent give the name and signature of the person and the researcher or other person authorized by him / her to perform the biomedical research and the date and time the document was signed. If the consent is given by another person entitled to give consent Informed person the consent form must also include a place to indicate the basis for his representation. 7. The informed consent form shall state the date on which it was drawn up and / or any other identifying mark (version, number, etc.). 8. The form of the informed person's consent must be in Lithuanian, written in a comprehensible manner, without use special medical or other scientific terms, rarely used international words. CHAPTER IV CONSENT PROCEDURE 9. Before giving consent to a person or other person entitled to consent, the investigator or other person an authorized biomedical researcher in accordance with the requirements set out in Chapter II of the Description, provides him with information on biomedical research. 10. The investigator or another person performing biomedical research authorized by him shall ensure that the person or other person the person entitled to give consent would be given sufficient time to decide on his / her participation in the biomedical system in the study, taking into account the nature of the biomedical study as well as other circumstances that may have an impact decision-making (eg uncertainty, doubt, lack of experience, cultural, linguistic aspects, etc.). 11. The investigator or any other person authorized by the biomedical researcher who has provided the information shall encourage the person or other person consent to give the person to ask questions. 12. If consent is requested from a person or another person with the right to consent who does not understand Lithuanian, he must be provided with a form of consent to participate in the biomedical research in his native or other form in understandable language. 13. If a person agrees to participate in an investigation or another person entitled to give consent consents to the person's participation in the investigation, he shall sign the Informed Person Consent Form, indicating the name, date and time. 14. The informed consent form for participation in a biomedical study must also be signed by the name, date and the researcher or another person performing biomedical research authorized by him or her. 5 15. The informed consent form shall be drawn up in duplicate, one of which shall be served on the investigation to the person involved or to another person entitled to give consent, and the other shall be kept at the research center. 16. The information referred to in item 3 of the description shall be discussed with the person or other person entitled to give consent person orally and in writing with the informed consent of the person to participate in the biomedical study form. CHAPTER V PROCEDURE FOR WITHDRAWAL OF CONSENT 17. A person or other person entitled to give consent to withdraw consent to participate biomedical research, submit a written request to withdraw the consent of the researcher or another authorized biomedical the person conducting the investigation. 18. Upon receipt of a person's written request to withdraw consent, the investigator shall immediately terminate the information on the collection of a person and perform other actions related to the termination of a person's participation in a biomedical research, provided for in the biomedical research protocol. 19. If a request to withdraw consent to participate in a biomedical study is sent by post or courier, the investigator or his the authorized person shall acknowledge receipt of the request in writing within 3 working days. CHAPTER VI FINAL PROVISIONS 20. The form of the informed person's consent shall be approved by the issuer of the permit to perform the biomedical research Lithuanian Bioethics Committee or Regional Biomedical Research Ethics Committee and approval to conduct a clinical trial Lithuanian Bioethics Committee issuing a study certificate for a medicinal product. 21. If it is planned to use the Informed Person's consent form in a biomedical research in a language other than Lithuanian, A translation must be submitted to the Lithuanian Bioethics Committee or the Regional Biomedical Research Ethics Committee confirmation of the translator on the compliance of the translation with the Informed Person's Consent Form in Lithuanian. 22. Any changes to the informed consent form shall be consistent with the authorization of the biomedical study the Lithuanian Bioethics Committee or the Regional Biomedical Research Ethics Committee or the approval to perform the Lithuanian Bioethics Committee that issued the certificate for the clinical trial of the medicinal product. Changed Informed Person 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 Changes must be clearly visible in the informed consent form. 23. If the information on the processing of personal data is changed in the informed consent form, it may be submitted to a person or other person entitled to give consent to obtain their consent only upon receipt of the Person the data inspectorate's permission for the data controller to perform personal data processing actions. 24. If, respectively, the Lithuanian Bioethics Committee issuing a permit to perform a biomedical research or Regional Committee for the Ethics of Biomedical Research and approval of a clinical trial of a medicinal product The Lithuanian Bioethics Committee issuing the study certificate approves the biomedical research during which interventional biomedical research methods are not used, in which cases the information may be provided to the individual in writing or by distance communication using the informed consent form. In this case, Describe 9-11 and Points 16 do not apply. 25. When the consent of a child to participate in a biomedical research is given by the child's legal representatives, as well as the description of the procedure for the child's participation in biomedical research approved by the Republic of Lithuania shall be followed by the order of the Minister of Health and the Minister of Social Security and Labor of the Republic of Lithuania.