79C3C34C52B45572883A05D425EB0F82

Guidelines for Patient Information Sheet and Informed Consent Form, Adopted by the Group of Experts on Biomedical Research of the LBEC (2017)

https://leaux.net/URLS/General/Lithuania_Guidelines_for_Patient_Information_Sheet_and_Informed_Consent_Form_adopted_by_the_Group_of_Experts_on_Biomedical_Research_of_the_Lithuanian_Bioethics_Committee_2016.pdf

http://leaux.net/URLS/ConvertAPI Text Files/68DE2066FD3E2BC603BC600F3582460F.en.txt

Examining the file media/Synopses/68DE2066FD3E2BC603BC600F3582460F.html:

This file was generated: 2020-12-01 07:07:34

Indicators in focus are typically shown highlighted in yellow;

Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink;

"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green;

Trigger Words/Phrases are shown highlighted in gray.

Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)

Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability Type	Vulnerability	Indicator	# Matches
Health	Drug Usage	drug	7
Health	Drug Usage	influence	1
Health	Motherhood/Family	family	1
Health	injured	injured	1
Social	Access to Social Goods	access	8
Social	Age	age	1
Social	Child	child	5
Social	Child	children	2
Social	Property Ownership	home	2
Social	Youth/Minors	minor	1
Social	parents	parents	1
General/Other	Incapacitated	incapacitated	2
General/Other	Incapacitated	incapacity	2
General/Other	participants in a control group	placebo	9

Health / Drug Usage

Searching for indicator drug:

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p.(None): 2. Scientific-research goal of biomedical research
p.(None): “It is important to understand that although you will be given medicines during a biomedical / clinical
p.(None): preparations, medical examinations or medical procedures, biomedical research is fundamentally different from
p.(None): normal (daily) clinical practice. The goal of normal (daily) clinical practice is to help you (i.e.
p.(None): specific person, patient) to cure and / or improve your health. Basic biomedical
p.(None): The aim of (scientific) research is to acquire new medical knowledge that will help other people with the disease in the future
p.(None): patient health. In other words, the main goal of this study is not to directly benefit you
p.(None): health. "
p.(None): 3. Scope of the study and justification as to why the biomedical study is required, what will be studied, the purpose of the study
p.(None): “The aim of this study was to evaluate the efficacy and safety of investigational medicinal product X in comparison
p.(None): efficacy and safety with any other medicinal product already authorized and used. At present, doctors
p.(None): prescribes one or more drugs in patients with Y disease, but none of them is effective enough either
p.(None): has side effects. This study will make it possible to determine which of the medicines under study is more effective and safer. ”
p.(None): "Disease X is one of the most common and dangerous diseases in the region. Not available at this time
p.(None): effective treatments for disease X - only 40%. current treatment with Z is effective in patients with
p.(None): Therefore, this study will try to find out whether the new medicine X is more effective (safer).
p.(None): for Z. "
p.(None): 4. Which persons are selected to participate in the biomedical research
p.(None): “We invite you to participate in a clinical trial of the drug because you have X disease and
p.(None): you meet the basic test criteria listed. The main criteria for inclusion in this study are as follows
p.(None): "
p.(None): 5. Name of the customer and, if any, the identity of the customer's representative (if the customer or his representative is a natural person) or
p.(None): name (if the customer or his representative is a legal entity)
p.(None): “The sponsor of this clinical trial is X (company name). It is a drug developer and
p.(None): a for-profit pharmaceutical company conducting clinical trials, which is for researchers and the research-performing medical institution
p.(None): will allocate the necessary funds for this study. "
p.(None): “The client of this biomedical research is X (name of the scientific institution). The funds needed for this study will be allocated
p.(None): Y (name (s) of company (ies), medicines / equipment / substances will be provided free of charge by their manufacturer Z (company
p.(None): Name (s) of the Member State (s). "
p.(None): 6. Likelihood of joining different study and / or control groups and characteristics of participation in these groups (if
p.(None): biomedical study is performed with the participation of different study and / or control groups)
p.(None): "Participants in this study will be divided into two groups by random assignment (like a coin for one year), one
p.(None): will use study drug XXX and another will receive placebo. Placebo looks and prescribes reminiscent
p.(None): study drug but has no therapeutic effect. The random route of administration means that it is not a physician-researcher
p.(None): decides, and the computer program indicates to which group you will be assigned. Each study participant has
p.(None): equal access (50%) to one of the groups. Because sometimes an improvement in health is alleged
p.(None): occurs solely as a result of the medicinal product being used (i.e. the subjective psychological ‘placebo effect’),
p.(None): In drug research, placebo is used to show that the medicine is
p.(None): effective for objective characteristics rather than for subjective psychological reasons. If you go to placebo
p.(None): group, you will not be able to take medicines that are usually given to patients with X disease. Without medication, you can
p.(None): deteriorating your health: ... "
p.(None): “It is also important to understand that neither you nor the medical researcher will know which group you are in. This will only become clear to the study
p.(None): or if your health deteriorates and the cause of this deterioration needs to be clarified
p.(None): (the medical condition was caused by the investigational medicinal product or the absence of standard treatment). "
p.(None): 7. The essence of placebo use (if the biomedical study is performed with placebo)
p.(None): Example See above p. 6
p.(None): 8. Example of denial of routine health care above p. 6
p.(None): justification (if subjects are not (or are not) receiving standard treatment at the time of study participation)
p.(None): See also 14 p.
p.(None): 9. Circumstances and Criteria for Exclusion from the Study “If you do not follow your doctor’s instructions or
p.(None): participation in the study will significantly worsen your health,
p.(None): You will no longer be able to participate in the study
p.(None): “The study doctor or the client has the right to suspend the study or your participation in it at any time. You will not be able to
p.(None): participate in the study if the study product causes adverse reactions and treatment is required that is not
p.(None): use in this study, and if you do not attend scheduled visits as indicated, you will not take the study drug or
p.(None): you will not follow the instructions of other investigators. "
p.(None): 10. Duration of the investigation “The total duration of the investigation is two years.
p.(None): You will participate for two months, i. y. from the first visit, when you sign the informed consent form, you will have
p.(None): visit the doctor's researcher 4 more times, once every two weeks. "
p.(None): 11. Number of subjects “It is expected that in this
p.(None): The biomedical / clinical trial will involve approximately 12,000 people, of whom
p.(None): about 150 people with severe XXX deficiency. "
p.(None): 12. Countries where a biomedical study is planned (the purpose of providing this information is to allow the study participant
p.(None): to get an overview of the study (local or global), so only the countries where it is planned are indicated
p.(None): to conduct an investigation (i.e. not necessarily a complete list of parties in the event of a change of parties in the course of the investigation). If there are a lot of countries
p.(None): it is possible to indicate, for example, the continent and the number of countries)
p.(None): 13. Methods of information gathering (survey), treatment, diagnosis or other procedures used in biomedical research,
p.(None): frequency of visits to a biomedical research center
p.(None): "The study will be conducted in fifteen European countries (including all the Baltic countries) and North America."
p.(None): “We will ask you to allow a small amount of blood (5 ml) to be taken from a vein for the purpose of this test. We will also ask for an answer to
p.(None): several questions in the research questionnaire about your symptoms, daily diet, medications, <...>.
p.(None): The information provided in the questionnaire will be anonymous and will not be used to identify you. "
...

p.(None): 26. The right of a child who no longer wishes to participate in a biomedical study to terminate its participation in the study, unless
p.(None): it is against the best interests of the child (if children are involved in the study)
p.(None): 27. The right to be informed about possible treatments in the event of a person's disagreement or withdrawal of consent
p.(None): “We would like to point out that the results of this study, i. y. in the investigation documents before your consent to participate
p.(None): data recorded in a biomedical study cancellation will not be destroyed because ....
p.(None): (we would recommend clarification). "
p.(None): "If due to the deteriorating health condition you will not be able to decide on further opportunities to participate in the study, at your request
p.(None): revoking consent to take part in the investigation will be taken into account, but this decision will legally be taken by the spouse if he or she is not present -
p.(None): one of the parents, adult children or another legal representative (of you). "
p.(None): "If your child no longer wishes to take part in the study, he or she has the right to withdraw from the study at any time, unless
p.(None): when discontinuation may result in health problems (eg abrupt discontinuation of the study drug or
p.(None): treatment regimen may be harmful to your child’s health). Therefore, we ask you before accepting with the child
p.(None): decision not to participate in the study to consult the investigating physician. "
p.(None): “If you decide not to take part in this study, your doctor will prescribe the usual treatment for the disease, taking into account all those involved
p.(None): circumstances - your age, other illnesses, general health, etc. He may prescribe pharmacies for you
p.(None): to participate in the study (alternatives to participation in the study) of preparations that have already been approved and sold in Lithuania. X
p.(None): Y groups are usually used to treat the disease
p.(None): medicinal products (eg A, E, P, etc.) that are fully reimbursed (not reimbursed) by compulsory health
p.(None): insurance fund. K treatments, special diets, etc. may also be prescribed. The doctor researcher will discuss with you all
p.(None): the benefits and risks of the possible options. "
p.(None): 28. Entitlement to compensation for the costs and time spent participating in a biomedical research,
p.(None): the person paying the compensation, the procedure and conditions for the calculation and payment of the compensation
p.(None): "Participation in biomedical / clinical trials of a medicinal product shall not be remunerated, but
p.(None): is entitled to compensation for costs incurred or time lost. In this study, the customer will reimburse travel,
p.(None): on the day of the meal visit, the cost of purchasing contraceptives. These costs will be reimbursed to the medical researcher
p.(None): on presentation of supporting documents (eg travel tickets, meal or medicine vouchers). "
...

Searching for indicator influence:

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p.(None): tel. (8-37) 326889, el. E-mail: kaunorbtek@lsmuni.lt. "
p.(None): 41. Permission of the State Medicines Control Agency to conduct a clinical trial of a medicinal product and telephone communication
p.(None): number, e-mail postal address, registered office address (if a clinical trial of the medicinal product is performed)
p.(None): 42. the permission of the State Data Protection Inspectorate to the data controller to perform personal data processing actions and
p.(None): telephone connection
p.(None): “Permission to perform this clinical trial of a medicinal product was issued by the State Medicines Control Agency under the Republic of Lithuania
p.(None): Ministry of Health, Žirmūnų str. 139 A, LT-09120 Vilnius, tel. 8,673,13235, el. e-mail: vvkt@vvkt.lt;
p.(None): ArunasVaitkevicius@vvkt.lt. ”
p.(None): “The permit XX (name of the data controller) to perform personal data processing actions was issued by the State Data Protection Agency
p.(None): Inspectorate, A. Juozapavičiaus st. 6, LT-09310 Vilnius, tel. (8-5) 2127535, el. e-mail: ada@ada.lt. "
p.(None): number, e-mail postal address, registered office address
p.(None): 43. Telephone number of the responsible researcher, e-mail postal address, registered office address (if the researcher 's address coincides with the address of the researcher)
p.(None): center - specify one)
p.(None): 44. Telephone number of the research center, e-mail postal address, registered office address
p.(None): 45. Telephone number of the Customer and / or the Customer's representative, e-mail postal address, registered office address
p.(None): 46. Other circumstances that may influence a person's decision to accept or refuse to participate are explained
p.(None): in biomedical research
p.(None): CONTENT OF THE CONSENT. The consent states that: The wording of the text is possible (if it cannot be moved verbatim -
p.(None): must be adapted to the specific study)
p.(None): a) The person understood the information provided to him “I have read this Informed Consent Form and
p.(None): I understood the information provided to me. "
p.(None): (b) He was given the opportunity to ask questions and received satisfactory answers
p.(None): (c) has understood that he or, if the consent is given by another person entitled to give consent
p.(None): a person participating in a biomedical study for whom he consents may withdraw from the study at any time
p.(None): without giving reasons
p.(None): "I was given the opportunity to ask questions and I received satisfactory answers."
p.(None): If the consent to participate in the study is given by the person himself:
p.(None): "I understand that I can withdraw from the investigation at any time without giving any reason."
p.(None): If another person consents to the study:
p.(None): "I understand that a person for whom I give consent to participate in a biomedical research may withdraw from the
p.(None): without giving reasons. "
p.(None): (d) has understood that in order to withdraw his consent to participate in a biomedical research, he must do so in writing
...

Health / Motherhood/Family

Searching for indicator family:

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p.(None): into groups, placebo use, and so on.
p.(None): If questions arise during the preparation of the Informed Consent Form, the Research Ethics Committee may be consulted
p.(None): (Lithuanian Bioethics Committee (tel .: 8-5 2610632, e-mail: lbek@bioetika.sam.lt), Vilnius Regional Biomedical
p.(None): Research Ethics Committee (tel .: 8-5 2686998, e-mail: rbtek@mf.vu.lt) or Kaunas Regional Biomedical Research Ethics Committee
p.(None): Committee (tel .: 8-37 32 68 89, kaunorbtek@lsmuni.lt).
p.(None): Requirement (explanation) Possible wording (if not verbatim -
p.(None): must be adapted to the specific study)
p.(None): 1. Purpose of the informed consent form “This form provides you with information about
p.(None): biomedical / clinical investigation of the medicinal product,
p.(None): discusses the reasons for conducting the study, the research procedures, benefits, risks, possible inconveniences, and other important things
p.(None): information. If you choose to participate, we will ask you to sign this consent form, which you agree to the study
p.(None): follow the instructions of the medical examiner and the study team. By signing this document, you agree
p.(None): participate in research. Take your time and read this document carefully if you do not understand any word or
p.(None): statement, be sure to ask the study physician or other members of the study team any questions you may have. Before
p.(None): you can consult family, friends or your doctor when making a decision. ”
p.(None): 2. Scientific-research goal of biomedical research
p.(None): “It is important to understand that although you will be given medicines during a biomedical / clinical
p.(None): preparations, medical examinations or medical procedures, biomedical research is fundamentally different from
p.(None): normal (daily) clinical practice. The goal of normal (daily) clinical practice is to help you (i.e.
p.(None): specific person, patient) to cure and / or improve your health. Basic biomedical
p.(None): The aim of (scientific) research is to acquire new medical knowledge that will help other people with the disease in the future
p.(None): patient health. In other words, the main goal of this study is not to directly benefit you
p.(None): health. "
p.(None): 3. Scope of the study and justification as to why the biomedical study is required, what will be studied, the purpose of the study
p.(None): “The aim of this study was to evaluate the efficacy and safety of investigational medicinal product X in comparison
p.(None): efficacy and safety with any other medicinal product already authorized and used. At present, doctors
p.(None): prescribes one or more drugs in patients with Y disease, but none of them is effective enough either
p.(None): has side effects. This study will make it possible to determine which of the medicines under study is more effective and safer. ”
p.(None): "Disease X is one of the most common and dangerous diseases in the region. Not available at this time
p.(None): effective treatments for disease X - only 40%. current treatment with Z is effective in patients with
p.(None): Therefore, this study will try to find out whether the new medicine X is more effective (safer).
p.(None): for Z. "
p.(None): 4. Which persons are selected to participate in the biomedical research
...

Health / injured

Searching for indicator injured:

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p.(None): the worker is in a biomedical study in which the person involved is subject to intervention
p.(None): biomedical research methods have only minor adverse temporary effects on his health,
p.(None): the sponsor or its employee is a researcher in such biomedical research,
p.(None): civil
p.(None): "You are entitled to health damage and related non-pecuniary damage incurred in participating in this study,
p.(None): remuneration. "
p.(None): "The health care institution has concluded an insurance contract, which provides for damages that may arise from this
p.(None): during a biomedical research. "
p.(None): “The research client and the principal investigator insure the biomedical research client and the principal investigator in civil
p.(None): compulsory liability insurance. Consequently, you are entitled to health damage and related non-pecuniary damage,
p.(None): incurred in participating in this investigation. "
p.(None): liability insurance for patients, covering pecuniary and non-pecuniary damage,
p.(None): which may arise in the course of such biomedical research)
p.(None): 20. Access to the civil liability insurance contract and where to apply in case of damage
p.(None): "Only non-interventional research methods that do not pose a risk to your health will be used in this biomedical study,
p.(None): therefore, biomedical research is not covered by the civil liability of biomedical research clients and principal investigators
p.(None): insurance. "
p.(None): “You can get acquainted with the insurance rules at the research site by contacting the researcher doctor. If you think during the study
p.(None): If you have been injured, consult your doctor. "
p.(None): 21. The right of a person to refuse to participate in the investigation and the consequences of such refusal and the right to withdraw the written consent to participate
p.(None): in the investigation at any time, without giving reasons and reasons
p.(None): 22. The right of a person to receive routine health care if a person refuses to participate in a biomedical research or
p.(None): withdraw consent to participate in a biomedical study
p.(None): 23. Procedure for withdrawal of consent to participate in a biomedical research (who to apply, how to write, etc.)
p.(None): "You are participating in the study voluntarily, so you have the right to opt out, and you can leave at any time once you start."
p.(None): "If a decision not to participate in a study (eg discontinuation of an investigational medicinal product) would endanger your health,
p.(None): the investigator will explain how best to proceed in this case. "
p.(None): "Your decision not to participate or to terminate your participation in the study will not affect the normal course of action
p.(None): health care. "
p.(None): "If you decide to withdraw from the study before the end of this period, the investigator will submit and ask you to write a free-form waiver.
p.(None): request or complete a waiver form. "
p.(None): 24. Explanation that the results of biomedical research, i. y. biomedical research documents prior to consent to participate
p.(None): data recorded in a biomedical study revocation shall not be deleted
...

Searching for indicator access:

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p.(None): "
p.(None): 5. Name of the customer and, if any, the identity of the customer's representative (if the customer or his representative is a natural person) or
p.(None): name (if the customer or his representative is a legal entity)
p.(None): “The sponsor of this clinical trial is X (company name). It is a drug developer and
p.(None): a for-profit pharmaceutical company conducting clinical trials, which is for researchers and the research-performing medical institution
p.(None): will allocate the necessary funds for this study. "
p.(None): “The client of this biomedical research is X (name of the scientific institution). The funds needed for this study will be allocated
p.(None): Y (name (s) of company (ies), medicines / equipment / substances will be provided free of charge by their manufacturer Z (company
p.(None): Name (s) of the Member State (s). "
p.(None): 6. Likelihood of joining different study and / or control groups and characteristics of participation in these groups (if
p.(None): biomedical study is performed with the participation of different study and / or control groups)
p.(None): "Participants in this study will be divided into two groups by random assignment (like a coin for one year), one
p.(None): will use study drug XXX and another will receive placebo. Placebo looks and prescribes reminiscent
p.(None): study drug but has no therapeutic effect. The random route of administration means that it is not a physician-researcher
p.(None): decides, and the computer program indicates to which group you will be assigned. Each study participant has
p.(None): equal access (50%) to one of the groups. Because sometimes an improvement in health is alleged
p.(None): occurs solely as a result of the medicinal product being used (i.e. the subjective psychological ‘placebo effect’),
p.(None): In drug research, placebo is used to show that the medicine is
p.(None): effective for objective characteristics rather than for subjective psychological reasons. If you go to placebo
p.(None): group, you will not be able to take medicines that are usually given to patients with X disease. Without medication, you can
p.(None): deteriorating your health: ... "
p.(None): “It is also important to understand that neither you nor the medical researcher will know which group you are in. This will only become clear to the study
p.(None): or if your health deteriorates and the cause of this deterioration needs to be clarified
p.(None): (the medical condition was caused by the investigational medicinal product or the absence of standard treatment). "
p.(None): 7. The essence of placebo use (if the biomedical study is performed with placebo)
p.(None): Example See above p. 6
p.(None): 8. Example of denial of routine health care above p. 6
p.(None): justification (if subjects are not (or are not) receiving standard treatment at the time of study participation)
p.(None): See also 14 p.
p.(None): 9. Circumstances and Criteria for Exclusion from the Study “If you do not follow your doctor’s instructions or
p.(None): participation in the study will significantly worsen your health,
p.(None): You will no longer be able to participate in the study
...

p.(None): 10. Duration of the investigation “The total duration of the investigation is two years.
p.(None): You will participate for two months, i. y. from the first visit, when you sign the informed consent form, you will have
p.(None): visit the doctor's researcher 4 more times, once every two weeks. "
p.(None): 11. Number of subjects “It is expected that in this
p.(None): The biomedical / clinical trial will involve approximately 12,000 people, of whom
p.(None): about 150 people with severe XXX deficiency. "
p.(None): 12. Countries where a biomedical study is planned (the purpose of providing this information is to allow the study participant
p.(None): to get an overview of the study (local or global), so only the countries where it is planned are indicated
p.(None): to conduct an investigation (i.e. not necessarily a complete list of parties in the event of a change of parties in the course of the investigation). If there are a lot of countries
p.(None): it is possible to indicate, for example, the continent and the number of countries)
p.(None): 13. Methods of information gathering (survey), treatment, diagnosis or other procedures used in biomedical research,
p.(None): frequency of visits to a biomedical research center
p.(None): "The study will be conducted in fifteen European countries (including all the Baltic countries) and North America."
p.(None): “We will ask you to allow a small amount of blood (5 ml) to be taken from a vein for the purpose of this test. We will also ask for an answer to
p.(None): several questions in the research questionnaire about your symptoms, daily diet, medications, <...>.
p.(None): The information provided in the questionnaire will be anonymous and will not be used to identify you. "
p.(None): "Please allow access to your medical records (medical history) on the basis of which data on X will be collected
p.(None): spread, course and tactics of treatment, development of the disease after treatment. If you agree to participate in the study, you will not have to come and
p.(None): perform any additional diagnostic or therapeutic procedures. "
p.(None): "If you agree to take part in the study, you will need to come to <> once. During this visit, the examination doctor will tell you
p.(None): will perform an X procedure, after which you will take your urine and blood sample (up to 5 ml). Procedure X is performed <. >.
p.(None): You may experience discomfort during procedure X, but it is painless. Researchers will need to use yours
p.(None): medical records (medical history) from which data on <. >. "
p.(None): 14. Explanation of what the biomedical research “The following procedures will be performed during the research: Some
p.(None): procedures referred to in
p.(None): the procedures used, the planned duration and frequency of visits to the biomedical research center and other circumstances vary
p.(None): from personal health care provided in accordance with normal clinical practice
p.(None): electrocardiogram, thyroid and adrenal examination - would not be performed during a routine doctor's visit. "
p.(None): “Procedure X usually takes about 15 minutes, but this biomedical / clinical study requires
p.(None): gather more information, so please allow 10 minutes. longer procedure. "
p.(None): "Typically, 5 ml of blood is taken from a patient to detect XX deficiency, but in this study we also want to look at ZZ factors, so
p.(None): 20 ml of blood will be taken instead of 5 ml. "
p.(None): 15. Expected benefits of the biomedical research to the subject, explaining whether and how the biomedical research can be useful
p.(None): to the subject
...

p.(None): memories or feelings. You may not answer your unpleasant questions or refuse to take tests if you feel like it
p.(None): awkward. "
p.(None): 18. Risks of processing health information “Due to unforeseen circumstances, confidential information may
p.(None): become available to third parties
p.(None): you have not given your consent to grant it. "
p.(None): 19. Insurance information (civil researcher of the principal investigator and the client of the biomedical research)
p.(None): compulsory liability insurance or by a personal health care institution which itself or it
p.(None): the worker is in a biomedical study in which the person involved is subject to intervention
p.(None): biomedical research methods have only minor adverse temporary effects on his health,
p.(None): the sponsor or its employee is a researcher in such biomedical research,
p.(None): civil
p.(None): "You are entitled to health damage and related non-pecuniary damage incurred in participating in this study,
p.(None): remuneration. "
p.(None): "The health care institution has concluded an insurance contract, which provides for damages that may arise from this
p.(None): during a biomedical research. "
p.(None): “The research client and the principal investigator insure the biomedical research client and the principal investigator in civil
p.(None): compulsory liability insurance. Consequently, you are entitled to health damage and related non-pecuniary damage,
p.(None): incurred in participating in this investigation. "
p.(None): liability insurance for patients, covering pecuniary and non-pecuniary damage,
p.(None): which may arise in the course of such biomedical research)
p.(None): 20. Access to the civil liability insurance contract and where to apply in case of damage
p.(None): "Only non-interventional research methods that do not pose a risk to your health will be used in this biomedical study,
p.(None): therefore, biomedical research is not covered by the civil liability of biomedical research clients and principal investigators
p.(None): insurance. "
p.(None): “You can get acquainted with the insurance rules at the research site by contacting the researcher doctor. If you think during the study
p.(None): If you have been injured, consult your doctor. "
p.(None): 21. The right of a person to refuse to participate in the investigation and the consequences of such refusal and the right to withdraw the written consent to participate
p.(None): in the investigation at any time, without giving reasons and reasons
p.(None): 22. The right of a person to receive routine health care if a person refuses to participate in a biomedical research or
p.(None): withdraw consent to participate in a biomedical study
p.(None): 23. Procedure for withdrawal of consent to participate in a biomedical research (who to apply, how to write, etc.)
p.(None): "You are participating in the study voluntarily, so you have the right to opt out, and you can leave at any time once you start."
p.(None): "If a decision not to participate in a study (eg discontinuation of an investigational medicinal product) would endanger your health,
p.(None): the investigator will explain how best to proceed in this case. "
p.(None): "Your decision not to participate or to terminate your participation in the study will not affect the normal course of action
...

p.(None): published without the consent of the subject, unless such health information can be obtained directly or through the publication
p.(None): indirect identification
p.(None): 32. Name, legal entity code and registered office of the controller (this information must be provided when
p.(None): the sponsor of the biomedical research and the controller are not the same legal entity, for example in the case of
p.(None): the controller is the healthcare institution where the study takes place)
p.(None): 33. Information on the specific measures taken by the biomedical research client, the biomedical research client
p.(None): a representative and persons carrying out biomedical research in order to preserve the persons involved in the biomedical research,
p.(None): confidentiality
p.(None): “Personal information (name, surname or other information about your health) that is not relevant to your health
p.(None): personally identifiable information) is not considered confidential and may be disclosed without your consent if it is
p.(None): it is not possible to identify you directly or indirectly after disclosure. "
p.(None): "The data controller is UAB Mmmm / VšĮ ZZ ligoninė, company code: 00000000000, address:
p.(None): .................... "
p.(None): “To protect the confidentiality of your data, you will be given a special code that will be listed on all of them
p.(None): documents other than the consent form and <. > (these documents will indicate your
p.(None): personal data). A list in which your name is linked to the code, the security chief investigator in the safe, to
p.(None): which only he and the authorized researcher have access to. "
p.(None): “Computers that store electronic research documents and data are password protected. Login codes
p.(None): only researchers know, these data are updated monthly. "
p.(None): "Documents are stored in a locker, the key of which is only available to researchers."
p.(None): 34. Explanation of where the personal data will be obtained, i. y. only from the subject himself, from the health care institution
p.(None): his medical records or other sources (specifying them)
p.(None): 35. It is listed what data about the person will be collected (final from the collection of the person and medical documents
p.(None): data list)
p.(None): 36. It is clarified who and for what purpose will have access to the data that allow to directly identify the subject
p.(None): identity (unencrypted data) and to whom and for what purpose only data
p.(None): directly identify the subject (coded data)
p.(None): “If you agree to participate in this study, the investigating physician and study staff will use the information you need to perform the study
p.(None): personal data. Data will be collected on the basis of the information provided by you, in this and other medical institutions
p.(None): stored medical documents, as well as in state registers, etc. information contained therein. "
p.(None): See e.g. 34
p.(None): "By signing this form, you agree that the researchers at the research center, the research control authorities (such as
p.(None): State Medicines Control Agency, ethics committees) and to commission an investigation by the sponsor (ZZZ)
p.(None): supervisors will have access to all information collected about you for the purposes of this investigation.
p.(None): Other people or companies will only be provided with encrypted health data that does not allow you to be identified directly
p.(None): identities. ("Encode" means that the documents will not contain your name, but a special number that
p.(None): only a medical researcher will be able to link to you). "
p.(None): “The data collected will be used by study physicians only for the purposes of this clinical trial. Customer-encoded health data
p.(None): may use in the conduct of a study by submitting applications for an investigational medicinal product
p.(None): registration and research, diagnosis or development of medical devices. "
p.(None): 37. If the data will be provided not only to the client of the biomedical research, the person must be informed about the recipients of the data
p.(None): groups (such as testing laboratories) and access to the data subject's data,
p.(None): indicating that he should contact the researcher for this
p.(None): 38. For how long will the personal data of the subjects collected during the biomedical research be kept and who will be responsible for it
p.(None): “Your blood samples (X-rays, magnetic resonance imaging, cardiogram and
p.(None): etc.) will be sent to research laboratories in other countries. Your researcher has a list of these laboratories and their contact information
p.(None): information - contact your researcher for this information. "
p.(None): "All information will be recorded in electronic and paper documents specially designed for the clinical trial
p.(None): and stored at the study center for XX years after the end of the study. So much time to store data is required by law / customer
p.(None): in order to ensure data quality and control. Later, your personal data will be destroyed by the investigation
p.(None): in accordance with the procedure laid down by the Center. The principal investigator / healthcare professional will be responsible for storing documents at the research center
p.(None): institution together with the principal investigator. "
p.(None): 39. The right of a person to have access to his or her personal data and the right to have inaccurate, incomplete,
p.(None): inaccurate personal data
p.(None): “You have the right to know what data has been collected, and you can also demand that it be rectified, destroyed or
p.(None): suspend the processing of your personal data if you decide to withdraw from the investigation earlier. Then
p.(None): researchers will no longer collect new information about you, but will not be able to destroy the data collected so far. "
p.(None): 40. Information on the permission of the Lithuanian Bioethics Committee and the Regional Biomedical Research Ethics Committee
p.(None): a biomedical study or a certificate of approval of the Lithuanian Bioethics Committee to perform a clinical trial of a medicinal product
p.(None): and phone number, e-mail postal address, registered office address and contact details of these institutions (telephone
p.(None): contact number, e-mail postal address, registered office address)
p.(None): “Due to your rights as a research participant, you can apply for permission to carry out this biomedical research / consent to perform it
p.(None): Lithuanian Bioethics Committee, which issued the certificate for the clinical trial of the medicinal product, Vilniaus st. 16, LT-01402 Vilnius,
p.(None): tel. (8-5) 2124565, el. e-mail: lbek@bioetika.sam.lt. "
p.(None): “For your rights as a research participant, you can apply for a permit to perform this biomedical research in Vilnius
p.(None): Regional Biomedical Research Ethics Committee, M. K. Čiurlionio str. 21/27 (room 231), LT-03101, Vilnius, tel. (8-5)
p.(None): 2686998, el. e-mail: rbtek@mf.vu.lt. "
...

Searching for indicator age:

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p.(None): “We would like to point out that the results of this study, i. y. in the investigation documents before your consent to participate
p.(None): data recorded in a biomedical study cancellation will not be destroyed because ....
p.(None): (we would recommend clarification). "
p.(None): "If due to the deteriorating health condition you will not be able to decide on further opportunities to participate in the study, at your request
p.(None): revoking consent to take part in the investigation will be taken into account, but this decision will legally be taken by the spouse if he or she is not present -
p.(None): one of the parents, adult children or another legal representative (of you). "
p.(None): "If your child no longer wishes to take part in the study, he or she has the right to withdraw from the study at any time, unless
p.(None): when discontinuation may result in health problems (eg abrupt discontinuation of the study drug or
p.(None): treatment regimen may be harmful to your child’s health). Therefore, we ask you before accepting with the child
p.(None): decision not to participate in the study to consult the investigating physician. "
p.(None): “If you decide not to take part in this study, your doctor will prescribe the usual treatment for the disease, taking into account all those involved
p.(None): circumstances - your age, other illnesses, general health, etc. He may prescribe pharmacies for you
p.(None): to participate in the study (alternatives to participation in the study) of preparations that have already been approved and sold in Lithuania. X
p.(None): Y groups are usually used to treat the disease
p.(None): medicinal products (eg A, E, P, etc.) that are fully reimbursed (not reimbursed) by compulsory health
p.(None): insurance fund. K treatments, special diets, etc. may also be prescribed. The doctor researcher will discuss with you all
p.(None): the benefits and risks of the possible options. "
p.(None): 28. Entitlement to compensation for the costs and time spent participating in a biomedical research,
p.(None): the person paying the compensation, the procedure and conditions for the calculation and payment of the compensation
p.(None): "Participation in biomedical / clinical trials of a medicinal product shall not be remunerated, but
p.(None): is entitled to compensation for costs incurred or time lost. In this study, the customer will reimburse travel,
p.(None): on the day of the meal visit, the cost of purchasing contraceptives. These costs will be reimbursed to the medical researcher
p.(None): on presentation of supporting documents (eg travel tickets, meal or medicine vouchers). "
p.(None): "There are no financial benefits to participating in this study. Only reasonable costs will be reimbursed (eg transport,
p.(None): parking) on arrival from home to the study center for scheduled study visits, as well as contraceptive
p.(None): the cost of purchasing the equipment on the basis of the supporting documents provided. Your request can also be
p.(None): reimbursed for the time spent on each return visit from the home to the research center and back, as well as for the
...

Searching for indicator child:

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p.(None): "You are participating in the study voluntarily, so you have the right to opt out, and you can leave at any time once you start."
p.(None): "If a decision not to participate in a study (eg discontinuation of an investigational medicinal product) would endanger your health,
p.(None): the investigator will explain how best to proceed in this case. "
p.(None): "Your decision not to participate or to terminate your participation in the study will not affect the normal course of action
p.(None): health care. "
p.(None): "If you decide to withdraw from the study before the end of this period, the investigator will submit and ask you to write a free-form waiver.
p.(None): request or complete a waiver form. "
p.(None): 24. Explanation that the results of biomedical research, i. y. biomedical research documents prior to consent to participate
p.(None): data recorded in a biomedical study revocation shall not be deleted
p.(None): 25. Persons who have the right to withdraw their consent in the event of incapacity, limitation of their capacity or
p.(None): health status cannot be considered to be able to reasonably assess their interests and the fact that will be taken into account
p.(None): when the incapacitated person is incapacitated, has incapacity or cannot be considered capable of
p.(None): to judge their interests wisely, the desire to withdraw consent
p.(None): 26. The right of a child who no longer wishes to participate in a biomedical study to terminate its participation in the study, unless
p.(None): it is against the best interests of the child (if children are involved in the study)
p.(None): 27. The right to be informed about possible treatments in the event of a person's disagreement or withdrawal of consent
p.(None): “We would like to point out that the results of this study, i. y. in the investigation documents before your consent to participate
p.(None): data recorded in a biomedical study cancellation will not be destroyed because ....
p.(None): (we would recommend clarification). "
p.(None): "If due to the deteriorating health condition you will not be able to decide on further opportunities to participate in the study, at your request
p.(None): revoking consent to take part in the investigation will be taken into account, but this decision will legally be taken by the spouse if he or she is not present -
p.(None): one of the parents, adult children or another legal representative (of you). "
p.(None): "If your child no longer wishes to take part in the study, he or she has the right to withdraw from the study at any time, unless
p.(None): when discontinuation may result in health problems (eg abrupt discontinuation of the study drug or
p.(None): treatment regimen may be harmful to your child’s health). Therefore, we ask you before accepting with the child
p.(None): decision not to participate in the study to consult the investigating physician. "
p.(None): “If you decide not to take part in this study, your doctor will prescribe the usual treatment for the disease, taking into account all those involved
p.(None): circumstances - your age, other illnesses, general health, etc. He may prescribe pharmacies for you
p.(None): to participate in the study (alternatives to participation in the study) of preparations that have already been approved and sold in Lithuania. X
p.(None): Y groups are usually used to treat the disease
p.(None): medicinal products (eg A, E, P, etc.) that are fully reimbursed (not reimbursed) by compulsory health
p.(None): insurance fund. K treatments, special diets, etc. may also be prescribed. The doctor researcher will discuss with you all
p.(None): the benefits and risks of the possible options. "
p.(None): 28. Entitlement to compensation for the costs and time spent participating in a biomedical research,
p.(None): the person paying the compensation, the procedure and conditions for the calculation and payment of the compensation
p.(None): "Participation in biomedical / clinical trials of a medicinal product shall not be remunerated, but
p.(None): is entitled to compensation for costs incurred or time lost. In this study, the customer will reimburse travel,
p.(None): on the day of the meal visit, the cost of purchasing contraceptives. These costs will be reimbursed to the medical researcher
p.(None): on presentation of supporting documents (eg travel tickets, meal or medicine vouchers). "
p.(None): "There are no financial benefits to participating in this study. Only reasonable costs will be reimbursed (eg transport,
p.(None): parking) on arrival from home to the study center for scheduled study visits, as well as contraceptive
...

Searching for indicator children:

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p.(None): "Your decision not to participate or to terminate your participation in the study will not affect the normal course of action
p.(None): health care. "
p.(None): "If you decide to withdraw from the study before the end of this period, the investigator will submit and ask you to write a free-form waiver.
p.(None): request or complete a waiver form. "
p.(None): 24. Explanation that the results of biomedical research, i. y. biomedical research documents prior to consent to participate
p.(None): data recorded in a biomedical study revocation shall not be deleted
p.(None): 25. Persons who have the right to withdraw their consent in the event of incapacity, limitation of their capacity or
p.(None): health status cannot be considered to be able to reasonably assess their interests and the fact that will be taken into account
p.(None): when the incapacitated person is incapacitated, has incapacity or cannot be considered capable of
p.(None): to judge their interests wisely, the desire to withdraw consent
p.(None): 26. The right of a child who no longer wishes to participate in a biomedical study to terminate its participation in the study, unless
p.(None): it is against the best interests of the child (if children are involved in the study)
p.(None): 27. The right to be informed about possible treatments in the event of a person's disagreement or withdrawal of consent
p.(None): “We would like to point out that the results of this study, i. y. in the investigation documents before your consent to participate
p.(None): data recorded in a biomedical study cancellation will not be destroyed because ....
p.(None): (we would recommend clarification). "
p.(None): "If due to the deteriorating health condition you will not be able to decide on further opportunities to participate in the study, at your request
p.(None): revoking consent to take part in the investigation will be taken into account, but this decision will legally be taken by the spouse if he or she is not present -
p.(None): one of the parents, adult children or another legal representative (of you). "
p.(None): "If your child no longer wishes to take part in the study, he or she has the right to withdraw from the study at any time, unless
p.(None): when discontinuation may result in health problems (eg abrupt discontinuation of the study drug or
p.(None): treatment regimen may be harmful to your child’s health). Therefore, we ask you before accepting with the child
p.(None): decision not to participate in the study to consult the investigating physician. "
p.(None): “If you decide not to take part in this study, your doctor will prescribe the usual treatment for the disease, taking into account all those involved
p.(None): circumstances - your age, other illnesses, general health, etc. He may prescribe pharmacies for you
p.(None): to participate in the study (alternatives to participation in the study) of preparations that have already been approved and sold in Lithuania. X
p.(None): Y groups are usually used to treat the disease
p.(None): medicinal products (eg A, E, P, etc.) that are fully reimbursed (not reimbursed) by compulsory health
p.(None): insurance fund. K treatments, special diets, etc. may also be prescribed. The doctor researcher will discuss with you all
p.(None): the benefits and risks of the possible options. "
p.(None): 28. Entitlement to compensation for the costs and time spent participating in a biomedical research,
...

Searching for indicator home:

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p.(None): decision not to participate in the study to consult the investigating physician. "
p.(None): “If you decide not to take part in this study, your doctor will prescribe the usual treatment for the disease, taking into account all those involved
p.(None): circumstances - your age, other illnesses, general health, etc. He may prescribe pharmacies for you
p.(None): to participate in the study (alternatives to participation in the study) of preparations that have already been approved and sold in Lithuania. X
p.(None): Y groups are usually used to treat the disease
p.(None): medicinal products (eg A, E, P, etc.) that are fully reimbursed (not reimbursed) by compulsory health
p.(None): insurance fund. K treatments, special diets, etc. may also be prescribed. The doctor researcher will discuss with you all
p.(None): the benefits and risks of the possible options. "
p.(None): 28. Entitlement to compensation for the costs and time spent participating in a biomedical research,
p.(None): the person paying the compensation, the procedure and conditions for the calculation and payment of the compensation
p.(None): "Participation in biomedical / clinical trials of a medicinal product shall not be remunerated, but
p.(None): is entitled to compensation for costs incurred or time lost. In this study, the customer will reimburse travel,
p.(None): on the day of the meal visit, the cost of purchasing contraceptives. These costs will be reimbursed to the medical researcher
p.(None): on presentation of supporting documents (eg travel tickets, meal or medicine vouchers). "
p.(None): "There are no financial benefits to participating in this study. Only reasonable costs will be reimbursed (eg transport,
p.(None): parking) on arrival from home to the study center for scheduled study visits, as well as contraceptive
p.(None): the cost of purchasing the equipment on the basis of the supporting documents provided. Your request can also be
p.(None): reimbursed for the time spent on each return visit from the home to the research center and back, as well as for the
p.(None): time spent in the center. Remuneration is calculated according to the minimum hourly rate approved by the Government of the Republic of Lithuania
p.(None): remuneration of EUR 2.13 per hour. This amount will be multiplied by the number of hours you specify, but not
p.(None): for more than 8 hours a day. If you provide the examining doctor with proof of travel expenses
p.(None): documents and / or a request for reimbursement for time spent on fact-finding visits will be reimbursed no later than the
p.(None): years. If you provide receipts for travel expenses and / or a request for reimbursement for time spent on research
p.(None): during the last visit or after you no longer participate in this study, you will be reimbursed within 3 working days of your
p.(None): application and / or submission of documents. "
p.(None): 29. The right to object to the continued use of health information obtained from biomedical research for the purpose of biomedical research
p.(None): a study in which he was included in accordance with the procedure established in Article 7 (6) of the Law on the Ethics of Biomedical Research without
p.(None): consent, at the time when the person refuses to continue to participate in the biomedical study (this information must be provided when
p.(None): planned investigation of critical conditions, i. y. when subjects will be included without informed consent)
p.(None): "You have the right to object to the continued use of your health information obtained for the purpose of biomedical research
p.(None): during this biomedical study. "
p.(None): "You have the right to object to the continued use of your loved one's health for the purpose of biomedical research
...

Searching for indicator minor:

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p.(None): with pain
p.(None): “You may experience any side effects while taking the study medicine
p.(None): effects: You may experience other discomforts, such as
p.(None): time spent traveling to the study site or completing study questionnaires. In addition, investigative procedures will be carried out which:
p.(None): may cause discomfort: pain or bruising may occur after taking the blood, in rare cases
p.(None): cases of infections; cardiac examination (electrocardiogram (ECG) is completely painless but sticky electrodes
p.(None): the skin at the attachment point may be slightly irritated and reddened.
p.(None): <...> '
p.(None): 17. Inconveniences that may result from participating in a biomedical study
p.(None): “When you take part in the study, you will have to fill in a diary every day (you will spend about 15 minutes), as well as every three
p.(None): months you will go to the research center. We will ask you to take some psychological tests whose questions can be unpleasant
p.(None): memories or feelings. You may not answer your unpleasant questions or refuse to take tests if you feel like it
p.(None): awkward. "
p.(None): 18. Risks of processing health information “Due to unforeseen circumstances, confidential information may
p.(None): become available to third parties
p.(None): you have not given your consent to grant it. "
p.(None): 19. Insurance information (civil researcher of the principal investigator and the client of the biomedical research)
p.(None): compulsory liability insurance or by a personal health care institution which itself or it
p.(None): the worker is in a biomedical study in which the person involved is subject to intervention
p.(None): biomedical research methods have only minor adverse temporary effects on his health,
p.(None): the sponsor or its employee is a researcher in such biomedical research,
p.(None): civil
p.(None): "You are entitled to health damage and related non-pecuniary damage incurred in participating in this study,
p.(None): remuneration. "
p.(None): "The health care institution has concluded an insurance contract, which provides for damages that may arise from this
p.(None): during a biomedical research. "
p.(None): “The research client and the principal investigator insure the biomedical research client and the principal investigator in civil
p.(None): compulsory liability insurance. Consequently, you are entitled to health damage and related non-pecuniary damage,
p.(None): incurred in participating in this investigation. "
p.(None): liability insurance for patients, covering pecuniary and non-pecuniary damage,
p.(None): which may arise in the course of such biomedical research)
p.(None): 20. Access to the civil liability insurance contract and where to apply in case of damage
p.(None): "Only non-interventional research methods that do not pose a risk to your health will be used in this biomedical study,
p.(None): therefore, biomedical research is not covered by the civil liability of biomedical research clients and principal investigators
p.(None): insurance. "
p.(None): “You can get acquainted with the insurance rules at the research site by contacting the researcher doctor. If you think during the study
p.(None): If you have been injured, consult your doctor. "
p.(None): 21. The right of a person to refuse to participate in the investigation and the consequences of such refusal and the right to withdraw the written consent to participate
...

Searching for indicator parents:

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p.(None): health status cannot be considered to be able to reasonably assess their interests and the fact that will be taken into account
p.(None): when the incapacitated person is incapacitated, has incapacity or cannot be considered capable of
p.(None): to judge their interests wisely, the desire to withdraw consent
p.(None): 26. The right of a child who no longer wishes to participate in a biomedical study to terminate its participation in the study, unless
p.(None): it is against the best interests of the child (if children are involved in the study)
p.(None): 27. The right to be informed about possible treatments in the event of a person's disagreement or withdrawal of consent
p.(None): “We would like to point out that the results of this study, i. y. in the investigation documents before your consent to participate
p.(None): data recorded in a biomedical study cancellation will not be destroyed because ....
p.(None): (we would recommend clarification). "
p.(None): "If due to the deteriorating health condition you will not be able to decide on further opportunities to participate in the study, at your request
p.(None): revoking consent to take part in the investigation will be taken into account, but this decision will legally be taken by the spouse if he or she is not present -
p.(None): one of the parents, adult children or another legal representative (of you). "
p.(None): "If your child no longer wishes to take part in the study, he or she has the right to withdraw from the study at any time, unless
p.(None): when discontinuation may result in health problems (eg abrupt discontinuation of the study drug or
p.(None): treatment regimen may be harmful to your child’s health). Therefore, we ask you before accepting with the child
p.(None): decision not to participate in the study to consult the investigating physician. "
p.(None): “If you decide not to take part in this study, your doctor will prescribe the usual treatment for the disease, taking into account all those involved
p.(None): circumstances - your age, other illnesses, general health, etc. He may prescribe pharmacies for you
p.(None): to participate in the study (alternatives to participation in the study) of preparations that have already been approved and sold in Lithuania. X
p.(None): Y groups are usually used to treat the disease
p.(None): medicinal products (eg A, E, P, etc.) that are fully reimbursed (not reimbursed) by compulsory health
p.(None): insurance fund. K treatments, special diets, etc. may also be prescribed. The doctor researcher will discuss with you all
p.(None): the benefits and risks of the possible options. "
p.(None): 28. Entitlement to compensation for the costs and time spent participating in a biomedical research,
p.(None): the person paying the compensation, the procedure and conditions for the calculation and payment of the compensation
...

General/Other / Incapacitated

Searching for indicator incapacitated:

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p.(None): withdraw consent to participate in a biomedical study
p.(None): 23. Procedure for withdrawal of consent to participate in a biomedical research (who to apply, how to write, etc.)
p.(None): "You are participating in the study voluntarily, so you have the right to opt out, and you can leave at any time once you start."
p.(None): "If a decision not to participate in a study (eg discontinuation of an investigational medicinal product) would endanger your health,
p.(None): the investigator will explain how best to proceed in this case. "
p.(None): "Your decision not to participate or to terminate your participation in the study will not affect the normal course of action
p.(None): health care. "
p.(None): "If you decide to withdraw from the study before the end of this period, the investigator will submit and ask you to write a free-form waiver.
p.(None): request or complete a waiver form. "
p.(None): 24. Explanation that the results of biomedical research, i. y. biomedical research documents prior to consent to participate
p.(None): data recorded in a biomedical study revocation shall not be deleted
p.(None): 25. Persons who have the right to withdraw their consent in the event of incapacity, limitation of their capacity or
p.(None): health status cannot be considered to be able to reasonably assess their interests and the fact that will be taken into account
p.(None): when the incapacitated person is incapacitated, has incapacity or cannot be considered capable of
p.(None): to judge their interests wisely, the desire to withdraw consent
p.(None): 26. The right of a child who no longer wishes to participate in a biomedical study to terminate its participation in the study, unless
p.(None): it is against the best interests of the child (if children are involved in the study)
p.(None): 27. The right to be informed about possible treatments in the event of a person's disagreement or withdrawal of consent
p.(None): “We would like to point out that the results of this study, i. y. in the investigation documents before your consent to participate
p.(None): data recorded in a biomedical study cancellation will not be destroyed because ....
p.(None): (we would recommend clarification). "
p.(None): "If due to the deteriorating health condition you will not be able to decide on further opportunities to participate in the study, at your request
p.(None): revoking consent to take part in the investigation will be taken into account, but this decision will legally be taken by the spouse if he or she is not present -
p.(None): one of the parents, adult children or another legal representative (of you). "
...

Searching for indicator incapacity:

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p.(None): 21. The right of a person to refuse to participate in the investigation and the consequences of such refusal and the right to withdraw the written consent to participate
p.(None): in the investigation at any time, without giving reasons and reasons
p.(None): 22. The right of a person to receive routine health care if a person refuses to participate in a biomedical research or
p.(None): withdraw consent to participate in a biomedical study
p.(None): 23. Procedure for withdrawal of consent to participate in a biomedical research (who to apply, how to write, etc.)
p.(None): "You are participating in the study voluntarily, so you have the right to opt out, and you can leave at any time once you start."
p.(None): "If a decision not to participate in a study (eg discontinuation of an investigational medicinal product) would endanger your health,
p.(None): the investigator will explain how best to proceed in this case. "
p.(None): "Your decision not to participate or to terminate your participation in the study will not affect the normal course of action
p.(None): health care. "
p.(None): "If you decide to withdraw from the study before the end of this period, the investigator will submit and ask you to write a free-form waiver.
p.(None): request or complete a waiver form. "
p.(None): 24. Explanation that the results of biomedical research, i. y. biomedical research documents prior to consent to participate
p.(None): data recorded in a biomedical study revocation shall not be deleted
p.(None): 25. Persons who have the right to withdraw their consent in the event of incapacity, limitation of their capacity or
p.(None): health status cannot be considered to be able to reasonably assess their interests and the fact that will be taken into account
p.(None): when the incapacitated person is incapacitated, has incapacity or cannot be considered capable of
p.(None): to judge their interests wisely, the desire to withdraw consent
p.(None): 26. The right of a child who no longer wishes to participate in a biomedical study to terminate its participation in the study, unless
p.(None): it is against the best interests of the child (if children are involved in the study)
p.(None): 27. The right to be informed about possible treatments in the event of a person's disagreement or withdrawal of consent
p.(None): “We would like to point out that the results of this study, i. y. in the investigation documents before your consent to participate
p.(None): data recorded in a biomedical study cancellation will not be destroyed because ....
p.(None): (we would recommend clarification). "
p.(None): "If due to the deteriorating health condition you will not be able to decide on further opportunities to participate in the study, at your request
p.(None): revoking consent to take part in the investigation will be taken into account, but this decision will legally be taken by the spouse if he or she is not present -
p.(None): one of the parents, adult children or another legal representative (of you). "
p.(None): "If your child no longer wishes to take part in the study, he or she has the right to withdraw from the study at any time, unless
...

General/Other / participants in a control group

Searching for indicator placebo:

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p.(None): APPROVED
p.(None): Lithuanian Bioethics Committee Biomedical Research Expert Group 2016 November 15 decision
p.(None): Recommendations of the Lithuanian Bioethics Committee for the Informed Person Consent Form
p.(None): The purpose of these Guidelines is to assist biomedical research clients and researchers in preparing informed consent
p.(None): forms. The guidelines explain the requirements for the informed consent form and provide examples.
p.(None): Exemplary formulations are more focused on patients in clinical trials
p.(None): information, but may be extended to other biomedical research.
p.(None): It is important to note that the Requirements are common to both clinical and non-clinical applications of the medicinal product
p.(None): Informed Consent Forms used in biomedical research. Therefore, not all of them are applicable
p.(None): for a specific research project. For example, if you are planning a retrospective study that will only analyze patients
p.(None): medical records, you will not include information about the distribution of subjects in the Informed Person Consent Form
p.(None): into groups, placebo use, and so on.
p.(None): If questions arise during the preparation of the Informed Consent Form, the Research Ethics Committee may be consulted
p.(None): (Lithuanian Bioethics Committee (tel .: 8-5 2610632, e-mail: lbek@bioetika.sam.lt), Vilnius Regional Biomedical
p.(None): Research Ethics Committee (tel .: 8-5 2686998, e-mail: rbtek@mf.vu.lt) or Kaunas Regional Biomedical Research Ethics Committee
p.(None): Committee (tel .: 8-37 32 68 89, kaunorbtek@lsmuni.lt).
p.(None): Requirement (explanation) Possible wording (if not verbatim -
p.(None): must be adapted to the specific study)
p.(None): 1. Purpose of the informed consent form “This form provides you with information about
p.(None): biomedical / clinical investigation of the medicinal product,
p.(None): discusses the reasons for conducting the study, the research procedures, benefits, risks, possible inconveniences, and other important things
p.(None): information. If you choose to participate, we will ask you to sign this consent form, which you agree to the study
p.(None): follow the instructions of the medical examiner and the study team. By signing this document, you agree
p.(None): participate in research. Take your time and read this document carefully if you do not understand any word or
p.(None): statement, be sure to ask the study physician or other members of the study team any questions you may have. Before
p.(None): you can consult family, friends or your doctor when making a decision. ”
p.(None): 2. Scientific-research goal of biomedical research
...

p.(None): Therefore, this study will try to find out whether the new medicine X is more effective (safer).
p.(None): for Z. "
p.(None): 4. Which persons are selected to participate in the biomedical research
p.(None): “We invite you to participate in a clinical trial of the drug because you have X disease and
p.(None): you meet the basic test criteria listed. The main criteria for inclusion in this study are as follows
p.(None): "
p.(None): 5. Name of the customer and, if any, the identity of the customer's representative (if the customer or his representative is a natural person) or
p.(None): name (if the customer or his representative is a legal entity)
p.(None): “The sponsor of this clinical trial is X (company name). It is a drug developer and
p.(None): a for-profit pharmaceutical company conducting clinical trials, which is for researchers and the research-performing medical institution
p.(None): will allocate the necessary funds for this study. "
p.(None): “The client of this biomedical research is X (name of the scientific institution). The funds needed for this study will be allocated
p.(None): Y (name (s) of company (ies), medicines / equipment / substances will be provided free of charge by their manufacturer Z (company
p.(None): Name (s) of the Member State (s). "
p.(None): 6. Likelihood of joining different study and / or control groups and characteristics of participation in these groups (if
p.(None): biomedical study is performed with the participation of different study and / or control groups)
p.(None): "Participants in this study will be divided into two groups by random assignment (like a coin for one year), one
p.(None): will use study drug XXX and another will receive placebo. Placebo looks and prescribes reminiscent
p.(None): study drug but has no therapeutic effect. The random route of administration means that it is not a physician-researcher
p.(None): decides, and the computer program indicates to which group you will be assigned. Each study participant has
p.(None): equal access (50%) to one of the groups. Because sometimes an improvement in health is alleged
p.(None): occurs solely as a result of the medicinal product being used (i.e. the subjective psychological ‘placebo effect’),
p.(None): In drug research, placebo is used to show that the medicine is
p.(None): effective for objective characteristics rather than for subjective psychological reasons. If you go to placebo
p.(None): group, you will not be able to take medicines that are usually given to patients with X disease. Without medication, you can
p.(None): deteriorating your health: ... "
p.(None): “It is also important to understand that neither you nor the medical researcher will know which group you are in. This will only become clear to the study
p.(None): or if your health deteriorates and the cause of this deterioration needs to be clarified
p.(None): (the medical condition was caused by the investigational medicinal product or the absence of standard treatment). "
p.(None): 7. The essence of placebo use (if the biomedical study is performed with placebo)
p.(None): Example See above p. 6
p.(None): 8. Example of denial of routine health care above p. 6
p.(None): justification (if subjects are not (or are not) receiving standard treatment at the time of study participation)
p.(None): See also 14 p.
p.(None): 9. Circumstances and Criteria for Exclusion from the Study “If you do not follow your doctor’s instructions or
p.(None): participation in the study will significantly worsen your health,
p.(None): You will no longer be able to participate in the study
p.(None): “The study doctor or the client has the right to suspend the study or your participation in it at any time. You will not be able to
p.(None): participate in the study if the study product causes adverse reactions and treatment is required that is not
p.(None): use in this study, and if you do not attend scheduled visits as indicated, you will not take the study drug or
p.(None): you will not follow the instructions of other investigators. "
p.(None): 10. Duration of the investigation “The total duration of the investigation is two years.
p.(None): You will participate for two months, i. y. from the first visit, when you sign the informed consent form, you will have
p.(None): visit the doctor's researcher 4 more times, once every two weeks. "
p.(None): 11. Number of subjects “It is expected that in this
p.(None): The biomedical / clinical trial will involve approximately 12,000 people, of whom
p.(None): about 150 people with severe XXX deficiency. "
p.(None): 12. Countries where a biomedical study is planned (the purpose of providing this information is to allow the study participant
p.(None): to get an overview of the study (local or global), so only the countries where it is planned are indicated
...

p.(None): spread, course and tactics of treatment, development of the disease after treatment. If you agree to participate in the study, you will not have to come and
p.(None): perform any additional diagnostic or therapeutic procedures. "
p.(None): "If you agree to take part in the study, you will need to come to <> once. During this visit, the examination doctor will tell you
p.(None): will perform an X procedure, after which you will take your urine and blood sample (up to 5 ml). Procedure X is performed <. >.
p.(None): You may experience discomfort during procedure X, but it is painless. Researchers will need to use yours
p.(None): medical records (medical history) from which data on <. >. "
p.(None): 14. Explanation of what the biomedical research “The following procedures will be performed during the research: Some
p.(None): procedures referred to in
p.(None): the procedures used, the planned duration and frequency of visits to the biomedical research center and other circumstances vary
p.(None): from personal health care provided in accordance with normal clinical practice
p.(None): electrocardiogram, thyroid and adrenal examination - would not be performed during a routine doctor's visit. "
p.(None): “Procedure X usually takes about 15 minutes, but this biomedical / clinical study requires
p.(None): gather more information, so please allow 10 minutes. longer procedure. "
p.(None): "Typically, 5 ml of blood is taken from a patient to detect XX deficiency, but in this study we also want to look at ZZ factors, so
p.(None): 20 ml of blood will be taken instead of 5 ml. "
p.(None): 15. Expected benefits of the biomedical research to the subject, explaining whether and how the biomedical research can be useful
p.(None): to the subject
p.(None): “If the study medicine is effective and you do not get into the placebo group, your health condition may
p.(None): improve, but there is no guarantee that this will happen. Participating in the study may not improve your health or even
p.(None): deteriorate. The information obtained during the study will help researchers develop new drugs or treatments in the future
p.(None): may be of benefit to patients with Z disease. "
p.(None): 16. Possible adverse reactions and / or events, discomfort to procedures or investigational medicinal product
p.(None): with pain
p.(None): “You may experience any side effects while taking the study medicine
p.(None): effects: You may experience other discomforts, such as
p.(None): time spent traveling to the study site or completing study questionnaires. In addition, investigative procedures will be carried out which:
p.(None): may cause discomfort: pain or bruising may occur after taking the blood, in rare cases
p.(None): cases of infections; cardiac examination (electrocardiogram (ECG) is completely painless but sticky electrodes
p.(None): the skin at the attachment point may be slightly irritated and reddened.
p.(None): <...> '
p.(None): 17. Inconveniences that may result from participating in a biomedical study
p.(None): “When you take part in the study, you will have to fill in a diary every day (you will spend about 15 minutes), as well as every three
p.(None): months you will go to the research center. We will ask you to take some psychological tests whose questions can be unpleasant
p.(None): memories or feelings. You may not answer your unpleasant questions or refuse to take tests if you feel like it
p.(None): awkward. "
p.(None): 18. Risks of processing health information “Due to unforeseen circumstances, confidential information may
p.(None): become available to third parties
p.(None): you have not given your consent to grant it. "
...

Orphaned Trigger Words

p.(None): years. If you provide receipts for travel expenses and / or a request for reimbursement for time spent on research
p.(None): during the last visit or after you no longer participate in this study, you will be reimbursed within 3 working days of your
p.(None): application and / or submission of documents. "
p.(None): 29. The right to object to the continued use of health information obtained from biomedical research for the purpose of biomedical research
p.(None): a study in which he was included in accordance with the procedure established in Article 7 (6) of the Law on the Ethics of Biomedical Research without
p.(None): consent, at the time when the person refuses to continue to participate in the biomedical study (this information must be provided when
p.(None): planned investigation of critical conditions, i. y. when subjects will be included without informed consent)
p.(None): "You have the right to object to the continued use of your health information obtained for the purpose of biomedical research
p.(None): during this biomedical study. "
p.(None): "You have the right to object to the continued use of your loved one's health for the purpose of biomedical research
p.(None): information obtained from this biomedical study. "
p.(None): 30. It has been stated that the health information obtained from a biomedical research, which allows the identification of a person, is
p.(None): confidential and may be provided only in accordance with the Law of the Republic of Lithuania on Patients' Rights and Compensation for Damage to Health, and
p.(None): Lithuanian
p.(None): "Health information obtained from a biomedical research shall be confidential and
p.(None): may be provided only in accordance with the law on patients' rights and the protection of personal data. "
p.(None): In accordance with the procedure established by the Law on the Legal Protection of Personal Data of the Republic of Lithuania
p.(None): 31. It is stated that health information obtained from a biomedical study is not considered confidential and may be
p.(None): published without the consent of the subject, unless such health information can be obtained directly or through the publication
p.(None): indirect identification
p.(None): 32. Name, legal entity code and registered office of the controller (this information must be provided when
p.(None): the sponsor of the biomedical research and the controller are not the same legal entity, for example in the case of
p.(None): the controller is the healthcare institution where the study takes place)
p.(None): 33. Information on the specific measures taken by the biomedical research client, the biomedical research client
p.(None): a representative and persons carrying out biomedical research in order to preserve the persons involved in the biomedical research,
p.(None): confidentiality
p.(None): “Personal information (name, surname or other information about your health) that is not relevant to your health
p.(None): personally identifiable information) is not considered confidential and may be disclosed without your consent if it is
p.(None): it is not possible to identify you directly or indirectly after disclosure. "
p.(None): "The data controller is UAB Mmmm / VšĮ ZZ ligoninė, company code: 00000000000, address:
p.(None): .................... "
p.(None): “To protect the confidentiality of your data, you will be given a special code that will be listed on all of them
p.(None): documents other than the consent form and <. > (these documents will indicate your ...

p.(None): must be adapted to the specific study)
p.(None): a) The person understood the information provided to him “I have read this Informed Consent Form and
p.(None): I understood the information provided to me. "
p.(None): (b) He was given the opportunity to ask questions and received satisfactory answers ...

p.(None): "I understand that I can withdraw from the investigation at any time without giving any reason."
p.(None): If another person consents to the study:
p.(None): "I understand that a person for whom I give consent to participate in a biomedical research may withdraw from the
p.(None): without giving reasons. "
p.(None): (d) has understood that in order to withdraw his consent to participate in a biomedical research, he must do so in writing
p.(None): to inform the researcher or another person performing biomedical research authorized by him
p.(None): (e) had sufficient time to consider the information provided to him concerning the biomedical research
p.(None): (f) understood that participation in the study was voluntary
p.(None): "I understand that in order to withdraw my consent to participate in a biomedical research, I must inform the researcher in writing.
p.(None): / another person authorized by him to carry out biomedical research. "
p.(None): "I confirm that I have had sufficient time to consider the information provided to me about the biomedical research."
p.(None): "I understand that participation in this study is voluntary."
p.(None): g) confirms that the consent is given voluntarily “I confirm that the consent to participate in this
p.(None): I give free will in biomedical research. "
p.(None): (h) allow the use of personal data to the extent and in the manner specified in the Informed Consent Form
p.(None): "I authorize the use of personal data to the extent and in the manner specified in the Informed Person's consent form."
p.(None): (i) acknowledge receipt of a copy of the informed consent form signed by the investigator or another person
p.(None): an authorized biomedical researcher
p.(None): 48. FORMALITY REQUIREMENTS
p.(None): 47.1. The intended place is a person or other person with the right to give consent and the researcher or another person
p.(None): an authorized biomedical researcher:
p.(None): (a) name, surname
p.(None): b) signature
p.(None): (c) the date of signature of the document
p.(None): d) time
p.(None): (e) state the grounds for representation
p.(None): Indicate the date of preparation of the form and / or other identification mark (version, number, etc.) Form
p.(None): written in a comprehensible manner, without the use of special medical or other scientific terms rarely used
p.(None): international words
p.(None): "I acknowledge receipt of a copy of the Informed Consent Form signed by the investigator / other authorized ...
...

Appendix

Indicator List

Indicator	Vulnerability
access	Access to Social Goods
age	Age
child	Child
children	Child
drug	Drug Usage
family	Motherhood/Family
home	Property Ownership
incapacitated	Incapacitated
incapacity	Incapacitated
influence	Drug Usage
injured	injured
minor	Youth/Minors
parents	parents
placebo	participants in a control group

Indicator Peers (Indicators in Same Vulnerability)

Indicator	Peers
child	['children']
children	['child']
drug	['influence']
incapacitated	['incapacity']
incapacity	['incapacitated']
influence	['drug']

Trigger Words

capacity

consent

ethics

protect

protection

risk

Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability Type	Vulnerability	Indicator	# Matches
Health	Drug Usage	drug	7
Health	Drug Usage	influence	1
Health	Motherhood/Family	family	1
Health	injured	injured	1
Social	Access to Social Goods	access	8
Social	Age	age	1
Social	Child	child	5
Social	Child	children	2
Social	Property Ownership	home	2
Social	Youth/Minors	minor	1
Social	parents	parents	1
General/Other	Incapacitated	incapacitated	2
General/Other	Incapacitated	incapacity	2
General/Other	participants in a control group	placebo	9

Guidelines for Patient Information Sheet and Informed Consent Form, Adopted by the Group of Experts on Biomedical Research of the LBEC (2017)

Applicable Type / Vulnerability / Indicator Overlay for this Input

Health / Drug Usage

Health / Motherhood/Family

Health / injured

Social / Access to Social Goods

Social / Age

Social / Child

Social / Property Ownership

Social / Youth/Minors

Social / parents

General/Other / Incapacitated

General/Other / participants in a control group

Orphaned Trigger Words

Appendix

Indicator List

Indicator Peers (Indicators in Same Vulnerability)

Trigger Words

Applicable Type / Vulnerability / Indicator Overlay for this Input