79C3C34C52B45572883A05D425EB0F82
V-28, Decree on the Procedure to Conduct Biomedical Research on Medical Documents, No. V-28 (2011)
https://leaux.net/URLS/General/Lithuania_V-28_Decree_on_the_Procedure_to_Conduct_Biomedical_Research_on_Medical_Documents_No._V-28_2011.pdf
http://leaux.net/URLS/ConvertAPI Text Files/01D9B954576803B46185D1992E547091.en.txt
Examining the file media/Synopses/01D9B954576803B46185D1992E547091.html:
This file was generated: 2020-12-01 07:05:46
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Illegal Activity
Searching for indicator illegal:
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p.(None): (Official Gazette Valstybės žinios, 2000, No. 44-1247), the Law on Legal Protection of Personal Data of the Republic of Lithuania (Official Gazette Valstybės žinios, 1996,
p.(None): No. 63-1479; 2000, no. 64-1924; 2003, No. 15-597; 2008, no. 22-804), Patients' Rights and Injuries of the Republic of Lithuania
p.(None): Health Remuneration Act (Official Gazette, 1996, No. 102-2317; 2004, No. 115-4284; 2009, No. 145-6425), the European
p.(None): Council Recommendation no. R (97) 5 on the protection of medical data, Council of Europe
p.(None): Recommendations on Research on Human Biological Matter, Declaration of Helsinki on Medical Research with
p.(None): and the practice of national health ethics committees.
p.(None): 3. The main terms used in the description of the Procedure are defined by the ethics of biomedical research of the Republic of Lithuania
p.(None): the Law on the Legal Protection of Personal Data of the Republic of Lithuania.
p.(None): II. GENERAL PRINCIPLES FOR PERFORMANCE OF BIOMEDICAL INVESTIGATIONS SUBJECT TO MEDICAL DOCUMENTS
p.(None): 4. A permit to perform a biomedical research, the object of which is medical documents, shall be issued by Lithuania in accordance with its competence
p.(None): the Bioethics Committee or the Regional Biomedical Research Ethics Committee. Biomedical research, the object of which
p.(None): there are medical documents, unauthorized performance is illegal and incurs statutory liability.
p.(None): 5. In order to carry out a biomedical examination, the object of which is medical records, the person
p.(None): whose consent the medical records will be used in the investigation (hereinafter referred to as the person).
p.(None): 6. Biomedical research involving medical records must be collected and used
p.(None): as much personal data as is necessary to achieve the purpose of the investigation. In a biomedical study whose object is
p.(None): medical records, personal data must be changed immediately so that the person cannot be identified
p.(None): identities, where possible and without jeopardizing the achievement of the objectives of the biomedical research.
p.(None): 7. It must be ensured that the biomedical research, the subject of which is medical records,
p.(None): confidentiality of personal data used through the implementation of appropriate organizational and technical data
p.(None): security measures.
p.(None): 8. Personal data must be processed for the purpose of biomedical research involving medical records
p.(None): in compliance with the requirements provided for in the Law on the Legal Protection of Personal Data of the Republic of Lithuania.
p.(None): III. PECULIARITIES OF PERFORMING BIOMEDICAL TESTS OBTAINING MEDICAL DOCUMENTS
p.(None): 9. The Lithuanian Bioethics Committee or the Regional Biomedical Research Ethics Committee may waive the requirement
p.(None): to obtain the consent of a person for the performance of biomedical research, the object of which is medical documents
p.(None): until the submission of a request for a biomedical research in accordance with the provisions of items 10–12 of the Description of the Procedure
...
Social / Access to Social Goods
Searching for indicator access:
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p.(None): medical records, personal data must be changed immediately so that the person cannot be identified
p.(None): identities, where possible and without jeopardizing the achievement of the objectives of the biomedical research.
p.(None): 7. It must be ensured that the biomedical research, the subject of which is medical records,
p.(None): confidentiality of personal data used through the implementation of appropriate organizational and technical data
p.(None): security measures.
p.(None): 8. Personal data must be processed for the purpose of biomedical research involving medical records
p.(None): in compliance with the requirements provided for in the Law on the Legal Protection of Personal Data of the Republic of Lithuania.
p.(None): III. PECULIARITIES OF PERFORMING BIOMEDICAL TESTS OBTAINING MEDICAL DOCUMENTS
p.(None): 9. The Lithuanian Bioethics Committee or the Regional Biomedical Research Ethics Committee may waive the requirement
p.(None): to obtain the consent of a person for the performance of biomedical research, the object of which is medical documents
p.(None): until the submission of a request for a biomedical research in accordance with the provisions of items 10–12 of the Description of the Procedure
p.(None): criteria.
p.(None): 10. The Lithuanian Bioethics Committee or the Regional Biomedical Research Ethics Committee may waive the requirement
p.(None): obtain the consent of the person when:
p.(None): 10.1. non-identifiable data used in a biomedical research;
p.(None): 10.2. an employee of a medical institution who has the right to access personal medical records,
p.(None): modifies personal data in such a way that it is not possible to identify the person and uses the biomedical system itself
p.(None): for research purposes and / or transfer the modified data to another researcher;
p.(None): 10.3. personal data shall be used in a biomedical research if the following criteria are met:
p.(None): 10.3.1. biomedical research raises an important scientific goal that cannot be achieved by biomedical research
p.(None): an examination with other data the use of which could lead to the individual 's consent, and
p.(None): 10.3.2. it is impossible or too difficult to contact the person.
p.(None): 11. It is considered impossible or excessively difficult to contact a person because of:
p.(None): 11.1. unreasonably high costs;
p.(None): 11.2. data age;
p.(None): 11.3. the large number of persons whose medical records are used in the study.
p.(None): 12. In the cases provided for in items 10–11 of the Description of the Procedure, the Lithuanian Bioethics Committee or the Regional Biomedical Committee
p.(None): the research ethics committee may waive the requirement to obtain the consent of the individual to perform the biomedical research,
p.(None): only if the person has not objected to the use of the person's medical records for biomedical purposes
p.(None): for research purposes. The person expresses his disagreement in writing. A person’s written statement must be kept
p.(None): personal medical records.
p.(None): IV. FINAL PROVISIONS
p.(None): 13. The criteria for exemption from consent to a biomedical study involving medical records may be
...
Social / Age
Searching for indicator age:
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p.(None): to obtain the consent of a person for the performance of biomedical research, the object of which is medical documents
p.(None): until the submission of a request for a biomedical research in accordance with the provisions of items 10–12 of the Description of the Procedure
p.(None): criteria.
p.(None): 10. The Lithuanian Bioethics Committee or the Regional Biomedical Research Ethics Committee may waive the requirement
p.(None): obtain the consent of the person when:
p.(None): 10.1. non-identifiable data used in a biomedical research;
p.(None): 10.2. an employee of a medical institution who has the right to access personal medical records,
p.(None): modifies personal data in such a way that it is not possible to identify the person and uses the biomedical system itself
p.(None): for research purposes and / or transfer the modified data to another researcher;
p.(None): 10.3. personal data shall be used in a biomedical research if the following criteria are met:
p.(None): 10.3.1. biomedical research raises an important scientific goal that cannot be achieved by biomedical research
p.(None): an examination with other data the use of which could lead to the individual 's consent, and
p.(None): 10.3.2. it is impossible or too difficult to contact the person.
p.(None): 11. It is considered impossible or excessively difficult to contact a person because of:
p.(None): 11.1. unreasonably high costs;
p.(None): 11.2. data age;
p.(None): 11.3. the large number of persons whose medical records are used in the study.
p.(None): 12. In the cases provided for in items 10–11 of the Description of the Procedure, the Lithuanian Bioethics Committee or the Regional Biomedical Committee
p.(None): the research ethics committee may waive the requirement to obtain the consent of the individual to perform the biomedical research,
p.(None): only if the person has not objected to the use of the person's medical records for biomedical purposes
p.(None): for research purposes. The person expresses his disagreement in writing. A person’s written statement must be kept
p.(None): personal medical records.
p.(None): IV. FINAL PROVISIONS
p.(None): 13. The criteria for exemption from consent to a biomedical study involving medical records may be
p.(None): be applied also in the performance of biomedical research, the objects of which have been determined by the biomedical research of the Republic of Lithuania
...
General/Other / declaration of helsinki
Searching for indicator helsinki:
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p.(None): DIRECTOR EUGENIJUS GEFENAS
p.(None): APPROVED
p.(None): Director of the Lithuanian Bioethics Committee in 2011 July 27 by order no. V-28
p.(None): DESCRIPTION OF THE PROCEDURE FOR PERFORMING BIOMEDICAL INVESTIGATIONS SUBJECT TO MEDICAL DOCUMENTS
p.(None): I. GENERAL PROVISIONS
p.(None): 1. Description of the procedure for conducting biomedical research involving medical records (hereinafter referred to as
p.(None): description) determines the peculiarities on the basis of which the Lithuanian Bioethics Committee and regional biomedical research ethics
p.(None): before authorizing a biomedical study involving medical records, the committees shall evaluate
p.(None): compliance of the submitted documents with the ethical requirements of biomedical research.
p.(None): 2. The description of the procedure has been prepared taking into account the Law on Ethics of Biomedical Research of the Republic of Lithuania
p.(None): (Official Gazette Valstybės žinios, 2000, No. 44-1247), the Law on Legal Protection of Personal Data of the Republic of Lithuania (Official Gazette Valstybės žinios, 1996,
p.(None): No. 63-1479; 2000, no. 64-1924; 2003, No. 15-597; 2008, no. 22-804), Patients' Rights and Injuries of the Republic of Lithuania
p.(None): Health Remuneration Act (Official Gazette, 1996, No. 102-2317; 2004, No. 115-4284; 2009, No. 145-6425), the European
p.(None): Council Recommendation no. R (97) 5 on the protection of medical data, Council of Europe
p.(None): Recommendations on Research on Human Biological Matter, Declaration of Helsinki on Medical Research with
p.(None): and the practice of national health ethics committees.
p.(None): 3. The main terms used in the description of the Procedure are defined by the ethics of biomedical research of the Republic of Lithuania
p.(None): the Law on the Legal Protection of Personal Data of the Republic of Lithuania.
p.(None): II. GENERAL PRINCIPLES FOR PERFORMANCE OF BIOMEDICAL INVESTIGATIONS SUBJECT TO MEDICAL DOCUMENTS
p.(None): 4. A permit to perform a biomedical research, the object of which is medical documents, shall be issued by Lithuania in accordance with its competence
p.(None): the Bioethics Committee or the Regional Biomedical Research Ethics Committee. Biomedical research, the object of which
p.(None): there are medical documents, unauthorized performance is illegal and incurs statutory liability.
p.(None): 5. In order to carry out a biomedical examination, the object of which is medical records, the person
p.(None): whose consent the medical records will be used in the investigation (hereinafter referred to as the person).
p.(None): 6. Biomedical research involving medical records must be collected and used
p.(None): as much personal data as is necessary to achieve the purpose of the investigation. In a biomedical study whose object is
p.(None): medical records, personal data must be changed immediately so that the person cannot be identified
p.(None): identities, where possible and without jeopardizing the achievement of the objectives of the biomedical research.
p.(None): 7. It must be ensured that the biomedical research, the subject of which is medical records,
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| age | Age |
| helsinki | declaration of helsinki |
| illegal | Illegal Activity |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
consent
ethics
protection
Applicable Type / Vulnerability / Indicator Overlay for this Input