DIRECTOR OF THE LITHUANIAN BIOETHICS COMMITTEE
ORDER
APPROVAL OF THE DESCRIPTION OF THE PROCEDURE FOR PERFORMING BIOMEDICAL INVESTIGATIONS SUBJECT TO MEDICAL DOCUMENTS
2011 July 27 No. V-28 Vilnius
Pursuant to the Law on Ethics of Biomedical Research of the Republic of Lithuania (Official Gazette Valstybės žinios, 2000, No. 44-1247; 2007, No.
125-5093) and Article 8 thereof
Paragraph 2,
t v i r t i n u Description of the procedure for performing biomedical research, the object of which is medical documents (attached).
DIRECTOR EUGENIJUS GEFENAS
APPROVED
Director of the Lithuanian Bioethics Committee in 2011 July 27 by order no. V-28
DESCRIPTION OF THE PROCEDURE FOR PERFORMING BIOMEDICAL INVESTIGATIONS SUBJECT TO MEDICAL DOCUMENTS
I. GENERAL PROVISIONS
1. Description of the procedure for conducting biomedical research involving medical records (hereinafter referred to as
description) determines the peculiarities on the basis of which the Lithuanian Bioethics Committee and regional biomedical research ethics
before authorizing a biomedical study involving medical records, the committees shall evaluate
compliance of the submitted documents with the ethical requirements of biomedical research.
2. The description of the procedure has been prepared taking into account the Law on Ethics of Biomedical Research of the Republic of Lithuania
(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,
No. 63-1479; 2000, no. 64-1924; 2003, No. 15-597; 2008, no. 22-804), Patients' Rights and Injuries of the Republic of Lithuania
Health Remuneration Act (Official Gazette, 1996, No. 102-2317; 2004, No. 115-4284; 2009, No. 145-6425), the European
Council Recommendation no. R (97) 5 on the protection of medical data, Council of Europe
Recommendations on Research on Human Biological Matter, Declaration of Helsinki on Medical Research with
and the practice of national health ethics committees.
3. The main terms used in the description of the Procedure are defined by the ethics of biomedical research of the Republic of Lithuania
the Law on the Legal Protection of Personal Data of the Republic of Lithuania.
II. GENERAL PRINCIPLES FOR PERFORMANCE OF BIOMEDICAL INVESTIGATIONS SUBJECT TO MEDICAL DOCUMENTS
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
the Bioethics Committee or the Regional Biomedical Research Ethics Committee. Biomedical research, the object of which
there are medical documents, unauthorized performance is illegal and incurs statutory liability.
5. In order to carry out a biomedical examination, the object of which is medical records, the person
whose consent the medical records will be used in the investigation (hereinafter referred to as the person).
6. Biomedical research involving medical records must be collected and used
as much personal data as is necessary to achieve the purpose of the investigation. In a biomedical study whose object is
medical records, personal data must be changed immediately so that the person cannot be identified
identities, where possible and without jeopardizing the achievement of the objectives of the biomedical research.
7. It must be ensured that the biomedical research, the subject of which is medical records,
confidentiality of personal data used through the implementation of appropriate organizational and technical data
security measures.
8. Personal data must be processed for the purpose of biomedical research involving medical records
in compliance with the requirements provided for in the Law on the Legal Protection of Personal Data of the Republic of Lithuania.
III. PECULIARITIES OF PERFORMING BIOMEDICAL TESTS OBTAINING MEDICAL DOCUMENTS
9. The Lithuanian Bioethics Committee or the Regional Biomedical Research Ethics Committee may waive the requirement
to obtain the consent of a person for the performance of biomedical research, the object of which is medical documents
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
criteria.
10. The Lithuanian Bioethics Committee or the Regional Biomedical Research Ethics Committee may waive the requirement
obtain the consent of the person when:
10.1. non-identifiable data used in a biomedical research;
10.2. an employee of a medical institution who has the right to access personal medical records,
modifies personal data in such a way that it is not possible to identify the person and uses the biomedical system itself
for research purposes and / or transfer the modified data to another researcher;
10.3. personal data shall be used in a biomedical research if the following criteria are met:
10.3.1. biomedical research raises an important scientific goal that cannot be achieved by biomedical research
an examination with other data the use of which could lead to the individual 's consent, and
10.3.2. it is impossible or too difficult to contact the person.
11. It is considered impossible or excessively difficult to contact a person because of:
11.1. unreasonably high costs;
11.2. data age;
11.3. the large number of persons whose medical records are used in the study.
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
the research ethics committee may waive the requirement to obtain the consent of the individual to perform the biomedical research,
only if the person has not objected to the use of the person's medical records for biomedical purposes
for research purposes. The person expresses his disagreement in writing. A person’s written statement must be kept
personal medical records.
IV. FINAL PROVISIONS
13. The criteria for exemption from consent to a biomedical study involving medical records may be
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
Article 8 (2) of the Research Act.