Consolidated version from 06/15/2018
The order was published: TAR 2015-01-06, i. k. 2015-00096
MINISTER OF HEALTH OF THE REPUBLIC OF LITHUANIA
ORDER
ON INTERVENTIONAL BIOMEDICAL INVESTIGATION METHODS WHICH CAUSE SMALL UNDESIRABLE TEMPORARY ADVERSE EFFECTS
APPROVAL OF THE LIST
2014 31 December No. V-1483 Vilnius
Pursuant to the Law on Ethics of Biomedical Research of the Republic of Lithuania (Law No.
XII-981) in accordance with Article 11 (3), as well as to ensure a uniform level of intervention for biomedical
research methods evaluation practice:
1. T al i r t i n u Interventional biomedical interventions with minor adverse effects on the health of the subject
list of research methods (attached).
2. It is established that the regional ethics committees for biomedical research inform the Lithuanian Bioethics Committee
In accordance with the procedure established by the Director of the Lithuanian Bioethics Committee, about the reasons adopted in accordance with their competence
solutions:
2.1. to store interventional biomedical research methods that are not specified in the one approved by this Order
Interventional biomedical research methods with minor adverse transient health effects
in the list (hereinafter - the List), which cause minor adverse temporary effects on the health of the subject;
2.2. to consider interventional biomedical research methods listed in the List which give rise to more than
minor adverse temporary effects on the subject's health;
2.3. to consider interventional biomedical research methods that do not pose a risk to the health of the subject.
3. To instruct the Lithuanian Bioethics Committee to review the List at least once every 5 years and
if necessary, prepare and submit to the Ministry of Health a draft amendment to the List.
4. It is established that this Order shall enter into force in 2015. January 1
Minister of Health Rimantė Šalaševičiūtė
APPROVED
Minister of Health of the Republic of Lithuania
2014 31 December by order no. V-1483
INTERVENTIONAL BIOMEDICAL INVESTIGATION METHODS WITH SMALL UNDESIRABLE TEMPORARY ADVERSE EFFECTS
LIST
1. Interventions in biomedical research that have a minor adverse temporary effect on the health of the subject
methods:
1.1. For the purpose of biomedical research, procedures are performed when there is a slight damage to tissues and / or organs
integrity and which require no more than local anesthesia, or procedures for personal health
during surgical operations or invasive and / or interventional procedures for surveillance purposes
an additional sample of tissue, cells or body fluid is taken:
1.1.1. blood sampling by puncturing the capillary of the finger, heel, ear cup, except for the blood sample
removal from an adult using self-monitoring medical devices;
1.1.2. blood sampling by peripheral venous puncture from a healthy adult (excluding pregnant women)
woman) weighing at least 50 kg, taking no more than 550 ml of blood in 8 weeks, and from other
adults and children - not more than 3 ml per 1 kg body weight in 8 weeks;
1.1.3. additional blood sampling for vascular punctures performed for personal health care purposes
and / or during catheterisation from a healthy adult (other than a pregnant woman) weighing at least 50
kg from 20 ml of blood in 24 hours but not more than 550 ml of blood in 8 weeks, from other
adults and children - from 0.3 ml per kg body weight in 24 hours, but not more than 3 ml per kg body weight in 8 hours
weeks;
1.1.4. additional blood sampling for vascular punctures performed for personal health care purposes
and / or by taking less blood than indicated during catheterization
1.1.2, but during catheter lavage or anticoagulation;
1.1.5. taking a small sample of extra tissue, cells or body fluid during surgery or
during other invasive and / or interventional procedures performed for personal health care purposes
(eg, additional pleural puncture, additional tissue biopsy during endoscopy);
1.1.6. removal of superficial structures, skin, subcutaneous tissue, muscle biopsy.
Item changes:
No. V-694, 11/06/2018, published in TAR 2018-06-14, i. k. 2018-09863
1.2. For the purpose of biomedical research, the anatomical structures of the body, organ systems and / or them are performed
functional monitoring procedures performed without compromising the integrity of the tissues and / or organs during which
medical devices emitting ionizing radiation are used:
1.2.1. radiography;
1.2.2. dual flow radioabsorption geometry (DXA).
1.3. For the purpose of biomedical research, the anatomical structures of the body, organ systems and / or them are performed
functional monitoring procedures performed without compromising the integrity of tissues and / or organs
organ systems and / or its functions are affected by medical devices (except Minor Adverse Reactions)
List of investigational methods of interventional biomedical research with a temporary effect on health (hereinafter - the List)
Medical devices referred to in point 1.2) at a maximum of an average intensity according to the age, weight and
his state of health:
1.3.1. The general examination procedure is magnetic resonance imaging (without contrast).
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1.3.2. Nervous system examination procedures:
1.3.2.1. examination of sensory (eg auditory, visual, somatosensory) evoked potentials, unless
the procedure is performed on an adult who does not have epilepsy and has a medical document confirming this;
1.3.2.2. electroencephalography by functional tests (eg using sound, light and
hyperventilation), unless the procedure is performed in an adult who does not have epilepsy,
with a medical document confirming this.
1.3.3. Hearing and vision examination procedures:
1.3.3.1. optical coherent tomography;
1.3.3.2. tonometry;
1.3.3.3. contact pachymetry;
1.3.3.4. electroretinography;
1.3.3.5. fluorescence angiography.
1.3.4. Cardiovascular examination procedure means a cardiopulmonary exercise test, except in the case of
when the procedure is performed on an adult who does not have cardiovascular and respiratory system disease
diseases with a medical certificate to that effect.
Item changes:
No. V-694, 11/06/2018, published in TAR 2018-06-14, i. k. 2018-09863
1.4. For the purpose of biomedical research, skin or mucous membrane samples (functional tests) shall be
a minor temporary local reaction of the skin or mucous membranes (eg redness, swelling) and when
requires no more than local anesthesia:
1.4.1. skin sample with autologous serum;
1.4.2. photolab test;
1.4.3. skin patch (application) sample;
1.4.4. skin prick specimen;
1.4.5. eye surface staining with diagnostic dyes.
1.5. Procedures for the collection of body secretions and / or scrapings for biomedical research
in contact with skin or mucous membranes, where this contact may cause only a small temporary local
reaction (eg redness, slight swelling) and when the procedure requires no more than local anesthesia:
1.5.1. removal of mucosal scabs, except for scaling from the surface of the nasopharyngeal mucosa
for an adult;
Item changes:
No. V-694, 11/06/2018, published in TAR 2018-06-14, i. k. 2018-09863
1.5.2. eye surface sampling.
1.6. Other interventional biomedical research methods developed by the Lithuanian Bioethics Committee,
issuing a permit for a biomedical study or issuing a consent for the clinical trial of a medicinal product
a research certificate, or a regional ethics committee for biomedical research
biomedical research shall, by reasoned decision, recognize as having a minor adverse temporary effect on the
health.
2. The interventional biomedical research methods referred to in points 1.1 to 1.6 of the list shall not be
a minor adverse temporary effect on the subject's health, if the Lithuanian Bioethics Committee or the regional one
the Ethics Committee for Biomedical Research, taking into account the specific tissue taken in the biomedical research,
the amount of sample of cells or body fluid, the frequency of application of the method, the age group of the subjects, the disease (s) or
other circumstances that may affect the effect of the method on the health of the subjects, decides that the biomedical
for study subjects or a group of subjects, these methods are considered to be of greater than low concern
adverse temporary effects on the subject's health.
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Changes:
1.
Ministry of Health of the Republic of Lithuania, Order
No. V-694, 11/06/2018, published in TAR 2018-06-14, i. k. 2018-09863
Regarding the Minister of Health of the Republic of Lithuania in 2014 31 December order no. V-1483 “For the Small
a list of research methods for interventional biomedical research that causes adverse temporary effects on health
approval "