79C3C34C52B45572883A05D425EB0F82
V-1483, Decree on the List of Interventional Methods of Biomedical Research Causing a Slightly Detrimental and Temporary Impact on the Subject’s Health (2014)
https://leaux.net/URLS/General/Lithuania_V-1483_Decree_on_the_List_of_Interventional_Methods_of_Biomedical_Research_Causing_a_Slightly_Detrimental_and_Temporary_Impact_on_the_Subjects_Health_2014.pdf
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Examining the file media/Synopses/2C1AF2369BF62706248AD63D1D18681A.html:
This file was generated: 2020-12-01 07:04:13
| 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
Health / Cognitive Impairment
Searching for indicator cognitive:
(return to top)
p.000002: 1.2. For the purpose of biomedical research, the anatomical structures of the body, organ systems and / or them are performed
p.000002: functional monitoring procedures performed without compromising the integrity of the tissues and / or organs during which
p.000002: medical devices emitting ionizing radiation are used:
p.000002: 1.2.1. radiography;
p.000002: 1.2.2. dual flow radioabsorption geometry (DXA).
p.000002: 1.3. For the purpose of biomedical research, the anatomical structures of the body, organ systems and / or them are performed
p.000002: functional monitoring procedures performed without compromising the integrity of tissues and / or organs
p.000002: organ systems and / or its functions are affected by medical devices (except Minor Adverse Reactions)
p.000002: List of investigational methods of interventional biomedical research with a temporary effect on health (hereinafter - the List)
p.000002: Medical devices referred to in point 1.2) at a maximum of an average intensity according to the age, weight and
p.000002: his state of health:
p.000002: 1.3.1. General investigation procedures:
p.000002: 1.3.1.1. magnetic resonance imaging (without contrast);
p.000002: 1.3.1.2. bioimpedance body composition study.
p.000002: 1.3.2. Respiratory test procedures:
p.000002: 1.3.2.1. lung capacity examination;
p.000002: 1.3.2.2. diffuse lung capacity study.
p.000002: 2
p.000002: 1.3.3. Nervous system examination procedures:
p.000002: 1.3.3.1. investigation of sensory (eg auditory, visual, somatosensory) evoked potentials;
p.000002: 1.3.3.2. study of cognitive evoked potentials;
p.000002: 1.3.3.3. study of motor induced potentials;
p.000002: 1.3.3.4. electroencephalography by functional tests (eg using sound, light and
p.000002: hyperventilation).
p.000002: 1.3.4. Hearing and vision examination procedures:
p.000002: 1.3.4.1. optical coherent tomography;
p.000002: 1.3.4.2. tonometry;
p.000002: 1.3.4.3. contact pachymetry;
p.000002: 1.3.4.4. electroretinography;
p.000002: 1.3.4.5. fluorescence angiography.
p.000002: 1.3.5. Cardiovascular examination procedure - cardiopulmonary exercise examination.
p.000002: 1.4. For the purpose of biomedical research, skin or mucous membrane samples (functional tests) shall be
p.000002: a minor temporary local reaction of the skin or mucous membranes (eg redness, swelling) and when
p.000002: requires no more than local anesthesia:
p.000002: 1.4.1. skin sample with autologous serum;
p.000002: 1.4.2. photolab test;
p.000002: 1.4.3. skin patch (application) sample;
p.000002: 1.4.4. skin prick specimen;
p.000002: 1.4.5. eye surface staining with diagnostic dyes.
p.000002: 1.5. Procedures for the collection of body secretions and / or scrapings for biomedical research
p.000002: in contact with skin or mucous membranes, where this contact may cause only a small temporary local
p.000002: reaction (eg redness, slight swelling) and when the procedure requires no more than local anesthesia:
p.000002: 1.5.1. removal of skin and mucous membranes;
p.000002: 1.5.2. eye surface sampling.
p.000002: 1.6. Other interventional biomedical research methods developed by the Lithuanian Bioethics Committee,
p.000002: issuing a permit for a biomedical study or issuing a consent for the clinical trial of a medicinal product
...
Health / Pregnant
Searching for indicator pregnant:
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p.000002: 2.2. to consider interventional biomedical research methods listed in the List which give rise to more than
p.000002: minor adverse temporary effects on the subject's health;
p.000002: 2.3. to consider interventional biomedical research methods that do not pose a risk to the health of the subject.
p.000002: 3. To instruct the Lithuanian Bioethics Committee to review the List at least once every 5 years and
p.000002: if necessary, prepare and submit to the Ministry of Health a draft amendment to the List.
p.000002: 4. It is established that this Order shall enter into force in 2015. January 1
p.000002: Minister of Health Rimantė Šalaševičiūtė
p.000002: APPROVED
p.000002: Minister of Health of the Republic of Lithuania
p.000002: 2014 31 December by order no. V-1483
p.000002: INTERVENTIONAL BIOMEDICAL INVESTIGATION METHODS WITH SMALL UNDESIRABLE TEMPORARY ADVERSE EFFECTS
p.000002: LIST
p.000002: 1. Interventions in biomedical research that have a minor adverse temporary effect on the health of the subject
p.000002: methods:
p.000002: 1.1. For the purpose of biomedical research, procedures are performed when there is a slight damage to tissues and / or organs
p.000002: integrity and which require no more than local anesthesia, or procedures for personal health
p.000002: during surgical operations or invasive and / or interventional procedures for surveillance purposes
p.000002: an additional sample of tissue, cells or body fluid is taken:
p.000002: 1.1.1. blood sampling by puncturing the capillary or peripheral vein of the finger, heel, ear cup from
p.000002: a healthy adult (other than a pregnant woman) weighing at least 50 kg, taking no more than 550 ml
p.000002: blood in 8 weeks and no more than 3 ml per kg body weight in other adults and children in 8 weeks.
p.000002: weeks;
p.000002: 1.1.2. additional blood sampling for vascular punctures performed for personal health care purposes
p.000002: and / or during catheterisation from a healthy adult (other than a pregnant woman) weighing at least 50
p.000002: kg from 20 ml of blood in 24 hours but not more than 550 ml of blood in 8 weeks, from other
p.000002: 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
p.000002: weeks;
p.000002: 1.1.3. additional blood sampling for vascular punctures performed for personal health care purposes
p.000002: and / or by taking less blood than indicated during catheterization
p.000002: 1.1.2, but during catheter lavage or anticoagulation;
p.000002: 1.1.4. taking a small sample of extra tissue, cells or body fluid during surgery or
p.000002: during other invasive and / or interventional procedures performed for personal health care purposes
p.000002: (eg, additional pleural puncture, additional tissue biopsy during endoscopy);
p.000002: 1.1.5. removal of superficial structures, skin, subcutaneous tissue, muscle biopsy.
p.000002: 1.2. For the purpose of biomedical research, the anatomical structures of the body, organ systems and / or them are performed
p.000002: functional monitoring procedures performed without compromising the integrity of the tissues and / or organs during which
p.000002: medical devices emitting ionizing radiation are used:
p.000002: 1.2.1. radiography;
p.000002: 1.2.2. dual flow radioabsorption geometry (DXA).
p.000002: 1.3. For the purpose of biomedical research, the anatomical structures of the body, organ systems and / or them are performed
p.000002: functional monitoring procedures performed without compromising the integrity of tissues and / or organs
p.000002: organ systems and / or its functions are affected by medical devices (except Minor Adverse Reactions)
...
Health / sensory impairment
Searching for indicator sensory:
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p.000002: 1.1.5. removal of superficial structures, skin, subcutaneous tissue, muscle biopsy.
p.000002: 1.2. For the purpose of biomedical research, the anatomical structures of the body, organ systems and / or them are performed
p.000002: functional monitoring procedures performed without compromising the integrity of the tissues and / or organs during which
p.000002: medical devices emitting ionizing radiation are used:
p.000002: 1.2.1. radiography;
p.000002: 1.2.2. dual flow radioabsorption geometry (DXA).
p.000002: 1.3. For the purpose of biomedical research, the anatomical structures of the body, organ systems and / or them are performed
p.000002: functional monitoring procedures performed without compromising the integrity of tissues and / or organs
p.000002: organ systems and / or its functions are affected by medical devices (except Minor Adverse Reactions)
p.000002: List of investigational methods of interventional biomedical research with a temporary effect on health (hereinafter - the List)
p.000002: Medical devices referred to in point 1.2) at a maximum of an average intensity according to the age, weight and
p.000002: his state of health:
p.000002: 1.3.1. General investigation procedures:
p.000002: 1.3.1.1. magnetic resonance imaging (without contrast);
p.000002: 1.3.1.2. bioimpedance body composition study.
p.000002: 1.3.2. Respiratory test procedures:
p.000002: 1.3.2.1. lung capacity examination;
p.000002: 1.3.2.2. diffuse lung capacity study.
p.000002: 2
p.000002: 1.3.3. Nervous system examination procedures:
p.000002: 1.3.3.1. investigation of sensory (eg auditory, visual, somatosensory) evoked potentials;
p.000002: 1.3.3.2. study of cognitive evoked potentials;
p.000002: 1.3.3.3. study of motor induced potentials;
p.000002: 1.3.3.4. electroencephalography by functional tests (eg using sound, light and
p.000002: hyperventilation).
p.000002: 1.3.4. Hearing and vision examination procedures:
p.000002: 1.3.4.1. optical coherent tomography;
p.000002: 1.3.4.2. tonometry;
p.000002: 1.3.4.3. contact pachymetry;
p.000002: 1.3.4.4. electroretinography;
p.000002: 1.3.4.5. fluorescence angiography.
p.000002: 1.3.5. Cardiovascular examination procedure - cardiopulmonary exercise examination.
p.000002: 1.4. For the purpose of biomedical research, skin or mucous membrane samples (functional tests) shall be
p.000002: a minor temporary local reaction of the skin or mucous membranes (eg redness, swelling) and when
p.000002: requires no more than local anesthesia:
p.000002: 1.4.1. skin sample with autologous serum;
p.000002: 1.4.2. photolab test;
p.000002: 1.4.3. skin patch (application) sample;
p.000002: 1.4.4. skin prick specimen;
p.000002: 1.4.5. eye surface staining with diagnostic dyes.
p.000002: 1.5. Procedures for the collection of body secretions and / or scrapings for biomedical research
p.000002: in contact with skin or mucous membranes, where this contact may cause only a small temporary local
p.000002: reaction (eg redness, slight swelling) and when the procedure requires no more than local anesthesia:
p.000002: 1.5.1. removal of skin and mucous membranes;
p.000002: 1.5.2. eye surface sampling.
p.000002: 1.6. Other interventional biomedical research methods developed by the Lithuanian Bioethics Committee,
...
Social / Age
Searching for indicator age:
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p.000002: weeks;
p.000002: 1.1.3. additional blood sampling for vascular punctures performed for personal health care purposes
p.000002: and / or by taking less blood than indicated during catheterization
p.000002: 1.1.2, but during catheter lavage or anticoagulation;
p.000002: 1.1.4. taking a small sample of extra tissue, cells or body fluid during surgery or
p.000002: during other invasive and / or interventional procedures performed for personal health care purposes
p.000002: (eg, additional pleural puncture, additional tissue biopsy during endoscopy);
p.000002: 1.1.5. removal of superficial structures, skin, subcutaneous tissue, muscle biopsy.
p.000002: 1.2. For the purpose of biomedical research, the anatomical structures of the body, organ systems and / or them are performed
p.000002: functional monitoring procedures performed without compromising the integrity of the tissues and / or organs during which
p.000002: medical devices emitting ionizing radiation are used:
p.000002: 1.2.1. radiography;
p.000002: 1.2.2. dual flow radioabsorption geometry (DXA).
p.000002: 1.3. For the purpose of biomedical research, the anatomical structures of the body, organ systems and / or them are performed
p.000002: functional monitoring procedures performed without compromising the integrity of tissues and / or organs
p.000002: organ systems and / or its functions are affected by medical devices (except Minor Adverse Reactions)
p.000002: List of investigational methods of interventional biomedical research with a temporary effect on health (hereinafter - the List)
p.000002: Medical devices referred to in point 1.2) at a maximum of an average intensity according to the age, weight and
p.000002: his state of health:
p.000002: 1.3.1. General investigation procedures:
p.000002: 1.3.1.1. magnetic resonance imaging (without contrast);
p.000002: 1.3.1.2. bioimpedance body composition study.
p.000002: 1.3.2. Respiratory test procedures:
p.000002: 1.3.2.1. lung capacity examination;
p.000002: 1.3.2.2. diffuse lung capacity study.
p.000002: 2
p.000002: 1.3.3. Nervous system examination procedures:
p.000002: 1.3.3.1. investigation of sensory (eg auditory, visual, somatosensory) evoked potentials;
p.000002: 1.3.3.2. study of cognitive evoked potentials;
p.000002: 1.3.3.3. study of motor induced potentials;
p.000002: 1.3.3.4. electroencephalography by functional tests (eg using sound, light and
p.000002: hyperventilation).
p.000002: 1.3.4. Hearing and vision examination procedures:
p.000002: 1.3.4.1. optical coherent tomography;
p.000002: 1.3.4.2. tonometry;
p.000002: 1.3.4.3. contact pachymetry;
p.000002: 1.3.4.4. electroretinography;
p.000002: 1.3.4.5. fluorescence angiography.
p.000002: 1.3.5. Cardiovascular examination procedure - cardiopulmonary exercise examination.
p.000002: 1.4. For the purpose of biomedical research, skin or mucous membrane samples (functional tests) shall be
p.000002: a minor temporary local reaction of the skin or mucous membranes (eg redness, swelling) and when
p.000002: requires no more than local anesthesia:
p.000002: 1.4.1. skin sample with autologous serum;
p.000002: 1.4.2. photolab test;
p.000002: 1.4.3. skin patch (application) sample;
p.000002: 1.4.4. skin prick specimen;
p.000002: 1.4.5. eye surface staining with diagnostic dyes.
p.000002: 1.5. Procedures for the collection of body secretions and / or scrapings for biomedical research
p.000002: in contact with skin or mucous membranes, where this contact may cause only a small temporary local
p.000002: reaction (eg redness, slight swelling) and when the procedure requires no more than local anesthesia:
p.000002: 1.5.1. removal of skin and mucous membranes;
p.000002: 1.5.2. eye surface sampling.
p.000002: 1.6. Other interventional biomedical research methods developed by the Lithuanian Bioethics Committee,
p.000002: issuing a permit for a biomedical study or issuing a consent for the clinical trial of a medicinal product
p.000002: a research certificate, or a regional ethics committee for biomedical research
p.000002: biomedical research shall, by reasoned decision, recognize as having a minor adverse temporary effect on the
p.000002: health.
p.000002: 2. The interventional biomedical research methods referred to in points 1.1 to 1.6 of the list shall not be
p.000002: a minor adverse temporary effect on the subject's health, if the Lithuanian Bioethics Committee or the regional one
p.000002: the Ethics Committee for Biomedical Research, taking into account the specific tissue taken in the biomedical research,
p.000002: 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
p.000002: other circumstances that may affect the effect of the method on the health of the subjects, decides that the biomedical
p.000002: for study subjects or a group of subjects, these methods are considered to be of greater than low concern
...
Social / Child
Searching for indicator children:
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p.000002: minor adverse temporary effects on the subject's health;
p.000002: 2.3. to consider interventional biomedical research methods that do not pose a risk to the health of the subject.
p.000002: 3. To instruct the Lithuanian Bioethics Committee to review the List at least once every 5 years and
p.000002: if necessary, prepare and submit to the Ministry of Health a draft amendment to the List.
p.000002: 4. It is established that this Order shall enter into force in 2015. January 1
p.000002: Minister of Health Rimantė Šalaševičiūtė
p.000002: APPROVED
p.000002: Minister of Health of the Republic of Lithuania
p.000002: 2014 31 December by order no. V-1483
p.000002: INTERVENTIONAL BIOMEDICAL INVESTIGATION METHODS WITH SMALL UNDESIRABLE TEMPORARY ADVERSE EFFECTS
p.000002: LIST
p.000002: 1. Interventions in biomedical research that have a minor adverse temporary effect on the health of the subject
p.000002: methods:
p.000002: 1.1. For the purpose of biomedical research, procedures are performed when there is a slight damage to tissues and / or organs
p.000002: integrity and which require no more than local anesthesia, or procedures for personal health
p.000002: during surgical operations or invasive and / or interventional procedures for surveillance purposes
p.000002: an additional sample of tissue, cells or body fluid is taken:
p.000002: 1.1.1. blood sampling by puncturing the capillary or peripheral vein of the finger, heel, ear cup from
p.000002: a healthy adult (other than a pregnant woman) weighing at least 50 kg, taking no more than 550 ml
p.000002: blood in 8 weeks and no more than 3 ml per kg body weight in other adults and children in 8 weeks.
p.000002: weeks;
p.000002: 1.1.2. additional blood sampling for vascular punctures performed for personal health care purposes
p.000002: and / or during catheterisation from a healthy adult (other than a pregnant woman) weighing at least 50
p.000002: kg from 20 ml of blood in 24 hours but not more than 550 ml of blood in 8 weeks, from other
p.000002: 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
p.000002: weeks;
p.000002: 1.1.3. additional blood sampling for vascular punctures performed for personal health care purposes
p.000002: and / or by taking less blood than indicated during catheterization
p.000002: 1.1.2, but during catheter lavage or anticoagulation;
p.000002: 1.1.4. taking a small sample of extra tissue, cells or body fluid during surgery or
p.000002: during other invasive and / or interventional procedures performed for personal health care purposes
p.000002: (eg, additional pleural puncture, additional tissue biopsy during endoscopy);
p.000002: 1.1.5. removal of superficial structures, skin, subcutaneous tissue, muscle biopsy.
p.000002: 1.2. For the purpose of biomedical research, the anatomical structures of the body, organ systems and / or them are performed
p.000002: functional monitoring procedures performed without compromising the integrity of the tissues and / or organs during which
p.000002: medical devices emitting ionizing radiation are used:
p.000002: 1.2.1. radiography;
p.000002: 1.2.2. dual flow radioabsorption geometry (DXA).
p.000002: 1.3. For the purpose of biomedical research, the anatomical structures of the body, organ systems and / or them are performed
p.000002: functional monitoring procedures performed without compromising the integrity of tissues and / or organs
p.000002: organ systems and / or its functions are affected by medical devices (except Minor Adverse Reactions)
p.000002: List of investigational methods of interventional biomedical research with a temporary effect on health (hereinafter - the List)
p.000002: Medical devices referred to in point 1.2) at a maximum of an average intensity according to the age, weight and
p.000002: his state of health:
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000002: MINISTER OF HEALTH OF THE REPUBLIC OF LITHUANIA
p.000002: ORDER
p.000002: ON INTERVENTIONAL BIOMEDICAL INVESTIGATION METHODS WHICH CAUSE SMALL UNDESIRABLE TEMPORARY ADVERSE EFFECTS
p.000002: APPROVAL OF THE LIST
p.000002: 2014 31 December No. V-1483 Vilnius
p.000002: Pursuant to the Law on Ethics of Biomedical Research of the Republic of Lithuania (Law No.
p.000002: XII-981) in accordance with Article 11 (3), as well as to ensure a uniform level of intervention for biomedical
p.000002: research methods evaluation practice:
p.000002: 1. T al i r t i n u Interventional biomedical interventions with minor adverse effects on the health of the subject
p.000002: list of research methods (attached).
p.000002: 2. It is established that the regional ethics committees for biomedical research inform the Lithuanian Bioethics Committee
p.000002: In accordance with the procedure established by the Director of the Lithuanian Bioethics Committee, about the reasons adopted in accordance with their competence
p.000002: solutions:
p.000002: 2.1. to store interventional biomedical research methods that are not specified in the one approved by this Order
p.000002: Interventional biomedical research methods with minor adverse transient health effects
p.000002: in the list (hereinafter - the List), which cause minor adverse temporary effects on the health of the subject;
p.000002: 2.2. to consider interventional biomedical research methods listed in the List which give rise to more than
p.000002: minor adverse temporary effects on the subject's health;
p.000002: 2.3. to consider interventional biomedical research methods that do not pose a risk to the health of the subject.
p.000002: 3. To instruct the Lithuanian Bioethics Committee to review the List at least once every 5 years and
p.000002: if necessary, prepare and submit to the Ministry of Health a draft amendment to the List.
p.000002: 4. It is established that this Order shall enter into force in 2015. January 1
p.000002: Minister of Health Rimantė Šalaševičiūtė
p.000002: APPROVED
p.000002: Minister of Health of the Republic of Lithuania
p.000002: 2014 31 December by order no. V-1483
p.000002: INTERVENTIONAL BIOMEDICAL INVESTIGATION METHODS WITH SMALL UNDESIRABLE TEMPORARY ADVERSE EFFECTS
p.000002: LIST
p.000002: 1. Interventions in biomedical research that have a minor adverse temporary effect on the health of the subject
p.000002: methods:
p.000002: 1.1. For the purpose of biomedical research, procedures are performed when there is a slight damage to tissues and / or organs
p.000002: integrity and which require no more than local anesthesia, or procedures for personal health
p.000002: during surgical operations or invasive and / or interventional procedures for surveillance purposes
p.000002: an additional sample of tissue, cells or body fluid is taken:
p.000002: 1.1.1. blood sampling by puncturing the capillary or peripheral vein of the finger, heel, ear cup from
p.000002: a healthy adult (other than a pregnant woman) weighing at least 50 kg, taking no more than 550 ml
p.000002: blood in 8 weeks and no more than 3 ml per kg body weight in other adults and children in 8 weeks.
p.000002: weeks;
p.000002: 1.1.2. additional blood sampling for vascular punctures performed for personal health care purposes
p.000002: and / or during catheterisation from a healthy adult (other than a pregnant woman) weighing at least 50
p.000002: kg from 20 ml of blood in 24 hours but not more than 550 ml of blood in 8 weeks, from other
p.000002: 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
p.000002: weeks;
p.000002: 1.1.3. additional blood sampling for vascular punctures performed for personal health care purposes
p.000002: and / or by taking less blood than indicated during catheterization
p.000002: 1.1.2, but during catheter lavage or anticoagulation;
p.000002: 1.1.4. taking a small sample of extra tissue, cells or body fluid during surgery or
p.000002: during other invasive and / or interventional procedures performed for personal health care purposes
p.000002: (eg, additional pleural puncture, additional tissue biopsy during endoscopy);
p.000002: 1.1.5. removal of superficial structures, skin, subcutaneous tissue, muscle biopsy.
p.000002: 1.2. For the purpose of biomedical research, the anatomical structures of the body, organ systems and / or them are performed
p.000002: functional monitoring procedures performed without compromising the integrity of the tissues and / or organs during which
p.000002: medical devices emitting ionizing radiation are used:
p.000002: 1.2.1. radiography;
p.000002: 1.2.2. dual flow radioabsorption geometry (DXA).
p.000002: 1.3. For the purpose of biomedical research, the anatomical structures of the body, organ systems and / or them are performed
p.000002: functional monitoring procedures performed without compromising the integrity of tissues and / or organs
p.000002: organ systems and / or its functions are affected by medical devices (except Minor Adverse Reactions)
p.000002: List of investigational methods of interventional biomedical research with a temporary effect on health (hereinafter - the List)
p.000002: Medical devices referred to in point 1.2) at a maximum of an average intensity according to the age, weight and
p.000002: his state of health:
p.000002: 1.3.1. General investigation procedures:
p.000002: 1.3.1.1. magnetic resonance imaging (without contrast);
p.000002: 1.3.1.2. bioimpedance body composition study.
p.000002: 1.3.2. Respiratory test procedures:
p.000002: 1.3.2.1. lung capacity examination;
p.000002: 1.3.2.2. diffuse lung capacity study.
p.000002: 2
p.000002: 1.3.3. Nervous system examination procedures:
p.000002: 1.3.3.1. investigation of sensory (eg auditory, visual, somatosensory) evoked potentials;
p.000002: 1.3.3.2. study of cognitive evoked potentials;
p.000002: 1.3.3.3. study of motor induced potentials;
p.000002: 1.3.3.4. electroencephalography by functional tests (eg using sound, light and
p.000002: hyperventilation).
p.000002: 1.3.4. Hearing and vision examination procedures:
p.000002: 1.3.4.1. optical coherent tomography;
p.000002: 1.3.4.2. tonometry;
p.000002: 1.3.4.3. contact pachymetry;
p.000002: 1.3.4.4. electroretinography;
p.000002: 1.3.4.5. fluorescence angiography.
p.000002: 1.3.5. Cardiovascular examination procedure - cardiopulmonary exercise examination.
p.000002: 1.4. For the purpose of biomedical research, skin or mucous membrane samples (functional tests) shall be
p.000002: a minor temporary local reaction of the skin or mucous membranes (eg redness, swelling) and when
p.000002: requires no more than local anesthesia:
p.000002: 1.4.1. skin sample with autologous serum;
p.000002: 1.4.2. photolab test;
p.000002: 1.4.3. skin patch (application) sample;
p.000002: 1.4.4. skin prick specimen;
p.000002: 1.4.5. eye surface staining with diagnostic dyes.
p.000002: 1.5. Procedures for the collection of body secretions and / or scrapings for biomedical research
p.000002: in contact with skin or mucous membranes, where this contact may cause only a small temporary local
p.000002: reaction (eg redness, slight swelling) and when the procedure requires no more than local anesthesia:
p.000002: 1.5.1. removal of skin and mucous membranes;
p.000002: 1.5.2. eye surface sampling.
p.000002: 1.6. Other interventional biomedical research methods developed by the Lithuanian Bioethics Committee,
p.000002: issuing a permit for a biomedical study or issuing a consent for the clinical trial of a medicinal product
p.000002: a research certificate, or a regional ethics committee for biomedical research
p.000002: biomedical research shall, by reasoned decision, recognize as having a minor adverse temporary effect on the
p.000002: health.
p.000002: 2. The interventional biomedical research methods referred to in points 1.1 to 1.6 of the list shall not be
p.000002: a minor adverse temporary effect on the subject's health, if the Lithuanian Bioethics Committee or the regional one
p.000002: the Ethics Committee for Biomedical Research, taking into account the specific tissue taken in the biomedical research,
p.000002: 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
p.000002: other circumstances that may affect the effect of the method on the health of the subjects, decides that the biomedical
p.000002: for study subjects or a group of subjects, these methods are considered to be of greater than low concern
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| age | Age |
| children | Child |
| cognitive | Cognitive Impairment |
| minor | Youth/Minors |
| pregnant | Pregnant |
| sensory | sensory impairment |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
capacity
consent
ethics
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input