Consolidated version from 13/09/2018
The order was published: TAR 2016-01-08, i. k. 2016-00453
MINISTER OF HEALTH OF THE REPUBLIC OF LITHUANIA
ORDER
ON EXPENDITURE INCURRED AND TIME TAKEN FOR PARTICIPATION
APPROVAL OF THE DESCRIPTION OF THE COMPENSATION CALCULATION AND PAYMENT PROCEDURE IN A BIOMEDICAL INVESTIGATION
2016 January 8 No. V-15 Vilnius
Pursuant to Article 10 of the Law on Ethics of Biomedical Research of the Republic of Lithuania and the Republic of Lithuania
Government 2000 August 18 Resolution no. 940 “On the granting of powers in the implementation of Lithuania
Of the Republic of Latvia on the Ethics of Biomedical Research ”:
1. Compensation for costs and time incurred in participating in a biomedical study
a description of the calculation and payment procedure (attached).
2. In view of the resignation of the Minister of Health of the Republic of Lithuania in 2000.
November 23 order no. 677 “Regarding the calculation of the costs incurred by the subjects for the biomedical research and
approval of the payment procedure ’.
Minister of Health Rimante
Šalaševičiūtė
APPROVED
Minister of Health of the Republic of Lithuania
2016 January 8 by order no. V-15
CALCULATION AND PAYMENT OF REIMBURSEMENT OF COSTS AND TIME LOST IN PARTICIPATING IN A BIOMEDICAL INVESTIGATION
DESCRIPTION OF THE PROCEDURE
CHAPTER I GENERAL PROVISIONS
1. Calculation and payment of compensation for costs incurred and time spent participating in a biomedical study
The Description of the Procedure (hereinafter referred to as the Description of the Procedure) establishes the compensation of the subjects for the participation
the procedure for calculating and paying the costs incurred and the time spent in the biomedical research (hereinafter - compensation).
2. The terms used in the description of the procedure are defined in the Law on Ethics of Biomedical Research of the Republic of Lithuania and
in other legislation.
3. Compensation for subjects shall be paid by the sponsor of the biomedical study or a person authorized by the sponsor (hereinafter
person paying compensation).
4. Compensation shall be paid only in the written agreement of the person paying the compensation and the subject, i. i.e. when it is
provided in the Informed Person Consent Form in accordance with the Minister of Health of the Republic of Lithuania 2016 January
8 d. by order no. V-28 “On Informed Person's Consent to Participate in Biomedical Research and Information on
requirements for biomedical research and informed consent to participate in biomedical research; and
approval of the description of the revocation procedure ”.
Item changes:
No. V-1004, 11/09/2018, published in TAR on 09/09/2018, i. k. 2018-14404
CHAPTER II PROCEDURE FOR CALCULATING THE COMPENSATION
5. Compensation for the costs incurred in participating in a biomedical research shall be calculated
summing up all the actual costs incurred by the subject for participating in the biomedical study on the basis of the following
supporting documents for expenditure.
6. The subject shall be reimbursed for the following costs incurred in participating in the biomedical research:
6.1. travel to a biomedical research center located in a different residential area than the subject
habitual residence, and return from it to the subject's habitual residence and travel
costs in the residential area where the biomedical research is carried out:
6.1.1. acquisition of travel documents (travel tickets) for all types of public transport, except
passenger cars by taxi, and in the residential area where the biomedical research is carried out, by all
types of public transport. These costs are reimbursed according to the data provided by the researcher
travel documents (travel tickets) or, if they are not submitted, in accordance with the procedure established by legal acts
approved fares for the carriage of passengers by bus and / or local train in the lowest class. Return
the costs of the subject's habitual residence may be reimbursed in conjunction with travel to the biomedical examination
costs without providing travel documents;
6.1.2. the cost of pre-purchasing and booking public transport tickets,
paid upon submission of relevant documents (receipts);
6.1.3. fuel used during the journey in the vehicle, rented or leased
acquisition costs. These costs shall be reimbursed on the basis of the number of kilometers traveled and
the fuel consumption rates approved by the person paying the compensation for the vehicle in question in accordance with
the manufacturer of the vehicle concerned
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the technical data of the vehicle (fuel consumption rates per 100 kilometers). In the study
the make, model and registration number of the vehicle must be indicated in the documents;
6.1.4. the cost of parking a car in a residential area where a biomedical one is performed
research;
6.2. the costs of renting a dwelling in a residential area where a biomedical research is carried out are reimbursed
according to the rental bills paid for by the research subject (for one place) or, if the research subject does not have
a document certifying the rental costs of the dwelling, - the person paying the compensation
the established procedure and amounts for the payment of the living space rental costs;
6.3. not less than 5 per cent of the basic social benefit approved by the Government of the Republic of Lithuania
daily allowance for each day of participation in a biomedical study
biomedical research center, if the subject is not fed at the biomedical research center, the following
cases:
6.3.1. when the subject visits a biomedical research center located in a different residential area than
the subject's habitual residence lasting more than one day;
6.3.2. when the biomedical research is performed in the residential area where the subject is domiciled
location, but due to the conditions of communication and / or the nature of the biomedical research being performed, there are no conditions for daily return
to a place of permanent residence;
6.4. communication (postal and telecommunications) costs;
6.5. the cost of local fees applicable in the residential area where the biomedical practice is performed
research;
6.6. other costs incurred as a result of participating in the biomedical research for which reimbursement is made
the subject and the person paying the compensation agreed in writing.
7. The person paying the compensation may determine the maximum compensation specified in Item 6 of the Description of the Procedure
expenditure amounts.
8. Compensation for time lost shall be calculated on the basis of the actual participation in the biomedical research
time spent (time spent at a biomedical research center and time spent arriving at a biomedical research center
center and return from him to the subject’s habitual residence). Subjects are compensated for one
the hour spent participating in a biomedical study may not exceed the average hourly wage calculated
Published by the Lithuanian Department of Statistics for the last quarter of the national economy (excluding individual enterprises
wage data) by dividing the average monthly gross wage of employees by Lithuania
Annual average monthly working hours approved by the Minister of Social Security and Labor of the Republic
five working days a week. Compensation to the researcher for participating in a biomedical research
the time spent during a calendar month may not exceed the last one published by the Lithuanian Department of Statistics
quarterly average monthly earnings of employees in the national economy (excluding wage data of individual enterprises)
gross wages and salaries.
Item changes:
No. V-1004, 11/09/2018, published in TAR on 09/09/2018, i. k. 2018-14404
CHAPTER III PROCEDURE FOR PAYMENT OF COMPENSATION
9. The research subject must submit the documents confirming the expenses specified in Item 6 of the Description of the Procedure or, if
none, - a request for reimbursement of these costs to the person paying the compensation for his participation
during the biomedical study or no later than 30 calendar days after the participation of the subject
end of biomedical research.
10. Compensation must be paid to the subject:
10.1. if the research subject submits the documents specified in Item 9 of the Description of the Procedure or a request for reimbursement of expenses
during the biomedical research, - not later than during the next visit to the biomedical research center;
3
10.2. if the research subject submits the documents specified in Item 9 of the Description of the Procedure or a request for reimbursement of expenses
during the last visit to the biomedical research center or after participation in the biomedical research
- within 3 working days from their submission within the term specified in Item 9 of the Description of the Procedure.
CHAPTER IV FINAL PROVISIONS
11. Complaints regarding the payment of compensation shall be resolved in accordance with the Law of the Republic of Lithuania on Ethics in Biomedical Research 25
in accordance with the procedure referred to in Article
Changes:
1.
Ministry of Health of the Republic of Lithuania, Order
No. V-1004, 11/09/2018, published in TAR on 09/09/2018, i. k. 2018-14404
Regarding the Minister of Health of the Republic of Lithuania in 2016 January 8 order no. V-15 “On the costs incurred and
a description of the procedure for calculating and paying compensation for time spent on participation in a biomedical study
approval "