Ethics Commission of the Ministry of Health of the Slovak Republic

Material
Methodological guidance Slovak Public Health Office Republics to the Immunological Review in the Slovak Republic in 2018

Adopted on 31 May 2018

Ethical Commission of the Ministry of Health of the Slovak Republic (hereinafter referred to as the at the request of the Minister for Health, meeting in Bratislava on 9 May 2018 as well as in the following period of professional Consultations and votes of 30 and 31 May 2018 dealt with the material of the public health authority's methodological guidance Slovak Republic for immunological overview in Slovak Republic in year 2018-2018 (hereinafter referred to as the "Guidelines') and came to the following opinion:

The Commission is aware of the importance of preparing guidelines to ensure that carrying out an immunological review in the Slovak Republic in 2018, which represents a significant social benefit due to changing immune situation the population, not only in Slovakia but also throughout the European Union. The issue of immunity of the population has been in Slovakia since 2002 inadequately processed. Therefore, the current epidemiological the information to be obtained is the objective of the intended immunological surveillance; and necessary to ensure rational prevention and other measures and procedures aimed at protecting public health. Membership The Slovak Republic (SR) in the European Union, together with the fulfilment of requirements freedom of movement for persons, goods and services, as well as the so-called migration crisis and others current problems present new challenges which must also be adequately addressed public health institutions.

The Commission believes that the procedures proposed in the immunological review help protect the public interest and represent an important medically important legal and ethical benefits, in particular in the realisation of the central values of constitutional order of the Slovak Republic, such as human dignity, fair access to health care and equality in the rights of individuals. To protect these values are mainly supported by efforts to objectivity of the immune state of the population, information on prevalence of relevant antibodies or other serological features the infection as well as an estimate of the burden on the population selected by communicable diseases.

The Commission is also aware of some methodological Conclusions limitsthe immunological surveillance obtained. This is mainly due to the fact that certain part of the population is not interested in participating in similar surveys, whether due to Ignorance or tradition of lack of cooperation with public institutions. This is the proportion of the population that represents the important a component in assessing the state of immunity of the population. Despite these limits, the findings of the immunological review can provide very valuable information.

The Commission is also aware of other possible risks that may arise in the the preparation of the guidelines. This is particularly the issue of instruction and information in expressing the free expression of the will of the participants. The Commission is convinced of the need to comply with all essential legal requirements the form of informed consent. It also recommends placing special emphasis on protection the rights of persons who are not competent to give informed consent.

The key theme in implementing the overview must also be protection of personal dataits participants. The Commission is aware that the individual's right to protection against the unauthorised collection of data on his person is a fundamental human right; and as such must enjoy a high degree of legal protection. The Commission is also aware of the dynamics of forms and methods of information acquisition in biomedical research, as well as changes in legislation, such as the adoption of No.18/2018 Coll. on Personal Data Protection and Amendment certain laws. The Commission also considers that when processing personal data in the context of the implementation of a given immunological overview is very specific data which may be relevant for the protection of the rights and freedoms of other persons. Therefore, on the one hand, to respect the meaning and substance of personal data and on the other hand, the protection of the legitimate interests of other persons and the consideration of other ethical considerations; and legal values.

On the basis of the above, the Commission concludes that, despite the risks involved, ethically beneficial and immunological overview established by This guidance can bring substantial benefits for better protection of essential values from which the Slovak Republic is based.

The Commission also notes that, from an ethical point of view, it does not object implementation of the intended immunological overview in accordance with the procedures described in the consolidated version of the Guideline.

Note

The members of the Commission were briefed at the Commission meeting on 9 May 2018. with the original and partially supplemented and modified version of the Guideline which has arisen following substantive consultations of the submitters with certain members of the Commission, in particular with Capitol 4, which addresses the ethical issues of the planned overview and Annexes 2a to 2e (draft forms for related forms). The above materials; and the information provided by the members of the Commission has provided further factual comments, and recommendations. After discussion and subsequent inclusion of comments by representatives the submitter has produced a consolidated, definitive version of the guidelines which became the basis for the adoption of the opinion of the Commission in the vote of the 30th - 31 May 2018.

Place: In Bratislava– Date:31 May 2018