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EURECNET - National Information: Poland

National Information: Poland

    Introduction

    The existing modern system of protection of interests and rights of participants in research involving human subjects covers:

    • International ethical recommendations and international law (European Union Directives)
    • National ethical recommendations and national legislation
    • A network of independent Research Ethics Committees for scientific research on human subjects


    The final component of the system was the last to appear. The first suggestions concerning the need for independent committees providing opinions on projects of biomedical research came from the USA. Only the second version of the Helsinki Declaration of 1975 recommended that independent commissions should give their opinions on research projects involving human subjects.

    In the current system Research Ethics Committees play the role of guardian of interests and rights of participants in biomedical research and also the role of arbitrator; who considers, comments, guides and approves every biomedical research project. Not in all countries, are all types of biomedical research assessed by Research Ethics Committees (e.g. Poland).

    Historical background

    The first Polish Code of Ethics, which recommended supervision over guidelines, programs and compliance with ethical and deontological principles of new methods and drugs in the pursuit of scientific knowledge, was the Collection of Ethical and Deontological Rules for the Polish Doctor approved in 1977. These guidelines were revised at the Extraordinary National Assembly of Delegates of the Polish Society of Medicine in Szczecin on 22 June 1984. The Collection of Ethical and Deontological Rules for the Polish Doctor was passed and recommended that new methods or new drugs would be introduced only by highly qualified teams and only in units entitled to do so, after obtaining prior permission from the relevant Ethics Committee. In 1989, Poland re-established the medical council which had been abolished in 1950. Two years later, a new version of the Code of Medical Ethics was created, which in art. 44 of Chapter II entitled "Scientific Research and Medical Experiments” states that: "The design of each experiment on human subjects should be clearly defined in writing and submitted for the assessment of an independent ethics committee in order to obtain consent."

    The first advocates of legal regulations concerning the creation of ethics committees were Professors Kornel Gibiński and Jan Nielubowicz in 1977. In 1982, the Ministry of Health published a decree on the Supervision Commission for Scientific Research on Human Subjects (this was the first Polish Research Ethics Committees). A network of committees was created which initially covered only medical schools, and later some medical institutions and institutes of the Polish Academy of Sciences. The first Polish Research Ethics Committee, for research on human subjects, was the Commission for Deontological Evaluation of Scientific Studies created in January 1979 by the Rector of the Medical University of Gdansk. Other commissions were subsequently set up at medical schools in Krakow, Katowice and Poznan. The mode of action of these commissions, especially in the initial period, was diverse, while in composition consisted almost exclusively of physicians. The commissions cooperated with the Central Commission established by the Ministry of Health.

    In 1997 the Medical Profession Act was published, which replaced the previously existing network of ethics committees for research on human subjects with a new network of Bioethics Committees created at medical schools, medical research and development centers and at Regional Chambers of Physicians.

    System of Local Research Ethics Committees (Bioethics Committees): Institutional Affiliation

    The current new network of ethics committees for research on human subjects was established under the Medical Profession Act. The Act also introduced a new name for the committee. Currently, ethics committees for human studies (Research Ethics Committees), which are carried out by doctors or dentists are called Bioethics Committees. Ethics committees work alongside:

    • Regional Chambers of Physicians
    • Medical colleges or universities with a medical department
    • Medical research and development units


    The committees are charged with providing opinions on medical research projects taking into account the ethical criteria, and the advisability and feasibility of the project. Each Bioethics Committee can review all types of medical research, including clinical trials of medicinal products and medical devices.

    In Poland there is a zoning of Bioethics Committees. Doctors employed in medical schools or medical research and development units should submit drafts of medical research projects to Bioethics Committees established at these institutions. All other physicians should submit drafts of medical research projects to Bioethics Committees operating at the Regional Chamber of Physicians.

    Poland has two instance system responsible for assessing medical research projects. In the case of a negative opinion about a medical experiment the researcher or sponsor of the experiment may appeal to the Appeal Bioethics Committee at the Ministry of Health (http://www.mz.gov.pl/rozwoj-i-inwestycje/nauka/komisje-bioetyczne/odwolawcza-komisja-bioetyczna/). Examination of appeals is the sole responsibility of this committee. The Appeal Bioethics Committee re-evaluates medical research projects and issues final opinions.

    Formally there is no institution coordinating the work of Bioethics Committees. The Center of Bioethics of the Supreme Medical Council (www.bioetyka.net) collects information and organizes meetings and conferences for members of Bioethics Committees.

    Which types of biomedical research involving human subjects must obtain the approval of a Bioethics Committee?

    The Constitution of the Republic of Poland (Article 39) prohibits conducting scientific experiments, including medical experiments, without voluntary consent. However, only medical experiments (i.e. experiments carried out by doctors or dentists) require notification of the Bioethics Committees. One of the types of medical experiments is clinical trials of medicinal products or clinical trials of medical device . The rules and regulations for clinical trials of medicinal products and clinical trials of medical devices are precisely regulated by Polish law (refer to legal acts).

    Poland has no regulations defining the rules of:

    • interventional studies involving human subjects other than medical experiments (e.g. experimental psychology)
    • research on human biological material
    • observational studies involving human subjects (including the analysis of records containing biomedical or other information).


    Conducting nontherapeutic medical research on conceived children is prohibited (Article 26 paragraph 3 of the Medical Profession Act)

    Polish ethical guidelines

    The Code of Medical Ethics (http://www.nil.org.pl/__data/assets/pdf_file/0003/4764/Kodeks-Etyki-Lekarskiej.pdf) sets forth the ethical rules of conduct of doctors and dentists in Poland. The ethical rules for the implementation of research and biomedical experiments are contained in Chapter II “Research and biomedical experiments” and in Chapter IIa “Relationship between doctors and the industry”. Article 41A of the Code of Medical Ethics requires the physician performing the research, and in particular medical experiments, to observe the standards and obligations under the Code of Medical Ethics and general principles of research ethics. Here, the Code cites two documents: the Helsinki Declaration (Polish translation: http://www.nil.org.pl/dzialalnosc/osrodki-naczelnej-izby-lekarskiej/orodek-bioetyki/deklaracja-helsinska2) and Good Clinical Practice (http://www.nil.org.pl/dzialalnosc/orodek-bioetyki/zasady-prawidlowego-prowadzenia-badan-klinicznych-good-clinical-practice).

    General principles of scientific research, which also apply to researchers carrying out scientific studies involving human subjects, are contained in the Code of Good Customs in Science developed by the Polish Academy of Sciences (http://www.ken.pan.pl/images/stories/pliki/pdf/down.pdf).

    Legal Situation / Implementation of the DIRECTIVE 2001/20/EC

    The legal situation in Poland Regarding Bioethics Committees is complex.

    There are several different pieces of legislation defining the role of Bioethics Committees, depending on the type of biomedical research.

    Medical research (all types)

    The Medical Profession Act of 1996 (http://isap.sejm.gov.pl/DetailsServlet?id=WDU20030900845), under Articles 21 to 29, provides legislation regarding medical experiments on humans and, basic regulations concerning Bioethics Committees. The Medical Act for example, specifies that only a physician (or a dentist) can conduct such experiments, including clinical trials. This Act was amended a few times. Detailed regulations concerning bioethics committees are specified in the Order of the Minister of Health and Social Welfare in the matter how to establish, create finance for and the mode of action of Bioethics Committees (http://isap.sejm.gov.pl/DetailsServlet?id=WDU19990470480) These two provisions contain basic regulations about bioethics committees and medical experiments.

    Clinical trials of medicinal products and clinical trials of medical devices

    The Pharmaceutical Act (http://isap.sejm.gov.pl/DetailsServlet?id=WDU20080450271) of 2004 includes, under Chapter 2a, legislation on Clinical Trials of Therapeutic Products. The detailed legislation is set out in Articles 37 a to z and aa to al, and adopts the principles of the clinical trials Directive 2001/20/EC. It also covers veterinary products. This Act was amended a few times since 2004.

    The Act about Medical Devices (http://isap.sejm.gov.pl/DetailsServlet?id=WDU20101070679) of 2004, April 20th, under Chapter 6 covers regulations about medical devises. The detailed legislation is set out in Articles 39 to 57.

    The ACT about the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, March 11, 2011 (http://isap.sejm.gov.pl/DetailsServlet?id=WDU20110820451) which specifies authorization of competent authority and relations between bioethics committees and competent authority.

    In Poland there is also the requirement to insure the investigator and the sponsor in connection with the implementation of a clinical trial of a medical product or medical device clinical trial. These principles are specified in two regulations: April 30, 2004 Order of the Minister of Finance concerning the mandatory civil liability insurance of researchers and sponsors. Legislation Journal of the Republic of Poland (2004) 101: Pos. 1034, Amended in 2005 (Dz.U. 2005 nr 101 poz. 845 - http://isap.sejm.gov.pl/DetailsServlet?id=WDU20041011034) and October 6, 2010 Order of the Minister of Finance concerning the mandatory civil liability insurance of researchers and sponsors in clinical trials of medicinal products. Legislation Journal of the Republic of Poland (2010) 194: pos. 1290. (http://isap.sejm.gov.pl/DetailsServlet?id=WDU20101941290)

    The other important national regulations concerning clinical trials are:


    The introduction of the Clinical Trials Directive 2001/20/EC has updated Pharmaceutical Law in such a way that multicenter clinical trial projects have to be evaluated by a Bioethics Committee only once in each Member State. Multicentre trial projects of medicinal products (as well as multicentre trials of medical devices) shall be reported to the Bioethics Committee of the country coordinator of the multicenter trial. The national coordinator of the multicenter clinical trial, who is one of the researchers, is appointed by the sponsor of the multicenter clinical trial. The Bioethics Committee, to which the national coordinator is subject to, assess the multicenter clinical trial project. Other Bioethics Committees can only raise objections to the regional centers, or researchers who intend to participate in the multicenter clinical trial project.

    Ethical assessment of the projects of clinical trials of medicinal products will change when Regulation No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC will apply. Polish supplementary regulations concerning this EU Regulation are not available yet.

    Number and Composition of Committees

    Now there are 53 Bioethics Committees in Poland, including 13 Bioethics Committees appointed by medical universities, 17 Bioethics Committees appointed by the medical research and development centers and 23 Bioethics Committees appointed by the Regional Chambers of Physicians and Dentists.

    The Bioethics Committee can consist of 11 to 15 members. The most common number is 13. Most of the members (2/3) are doctors. Normally apart from doctors Bioethics Committees will include: nurses, pharmacists, lawyers, philosophers and clergymen. The legislation does not limit the number of non-physician members of a Bioethics Committee nor the presence of people with different professions than previously mentioned. The committees usually meet once a month, while some committees issue opinions on a large number of projects every two weeks. The procedure of providing opinions on projects is standardized, and is based on Polish law. For more information about Polish Bioethics Committees see: (M. Czarkowski Analiza działalności polskich komisji bioetrycznych opiniujących projekty eksperymentów medycznych. WUM, Warszawa 2010, M. Czarkowski Polish Research Ethics Committees in the European Union system of assessing medical experiments. Sci Eng Ethics 2009 2: 201-12).

    Principles of financing of Polish Research Ethics Committees

    Funding for the activities of Bioethics Committees comes from fees for issuing opinions on medical research projects. It is also possible to obtain an opinion from the Bioethics Committee at no cost in the situation that the subject who appoints the Bioethics Committee (the rector of a university or the medical director of research and development unit or Regional Chamber of Physicians and Dentists) agrees to cover the costs of issuing the opinion out of his own funds. In practice, issuing opinions on medical experiments sponsored by industry (clinical trials of medicinal products or medical devices) is charged for. Research Doctors pursuing their own unsponsored medical experiments are usually exempted from fees. The fees are not uniform. They are determined by the Bioethics Committee founding bodies. The fee is on average about 2000 euros.

    The list of Polish Bioethics Committees is available at: https://www.nil.org.pl/dzialalnosc/osrodki-naczelnej-izby-lekarskiej/orodek-bioetyki/Komisje-etyczne

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