W przypadku konieczności uwzględnienia we wniosku zagadnień związanych z aspektami etycznymi, zachęcamy do zapoznania się z informacjami zamieszczonymi poniżej i dostosowania ich do treści Państwa wniosku.
Actions carried out under the [proposal acronym] project will comply with the ethical principles and relevant EU, national and international laws, including the Charter and the European Convention for the Protection of Human Rights and Fundamental Freedoms and its Supplementary Protocols, especially with ‘do no significant harm’ principle (A17/EU No.2020/852), and EU regulations on ethical issues, including: Directive 95/46/EC on the protection of individuals with regard to the processing of personal data and the free movement of such data, Directives 2001/20/EC and 2005/28/EC related to the implementation of good clinical practice in clinical studies, EU Directive 2004/23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (OJ L 102, 7.4.2004, p. 48), Directive 2010/63/EU on the protection of animals used for scientific purposes, and Directive 2009/41/EC on the continued use of genetically modified microorganisms. [proposal acronym] will involve close cooperation with the MUB Bioethics Committee as well as local ethics committees, particularly in relation to the clinical and animal studies planned. Partners within the [proposal acronym] project will follow other docuemnts related to international guidance, including the Declaration of Helsinki of the World Medical Association, International Ethical Guidelines for Biomedical Research Involving Human Subjects of the Council for International Organisations of Medical Sciences (CIOMS), Charter of Fundamental Rights of the European Union (2000/C364/01), Convention on Human Rights and Biomedicine of the Council of Europe (CETS 164), International Declaration on Human Genetic Data adopted by UNESCO on 16 October 2003, and Universal Declaration on Bioethics and Human Rights adopted by UNESCO on 19 October 2005.
[proposal acronym] may involve clinical studies as defined by the Clinical Trials Regulation (EU 536/2014), using pharmaceuticals, biologicals, radiopharmaceuticals, or advanced therapy medicinal products. The clinical trials conducted within the framework of the project will be low-interventional, compliant with the specific regulations, and the necessary permissions will be obtained for them.
All data processing performed throughout the project will comply with the General Data Protection Regulation (EU 2016/679).
The research planned in this project will be conducted in accordance with EU Directives: 2000/43/EC, 2000/78/EC, 2004/113/EC, and 2006/54/EC. It means that we are going to avoid discrimination based on such factors as 'sex, race, colour, language, religion, political or other opinion, national or social origin, association with a national minority, property, birth or other status' (cited from Article 14 EU Charter of Fundamental Rights). Thus, we will utilize explainable machine learning to ensure (if applicable) that the models trained during this project will not discriminate based on these grounds.
[proposal acronym] will comply with all relevant Polish ethics-related regulations:
❏ Act of 26 June 1974 – Labour Code ( Journal of Laws [Dziennik Ustaw] of 2019, Item 1040, as amended).
❏ Act of 5 December 1996 on the Professions of Doctor and Dentist (Journal of Laws [Dziennik Ustaw] of 2019, Items 537, 577, 730, 1590).
❏ Act of 6 September 2001 – Pharmaceutical Law (Journal of Laws [Dziennik Ustaw] of 2019, Item 499, as amended).
❏ Act of 6 November 2008 on the Patient's Rights and the Patient Ombudsman (Journal of Laws [Dziennik Ustaw] of 2009, No. 52, Item 417).
❏ Regulation of the Minister of Health of 2 May 2012 on Good Clinical Practice (Journal of Laws [Dziennik Ustaw] of 2012, Item 489).
❏ Act of 15 January 2015 on the Protection of Animals Used for Scientific or Educational Purposes (Journal of Laws [Dziennik Ustaw] of 2015, Item 266 as amended).
❏ Act of 10 May 2018 on the Protection of Personal Data (consolidated text, Journal of Laws [Dziennik Ustaw] of 2019, Item 1781).
❏ Act of 20 July 2018 – Law on Higher Education and Science (Journal of Laws [Dziennik Ustaw] of 2018, Item 1668 as amended).
❏ Act of 9 March 2023 on Clinical Trials of Medicinal Products for Human Use (Journal of Laws [Dziennik Ustaw] of 2023, Item 605).
[proposal acronym] will comply with all relevant MUB ethics-related regulations:
❏ Resolution No. 55/2011 of the Senate of the Medical University of Bialystok of 13 June 2011 on the adoption of the Code of Ethics of the Medical University of Bialystok.
❏ Resolution No. 58/2019 of the Senate of the Medical University of Bialystok of 27 June 2019 on the adoption of the Statute of the Medical University of Bialystok, Human Resources Strategy for Researchers including provisions of the European Charter for Researchers and the Code of Conduct for the Recruitment of Researchers of Medical University of Bialystok introduced by Rector’s Regulation No. 53/16 of 9 September 2016.
❏ Resolution No. I/2020 Senate of the Medical University of Bialystok of 26 November 2020 on the adoption of the Code of Ethics of an Academic Employee.
CLINICAL TRIALS:
❏ Act of 13 October 1998 on the Social Insurance System (Journal of Laws [Dziennik Ustaw] of 2019, Item 300).
❏ Regulation of the Minister of Health and Social Welfare of 11 May 1999 on the Detailed Rules of Appointment, Financing and Mode of Operation of Ethics Commitees (Journal of Laws [Dziennik Ustaw] of 1999, No. 47, Item 480).
❏ Regulation of the Minister of Finance of 30 April 2004 on Obligatory Civil Liability Insurance for the Investigator and Sponsor (Journal of Laws [Dziennik Ustaw] No. 101, Item 1034 as amended).
❏ Regulation of the Minister of Health of 30 April 2004 on reporting serious unexpected adverse reactions to a medicinal product (Journal of Laws [Dziennik Ustaw] of 2004, No. 104, Item 1107).
❏ Regulation of the Minister of Health of 30 April 2004 on Clinical Trials on Minors (Journal of Laws [Dziennik Ustaw] of 2004, No. 104, Item 1108).
❏ Act of 20 May 2010 on Medical Devices (Journal of Laws [Dziennik Ustaw] of 2019, Item 175).
❏ Regulation of the Minister of Finance of 6 October 2010 on the mandatory civil liability insurance of researchers and sponsors in clinical trials of medicinal products (Journal of Laws [Dziennik Ustaw] of 2010, No. 194, Item 1290).
❏ Act of 18 March 2011 on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
❏ Regulation of the Minister of Health of 26 April 2012 on Inspections of Clinical Trials (Journal of Laws [Dziennik Ustaw] of 2012, Item 477).
❏ Regulation of the Minister of Health of 2 May 2012 on the application forms of documents submitted due to the clinical trial of medicinal products and about the amount of charges and the way of their payments for the commencement of clinical trials (Journal of Laws [Dziennik Ustaw] ofthe Republic of Poland).
❏ Act of 15 January 2015 amending the Act on Genetically Modified Organisms and other acts (Journal of Laws [Dziennik Ustaw] of 2015, Item 277).
❏ Regulation of the Minister of Science and Higher Education of 5 May 2015 on the National Ethical Committee for Animal Experiments and the local ethics committees for the animal experiments (Journal of Laws [Dziennik Ustaw] of 2019, Item 1019).
❏ Regulation of the Minister of Health of 20 October 2015 on preparations containing narcotic drugs or psychotropic substances, which can be owned and used for medical purposes and for clinical trials, after obtaining the consent of the provincial pharmaceutical inspector (Journal of Laws [Dziennik Ustaw] of 2015, Item 1819).
❏ Regulation of the Minister of Health of 9 November 2015 on requirements of Good Manufacturing Practice (Journal of Laws [Dziennik Ustaw] of 2015, Item 1979).
❏ Regulation of the Minister of Health of 16 February 2016 on the detailed requirements for the planning, conducting, monitoring and documenting clinical study of a medical device (Journal of Laws [Dziennik Ustaw] of 2016, Item 209).
❏ Regulation of the Minister of Health of 17 February 2016 on application forms related to the clinical trial selection of the medical device or implantable medical device and fees for the submission of applications (Journal of Laws [Dziennik Ustaw] of 2016, Item 208).