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 European Union, 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 not significant harm’ principle (A17/EU No.2020/852) and EU regulations on ethical issues, including Directive 95/46/EC on the protection of individuals regarding personal data processing and free movement, Directives 2001/20/EC, 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) and Directive 2010/63/EU on the use of animals for scientific purposes and the Directive 2009/41/EC of the European Parliament and the Council of 6 May 2009, on the use of genetically modified microorganisms. [proposal acronym] will work closely with the MUB Bioethics Committee and local ethics committees, particularly in relation to the clinical and animal studies planned. [proposal acronym] partners will also consider other international guidance, including The Declaration of Helsinki by the World Medical Association, The International Ethical Guidelines for Biomedical Research Involving Human Subjects by the Council for International Organisations of Medical Sciences (CIOMS), The “Charter of Fundamental Rights” of the European Union (2000/C364/01), The Convention of the Council of Europe on “Human Rights and Biomedicine” (CETS 164), The Declaration on Human Genetic Data adopted by UNESCO on 16 October 2003, and The 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 Trial Regulation (EU 536/2014), using pharmaceuticals, biologicals, radiopharmaceuticals or advanced therapy medicinal products. The clinical trials conducted in the framework of the project will be low-interventional, comply with the specific regulations, and obtain permissions.
All data processing performed by the project will be compliant with the General Data Protection Regulation (EU 2016/679).
The research planned in this project will be conducted following EU Directives 2000/43/EC, 2000/78/EC, 2004/113/EC, and 2006/54/EC. It means that we avoid discrimination based on the 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 on the Labour Code (Official Journal of Laws 2019 Item 1040, as amended).
❏ Act of 5 December 1996 on the Medical and Dental Professions (Journal of Laws 2019, Items 537, 577, 730, 1590).
❏ Act of 6 September 2001 - Pharmaceutical Law (Journal of Laws 2019, Item 499, as amended).
❏ Act of 6 November 2008 on the Patient's Rights and the Patient Ombudsman (Official Journal of Laws of 2009, No. 52, Item 417).
❏ Regulation of the Minister of Health of 2 May 2012 on Good Clinical Practice (Journal of Laws 2012, Item 489).
❏ Act of 15 January 2015 on the protection of animals used for scientific or educational purposes (Official Journal of Laws of 2015, Item 266 with later amendments).
❏ Act of 10 May 2018 on the Protection of Personal Data (consolidated text, Journal of Laws 2019, Item 1781).
❏ Act of 20 July 2018 – Law on Higher Education and Science (Journal of Laws of 2018, Item 1668 with amendments).
❏ Act of 9 March 2023 on Clinical Trials of Medicinal Products for Human Use (Official Journal of Laws 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 Security System (Official Journal of Laws of 2019, Item 300).
❏ Order of the Minister of Health and Social Welfare of 11 May 1999 on the Detailed Rules of Appointment, Financing and Mode of Operation of the Bioethical Commissions (Official Journal of Laws 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 No. 101, Item 1034 and Journal of Laws No. 101, Item 845).
❏ Order of the Minister of Finance of 30 April 2004 on the mandatory civil liability insurance of researchers and sponsors (Official Journal of Laws of 2004, No. 101, Item 1034), amended in 2005 (Official Journal of Laws 2005 No. 101, Item 845).
❏ Order of the Minister of Health of 30 April 2004 on reporting of unexpected serious adverse reaction to a medicinal product (Official Journal of Laws of 2004, No. 104, Item 1107).
❏ Order of the Minister of Health of 30 April 2004 on Clinical Trials on Minors (Official Journal of Laws of 2004, No. 104, Item 1108).
❏ Act of 20 May 2010 on Medical Devices (Official Journal of Laws 2019, Item 175).
❏ Order 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 (Official Journal of Laws of 2010, No. 194, Item 1290).
❏ Act of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of 18 March 2011.
❏ Regulation of the Minister of Health of 26 April 2012 on inspections of clinical trials (Journal of Laws 2012, Item 477).
❏ Order 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. Legislation Journal of the Republic of Poland.
❏ Act of 15 January 2015 – Law on Genetically Modified Organisms and other acts (Official Journal of Laws of 2015, Item 277).
❏ Order 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 (Official Journal of Laws of 2019, Item 1019).
❏ Order 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 (Official Journal of Laws of 2015, Item 1819).
❏ Order of the Minister of Health of 9 November 2015 on requirements of Good Manufacturing Practice (Official Journal of Laws from 2015, Item 1979).
❏ Order 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 (Official Journal of Laws of 2016, Item 209).
❏ Order 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 (Official Journal of Laws of 2016, Item 208).