Research Ethics 3800-BE-EBN
This is a seminar in research ethics. Its primary goal is to provide students with conceptual, theoretical and methodological tools necessary to understand and analyze problems of research practice, in particular biomedical research involving human subjects and research on animals. Secondarily, it is designed to help students develop analytical and argumentative skills necessary for identifying, examining and resolving ethical dilemmas brought about by the rapid development of biomedical sciences.
The course covers following topics:
I - Research Integrity
1) Science and ethos of researchers.
2) Good research practice: main principles and forms of scientific misconduct.
3) Ethical management of research data and results. Open science policy.
4) Publication and peer review ethics.
5) Conflict of interests in research.
II – Ethics of biomedical research involving humans.
6) History on research ethics and research governance.
7) Princia ethica for biomedical research on humans. Dignity and human rights.
8) Principle of respect for persons. Informed consent for research.
9) Problems with obtaining informed consent.
10) Principle of beneficience in research. Clinical Equipoise.
11) Models of risks-benefits assessment in research.
12) Special protection of vulnerable participants and/or populations.
13) Principle of justice. Justice and international research .
14) Research on biological material of human origin. Biobanks.
15) Ethical review of human research protocols.
16-18) WORKSHOP (6 hrs) - REC simulation
III – Research in social sciences.
19) Ethics of covert research and the use of deception in research.
20) Ethics of social research and cultural diversity.
21) Ethics of internet research and social media research.
22-23) WORKSHOP (4 hrs) - REC simulation.
IV – Ethics of animal research, embryo research, and research using alternative models and tools.
24) Ethics of animal research. History and evolution of the practice.
25) Ethics of animal research. Basic principles: 3Rs. Ethical review.
26) WORKSHOP (2 hrs) Ethical review of animal research protocols.
27) Ethics of human embryo research.
28) Ethics of human organoid research.
29) Ethics of Big Data and AI research.
These topics are primarily analyzed from an ethical perspective. However, since research ethics is a highly practical and interdisciplinary field, attention is also given to the medical, legal, and sociological aspects of research practices. The course is conducted in a seminar format. Teaching methods include short interactive lectures, student presentations, discussions, group work, and case analysis. There are also workshops that simulate the work of research ethics committees reviewing protocols for research involving humans or animals.
Type of course
Course coordinators
Term 2024: | Term 2025: |
Learning outcomes
KNOWLEDGE
At the end of the seminar, the student has in-depth knowledge of and understanding of:
- the history, origins, and nature of research ethics, as well as its subject matter, methodological specificity, and links with various disciplines and subdisciplines of science and social practice;
- the role of research ethics and bioethics in the practice and development of biomedical sciences and other life sciences;
- advanced, multi- and interdisciplinary terminology used in research ethics;
- ethical issues in contemporary research practices in the biomedical and other life sciences, as well theoretical and research perspectives, axiological and normative assumptions, and methods of research ethics;
- the origins, objectives, and rules that govern the organization and functioning of research ethics committees and animal experimentation ethics committees in Poland;
- the most important rights of research participants as well as the legal and institutional mechanisms for protecting these rights;
- Polish legal regulations concerning research activities, including the conduct of medical experiments and clinical trials;
- rules for protecting intellectual property in the context of scientific research.
SKILLS
At the end of the seminar, the student is able to:
- identify ethical problems and conflicts that arise in the research practice;
- critically analyse oral and written statements by other authors in the field of research ethics, including reconstructing theses, identifying factual and normative assumptions, and critically evaluating the correctness and strength of arguments;
- conduct an ethical review of a research project involving humans or non-human animals in an orderly and methodical manner; formulate and substantively justify an ethical opinion on the project;
- prepare or evaluate a draft regulatory document setting out the rules for the functioning of entities involved in research practice;
- apply legal provisions and recognized ethical guidelines to solve specific research practice problems or cases;
- conduct a debate on subjects connected to research ethics;
- communicate, in particular on topics related to research ethics, with specialists and non-specialists in this field, including through various channels and information and communication technologies;
- prepare a short written paper on a topic related to research ethics in accordance with the rules for writing papers of this type;
- prepare and deliver an oral presentation on a topic related to research ethics;
- manage the work of the team and cooperate within the group, in particular participate in the group preparation of opinions on submitted research projects;
- independently acquire knowledge and develop skills in the field of research ethics.
SOCIAL COMPETENCES
At the end of the seminar, the student is able to:
- critically evaluate their knowledge, acquired information, and received content;
- recognize the importance of knowledge in the fields of research ethics and law in solving problems arising from the research practice; seek expert advice when encountering difficulties in solving these problems independently;
- engage in the design and conduct of consultative, advisory, and regulatory activities to raise ethical standards in Polish research practice, particularly in the field of biomedical sciences and other life sciences
- active participation in ongoing debates and disputes concerning the ethics of scientific research, with a sense of shared responsibility for shaping Polish political, public, and media discourse on these issues;
- develop research ethics, reliably and responsibly as a theoretical field and social practice;
- recognize ethical, legal, and sociocultural problems and challenges related to their own research and professional work, in particular, to comply with, develop, and promote ethical standards for research ethics committees and various committees for research integrity.
Assessment criteria
Final EXAM grade is based upon:
- Activity in the class - 20%
- Oral presentations (2) - 10%
- Written analysis of a research protocol - 20%
- Written analysis of a regulatory document - 20%
- Oral exam - 30%.
100-90% - 5,0; 89-85% - 4,5; 84-75% - 4,0; 74-70% - 3,5; 69-60% - 3,0; 59-0% - 2,0
Two absences are allowed in a term.
Bibliography
Main sources (in alphabetical order):
-- E.J. Emanuel, R. Crouch, J. Arras, J. Moreno, C. Grady (eds.), Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary, Johns Hopkins University Press, Baltimore, Maryland 2003.
-- E.J. Emanuel, Ch.C. Grady, R. A. Crouch and R. K. Lie (eds.), The Oxford Textbook of Clinical Research Ethics, Oxford University Press 2011.
-- W. Galewicz (red.), Badania z udziałem ludzi, Universitas, Kraków 2010.
-- J. Huges (ed.), European Textbook on Ethics in Research, European Commission Directorate-General for Research, Publications Office of the European Union, Luxembourg 2010.
-- F.L.Macrina, Scientific Integrity: Text And Cases in Responsible Conduct Of Research, 3 edition, Amer Society for Microbiol 2005.
-- D.M. Mertens, P.E. Ginsberg, The Handbook of Social Science Research, SAGE Publications 2009.
-- J. Różyńska, M. Waligóra (red). Badania naukowe w biomedycynie z udziałem ludzi. Standardy międzynarodowe, Wolters Kluwer, Warszawa 2012.
-- E. Shamoo, D. B. Resnik, Responsible Conduct of Research, Oxford University Press 2022.
-- European Commission, DG Research & Innovation, Ethics in Social Science and Humanities, Brussels 2021.
Regulatory standards
Additional information
Additional information (registration calendar, class conductors, localization and schedules of classes), might be available in the USOSweb system: