Research Ethics

obligatory courses

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.

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. Scientific misconduct

3) Publication and peer review ethics

4) Conflict of interests in research

II – Ethics of biomedical research involving human subjects

5) History on research ethics and research law

6) Princia ethica for biomedical research on humans. Dignity and human rights

7) Principle of respect for persons. Informed consent for research.

8) Problems with obtaining informed consent

9) Principle of beneficience in research. Clinical Equipoise

10) Balancing risks and benefits in research.

11) Protection of vulnerable subjects and populations.

12) Principle of justice. Fair selection of research subjects. Fair access to research benefits.

13) Justice and international research

14) Ethical review of human research protocols.

15-17) WORKSHOP (6 hrs) - REC simulation

III – Selected problems of human research

18) Research in social sciences.

19) Research on biological material of human origin. Biobanks.

20) Research on human genome.

21) Research on human embryos.

22) Epidemiological research.

IV – Ethics of animal research

23) Moral status of animals

24) Principles for research on animals. 3Rs.

25) Ethical review of animal research protocols.

26-27) WORKSHOP (2 hrs) - Animal REC simulation

28) Research and natural environment.

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 2009.

Regulatory standards

Knowledge:

- knowledge of the multi- and interdisciplinary terminology used in research ethics;

- enhanced knowledge of the subject-matters and methodology of contemporary research ethics: main problems, theoretical and research approaches, main axiological and normative positions;

- understanding of the multi- and interdisciplinary nature of research ethics;

- comprehensive knowledge of the role of ethics in research practice

- understanding of the role of socio-cultural, legal and economic factors in development of biomedical science and technology;

- knowledge of the methods of ethical review of research protocols.

Skills:

- critical analysis of the scholarly texts relating to the subject-matter of the course;

- adequate identification and interpretation of the ethical problems in research practice;

- adequate argumentation and construction of defensible normative and factual arguments, and response to criticism;

- advanced skills of preparation of oral presentations concerning the topics of the course;

- advanced skills of preparation of written analytical-critical texts associated with the topics of the course;

- ability to conduct an ordered and methodical ethical review of research protocols, based on the knowledge acquired during the course;

- advanced research under the supervision of the instructor in the filed of research ethics;

- selection, analysis and evaluation of information relevant to problems of research ethics.

Social competencies:

- appreciation of ethical reflection in research practice;

- identification of ethical problems associated with research in the field of research ethics, sense of responsibility towards co-workers and other members of society, active participation of problem-solving;

- thoroughness and involvement in designing, planning, and realization of research activities;

- initiation of research and professional activities;

- cooperation in group in different team roles;

- interest in public debates on research ethics issues.

Final grade is based upon:

Activity - 20%

Oral presentation - 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.