Study-Unit Description

Study-Unit Description


TITLE Ethical, Legal and Social Implications (ELSI) in Medical Research

LEVEL 03 - Years 2, 3, 4 in Modular Undergraduate Course


DEPARTMENT Faculty of Medicine and Surgery

DESCRIPTION This study-unit is innovative in design, featuring a series of seminars, by at least two tutors, addressing various ELSI (Ethical, Legal and Social Implications) issues that arise in scientific research, in particular in medical research. The tutors are chosen from multidisciplinary fields, such as science, medicine, law, sociology, and ethics and also include non-academic staff, such as patient advocacy groups and even patients themselves.

The seminars will focus on selected ELSI features in diverse topics, namely effective project Management (personal and interpersonal), Informed Consent and Ethical Approval, Raising Funds, Intellectual Property Rights & Commercial Interests, Data Protection and Research Errors and Fraud. Personalized medicine is addressed by evaluating Genetic and Genomic Studies and their Impact on Society, the Role of Patient Advocacy Groups, the importance of Cell and Tissue Banks and the establishment of Biobanks for Research.

The main tutor/s will provide problem cases for discussion, at least one case per tutor, preferably from real life scenarios, related to the topics discussed in the Seminar. Each student will have to review 2 cases of their choice and then present them for interactive discussion in class, using a digital format. Appraisal of the problem case should include the identification of the areas of concern, with a critical assessment of the ethical, legal and social issues followed by suggested solutions to resolve the problems. The student should also indicate the relevance of the problems outlined to their own research projects. The presentation will be followed by a class discussion.

Study-unit Aims:

The Aims are:
1. to raise awareness about the ethical and legal issues that underpin medical research;
2. to promote awareness of how society views medical research;
3. to develop critical thinking skills to identify, analyse and address ELSI issues in designing research projects; and
4. to promote a culture of multidisciplinary teamwork in problem solving of complex ELSI issues in medical research.

Learning Outcomes:

1. Knowledge & Understanding:
By the end of the study-unit the student will be able to:

1. describe the ethical issues that need to be addressed in designing and conducting research, in particular genetic and genomic research projects, with emphasis on consent and data protection;
2. describe how research ethics committees work within established regulatory frameworks;
3. outline the role of patient advocacy groups;
4. discuss the rights of investigators in terms of intellectual property rights and commercial interests;
5. outline the principles of effective teamwork;
6. describe how biobanks and tissue and cell banks operate within an established regulatory frameworks;
7. discuss the importance of clinical trials in personalized medicine; and
8. discuss the role of biobanks in promoting medical research.

2. Skills:
By the end of the study-unit the student will be able to:

1. identify the ethical issues that need to be addressed in designing and conducting research, in particular genetic and genomic research projects, with emphasis on consent and data protection;
2. write an application form for Research Ethics Approval of a research project, with particular attention to consent and Data Protection issues;
3. provide a list of sources of research funding, both local and international, and explain how to apply for research funds;
4. evaluate the sociological impact of medical research, with particular reference to genetic and genomic studies;
5. deliver effectively a class presentation on a set case, using digital tools;
6. demonstrate to the class development of analytical skills in assessing conflicting ethical and legal issues in the problem cases;
7. demonstrate to the class increasing confidence in decision making;
8. display effective communication skills during the interactive class presentations; and
9. participate in team building through effective contribution during the seminars and class presentations.

Main Text/s and any supplementary readings:

Main Text

Students will be provided with relevant online literature, including various guidelines, local laws and international legal instruments

- A guide to Research Ethics. (2003). University of Minnesota, Center For Bioethics.
- Cash, R., & Gutnick, R. et al (Eds.). (2009).Casebook on ethical issues in international health research, World Health Organization.
- Bongso, A., & Lee, E. H. (2011). Stem cells: from bench to bedside. World Scientific.
- Foster, C. (2001). The Ethics of Medical Research on Humans. Cambridge University Press.
- Lo, B. (2012). Ethical Issues in clinical research: A practical guide. Lippincott Williams & Wilkins.


- Beauchamp, T. L., & Childress, J. F. (2013). Principles of biomedical ethics. Oxford University Press, USA.
- Galea, G. (2010) Essentials of Tissue banking. 1st Edition. Springer.
- Grech, G., & Grossman, I. (Eds.). (2015). Preventive and predictive genetics: Towards personalised medicine (Vol. 9). Springer.
- Hulley, S. B. & Cummings, S. R. et al. (2013) Designing Clinical Research. Fourth Edition. Wolters Kluwer/ Lippincott Williams & Wilkins.
- McPhaul, M., & Toto, R. (2011). Clinical research: From proposal to implementation. Wolters Kluwer/Lippincott Williams & Wilkins Health.
- Rhodes, R., Francis, L., & Silvers, A. (2007). The Blackwell guide to medical ethics (Blackwell philosophy guides). Blackwell.

STUDY-UNIT TYPE Group Learning, Independent Study and Seminar

Assessment Component/s Assessment Due Resit Availability Weighting
Presentation SEM2 Yes 50%
Presentation SEM2 Yes 50%

LECTURER/S Neville Calleja
Mireille-Martine Caruana
David Cassar
Bridget Ellul
Rosienne Farrugia
George Galea
Godfrey Grech
Gillian M. Martin
Janet Mifsud
Josanne Vassallo

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The availability of optional units may be subject to timetabling constraints.
Units not attracting a sufficient number of registrations may be withdrawn without notice.
It should be noted that all the information in the description above applies to study-units available during the academic year 2020/1. It may be subject to change in subsequent years.