University of Malta

Study-Unit Description
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Apply - Admissions 2016


TITLE Research Ethics

LEVEL 05 - Postgraduate Modular Diploma or Degree Course


DEPARTMENT Moral Theology

DESCRIPTION Scientific research is important both for the theoretical knowledge it produces but also for its contribution to improved health care. Abuses in the past, however, have made it abundantly clear that science cannot function in a moral vacuum and that it is imperative that research be designed, conducted and reported in an ethically sound manner.

This study-unit will therefore focus on the issues and requirements students will encounter in their health care profession. They will be acquainted with the international and local regulations which have been set up for the ethical vigilance of scientific research and clinical trials, while enabling them to move beyond mere compliance by thinking critically about what it means to be an ethical researcher.

Learning Objectives

By the end of the course students should:

a) be able to justify experimentation on humans and animals;
b) be able to identify and analyse the ethical issues related to the design, conducting and reporting of research;
c) be able to interpret and implement policies and regulations related to research in accordance with their underlying ethical principles;
d) be able to design ethically sound research protocols and informed consent documents;
e) have an enhanced understanding of the institutional review board system in place locally.

Reading List

- Clinical Trials Regulations, 2004 (LN 490). Government of Malta, 2004.

- EUROPEAN PARLIAMENT, Directive 2001/20/EC relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (4 April 2001).

- European Economic Community Council Directive 86/609/EEC regarding the protection of animals used for experimental and other scientific purposes (24 November 1986), currently being revised.

- JONAS H, “Philosophical reflections on experimenting with human subjects”, in PA Freund (ed.), Experimentation with human subjects, New York: George Braziller, 1970, 1-31.

- KING NMP et al. (eds.). Beyond regulations: Ethics in human subjects research, Chapel Hill, NC: University of North Carolina Press 1999.

- Penslar RL (ed.), Research ethics: Cases and materials. Bloomington, IN: Indiana University Press 1995.

- The Belmont report: Ethical principles and guidelines for the protection of human subjects of research, Washington, DC: Department of Health, Education, and Welfare 1979.


Assessment Component/s Resit Availability Weighting
Assignment Yes 100%

LECTURER/S Raymond Zammit

The University makes every effort to ensure that the published Courses Plans, Programmes of Study and Study-Unit information are complete and up-to-date at the time of publication. The University reserves the right to make changes in case errors are detected after publication.
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 study-unit description above applies to the academic year 2017/8, if study-unit is available during this academic year, and may be subject to change in subsequent years.

Augustinian Institute Academic Year 2017-18

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