Module Objectives

This module gives the student an appreciation of ethical issues that currently affect the pharmaceutical industry and regulation of medicines. The purpose of medical research is to benefit society by the systematic acquisition of useful, empirical knowledge driven by a desire to understand the causes of disease and find effective methods of prevention or treatment.

In extreme cases, however, even such humanitarian aims can be risky. Especially as the very potential for achieving tangible benefits can feed the temptation to press on beyond acceptable boundaries and arguments about an anticipated greater good are commonly invoked by those willing to sacrifice the rights of research subjects.

In addition to humanitarian aims, scientific curiosity is another major impetus for experimentation, after all the achievements of modern medicine stem from research and advances now taken for granted were developed through experimentation, which for the most part was probably responsibly conducted according to the standards and theories available at the time.  Some research, however, involves such risk or definite harm for the participants that it clearly falls out-side all acceptable parameters. Coerced participation in research is clearly abusive but lack of opportunity to participate can also be so. These are some of the issues addressed in the course.

Intended Module Learning Outcomes

Evaluate the ethical suitability of research methodologies for the purpose of undertaking research in regulatory sciences especially with respect to vulnerable groups

Critically review the ethical issues involved in the undertaking of clinical research

Recognize the subjectivity in ethical issues which impact on research of human and non-human subjects and construct reasoned arguments for their own opinion or the opinion of others.

Demonstrate the ability to formulate effective and ethical leadership tools in Regulatory Sciences

FCD College Ethics Module