This module offers an overview of the ethical issues in clinical research ethics, i.e. the practice of investigating new drugs and treatments on humans through randomised clinical studies (RCTs). The first session of the course will discuss paradigmatic cases of research misconduct and how they have shaped the foundations of clinical research ethics. The subsequent lectures will introduce students to fundamental concepts in clinical research ethics, including: capacity and competence, informed consent, clinical equipoise, therapeutic misconception, vulnerability, exploitation, undue inducement, experimental labour, dual-use consent, among others.
The discussion-based seminars will apply these concepts to case studies and be dedicated to a critical discussion of ongoing controversies in clinical research ethics. Examples of topics that are covered in this module are:
- the off-shoring of clinical trials to low and middle income countries
- serial participation in clinical trials of healthy volunteers ('guinea pigs')
- the ethical challenges raised by conducting research on 'vulnerable' subjects such as children, pregnant women, or patients with absent of fluctuating capacity
- gene therapy trials and first-in investigational studies such as Phase 0 studies
- genetic research, biobanking, and tissue/gamete donation
- ethics of access to investigational treatments
- ethics of outsourcing medical research to contract research organisations (CROs)
Note: topics are not fixed and might be subject to change on a given year depending on ongoing controversies; module convenor strives to update content to reflect current debates.
Dr Silvia Camporesi
Term 2 for 2019/20 (10-week teaching)
Module assessment - more information
3,000 word summative essay