Summary

Historically, research has been tainted by incidents of unethical conduct in which vulnerable individuals were harmed. This chapter reviews events that have led to the development of codes of conduct and guidance, together with requirements to conduct ethical reviews of research involving human subjects. An overarching aim of ethical review is to protect the rights, health and well-being of research participants, utilising an approach that is sensitive to diversity, cultural values and the social and cultural context in which research is conducted. Ethical principles of respect for autonomy, beneficence, non-maleficence and justice are examined and applied to the research context as a basis for decision making. Characteristics of vulnerable groups and special considerations that can apply to their participation in research are considered. Recent developments in the arena of research governance frameworks, intended to provide accountability for the moral acceptability, scientific quality and safety of research, are also briefly reviewed.

Introduction

Research can be defined as a process of systematic enquiry involving human subjects past, present or future. In considering the moral imperative for research, few would argue with the benefits that have accrued from improvements in prophylactic, diagnostic and therapeutic procedures, the eradication of some diseases, together with improvements in quality and duration of life. The World Medical Association Declaration of Helsinki principles encapsulate key ethical principles of respect for autonomy, beneficence, non-maleficence and justice relating to medical research involving human subjects, emphasising that research is subject to ethical standards that promote respect for participants, protect their health and promote their rights:

In the conduct of research, it is vital that any foreseeable risks to the participant, whether physical, psychological or social, are removed, human dignity maintained and rights respected.