Research and Ethical Approval
For most of its history, biomedical research has been conducted in a
relatively unregulated environment, with research justified solely on
the basis that the activity ultimately benefits mankind. Research
subjects often felt obliged to participate, with little or no hope of
personal benefit. In this module, we will look at how attitudes,
conditions, standards and safeguards have developed and changed over the
last hundred years, including the emergence of substantial human rights
protections, and protocols for protecting 'vulnerable' patient-subjects.
Today, modern medical research is guided by a literal profusion of codes
of practice, professional association and research committee guidelines,
international protocols and national legislation. Research purposes,
effectiveness and methods now have to be stringently justified, subject
to broad principles and high standards of good clinical practice.
Aims & objectives
To become familiar with standards that have been established and
accepted both internationally and nationally, and gain an appreciation
for both the potential benefits and problems associated with research
conducted on human subjects in general;
Survey the particular difficulties inherent in constructing ethical
research protocols that require the use of 'vulnerable' patients, like
children or the mentally incapacitated, or requiring the use of embryos,
fetal tissue or stem cells; and
Consider the safeguards and consent requirements that need to be put in
place for different 'categories' of subject, as well as the differences
in the standards required when talking about 'therapeutic' versus
'non-therapeutic' research.
Learning outcomes
By the end of this module, you will be able to:
Contextualise current issues in terms of the historic development of
codes and principles that have arisen in direct response to events in
the last century;
Identify and design research plans that address the differences in
practice between 'medical experimentation' and 'medical research', and
the different requirements for 'therapeutic' versus 'non-therapeutic
research; and
Critically discuss whether research is defensible in the absence of
direct or immediate benefits to the actual research subjects, and the
appropriateness of research on stem cells, embryos and fetal tissue.
Examples of the questions explored in this module
Is there an important distinction between 'experimentation' and
'deviation from ordinary professional practice' in the course of
treatment?
How and why is consent to participation in research different from
consent to medical treatment?
Take-away Toolkit
"Checklist of Key Factors" for the conduct of ethical and legally valid
patient research.
