The main aim of this module is to familiarise you with the legal and ethical issues surrounding different forms of clinical research and with the priniciples of research governance. The module is designed to prepare you to plan and conduct original clinical research by providing you with specific knowledge and enabling you to develop understanding of the subject as well as a portfolio of skills.
The module will be delivered in an e-learning (distance learning) format, with all teaching delivered online through Blackboard VLE.
Outline of syllabus:
- Current legislation and the law
- What is needed
- Audit, research or service provision
- Principles of Good Clinical Practice and overview of Research Governance Framework
- Informed consent
- Ethical approval (favourable opinion)
- Regulatory (MHRA) approval - clinical trial authorisation permission
- NHS permission
- Data protection and Caldicott
- Setting up an investigator site file
- Human Tissue Act
- Research Governance Audit - what is it and how to survive it
- Consumer involvement
- The ethical dilemma - debate
- Be able to describe current legislation relating to different forms of clinical research
- Have an understanding of the current issues related to governance in different forms of clinical research
- Have an understanding of the local and national regulations and processes for obtaining permissions and approval for clinical research
- Have an understanding of the need for good practice in clinical research
- Have an understanding of the need for effective governance in clinical research
- Be able to prepare and evaluate required paperwork for real clinical research projects including, for example, applications for a favourable opinion from research ethics committee, forms for informed consent from clinical trials etc.