1. Demonstrate a critical awareness of the principles that guide research.
Knowledge and Understanding, Learning
2. Critically appraise the procedural data collection issues such as ethical principles and methods of analysing and interpreting data.
Analysis, Enquiry
3. Critically evaluate the contemporary socio cultural issues relating to research
design and reporting
Application
4. Demonstrate a critical awareness of legal and governance issues relating to the
conduct of research and data storage
Learning, Problem Solving, Application and Reflection

A reflective essay based on an agreed topic, including a critical appraisal of issues and relevant literature. (LO 1-4)

Students will receive formative feedback throughout the module comprising of a combination of task related feedback and comments on online discussion contributions.

This module has been designed to enable you to undertake an in-depth critical analysis of research ethics and governance currently used in a variety of clinical research settings. In addition to standard approaches and issues, there are several contemporary issues of governance in clinical/ biomedical research. This is complicated not only by inter and multidisciplinarity of researchers but also by evolving socio cultural issues. These issues include the research-care distinction, risk evaluation in research trials, handling of risks, handling of incidental findings and publication bias.

The debate and discussions within this module will introduce you to the usage of new technologies and novel research designs. In addition, you will discuss known governance challenges, along with ethical analysis and complex moral choices. In practical terms this module will provide an overview of the existing regulatory landscape for clinical research and how these regulations and ethical frameworks are developed and work.

You will learn how to design an ethical informed consent. Within this module you will understand that research ethics is not just about writing guidelines that professionals have to follow but about the practice through discourse and regulatory frameworks. You will understand that ethics review is not an application of bureaucracy and a burden for researchers but an arena where researchers discuss their projects, receive advice and practice their ethics skills. Clinical applications and research have been kept separate, but the blurring lines challenges existing regulations and ethical frameworks.

Additionally, you gain knowledge about the patient and public engagement in relation to its importance in research governance and ethics.

This module is aimed at providing space for contextualized reflections on clinical and/or biomedical research with a focus on appropriate research design, conduct of research, regulation and data storage and applying for funding.

This module has been designed to enable you to undertake an in-depth critical analysis of research ethics and governance currently used in a variety of clinical research settings. In addition to standard approaches and issues, there are several contemporary issues of governance in clinical/ biomedical research. This is complicated not only by inter and multidisciplinarity of researchers but also by evolving socio cultural issues. These issues include the research-care distinction, risk evaluation in research trials, handling of risks, handling of incidental findings and publication bias.

The debate and discussions within this module will introduce you to the usage of new technologies and novel research designs. In addition, you will discuss known governance challenges, along with ethical analysis and complex moral choices. In practical terms this module will provide an overview of the existing regulatory landscape for clinical research and how these regulations and ethical frameworks are developed and work.

You will learn how to design an ethical informed consent. Within this module you will understand that research ethics is not just about writing guidelines that professionals have to follow but about the practice through discourse and regulatory frameworks. You will understand that ethics review is not an application of bureaucracy and a burden for researchers but an arena where researchers discuss their projects, receive advice and practice their ethics skills. Clinical applications and research have been kept separate, but the blurring lines challenges existing regulations and ethical frameworks.

Additionally, you gain knowledge about the patient and public engagement in relation to its importance in research governance and ethics.

This module is aimed at providing space for contextualized reflections on clinical and/or biomedical research with a focus on appropriate research design, conduct of research, regulation and data storage and applying for funding.

Independent directed learning will be presented on the theoretical perspectives of research that is closely linked to your work in preparation for the assessed elements of the module. The general mode of delivering this module is through directed reading and activities supported through seminar and workshop activities delivered via black board. A great strength will be to ensure that the experiences of the group are shared. Particular emphasis will be placed on a strategy to integrate the whole process of knowledge delivery, application to research. It is designed to ensure that all strands of the educational experience contribute to learning and to giving you the confidence to enter research and debate.

Chambers, R & Boath, E.H. (2007) Clinical effectiveness and Clinical Governance Made Easy. 4th Edition. Abingdon, Radcliffe Medical Press

Strech, Daniel, Mertz, Marcel (Eds.) (2016) Ethics and Governance of Biomedical Research: Theory and Practice. Springer International Publishing. ISBN 978-3-319-28731-7 Deborah Mascalzoni (ed) (2015) Ethics, Law and Governance of Biobanking. Springer Netherlands. ISBN 978-94-017-9572-2

Access to the online library, blackboard, Voicethread and Turnitin is required.