Newcastle University

Aims

This module, ‘Research Governance and Ethics'(MCR8009), aims to familiarise students with the legal and ethical issues surrounding different forms of clinical research and with the principles of research governance. The module is designed to prepare students to plan and conduct original clinical research by providing them with specific knowledge and enabling them to develop understanding of the subject as well as a portfolio of skills to this end. The module concentrates on legislation and the necessary paperwork and permissions required for the clinical research.

Outline Of Syllabus

i.       Current Legislation and the Law
ii.       What is needed
iii.       Audit, Research or Service Provision
iv.       Principles of Good Clinical Practice & overview of Research Governance Framework
v.       Informed Consent
vi.       Ethical Approval (favourable opinion)
vii.       Regulatory (MHRA) Approval – clinical trial authorisation Permission
viii.       NHS Permission
ix.       Data protection & Caldicott
x.       Setting up an Investigator Site File
xi.       Human Tissue Act
xii.       Research Governance Audit – What it is & how to survive it
xiii.       Consumer Involvement
xiv.       The Ethical Dilemma – debate

Teaching Rationale And Relationship

Students will learn fundamental principles of research governance and Good Clinical Practice as they apply to current clinical research. This module will be delivered as e-learning as an alternative to the direct delivery module. The curriculum will be delivered via Blackboard VLE through a series of guided learning opportunities including e-based lectures or tutorials. Teaching will also take the form of reflectives learning activities such as wiki's, discussion board and several Adobe Connect evening sessions. Assessments will be submitted to the Blackboard VLE.

Assessment Rationale And Relationship

Using a protocol students will be required to prepare and evaluate paperwork for real clinical research projects. Students will produce relevant research documentation based on current ethical committee approval forms (Consent form, PIS and IRAS from). This will be assessed and formative feedback will be given electronically. The ability to correctly identify the prerequisites within the current forms will indicate a student’s knowledge and understanding of the module as taught.

A participation grade is included to reflect the student's engagement with the collaborative activities included throughout this e-learning module. These activities include the Discussion Board, Blog and Wiki.