Newcastle University

Aims

This module, ‘Research Governance and Ethics: E-Learning’ (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. The module will be delivered as e-learning via Blackboard VLE. The curriculum will be delivered through a series of guided learning opportunities including e-based lectures or tutorials. Students will submit their work for assessment via the Blackboard VLE. Students will be asked to prepare paperwork for formative and summative assessment and submit these for assessment through the VLE. The work for summative assessment will use the knowledge package, their individual feedback, notes and other sources. Student work will be submitted and feedback given electronically.

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. Work will be submitted to Blackboard VLE for assessment.

Assessment Rationale And Relationship

This module is delivered as e-learning. The curriculum is delivered via Blackboard VLE through a series of guided learning opportunities including e-based lectures or tutorials. Work will be submitted to Blackboard VLE for assessment. Students will be required to prepare and evaluate paperwork for real clinical research projects. They will produce relevant research documentation based on current ethical committee approval and R & D approval forms (CV, 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 collabroative activities included throughout this e-learning module. These activities include the Discussion Board, Blog and Wiki.