Newcastle University

Aims

This module, ‘Research Governance and Ethics’ (MCR8001), 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 an 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 in two half-day and two full-day sessions. Prior to the module, students will receive a knowledge package with a series of exercises to complete before the first session. During the taught sessions there will be a series of lectures and interactive activities to ensure learning objectives are met. Students are asked to prepare tasks for formative and summative assessments. The students will then submit their work and it will be assessed. Extensive written feedback is provided.

Outline Of Syllabus

i.       Current Legislation and the Law
ii.       What is needed
iii.       Audit, Research or Service Evaluation
iv.       Principles of Good Clinical Practice
v. Overview of Research Governance Framework
vi.       Informed Consent
vii.       Gaining Successful Ethical Approval
viii.       Regulatory (MHRA) Approval – Clinical Trial Authorisation Permission
ix.       NHS Permission
x.       Data Protection & Caldicott
xi. Contemporary Issues in Clinical Research
xii.       Setting up an Investigator Site File
xiii.       Human Tissue Act
xiv. Mental Capacity Act
xv.       Research Governance Audit
xvi.       Consumer Involvement
xvii.       Ethical Principles

Teaching Rationale And Relationship

This will be a mainly didactic module. In lectures, students will learn fundamental principles of research governance and Good Clinical Practice as they apply to current clinical research. The tutorial is designed as a formative feedback session on the assessment of research applications.

Assessment Rationale And Relationship

Students will produce relevant research documentation based on the requirement for current ethical committee approval and R & D approval forms. This work will be assessed in and formative feedback given in the tutorial. The ability to correctly identify the prerequisites within the current forms will indicate a student’s knowledge and understanding of the module as taught.