MCR8009 : Research Governance and Ethics (E-Learning)

  • Offered for Year: 2013/14
  • Module Leader(s): Mrs Sam Ducker
  • Owning School: FMS Graduate School
Semesters
Semester 1 Credit Value: 20
ECTS Credits: 10.0

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 Methods

Teaching Activities
Category Activity Number Length Student Hours Comment
Guided Independent StudyAssessment preparation and completion821:0082:00N/A
Guided Independent StudyDirected research and reading301:0030:00Self directive research and reading.
Guided Independent StudyDirected research and reading401:0040:00Online tutorials.
Guided Independent StudyReflective learning activity401:0040:00Discussion Board, Blog and Wiki.
Scheduled Learning And Teaching ActivitiesScheduled on-line discussion42:008:00Evening support via Adobe Connect
Total200:00
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 Methods

The format of resits will be determined by the Board of Examiners

Other Assessment
Description Semester When Set Percentage Comment
Written exercise1M45Production of a completed Consent Form and Patient Information Sheet(Standard Length Document).
Computer assessment1M45Online IRAS application (Standard Length Document).
Portfolio1M10Participation in collaborative e-learning activities throughout the module (Discussion Board, Blog, Wiki).
Formative Assessments
Description Semester When Set Comment
Written exercise1MProduction of a personal CV using the IRAS template (Standard Length Document).
Written exercise1MComplete an R&D form
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.

Reading Lists

Timetable

Disclaimer: The University will use all reasonable endeavours to deliver modules in accordance with the descriptions set out in this catalogue. Every effort has been made to ensure the accuracy of the information, however, the University reserves the right to introduce changes to the information given including the addition, withdrawal or restructuring of modules if it considers such action to be necessary.

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