MCR8009 : Research Governance and Ethics (E-Learning)

  • Offered for Year: 2012
  • 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: 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 Methods

Teaching Activities
Category Activity Number Length Student Hours Academic Staff Contact Hours Comment
Guided Independent StudyAssessment preparation and completion841:0084:000:00N/A
Guided Independent StudyDirected research and reading201:0020:000:00N/A
Guided Independent StudySkills practice201:0020:000:00N/A
Guided Independent StudyProject work201:0020:000:00N/A
Guided Independent StudyReflective learning activity201:0020:000:00Discussion Board, Blog and Wiki.
Guided Independent StudyIndependent study201:0020:000:00N/A
Scheduled Learning And Teaching ActivitiesScheduled on-line discussion161:0016:0032:00Skype discussions and support in evenings accross 16 weeks.
Total200:0032:00
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. Work will be submitted to Blackboard VLE for assessment.

Assessment Methods

Other Assessment
Description Semester When Set Percentage Comment
Written exercise1M10Production of a completed Consent Form (Standard Length Document).
Written exercise1M10Production of a personal CV using the IRAS template (Standard Length Document).
Written exercise1M20Production of a completed Patient Information Sheet (Standard Length Document).
Computer assessment1M50Online R&D IRAS application (Standard Length Document).
Portfolio1M10Participation in collaborative e-learning activities throughout the module (Discussion Board, Blog, Wiki).
Other Assessment Resits
Description When Set Percentage Comment
Written exerciseM10Production of a completed Consent Form (Standard Length Document).
Written exerciseM10Production of a personal CV using the IRAS template (Standard Length Document).
Written exerciseM20Production of a completed Patient Information Sheet (Standard Length Document).
Written exerciseM50Online R&D IRAS application (Standard Length Document).
PortfolioM10Participation in collaborative e-learning activities throughout the module (Discussion Board, Blog, Wiki).
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.

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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