MCR8001 : Research Governance and Ethics

  • Offered for Year: 2012
  • Module Leader(s): Dr Debbie Carrick-Sen
  • Owning School: FMS Graduate School
Semesters
Semester 1 Credit Value: 20
ECTS Credits: 10.0

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 Methods

Teaching Activities
Category Activity Number Length Student Hours Academic Staff Contact Hours Comment
Scheduled Learning And Teaching ActivitiesLecture181:0018:0018:0018 lectures of varying length totalling 18h
Guided Independent StudyAssessment preparation and completion701:0070:000:00Preparation for summative tasks.
Scheduled Learning And Teaching ActivitiesPractical40:553:403:404 practical sessions varying in length totalling to 3h 40m
Guided Independent StudyDirected research and reading201:0020:000:00Reading self-directed.
Scheduled Learning And Teaching ActivitiesSmall group teaching51:005:005:00Small group work with group feedback.
Scheduled Learning And Teaching ActivitiesWorkshops10:300:300:30N/A
Guided Independent StudyProject work201:0020:000:00N/A
Scheduled Learning And Teaching ActivitiesFieldwork10:200:200:20N/A
Guided Independent StudyReflective learning activity151:0015:000:00N/A
Scheduled Learning And Teaching ActivitiesDrop-in/surgery60:151:301:306 drop-in sessions varying in length totalling to 1h 30m
Guided Independent StudyIndependent study121:0012:000:00N/A
Scheduled Learning And Teaching ActivitiesScheduled on-line discussion172:0034:0032:00Skype discussions and support in evenings over 16 weeks.
Total200:0061:00
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 Methods

Other Assessment
Description Semester When Set Percentage Comment
Written exercise1M10Production of a Completed Consent Form
Written exercise1M10Production of a Personal CV using the IRAS Template
Written exercise1M30Production of Patient Information Sheet
Written exercise1M50Online R&D IRAS Application
Other Assessment Resits
Description When Set Percentage Comment
Written exerciseM10Production of Completed Consent Form
Written exerciseM10Production of Personal CV using the IRAS Template
Written exerciseM30Production of Patient Information Sheet
Written exerciseM50Online R&D IRAS Application
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.

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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