Module Catalogue

MCR8001 : Research Governance and Ethics

  • Offered for Year: 2017/18
  • Module Leader(s): Prof. Elaine McColl
  • Demonstrator: Mr Alex Inskip
  • Lecturer: Dr Jennifer Wilkinson, Mr Paddy Stevenson, Dr Lisa Robinson, Dr Emma Raine, Mr Jan Deckers, Mrs Erika Gavillet, Miss Jill Peacock
  • Teaching Location: Newcastle City Campus
Semesters
Semester 1 Credit Value: 20
ECTS Credits: 10.0

Aims

This module 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. The module concentrates on legislation and the necessary paperwork and permissions required for the clinical research.

Outline Of Syllabus

-       Introduction to clinical research
-       Overview of research governance framework and legislation
- Good Clinical Practice in research training

-       Process to gain approvals to include:
-       Ethics favourable opinion
-       MHRA Clinical Trial Authorisation
-       Health Research authority approval
-       Research passports
-       Data Protection Act & Caldicott Approval

-       The Human Tissue Act
-       Mental Capacity Act 2005
-       Ethical principles & dilemmas
-       History of research ethics
-       Developing the patient information sheet and informed consent form
-       Taking verbal consent
-       Completing the IRAS form
-       Attending the ethics committee
-       Regulatory compliance during active study
-       Setting up an investigator site file
-       Trial and data monitoring and audit
-       Consumer involvement
-       Close down and archive

Teaching Methods

Teaching Activities
Category Activity Number Length Student Hours Comment
Guided Independent StudyAssessment preparation and completion801:0080:00Preparation for formative and summative assessments.
Scheduled Learning And Teaching ActivitiesLecture181:0018:00Ethics, legislation, governance, approvals, PIS sheet, consent form, IRAS applications
Guided Independent StudyDirected research and reading951:0095:00Reading self-directed.
Scheduled Learning And Teaching ActivitiesWorkshops71:007:00Mock ethics committee (2hrs) and completion of online GCP training (5hrs)
Total200:00
Teaching Rationale And Relationship

In lectures, students will learn fundamental principles of research governance and Good Clinical Practice as they apply to current clinical research. Students will also take part in a practical mock ethics committee.

Assessment Methods

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

Other Assessment
Description Semester When Set Percentage Comment
Written exercise1M50Production of a completed Consent Form and Participant Information Sheet using a given protocol
Written exercise1M50Complete key questions from a NHS Research Ethics Committee application form using a given protocol
Formative Assessments
Description Semester When Set Comment
Written exercise1MProduction of a Personal CV using the IRAS Template
Prof skill assessmnt1MPractical IRAS assessment during workshop
Assessment Rationale And Relationship

Using a given protocol and Health Research Authority guidance students will produce a research CV (formative), participant information sheet and consent form (summative). They will also launch an application process for research approvals via IRAS (formative) and complete key answers from the application form (summative). All exercises will assess vital skills needed in practical clinical research to become an independent researcher.

Reading Lists

Timetable