Postgraduate

MCR8009 : Research Governance and Ethics (E-learning)

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.

Outline Of Syllabus

-       Introduction to clinical research
-       Overview of research governance framework and legislation
-       Process to gain relevant study approvals
-       Good Clinical Practice
-       Ethical principles & dilemmas
-       History of research ethics
- Informed consent process
-       Regulatory compliance during active study
-       Consumer involvement

Teaching Methods

Please note that module leaders are reviewing the module teaching and assessment methods for Semester 2 modules, in light of the Covid-19 restrictions. There may also be a few further changes to Semester 1 modules. Final information will be available by the end of August 2020 in for Semester 1 modules and the end of October 2020 for Semester 2 modules.

Teaching Activities
Category Activity Number Length Student Hours Comment
Guided Independent StudyAssessment preparation and completion220:0040:00N/A
Guided Independent StudyDirected research and reading105:0050:00Online content
Guided Independent StudySkills practice12:002:00Use of software
Guided Independent StudyReflective learning activity102:0020:00eJournal / reflective blog
Guided Independent StudyStudent-led group activity53:0015:00online collaborative exercises e.g. wiki
Guided Independent StudyIndependent study103:0030:00Supplemental reading
Scheduled Learning And Teaching ActivitiesScheduled on-line contact time31:003:00Synchronous webinar
Guided Independent StudyOnline Discussion104:0040:00collaborative blog / discussion
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 synchronous webinars. Assessments will be submitted to the Blackboard VLE.

Assessment Methods

Please note that module leaders are reviewing the module teaching and assessment methods for Semester 2 modules, in light of the Covid-19 restrictions. There may also be a few further changes to Semester 1 modules. Final information will be available by the end of August 2020 in for Semester 1 modules and the end of October 2020 for Semester 2 modules.

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 Participant Information Sheet (Standard Length Document).
Computer assessment1M45Complete key questions from a NHS Research Ethics Committee application form using a given protocol
Portfolio1M10Participation in collaborative e-learning activities throughout the module (Discussion Board, Blog, Wiki) and evidence of completion
Formative Assessments
Description Semester When Set Comment
Written exercise1MProduction of a personal CV using the IRAS template (Standard Length Document).
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 complete key answers from the IRAS application form (summative). All exercises will assess vital skills needed in practical clinical research to become an independent researcher.

A participation grade is included to encourage and reward the student's engagement with the collaborative activities.

Should a student fail the participation assessment and have to undertake a re-sit they will have to complete a different form of assessment. The student will be asked to look at 2 participation activities as identified by the module leader/team and submit a 500 word written summary (approx. 250 words per activity).

Reading Lists

Timetable