MCR8009 : Research Governance and Ethics (E-learning)
- Offered for Year: 2019/20
- Module Leader(s): Dr Jennifer Wilkinson
- Owning School: FMS Graduate School
- Teaching Location: Off Campus
|Semester 1 Credit Value:||20|
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
|Guided Independent Study||Assessment preparation and completion||2||20:00||40:00||N/A|
|Guided Independent Study||Directed research and reading||10||5:00||50:00||Online content|
|Guided Independent Study||Skills practice||1||2:00||2:00||Use of software|
|Guided Independent Study||Reflective learning activity||10||2:00||20:00||eJournal / reflective blog|
|Guided Independent Study||Student-led group activity||5||3:00||15:00||online collaborative exercises e.g. wiki|
|Guided Independent Study||Independent study||10||3:00||30:00||Supplemental reading|
|Scheduled Learning And Teaching Activities||Scheduled on-line contact time||3||1:00||3:00||Synchronous webinar|
|Guided Independent Study||Online Discussion||10||4:00||40:00||collaborative blog / discussion|
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.
The format of resits will be determined by the Board of Examiners
|Written exercise||1||M||45||Production of a completed Consent Form and Participant Information Sheet (Standard Length Document).|
|Computer assessment||1||M||45||Complete key questions from a NHS Research Ethics Committee application form using a given protocol|
|Portfolio||1||M||10||Participation in collaborative e-learning activities throughout the module (Discussion Board, Blog, Wiki) and evidence of completion|
|Written exercise||1||M||Production 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).