THE UNIVERSITY of EDINBURGH

DEGREE REGULATIONS & PROGRAMMES OF STUDY 2020/2021

Information in the Degree Programme Tables may still be subject to change in response to Covid-19

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DRPS : Course Catalogue : School of Law : Law

Postgraduate Course: Risk and Regulation: Theories and Practices (LAWS11399)

Course Outline
SchoolSchool of Law CollegeCollege of Arts, Humanities and Social Sciences
Credit level (Normal year taken)SCQF Level 11 (Postgraduate) AvailabilityNot available to visiting students
SCQF Credits20 ECTS Credits10
SummaryThis course provides a detailed exploration of risk and its regulation, examining how regulatory frameworks are shaped and/or respond to new and emerging human activities, many of which rely on or prompt new modes of action, new technologies, new relationships, and, importantly, new risks.

Focusing on biomedical case studies in the second half of the course, it explores different regulatory theories, instruments and institutions - legal and non-legal, domestic, regional and international - that govern and shape individual and organisational conduct. Specifically, following detailed investigation of the concept of risk and regulatory theories and practices, the course explores regulatory frameworks in biomedicine (health research and medicinal products and devices), and how they interact with other regulatory frameworks (e.g. EU governance, public health, data protection), concluding with a session on alternative (non-risk-based) approaches to regulation. Students will then have an opportunity to present a topic in risk and regulation in the last three sessions of the course.

The aims and objectives of the course are to:

Consider the concept of 'risk' and how it features in modern discourses and regulatory actions;
Consider the articulation and governance or management of risks across a number of human activities through specific case studies;
Consider the different theories and practices of regulation;
Discuss the strengths and weaknesses of various legal interventions at different levels of regulation;
Explore and comment critically on how regulatory frameworks shape notions of risk in medicine and health research.
Course description Week 1: Course Introduction / History and Concept of Risk
Week 2: History and Concept of Risk: Biomedical Risks
Week 3: Regulatory Theory: What is Regulation, and Why Regulate?
Week 4: Regulatory Theory: Public Interest, Private Interest, and Institutional Theories
Week 5: Regulatory Practice: What Kind(s) of Regulation Should We Use?
Week 6: No class: Reading Week
Week 7: Case study: Regulating Health Research
Week 8: Case study: Regulating Medicinal Products and Devices
Week 9: Student Presentations
Week 10: Student Presentations
Week 11: Student Presentations / Course Conclusion: Beyond (Risk-based) Regulation?
Entry Requirements (not applicable to Visiting Students)
Pre-requisites Co-requisites
Prohibited Combinations Other requirements None
Course Delivery Information
Academic year 2020/21, Not available to visiting students (SS1) Quota:  28
Course Start Semester 2
Timetable Timetable
Learning and Teaching activities (Further Info) Total Hours: 200 ( Seminar/Tutorial Hours 20, Programme Level Learning and Teaching Hours 4, Directed Learning and Independent Learning Hours 176 )
Assessment (Further Info) Written Exam 0 %, Coursework 100 %, Practical Exam 0 %
Additional Information (Assessment) Formative Assessment (does not contribute toward final course mark):

One brief (no more than 1200 words, including footnotes).

Summative Assessment:

This course will be assessed by means of 2 components:

1) An oral presentation (approximately 15-minutes in length, presented in group format) which is worth 40% of overall course mark.

2) A 3000 word essay, from a choice of questions), which is worth 60% of the overall course mark.
Feedback Formative feedback will be available throughout the semester to aid students in the completion of summative assessments.

Feedback on the formative assessment may be provided in various formats, for example, to include written, oral, video, face-to-face, whole class, or individual. The course organiser will decide which format is most appropriate in relation to the nature of the assessment.

Feedback on both formative and summative in-course assessed work will be provided in time to be of use in subsequent assessments within the course.

Feedback on the summative assessment will be provided in written form via Learn, the University of Edinburgh's Virtual Learning Environment (VLE).
No Exam Information
Learning Outcomes
On completion of this course, the student will be able to:
  1. Demonstrate a critical understanding of the principle theories and concepts underpinning risk and regulation.
  2. Evidence a critical awareness of the current issues related to regulation of risks in biomedicine, particularly in the UK.
  3. Thoroughly understand how risk and regulation sits within the broader context of medical law and ethics.
Reading List
Robert Baldwin, Martin Cave & Martin Lodge, Understanding Regulation, 2d ed. (OUP, 2012)

Bronwen Morgan & Karen Yeung, An Introduction to Law and Regulation (CUP, 2007)

Robert Baldwin, Martin Cave & Martin Lodge (eds), The Oxford Handbook of Regulation (OUP, 2012)

Deborah Lupton, Risk, 2nd ed. (Routledge, 2013)

Ulrich Beck, The Risk Society (SAGE, 1992)

Journal articles and book chapters will be the primary assigned readings for this course. The following is an indicative list of journal titles, to which the library already holds a subscription:
* European Journal of Risk Regulation
* Regulation & Governance
* Governance
* European Journal of Health Law
* Medical Law International
* Medical Law Reviw
Additional Information
Graduate Attributes and Skills Students will be able to plan and execute an oral presentation in pairs.
Critical research skills will be developed in preparing for the oral presentation and summative essay.
Advanced practical application of law and regulation will be acquired through the course in both group presentation and individual research.
Individual assessed work will allow the students to exercise academic autonomy and rigorous delivery of research findings.
Advanced critical research, argumentation and communication skills.
Communication of complex legal and regulatory issues to a range of audiences.
Advanced written and oral communication of complex legal and regulatory issues.
Plan and execute an oral presentation utilising practice-relevant materials.
Critical legal analysis.
Problem-solving.
Sophisticated use of primary and secondary materials, and the ability to articulate their meaning both orally and in writing.
Identify and conceptualise contemporary problems and issues in risk and regulation, focusing on biomedicine.
KeywordsRegulation,regulatory frameworks,Regulatory Theory,Regulatory Practice,Biomedical
Contacts
Course organiserMr Edward Dove
Tel: (0131 6)50 6320
Email: edward.dove@ed.ac.uk
Course secretaryMs Ruth Johnston
Tel: (0131 6)50 9094
Email: Ruth.Johnston@ed.ac.uk
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