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DRPS : Course Catalogue : School of Law : Law

Postgraduate Course: Health Research & Commercialisation (LAWS11302)

Course Outline
SchoolSchool of Law CollegeCollege of Humanities and Social Science
Course typeOnline Distance Learning AvailabilityAvailable to all students
Credit level (Normal year taken)SCQF Level 11 (Postgraduate) Credits20
Home subject areaLaw Other subject areaNone
Course website Taught in Gaelic?No
Course descriptionThis module examines the key relationships, objectives and rights that underlie the ever-changing (international) health research model, and the interaction of health research with commerce, and it explores the role of the law in regulating that interaction. In doing so, it examines three central problems relating to the use of law in the dynamic field that is modern health research: (1) in an age of moral pluralism, it can be difficult for stakeholders to secure social consensus on how new models of research and their associated technologies should be controlled and exploited (so health research regulation has often been a site of sharp social disagreement); (2) it is often difficult for regulators to keep pace with rapid advances in research practices and technologies (so existing legal concepts and regulatory frameworks can soon appear outmoded and inadequate); and (3) health research is increasingly influenced by commercial interests and pressures (so how activities in this field are influenced by regulatory rules from the commercial field is important). The module will examine how these fundamental tensions are mediated within the legal and regulatory structures governing (international) health research and (international) commerce.
Entry Requirements (not applicable to Visiting Students)
Pre-requisites Co-requisites
Prohibited Combinations Other requirements Please contact the distance learning team at
Additional Costs Students should have regular and reliable access to the Internet.
Information for Visiting Students
Pre-requisitesPlease contact the distance learning team at
Displayed in Visiting Students Prospectus?No
Course Delivery Information
Delivery period: 2013/14 Semester 1, Available to all students (SV1) Learn enabled:  Yes Quota:  None
Web Timetable Web Timetable
Class Delivery Information This course is taught by distance learning.
Course Start Date 16/09/2013
Breakdown of Learning and Teaching activities (Further Info) Total Hours: 200 ( Programme Level Learning and Teaching Hours 4, Directed Learning and Independent Learning Hours 196 )
Additional Notes
Breakdown of Assessment Methods (Further Info) Written Exam 0 %, Coursework 100 %, Practical Exam 0 %
No Exam Information
Summary of Intended Learning Outcomes
The module aims to:
1. consider the nature and diverse manifestations of modern health research in the international context;
2. consider health research as a social, technological and economic endeavour;
3. explore the role played by the law in resolving technical, ethical and commercial issues and conflicts;
4. discuss the strengths and weaknesses of various legal interventions in international health research from both the health and commercial regulatory regimes.

By the end of the module students should be able to:

1. appreciate the range of competing interests and values at play in the regulation of international health research;
2. appreciate how international regulatory frameworks for health research and international regulatory frameworks for commercialisation co-evolve and shape research activities;
3. formulate well-reasoned and coherent arguments relating to health research and commercial practices and rules, and, where appropriate, suggest reforms thereto.
Assessment Information
One essay of up to 4,000 words (60%); one individual assignment (20%); contribution to weekly online discussions throughout the semester (20%). Requirements for all module assessment will be outlined to students within the individual modules at the start of each semester.
Special Arrangements
This course is taught by distance learning.
Additional Information
Academic description Not entered
Syllabus Session 1: Health, Research and Human Rights Key Institutions and Instruments
Session 2: Research, Development and Commercialisation Key Institutions and Instruments
Session 3: Rights to Health, Rights to Research and Rights of Participants
Session 4: Research Structures & Funding Models
Session 5: Information Governance of Health Research
Session 6: Research, Tissue and Property in the Body
Session 7: Patenting Human Tissue & Morality
Session 8: Medical Devices & Access to Medicine
Session 9: Medicinal Products & Clinical Trials
Session 10: Health Benefits v Benefit Sharing
Transferable skills Not entered
Reading list Not entered
Study Abroad Not entered
Study Pattern Not entered
KeywordsNot entered
Course organiserMr Shawn Harmon
Tel: (0131 6)51 4267
Course secretaryMs Clare Polson
Tel: (0131 6)51 4411
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