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Research Ethics and Regulation

  • 30 hours (plus 120 hours of independent study)
  • 11 weeks

Overview

The main aim of this course is to equip learners with the skills and knowledge required to understand and critically evaluate both domestic and international rules that govern research.

By understanding the rationales behind different systems of governing research in different contexts, we will reveal the moral and political values that underpin different organisational rules around research.

Taking a novel multidisciplinary perspective, the course draws critically on philosophical, legal and empirical data to inform the values that should be used in the rules introduced by legislators and professional policy-makers. It also aims to define measures for assessing the effectiveness and efficiency of governance systems, particularly in relation to health across different sectors.

Who this course is for

This course would suit and benefit all learners interested in a career in research or the regulation of research, particularly related to health and medicine. This includes PhD students and early career researchers or scientists (industry), and regulatory affairs professionals.

Course content

The course topics will trace contemporary thinking around research governance rules to illustrate how values affect decision-making in scientific research and technological development. Various contexts will be explored, such as in medicine, public health crises and in social sciences, as well as in response to different priorities and needs from the perspectives of public and private sectors.

Within the course we pick up on pinch-points in current rules using case examples, empirical data and philosophical arguments to provide probing yet rounded views such as clinical research and ‘compassionate’ access to innovative therapies, metrics for prioritisation and funding of research, limitations to regulatory oversight and case law, ethics review of research by committee and governance structures in different sectors, theory and trends behind patient and public involvement, consent, privacy, intellectual property, and international standards meets cultural sensitivities. 

Teaching and structure

This hybrid course will be delivered through a combination of lectures, tutorials, and hands-on individual and/or group work. All activities can be attended either in-person or online.

  • Student-led tutorials: Each student will be expected to lead at least a discussion segment in a tutorial session during the course to develop and demonstrate conceptual and empirical understandings and their progression towards the learning outcomes.
  • Health, technology and public policy case studies: Each student will give a 10-minute presentation during the course on a topical case study from a country or sector of their choice, as a way of illustrating their engagement with and interrogation of contemporary health, technology and public policy issues.
  • Contribution of readings and to discussions on online forum: Students will be encouraged to suggest relevant readings on weekly topics as a demonstration of their own reading outside class.

Assessment

The course assessment includes:

  • Oral assessment (required for all learners)
  • Written coursework (optional for Short Course learners)

Feedback and grades will be provided for all completed assessments. These are to give an indication of performance and support further learning only. Grades on individual assignments will not impact learners’ ability to complete the course.

Certificate

Upon completion of this course, learners will receive a certificate of participation.

Cost and concessions

The standard course fee is £1700.

A discounted rate of £700 is available for UCL and NHS staff. Please ensure you use your UCL or NHS email when completing the booking in order to receive this discount.

Entry requirements

A minimum of an upper second-class bachelor’s degree from a UK university or an overseas qualification of an equivalent standard. Students are encouraged (but are not required) to have work experience prior to enrolling on this programme.

Learning outcomes

Learners will develop critical skills and insights on leveraging and evaluating systems of governing research, including:

  • Subject-Specific Knowledge: Deep and context-relevant understandings of the ethical, scientific, policy, social and economic factors shaping research priorities and practices.
  • Intellectual, Academic and Research Skills: Advanced cross-disciplinary understandings of the integrative roles of ethics in shaping research priorities, practices.
  • Practical and Transferable Skills: Enhanced ability to understand and inform decisions and actions at the interface of ethics, scientific methods, and health technologies and public policy.

Further information

The course is a postgraduate taught module offered to UCL students as an elective by the Department of Science, Technology, Engineering and Public Policy (STEaPP).

Students from the STEaPP Masters of Public Administration, as well as students from wider UCL postgraduate taught programmes, are able to complete the course within their degree studies.

Course team

Professor Sarah Edwards

Professor Sarah Edwards

Sarah JL Edwards is the Professor of Bioethics at UCL having trained in Psychology, in Philosophy, and in Medical Ethics and Law, concentrating her research career on research ethics in health. She has a track record of interdisciplinary research publications and policy impact. She currently leads several research projects on use of real-world evidence in regulatory decision making, on using social sciences alongside clinical trials eg to improve recruitment rates, and on cultural challenges to harmonisation of regulatory rules. She is currently collaborating with members of international bodies such as CIOMS and WHO as part of these projects. She also leads the new Professional Education programme in science, technology and engineering policy and co-leads new health route through the Masters in Public Administration at UCL having taught medical ethics and law to medical students, translational clinical science and regulatory affairs for postgraduates, and research ethics and governance to clinical researchers and managers.  

Dr Maria Cross

Dr Maria Cross

Maria Cross is a lecturer with the UCL Department of Science, Technology, Engineering and Public Policy (STEaPP). Maria's background is multidisciplinary, spanning the biomedical, social and computing sciences. Within her research, she has explored ethical and responsible uses of routinely-collected and large datasets. In her current role, Maria is focused on the delivery of professional education that draws together her scientific training and prior practical experience in health policy and governance.

Course information last modified: 18 Oct 2023, 15:53