2016/17 Taught Postgraduate Module Catalogue

YCHI5015M The Legal, Ethical and Professional Considerations in Healthcare Data Research

15 creditsClass Size: 40

Module manager: Dr Jon Fistein
Email: J.L.Fistein@leeds.ac.uk

Taught: Semester 2 (Jan to Jun) View Timetable

Year running 2016/17

Pre-requisite qualifications

Academic
The module is academically rigorous and most candidates are expected to have an upper second class (2:1) honours degree. Applicants with other qualifications may be accepted if they can demonstrate suitable professional experience. Please contact the admissions office if you are unsure of your eligibility.
[The MSc programme is also available as an an intercalated Masters to medical students who have successfully completed three years of a UK medical degree and are ranked in the top 50% of the year 3 cohort.]
English language requirements
IELTS: overall score of 6.5 with no element less than 6.0
TOEFL iBT: overall score of 92 with the reading and listening elements no less than 21, speaking element no less than 23 and the writing element no less than 22.

This module is not approved as an Elective

Module summary

This module will enable students to understand the legal, ethical and professional frameworks that are relevant to research data use. The frameworks will be described and analysed in order to highlight their consistent themes and potential differences. This will be set in the context of the practical steps that researchers need to follow in order to ensure their research project is legally and ethically justifiable. As well as focusing on the particular issues relating to research data use, the module will give students generic tools in legal and ethical analysis that can be applied in other complex settings.

Objectives

The purpose of this module is to:
- Give students a solid grounding in the legal, ethical and professional guidelines that are relevant to research data use including Data Protection Law, confidentiality and privacy, the principles of medical/research ethics and relevant GMC/NMC codes of practice.
- Enable students to recognise and deal appropriately with legal and ethical dilemmas in research data use.
- Equip students with the ability to evaluate the applicability and usefulness of a range of 'privacy enhancing techniques'.

Learning outcomes
On completion of the module, students should be able to:
- Analyse the similarities and differences between and within the laws, ethical principles and professional guidelines that are relevant to research data use.
- Synthesise these into defensible, practical frameworks that can be applied to real-world research settings.
- Evaluate whether research data uses are lawful and ethical.
- Critically assess the appropriateness of different technical measures ('privacy enhancing techniques') in overcoming legal and ethical barriers to data access and use.

Skills outcomes
- Critically review published research and policy documents relating to the legal, ethical and professional issues in research data use
- Apply legal and ethical analysis techniques to research scenarios
- Determine the appropriateness of particular 'privacy enhancing techniques' in helping to ensure compliance with legal and ethical standards
- Identify and assess the impacts on patient and researchers of failures to comply with legal and ethical standards

Syllabus

This module aims to enable students to understand, apply and evaluate the legal, ethical and professional frameworks that apply when using health and social care in research. The module will define and explore:
- Relevant legal concepts, including common law confidentiality and privacy
- Legislation, including the Data Protection Act 1998, the Human Rights Act 1998, the Health and Social Care Act 2012 and other Regulations, set in the context of changes to European law
- Ethical principles including autonomy, social justice and utilitarianism
- The role of consent
- Professional guidelines and standards, from professional bodies and the department of health
- Patient expectations surrounding research data use and trustworthiness
- 'Privacy enhancing techniques'
- The research governance landscape: the role of organisations that govern research data activities
Students will learn how the frameworks relate to each other, and will analyse how they differ. They will develop the practical skills to be able to apply the frameworks when justifying a research application using healthcare data and will evaluate the strengths and weaknesses of the frameworks in various research contexts.

Teaching methods

Delivery type	Number	Length hours	Student hours
Group learning	2	3.00	6.00
Lecture	8	1.00	8.00
Practical	1	6.00	6.00
Seminar	8	2.00	16.00
Tutorial	2	1.00	2.00
Private study hours			112.00
Total Contact hours			38.00
Total hours (100hr per 10 credits)			150.00

Private study

Module pre-reading (with directed exercises): (15 hours total)
- Introduction to medical ethics and law (5 hours)
- GMC guidelines on research and confidentiality (5 hours)
- Selected articles/papers on current issues about data sharing for research (5 hours)

During the module: (11 hours total)
- Preparation for seminar discussions (8x1 hours = 8 hours)
- Production of formative assessment presentation (3 hours)
At the end of the module: (86 hours total)
- Formative assessment exercise (50 hours)
- Summative assessment (36 hours)

Opportunities for Formative Feedback

Group feedback:
- Seminar discussions and short exercises, with feedback on answers. Seminars will follow content-based lectures (which will introduce a particular topic). They will consist of facilitated small-group discussion around the topic giving the students the opportunity to reinforce their factual learning, to apply this in a realistic setting and to reflect on and evaluate their effectiveness in using theoretical frameworks in practical scenarios.
- Formative peer and tutor assessed presentation, with immediate feedback. Groups will be required to produce a presentation on a particular area and deliver this to their peer group. Feedback will be to the group.
Individual feedback:
- Formative assignment to be completed following the contact week, with individual feedback due before coursework due.
- Email and tutorials will be used to provide individual feedback and support

Methods of assessment

Coursework

Assessment type	Notes	% of formal assessment
Assignment	A set of short problem-solving tasks requiring answers of approx. 500 words each	100.00
Presentation	Formative peer and tutor assessed presentation, with immediate feedback.	0.00
Assignment	Formative assignment to be completed following the contact week, with individual feedback due before coursework due	0.00
Total percentage (Assessment Coursework)		100.00

As the contact week dates are not know yet, week numbers for coursework setting and submission cannot be stated. These dates will be included in the module handbook.

Reading list

The reading list is available from the Library website

Last updated: 30/04/2015

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