Unit information: Responsible Innovation and Research Methods in Digital Health in 2022/23

Unit name	Responsible Innovation and Research Methods in Digital Health
Unit code	EENGM0023
Credit points	20
Level of study	M/7
Teaching block(s)	Teaching Block 4 (weeks 1-24)
Unit director	Dr. Brigden
Open unit status	Not open
Units you must take before you take this one (pre-requisite units)	None
Units you must take alongside this one (co-requisite units)	None
Units you may not take alongside this one
School/department	School of Engineering Mathematics and Technology
Faculty	Faculty of Engineering

Unit Information

The aim of this unit is to provide students with a thorough grounding in research methods used in the development and validation of digital devices and associated algorithms in health and care. Ethical issues associated with the design, development, evaluation, distribution and application of digital technology will be introduced, along with concepts such as privacy, safety, device regulation and the law.

Unit content:

• The main forms of data held by health and social care organizations
• Issues around interoperability, governance and GDPR.
• The value of working with communities, participatory design, Public Engagement and Public Patient Involvement (PPI) will be explained in terms of anticipating acceptability issues, de-risking subject recruitment to a trial and thinking through the impact of a new technology on wider society.
• Introduction to issues that may arise relating to protected characteristics (such as race, gender and disability) and ensuring that research and product development is undertaken in an inclusive manner, making use of PPI and user-centred/participatory design.
• Opportunities to develop technologies that specifically address health problems in e.g. vulnerable or minority groups.

Your learning on this unit

Having completed this unit, the student is expected to:

1. Be able to explain and justify how data is collected, stored and responsibly shared in and between health and care settings
2. Discuss processes relating to clinical trials
3. Explain and be able to apply the current regulatory guidelines associated with data collection and sharing between industry and research organisations, and health and care settings
4. Critically discuss the major societal challenges around ensuring that the needs of diverse health communities are adequately represented in novel technologies.

How you will learn

This unit will consist of a combination of teaching and learning methods including key lectures, workshops, group seminars and structured reflection.

How you will be assessed

Group video report: ethical questions linked to responsible innovation in digital health will be posed. Each group will need to discuss their views and ideas by means of an online collaborative space and formulate a video report that represents a balanced answer to the problem. 50% (All ILOs).

Group written report: A paper reporting a Randomised Controlled Trial (RCT) in the field of digital health will be chosen. Each group will present a critique of the trial in a written group report. 50% (All ILOs).
The word limit is 2,500 (not including references). For work that exceeds a specified maximum length by 10% or more the mark will be reduced by ten percentage points (i.e. 10 marks), but the penalised
mark will not be reduced below the pass mark: marks already at or below the pass mark will not be reduced.

Students will complete a contribution agreement individually, indicating the level of contribution from each team member. The contribution impacts 25% of the weight of the final mark. Note: The contribution agreement is a guide and the final mark will be determined by the unit director, particularly for discrepancies of more than 10% between group and personal mark.

Resources

If this unit has a Resource List, you will normally find a link to it in the Blackboard area for the unit. Sometimes there will be a separate link for each weekly topic.

If you are unable to access a list through Blackboard, you can also find it via the Resource Lists homepage. Search for the list by the unit name or code (e.g. EENGM0023).

How much time the unit requires
Each credit equates to 10 hours of total student input. For example a 20 credit unit will take you 200 hours of study to complete. Your total learning time is made up of contact time, directed learning tasks, independent learning and assessment activity.

See the Faculty workload statement relating to this unit for more information.

Assessment
The Board of Examiners will consider all cases where students have failed or not completed the assessments required for credit. The Board considers each student's outcomes across all the units which contribute to each year's programme of study. If you have self-certificated your absence from an assessment, you will normally be required to complete it the next time it runs (this is usually in the next assessment period).
The Board of Examiners will take into account any extenuating circumstances and operates within the Regulations and Code of Practice for Taught Programmes.