1. Research Ethics and Data Management: An Introduction
Dr Helen Morley – Research Ethics Senior Training & Development Officer (Maternity Cover), SDDU

2. Overview Principles of research ethics Research ethics in practice
Data Protection
Support and training

3. Principles of research ethics
What ethical considerations bear on research?
What principles motivate those considerations?

4. Possible considerations
Consent
Confidentiality
Incentives, coercion
Researcher safety
Participant safety/vulnerability
Deception
Conflicts of interest
Data handling and storage
Responsible Authorship
Appropriate open data sharing
Acting in areas of competence

5. Possible Principles
Respect the rights/autonomy of participants/other researchers
Act in accordance with your duties as a researcher
Do no harm
Weigh the benefits of research against the risks
Inculcate in yourself a virtuous character (qua researcher)

6. Key Issues What is ethical and unethical in research?
What does it mean to be ethical or unethical?
Who should decide whether researchers are behaving ethically?
How is this to be done?

7. Ethical Theories Deontology – rights duties
Consequentialism – beneficence, harm principles
Virtue ethics – virtuous character

8. University Research Ethics Policy
All research involving human subjects or their data subject to review through a University committee.
Researchers’ obligations conduct research with
Integrity and sensitivity
Compliance with legislation
Regard for obtaining informed consent
Any risk to participants or researchers is proportionate

9. Role of a Research Ethics Committee
Supports staff and students to carry out research ethically
Cross-faculty Ethics Committees – ESSL, LUBS, Env; Arts and PVAC; MAPS and Eng; BioSci; Medicine and Health
Representatives from different research areas
Active researchers

10. University of Leeds Ethical Review
University Research Ethics Committee (UREC)
ESSL, Environment & LUBS (AREA) FREC
Biological Sciences FREC
Medicine & Health FREC
Dentistry (DREC)
Psychology (IPSREC)
School of Healthcare (SHREC)
School of Medicine (SoMREC)
MaPS & Engineering (MEEC) FREC
PVAC & Arts (PVAR) FREC

11. Types of review Full review Light touch review
Block approval (taught student modules)

12. Application Process Forms are available at:
Ensure that the forms are fully completed and that attachments are sent
Student applications must be signed off by supervisors
Usual turn around is 2-3 weeks for full review but can take up to 6 weeks
Committee may ask for further information/clarification

13. Why? Bench mark of high quality research
Good practice & ensures appropriate initial agreements & consent
Safety/well-being and security of
Investigators
Research participants
Leave research sites and participants willing to engage in future research
University’s reputation
Journals

14. Human Tissue Act
If you work in any of these areas, you need to understand what the legislation means for the University and the Trust and for you as a member of staff.
For more information contact Debby Gibson, Human Tissue Act Manager for the Trust and University on tel or e mail

15. Further information
New code of Practice governing research with human tissue published Sept 09
For advice on the use of human tissue first contact Debbie Gibson, of Leeds Teaching Hospitals Trust:

16. Data Protection The data protection Zeitgeist Data needs managing
Management requires personal responsibility
The University’s approach
University’s Code of Practice
Policy on Safeguarding Data

17. Confidentiality “The duty of confidentiality” Express duty
What is confidential information?
Express duty
“Endeavours commitments”
“Everything we tell you”
Implied duty
A “small” Welsh wedding, an alcoholic model, a single mum “done good”,

18. Quiz
Do you as an individual or your School have to register under the Data Protection Act?
Can an individual revoke their consent to be involved in research after consent given?
Are the records of deceased individuals covered by the DPA?
The University has anonymised data but external collaborator has unanonymised personal data – is the University’s data now personal data?
When is personal data truly anonymised?

19. Quiz
Do you always have to get someone’s consent to use their personal data?
How long can you keep personal data for after the completion of the relevant research project?
Where in the University can you find guidance on data protection?

20. When does data need to be encrypted?
If the data is known to be University/research sponsor confidential
If the data is subject to a non-disclosure agreement
If the University’s reputation would be damaged if the data were found
If the data is to be removed from secure campus storage e.g. via laptop, memory stick or .

21. Data Protection
The eight principles, which state that personal data must:
1. Be obtained and processed fairly and lawfully and shall not be processed unless certain conditions are met
Be obtained for a specified and lawful purpose and shall not be processed in any manner incompatible with that purpose

22. Data Protection Act Cont’d
3. Be accurate and kept up to date
4. Be adequate, relevant and not excessive for those purposes
5. Not be kept for longer than is necessary for that purpose
6. Be processed in accordance with the data subject’s rights
7. Be kept safe from unauthorised access, accidental loss or destruction
8. Not be transferred to a country outside the European Economic Area, unless that country has equivalent levels of protection for personal data

23. Data Risk Assessment Data storage needs:
What volume of storage is needed?
Can data be reacquired or recreated if lost?
If not, what types of protection or replication are needed?
Are copies of the data required at geographically remote locations?
How long a period would it be before unavailability of the data becomes an issue i.e. what period of data loss can be handled?
How is the integrity (accuracy and currency) of the data to be maintained?
Does the funding body require retention of data beyond the end of the project?

24. Key Contacts UREC – Helena Smith Medicine and Health- Dr Janet Holt
Physical Sciences/Engineering – Prof. Gary Williamson
Biological Sciences – Prof Ed White
ESSL, Environment, Business – Dr Andy Evans
Arts, PVAC – Dr Kevin Macnish

25. The Value of Research With Thanks to Dr Kevin Macnish
What are you researching?
Why are you researching it?
How might your research be misrepresented?
How might your research be abused or misused?
What are your red lines?

26. Further resources on research ethics available at:
Med & Health =