Research Ethics and Data Management: An Introduction Dr Helen Morley – Research Ethics Senior Training & Development Officer (Maternity Cover), SDDU H.R.Morley@leeds.ac.uk

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

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

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

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)

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?

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

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 http://researchsupport.leeds.ac.uk/index.php/academic_staff/good_practice/university_ethics_policies/

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 http://www.leeds.ac.uk/ethics

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

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

Application Process Forms are available at: http://researchsupport.leeds.ac.uk/index.php/academic_staff/good_practice/ethical_review_process/university_ethical_review-1 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

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

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 20 67126 or e mail debbie.gibson@leedsth.nhs.uk

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: debbie.gibson@leedsth.nhs.uk www.hta.gov.uk

Data Protection The data protection Zeitgeist Data needs managing Management requires personal responsibility The University’s approach University’s Code of Practice http://campus.leeds.ac.uk/dpa/code.html Policy on Safeguarding Data http://campus.leeds.ac.uk/isms

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”,

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?

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?

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 e-mail.

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

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

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?

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

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?

Further resources on research ethics available at: http://www.sddu.leeds.ac.uk/research-innovation/research-ethics-training-and-guidance/ http://www.leeds.ac.uk/ethics H.R.Morley@leeds.ac.uk J.M.Blaikie@leeds.ac.uk Med & Health = governance-ethics@leeds.ac.uk