Research Governance and Ethics

1. Research Governance and Ethics What it means for you as a member of staff at the University of Derby

2. Purpose of today’s session • To define Research Governance • To discuss the main areas covered by Research Governance • To discuss how ethics sits within Research Governance • To discuss how the University of Derby intends to ensure staff understand Research Governance and Ethics and how they apply to them and their students.

3. What is Research Governance? • Research Governance is the means by which organisations and individuals ensure the delivery of high quality research • It applies to all research and in particular research that involves human participants

4. Research Governance • Sets out principles, requirements and standards of good research practice • Defines mechanisms to deliver them • Improves research quality by enhancing ethical and scientific quality • Promotes good practice • Reduces adverse incidents and ensures lessons are learned • Prevents poor performance and misconduct

5. What is the impact on Universities? Quality Research Culture • Strong leadership • Clear strategy linking research to national priorities and needs, the organisational business and clinical governance • HR strategy and financial systems and processes supportive of research • Systems to monitor compliance with standards and investigate complaints • Service user involvement in research

6. Research Governance • There are minimum standards in five broad domains that academics must adhere to. These are:- • Science (Research Methods and Process) • Ethics • Information • Health & Safety • Finance

7. Science (research methods & process) • As academics and researchers we should ensure the validity and quality of our research proposals • FRRDC; UREC; URRDC • Subject area/cluster research ethics committees

8. Ethics • We need to ensure the dignity, rights, safety and well being of participants • This includes informed consent, right to withdraw, debriefing etc • Ethical review is mandatory for ALL research projects and should be in accordance with the University’s Code of Practice on Research Ethics http://www.derby.ac.uk/research/ethics/policy-document

9. Ethics - NHS based research • Approval from the relevant NHS Trust and relevant NHS Research Ethics Committee should be sought for any research conducted in the NHS • Patients and users of the NHS • Relatives or carers of patients and users of the NHS, identified through NHS resources • Access to data, organs and other bodily material • Foetal material and IVF involving NHS patients • Recently dead in NHS premises • NHS staff recruited as participants because of their NHS role

10. Implementation of research ethics code of practice for PGR students Standardised proposal form including ethics section Subject Area (cluster) Committee Ethics case movement RD5 and RD7 Faculty FRRDCs Ethics information, guidance and monitoring Implementation and monitoring of the procedure University Research Ethics Committee URRDC

11. Standardised proposal form including ethics section Subject Area (cluster) Committee SQCs Ethics case movement Faculty FRRDCs FQECs Ethics information, guidance and monitoring Implementation and monitoring of the procedure University Research Ethics Committee Information exchange related to process URRDC UQEC Implementation of research ethics code of practice – Independent Studies for PGT and UG students

12. Implementation of research ethics code of practice – Independent Research Projects for PGP students Standardised proposal form including ethics section Subject Area (cluster) Committee Ethics case movement Faculty FRRDCs Ethics information, guidance and monitoring Implementation and monitoring of the procedure University Research Ethics Committee URRDC

13. Implementation of research ethics code of practice – Staff Research and Scholarly Activity (Funded and Non-funded) Standardised proposal form including ethics section Subject Area (cluster) Committee Ethics case movement Ethics information and guidance Faculty FRRDCs Ethics monitoring Implementation and monitoring of the procedure University Research Ethics Committee URRDC

14. Information • We need to ensure free access to results of any research (anonymised and in the form of a report or paper) • Information about proposed research projects and their conclusions should be presented in an accessible format for participants • Personal information should be kept confidential • Data for research purposes needs to be kept in accordance with the Data Protection Act 1998 • Researchers undertaking research within Health and Social Care should be aware of the Caldicott principles • Consideration needs to be given to Intellectual Property rights

15. Health & Safety • Health and safety of participants, researchers and other staff must be given priority at all times. • As members of the University we must ensure that we work under the University’s Health and Safety Guidelines http://www.derby.ac.uk/hr/healthandsafety

16. Finance • We need to ensure we comply with the University Financial Regulations regarding the financial aspects of our research projects http://intranet.derby.ac.uk/finance-regs/ • Research proposals should set out the funding arrangements in line with University’s financial guidelines. • Costings should be made in consultation with relevant depts and approvals from appropriate signatory levels • For external bids the use of the external application record is expected

17. Finance • External research contracts have to be approved by the Faculty and Faculty Business Accountant • Costs in relation to research projects must not be incurred until a fully signed contract is in place • Public funds for research must comply with the requirements for the funding body • To safeguard against non-compliance the University has a Risk Management Policy

18. Finance • Essentially research projects should use the University’s project management system http://www.derby.ac.uk/signpost/project-management/what-is-a-project • University guidance on the preparation of bids for external funding can be found at https://uintranet.derby.ac.uk/bidprocess/

19. Responsibilities of the University • Develop and promote a high quality research culture • Promoter working with sound methodological framework and principles • Ensure all members of the University work within the University's ethical framework • Develop financial systems and processes to be supportive of research • Ensure staff and students understand and work by the Research Governace framework • Provide CPD for staff at all levels

20. Responsibilities of staff • Ensure all programme and relevant module handbooks use standard statements approved by AQSC in relation to Research Governance and Ethics • Monitor research conducted by students. • Ensure students and staff are aware of ethical issues and systems and processes to manage these • CPD to ensure awareness and practice is up-to-date

21. References • University of Derby Ethics and Governance web site http://www.derby.ac.uk/research/ethics • Research Governance Frameworkhttp://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4008777 • Research Governance http://www.dh.gov.uk/en/Researchanddevelopment/A-Z/Researchgovernance/index.htm • Research passports http://www.ukcrn.org.uk/index/clinical/passport.html • Research Ethics resourceshttp://www.derby.ac.uk/research/ethics/links • Health and Safety Executivewww.hse.gov.uk/index.htm

22. ANY QUESTIONS?