Research Integrity and Research Ethics

1. Research Integrity and Research Ethics Catherine Fieulleteau Ethics Integrity Manager

2. Research Integrity The University has a responsibility to ensure that research is conducted with integrity and good research practices are upheld. The University conducts high quality, innovative research and is guided by the principles and standards outlined in The Concordat to Support Research Integrity, Research Governance Framework for Health and Social care and other documents. Source: The Concordat to Support Research Integrity, 2012: http://www.universitiesuk.ac.uk/highereducation/Documents/2012/TheConcordatToSupportResearchIntegrity.pdf

3. Research Integrity The core elements of research integrity are: • Honesty in all aspects of research. • Accountability in the conduct of research. • Professional courtesy and fairness in working with others. • Good stewardship of research on behalf of others. Source Singapore Statement, 2010 http://www.singaporestatement.org/

4. Research Integrity • Demonstrate openness and transparency when reporting results; including sharing negative results. • Acknowledge all contributors who had significant involvement in the research. Provide a full and accurate bibliography. • Comply with all legal, ethical and contractual requirements. Source: The Concordat to Support Research Integrity, 2012: http://www.universitiesuk.ac.uk/highereducation/Documents/2012/TheConcordatToSupportResearchIntegrity.pdf

5. Experienced and New Researchers • The University recognises that both senior researchers and new researchers should understand their responsibilities. • Researchers should be aware of and keep actively up-to-date with research integrity issues. • Comply with legal and ethical requirements when conducting or collaborating in research in other countries. Both UK and legislation of the other countries must be observed.

6. Background • In the 20th century significant abuses prompted action to improve the governance of research ethics, including: • Nazi atrocities – including scientific experimentation on human beings without consent. • Medical research conducted without informed consent, such as Tuskegee Syphilis Study and Thalidomide drug testing. • Increased research governance has meant that an appropriate functioning system of ethical scrutiny in research Institutions should be in force, to ensure that there is an explicit discussion of ethical concerns before a project goes ahead.

7. When is ethical approval required? • Research involving the following requires ethical approval: • Human participants – including simple, anonymous questionnaires, interviewing professionals at their place of work, focus groups, observations and taught courses/practicals. • Human data, personal, sensitive data – even if anonymised, may require ethical approval. • Research on animals. • Raises social and environmental issues.

8. Why is ethical approval necessary? • Protects the safety and well-being of research participants. • Protects researchers. • Ensures you conduct your research to high ethical standards. Protecting integrity of ethics. • Informed consent (written where possible) or recorded verbal consent. • Meet the criteria of funding bodies/sponsors.

9. UEL Ethics Committees • University Research Ethics Committee (UREC) reviews research involving: • human subjects submitted by staff, PhD, MPhil, professional doctorates and Masters by research students. • School Research Ethics Committees (SRECs) review applications for ethical approval from: • undergraduate and taught Masters students. Source: UEL Research Ethics web page http://www.uel.ac.uk/gradschool/ethics/

10. UEL Ethics Committees • Collaborative Research Ethics Committees (CRECs) are Partner Institutions of UEL who conduct research with human subjects or human data. • UREC, SRECs and CRECs are made up of a Chair, Deputy Chair and subject area representatives reflecting the mix of School disciplines within each Committee. • Each discipline at UEL has a SREC that reviews applications for ethical approval. This includes non health/medical research for all Schools: Social Sciences, Law, Business, Education, Engineering, Arts and Humanities, as well as Health, Sport and Bioscience. • Staff and students conducting research with human participants must obtain ethical approval. UEL does not grant retrospective approval.

11. What does UREC look for? • Design of the study – rationale, hypothesis • Expertise/experience of researchers • Benefits of the research – present or future? • Recruitment of participants – approach. • Care and protection of participants. • Informed consent! • Confidentiality. • Risks minimised. • Compliance issues – DPA, DBS and legal regulations.

12. Recruitment Documents • Information Sheets: • Given in advance. • Lay language and age appropriate. • I.S. for each group of participants. In writing (preferable) or script to be read. • Understandable by all participants, e.g. parents, guardians and children. • Emphasise that participation in the study is voluntary. • State right to withdraw and deadlines for withdrawal of data, normally up to the point of anonymisation. • State whether you hope to publish the data.

13. Recruitment Documents • Consent Forms: • Given in advance. • Must obtain consent from relevant authorities and gatekeeper organisations. • Permission to publish the data. • Researchers should provide: • Draft interview topic guide, copy of questionnaire(s), permission letters and adverts for the study. • IMPORTANT: • Apply for ethical approval in good time!

14. Processes for submission • UREC and SRECs processes differ. • Applications made to UREC are required to use UREC application form and template recruitment documents. • One hard, ink-signed copy of the full application, including recruitment documents should be submitted. • One electronic copy of the full application form in PDF format should be emailed to researchethics@uel.ac.uk. • UREC will not accept applications that do not bear an ink-signed signature. Source: UEL Research Ethics web page http://www.uel.ac.uk/gradschool/ethics/

15. SREC Process for submission • SRECs may have a simpler, condensed version of the research ethics application form. • Recruitment documents are still required. All applications should include an Information Sheet and a Consent Form, where applicable. • Each SREC has its own procedures for granting ethical approval. Supervisors should be aware of the processes. Consult the SREC Chair for guidance. • Any amendments to approved applications, however minor, must be submitted to the relevant research ethics committee.

16. Research requiring NHS Approval • NHS Research Ethics Committees (RECS) review research involving: • Patients, users of the NHS and their carers. • Patients who fall under the Mental Capacity Act 2005. • Research governed by Human Tissue Act 2004 • Social Care Research Ethics Committees review all social care research funded by the Department of Health. Applies to users of the social care system.

17. Responsibilities of staff and students • Academic staffmembers involved in the supervision and development of other researchers must be aware of their responsibilities and ensure that they have the necessary training, time and resources to carry out that role. Academic staff should request support, if required. • Research staff and students, at all levels, are expected to comply with all legal, ethical and other requirements or guidelines that apply to research. UEL Code of Practice for Research, June 2013 http://www.uel.ac.uk/gradschool/currentstudents/library/

18. Training • Research Integrity Modules - provide guidance and support to conduct high quality research. • Ethics Integrity Manager - provides training, guidance and support, from Codes of Practice to the UEL application process. • ‘Drop in sessions’ at both Docklands and Stratford campus for staff and students. • External training provided – e.g. Association for Research Ethics (AfRE). • Chair of UREC – runs bi-annual PGR and staff research ethics training. • New polices, guidelines, support and best practice are communicated via the web page, Deans of School, email and UEL’s inFocus magazine.

19. Advice and Support Research Ethics Department in Graduate School. 0208 223 6683 researchethics@uel.ac.uk University of East London EB1.43, Docklands Campus 4-6 University Way London E16 2RD

20. Useful references • UEL Site: http://www.uel.ac.uk/qa/research/ • IRAS Site: https://www.myresearchproject.org.uk/ • The Concordat to Support Research Integrity: http://www.universitiesuk.ac.uk/highereducation/Documents/2012/TheConcordatToSupportResearchIntegrity.pdf • European Code of Conduct for Research Integrity: http://www.nsf.gov/od/iia/ise/Code_Conduct_ResearchIntegrity.pdf • Research Governance Framework for Health and Social Care. Second edition, Department of Health 2005https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/139565/dh_4122427.pdf • A Framework of Policies and Procedures for University Research Ethics Committees. The Association of Research Ethics Committees, 2013 http://s3.spanglefish.com/s/21217/documents/independent-membership/12-11-13-framework-complete.pdf