1. Introduction to Research Ethics Graduate School Students Dave Carpenter University Research Ethics Adviser 5 th February 2014

2. Research Ethics – A basic introduction and a few warnings!

3. A few key points You should not attempt to recruit any participants before the ethical review Ethical review should not be sought until the research design has been completed and a protocol produced (advice can be sought at any time) Guidance on the ethical design and conduct of the research should be provided by your supervisor There is no rule which states that the ethical review must take place before your major review Use available guidance and templates http://www.port.ac.uk/research/ethics/

4. Policy: UoP and National UoP: Ethics Policy http://www.port.ac.uk/accesstoinformation/policies/humanresources/filetodownload,88682,en.pdf UoP: Procedure for the Investigation of Allegations of Misconduct in Research http://www.port.ac.uk/accesstoinformation/policies/researchandknowledgetransferservices/filetodownload,1802 25,en.pdf RCUK: Terms and conditions of research Council fEC grants http://www.rcuk.ac.uk/documents/reviews/grc/RCUKPolicyandGuidelinesonGovernanceofGoodResearchPracticeF ebruary2013.pdf RCUK: Policy and Guidelines on Governance of Good Research Conduct http://www.rcuk.ac.uk/Publications/researchers/Pages/grc.aspx UUK: The Concordat to Support Research Integrity http://www.universitiesuk.ac.uk/highereducation/Documents/2012/TheConcordatToSupportResearchIntegrity.p df UKRIO: Code of Practice http://www.ukrio.org/publications/code-of-practice-for-research/

5. Registry UPR 8 http://www.port.ac.uk/departments/services/academicregistry/qualitymanagementdivision/researchdegrees/forms/p dffiletodownload,142242,en.pdf UPR 16 http://www.port.ac.uk/departments/services/academicregistry/qualitymanagementdivision/researchdegrees/forms/p dffiletodownload,142256,en.pdf PgRS Handbook http://www.port.ac.uk/accesstoinformation/policies/curriculumand

6. Do I really need to get an ethical review? Human Subjects: Research not involving human subjects is not normally ethically reviewed unless it is particularly sensitive. Involvement of human subjects is not always easy to define. Grey areas include: –Archival research –Web-based research – acquiring data from public web-based forums is increasingly popular Possible impact on the integrity of the environment Possible impact on cultural heritage

7. National Policy and Law NHS https://www.gov.uk/government/publications/health-research-ethics-committees-governance-arrangements http://www.nres.nhs.uk/EasySiteWeb/GatewayLink.aspx?alId=134016 Human tissue Ionising radiation Prisoners Mentally incapacitated adults Clinical trials of medicinal products Medical devices

8. Faculty/ DeptChairEC BusinessLisa JackPBS EC Creative and Cultural Industries Wendy PowellCCI EC HumanitiesJane WinstoneHUMS EC (ICJS Departmental EC) Science Chris Markham SCIENCE FACULTY EC Departmental ECs: SHSSW PSYCHOLOGY SPORTS SCIENCE BIOMED. SCIENCE TechnologyJohn WilliamsTECH REC Central ServicesUsually HUMS NHS ResearchNRES Social Care ResearchSCREC Which ethics committee?

9. What does an EC look for? Scientific design and conduct of the study Recruitment of research participants Care and protection of research participants Protection of research participants’ confidentiality Informed consent process

10. Why should I get my research ethically reviewed?

11. Care and protection of research subjects Reputation of the University Your own safety Funding Publication Policy Law

12. Unethical research Inadequate review of the literature Poor design Underpowered Likely outcomes not commensurate with burdens ?? Limited or no social value Role conflict

13. When should I seek ethical review?

14. There is no need for PhD students to seek ethical review until their research plans are clear – this might well be some time after major review. The position regarding ethical review is monitored via the annual report (UPR 8). It is perfectly acceptable to record that ethical review will be sought later, or in some cases, not at all – the research might not involve human subjects. Please note the reminder – the final thesis will not be accepted unless (where necessary) ethical review has been undertaken and a favourable opinion provided. The final declaration with regard to ethical review is given in UPR 16 – it includes a direct link to the United Kingdom Research Integrity Office Code of Practice and the UKRIO checklist. The checklist is a useful tool for ethically monitoring research from conception to completion.UPR 8UPR 16Code of Practicechecklist