User Engagement Toolkit

1. User Engagement Toolkit

2. User Engagement Toolkit • Irish Legislation • Health and Safety • Insurance • Garda Clearance • Responsibilities • Design Project Protocol • Risks and Benefits • User Engagement Plan • Data Management Plan • Ethics Protocol • Ethical Approval • Reimbursement or Payment • Understanding the Specific Needs of Your Users • Confidentiality and Privacy • Participant Information • Informed Consent • Use of Data • Following up with the User

3. Which sections where? • Before design • (1), (2), (3), (4), (6), (7), (8), (9), (10), (11), (13), (14), (15), (16), (17) • During design • (1), (5), (7), (8), (9), (11), (13), (14), (16), (17) • After design • (5),(7), (9), (12), (14), (17), (18)

4. Group 1 • Barry Sheridan • Andrea Gasser • VusalaGurbanova • Gareth Hunter • Martin Cronin

5. Group 2 • Joan Murphy • Peter Kovar • Danielle Pouvaneeswaree • SameerHanda • AreejAlgathani

6. Group 3 • Ronan Clancy • William Jones • MaryamAlmussalam • SarfrazRamay • David Hurley

7. Group 4 • Atul Swami • DivyaaManimaran • Sohaib Khan • Fei Wang • Peter Keogh

8. Group 5 • Alex Hannon-Cross • DajanaDavidovic • MansourAlnakhli • Stephen Mckeown

9. Irish Legislation

10. Who • Principal Investigator • Oversees/Directs all legislative responsibilities • Lecturer • Understand legislation at a detailed level • Student • Understand the limits imposed by legislation • User • Brief understanding of legislation • Institution • Defines codes of practice for user from legislation

11. Details • Applying Irish Legislation varies from project to project • Projects/Individuals associated with projects should identify the legal requirements in each situation • Different types of institutions have different requirements under legislation • Examples • Ethics for Social Workers bye-law • National Vetting Bureau • European Communities • Data Protection Act • Freedom of Information

12. References • Code of Professional Conduct and Ethics for Social Workers bye-law 2011 (S.I. No. 143/2011). http://www.irishstatutebook.ie/2011/en/si/0143.html. Accessed 18th July 2013. • The National Vetting Bureau (Children and Vulnerable Persons) Act 2012 (SI Number 47 of 2012). http://www.irishstatutebook.ie/pdf/2012/en.act.2012.0047.pdf. Accessed 18th July 2013. • European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations, 2004) (S.I. 190 of 2004) which implement the EU Clinical Trials Directive (2001/20/EC). http://www.dohc.ie/other_health_issues/clinical_trials/. Accessed 18th July 2013. • Equality Authority (2011) Guide to the Equal Status Acts 2000 to 2008. http://www.equality.ie/Files/Guide-to-the-Equal-Status-Acts-2000-2008.pdf. Accessed 18th July 2013. • Data Protection Act 1998 (SI Number 25 of 1988) and Data Protection (Amendment) Act 2003 (SI Number 6 of 2003). http://www.dataprotection.ie/ViewDoc.asp?fn=%2Fdocuments%2Flegal%2FLawOnDP.htm&CatID=7&m=. Accessed 18th July 2013. • Data Protection Commissioner (2013). The Data Protection Rules. http://www.dataprotection.ie/ViewDoc.asp?fn=/documents/responsibilities/3bii.htm&CatID=54&m=y. Accessed 18th July 2013. • Citizens Information (2013). Freedom of Information in Ireland. Citizens Information website section. http://www.citizensinformation.ie/en/government_in_ireland/national_government/standards_and_accountability/freedom_of_information.html. Accessed 22nd July 2013. • Information on the Health Information Bill found on the Department of Health and Children website. http://www.dohc.ie/issues/hib//. Accessed 17th July 2013. • Department of An Taoiseach website. Information on timing of the Health Information Bill. http://www.taoiseach.gov.ie/eng/Taoiseach_and_Government/Government_Legislation_Programme/SECTION_B1.html. Accessed 17th July 2013.

13. Insurance

14. Who? • Principal Investigator • Discuss user engagement activities with the relevant Institution department • Lecturer • Discuss user engagement activities with the relevant Institution department • Student • Ask if the appropriate insurance is in place • User • Discuss concerns with the Principal Investigator, design researchers or students. • Institution • Advise staff and students on insurance issues

15. Details • Before user engagement begins, any necessary insurance arrangements need to be in place • In proportion to risk • Potential cover for researcher and sponsor • Insurance issues going to be different according to institution • Examples of potential issues

16. References • Irish Council for Bioethics (2004) Operational Procedures for Research Ethics Committees. • HSE (2008). Review of Research Ethics Committees and Processes in the Republic of Ireland. Research Ethics Committees Review Group 2008, Health Services Executive, Ireland. • UK Department of Health (2005). Research Governance Framework for Health and Social Care. • WHO (2011). Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants. World Health Organisation.

17. Garda Clearance

18. Who? • Principal Investigator • The design project protocol should identify if vetting of staff or students is required. • Lecturer • The design project protocol should identify if vetting of staff or students is required. • Student • Ask if you need to get Garda clearance in advance of user engagement commencing. • User • Discuss Garda vetting as an option in advance of the engagement commencing. • Institution • Advise staff and students on this issue and whether or not vetting is required.

19. Garda Clearance • If Research/Developers or Stakeholders on a project require engaging with vulnerable user groups. Adults with learning disabilities , dementia or Children. • May need to be vetted by the National Vetting Bereau. Before engaging. • Can take up to 12 weeks or longer.

20. References • Citizens Information (2013). Garda Clearance for Employees. Available at http://www.citizensinformation.ie/en/employment/employment_rights_and_conditions/monitoring_and_surveillance_at_work/garda_clearance_for_employees.html. Accessed 23rd August 2013.

21. Health & Safety

22. Who • Principal Investigator • Identify H&S issues and engage with appropriate departments & student • Lecturer • As above • Student • Follow codes of practice • User • Inform Principal Investigator, researchers or students of any issues • Institution • Provide guidance and training

23. Details • Health & Safety – to be considered from POV of DIT, researcher & user • E.g. are physical tasks are part of the study? • H&S issues with venue to be considered • Are there H&S issues in the interaction of people involved? • Seek advice! • Review Health & Safety Authority guidelines

24. References • Health and Safety Authority (2013). Guidelines: Your Industry. Available at http://www.hsa.ie/eng/Your_Industry/. Accessed 23rd August 2013.

25. Design Project Protocol

26. Who ? • Principal Investigator • Prepare design project • Lecturer • Prepare design project • Student • Follow design project protocol • User • Request a more detailed or clearer explaination • Institution • Provide practical guidance

27. Details • Design project protocol will cover a list of topics before, during and after the project • Include a list of aims and objectives • PI create a design Protocol Template as a standard for all projects • User engagement areas should cover • Risks and benefits to the user • User Engagement plan • Data Management plan • Ethics plan • User payment • Follow-up with user

28. References • Durham University (2012) Community-based Participatory Research: A Guide to Ethical Principles and Practice. Centre for Social Justice and Community Action, Durham University. • Irish Council for Bioethics (2004) Operational Procedures for Research Ethics Committees. • National Institutes of Health (2003). Research Ethics: How to Treat People Who Participate in Research. National Institutes of Health, USA. Available at http://www.bioethics.nih.gov/education/FNIH_BioethicsBrochure_WEB.PDF. Accessed 1st August 2013. • NCBI (Draft) Research Code of Practice Policy and Procedure: Principles of Best Practice in Quality Research. NCBI – Working for People with Sight Loss, 2013. • WHO (2011). Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants. World Health Organisation. Available at http://whqlibdoc.who.int/publications/2011/9789241502948_eng.pdf. Accessed 1st August 2013.

29. Responsibilities

30. Who ? • Principal Investigator • Identify roles and responsibilities. Understand relevant codes of practice, legislation & guidelines • Lecturer • Identify roles and responsibilities. Understand relevant codes of practice, legislation & guidelines • Student • Adhere to codes of practice and guidelines. Uphold standards when engaging with users • User • Be aware of point of contact for user engagement • Institution • Ensure roles and responsibilities are clearly identified. Develop code of good practice. Ensure all staff members aware of codes od practice and responsibilities.

31. Details • Ensure that the project is carried out to highest possible standards • Any codes or guidelines of good practice are adhered to • Clear project plan • Include the principal investigator, design student and project leader • Identify the department and staff members • Ensure all issues are addressed

32. References • European Science Foundation (2000). Good Scientific Practice in Research and Scholarship. European Science Foundation Policy Briefing. Available at http://www.esf.org/fileadmin/Public_documents/Publications/ESPB10.pdf. Accessed 1st August 2013. • National Institutes of Health (2007). Guidelines for the Conduct of Research in the Intramural Research Programme at the National Institute of Health, USA. Available at http://sourcebook.od.nih.gov/ethic-conduct/conduct%20research%206-11-07.pdf. Accessed 1st August 2013.

33. User Engagement Plan

34. Who ? • Principal Investigator • Prepare the user engagement plan • Lecturer • Prepare the user engagement plan • Student • Understand user engagement plan, and prepare plans where required • User • Request more detailed/clearer explanations • Institution • Provide advice on how to prepare a design or protocol – including the user engagement plan

35. Details • Ask the following questions • Who is being engaged • What type of engagement is planned • When will the engagement take place during the project • Where will the engagement take place • Why has the particular user group been selected • How do you intend to use the collected data • How many users do intend recruit and why ? • User engagement plan is a living document • Timeline for key actions should be included (communications, actions) • Users should be asked for their feedback

36. References • British Psychological Society Code of Conduct: Ethical Principles for Conducting Research with Human Participants. Available at http://www.bps.org.uk/sites/default/files/documents/code_of_human_research_ethics.pdf. Accessed on 23rd August 2013. • Dalton, AJ, McVilly, KR (2004) Ethics Guidelines for International Multi-Centre Research Involving People with Disabilities. • European Commission (2013). Ethical Review in FP7: European Commission Guidance for Applicants – Getting Through Ethical Review. Available at http://cordis.europa.eu/fp7/ethics_en.html. Accessed on 23rd August 2013. • RCA (2013). Design with People – Ethics Guidelines. Royal College of Art Helen Hamlyn Centre, UK. Available at http://designingwithpeople.rca.ac.uk/ethics. Accessed on 23rd August 2013. • Sociological Association of Ireland (1997) Ethical Guidelines.

37. Risks & Benefits

38. Who ? • Principal Investigator • Identify risks and benefits in advance. And advise students on how to identify them. • Lecturer • Identify risks and benefits in advance. And advise students on how to identify them. • Student • Familiarise self with risks and benefits • User • Ask for clarification where necessary • Institution • Provide advice on how to prepare project protocols. Identify realistic risks and benefits.

39. Details • Design research should have a positive effect on the lives or activities of all involved • It is unethical to put people at risk of harm or discomfort • Use to decide on project direction – include in participant information and informed consent • Identify potential risks and benefits of the project (direct or indirect) • Physical • Social • Financial • Psychological • Identified risks • should be used to Inform protocols in case of adverse events occurring • Should be honest, realistic and shouldn’t coerce the user in any way • Longevity of benefits estimation • Manage user expectations

40. References • COPE Foundation (2005) A Policy Document for Conducting Research. • Durham University (2012) Community-based Participatory Research: A Guide to Ethical Principles and Practice. Centre for Social Justice and Community Action, Durham University. • European Science Foundation (2000). Good Scientific Practice in Research and Scholarship. European Science Foundation Policy Briefing. Available at http://www.esf.org/fileadmin/Public_documents/Publications/ESPB10.pdf. Accessed 1st August 2013. • Irish Council for Bioethics (2004) Operational Procedures for Research Ethics Committees. • National Disability Authority (2009) Ethical Guidance for Research with People with Disabilities. National Disability Authority, Ireland. • National Institutes of Health (2003). Research Ethics: How to Treat People Who Participate in Research. National Institutes of Health, USA. Available at http://www.bioethics.nih.gov/education/FNIH_BioethicsBrochure_WEB.PDF. Accessed 1st August 2013. • Sociological Association of Ireland (1997) Ethical Guidelines. • WHO (2011). Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants. World Health Organisation. Available at http://whqlibdoc.who.int/publications/2011/9789241502948_eng.pdf. Accessed 1st August 2013.

41. Data Management Plan

42. Who? • Principal Investigator • Create a data managment plan and advise the student to create their own plan. • Lecturer • Same as above • Student • Follow data management plan identified by principal investigator • User • Ask for more details or more explanation. If the information provided to you isn’t clear • Institution • Provide advise to prepare design or research project protocol.

43. Data Management Plan -Details • Many designer may be they are unaware of the importance of maintaining a high standard regard to user data management. • All users should be treated the same level of confidentially and privacy • Learning a good practice in data management will prepare you for managing complex sets of user data in the future. • At least question why you are creating a data management plan. • A data management plan should cover every single piece of personal and other data collected about user. • Be aware of Irish Data Protection rules.

44. References • Durham University (2012) Community-based Participatory Research: A Guide to Ethical Principles and Practice. Centre for Social Justice and Community Action, Durham University. • European Science Foundation (2000). Good Scientific Practice in Research and Scholarship. European Science Foundation Policy Briefing. Available at http://www.esf.org/fileadmin/Public_documents/Publications/ESPB10.pdf. Accessed 1st August 2013. • UK Medical Research Council (2012) Good Research Practice: Principles and Guidelines. • UK Medical Research Council (2013). MRC Guidance on Data Management Plans. UK Medical Research Council Website. Available at http://www.mrc.ac.uk/Ourresearch/Ethicsresearchguidance/datasharing/DMPs/index.htm. Accessed 23rd August 2013. • National Institutes of Health (2007). Guidelines for the Conduct of Research in the Intramural Research Programme at the National Institute of Health, USA. Available at http://sourcebook.od.nih.gov/ethic-conduct/conduct%20research%206-11-07.pdf. Accessed 1st August 2013. • NCBI (Draft) Research Code of Practice Policy and Procedure: Principles of Best Practice in Quality Research. NCBI – Working for People with Sight Loss, 2013.

45. Ethics Protocol

46. Who? • Principal Investigator • Prepares ethics protocol and advises students how to prepare their own. • Lecturer • Same as above • Student • Follows ethics protocol identified by principal investigator or where required prepares protocol. • User • Participant information should explain ethical issues otherwise a clear explanation should be asked for. • Institution • Prepares a code of practice for design research ethics and raises awareness of ethical issues that should be addressed in design projects. Provides guidance on how to prepare ethics protocol and obtain informed consent.

47. Ethics Protocol - Details • Should be used when planning a design project that includes user engagement • Outlines potential ethical issues and the steps to address the issues • Acts as a record of unexpected ethics issues • Contain a user engagement plan, preparing data management plan and getting informed consent • Contain information on how informed consent is obtained, recruiting in an ethical manner treatment of users, treatment of personal information etc.

48. References • British Psychological Society Code of Conduct: Ethical Principles for Conducting Research with Human Participants. Available at http://www.bps.org.uk/sites/default/files/documents/code_of_human_research_ethics.pdf. Accessed on 23rd August 2013. • Dalton, AJ, McVilly, KR (2004) Ethics Guidelines for International Multi-Centre Research Involving People with Disabilities. • European Commission (2013). Ethical Review in FP7: European Commission Guidance for Applicants – Getting Through Ethical Review. Available at http://cordis.europa.eu/fp7/ethics_en.html. Accessed on 23rd August 2013. • Sociological Association of Ireland (1997) Ethical Guidelines.

49. Ethical Approval

50. Who? • Principal Investigator • Finding research ethics committee and apply for approval and identify any ethics requirements • Lecturer • Same as above • Student • Follow the principal investigators approval instructions • User • If unclear ethical issues are provided to ask for more details • Institution • Set up a research ethics committee or find one and to set up codes of practice and training if needed.