User Engagement Toolkit

User Engagement Toolkit1. Irish Legislation2. Health and Safety3. Insurance4. Garda Clearance5. Responsibilities6. Design Project

Protocol7. Risks and Benefits8. User Engagement

Plan9. Data Management

Plan

10. Ethics Protocol11. Ethical Approval12. Reimbursement or

Payment13. Understanding the

Specific Needs of Your Users

14. Confidentiality and Privacy

15. Participant Information16. Informed Consent17. Use of Data18. Following up with the

User

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)

Which sections where?

Barry Sheridan Andrea Gasser Vusala Gurbanova Gareth Hunter Martin Cronin

Group 1

Joan Murphy Peter Kovar Danielle Pouvaneeswaree Sameer Handa Areej Algathani

Group 2

Ronan Clancy William Jones Maryam Almussalam Sarfraz Ramay David Hurley

Group 3

Atul Swami Divyaa Manimaran Sohaib Khan Fei Wang Peter Keogh

Group 4

Alex Hannon-Cross Dajana Davidovic Mansour Alnakhli Stephen Mckeown

Group 5

Irish Legislation

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

Who

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

Details

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.

References

Insurance

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

Who?

◦ 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

Details

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.

References

Garda Clearance

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.

Who?

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.

Garda Clearance

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.

References

http://www.citizensinformation.ie/en/employment/employment_rights_and_conditions/monitoring_and_surveillance_at_work/garda_clearance_for_employees.html




Health & Safety

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

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

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

References

Design Project Protocol

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

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

Durham University (2012) Community-based Participatory Research: A Guide to Ethical Principles and Practice. Centre for Social Justice and Community Action, Durham University.


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.

References

http://whqlibdoc.who.int/publications/2011/9789241502948_eng.pdf

Responsibilities


◦ 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.

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

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.

References

http://www.esf.org/fileadmin/Public_documents/Publications/ESPB10.pdf


http://sourcebook.od.nih.gov/ethic-conduct/conduct%20research%206-11-07.pdf


User Engagement Plan


◦ 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

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

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.

References

http://www.bps.org.uk/sites/default/files/documents/code_of_human_research_ethics.pdf


http://cordis.europa.eu/fp7/ethics_en.html

http://designingwithpeople.rca.ac.uk/ethics

Risks & Benefits


◦ 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.

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

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.


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.

References



Data Management Plan

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.

Who?

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.

Data Management Plan -Details



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.



References


http://www.mrc.ac.uk/Ourresearch/Ethicsresearchguidance/datasharing/DMPs/index.htm

http://www.mrc.ac.uk/Ourresearch/Ethicsresearchguidance/datasharing/DMPs/index.htm


Ethics Protocol

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.

Who?

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.

Ethics Protocol - Details

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.


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.


References



http://cordis.europa.eu/fp7/ethics_en.html

Ethical Approval

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.

Who?

Check what rules or requirements are for the school/institution or department

Check if a research ethics committee exists if not identify one and seek its approval

Check if you need approval from external organisation or board.

Check if source of funding requires ethical approval

Ethical Approval - Details

HSE (2008). Review of Research Ethics Committees and Processes in the Republic of Ireland. Research Ethics Committees Review Group 2008, Health Services Executive, Ireland.


Irish Medicines Board (2013). Medical Devices. Available at http://www.imb.ie/EN/Medical-Devices.aspx. Accessed on 23rd August 2013.

NDA (2009). Ethical Guidance for Research with People with Disabilities. Disability Research Series 13. National Disability Authority, Ireland.

Privireal (2005). Ireland - RECs and Medical Research. Available at http://www.privireal.org/content/rec/ireland.php. Accessed on 23rd 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.

References

http://www.imb.ie/EN/Medical-Devices.aspx

http://www.privireal.org/content/rec/ireland.php

Reimbursement of Payment

Principal Investigator◦ Consider the cost of user engagement and method for

reimbursement. Lecturer

◦ Consider personal details that will be required from the users for payment.

Student◦ Collect necessary information from users so that payment process is

smooth. User

◦ Document the receipt of payment. Make it easy for principal investigator by providing all the necessary relevant info.

Institution◦ Improve coordination between finance department and principal

investigator to make process efficient.

Who?

There are different types of compensations e.g. payment, voucher, a gift voucher. It may be appropriate to provide some sort of compensation e.g. parking, travelling, food or accommodation.

In some automous surveys payments cannot be made unless identity of the user is known.

Payment to users is controversial as it encourages the user to take part in the project and can pollute the results.

Payment to users should be clearly recorded. Payment process should be transparent & efficient.

Reimbursement of Payment - Details

National Disability Authority (2009) Ethical Guidance for Research with People with Disabilities. National Disability Authority, Ireland.


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.

References





Understanding the Specific Needs of Your Users

Principal Investigator◦ Responsible for identifying user needs and to address them.

Lecturer◦ Same as Principal Investigator

Student◦ Educate yourself on extreme user needs and follow

investigator’s guidance. User

◦ Providing particular requirements to the researchers. Institution

◦ To educate the staff about the needs of older and disabled people and how to collect information in an accessible format.

Who?

Most of the times requirements are almost same to every user but in some cases, requirements may be specific. The best approach to find out if someone has specific requirements is to get engage with them and simply ask.

To ensure that user engagement goes smoothly, they should be provided comfort and easy access to the venue and activities . And it is important to provide users the complete and clear details of the user engagement program.

And while compiling any thing that serves the purpose of the communication, we should follow some protocols so that our words be heard and read by all users, regardless of their age, or disability. And its wise to know your users earliest as possible.

Details

ISO (2001) ISO/IEC Guide 71: 2001. Guidelines for Standards Developers to Address the Needs of Older Persons and Persons with Disabilities.

NDA (2013). Centre for Excellence in Universal Design website (Customer Engagement Toolkits). Available at www.universaldesign.ie. Accessed 23rd August 2013.

NDA (2002). Guidelines for Including People with Disabilities in Research. National Disability Authority, Ireland.

NDA (2002). Ask Me: Guidelines for Effective Consultation with People with Disabilities. National Disability Authority, Ireland.

References

http://www.universaldesign.ie/

Confidentiality and Privacy

Principal Investigator◦ Familiar with user data best practice & keeping students

informed of those practices. Lecturer

◦ Same as Principal Investigator Student

◦ Follow guidance of PI and learn methods of data sensitivity User

◦ Understand rights and why the data is being collected. Don’t provide data you don’t feel comfortable providing

Institution◦ Develop protocols and educate staff on data collection

issues.

Who?

Always treat data with confidentiality and privacy. Educate anyone with access to the data about their

responsibilities Store data securely Separate data from users identification Transport data securely People should not be identifiable without permission When sharing data, balance data protection while

getting the most out of the data. Don’t protect data to the point where datasets need to be recreated unnecessarily

Details

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.



Medical Research Council (2012) Good Research Practice: Principles and Guidelines.



References

http://www.dataprotection.ie/ViewDoc.asp?fn=/documents/responsibilities/3bii.htm&CatID=54&m=y

http://www.dataprotection.ie/ViewDoc.asp?fn=/documents/responsibilities/3bii.htm&CatID=54&m=y


65

Participant Information

66

Principle Investigator – Prepare clear concise Participant Information. Advise students on preparation of Participant Information.

Lecturer- Prepare clear concise Participant Information.

Student- Preparation and communication of Participant Information.

User – Request appropriate information format; if necessary ask for more details

Institute – Guidelines/advice to preparation of Participant Information.

Who Does What?

67

Details- Crucial: Clear and understandable information (in

recruitment stage or introduction to Informed Consent)

- Format of the Participant Information must comply with user access, so that specific user needs are met (wrt written or f2f communication)

- Include User Understanding and Freedom, see p.3 - Include project details, its purpose, the procedure

and contact details- Give one copy of PI to the user; keep one signed

version

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.



WHO (2011). Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants. World Health Organisation.

References

69

Informed Consent

70

Who Does What? Principle Investigator – Co-ordinator Lecturer- Advisor Student- Collector User – Inform Institute – Guidelines and codes

71

DetailsStart of the engagement process User Understanding and Freedom

◦ Implications of the project◦ Freedom of participation◦ Ability to withdraw

Be careful of anonymity, use of photo’s and videos Acquire proxy consent Proxy consent and assent Factors influencing users

◦ Knowing the person◦ Developing a relationship◦ Professional connection◦ Skewing information through reimbursement or payment





References

73

Use of Data

74

Who Does What? Principle Investigator – User data Lecturer- User Data Student- Follow Guidance , IP User – If short information, more details Institute – Education & Guidance

75

Details Stick to the agreement of the data use In case of change, inform the user Confidentiality & privacy Maybe IP agreement



Health Research Board (2007) Health Research Board Guidelines for Host Institutions on Good Research Practice.

Medical Research Council (2012) Good Research Practice: Principles and Guidelines.



References



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Following up on the User

78

Who Does What? Principle Investigator – Co-ordinator/Advisor Lecturer-Co-ordinator/Advisor Student- Follow Guidance , Actioner User – Inquire about design project aspects Institute – Advice on Policy

79

Details Send Thank you Possible reimbursement or payment Hear final findings Form of recognition or acknowledgement Peer review stage user included Format accessible to user.


Irish Council for Bioethics (2010) Recommendations for Promoting Research Integrity.


NDA (2002). Ask Me: Guidelines for Effective Consultation with People with Disabilities. National Disability Authority, Ireland.

References

User Engagement Toolkit

Documents

Transcript of User Engagement Toolkit