1. How best to improve the University’s Ethics Policy for Research Involving Human Participants, Data and Tissue Ethics Review Procedure

2. Aim

3. ‘Principles’ (section 2 of Policy) ‘Procedure’ (section 3 of Policy)
Aims:
To stimulate discussion –
is improvement required?
what do we mean by ‘improvement’?
which aspects need improving?
which aspects most need improving?
conservative, moderate or radical change?
04/06/2019
© The University of Sheffield / Department of Marketing and Communications

4. Improvements in order to …
Principles & Procedure
Improvements in order to …
Trade-offs? (minimalist or purist or pragmatic approach?)
Better safeguard dignity, rights, safety & well-being of human participants & of researchers?
Make efficiency gains?
Reduce University’s exposure to risk?
04/06/2019
© The University of Sheffield / Department of Marketing and Communications

5. Summary of the Policy

6. Purpose of the Overview
Explains drivers behind the Policy, its origins, sources & its fit with University governance
Clarifies Policy’s remit and who it applies to
Clarifies responsibilities (Heads, individuals)
Defines research, ethics & research ethics
Need to be sensitive to University culture
Need to be flexible due to diverse research
Complements NHS ethics review system
Benefits
Frequency of review
04/06/2019
© The University of Sheffield / Department of Marketing and Communications

7. Purpose of the Principles
Opening statements of values & expectations
* High academic & ethical standards, integrity, honesty, openness, protecting people
* consider ethical implications & consequences
* potential risks in any research with people
Primary responsibility: PI, Supervisor
Defines ‘participant’, ‘data’ (personal & sensitive), ‘tissue’, ‘particularly vulnerable’
Principles: Safety & Well-being, Consent, Anonymity, Confidentiality, Data Protection
04/06/2019
© The University of Sheffield / Department of Marketing and Communications

8. Purpose of the Procedure
Clarifies who it applies to – i.e. members of staff, registered students and individuals conducting research on University premises
All researchers must have access to it
Seven generic standards for research involving human participants, data & tissue
Three potential ethics review routes [weblink to central research ethics website]
University Research Ethics Committee (UREC) terms of reference, membership, monitoring)
04/06/2019
© The University of Sheffield / Department of Marketing and Communications

9. The Research Ethics Principles: Identifying principles for the University’s richly diverse research base

10. Ethics Review Procedure for But the UREC can advise on
Research with Human Participants
But the UREC can advise on
any ethical issue in research
Social Sciences
Health-Related
Arts & Humanities
Require generic ethical principles to benefit a diversity of research methodologies
Physical Sciences
Biological
Medical
Engineering
04/06/2019
© The University of Sheffield / Department of Marketing and Communications

11. Safety and Well-Being Current Key Principle
Exposure to risks not greater than normal
Procedures in place to contact researcher
Medical conditions that might create risks
Physical or psychological problems found
Sensitive questions (qualitative research)
Informed about / witness illegal activities
Section: Protecting researchers from harm
04/06/2019
© The University of Sheffield / Department of Marketing and Communications

12. Consent Current Key Principle Free, voluntary (no coercion)
Be given time … an ongoing process
Written consent where possible
Informed consent (competency, lay language)
Free to withdraw at any time
Children, incompetent adults, people in dependent relationships
Covert research, observational research
04/06/2019
© The University of Sheffield / Department of Marketing and Communications

13. Anonymity, confidentiality & data protection
Current Key Principle
Anonymity, confidentiality & data protection
Data Protection Act (1998) compliant
Protect dignity and rights: Personal data = privileged information
Flag up potential risks, access, purpose
Storage & processing risks
‘True’ anonymity
04/06/2019
© The University of Sheffield / Department of Marketing and Communications

14. Key Principles Food for thought …
Are these the only key generic principles? (e.g. developing countries … dual use …)
Does the text associated with each current key principle allow for sufficient flexibility?
Does the text associated with each current key principle cover all the key points?
Does each key point (e.g. informed consent) cover all key issues & in sufficient depth?
04/06/2019
© The University of Sheffield / Department of Marketing and Communications

15. Ethics Review Procedure - Overview

16. Ethics Review System NHS University
Procedure
Ethics Review System
NHS
University
Alternative
Research with:
- NHS patients & NHS users
- Relatives & carers
- Access to data, organs,, other bodily material of NHS patients (past, present)
- Recently dead in NHS premises
- Phase 1 clinical trials involving healthy volunteers
- NHS premises or facilities
- NHS staff recruited by virtue of
professional role
Research project with human participants & - not requiring NHS review - Sheffield-led project - project is UK-based
- Other HEI is lead project partner (or)
- Project takes place in other country(ies)
Grey areas?
04/06/2019
© The University of Sheffield / Department of Marketing and Communications

17. Procedure’s Governing Principles:
University Procedure
Procedure’s Governing Principles:
Effective (Quality)
- Competent decisions
- Consistency in quality of decision-making
- Key issues addressed
- Independence
- Transparent
Efficient (Speed)
- Pragmatic choice (limited resources, competing work)
- Proportionality
Flexibility
User-friendly
Based on trust (& UREC random sampling of applications)
04/06/2019
© The University of Sheffield / Department of Marketing and Communications

18. University Procedure Dept. level ethics review:1, 2 or 3 reviewers
Ethics Review Panels
Ethics Review Panels
Contentious projects appeals
Contentious projects appeals
UREC
Ethics Review Panels
Ethics Review Panels
Dept. level ethics review:1, 2 or 3 reviewers
Dept. level ethics review:1, 2 or 3 reviewers
04/06/2019
© The University of Sheffield / Department of Marketing and Communications

19. Staff & Postgrad. Research Students
Procedure in practice
Staff & Postgrad. Research Students
UREC
Potential Decisions: - approved - approved with optional suggestions - approved subject to required changes - not approved (applicant may appeal) - no decision: application is contentious
School
Ethics Review Panel
Ethics Review Outcome
Route for Appeals & Contentious Applications
Minimum of 3
Independent ethics reviewers
Ethics Administrator
e.g. consent form, information sheet
Applicant completes University
research ethics application form (+ other documents if appropriate)
04/06/2019
© The University of Sheffield / Department of Marketing and Communications

20. Procedure in practice Undergrad./Postgrad.-taught students
Particularly vulnerable people: Infants and children under 18 People with physical and/or psychological disabilities People dependant on the protection or under the control/influence of others Relatives of sick people (e.g. parents of sick children) People with a basic/elementary knowledge of English
Focuses on highly sensitive topics: Race, ethnicity, political opinion, religious beliefs/other beliefs of a similar nature, physical or mental health or condition, sexual life Abuse (child, adult); nudity; obesity People affected by conflict situations
04/06/2019
© The University of Sheffield / Department of Marketing and Communications

21. Undergrad./Postgrad.-taught students
Procedure in practice
Undergrad./Postgrad.-taught students
UREC
Supervisor gives Administrator copy of application & decision
School
Ethics Review Panel
Ethics Review Outcome
Route for Appeals & Contentious Applications
LOW RISK applications:
Minimum of 1 ethics reviewer
(this can be the Supervisor)
Potentially HIGH RISK applications:
Minimum of 2 independent
ethics reviewer
Supervisor
Ethics Administrator
Applicant completes the University’s STUDENT research ethics application form (+ other documents if appropriate)
04/06/2019
© The University of Sheffield / Department of Marketing and Communications

22. Generic Research Projects
Procedure in practice
Generic Research Projects
Sufficiently similar student projects in terms of:
research topic
question, aims, objectives
methodology
type of participant
nature of participation
type of method chosen to inform participants
content of information sheet/consent form
- Module leader submits ethics form to Review Panel
- Good practice for students to complete form for educational purposes
04/06/2019
© The University of Sheffield / Department of Marketing and Communications

23. Policy, Principles, Procedure
04/06/2019
© The University of Sheffield / Department of Marketing and Communications

24. Some thoughts …

25. SWOT Potential Strengths:
Few Principles (concise) - Procedure is flexible - Procedure is relatively efficient (at departmental level, electronic)
Potential Weaknesses:
Oversimplified Principles Procedure: - complex (procedures, forms, guidance) - not independent - additional work for staff
04/06/2019
© The University of Sheffield / Department of Marketing and Communications

26. SWOT Potential Strengths:
Few Principles (concise) - Procedure is flexible - Procedure is relatively efficient (at departmental level, electronic)
Potential Weaknesses:
Oversimplified Principles Procedure: - complex (procedures, forms, guidance) - not independent - additional work for staff
Potential Opportunities: - Principles & Procedure are sufficiently flexible for all research methods without adversely affecting participants
Potential Threats:
- Principles: Too rigid? Meet current legislation? - Procedure: Tick box? (or) overzealously applied?
04/06/2019
© The University of Sheffield / Department of Marketing and Communications

27. Further thoughts … Policy, Principles & Procedure:
Need for a broader concept of research ethics (i.e. wider than human participant-based research)?
Need for language to be less formal & more ‘alive’?
Need to better demonstrate the link between the Policy & the operational forms and guidance?
Need to better demonstrate the link between the Policy & existing legislation and funding rules?
Need for greater pooling of the operation of the Procedure across cognate academic departments?
04/06/2019
© The University of Sheffield / Department of Marketing and Communications

28. Group Discussion Task – - How could the Principles (Policy, section 2) be improved &, if so, in what ways? - How could the Procedure (Policy, section 3) be improved &, if so, in what ways?