How best to improve the University’s Ethics Policy for Research Involving Human Participants, Data and Tissue Ethics Review Procedure
Aim
‘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
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
Summary of the Policy
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
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
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
The Research Ethics Principles: Identifying principles for the University’s richly diverse research base
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
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
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
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
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
Ethics Review Procedure - Overview
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
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
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
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
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
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
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
Policy, Principles, Procedure 04/06/2019 © The University of Sheffield / Department of Marketing and Communications
Some thoughts …
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
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
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
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?