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Introducing Research Ethics:
Policy and Procedure
www.shef.ac.uk/ethics
What is Research Ethics?
Ethical review aims to protect welfare, dignity and rights of participants in research. It considers the rights of the research participants and the obligations of the researcher.
‘Unimpeachable ethics are at the heart of the research process, across all of our disciplines’ Keith Burnett
Safety and Wellbeing of all participants (including the researcher)
Principles of Informed consent
Anonymity, confidentiality and data protection
Researchers then have the obligation to ensure that their research is conducted with honesty; integrity; minimal risk to participants and themselves and cultural sensitivity
Ethics and TUOSwww.shef.ac.uk/ethics
General Principles and Statements
Ethics Approval Procedure
Research Ethics Policy Notes
Specialist Research Ethics Guidance Papers
Other Guidance and Advice
www.shef.ac.uk/ris/other/gov-ethics/ethicspolicy/general-principles
www.shef.ac.uk/ris/other/gov-ethics/ethicspolicy/approval-procedure
www.shef.ac.uk/ris/other/gov-ethics/ethicspolicy/policy-notes
www.shef.ac.uk/ris/other/gov-ethics/ethicspolicy/further-guidance/special-guidance/papers
www.shef.ac.uk/ris/other/gov-ethics/ethicspolicy/further-guidance/universityprocedure2www.shef.ac.uk/ris/other/gov-ethics/ethicspolicy/further-guidance/special-guidance/guidance
When is ethics approval required?
All research projects involving human participants, personal data or human tissue.
Policy Overview
What is Research?‘All investigation undertaken to acquire knowledge and understanding’ (RAE, 2008)
- Work of educational value designed to improve understanding of the research process
- administrative research (for example within Professional Services)
It does not include:
- Routine audit and evaluation
- Routine testing and analysis of materials, components, processes etc.
It includes:
Policy OverviewWhere can approval be gained from?
University of Sheffield ethics review procedure
NHS ethics review procedure/ Social care research ethics committee
An alternative ethics review procedure - Research led by another UK University/ research organisation - Research conducted outside the UK
(These procedures must have been judged to be sufficiently robust by the University Research Ethics Committee (UREC))
DoH Governance Arrangements for Research Ethics committees:www.gov.uk/government/uploads/system/uploads/attachment_data/file/213753/dh_133993.pdf
Legislative Requirements for Ethical Review:www.nres.nhs.uk/applications/approval-requirements/ethical-review-requirements/requirements-for-ethical-review-under-legislation/
Generally applicable for research involving NHS patients (inc. data) or Social Care users:
How does the University Ethics approval process work?
www.shef.ac.uk/ris/other/committees/ethicscommittee
Procedures
- promote awareness and understanding
- annually monitoring departmental review arrangements
- accrediting and reviewing departmental review arrangements
- providing guidance in cases of uncertainty
- making decisions on cases that cannot be resolved by ethics review panels
- hearing appeals against decisions made by departmental ethics review panels
- reviewing applications when necessary due to funding requirements
University Research Ethics Committee (UREC)Provides oversight to the process and monitors its implementation.
Process of ethical review devolved to Departments (excluding where required by funders or for contentious applications)
www.shef.ac.uk/polopoly_fs/1.365132!/file/Principal-Ethics-Contacts.pdf
www.shef.ac.uk/polopoly_fs/1.361915!/file/Ethics-Administrators-2014.pdf
ProceduresHow does the University Ethics approval process work?
To support this each department has a Principal Ethics Contact (responsible for communicating the policy and any changes that occur) and an Ethics Administrator (responsible for the day-to-day administration of the procedure). These contact details can be found at:
Each department also has a pool of ethics reviewers who conduct the majority of ethical reviews and maintain their own webpages giving the details of their departmental Research Ethics review processes
Departmental Devolution
Procedures
Departmental Ethics Review procedures:
- Staff led projects and supervised PGR projects
- Potentially low risk UG/ PGT
- Potentially high risk UG/ PGT
- Generic Applications
- ESRC funded and some social care research
- Contentious applications
www.sheffield.ac.uk/ris/other/gov-ethics/ethicspolicy/approval-procedure/review-procedure
Types of Application
Possible outcomes of the Procedures:
- Approval
- Approval with suggested amendments
- Approval with compulsory amendments
- Approval with suggested and compulsory amendments
- Not approved
- No decision – referred to Departmental Ethics Panel and then UREC
www.sheffield.ac.uk/ris/other/gov-ethics/ethicspolicy/approval-procedure/review-procedure/possible-project-outcomes
Procedures
ProceduresPostgraduate research (PGR) / Staff applications:
Compiles application and documents for ethical review
Researcher
Collates decisions / recommendations and informs Ethics Administrator
Lead reviewer
IF PGR , Supervisor to sign off
Supervisor
For PGR these cannot include SupervisorFor those projects requiring lay reviewers
this involves UREC
3 reviewers
Receives and records the decision ; informs researcher of outcome
Ethics administrator
Records and distributes to appropriate reviewers
Ethics administrator
Receives decision - amends processes / responds as necessary : DELIVERS RESEARCH IN ACCORDANCE WITH DECISION
Researcher
www.sheffield.ac.uk/ris/other/gov-ethics/ethicspolicy/approval-procedure/review-procedure/how-is-review-carried-out
ProceduresUndergraduate/ Postgraduate (taught) applications:
LOW RISK
HIGH RISK
Compiles application and documents for ethical review
Student
Assesses the risk of the project
Supervisor
Neither ‘potentially vulnerable’ participants / potentially sensitive research or containing
another risk within the research
POTENTIALLY LOW RISK
Usually supervisor plus one
(minimum) 2 reviewers
Receives and records the decision ; informs student of outcome
Ethics administrator
One reviewer required and most commonly the supervisor
Supervisor review
Receives decision from
supervisor / amends
processes as necessary
Student
Involving potentially vulnerable participants and / or address potentially sensitive topics
POTENTIALLY HIGH RISK
Records and distributes to appropriate reviewers
Ethics administrator
Receives decision - amends processes / responds as necessary . DELIVERS RESEARCH IN ACCORDANCE WITH DECISION
Student
Receives and records the decision
Ethics administrator Collates decisions /
recommendations and informs Ethics Administrator
Lead reviewer
www.sheffield.ac.uk/ris/other/gov-ethics/ethicspolicy/approval-procedure/review-procedure/distinct-research-projects
ProceduresStaff application for UG/ PG (taught) applications:
GENERIC
A cohort of students undertakes the same research exercise involving human
participants at a particular stage of a course
TYPE 1Students undertaking slightly different research projects which are sufficiently
similar within set parameters to allow for a generic review
TYPE 2
Submit ‘Generic’ application (on standard application form for staff / PGR students (or Departmental Equivalent ))
Course Leader
Records and distributes to appropriate review group
Ethics administrator
Review the application
Group of at least 3 Reviewers
Annual Review of the approval and planned activity
Course Leader + Ethics Administrator
Records the decision and informs the applicant
Ethics administrator
Renewal (resubmission ) of application . Minimum every 5
years
Course Leader
http://www.sheffield.ac.uk/ris/other/gov-ethics/ethicspolicy/approval-procedure/review-procedure/generic-research-projects
Considerations
www.shef.ac.uk/polopoly_fs/1.221498!/file/ABriefStudentGuideToResearchEthics.pdfwww.shef.ac.uk/ris/other/gov-ethics/ethicspolicy/further-guidance/universityprocedure2/reviewers
Considerations
Safety and Wellbeing (Ethics Policy Note 3):
• Consideration must be given to potential for harm/distress
• Steps should be taken to minimise harm/distress (e.g. informing participants of possibility; providing help/support after participation)
• In some research (e.g. clinical trials), the researcher may need to knowingly cause harm BUT possible harm should be outweighed by the potential benefits
• Participants should be informed of procedures for contacting researcher if problems arise
• Safety/well-being of researcher should also be considered
www.sheffield.ac.uk/ris/other/gov-ethics/ethicspolicy/policy-notes/safety-well-being
Considerations
Informed Consent(Ethics Policy Note 2)
• Consent should be gained using language and actions appropriate to those taking part in the study
• Participants should be fully informed about reasons/method and be able to ask questions/reflect
• Participants should give free and voluntary consent, and not be coerced
• Consent should ideally be in writing or witnessed oral consent instead, although this may not always be appropriate
• Must have right to refuse to participate or withdraw
• Need consent for data to be used for secondary analysis
• Special consideration should be given to projects where informed consent is not being obtainedwww.sheffield.ac.uk/ris/other/gov-ethics/ethicspolicy/policy-notes/consent
ConsiderationsAnonymity, confidentiality and data protection (Ethics Policy Note 4):
• Must comply with Data Protection Act 1998
• Participants’ identities should not be disclosed without prior consent; data should be anonymised where possible
• Access to data that could identify individuals should be restricted to lead researcher(s) unless there is agreement from the research participants
• Participants should be informed of:
1. Any risk that confidentiality may not be maintained (eg. disclosure of criminal activity);
2. Who will have access to data;
3. The purpose for which the data is to be usedwww.sheffield.ac.uk/ris/other/gov-ethics/ethicspolicy/policy-notes/confidentiality-anonymity-data-protection
Other procedures
Is ethics the only approval needed?
Departmental Contacts
Departmental Ethics Contact
Departmental Ethics Administrator
Departmental Ethics pages
www.shef.ac.uk/polopoly_fs/1.365132!/file/Principal-Ethics-Contacts.pdf
www.shef.ac.uk/polopoly_fs/1.361915!/file/Ethics-Administrators-2014.pdf
Further Information
www.shef.ac.uk/ethics
UREC SecretaryPeggy Haughton
[email protected] 22 21433
UREC Minute SecretaryCatherine Wynn
[email protected] 22 21400
“Thinking is NOT Optional”
