Research Ethics A guide to principles and procedures

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Research EthicsA guide to principles and
procedures

• Dr Ruth Green
• Chair University Ethics Sub-Committee

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Why is Research Ethics Important?

• It is a reflection of respect for those who take
  part in research
• It ensures no unreasonable, unsafe or thoughtless
  demands are made by researchers
• It ensures sufficient knowledge is shared by all
  concerned
• It imposes a common standard in all the above
  respects

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Why is Research Ethics Important

• It has become the norm as an expectation for
  research activity
• . a professional requirement for practitioners
  in some disciplines e.g. psychology
• a requirement for access to participants in
  others e.g. health
• and a requirement to comply with external REFs
  to obtain funding e.g. ESRC

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What Projects Need Ethical Approval?

• Human participants
• Use of the products of human participants
• Animal participants
• Work that potentially impacts on human
  participants
• Where ethical approval is deemed unnecessary a
  disclaimer may be signed by researcher (and
  supervisor)

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Key Ethical Issues

• Informed Consent - special consideration for
  minors
• Deception
• Need for debriefing
• Right to withdraw
• Confidentiality
• Safety and risk

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What Else Does the Panel Need to Know?

• Summary of background to and rationale for
  proposal
• Nature of data to be collected
• Procedures and measuring tools/equipment
• Who are the participants?
• Where will data collection occur?
• How will data be stored and for how long?

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Structure of Ethics Committees

• University Ethics Sub-Committee
• policy making, dissemination, monitoring/audit
• Faculty Ethics Panel
• routine approval, monitoring of sub-panels if
  they exist
• Optional Programme/Subject Area Sub-Panels
• routine approval

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Full Procedure

• Complete Full University Approval form
• Attach consent form, information sheet and
  additional material e.g. questionnaires
• Students must get form checked signed by
  supervisor
• Submit to appropriate Ethics Panel where
  Sub-Panels exist, staff and PG researchers must
  still submit to Faculty Panel
• DATA COLLECTION MUST NOT START UNTIL PANEL
  INFORMS

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Outcomes of First Application

• Approved - must begin within the timescale
  indicated
• Approved subject to amendments supervisor
  confirms with Chair of FEP
• Deferred passed to UESC (v. rare!)
• Not Approved major revisions and resubmit

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Additional Issues

• Changes to original proposal must be notified
• Completion of project must be notified
• Adverse events must be notified
• Some applications will require evidence of risk
  assessment
• Some applications will require evidence of Police
  Clearance

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Recent Developments

• University Ethics Website
• Assessment of training needs and development of
  generic training material
• Wider dissemination of key information
• E.g. new staff, admin staff, partners
• Extension of principles to non-Faculty staff
• ADI to form Ethics Panel
• Extension to home and international partners

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Recent Developments

• Extension of remit to enterprise and knowledge
  transfer activities
• Auditing of Faculty activities
• Publication of new Code of Conduct for Research
• Appointment of lay members
• Development of Fast-Track Approval Procedures

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Fast Track Approval Procedures

• Accepts principle that much routine research
  conforms to accepted ethical principles
• Form requires checking off a series of questions
  if OK add 150 word summary
• Student form to be signed by supervisor one
  other
• All ft forms sent to Chair of FEP for information
• Option in student forms for signing in 2 stages