Prof. Christine Milligan

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Ethics and Ethical Practice inResearch

• Prof. Christine Milligan
• School of Health and Medicine Lancaster University

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Key Terms

• Research Ethics moral principles guiding
  research
• Ethical Principles concerned with rights,
  dignity safety of researched
• Research Governance development of shared
  standards and mechanisms for monitoring/management
  of research ( sanctions if required).

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6 key principles

• Research should be designed, reviewed and
  undertaken to ensure integrity and quality
• Informed consent of both research staff and
  subjects
• Confidentially of information and anonymity of
  respondents must be respected
• Participation must be voluntary and free from
  coercion
• Harm avoidance
• Independence of research - any conflicts of
  interest or partiality must be explicit.

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Implementation

• Responsibility for conduct of research rests with
  the principal investigator (PI)
• Responsibility for gaining appropriate ethical
  review monitoring lies with the institution
  employing the PI and researchers
• Research involving primary data collection or use
  of organs/tissues etc. will ALWAYS raises some
  ethical issues
• Use of secondary datasets is often
  uncontroversial BUT we cannot automatically
  assume so (e.g. novel use of existing databases
  or data linkage)

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Research Councils and their REFs

• Breaches of good ethical practice can bring to
  bear both individual AND institutional level
  sanctions.

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Ethics in Practice

• Proposals need to demonstrate what ethical
  approval is required how this will be achieved
  - in signing off a proposal an institution is
  indicating it concurs with this
• All legal requirements must be met, e.g. data
  protection, health and safety, privacy laws, IPR
  etc. Data cannot be stored or transferred to a
  country outside the EU unless to country has
  equivalent levels of protection for personal data
  or UNLESS data stripping has occurred.
• Researcher needs to be alert to unanticipated
  ethical issues that arise in course of carrying
  out research

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Expedited Review

• Where potential risk or harm to participants
  minimal, e.g. use of secondary datasets or
  published data in public domain
• May also be needed where projects have short lead
  time or in response to demand of pressing
  importance
• Often carried out by Chair or sub-group of REC
  or virtual committee.

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Informed Consent

• Information sheets
• Content of signed consent forms
• Who signs? (working with vulnerable groups)
• Staged consent?

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Anonymity Confidentiality

• Anonymity (people and text) refers to concealing
  the identity of participants/places in all
  documents resulting from the research
• Confidentiality is concerned with who has the
  right of access to the data provided by
  participants.

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Risk in Social Research

• Refers to the potential physical or psychological
  harm, discomfort or stress that might be
  generated by research.
• Wide range of methods used in research means
  there is a diverse range of potential risks that
  may need to be managed
• Includes risk to a subjects personal social
  standing, privacy, personal values and beliefs,
  links to family wider community and position
  within an occupational (work-related) setting
• Potential for harm can also arise from revealing
  information related to illegal, sexual or deviant
  behaviour
• Highlights importance of informed consent .

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Social Research incurring more than minimal risk

• Research involving vulnerable groups
• Research involving sensitive topics
• Research requiring access through gatekeepers
• Covert research
• Research involving access to confidential records
  or personal information
• Research that could induce psychological stress,
  anxiety, humiliation or more than minimal pain
• Research involving intrusive interventions.

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Ethics Resource

• http//www.lancs.ac.uk/researchethics/