Ethics and Ethical Practice in
Research
PROF. CHRISTINE MILLIGAN
SCHOOL OF HEALTH AND MEDICINE
LANCASTER UNIVERSITY
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).
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.
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)
Research Councils and their
REFs:
 Breaches of good ethical
practice can bring to bear
both individual AND
institutional level sanctions.
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;
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’.
Informed Consent
 Information sheets;
 Content of signed consent forms;
 Who signs? (working with vulnerable
groups)
 Staged consent?
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.
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 subject’s personal social standing,
privacy, personal values and beliefs, links to family & wider
community and position within an occupational (workrelated) setting;
 Potential for harm can also arise from revealing
information related to illegal, sexual or deviant behaviour;
 Highlights importance of informed consent .
Social Research incurring more than minimal risk
 Research involving vulnerable groups;
 Research involving sensitive topics;
 Research requiring access through
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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.
Ethics Resource
 http://www.lancs.ac.uk/researchethics/