 The document discusses research ethics guidelines and procedures in the UK and at the University of Cumbria. It outlines the role of Research Ethics Committees in reviewing research proposals to protect participants. It also addresses ethics review for student research projects. Finally, it provides guidance on the research ethics review process and documents required for seeking ethical approval.

1. Tempus Masters Programmes in Public health and Social Services
Training Week 8th – 14th May 2011
Tamara Kudaibergenova, PhD
The Leverhulme Fellow
University of Cumbria
Lancaster, UK

2.  Research Ethics in the UK
 University Research Ethics Committees (UREC)
 University of Cumbria Research Ethics
Committee (Ethics Panel):
Student‟s Research projects

3.  UK Research Integrity Office Code of Research Practice:
“Organisations and researchers working with, for, or under
the auspices of, any of the UK Departments of Health
and/or the National Health Service must adhere to all
relevant guidelines”.
 All reputable medical journals now require proof that
research has been passed by an ethics committee.
 NHS claims that all research involving NHS staff and
facilities must be passed by the Research Ethics
Committee.
 All research involving the NHS is governed by the
Governance Arrangements for Research Ethics Committees
(GafREC) document.

4. A question to ponder: does research in non-
medical research and social science need
such a rigid approach to research scrutiny
and governance?

5.  The ESRC is the UK's largest organization for funding research on
economic and social issues.
 It is a non-departmental public body established by Royal
Charter in 1965 and receive most of funding through the
Department for Business, Innovation and Skills.
 It supports independent, high quality research which has an
impact on business, the public sector, and the third sector.
It funds research and training in social and economic issues.
 It distributes funds to academics in universities and other
institutes throughout the UK
 It supports over 4,000 researchers and postgraduate students in
academic institutions and independent research institutes in the
UK.

6.  Social science is, in its broadest sense, the study of society and the
manner in which people behave and influence the world around us.
 The main social sciences include:
•anthropology
•communication
•criminology
•cultural studies
•economics
•human geography
•linguistics
•law
•political science
•psychology
•sociology
•development studies

7.  Launched July 2005, implemented January
2006, revised 2010;
 All grant applicants to ESRC must comply with
the conditions set down in the REF;
 But the ESRC is trying not to force a single
model on all institutions;
 And ESRC Framework aims to make the
burden of research ethics oversight
proportional to the dangers.

8.  The principal aim of the ethics review is to
protect all groups involved in research:
participants, institutions, funders, researcher
s throughout the lifetime of the research and
into the dissemination process.
 Research integrity is closely linked.
 It sees as good practice for all social science
research.
 Whilst it is mandatory for ESRC- funded
research, it is also recommended for use by
other funders.

9.  The ESRC Framework for Research Ethics
2010 that core changes introduced
 The guidance in regards to research with
participants who lack mental capacity, in light
of the Mental Capacity act (2005)
 Clarity in ESRC requirements in regards to
ethical review (all research ought to receive at
least light touch” review) and student
research (all student research should likewise
receive at least “light touch” review)

10.  Is this research?
 Professional codes of practice still apply?
 Does proposal address subject of ethics?
 Principal Investigator to write Ethics Discussion
 Does it involve more than minimal risk
 Review by „Light touch‟ Department REC
 Does the research involve NHS
patients, records, equipment, premises or
vulnerable people under the Mental Capacity Act
2005?
 Review by NHS NRES
 Review by UREC

11.  To have dedicated research ethics
committees:
 To delimit of activities of the ethics
committees so that it has a clearly defined
role and a realistic workload
 To meet requirements of external
bodies, notably funding and professional
bodies

12.  Research is any form of disciplined inquiry that aims
to contribute to a body of knowledge or theory (ESRC
FRE 2010).
 Research requires the creation of new knowledge. It
must advance the academic community‟s
knowledge, not merely investigator‟s;
 Research presuppose formal and disciplined of
inquiry (e.g. Caesar salad by Caesar Cardini
1924, FerranAdria head chief of El Bulli restaurants)
 Commitment to publication

13.  Research Ethics refers to the moral principles
guiding research, from its inception through
to completion and publication of results and
beyond – for example, the curation of data
and physical samples after the research has
been published.

14.  1. Research should be designed, reviewed and undertaken to ensure
integrity, quality and transparency.
 2. Research staff and participants must normally be informed fully about the
purpose, methods and intended possible uses of the research, what their
participation in the research entails and what risks, if any, are involved. Some
variation is allowed in very specific research context for which detailed
guidance is provided in Section 2 of the ESRC FRE.
 3. The confidentiality of information supplied by research participants and
the anonymity of respondents must be respected.
 4. Research participants must take part voluntarily, free from any coercion.
 5. Harm to research participants must be avoided in all instances.
 6. The independence of research must be clear, and any conflicts of interest
or partiality must be explicit.

15.  The responsibility to implement these principles rests with
the principal investigator and the research/ employing
organisation.
 Breaches of good ethics practice in ESRC funded research
will be treated as a serious matter by the Council.
 Where these occur, the institution, researchers and
Principal Investigator will be called to account by the
Council and sanctions may apply depending on the
severity of the breach. These could result in the immediate
suspension of the individual project and other projects
based at or under the co-ordination of the contracting
institution, and a halt to the consideration of further
applications from that institution.

16.  A „Research Ethics Committee‟ (REC) is
defined as a multidisciplinary, independent
body charged with reviewing research
involving human participants to ensure that
their dignity, rights and welfare are
protected. The independence of a REC is
founded on its membership, on strict rules
regarding conflict of interests, and on regular
monitoring of and accountability for its
decisions

17.  Some RECs were set up before 1990 (Anthea
Tinker, Vera Coomber, 2004);
 The Nuffield Council Report, University
Research Ethics Committees: Their role, remit
and conduct (2004) found that:
80% of universities had a UREC;
half of them were set up since 2000;
Most URECs covered only staff and
graduate students but not undegraduate
students;

18.  The primary role of a REC is to protect the
dignity, rights and welfare of research
participants.
 RECs should also give due regard to the
consequences of the proposed research for
others directly affected by it and to the interests
of those who do not take part in the research but
who might benefit or suffer from its outcomes in
the future.
 RECs also need to consider the safety of
researchers, especially where they are working
abroad, in covert situations and/or conducting
lone fieldwork in settings that may pose risk to
their safety.

19.  Institutional RECs are responsible for reviewing all
research involving human participants, personal data and
sensitive personal data conducted under their auspices
and undertaken by13 of 50individuals employed by the
institution that does not come under the remit of the NHS
NRES.
 RECs should review research proposals in a way that is
independent, competent and timely. In some
circumstances RECs may authorise other sub-committees
or their chair to conduct reviews on research involving
minimal risk on their behalf.
 These sub-committees and chair will be accountable to
the REC and through it to the appropriate institutional
authorities for the decisions they make.

20.  RECs should be multidisciplinary and comprised of both men and
women.
 They must include at least one lay member with no affiliation to
the university or research institution in question.
 There must be members who have broad experience of and
expertise in the areas of research regularly reviewed by the REC
who have the confidence and esteem of the research community.
 At least one member must be knowledgeable in ethics. There
must be a chairperson
 RECs would also benefit from including individuals who reflect
ethnic diversity, users of specialist health, education or social
services, where these are the focus of research
activities, individuals with experience of professional care or
counselling, and individuals with specific methodological
expertise (for example, statistics or qualitative methods) relevant
to the research they review
 RECs would normally need at least seven members.

21.  Principal REC
 Secondary RECs (Faculty, School or
Department based).

22.  Light touch review:
All ESRC-funded research should undergo it.
Many student projects may fall under this
category.
 Full REC review:
The projects that involve more than minimal risk.
 Expedited review:
In exceptional circumstances where research
projects require a full review but have a short
lead time and are commissioned in response to a
demand of pressing importance.

23.  Goal-based ethics
Goals are outcomes that we are aiming to
achieve
 Constrained-based ethics
Constraints are restrictions or barriers to
research which limit what it is permissible
you do even in pursuit of valuable goals

24.  Deontology is the view that some kind of action
(e.g. killing, deceiving, causing serious harms)
are wrong even the benefits they produce exceed
the harms.
 Rights-based approaches are an example of
deontological thinking, is that they place
constraints on how we may treat individuals even
in pursuit of worthwhile goals.
 Constraints need to be absolute, but they need
more that a marginal balance of benefit over
harm to be justifiably overridden

25.  Consequentialism is the view that the right actions is
always the one that produces the best overall
consequences, so any action can be justified provided
the benefits (to society as the whole) outweigh the
harms.
 Consequentialism tells to maximize that extent to
which morally important goals are satisfied even it
this involves some significant trade-offs or sacrifices.
 Utilitarianism is an influential form of
cinsequentialism, in which the relevant moral goal is
identified as maximizing overall welfare or happiness
(pleasure an the absence pain or satisfaction of
individual's preferences)

26. Research that could damage the university‟s
reputation:
 Research that is funded by “tainted” sources;
 Research that is funded by potentially
embarrassing sources;
 Research that may offend people;

27.  Universities and research institutions should establish procedures specifically
for reviewing research projects undertaken by undergraduate students and
students on taught postgraduate courses.
 The same principles should apply to postgraduate student research as to
staff research.
 Student research poses particular challenges in relation to ethics review
because of the large numbers, short timescales and limited scope of the
projects involved. Nevertheless, the same high ethical standards should be
expected in student research.
 Student projects involving more than minimal risk may need careful
consideration and possibly a full ethics review.

28.  However, in many cases student research may be
managed at school/department level and overseen
by a light touch Departmental Ethics Committee
using an initial checklist.
 Established protocols for commonly occurring
research can expedite the review process.
 It should be made clear to potential research
participants that the study is a student project.
 Universities also need to ensure that students are
not exposed to undue risk in conducting their
research.

29. Process Chart and Guidance Notes:
Developing Research and Completing a Request for Ethical Clearance
 Document E1:
Checklist of Ethical Principles for Research
 Document E1A
Checklist of Ethical Principles for Research involving Animals
 Document E2:
Ethical Principles and Guidelines for Research involving Human Participants
 Document E3:
Policy for Addressing Safeguarding Children and Young Persons
(on the S-drive at S:Student And Staff PoliciesSafeguarding Children and
Young PeoplePolicy documentsPolicy approved Oct07 amended Oct08)
 Document E4A:
 Application Form: Research involving Animals

 Document E4H:
 Application Form: Research involving Human Participants

30. Fully committed to inclusivity and accessibility, the University of Cumbria will reflect
the Christian values and creative traditions on which it was founded, and will
promote an environment where diversity is celebrated and inventiveness flourishes
with a mission:
 To excel in the design and delivery of a range of accessible lifelong learning
opportunities through a network of centres within Cumbria and North Lancashire
 To inspire all of our students to achieve their potential by providing progressive
teaching and an innovative and flexible learning environment which encourages
independent thinking, tolerance and social responsibility
 To support economic advancement and the development of diverse and
sustainable communities by playing a prominent role in assisting the growth of
the regional economy and enhancing its skills base
 To encourage research, scholarship and knowledge transfer activities of
excellence, much of which will help shape and support sonstructuve
social, cultural and economic change and development.

31. ACCOUNTABLE Researchers should consider, from the outset, the potential beneficiaries
of their research. The research should be based on the informed consent of participants
and/or their guardians.
 CONFIDENTIAL
 ANTI-DISCRIMINATORY
 RECIPROCAL Research should be based on mutual dialogue between researcher and
participants and should seek to ensure that results can be used for the common good.
 EMPOWERING Research should be directed towards providing people, particularly those
who are disadvantaged and discriminated against, with the means to improve their
health and well-being in society.
 HONOURING OF PROFESSIONAL VALUES Professions have their own ethical codes of
conduct. These ethics should not in any way be undermined or subverted by research.
 ACCESSIBLE All research should be capable of being disseminated in the public domain
and be appropriate to the teaching and learning role of the university.
 CHALLENGING Research should seek to challenge received wisdom and embrace
openness and creativity in order to further understanding.

32.  RESPONSIBILITY TO THE RESEARCH PARTICIPANTS
 RESPONSIBILITY TO THE RESEARCH COMMUNITY
 RESPONSIBILITY TO THE FUNDING AGENCY
 RESPONSIBILITY TO THE PUBLIC
 RESPONSIBILITY TO THE UNIVERSITY OF CUMBRIA
No research should be carried out which, once
published, would demean the reputation of the
University as an institution

33.  Will it involve animals? yes - Submit to Ethics Committee;
 Will it involve Professional Body approval? Yes - Consult Tutor -
Consult Professional Body - Submit to Professional Body Ethics
Committee (eg BPS for work in the field of psychology, NHS Local
Research Ethics Committees (RECs))
 Will it involve Human Participants?
 Are the data in the Public Domain?
 Staff or Research Student?
No - Submit to Supervisor
Yes - Submit to Ethics Committee
If you are a student then seek advice of your Supervisor. If you are
a member of staff you will probably already be aware of any
requirements of your Professional Body, where applicable. If not
then you should consult with a colleague.