Staffordshire University Ethical Review Policy

1. Introduction
1.1 The University’s Ethical Review policy applies to everyone carrying out research
under the auspices of Staffordshire University, whether within or outside University
premises or facilities. This includes, but is not limited to, undergraduate and
postgraduate students; staff members; visiting researchers; and individuals holding
honorary posts.
1.2 The University Research Ethics Policy is designed to complement the National
Health Service (NHS) ethics review system. The University’s Ethics Review Procedures
do not, therefore, duplicate the functions, or overlap with the remit, of the NHS
ethics review system.
1.3 Any queries regarding the applicability of this policy should be referred to the Chair
of the University’s Research Ethics Committee.
1.4 For the purpose of this policy, ‘research’ includes all investigation undertaken in
order to acquire knowledge and understanding, across the full range of academic
disciplines and also incorporates research undertaken within, or on behalf of,
professional support departments (REF, 2011. P. 43). This includes:
• work of educational value designed to improve understanding of the research
process;
• work of relevance to commerce, industry;
• work of relevance to the public and voluntary sectors;
• scholarship supporting the intellectual infrastructure of subjects and disciplines
(such as dictionaries, scholarly editions, catalogues, and contributions to
research databases);
• the invention, design and generation of ideas, images, performances and
artefacts, where these lead to new or substantially improved understanding;
and
• the experimental use of existing knowledge to develop, design and construct
new or substantially improved materials, devices, products and processes.
This definition of research excludes:
• the production of student assessments which do not require original research
(e.g. the critical analysis and evaluation of existing published material including
text books and academic journals);
• the development of teaching materials that do not embody original research;
• routine audit and evaluation, within the established management procedures
of organisations.
1.5 Types of research activity covered by this policy include, but are not limited to:
 Undergraduate and postgraduate taught dissertations or projects;
 Postgraduate research degrees;

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  Research that is funded in whole or in part by Staffordshire University or an
external organisation;
 Work undertaken by a member of staff under the auspices of Staffordshire
University; for example:
o Non-funded research
o Consultancy activity
o Work undertaken in the capacity of an expert witness
 Institutional Research conducted or commissioned by Staffordshire University
(e.g. Market Research).

2. Ethical Principles
2.1 Research ethics at Staffordshire University is underpinned by the following
commonly agreed principles of ethical research (Association of Research Ethics
Committees, 2013, p. 5):
 Autonomy - Individuals participating in the research must be made aware of
the purpose of the research and be free to take part without coercion or
penalty for non-participation. Individuals should be able to withdraw at any
time without being required to give a reason and without threat of any adverse
consequences arising from their withdrawal.

 Beneficence – The research must be worthwhile and provide a reasonable

opportunity for securing beneficial outcomes which outweigh any associated
risks. The research methodology must be sound, ensuring the best results are
obtained.

 Non-maleficence – Any possible harm must be avoided by robust precautions.

 Confidentiality – Personal data must remain unknown to all but the research
team (unless the participant agrees otherwise, or in cases where there is an
overriding public interest, or where participants wish their voices to be heard
and identified).

 Integrity – The researcher must acknowledge any actual or potential conflicts

of interest, and undertake their research in a manner that recognises standards
of research integrity.
2.2 The University’s policy and procedures for the ethical review of research proposals
have been informed by the following expectations (Association of Research Ethics
Committees, 2013, p. 6):
 Independence – The ethical review of research projects must include reviewers
who are not connected to the research and are free to reach an independent
judgement, unimpeded by potential conflicts of interest.
 Competence – Ethical review decisions should be informed by relevant
expertise and be made by competent reviewers who are fully conversant with
the University’s Research Ethics Policy and its associated procedures.

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  Facilitation – The ethical review process should be efficient and effective. The
process should protect the interests of those potentially affected by the
research, whilst not presenting unnecessary or unreasonable barriers to the
conduct of good research.
 Openness – The ethical review process should be transparent and accountable,
with clear lines of responsibility. Details of the research ethics review process
should be published and made available to the public.

3. Research Requiring Ethical Approval (Proportionate or Full Ethical Review)

3.1 The need to consider the ethical implications of a proposed piece of research is not
dependent on the length of a piece of work or the academic level at which it is being
undertaken.
3.2 Ethical approval is required prior to the commencement of all:
 Research that involves human or animal participants. This includes direct
participants in the research, but also includes others affected by it e.g. at risk
of physical or mental harm.
 Research that does not directly involve human and animal participants but
does raise other ethical issues due to the potential social or environmental
implications of the study.
 Research which re-uses previously collected personal data which is sensitive in
nature, or enables the identification of individuals.
3.3 Ethical approval is not normally required when:
 The research will only employ information freely available in the public
domain. This includes: published biographies, newspaper articles, and
published minutes of meetings.
 The research will only draw upon anonymised records and data sets that
already exist in the public domain. (e.g. published by the Office of National
Statistics).
3.4 It is acknowledged that there are sometimes difficulties in establishing a clear line
between research requiring and not requiring ethical approval. Where these
situations arise, researchers are advised to adopt a precautionary approach and
follow the ethical approval procedure, or seek further advice from the Chair of the
appropriate Faculty Research Ethics Committee.

4. Responsibilities
4.1 Responsibility for maintaining ethical conduct lies, in the first instance, with the
individual researcher. All researchers must ensure that their research is conducted in
accordance with the University’s Research Ethics Policy and its associated
procedures.
4.2 Associate Deans for Scholarship Enterprise and Research and Heads of School,
Service or Research Institute are responsible for the conduct of the research in their
areas. They are therefore responsible for ensuring that researchers have access to

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 the appropriate ethics review procedures. They are responsible for ensuring that all
research-active staff and students are familiar with the content of the University’s
Research Ethics Policy.
4.3 Each Faculty is responsible for identifying staff members responsible for the storage
of documentation arising from the operation of University and Faculty Research
Ethics procedures.

5. University Research Ethics Sub-Committee

5.1 The University Research Ethics Sub-Committee is responsible for monitoring and
reviewing University policies and procedures governing the ethical scrutiny and
conduct of research and for recommending proposals for their development and
enhancement.
5.2 The Sub-Committee will be responsible for considering appeals against Faculty
Research Ethics Committee decisions and will consider complex ethical review
applications referred to it by Faculty Research Ethics Committees.
5.3 The terms of reference and composition of the Research Ethics Sub-Committee will
be published on the University’s Research Ethics Website.
5.4 The terms of reference and composition will be confirmed at the commencement of
each academic year, with proposed changes being submitted for approval by the
University’s Academic Board.

6. Faculty Research Ethics Committees

6.1 Each University Faculty will have a formally convened Faculty Research Ethics
Committee.
6.2 The terms of reference of Faculty Research Ethics Committees will include, as a
minimum:
i. To consider applications for full ethical review.
ii. To inform the University Research Ethics Sub-Committee of high-risk
projects identified and under review.
iii. To refer cases to the University Research Ethics Sub-Committee where
necessary.
iv. To provide advice and guidance on any matters relating to the ethical
scrutiny and conduct of research.
v. To act as the vehicle for the dissemination of good practice in matters
related to the ethical scrutiny and conduct of research.
6.3 The composition of each Committee should include a minimum of five members,
including at least one lay member.

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7. Lay Members
7.1 Voluntary lay member appointments to the University and Faculty Research Ethics
Committee will be approved by the Chair of the University Research Ethics
Committee.
7.2 Lay Members are normally appointed by the University for three years and can be
renewed for a further three year term.
7.3 Lay member appointments are unpaid. The University will reimburse reasonable
expenses incurred during the performance of the role.
7.4 In order to ensure impartiality, they will normally not have had close involvement
with the University during the last five years. For example as a member of staff; a
member of the Board of Governors; a student; or a near relative of a member of
staff. They will not be personally associated with the sponsorship of students;
involved in assessing; or involved closely with student placements.

8. Ethical Review Level 1: Ethics Disclaimer

8.1 Where the proposed research raises no ethical risk the researcher should complete a
Staffordshire University Ethics Disclaimer (available on the Research Ethics Website).
8.2 An Ethics Disclaimer form is not required where an assessment task allocated to a
student falls outside the definition of research as outlined in section 1.4.

9. Ethical Review Level 2: Proportionate Review

9.1 The Proportionate Review process may be used where the proposed research raises
only minimal ethical risk. This research must: focus on minimally sensitive topics;
entail minimal intrusion or disruption to others; and involve participants who would
not be considered vulnerable in the context of the research. This may include (ESRC,
2012, p. 8)
 Research that involves the use of an anonymous, self-completion
questionnaire, or the completion of a standard survey that has no ethical
implications and addresses an uncontentious topic (e.g. a transport survey).
 The use of unlinked or aggregated human data, which when collected, was
subject to relevant Research Ethics Committee approval.
 Research that replicates a previous study previously approved by a Faculty
Research Ethics Committee.
9.2 Undergraduate research: The completed form should be signed by the student, their
supervisor and one other member of academic staff with no direct connection with
the student or his/her research.
9.3 Postgraduate research: The completed form should be signed by the student, their
supervisor and one member of the Faculty Research Ethics Committee with no direct
connection with the student or his/her research.
9.4 Staff research: The researcher and one member of the Faculty Research Ethics
Committee must sign the completed form. The Faculty Research Ethics Committee

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 Member should be located within another School and have no connection with the
research being undertaken.
9.5 Where significant ethical implications are identified through the completion of the
proportionate review process, the researcher must complete the full ethical review
process.

10. Ethical Review Level 3: Full Ethical Review

10.1 Full ethical review will be used for research involving above minimal risk and
therefore necessitating a more thorough ethical review prior to approval. This will
include (ESRC, 2012, p. 8):
 Research involving vulnerable groups. This includes: children and young
people, those with a learning disability or cognitive impairment, or individuals
in a dependent or unequal relationship.
 Research involving sensitive topics. This includes: participants’ sexual
behaviour, their illegal or political behaviour, their experience of violence, their
abuse or exploitation, their mental health, or their gender or ethnic status.
 Research involving groups where permission of a gatekeeper is normally
required for initial access to members, for example, ethnic or cultural groups,
native peoples or indigenous communities.
 Research involving deception or which is conducted without participants’ full
and informed consent at the time the study is carried out.
 Research involving access to records of personal or confidential information,
including genetic or other biological information, concerning identifiable
individuals.
 Research which would induce psychological stress, anxiety or humiliation or
cause more than minimal pain.
 Research involving intrusive interventions. This includes: the administration of
drugs or other substances, vigorous physical exercise, or techniques such as
hypnotherapy which may cause participants to reveal information which could
cause concern, in the course of their everyday life.
10.2 The application for full ethical review must be considered by at least two members
of the Faculty Research Ethics Committee. Where the two reviewers are unable to
reach an agreed judgment the application should be referred to a full meeting of the
Faculty Research Ethics Committee. Where the Committee is unable to reach a
judgement the application should be referred to the University Research Ethics Sub-
Committee.
10.3 Applications should be submitted for approval as early as possible. All projects must
be signed off from an ethics perspective before that part of the work for which
approval is being sought begins.

11. NHS Research - Independent Peer Review (IPR)

11.1 All research projects which require NHS Research Ethics Committee approval must
provide evidence of Independent Peer Review of their Scientific Merit.

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11.2 Relevant projects will be considered by the Independent Peer Review Panel located
within the Faculty of Health Sciences. The panel will be formally constituted as a sub-
Committee of the Faculty of Health Sciences Research Ethics Committee.
11.3 Peer review should be appropriate to the nature of the research being undertaken
and the source of funding/review. Researchers should review the current advice and
guidance published by the National Research Ethics Service (www.nres.nhs.uk) and
seek advice regarding their proposal from the relevant Research & Development
Department within their Trust.
11.4 Projects will normally be reviewed by senior researchers at Staffordshire University
who have no prior connection with the project. Where senior researchers with the
requisite specialist knowledge are unavailable within the University, the project will
be subject to external review.
11.5 Where a project is approved subject to amendments the applicant and supervisor[s]
will receive a letter from the Chair of the IPR Panel to this effect indicating the points
that require clarification. A revised IPR form responding to the points raised should
be re-submitted to the IPR Panel for approval.
11.6 Where a project is not approved because it contains major flaws the applicant and
supervisor[s]/mentors will receive a letter from the Chair of the IPR Panel detailing
the issues to be addressed. The project must be substantially revised and the IPR
form should be re-submitted to the Panel for consideration.
11.7 The IPR Panel may choose to defer a decision about a project and refer it to the
Faculty Ethics Committee and in turn the University Research Ethics Sub-Committee
for consideration outlining the issues that they can’t decide on.
11.8 On securing Independent Peer Review Panel approval, the IPR form will be submitted
for consideration by the Faculty of Health Sciences Research Ethics Committee. The
Faculty Committee will be responsible for forwarding approved forms to the Chair of
the University Academic Ethics Sub-Committee for his authorisation of the project
and for insurance and indemnity.
11.9 When the project has received final authorisation, the researcher(s) will be notified
in writing that the project has been approved, normally within three weeks of the
final approval by the Chair of the IPR Panel.
11.10 No external project submission should take place until authorisation has been
received.
11.11 On receipt of final authorisation, the researcher will submit the research ethics
application to the NHS Research Ethics Committee, in accordance with NHS
procedures.
11.12 The researcher is responsible for informing his/her Faculty Research Ethics
Committee of the outcome of the NHS Research Ethics application.

12. Non-Compliance with Ethical Review Procedures

12.1 The University expects that all research carried out in its name complies with the
requirements and expectations of this policy and associated procedures. Where a
researcher is suspected to be in breach of this Policy, the University may take action
in accordance with its staff or student disciplinary procedures.

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12.2 The individual researcher will NOT be covered by the University’s insurance if a
favourable ethical review was not secured prior to the commencement of the
research activity. This means that should a participant make a claim regarding the
research, then the student or staff member would be personally liable.

13. Appeals
13.1 A researcher may appeal against a Faculty Ethics Committee decision on the
following grounds:
i. There existed material circumstances relating to the application of which
the Faculty Research Ethics Committee was unaware.
ii. Procedural irregularities occurred during the review process, resulting in
reasonable doubt that the Committee would have reached the same
conclusion regarding the application had the irregularities not taken place.
iii. There is demonstrable evidence of prejudice, bias, or inadequate review.
13.2 Stage 1: Where a researcher is dissatisfied with the decision reached by a Faculty
Ethics Committee the researcher may request that the Faculty Committee review its
decision. When requesting the review, the researcher, must clearly articulate the
reason for the request, including the provision of additional information not
originally made available.
13.3 Stage2: Should the outcome of the review be contested by the researcher, he or she
can submit an appeal to the University Research Ethics Sub-Committee.
13.4 If a researcher wishes to appeal to the University Research Ethics Committee, he or
she should notify the Officer to the University Committee within ten days of
receiving the Faculty Research Ethics Committee appeal decision.
13.5 An appeal should be submitted in writing and provide the following information:
i. The title of the research proposal
ii. The title of the Faculty Research Ethics Committee to which the ethical
review application was submitted.
iii. The reason for the appeal.
iv. Any documentary evidence to support the appeal.
13.6 Appeals will be considered by a panel drawn from members of the University
Research Ethics Sub-Committee. All panel members will be independent, having no
previous involvement in the ethical review process leading up to the appeal.
13.7 The researcher and the Faculty chair will be informed in writing of the Committee’s
decision.

14. Retention and Storage of Ethical Review Documentation

14.1 All documentation arising from the ethical review procedures (including disclaimer,
proportionate and full ethical review forms) will be stored centrally by the
appropriate Faculty or Service in such a way that records can be easily subject to
audit when required.

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14.2 Minutes from University and Faculty Research Ethics Committees should be held
electronically in perpetuity.
14.3 Faculty’s will retain disclaimer, proportionate review and full ethical review
documentation for nine years, subject to any external requirements for the retention
of documentation. Faculty and University Ethics Committees may further extend this
retention period on a case-by-case basis.
14.4 All documentation should be stored in such a way as to ensure that individual
documents can be easily located and audited by the University.

15. Annual Faculty Reports

15.1 The Chair of each Faculty Research Ethics Committee will provide an annual report to
the University Research Ethics Committee in respect of ethical issues in non-clinical
research i.e. research not reviewed by an NHS ethics committee.
15.2 Reports to the University Research Ethics Committee will include the following:
 The current Committee membership.
 Details of any suggested changes to the approved Faculty procedures.
 The number of applications considered by Proportionate Review and Full
Ethical Review; the decisions taken (approved, referred); and any particular
difficulties encountered or action taken.
 Any issues for consideration by the University Research Ethics Committee.
15.3 The University Research Ethics Sub-Committee will consider the annual reports, offer
advice and recommendations as appropriate, and report to the University Quality
Committee and Research and Advanced Scholarship Committee on any major policy
issues or outstanding difficulties.

16. Audit of Ethical Review Procedures

16.1 The Quality Enhancement Service will develop an annual Ethical Review Audit
schedule for consideration by the University Research Ethics Sub-Committee. The
proposed schedule will be considered at the first meeting of the Sub-Committee in
each academic year. The schedule will ensure that all University Faculties receive an
Ethical Review Audit over a two year period.
16.2 Audits will be conducted by a member of the University Research Ethics Committee,
independent from the Faculty being audited.
16.3 An audit checklist will be produced by the auditor and approved by the Chair of the
University Research Ethics Sub-Committee. The approved checklist will be circulated
to the relevant University Faculty one week prior to the conduct of the audit.
16.4 A report detailing the findings of the audit will be submitted for consideration by the
University Research Ethics Sub-Committee and the relevant Faculty Research Ethics
Committee.

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16.5 The Faculty Research Ethics Committee (to whom the audit report relates) will
produce a formal response and action plan detailing the corrective and preventative
action that will be taken by the Faculty to address any issues or non-conformance
identified by the audit. The formal response will be submitted to the Chair of the
University Research Ethics Committee within 20 working days of receiving the audit
report.
16.6 The Faculty audit response and action plan will be submitted to, and considered by,
the University Research Ethics Sub-Committee.
16.7 The University Research Ethics Sub-Committee will be responsible for monitoring the
completion of the Faculty Action plan and for disseminating any recommendations
or good practice identified by the audit to other areas of the University.

17. Collaborative Provision

17.1 Arrangements for the ethical review of research proposals will be considered during
the initial development and approval of collaborative provision. The proposals put
forward for approval will clarify whether research proposals will be considered in
accordance with University or partner ethical review policy and procedures.
17.2 Where research proposals will be considered in accordance with the partner’s ethical
review policy and/or procedures, a copy of the policy, procedure and associated
documentation should be made available to the University Research Ethics
Committee.
17.3 The operation of research ethics policies and procedures (University or partner) will
be audited by Staffordshire University in accordance with section 16 of this policy.

18. References
REF (2011) Assessment Framework and Guidance on Submissions.
(http://www.ref.ac.uk/media/ref/content/pub/assessmentframeworkandguidanceo
nsubmissions/02_11.pdf), 23 May 2012.
The Association of Research Ethics (2013) A Framework of Policies and Procedures
for University Research Ethics Committee.
ESRC (2012) ESRC Framework for Research Ethics
(http://www.esrc.ac.uk/_images/framework-for-research-ethics-09-12_tcm8-
4586.pdf)

Approved by Staffordshire University’s Academic Board on 26th November 2014

This policy will be reviewed in November 2016

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