RESEARCH ETHICS COMMITTEES: POLICY AND PROCEDURES FOR RESEARCH ETHICAL
APPROVAL
CONTENTS
INTRODUCTION
PROCEDURES
1
2
3
4
5
6
7
8
9
10
Establishment of Research Ethics Committees
Responsibilities of the University Research Ethics Committee
Terms of Reference of Faculty Research Ethics Sub-Committees
Responsibilities of Faculty Research Ethics Sub-Committees
Composition and Membership
Basis of approval by the UREC and FRESCs
Procedures
The Department of Health Research Governance Framework and Ethics Procedures
Monitoring, Auditing and Reporting
UREC Review Process
Appendix 1
Appendix 2
Appendix 3
Appendix 4
Appendix 5
Defining Low Risk Research
Information for Applicants
UREC Procedures (Flowchart A) for applications which do NOT require
approval under the Department of Health Research Governance Framework
Research Governance Framework UREC Procedures (Flowchart B) for
applications requiring approval under the Department of Health Research
Governance Framework
UREC Application Form
INTRODUCTION
The dignity, rights, safety and well being of participants must be a significant consideration in any
research study involving people or human tissue. There are agencies, such as the Department of
Health, that require that all research involving patients, service users, care professionals or
volunteers, or their organs, tissue, data or other bodily material to be reviewed independently to
ensure that it meets ethical standards. The Economic and Social Research Council introduced its
own Research Ethics Framework in 2006 which requires formal ethics scrutiny for all human
participant research that it funds. However, a further important consideration must be that the
researcher must be facilitated to carry out important pieces of research. Any ethical scrutiny of the
work therefore must not be such as to prevent the researcher from carrying out work that might
have significant long or shorter term benefits for society and for individuals. In other words the
scrutiny must be appropriate and efficient.
The UWE approach is based upon the bulk of the ethical scrutiny of individual research projects
being carried out by the Faculty Research Ethics Sub-Committees which have been established in
each of the five Faculties of the University. These operate to broadly similar terms of reference,
composition and procedures although there is limited discretion to make adjustments to meet
specific disciplinary or funding requirements which it would not be appropriate to roll out across the
University.
The University embraces and encourages the wide range of research activity with which staff and
students engage. It recognises that how ethical issues have been addressed in the past varies
considerably because of different research traditions and cultures. It understands that formal
research ethical scrutiny is not the only mechanism needed to ensure research is pursued to the
highest ethical standards. It also appreciates that there are practical issues relating to the volume
of research in some Faculties and also that not all research carries the same level of ethical risk.
The proposals aim to establish a scheme which is flexible enough to recognise this diversity of
research practice and culture but is sufficiently rigorous to meet current and likely future external
requirements.
The University considers as a matter of course issues other than ethical matters when reviewing
proposals for research by staff and students, particularly with regard to risk management. It is
important to recognise this and that a favourable view from a Research Ethics Committee does not
constitute approval by the University to proceed with the research.
The procedures apply to all staff and student members of the University conducting or contributing
to research activities involving human participants, data and /or tissue, which take place within or
outside of the University. They apply also to individuals who are not members of the University but
are engaged in such research activities involving University premises, facilities, students or staff.
December 2007
Updated July 2009 (AV)
PROCEDURES
1
Establishment of the University Research Ethics Committee and Faculty Research
Ethics Sub-Committees
The University Research Ethics Committee reports to the University Research Committee
which is chaired by the Pro Vice-Chancellor of the University.
Each Faculty is required to establish a Faculty Research Ethics Sub-Committee whose
composition, terms of reference and procedures have to be approved by the University
Research Ethics Committee.
2
Responsibilities of the University Research Ethics Committee
The responsibilities of the University Research Ethics Committee (UREC) are as follows:
Ethical Review
a) To develop, review and evaluate procedures, policy and guidelines for the UREC and
Faculty Research Ethics Sub-Committees (FRESCs), for the ethical review of all
research with human participation conducted by academic staff and students.
b) To receive, consider and give ethical approval for research to proceed where
appropriate, to applications from academic staff and students who wish to carry out
research involving human participants, data and tissue in situations where an approved
FRESC is not available and also for those applications which FRESCs feel unable to
deal with.
c)
To consider proposals under the Department of Health Research Governance
Framework (where these cannot be delegated to a FRESC), under the Framework of
the Economic and Social Research Council*, from Central Services and applications in
respect of research projects which survey on a University-wide basis.
d) To ensure that people taking part in research conducted by academic staff and students
of the University are afforded appropriate ethical protection.
e) To advise researchers and faculties on the ethical conduct of research.
f)
To disseminate information on the proper ethical conduct of research and to provide an
avenue for the spread of good ethical practice.
g) To monitor and audit the ethical conduct of research involving human participants, data
and tissue conducted by academic staff, students and researchers.
h) To seek clarification from external expert bodies, as necessary, on matters of ethical
review policy and practice.
i)
To advise on and, where necessary, comply with external regulations and/or guidance
on the ethical conduct of research, such as: EU regulations, the Helsinki Agreement,
Department of Health and Research Council requirements and others.
j)
The regulation of ethics in Research and Knowledge Exchange, while protecting
participants in enquiry, should also serve to provide protection to the researcher where
necessary. In particular UWE research ethics committees should be aware of the
following:
* The arrangement for UREC to review all ESRC-funded research applications is an interim
measure until all faculties have an approved Faculty Research Ethics Sub-Committee,
at which time this will be reviewed
 circumstances where the intellectual property rights of the researcher are being
unreasonably threatened;
 circumstances in which the researcher may be subjected to unreasonable pressure
by sponsors or other powerful interests;
 circumstances where the researcher may experience emotional, psychological or
physical danger and where there might be a need for remedial support;
 circumstances in which the academic freedom of the researcher may be under threat.
In some of these cases an ethics committee might recommend forms of support from
the University, and might encourage the researcher to report back on their experience.
Relations with Faculty Research Ethics Sub-Committees
k)
To approve, with advice from the University’s Executive, the formation of Faculty
Research Ethics Sub-Committees (FRESC) where appropriate and in line with this
scheme, including the membership, terms of reference and procedures, to conduct
business on behalf of the UREC.
l)
To consider and advise on controversial or difficult ethical issues arising from proposals
that come before a FRESC and which are subsequently referred to the UREC by the
FRESC or by others.
m) To identify, and where appropriate assist with, the provision of appropriate training on
ethical review for members of the UREC and FRESCs.
n) To devise and implement procedures for the audit of the practice of the FRESCs.
o) To receive and comment upon the annual report of each FRESC.
p) To advise FRESCs on how best to ensure an appropriate balance between risk and the
level of scrutiny.
Relations with the University Research Committee and other bodies
q)
To advise the University Research Committee on matters relating to the ethical
protection of human participants in research.
r)
To make an annual report to the Committee on the operation of procedures for ethical
review of research involving human participants, data and tissue within the University,
and on the management of ethical issues in research, offering advice and making
recommendations as appropriate on the operation of the FRESCs.
s)
To raise with the University Management Group any outstanding difficulties in respect of
ethical review of research involving human participants, data and tissue.
3
Terms of Reference of Faculty Research Ethics Sub-Committees
a)
b)
c)
d)
e)
f)
To provide feedback to the UREC concerning matters and procedures for the well-being
of human participants and proper treatment of human tissues involved in research.
To disseminate guidelines produced by the UREC on the proper conduct of research
investigations and to provide an avenue for the spread of good ethical practice.
To approve/endorse, where appropriate, applications from members of the Faculty to
carry out research involving human participants and/or tissues. For multi-faculty
research projects ethical approval is to be sought from the FRESC of the lead
investigator (or where there is no approved Faculty Sub-Committee from UREC).
To audit research investigations carried out by undergraduate and postgraduate
students and staff within the Faculty involving human participants and/or tissues with
respect to ethical practice.
To encourage a culture within the Faculty which recognises the central importance of
ethical considerations in the design and performance of research.
To report to the UREC annually, or more frequently if required.
4
Responsibilities of Faculty Research Ethics Sub-Committees
a)
b)
c)
d)
e)
f)
5
All UWE FRESCs act under the authority and guidance of the UREC.
The UREC will grant each FRESC the powers as described in 4c below, subject to the
FRESC being properly constituted in line with this scheme and the members of the
FRESC being properly trained as detailed below. Faculties wishing to establish
Research Ethics Sub-Committees are required to submit proposals to the UREC for
approval.
Subject to 4b above, the FRESCs may receive, consider and approve where
appropriate, applications from academic staff and students, for approval to proceed with
research, experiments and observations involving human participants, data and tissue
and externally funded research.
Each FRESC will appoint a named member of staff, normally the Chair of the
Committee, to act as the designated officer with responsibility for reporting to the
UREC. This designated officer will also be a member of the UREC.
The FRESC designated officer will conduct an annual review of the FRESC operations,
and report to the UREC on the findings and keep ethical issues in research under
regular review.
The FRESC will refer cases to the UREC that require advice or opinion. Referral to the
UREC for a review will be in exceptional circumstances only.
Composition and Membership
Research ethics committees should provide independent, competent and timely review of the
ethics of proposed research studies. In their decision-making, research ethics committees
need to have independence from political, institutional, profession-related or market
influences. They need similarly to demonstrate competence and efficiency in their work.
Research ethics committees are constituted therefore to ensure the competent review and
evaluation of all ethical aspects of the research projects they receive, and to ensure that their
tasks can be executed free from bias and influence that could affect their independence in
reaching decisions. There is provision for representation on committees from qualified people
from outside the University. Any committee considering applications to which the Department
of Health Research Governance Framework applies, must be set up in such a way that its
membership complies with that Framework. It should also be noted that the ESRC Research
Ethics Framework requires independence and impartiality on the part of research ethics
committees, and to this end Paragraph 2c requires staff and students to submit ESRC funded
research to the UREC rather than to their FRESC. * The University will expect the
membership of committees to be inclusive, recognising the diversity of the research
community in terms of the gender, age, ethnicity and background of members.
Composition of the UREC and FRESCs
5.1
The UREC and FRESCs must have sufficient members to guarantee the presence of a
core group at each meeting and to allow for a sufficiently broad range of experience
and expertise.
________________________________________________________________________
* The arrangement for UREC to review all ESRC-funded research applications is an interim
measure until all faculties have an approved Faculty Research Ethics Sub-Committee,
at which time this will be reviewed
5.2
5.3
The UREC shall comprise the following minimum membership:
- 2 members from each Faculty Research Ethics Sub-Committee, one of whom shall
be the designated officer from the FRESC (see 4d)
- 1 member from Hartpury College
- 2 people not employed by UWE, preferably one of whom should be medically
qualified
All FRESCs shall comprise the following minimum membership:
- 1 person not employed by UWE
- 3 members of the appropriate Faculty, one of whom (the designated officer, see 4d)
shall be a member of the UREC
- 2 members from other faculties.
Other Criteria for the Composition of Research Ethics Committees
5.4
In addition to the minimum membership, it will be essential to ensure that the
membership of all the Research Ethics Committees contains research expertise across
the wide range of methodologies for research involving human participants, data and
tissue.
5.5
Given the need to ensure that the committees are impartial, and in order to achieve the
requirements of the overall membership set out above, it is recommended that alternate
members are appointed to act in respect of proposals put forward by, or involving, more
than one member of the committee. Any alternate members shall be subject to the
same scrutiny and training requirements as all other members of Research Ethics
Committees.
Appointment
5.6
Appointment of members should be by an open process.
5.7
The Chair and Deputy Chair of the UREC shall be appointed by the Vice-Chancellor
after consultation with the UREC Secretary and Committee members. The appointees
should have had at least one year’s experience of the work of the UREC or equivalent
research ethics committee. Those appointed should have received training in research
ethics reviewing, and possess the relevant chairing skills. Potential candidates should
be offered any appropriate supplementary training.
5.8
The Chair and Deputy Chair of FRESCs shall be appointed as such by the UREC in
consultation with the Dean of the Faculty. The appointees should normally have at
least one year’s experience of the work of the FRESC or equivalent research ethics
committee. Those appointed should have received training in research ethics reviewing,
and possess the relevant chairing skills. Potential candidates should be offered any
necessary supplementary training prior to appointment.
5.9
Appointments will normally be for a maximum period of five years. Appointments
should be staggered to ensure staged turnover of membership.
Membership Requirements
5.10 An appointed member must be prepared to have published his/her full name, profession
and affiliation. When making appointments, possible conflicts of interest should be
declared and avoided if at all possible. Where unavoidable there should be
transparency with regard to such interests, and they should be recorded and published
with the above personal details.
5.11 An appointed member is expected to maintain confidentiality regarding applications,
meeting deliberations, information on research participants, and related matters.
5.12 For University staff, the time required for undertaking such service and the necessary
training should be protected, and form a recognised part of the individual’s job plan.
5.13 A Committee member is normally required to attend in full at least two-thirds of all
scheduled Committee meetings in each academic year. Attendance at scheduled
meetings should be of sufficient frequency to ensure a member’s effective contribution
to the work of the Committee. Committee members will normally be required to
scrutinise at least two-thirds of the applications they are asked to review in each
academic year.
Training
5.14 UREC and FRESC members will need initial and continuing education and training
regarding research ethics, research methodology and research governance. As a
condition of appointment, a member should agree to take part in initial and continuing
education appropriate to his or her role as a research ethics committee member. It is
particularly important that Chairs and Deputy Chairs are fully aware of and up to date
with ethical considerations, and are therefore expected to undergo any additional
training identified for them.
5.15 In addition to the training of research ethics committee members, UREC will audit the
training made available centrally and through faculties in order to appraise them of
aspects of ethics and research governance within the University.
UREC Special Sub-Committees
5.16 Some projects supported by external funds will be subject to additional scrutiny where
subject to foreign or other special conditions. For example, those supported by funds
from the USA may require arrangements similar to those of an Institutional Review
Board. UREC Special Sub-Committees will be set up, by the Chair on the advice of the
Chair of the University Research Committee, to undertake this activity, with at least
annual reporting back to the main UREC.
6
Basis of Approval by the UREC and FRESCs
6.1
The primary task of the Research Ethics Committees lies in the ethical review of
research proposals and their supporting documents, with special attention given to the
nature of any intervention and its safety and protection for participants and researchers,
to the informed consent process, documentation, and to the suitability and feasibility of
the proposal.
6.2
A decision by the UREC or a FRESC to give ethical approval to a research project does
not imply an expert assessment of all possible ethical issues or of all possible dangers
or risks involved, nor does it detract in any way from the ultimate responsibility which
researchers must themselves have for all research which they carry out and for its
effects on human participants. The Committees address themselves to ethical matters
and are dependent upon information supplied by the researcher. This information is
expected to be properly researched, full, truthful and accurate. Failure to follow the
University's guidance on ethical review of research may result in disciplinary action.
6.3
In order to give ethical approval, the UREC or FRESC shall be adequately reassured
about the following issues, as applicable:
- the design and conduct of the study
- the recruitment of research participants
- the care and protection of research participants
- the right of research participants to withdraw
- the protection of research participants’ confidentiality
- proposed arrangements for the retention of records
- the consent process
- any community considerations both within and externally to the University
- any other relevant ethical issues.
6.4
A decision by the UREC or a FRESC to give ethical approval on a research project
does not constitute a precedent and each application will be judged on its own merits
and in the light of present circumstances. For that reason, a decision may be made to
approve research of a kind not previously approved. Equally, a decision may be made
not to approve research of a kind that was previously approved. In neither case does
this imply that the Committee's decision or decision-making process is flawed since
proper ethical review cannot be reduced to a mechanical or formulaic approach.
6.5
A decision to change the University's policies or procedures for ethical review of
research does not imply that previous policies or procedures were inappropriate and
any such changes do not invalidate ethical approval that has been given. However,
researchers are expected to make themselves aware of changes in policies or
procedures and to adopt them as necessary.
6.6
The location or nature of the proposed research may require that the researcher
approaches partner organisations for approval, for example this might be through an
NHS Research Ethics Committee. This will always be in addition to the University
ethics approval process. However, when ethical approval has been obtained from an
appropriately constituted external ethics committee, the UREC or a FRESC, may accept
that opinion with further review only of the ‘locality issues’. ‘Locality issues’ are
particularly concerned with:
- the suitability of the researcher
- the appropriateness of the local research environment and facilities
- the University’s reputation and the level of risk of the project.
In the faculties which regularly receive applications requiring scrutiny by an external
research ethics committee, such as through the National Research Ethics Service, the
FRESC’s procedures should set out the way in which such applications are handled
internally.
If an external ethics committee declines to give ethical approval to the application, any
approval by a UWE Research Ethics Committee still stands, but the research would still
not be permitted to proceed unchanged without approval by the external organisation.
The appropriate UWE Research Ethics Committee dealing with an application for
review must always be informed by the researcher of an external ethics committee
decision.
Legal Issues
6.7
Research Ethics Committees have a responsibility to take into account legal matters
directly related to the ethical consideration of the way in which research involving
human participation is to be conducted, such as requirements to obtain informed
consent. It is not the responsibility of the Research Ethics Committee to consider and
give advice on wider legal issues which might affect whether and how the research
should be permitted to go ahead. The University will set up separate arrangements for
consideration of these issues. Should a Research Ethics Committee identify any such
issues, it should refer them to the appropriate officer for further consideration.
7
Procedures (see Flowchart A, Appendix 3)
7.1
The UREC and FRESCs shall make decisions at scheduled meetings at which a
quorum is present (see 7.3 and 7.4). The regularly scheduled meeting dates shall be
announced in advance. FRESCs are invited to submit proposals to the UREC on how
this might vary for research it has identified as low risk.
7.2
The Chair (in consultation with others) may need to decide that a proposal has to be
considered between meetings and is responsible for ensuring that an appropriate level
of scrutiny informs the decision.
7.3
For UREC meetings, a quorum of one-third of the membership is required, including the
Chair and/or Deputy Chair.
7.4
For FRESC meetings, a quorum of one-third of the membership is required. This should
include the Chair and/or Deputy Chair, and at least one member who is independent of
the Faculty where the research is to take place. Where the FRESC has to comply with
Department of Health requirements, there also needs to be at least one “expert”
member and one “lay” member present.
7.5
In respect of a proposal being put forward by a member of the reviewing Committee,
those involved in the research submission should withdraw from the meeting while the
submission is considered.
7.6
In research where there is a clear risk to the participant’s health such as research
involving taking body material samples, it is recommended that an opinion is obtained
from an appropriately qualified health practitioner.
7.7
Observers, who should play no part in the Committee’s deliberations, may be invited
subject to the prior agreement of members. Observers should be allowed only if they
accept in writing the same duty of confidentiality as Committee members.
7.8
Meetings shall be minuted and there shall be an approval procedure for the minutes.
7.9
The Secretary of the UREC shall be the Director of Research and Development at RBI
or his/her nominee. The secretary for a FRESC shall be an appropriately qualified
member of staff from the relevant Faculty, appointed by the Dean after consultation with
the Secretary of the UREC.
7.10 The UREC and FRESCs shall keep a register of all proposals that come before them.
These registers will be available for public consultation, except where there are matters
of confidentiality which must be respected. Appropriate sections will be shared with
relevant partner bodies, such as NHS Trusts hosting the research, for the purposes of
governance and management. The registers shall form the basis of the UREC’s and
FRESCs’ annual reports.
7.11 The UREC and FRESCs shall retain all relevant records for a period of at least six
years or longer if required for insurance purposes, after completion of a research
project. Advice should be taken from the University officer responsible for record
retention and management before records are destroyed. Records shall be made
available upon request to any member of the Vice-Chancellor’s Senior Management
Team and regulatory authorities.
7.12 The UREC and FRESCs should always be able to demonstrate that they have acted
responsibly in reaching a particular decision. When the UREC or a FRESC rejects
research proposals, the reasons for that decision shall be made available to the
applicant and, where appropriate, opportunities for resubmission provided.
7.13 The UREC and FRESCs shall consider valid applications in a timely manner. A decision
should be reached and communicated to the applicant, wherever possible, within 6
weeks of the submission of a valid application.
7.14 Where a decision is made by Chair’s Action, this should be on the basis of detailed
scrutiny by a least two members of the Committee. The decision will be reported to the
next available meeting of the Committee.
7.15 Amendments submitted once ethical scrutiny has been completed shall normally be
dealt with through Chair’s Action.
7.16 Where the research is terminated prematurely, a report shall be provided to the relevant
committee within 14 days, indicating the reasons for early termination.
Confidentiality
7.17 Research Ethics Committee members do not sit on the Committee in any representative
capacity and need to be able to discuss freely the proposals that come before them. For
these reasons, all Research Ethics Committee meetings will be held in private (though
see 7.7 above).
7.18 However, subject to any contractual obligations relating to confidentiality, a summary of
details of the application shall be made publicly available once the final decision on the
application is ratified by the Committee.
7.19 All Research Ethics Committee members will be bound by the duty of confidentiality,
and will not disclose to any other third party the research particulars or detailed
discussions held during committee meetings.
Complaints
7.20 There is no appeal against the decision of a Research Ethics Committee. Complaints
on procedural grounds should be sent to the Chair of the UREC in the case of FRESCs
or to the Chair of the University Research and Knowledge Exchange Committee in the
case of the UREC.
8
The Department of Health Research Governance Framework and Ethics Procedures
(See Flowchart B, Appendix 4)
8.1
Flowchart B sets out how procedures need to be varied for research requiring
consideration by a NHS Local Research Ethics Committee (LRECs) of the National
Research Ethics Service (NRES). This approach has been designed to retain the right
of ultimate ‘sign off’ by the University without asking all researchers requiring LREC
approval to also have to go through a separate university process.
8.2
9
10
LRECs and NRES operate within the Department of Health’s Research Governance
Framework. Research ethics applicants will need to check the Research Ethics web
pages of UWE for the latest guidance from the Department of Health on which research
does and does not require LREC approval. This can be particularly complex for those
carrying out social care rather than health care research, those carrying out what the
NHS might deem to be an audit or a service evaluation and when research involves
respondents who lack mental capacity.
Monitoring, Auditing and Reporting
9.1
The UREC and FRESCs recognise that the definition and perceived significance of
ethical problems may be subject to change and difference of opinion. In this light, the
UREC will conduct an annual review of its policies and procedures and report to the
University Research Committee on the management of the Committees, indicating in
particular any suggested or agreed change in procedures. The UREC will also report
on any outstanding or anticipated difficulties. Each FRESC will provide a report to the
UREC for these purposes. A list of all submissions and the decision taken in respect of
them together with any major issues arising and a record of applications considered
outside formal meetings will be required as part of the annual report. Each FRESC
annual report will also be presented to the appropriate Faculty Research Committee for
information.
9.2
A detailed audit of the operation of the UREC and FRESC procedures will be part of a
three-yearly review process carried out by the University Research Committee or its
authorised representative. Advice will be given on documentation and potential audit
trails. Requests to see minutes and individual applications may be made at any time by
the Chair of the University Research Committee, or for FRESCs by the UREC.
9.3
The UREC will carry out annual monitoring and regular auditing of the FRESCs’ work,
including reviewing selected research proposals and monitoring and auditing of
research activities to ensure compliance with the decisions of the Research Ethics
Committees.
UREC Review Process
10.1 In the event that a FRESC finds itself unable to make a decision regarding a particular
research proposal, it may at any time, forward the research proposal to the UREC for its
consideration. This could be due, for example, to the complexity of the proposed
research, or due to a split decision within the FRESC.
10.2 The FRESC can refer cases to the UREC that require advice or opinion. Referral to the
UREC for a review will be in exceptional circumstances only. The UREC will not
normally challenge FRESC decisions.
10.3 Once a FRESC has declined to give a favourable opinion on the application and
opportunities for resubmission have been exhausted no further application using the
same proposal may be made to any other FRESC.
APPENDIX 1
DEFINING LOW RISK RESEARCH
In order for an application to qualify for ‘light touch’ scrutiny by UREC or in Faculties the research must
not fall into any of the following categories (which replicate research described in the ESRC Research
Governance Framework as involving more than minimal risk):

Research involving vulnerable groups – for example, children and young people, those with
a learning disability or cognitive impairment or individuals in a dependent or unequal
relationship.

Research involving sensitive topics – for example, 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 – for example, the administration of drugs or other
substances, vigorous physical exercise or techniques such as hypnotherapy. Participants
would not encounter such interventions, which may cause them to reveal information which
causes concern, in the course of their everyday life.
Low risk research should, therefore, be characterised by the absence of any of the above
components. It should be noted than no category of research (e.g. undergraduate research
dissertations) will always meet the low risk criteria.
APPENDIX 2
INFORMATION FOR APPLICANTS
1
2
Applications to the Research Ethics Committees should provide sufficient information for an
ethical judgment to be reached by the Committee. In particular, data should include definition
or consideration of the following:
Name of applicant(s) and whether staff, postgraduate or undergraduate.
The title of the investigation/consultancy.
The place and dates during which the work is planned to be done.
The source of funding for the work.
The aims and objectives of the proposal.
Information on the background of the proposal, including relevant published work.
The methodology to be used, including analysis of the collected data.
Which participants will form an experimental group and which might form a control
group.
Proposed participant information sheets.
Proposed participant consent forms.
A consideration of safety and ethical issues, eg how a participant will be informed about
the work and give their consent, whether the participant will receive payment or other
reward for participation, whether there are risks to the physical and psychological health
and safety of the participant and what risk minimisation strategies will be in place, how
participant anonymity will be achieved, how the participant may withdraw from the work
without prejudice, what will be the method of keeping records secure and what will be
the ultimate fate of the raw data collected, and how the data will be disseminated and
published.
Aftercare of the participants.
Process for Application
Applications should be sent to the secretary of the relevant Research Ethics Committee.
The Committee Secretary will register the application. The Committee will form a collective
judgment on whether or not to approve the application, seek further information from the
applicant or in the case of a FRESC, refer it to the UREC for review. Depending on the time of
year at which the application is submitted, this process may take up to 6 weeks. The outcome
of the Committee deliberations will be notified to the applicant at the address on the
application. Generally feedback from the UREC or FRESC will be made available to the
applicant.
Applicants are encouraged to regard the comments and feedback from a research ethics
committee as helpful and to respond constructively, especially where further work is required
for the committee to be able to recommend ethical approval.
3
Independent applications for approval by other Research Ethics Committees
The location or nature of the proposed work may require that NHS partner organisations be
approached for approval through their own Local Research Ethics Committee. This will be in
addition to, and in advance of, the University’s research ethics approval.
The following types of research must be referred to a NHS research ethics committee.
Research involving:
Patients and users of the NHS. This is intended to mean all potential research
participants recruited by virtue of the patient’s or user’s past or present treatment by, or
use of, the NHS. It includes NHS patients treated under contracts with private sector
-
institutions.
Individuals identified as potential research participants because of their status as
relatives or carers of patients and users of the NHS as defined above.
Access to data, organs or other bodily material of past or present NHS patients
Fetal materials and IVF involving NHS patients.
The recently dead in NHS premises.
The use of, or potential access to, NHS premises or facilities.
NHS staff recruited as research participants by virtue of their professional role.
The following types of work do not need to be referred to a NHS research ethics committee:
Service Evaluation
Audit
N.B. National arrangements for the ethical review of social care research are not yet fully
developed and UWE may need to revise this section in the light of these developments.
4
Application Form
A standard application form has been developed for recommended use across the University.
See Appendix 5
5
Exceptional Projects
The RIGS Executive determined that some of the projects supported by funds subject to
special conditions will be subject to additional scrutiny, eg, as if by an Institutional Review
Board (IRB) in the USA. UREC Special Sub-Committees will be set up to undertake this
activity, with at least annual reporting back to the main UREC.
6
Amendments
Once ethical approval has been given, the researcher is required to notify the Research Ethics
Committee, in advance, of any proposed amendment to the original protocol. The Committee
may then wish to review its opinion.
7
Termination
Where the research is terminated prematurely, a report shall be provided to the relevant
committee within 14 days, indicating the reasons for early termination.
UNIVERSITY RESEARCH ETHICS COMMITTEE – Flowchart A
The following flowchart outlines the stages in making an application for research ethics approval for
research projects other than those that fall within the Department of Health Research Governance
Framework at the University of the West of England, Bristol.
Does project need ethical approval?
NO
YES
Does your faculty have a Research
Ethics Sub-committee (FRESC)?
NO
YES
Applicant completes
application and sends
to UREC Secretary
Is this an ESRC funded
research project?
YES
NO
O
Follow faculty research ethics procedures.
FRESC Contacts:
HLS (HSC):
HLS (SOLS):
FCA:
FET:
SSH:
leigh.taylor@uwe.ac.uk
ruth.morse@uwe,ac,uk
matthew.partington@uwe.ac.uk
jane.newton@uwe.ac.uk
Vivien.calway@uwe.ac.uk
UREC Secretary
registers application &
checks that paperwork
is complete
Secretary sends to
scrutineers (UREC
members) for review
Scrutineers comments
returned to Secretary
Chair / Deputy makes
recommendations to
UREC
Email address for enquiries to the UREC Secretary:
urec.enquiries@uwe.ac.uk
May 2008
UREC considers
recommendations in
Committee Meeting
Outcome is notified to
applicant
UNIVERSITY RESEARCH ETHICS COMMITTEE – Flowchart B
Projects that fall within the Department of Health Research Governance Framework
The following flowchart outlines the stages in making an application for research ethics approval to
the National Research Ethics Service (NRES) for research projects that fall within the Department
of Health Research Governance Framework at UWE
Does project need ethical approval?
NO
YES
Does your faculty have a Research
Ethics Sub-committee (FRESC)?
YES
Notify FRESC and
seek advice before
applicant submits to
NRES
NO
Experts
available to
provide
advice on
NRES
application,
on request
Notify UREC Secretary & seek
advice on NRES application.
Applicant submits to NRES.
Applicant sends copy of final
NRES application & REC decision
letter to UREC Secretary
Follow faculty
research ethics
procedures (see
contacts below)
Ensure copy of final NRES application & REC
decision letter is sent to FRESC
Secretary reviews application in
context of UWE concerns
Secretary makes recommendation
to Chair/Deputy
FRESC Contacts:
HLS (HSC):
leigh.taylor@uwe.ac.uk
HLS (SOLS): ruth.morse@uwe,ac,uk
FCA:
matthew.partington@uwe.ac.uk
FET:
jane.newton@uwe.ac.uk
SSH:
Vivien.calway@uwe.ac.uk
Email address for enquiries to the UREC Secretary:
urec.enquiries@uwe.ac.uk
May 2008
Outcome is notified to applicant
APPENDIX 5
UNIVERSITY RESEARCH ETHICS COMMITTEE
APPLICATION FOR ETHICAL REVIEW
This form should be submitted electronically to the Secretary of the University Research
Ethics Committee, RBI, Wallscourt House (urec.enquiries@uwe.ac.uk) together with all
supporting documentation (see below)
You are advised to read the guidance at http://rbi.uwe.ac.uk/intranet/research/ethics/
on ‘How to complete an application for ethical approval’ in conjunction with this form.
Please provide all the information requested and justify where appropriate – the spaces will
expand to provide additional space.
For further guidance please contact Amanda Longley or Alison Vaughton at RBI,
urec.enquiries@uwe.ac.uk or telephone 0117 328 2872.
Project Details:
Project title
Project funder
Proposed project start
date
Anticipated project end
date
Applicant Details:
Name of researcher
(applicant)
Faculty and School
Status (Staff/
Postgraduate Student/
Undergraduate Student)
Email address
Contact postal address
Contact telephone
number
(for completion by UREC)
Date received:
UREC reference number:
Scrutiny – Cttee/CA
Outcome:
Applicant informed:
-
Applicant Details continued:
Name of co-researchers
(where applicable)
For student applicants only:
Name of Supervisor (for
PG and UG student
applicants)¹
Supervisor’s email
address
Supervisor’s telephone
number
Details of course/degree
for which research is
being undertaken
¹For student applications supervisors should ensure that all of the following are satisfied
before the study begins:
The topic merits further research
The student has the skills to carry out the research
The participant information sheet or leaflet is appropriate
The procedures for recruitment of research participants and obtaining informed consent are
appropriate
Supervisor comments:
Details of the proposed work:
1 Aims and objectives of, and background to the research:
2 Research methodology to be used (include a copy of the interview schedule/
questionnaire/observation schedule where appropriate):
3 Selection of participants:
Will the participants be from any of the following groups?(Tick as appropriate)
Children under 18
Adults who are unable to consent for themselves²
Adults who are unconscious, very severely ill or have a terminal illness
Adults in emergency situations
Adults with mental illness (particularly if detained under Mental Health
Legislation)
Prisoners
Young Offenders
Healthy Volunteers
Those who could be considered to have a particularly dependent relationship
with the investigator, e.g. those in care homes, medical students
Other vulnerable groups
(² Please note, the Mental Capacity Act requires all intrusive research involving
adults who are unable to consent for themselves to be scrutinised by an NHS Local
Research Ethics Committee – Please consult the Chair of your Faculty Research
Ethics Sub-Committee or Amanda Longley or Alison Vaughton (RBI) for advice)
If any of the above applies, please justify their inclusion in this research
Note: If you are proposing to undertake research which involves contact with
children or vulnerable adults you will generally need to hold a valid Criminal
Records Bureau check. Please provide evidence of the check with your
application.
4 Please explain how you will determine your sample size, and identify,
approach and recruit your participants:
5 What risks, if any, do the participants face in taking part in this research and
how will you overcome these risks?
6 How will you obtain informed consent from the participants (include copies
of participant information sheets and consent forms)?
7 How have you addressed the health and safety concerns of the participants,
researchers and any other people impacted by this study?
8 Please explain how confidentiality will be maintained:
9 Please describe how you will store information collected in the course of
your research and maintain data protection:
10 How will the results of the research be reported and disseminated? (Select
all that apply)
Peer reviewed journal
Conference presentation
Internal report
Dissertation/Thesis
Other publication
Written feedback to research participants
Presentation to participants or relevant community groups
Other (Please specify below)
Checklist
Please complete before submitting form
Is a copy of the research proposal attached?
Does the project involve human participants?
Have you explained how you will select the participants?
Have you described the ethical issues related to the well-being of
participants?
Have you considered health and safety issues for the participants
and researchers?
Have you included details of data protection including data storage?
Have you described fully how you will maintain confidentiality?
Is a participant consent form attached?
Is a participant information sheet attached?
Is a copy of your questionnaire attached?
Where applicable, is evidence of a current CRB check attached?
Yes/No
-
Declaration
Principal Investigator
Signed
Date
Supervisor or module
leader (where appropriate)
Signed
Date
The signed form should be emailed to the Secretary of the University Research Ethics Committee
at urec.enquiries@uwe.ac.uk . Any application by/on behalf of a student must be accompanied by
an email from the student’s supervisor confirming the content of the form. A paper copy with
signatures should be sent to Alison Vaughton at RBI, Wallscourt House, Frenchay Campus within 5
working days of the electronic version.