Applicant Information

Most research ethics applications will be reviewed by a Faculty Research
Ethics Committee (FREC). Please contact the Chair or Secretary of the
FREC for an application form and details of the process to be followed
in your faculty;

Contacts

FBL – Prof Nicholas O'Regan (Chair), Jane Askew (Secretary)

ACE - Dr Matthew Partington (Chair), Lesley Brock (Secretary)

FET – Dr Mark Palmer (Chair), Lynn Goh (Clerk)

HLS –Professor Julie Kent (Chair), Leigh Taylor (Secretary)

If your research is ESRC funded, or involves surveying on a University-wide basis,
or if you are a member of staff in the Central Services, you should apply directly to UREC.

Application Process

Applications should be sent to the secretary of the relevant Faculty Research Ethics
Committee (FREC) or to the University Research Ethics Committee (UREC).

The Committee secretary will register the application. The Committee will form a
collective judgement on whether or not to approve the application, and where
necessary seek further information from the applicant. Occasionally a FREC may
refer the application 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 FREC 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 reach a favourable decision.

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Completing an Ethics Application

Applications to the University's Research Ethics Committees should provide
sufficient information for an ethical judgement to be reached by the Committee.

Please read the guidance appended to the application form.

For further guidance on compiling your ethics application please see;

Participant Information Sheets

Consent

Criminal Records Bureau

Ethics Requirements of Key Funders

Guide to EU Ethics

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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
Research Ethics Committee. This will be in addition to, and in advance of,
the University’s research ethics approval.

The ‘Governance arrangements for research ethics committees: A harmonised
edition’ Department of Health, May 2011 (in force from 1 September 2011)
give full details of the scope, policy requirements and legal requirements
for research ethics committee review. These include but are not restricted to:

(i) potential research participants identified from, or because of, their past or
present use of the services listed above (including services provided under
contract with the private or voluntary sectors), including participants recruited
through these services as healthy controls;

(ii) potential research participants identified because of their status as relatives
or carers of past or present users of these services;

(iii) collection of tissue (i.e. any material consisting of or including human cells)
or information from users of these services; or

(iv) use of previously collected tissue or information from which individual past
or present users of these services could be identified, either directly from that
tissue or information, or from its combination with other tissue or information in,
or likely to come into, the possession of someone to whom the tissue or
information is made available

(v) people who lack (or lose) the capacity to give informed consent to take
part (or to keep taking part) in the research;

(vi) processing of confidential patient information without consent where this
would otherwise breach confidentiality;

(vii) material consisting of or including human cells, which has been taken
from the living or the deceased;

(viii) patients who are cared for in private and voluntary sector nursing homes
(in England, Wales and Northern Ireland) and/or residents of residential care
homes (in Northern Ireland only)

You are advised to consult the document for full details of research
covered by the Department of Health arrangements.

It should be noted that:

• Research projects involving human subjects or their tissue or
  information may be undertaken on the premises of NHS/HSC
  or social care organisations by third party organisations, for
  example contract research organisations or research units
  owned by universities or voluntary organisations. Where the
  project falls within the scope of paragraphs 2.3.2–2.3.3 in
  the Governance arrangements for research ethics committees,
  for example because it involves participants recruited through
  NHS/HSC or social care organisations, REC review is required.
  Where the project only involves care organisations insofar as it
  involves use of or access to the organisation’s premises or facilities,
  REC review is not required. Responsibility for considering and
  managing any risks relating to access to or use of the premises or
  facilities by visitors lies not with the Research Ethics Service but
  with the organisation concerned.
• Research involving staff of the services listed in paragraph 2.3.1,
  who are recruited by virtue of their professional role, does not
  require REC review except where it would otherwise require
  REC review under this document (for example, because there
  is a legal requirement for REC review, or because the research
  also involves patients or service users as research participants).

The following types of work do not need to be referred to a NHS
research ethics committee:

• Service Evaluation
• Audit

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Exceptional Projects

Some projects supported by funds subject to special conditions may
require additional scrutiny, e.g. 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.

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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.

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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.

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Audit

The UREC is required to monitor and audit the ethical conduct
of research involving human participants, data and tissue
conducted by academic staff, students and researchers. To
this end an audit of a small number of approved projects is
undertaken each year.

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Tips for completing an Ethics Application

• Describe the proposed project and related processes in
  terms that a lay audience will understand.
• Describe the proposed project in full – do not assume the
  readers know you or your area of work.
• Describe ethical issues related to the physical, psychological
  and emotional well being of the participants, and what you
  will do to protect their wellbeing.
• Describe any health and safety issues including risks and
  dangers for both the participants and yourself (if appropriate)
  and what you will do about them.
• Describe fully how you will gain consent from the participants
  and how you will record this.
• Describe fully how you will maintain confidentiality.
• Describe fully the measures you will take to ensure data is
  anonymised.
• Describe how you will store data, who will have access to
  it, and what happens to it at the end of the project.
• Attach to your application i) the participants information sheet
  ii) a consent form iii) questionnaire or indicative interview
  questions (if appropriate) iv) screening procedure (if appropriate)
  v) letters of permission (if appropriate).
• Answer all the questions/fill in all the boxes – if ‘not applicable’,
  describe why if it is not obvious.
• Check whether you need approval from the National Research
  Ethics Service – if so, familiarise yourself with the website. This
  has examples of participant information sheets and consent forms
  that you could use as a template, as well as copies of the NHS
  Ethics approval form and full details of NHS application procedures.

Prepare ethics applications early as the processes and procedures
of scrutiny can take a couple of months to complete.

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