GUIDELINES FOR COMPLETION OF
RESEARCH ETHICS APPLICATION FORM
Completing the University’s Research Ethics Application Form
When answering the form’s questions it is best to answer them as comprehensively as possible to
ensure that the ethics reviewers have sufficient information and explanation to enable them to make
an informed judgment. Whilst the expectation is that the University’s ethics review procedure is
reasonably short, a delay can occur if insufficient information is provided as this necessitates a
request by the ethics reviewers for further information.
Note: the form is intended to expand to allow as much space as needed.
Cover Sheet (the relevance of information sheets, consent forms etc.)
The method of informing prospective participants about a research project (e.g. an information
sheet/covering letter/pre-written script) is a less important consideration than considering what
information should be communicated to the prospective participants (i.e. the method is less
important than the content). The information provided should be legible and understandable from a
lay person’s perspective and, depending on the project’s nature, may need to be translated into
languages other than English. Applicants should be encouraged to write no more than one A4
sheet.
An applicant should consult the ethics guidance on consent for advice on what information to
provide to prospective participants. This is available at:
http://www.bradford.ac.uk/gateway/research/research-support-foracademics/ethics/GuidanceonEthicalIssues/Consent/
Wherever possible, and proportionate to the nature of the research, an individual’s consent should
be obtained in writing. Where this is not possible oral consent should be obtained, ideally in the
presence of at least one witness. Witnessed consent is required for particularly vulnerable
participants who have intellectual difficulties or cultural background which affect their
understanding, but who are deemed capable of giving consent. Although it is not possible to
prescribe a rule on when a consent form is inappropriate or disproportionate here are some
examples:
Example 1 - observational research:
In this type of research the use of consent forms may not be appropriate and may be impractical.
Example 2 - a researcher sends a questionnaire to a participant:
If the participant returns the questionnaire this signifies ‘implied consent’ and negates the need for
the participant to sign a consent form, although s/he should have received information (e.g. in the
form of an information sheet or covering letter).
Example 3 - a street questionnaire:
A researcher stops pedestrians in the street to ask them whether they would be willing to answer a
series of questions. The researcher does not need to ask the person to sign a consent form, but
does need to provide sufficient information to the person to enable him/her to make an informed
Application Form Guidance Notes
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decision as regards whether or not to answer the questions (e.g. in the form of a pre-written script).
If the person agrees to answer the questions this implies verbal informed consent.
Generic Approval
Generic approval is required if an application will cover several sufficiently similar research
projects with similar methodology or projects where the difference between the tests
involved is not ethically relevant. Please contact the Chair of the appropriate Research
Ethics Panel in the first instance. There is a separate generic approval application form
available at Stage 2 at: http://www.bradford.ac.uk/gateway/research/research-support-foracademics/ethics/ResearchEthicsApprovalProcess/
Part A:
A1.
Research Project Title
This should be a suitable title for identifying the project during correspondence.
A2
Contact person
This should be the person to whom correspondence will be sent. It will normally be the
Principal Investigator or Principal Supervisor.
A2.1
Is this a supervised-student research project?
If it is a supervised student research project please provide the contact details and course
of the project student so that any correspondence can also be copied to him/her.
A2.2. Other key investigators/co-applicants
This information can be useful for an ethics reviewer when judging whether the research
team has the appropriate skills to undertake the research.
A2.3. Name of body funding the project (if appropriate) and any other declarations of
interest
Any interests that may affect the project should be listed here. NOTE: applications for
research funding do not normally require ethical approval prior to submission (although
advice may be sought at any time). Only when funding has been granted will approval be
required.
A3.
Proposed project duration
Definitive dates (i.e. to the month) are not required, but an estimated duration (e.g. x
number of years) provides the ethics reviewer with an indication of the project’s timescale,
which can assist project monitoring.
A4.
Type of research
This gives the ethics reviewer an initial indication of the type of research that you are
proposing and ethical issues that it may involve. You can tick as many boxes as necessary.
Do not worry if none of them apply.
The amount of information to provide in answer to questions A5 to A11 cannot be prescribed.
However, it is expected that this should be proportional to:
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whether or not the project will involve sensitive personal data and/or particularly vulnerable
participants or covert research methods;
whether or not explicit or implicit consent is being sought from the prospective participants;
the complexity of the project.
Application Form Guidance Notes
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An applicant should seek to provide sufficient detail to enable the ethics reviewers to make an
informed judgement (i.e. thereby avoid a situation in which, due to there being insufficient detail,
the ethics reviewers feel a need to ask many supplementary questions).
Therefore, in addition to the advice below about how to answer questions A5 – A11, you might find
it useful to scan down the type of questions that ethics reviewers themselves consider when
reviewing applications.
This information can be found at Stages 4 and 5 – reviewers’ comments form and reviewers’
guidance notes at http://www.bradford.ac.uk/gateway/research/research-support-foracademics/ethics/ResearchEthicsApprovalProcess/
A5.
Briefly summarise the project’s aims, objectives and methodology?
In this section you should provide a brief summary of the aims, objectives, methods and
overview of the planned research. It should be in sufficient detail for the ethics reviewer to
understand what the research will involve. Please remember that the ethics reviewer may
not be an expert in your field so use language comprehensible to a lay person. You may
also wish to include the scientific justification and background for the research. Flow charts
may also be helpful. Applicants should also normally submit a full research proposal, which
describes all methods in detail.
Note: The purpose of ethics review is not to conduct scientific review but a project must
be of sufficient merit to warrant the time and effort contributed by the prospective
participants. It is recognised that student research will be of lower scientific merit but
again the project should be of a suitable standard to achieve the educational aims and
objectives. The design of a project’s methodology (e.g. method of obtaining informed
consent) is an important consideration especially if a project will involve sensitive
personal data and/or particularly vulnerable participants.
A6.
What is the potential for physical and/or psychological harm / distress to
participants?
The main objective of ethics review is to minimise harm to research participants. In
answering this question the applicant should specify, however minor it may be, the 'degree'
of harm expected (e.g. inconvenience) and how this degree of harm is justified (e.g. by the
project’s objectives). For example, interviews always have the potential for raising difficult
and challenging issues and a recognition of the potential for harm as well as an explanation
of the approach that would be taken if harm was caused, is good practice.
It could be possible that criminal or other disclosures (e.g. of professional malpractice)
requiring action could take place during the project (e.g. during interviews or use of
screening tests for drugs). You should also explain how you would handle incidental
findings during the research (e.g. what course of action, if any, would be taken if an
incidental abnormality were discovered as part of a blood test taken during the research). If
such situations are relevant to your research you should clarify how you would propose to
handle them in the Participant Information Sheet.
Special consideration would need to be given to “covert” research or any variation thereof.
A7.
Does your research raise any issues of personal safety for you or other researchers
involved in the project and, if yes, explain how these issues will be managed?
(especially if taking place outside working hours , off University premises or outside the UK)
For interviews conducted outside normal working hours and/or off University premises a
risk assessment should be made by both the Project Manager/Supervisor and the relevant
Application Form Guidance Notes
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academic manager, in discussion with the fieldworker. Issues to be considered include
those relating to the person and to any equipment used, plus the setting in which the
interviews will be carried out. For example: Is the researcher working alone? Is the
researcher working with people who are potentially threatening to the researcher? Is the
person working in an environment that is physically dangerous? The use of alarms and
procedures to check that a researcher is safe after completing an interview etc. should be
considered for research involving such risks.
When travelling outside the UK as part of your research you are covered by the University’s
travel insurance with some exceptions. See link for details:
www.bradford.ac.uk/admin/purchasing/uni/overseas.php
A8.
How will the potential participants in the project be (i) identified, (ii) approached and
(iii) recruited?
Research participants (or people from whom data or tissue is obtained) should normally be
competent adults. Of course research with children or adults who lack mental capacity is
sometimes also necessary, and, if adequately justified, is permissible. Reviewers will also
be particularly concerned about research involving participants who are in dependent
relationships (e.g. members of staff/students who work with/for a member of the research
team). Again, research in such circumstances is permissible, but the applicant should
demonstrate that s/he is aware of the risk of coercion.
A9.
Informed consent
An applicant should consult the ethics guidance on consent for advice on what information
to provide to prospective participants. This is available at:
http://www.bradford.ac.uk/gateway/research/research-support-foracademics/ethics/GuidanceonEthicalIssues/Consent/
In addition to checking that the participant has the necessary competence to give consent
and is not subject to inducements (see question A12) the ethics reviewer will need to
assess whether the potential participant has been given adequate information about what
the research will involve and that there is an appropriate mechanism for the participant to
document consent. It is usually expected that potential participants will be given information
in writing, sufficient time to consider whether or not they wish to participate and then to sign
a written consent form. However, this is not always possible or desirable (e.g. with
population observational research or where some degree of covert research is required as
part of the methodology). In such cases not obtaining consent is acceptable provided it can
be justified. Similarly consent can be implied by the act of completing and returning a
questionnaire.
A10.
Language Use
Normally, it is expected that researchers will be inclusive in their approach to recruitment to
studies. This means that samples should adequately reflect the diversity of the population.
Linguistic ability is a recognised barrier to inclusion. It is not normally acceptable to exclude
participants on the basis of linguistic ability. It may be acceptable to exclude in this basis if
validated measures do not exist in certain languages or cultures and where interpretation is
impractical (e.g. very sensitive material). In such circumstances, it is normally a minimum
requirement that researchers record and report instances where participants have been
excluded.
A11.
Frequency of Approach
Sometimes potential participants are approached many times (for example, because they
are members of a low frequency group). It is good practice to ensure that participants are
Application Form Guidance Notes
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not involved in many studies at or around the same time, particularly where these involve
physical investigations or where inducements are involved, where this may be an issue.
A12.
Equality of Access
Researchers should ensure equality of access where some potentially valuable intervention
is offered as part of a research project (e.g. increased educational input or support; novel
potentially beneficial intervention).
A13.
What measures will be put in place to ensure confidentiality of personal data, where
appropriate?
The ethics reviewer may need to know:
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Who will have control of, and act as the custodian for, the data generated by the
project?
Where the analysis of the data from the project will take place and who will analyse the
data?
Whether any encryption or other anonymisation will be used and at what stage?
Who will have access to the data generated by the project?
How long data will be retained and how it will be stored?
This information should usually be disclosed to the participant as part of the process of
seeking consent.
A14.
Will financial / in kind payments (other than reasonable expenses and compensation
for time) be offered to participants?
Another factor that may affect the judgement of a potential participant when deciding
whether or not to participate in research is whether money or payments in kind (e.g. gift
vouchers) will be offered. It is reasonable for expenses and compensation of time to be
offered. However these should not be so large that a participant is more concerned about
what s/he will be receiving rather than the risks involved with the research. Particular
consideration of this issue is needed when working with poor communities or individuals,
whether in the UK or elsewhere. For those conducting research involving children the
researchers might consider the fact that what an adult considers to be a reasonable
expense/compensation might be very different from a child’s.
A15.
Will the research involve the production of recorded media such as audio and/or
video recordings?
If interactions with participants are to be recorded there should be clear agreement as to
how these recordings may be stored, used and (if appropriate) destroyed.
A16.
Which institution has agreed to act as research sponsorship for the project?
If you are conducting the research as either a student of the University of Bradford or as a
member of staff working on a University of Bradford research project, University of Bradford
will normally act as research sponsor. If you are conducting the research as a student or
employee of another university/organisation, that organisation should normally sponsor the
research.
A17.
Please confirm that the research sponsor has provision in place for indemnifying the
researcher for negligent or non-negligent harm to participants.
If you are conducting the research as either a student of the University of Bradford or as a
member of staff working on a University of Bradford research project, such indemnity will
Application Form Guidance Notes
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normally be in place. If you are conducting the research as a student or employee of
another university/organisation, that organisation should normally provide indemnity.
http://www.bradford.ac.uk/gateway/research/research-support-foracademics/ethics/GuidanceonEthicalIssues/InsuranceforResearch/
If you are unsure whether your research is covered please contact Keith Waddingham on
ext 3132 or k.waddingham@bradford.ac.uk.
Application Form Guidance Notes
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ANNEX 1
ISSUES TO CONSIDER WHEN REVIEWING A RESEARCH ETHICS APPLICATION
Ethics Reviewers should pay particular attention to how projects intend to:
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protect the dignity, rights, safety and well-being of participants;
obtain consent from participants;
inform participants about the purpose, methods and use of the research;
safeguard the anonymity of participants;
protect the confidentiality of information relating to participants
ensure compliance with data protection;
protect researchers, particularly those conducting research off campus;
protect the reputation of the University.
It is especially important to pay attention to these issues when:
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research involves ‘particularly vulnerable human participants’
research focuses on ‘highly sensitive subject topics’ (e.g. race, ethnicity, political opinion,
religious beliefs/other beliefs of a similar nature, physical or mental health condition, sexual life,
abuse (child, adult), nudity, obesity, people affected by conflict situations (e.g. ethics, religious,
tribal, conflicts/wars));
research involves covert research methods;
there is no evidence that either explicit or implicit consent is being sought.
General Concerns
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Is there likely to be a worthwhile outcome? (For example, is the methodology or sample size
adequate to achieve the study’s intended aim?). The purpose of the ethical review is not to
conduct a scientific review but it must be of sufficient merit to warrant the time and effort
contributed by research participants. It is recognised that student research will normally be of
relatively lower scientific merit but the project should be of a suitable standard to achieve the
educational aims and objectives.
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An applicant has not answered questions in sufficient detail (e.g. stating that the identities of
participants will be anonymised without explaining the anonymisation procedure to be
established).
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Technical Terms, Jargon and Abbreviations:
The avoidance of this is particularly important in the case of participant information sheets,
which need to be clear and simple and easily understood by a lay person (i.e. need to provide
sufficient but clear information to enable participants to make an informed choice when
deciding whether or not to participate in the research).
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Potential for ‘Harm’:
Nearly all projects involving participants have the potential to cause harm, discomfort, stress
(physical and/or psychological) for the participants, however minor. Projects should at least
recognise this potential and explain what plan of action they would take, if any, should
participants experience pain, discomfort or stress. As part of the review the potential risks
should be balanced against the potential benefits.
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Projects involving the taking of blood samples from participants:
Projects should explain what plan of action, if any, they would take if they noticed any
incidental abnormalities in the blood samples.
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Illegal Issue/Practice(s):
If a participant informed a researcher of an illegal issue/practice(s) not related to the research
project (e.g. occurring where s/he worked), what plan of action would the researcher take, if
Application Form Guidance Notes
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any?
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Potential Benefit(s):
Not all projects will benefit the participants directly but might serve ‘the public good’. Applicants
could state how their projects might benefit the public good.
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Inducements
There should not be evidence of bias or coercion or any inappropriate inducements to
persuade people to participate in research.
Issues which should be addressed in any review
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How appropriate is the study design in relation to the study’s objectives?
Has there been an assessment of the risks/benefits for the participants and researchers?
How have the predictable risks and inconveniences been justified in relation to the anticipated
benefits for participants (concerned communities, wider public)?
How safe is the intervention to be used in the proposed research?
Will there be impact on the local community?
What steps have been taken to consult with the concerned communities during the course of
the study design process?
Are the participants’ rights to physical and mental integrity and privacy and protection
safeguarded?
What measures have been taken to ensure the confidentiality and security of personal
information concerning research participants?
To what extent will information about participants be anonymous?
How will initial contact and recruitment be conducted?
Where research subjects are unable to write, has provision been made for consent to be
obtained orally with at least one witness?
How will information be conveyed to potential participants or their representatives?
Is the information given appropriate, complete and understandable?
How will consent by obtained?
Oral or implied consent is acceptable in some circumstances but this must be justified (for
example, the act of completing and returning a questionnaire implies consent).
How will consent for the acquisition of personal data/samples be obtained?
What are the inclusion criteria for participants, and are they justified?
What is the justification for including in the research individuals who cannot consent? What
arrangements have been made for obtaining the consent of such individuals?
What are the exclusion criteria for participants and are they justified?
What statistical methodology will be employed (including sample size calculation)? What is
the potential for reaching a sound conclusion with the smallest number of participants?
Who will have access to the personal data of the participants with justification?
Will the participants incur any financial costs as a result of their participation in the research?
Will the participants receive any rewards/compensation for their participation in the study?
What are the criteria for prematurely withdrawing participants?
What steps will be taken if participants withdraw?
Will the study product be made available to the participants following the research?
How long will the data/samples be kept?
How will they be stored?
Issues to Consider in respect of Research involving Children
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Appropriate consent procedures must be in place from either the child or parents, depending
on the child’s competence.
The applicant should confirm the research results cannot be obtained from any other group of
participants.
The protocol should ensure that the consent obtained represents the child’s presumed will and
can be revoked at any time without detriment to the child.
Application Form Guidance Notes
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The protocol should ensure the child receives information on risks and benefits according to
their capacity to understand from staff experienced with children.
The protocol should ensure the explicit wish of the child to refuse to participate or withdraw at
any time is considered and acted upon by the Principal Investigator.
The protocol and participant information sheet should make clear that no incentives or
inducements are given, apart from reasonable travel and out of pocket expenses where
warranted.
The research design/protocol/participant information sheet should address the need to
minimise pain, discomfort and fear and other foreseeable risks. There should be provision to
monitor and report on any of these issues.
Issues to consider in respect of Research involving Incapacitated Adults not able to give
Informed Consent
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The protocol should ensure the person has received information according to their capacity to
understand, regarding risks and benefits.
The research design/protocol/participant information sheet should address the need to
minimise pain, discomfort and fear and other foreseeable risks.
Application Form Guidance Notes
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