This form is generic, to be used for general guidance and application for ethical review outside of normal
faculty structures; all faculties have their own application forms – these should normally be used.
Application for Ethical Review
Guidance Notes (please delete these notes before submitting the form)
Who should complete this application form?
This application form is for the use of any researcher, normally a member of staff or postgraduate research
student (PGRS), who intends to conduct a study which includes significant ethical issues. Key examples
include research involving human participants, research on sensitive issues1, research which might have an
impact on the environment or our cultural heritage and any research which risks the reputation of the
University. ‘Research’ should be interpreted to include knowledge transfer and innovations projects where
these include significant ethical issues. It is not possible to produce a definitive list of what comprises
significant ethical issues. With regard to knowledge transfer and innovations projects, researchers should
use their own discretion but obvious examples would include activities involving sensitive issues, work for
organisations which might be regarded as ethically contentious, (the University specifically excludes any
business with tobacco companies) where our reputation might be jeopardised and any activity which might
be regarded (perhaps covertly) as seeking UoP endorsement of a product or service. You should also use
this form if you are undertaking a discrete component of a bigger programme of research; this is often the
case when members of staff are contracted to undertake work for an external organisation. The Ethics
Committee will only review the element of research to be undertaken by the member of staff.
I am making a funding application – do I need to complete this form?
Most funders do not require ethical review of proposed research before the application is made. Most just
require evidence that the University has the necessary procedures in place to ethically review research and
that any funded research will not progress until a favourable opinion has been provided. It is also normal
to refer funders to the various policies, both internal and external, which will guide the design and conduct
of research – examples are provided later in these guidance notes. It is normal to require evidence of a
favourable ethical opinion before any funding is released. However many funders invite evidence of a
completed ethical review and most welcome sight of participant documents, in at least, draft form.
Researchers are often of the opinion that it is not worth seeking ethical review because the funding
application might not be successful. This view is understandable but might be misguided; it would seem
likely that a proposal for research, that has taken ethical issues into account, has already been ethically
reviewed and is ready to ‘up and run’ will be attractive. The Faculty Ethics Committee is always willing to
review applications and provide support and guidance for studies which might be regarded as speculative.
Do I have to complete the form? My research does not involve any ethical issues.
If you are sure that your research does not involve any ethical issues, for example it might be entirely
theoretical, drawing on data that is in the public domain, you should use the online reviewing system
<insert link here>2. This system will issue a certificate providing a favourable opinion unless it detects any
ethically significant issues, in which case the Ethics Committee Administrator will receive an automatic
email alert and you will be required to complete and submit this form.
1
Some research entails the storage and use of data, which might be freely available but nevertheless sensitive, for example
documents compiled by terrorist organisations, lawful pornography etc. Please seek further advice from the Ethics Committee
Chair or the University Ethics Advisor david.carpenter@port.ac.uk
2
Will be available by the end of September 2015
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Do I have to complete the form? I know that my research will have to be externally reviewed.
If you intend to submit your research for external review by, for example, an NHS Research Ethics
Committee, the National Social Care Research Ethics Committee or the MoD Research Ethics Committee,
there is no need to complete this form; the University will accept the favourable opinion of these external
committees. You must complete the online reviewing system <insert link here>3 which will alert the Ethics
Committee Administrator of your intention. Some research requires formal application to other bodies e.g.
the National Offender Management Service (NOMS) in addition to the Faculty; often NOMS will require
you to secure a favourable ethical opinion before considering an application.
Do I have to complete the form? My research has already been reviewed by another university.
If you are a collaborator in a study in another university which is sponsoring it, and has conducted the
ethical review, there is no need to complete this form. If you are a new member of staff who is intending
to continue your previously approved research at the University of Portsmouth, it is not normally necessary
to complete this form – but please consider the list of governance issues towards the end of these guidance
notes and ensure that there are no new concerns. If you have any doubts you should consult with your
Head of Department or ADR.
What further guidance should I take in to account and refer to?
When designing research and preparing an application for ethical review, researchers must consult key
laws, policies, procedures, codes and declarations. It is helpful to refer to these in the application to the
ethics committee. The following comprise the main sources –some are for guidance purposes, others state
mandatory obligations:
3

The University of Portsmouth Ethics Policy

Guidance on conducting research in your own place of work

The University Research Data Management Policy and associated retention schedules

The UUK Concordat to Support Research Integrity- the University has signed up to the
commitments expressed in the Concordat – researchers are required to respect these
commitments

The RCUK Policy and Guidelines on Governance of Good Research Conduct – this document is
useful regardless of funding matters

The RCUK Concordat for Engaging the Public with Research – this is helpful in demonstrating
research impact

The UKRIO Code of Practice for Research – the University has adopted this Code as its own. Any
breach of the Code could invoke the University Procedure for the Investigation of Alleged
Misconduct in Research

Research Ethics Guidance issued by research funding councils
 AHRC: This report provides useful ethical guidance on community based collaborative
research
 ESRC: www.esrc.ac.uk/ResearchEthics
 MRC Research Ethics and Policy
 BBSRC The Research Ethics Guidebook
Will be available by the end of September 2015
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

EPSRC Ethics in ICT; Framework for Responsible Innovation
NERC Ethics Policy

STFC Ethics Policy
of Social Anthropologists of t and
Commonwealth

Discipline specific guidance – most subject disciplines publish guidance on the ethical conduct of
research.

Please add any discipline specific guidance
What documents do I need to submit?
In addition to the completed application form you must submit all other relevant documents. Templates,
including further guidance, are provided for letters of invitation to participants, participant information
sheets, consent forms and surveys. If you intend to undertake interviews you must provide a schedule
giving the questions to be asked or a broad topic list. Survey questionnaires should be presented in full,
including any invitation paragraph and instructions – it is acceptable to provide a link to an electronic
survey. If you have evidence of any peer or other independent review of your research you should append
it to the application.
ALL DOCUMENTS MUST BE ADDED AS APPENDICES TO THE APPLICATION FORM ENABLING A SINGLE DOCUMENT TO
BE SUBMITTED TO THE ETHICS COMMITTEE
To whom should I send my completed application?
A single document, incorporating all essential elements, should be sent to the University Ethics Adviser
david.carpenter@port.ac.uk
How long will the review take?
Ethical review is normally undertaken within a period of 10 working days but you should allow a day or two
at each end of this period for necessary administration.
What sort of response can I expect from the Committee?
The Ethics Committee can issue a favourable opinion, an unfavourable opinion or a provisional opinion.
Sometimes the Committee will issue a favourable opinion with conditions, following first review; you must
comply with these conditions but you do not have to make any formal response to the Committee. The
most frequent response is provisional; you may be asked for further information or required to make
amendments to your research plans. You will normally receive an email providing details of the provisional
opinion; you must address any conditions and resubmit the application. The resubmission must make
responses to the Committee clear – this is best shown in the form of tracked changes to the document or a
detailed commentary explaining your response. The Committee will review your amended documents,
again within 10 working days. If all conditions are met you will be issued a formal favourable opinion letter,
which will also include advice with regard to general conditions relating to the conduct of your research,
reporting requirements and advice with regard to submitting any substantial amendments.4 The letter will
normally be sent to you as an email attachment, copies are sent to supervisors where relevant. PGR
students should include the letter in their bound theses thereby providing evidence of ethical review.
YOU MUST NOT ATTEMPT TO RECRUIT ANY PARTICIPANTS UNTIL A FAVOURABLE OPINION HAS BEEN
ISSUED
Can I start my research as soon as I have a favourable ethical opinion?
The simple answer is ‘no’. The favourable opinion of the Ethics Committee provides assurance that if you
conduct your research, in line with the documents you have submitted to the Committee, it will be deemed
4
Forms can be accessed from www.port.ac.uk/research/ethics
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as ethical. The Committee is not empowered to give permission to conduct research; there are wider
matters of governance which should also be addressed. The University does not have any formal approach
to reviewing governance arrangements; researchers should consider the following (not necessarily
exhaustive list) before commencing their research:
 Does your research meet the strategic objectives of your department / the University?
 Does the research address pertinent question(s) and is it designed either to add to existing
knowledge about the subject in question or to develop methods for research into it?
 Do you have support from your HoD / ADR?
 Are the necessary resources available?
 Have you gained any necessary management permissions (sometimes formal consent is
necessary) to conduct research in external organisations – including access to data? Are
you familiar with any organisation’s relevant policies e.g. safeguarding? Will you need any
sort of honorary contract?
 Have you secured any necessary licences or checks e.g. DBS?
 Have you undertaken any training necessary for the proper conduct of the research?
 Have material and reputational risks been identified and mitigated?
 Does your research have any implications for the University’s relationships with external
partners?
 Is there any need for an ongoing steering, PPI or advisory group? Have clear terms of
reference been drafted?
 Are all necessary contracts /memoranda of understanding/agreement in place, including
considerations of data ownership, intellectual property and publication rights?
 Have you met any conditions imposed by external bodies e.g. funders?
 Have you considered and managed any conflicts of interest?
 Are any travel arrangements safe?
Can I appeal against any decision of the Committee?
Yes. If you believe that you have cause to dispute the decision of the Committee you should contact the
University Ethics Adviser david.carpenter@port.ac.uk in the first instance. Applications which are the
subject of appeal will normally be reviewed by the University Ethics Committee.
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Application for Ethical Review
Guidance notes for applicants completing this combined form and protocol template are given throughout
in red text. Please delete all of the guidance notes, including this one, before submitting this application to
FHSS Ethics Committee for ethical review.
Please do not delete any sections, but mark as ‘n/a’ if not applicable, explaining, briefly, why.
This is only a template, and is not intended to exclude anything, so please add further information as you
see fit.
1.
Study Title and Key Dates
1.1 Title:
The study title must be consistent with any other references to it in other documents, including
information sheets and consent forms – unless the study involves deception and the Ethics Committee
gives a favourable opinion with regard to the use of a different title. Titles should ideally include the
following elements (as appropriate):
o
o
o
o
Any study intervention
The study population
The research outcomes
The use of any comparitor
e.g. ‘An ethnographic study of women in Sudan who have experienced FGM(C) to investigate culturally
significant factors which might assist in informing eradication measures’
‘A qualitative study of the perceptions of life prisoners regarding the effectiveness and availability of
education in prison’
‘A controlled trial of a new technique for improving the writing skills of primary school children comparing
the performance of the trial participants with that of other students’
1.2 Date of submission:
Version Number:
Ethics Committee Reference Number: (this should be added after the review)
1.3 Date of study commencement:
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2.
Applicant Details
2.1 Principal Investigator (Member of staff)
Name:
Telephone:
Title /Role:
Email:
Department:
2.2 Principal Investigator (PGRS or other student)
Name:
Title /Role:
Department:
Course of study:
Telephone:
Email:
Main Supervisor’s Name:
Telephone:
Email:
Names and contact details of any other supervisors (if relevant)
Supervisors will have to confirm to david.carpenter@port.ac.uk that this proposal is ready for ethical
review, either by submitting the application on behalf of the student, or by sending the student or
david.carpenter@port.ac.uk a separate email confirming that this protocol (version and date) is ready to
be submitted to FHSS Ethics Committee for ethical review.
2.3 Co-Researchers / Collaborators
Please add names and contact details if appropriate
2.4 Independent or Peer Reviewer
Please add the name(s) and contact details of any reviewer here. Any documented review should be
added as an appendix to this document. Independent review, commenting on design and methodology, is
a reasonable expectation for staff research. It is normally accepted that PGRS supervisors fulfil this
requirement – as evidenced in their support for this application.
3.
Funding Details
Please include relevant funding details. These might be:
a. Fully funded by the University of Portsmouth (UoP).
b. Jointly funded between UoP (X% £X) and …….. (Y% £Y)
c. Fully funded by ………………£Z
d. Self-funded
e. A funding application has been submitted to………………..
It is important to identify any funder that might have a commercial interest in the research.
Will you or any other member of the research team receive any payment other than your normal salary or
bursary?
4.
Research Sites
Please add details of where the research will take place. You should identify any particular concerns
regarding the health, safety and welfare of both researcher(s) and participants. If appropriate please refer
to any risk assessment here and append a risk assessment form. Please add details of any necessary
management permissions including matters such as DBS checks. If there are any special considerations
such as the researcher conducting covert observational research or covert ethnography please raise them
here.
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5.
Insurance Arrangements
Normally the University provides indemnity for ethically approved research but if you believe that your
research raises particularly significant risks you should seek advice from the University Insurance Officer please see University Insurance Pages
Please add any further information here.
6.
Study Summary
6.1 Study Summary
Please provide a brief summary of your study here – you will be required to give more detailed
information later in the form. Describe here the purpose of the study, its background, and a rationale for
the work within the context of present knowledge (i.e. where are the gaps), and its methodology, as
appropriate. Refer to relevant literature. Explain the specific focus of the study. This section should be
concise, and should give the reader a clear impression that the study is viable, and likely to achieve its
stated objectives, which are, in turn, worthwhile and for the good of at least some section of society. A
justification of the study’s focus should be presented. If this study is part of a series of experiments,
describe how it fits in with previous work, and mention the likely next step(s). What are you aiming to find
out? How are you going to do it? Who are your participants? What methods will you use? What are your
main objectives?
Please ensure that this summary is in lay language.
6.2 Main Ethical Issues
Please identify the main ethical issues here e.g. vulnerable participants; sensitive data; risks of disclosing
unprosecuted crimes; risks of disclosing professional malpractice; risks of accidental disclosure of personal
and/or sensitive data; safeguarding concerns; use of deception etc.
6.3 Other Risks or Concerns
Please note any other concerns such as: risks to the University’s reputation; conflicts of interest – financial
conflicts; personal relationships with other researchers or participants; expectations of employers if
conducting research in your own place of work –guidance here; expectations of commercial funders etc.
Further information on conflicts of interest is published by UKRIO.
7.
Compliance With Codes, Guidance, Policies and Procedures
Most significantly, all research should reflect the University’s adherence to the commitments set out in the
Concordat to Support Research Integrity and the RCUK Policy and Guidelines on Governance of Good
Research Conduct.
Please refer back to the guidance notes and consider any other examples of compliance you might add
here – the aim is to establish a set of reference points to support later elements of the application.
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8.
Study Aims and Objectives
8.1 Main Aim / Research Question/Hypothesis
Please add the main aim and/or research question here:
e.g. To explore the idea of the so-called ‘grey vote’ OR (expressed as a question) Do older people
comprise a discrete segment of the electorate? OR Hypothesis: Older people have a distinct set of political
characteristics or ‘leanings’ OR Null Hypothesis: Older people share the same political characteristics or
‘leanings’ as other members of the electorate.
8.2 Primary Objective
Please add your primary objective (outcome) here:
e.g. To identify the political characteristics and leanings of older people
(remember that later in this application, you will need to show what measures you will use to test this
primary objective – it could, in this example, be participants’ responses to a series of questions compared
with those of other members of the electorate).
8.3 Secondary Objective(s)
Not all research includes secondary objectives – if you have any state them here, remembering again, that
you will have to show how you intend to measure them.
Examples might include (staying with the same example):
1. To identify the most popular political party supported by older people
2. To identify the main political concerns of older people
3. To test the impact of election advertising campaigns on older people
9.
Research Methods
9.1 Research Method(s)
Please describe your main method(s) here. Examples might include:
A survey (template available here) – you should describe the medium you intend to use e.g. paper, online
using ‘survey monkey’ (or other software) etc. The draft survey or a link to it must be provided for the
Ethics Committee to review.
Interviews – give an indication of duration, any special concerns about the sensitivity of the topic,
theoretical approach e.g. Interpretative Phenomenology, Grounded Theory etc. (you will need to append
the interview questions / topic list).
Observation – provide some detail – will it be overt or covert? Will you be using some sort of data
collection instrument? How will you schedule the observation – a single period or some sort of sampling
strategy?
Focus Group – give an indication of duration, questions or topic lists (to be appended to this application),
any ground rules etc.
Ethnography – covert or overt? How will data be collected?
Experimental intervention – will it be a controlled trial? Briefly explain issues such as sample size,
statistical significance, effect sizes etc. Experiments often include stopping rules such as
a.
on the request of the participant.
b.
on the decision of the researcher or supervisor [if appropriate].
c.
on the request of an independent medical officer or paramedic [if appropriate].
These should be explained here.
The examples above do not comprise an exhaustive list – you may have chosen other methods
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Note: the chosen method must have the capacity to test your hypothesis / address your research
question / provide the data you need to meet your primary objective and any secondary objectives
Have you undertaken any necessary piloting? Have you consulted with any participant interest groups
regarding your methods? Public and participant involvement in research is a reasonable ethical
expectation and is likely to improve the quality of a study. The RCUK Concordat for Engaging the Public
with Research –is helpful in this respect.
9.
Recruitment of Participants
10.1 General Considerations
Please keep in mind the general idea of fair recruitment. You must avoid any sort of indefensible
discrimination e.g. deliberately excluding some populations and depriving them of potential benefits of
participation, deliberately including some populations in such a way that its members bear all the burdens
and risks entailed by the study. You must also be mindful of potential coercion and inducements.
Please provide a brief overview of your recruitment strategy here.
10.2 The Research Population
Please describe your research population clearly – the population is the group comprising the source of
potential participants e.g. children in year 11, victims of fraud, women voters, Chinese students at the
University of Portsmouth. Have you involved any members of the population in the research design? Have
you invited members to review participant documents such as information sheets and consent forms? You
should give an indication of the size of the total population.
10.3 Sampling Strategy
How will you select your sample from the population? It is normal to use some clear criteria – please state
them here
Inclusion Criteria:
Exclusion Criteria: please include any criteria which might be used for screening e.g. some studies might
screen out participants who have suffered a traumatic event related to the topic of research, others might
use some sort of medical screening
Sometimes it is acceptable to use a convenience sample – often comprising participants who are easily
accessed – recruiting on a ‘first come’ basis. You should be wary of convenience samples – they can
impact negatively on the validity of the study.
Purposive sampling is often used when participants with certain statuses or expertise are required.
Random sampling normally requires a clear randomisation strategy – it must be distinguished from
convenience sampling.
You should be wary of terms such as ‘representative’ or ‘stratified’ unless you can demonstrate that your
sample is precisely that.
Please give an indication of your sample size, making reference to your chosen method(s) e.g. if you are
conducting a controlled trial the sample size must be calculated, if you are using grounded theory the
sample size might be determined by data saturation, in the case of a survey you might want to decide the
minimum response rate which would still allow meaningful analysis.
Will there be any particular risks or burdens imposed on the sample? How long will their involvement be –
it might be no more than the length of an interview, on the other hand, in the case of a longitudinal study,
it could be many years.
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10.4 Recruitment Strategy – Invitations to Potential Participants
How will you recruit your sample? If you intend to use posters or advertisements you must append them
to this application. If you intend to use the University website or any pool of student volunteers, as a
recruitment platform, please submit the intended text as an appendix to this application form. If you
intend to recruit students as participants, please be mindful of the Student Voice Policy, (para 4).
You might have lawful access to contact details of potential participants – you should append any letter of
invitation – it might be used, literally, as a letter, or it could comprise the body of an email. You may have
conducted a previous study and sought consent from participants to be approached for future studies – if
this is the case please give an explanation here and add appropriate evidence as an appendix to this form.
If you don’t have lawful access to contact details you will need the services of a gatekeeper who is willing
to pass on study materials or seek consent to pass on contact details of potential participants. You must
explain any gatekeeping arrangements here – it might be necessary to gain permission from managers of
organisations in order to use the services of a gatekeeper e.g. a school teacher might be willing to pass on
recruitment material to parents of children in their class but they would not be able to do so without the
permission of the head teacher; an employee in a private company might be willing to be interviewed but
if this is in their capacity as an employee rather than a private individual, permission from the company
management will be necessary. You should note that data which identify individuals, including contact
details, cannot be passed on to you without the consent of the data subject.
It is acceptable to pay participants for their time and efforts; any payment should not operate as any sort
of inducement or be coercive. Often there are no funds for any payment – in which case participants
need to be informed and asked to contribute without recompense. Some researchers offer a ‘thank you’
token in the form of a shopping voucher. Prize draws can be used to encourage participation but it should
be recognised that they will inevitably compromise any anonymisation strategy and make promises of
confidentiality more challenging. It is normal to reimburse any out of pocket expenses such as travel,
including parking.
10.5 Obtaining Consent
Please give an overview of the approach you will use to gain consent. How will you distribute study
information? How long will you give participants to consider the information before asking them to
consent? Will you be explaining the research and seeking consent in person?
Not all research requires formal written consent, given after a reasonable period of time to read and
reflect upon written information. A completed and returned survey questionnaire can normally be taken
as implied consent. Some research is so benign that oral consent is sufficient. Some participants,
particularly experts, are keen to assist with research but reluctant to provide written consent; in this case
you should explain how you intend to gain oral consent and how you will keep a record of having done so.
If you are intending to record an interview you might choose to record the oral consent of the participant
– if you wish to do this you must append the script you will use to this application. If you receive
anonymous data from an external organisation it will not be necessary to gain any consent from the data
subject.
In many cases a formal consent form is necessary – you will find a template and further guidance here.
Consent must be ‘informed’; this is usually ensured by the provision of an information sheet – you will find
a template and further guidance here. It is possible to use media other than written information sheets;
sometimes a video recording is better – if you intend to use one, please provide the url. Whatever the
medium used to provide information, reasonable steps must always be taken to make sure that any
potential participant is fully informed before signing the consent form and participating in the study.
Sometimes, for example in studies involving deception, re-consenting is necessary, participants have the
right to decide whether they wish data obtained following deception, to be retained and used in the
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study.
You must explain how you intend to store completed consent forms, bearing in mind that they identify
participants and should therefore be securely stored.
Please add any participant documents to this application form as appendices – it will help the Ethics
Committee to review your application more efficiently. If you intend to recruit more than one discrete
group of participants in your study, you will need to provide examples of information sheets and consent
forms for each group e.g. professionals and clients; experimental group and control group etc.
Will you be providing any feedback to participants? If so you will probably need consent to use contact
details for this purpose.
10.6 Organisational Consent
If you intend to conduct your research in any external organisation, either a public body or a private
company, please add details here. You will also need to include information regarding use of any data
that are not in the public domain. In some cases a record of formal consent is required, in others, a
confirmatory letter or email is sufficient. The Ethics Committee will wish to see evidence of any consents
or permissions – please append any evidence to this form.
10.7 Participant Withdrawal
Please explain any circumstances relating to participant withdrawal, e.g.
-on the request of the participant – participants should be free to withdraw from the study at any time
though it is accepted that there will be time limits with regard to data
-on the decision of the researcher (and / or supervisor if appropriate) – the researcher should exercise
their judgment in the event of physical or mental distress
- (if appropriate) on the instruction of the independent medical officer (or any other independent monitor)
or any supervising medical personnel.
11.
Research Data Management
11.1 General
Before you complete the following sections please read the University of Portsmouth Research Data
Management Policy and the associated retention schedules. You should draft a research data
management plan – details in the policy – and append it to this application form.
Please provide a brief summary, explaining how your research complies with the University policy.
11.2 Data Analysis and Collection
Please list all the data you will be collecting here. Examples might include survey data, interview
recordings, interview transcripts, video recordings, photographs, responses to validated questionnaires,
demographic data (be cautious if you are promising anonymity – sometimes these data will identify the
participant) etc.
If you propose to collect other material such as DNA or human tissue which is not classified as relevant
material please list it here. You will find guidance on human tissue here.
If you propose to collect data (not relating to individual people) from commercial or other organisations
please explain the arrangements here. You may need formal consent from the company or organisation if
the data are not in the public domain.
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Please explain how you will analyse your data. Will you use, for example, a form of thematic or content
analysis for interview material, will you be using descriptive or inferential statistics and any particular
statistical tests etc.?
11.3 Data Storage
Please give details of data storage arrangements. Secure storage (particularly of personal data which will
be confidential- please see below) is required. A good example of safe storage is the University N drive – it
is password protected. The use of unencrypted memory sticks, other than for very temporary storage, is
not permitted. Similarly, the use of personal laptops or any mobile storage device needs very careful
consideration.
11.4 Personal Data – Confidentiality and Anonymisation
Personal data should normally be treated in confidence. Please explain how you will ensure confidentiality
including storage and access arrangements. Where will the data be stored? Who will have access to
them? Personal data identify individual data subjects. Some data collection instruments, e.g. anonymous
surveys, do not necessitate collection of any personal data – but caution is required to ensure that other
data, e.g. demographic data, do not identify the respondent. You should also be wary that if it is possible
to identify respondents from their IP addresses, and if you claim that your survey is anonymous, you
should make a brief statement in the survey document, explaining that whilst it might be possible to
identify the respondent you have no intention of doing so. In some cases collection of personal data is
essential, e.g. if there is a need to maintain contact with the participant or if it might be necessary to keep
a clear record of the individual’s participation in case of any later enquiry or complaint.
Personal sensitive data (typically relating to issues such as ethnicity, religion, sexuality etc.) must be
treated in confidence and carefully stored.
If you propose to anonymise data please explain the strategy you will use here. If the data are to be
linked-anonymised please explain the arrangements here.
11.5 Destruction, Retention and Reuse of Data
Please describe plans for any data destruction – some studies entail the destruction of any personal data
following analysis for research purposes. Please take note of the UoP retention schedules. It is usual to
retain research data (the analysed data used to inform any sort of publication) to enable verification of any
research results. Data might be retained for future research, if you intend to do this please give an
explanation here – you should note that consent from participants is required and it should be made clear
whether the data will be used for any further research or only research approved by an ethics committee
and whether those data are anonymous or identify the subject.
In the absence of any direct instruction on data retention from the funding authority (e.g. a Research
Council may require you to retain data for future research on the ground that they were collected using
public money) or any plans you might have, please see the following guidance instead, the last link (section
7.3) being the briefest instruction as to how long to retain research data:
Guidance on how to retain research data is given in the links below. You may find some of the following
text helpful:
The original consent forms will be retained securely by the researcher for 30 years from completion of the
study. The research data will be retained for 10 / 20 / 30 years in accordance with the UoP Retention
Schedule for Research Data (see 3rd link below). Paper records may be scanned and originals destroyed.
Ethics Application-Generic-Form
Version 1.0 September 2015
David Carpenter University Ethics Adviser
Departments will be responsible for retaining the data when the PI leaves the University.
UoP Guidance on retaining data:
UoP Library - Research data: Life cycle and archiving
www.port.ac.uk/library/help/research/researchdata/
UoP - Research Data Management (RDM) Policy
www.port.ac.uk/accesstoinformation/policies/researchandknowledgetransferservices/filetodownload,189
755,en.pdf
UoP Research Data - Retention (Schedule 7)
https://documents.port.ac.uk/id:A23919/document/versions/published
12.
Hazards and Risks
12.1 Risks to Participants
Please outline any particular risks here
Further advice and blank forms can be found here.
12.2 Risks to Researchers
Are there any risks to you or any other members of the research team? Please consider examples such as
lone working or threats to personal security and safety arising from undertaking research in some
countries. Advice from the Foreign and Commonwealth Office can be found here.
13.
Publication Plans
Please add any publication plans here. There is an ethical imperative to publish and share research which
might be of value to the academic community and society as a whole. This is particularly important if the
research has been burdensome for participants – publication might well prevent repeating those burdens.
It is also conceivable that the results of research might have significant implications for policies and
practices which directly impact on members of society.
14.
References
Please ensure that you provide a comprehensive bibliography here.
15.
Appendices
Please complete the table below, providing a list of all the documents appended to this application. It is
essential that this is accurate – the Ethics Committee Administrator will copy and paste it in to the final
opinion letter thus providing a clear record of the documents reviewed and approved by the Committee.
Please make any necessary deletions or additions to the table.
Study Title:
Document
Application Form
Participant Information Sheet(s) (list if necessary)
Ethics Application-Generic-Form
Version 1.0 September 2015
Date
Version No.
David Carpenter University Ethics Adviser
Consent Form(s) (list if necessary)
Invitation Letter
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Peer / Independent Review
Research Data Management Plan
Supervisor Email Confirming Application
Evidence From External Organisation Showing Support
Terms of Reference for Steering / Advisory Group
Survey Instrument
Interview Questions / Topic List
Focus Group Questions / Topic List
Focus Group Ground Rules
Script for Oral Consent
Questionnaire
Observational Data Collection Form
Risk Assessment Form
Principal Investigator’s Response the Ethics Committee
Other – please describe
16.
Declaration
Declaration by Principal Investigator, and, if necessary, the Supervisor
1. The information in this form is accurate to the best of my/our knowledge and belief and I/we take full
responsibility for it.
2. I/we undertake to conduct the research in compliance with the University of Portsmouth Ethics Policy,
UUK Concordat to Support Research Integrity, the UKRIO Code of Practice and any other guidance I/we
have referred to in this application.
3. If the research is given a favourable opinion I/we undertake to adhere to the study protocol, the terms
of the full application as approved and any conditions set out by the Ethics Committee in giving its
favourable opinion.
4. I/we undertake to notify the Ethics Committee of substantial amendments to the protocol or the terms
of the approved application, and to seek a favourable opinion before implementing the amendment.
5. I/we undertake to submit annual progress reports (if the study is of more than a year’s duration) setting
out the progress of the research, as required by the Ethics Committee.
6. I/we undertake to inform the Ethics Committee when the study is complete and provide a declaration
accordingly.
7. I/we am/are aware of my/our responsibility to be up to date and comply with the requirements of the
law and relevant guidelines relating to security and confidentiality of personal data, including the need to
register, when necessary, with the appropriate Data Protection Officer. I/we understand that I/we am/are
not permitted to disclose identifiable data to third parties unless the disclosure has the consent of the data
subject.
8. I/we undertake to comply with the University of Portsmouth Research Data Management Policy.
9. I /we understand that research records/data may be subject to inspection by internal and external
bodies for audit purposes if required.
10. I/we understand that any personal data in this application will be held by the Ethics Committee, its
Administrator and its operational managers and that this will be managed according to the principles
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David Carpenter University Ethics Adviser
established in the Data Protection Act 1998.
11. I understand that the information contained in this application, any supporting documentation and all
correspondence with the Ethics Committee and its Administrator relating to the application:
 Will be held by the Ethics Committee until at least 3 years after the end of the study
 Will be subject to the provisions of the Freedom of Information Acts and may be disclosed in
response to requests made under the Acts except where statutory exemptions apply.
 May be sent by email or other electronic distribution to Ethics Committee members.
Principal Investigator………………..
Supervisor……………………………..
Date…………………….
Date…………………….
Please print names and dates above and send this application as an attachment to an email using a
University of Portsmouth email address.
Ethics Application-Generic-Form
Version 1.0 September 2015
David Carpenter University Ethics Adviser