CCi Ethics & Combined Protocol

advertisement

Faculty of Creative and Cultural Industries

Application for Ethical Review – Staff and Postgraduate Research Students

Guidance Notes (please delete these notes before submitting the form, you may find it helpful to leave this and the deletion of other guidance notes until you have completed the full 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 issues 1 , 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 https://ethicsreview.port.ac.uk/ This system will issue a certificate providing a favourable opinion unless it

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

CCi Ethics & Combined Protocol Application Version 3.0 January 2016 David Carpenter – University Ethics Advisor

P a g e | 1

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.

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 https://ethicsreview.port.ac.uk/ 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:

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 Universities UK 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 Research Councils UK Policy and Guidelines on Governance of Good Research Conduct – this document is useful regardless of funding matters

The Research Councils UK Concordat for Engaging the Public with Research – this is helpful in demonstrating research impact

The UK Research Integrity Office 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

CCi Ethics & Combined Protocol Application Version 3.0 January 2016 David Carpenter – University Ethics Advisor

P a g e | 2

BBSRC The Research Ethics Guidebook

EPSRC Ethics in ICT ; Framework for Responsible Innovation

NERC Ethics Policy

STFC Ethics Policy

of Social Anthropologists of t and

Discipline specific guidance – most subject disciplines publish guidance on the ethical conduct of research.

Association of Social Anthropologists of the UK and Commonwealth – Ethical Guidelines

British Association of Applied Linguistics – Good Practice

British Educational Research Association – Ethical Guidelines

British Psychological Society – Code of Human Research Ethics

British Sociological Association – Statement of Ethical Practice

British Society of Criminology – Statement of Ethics

Oral History Society - Guidance

Political Studies Association – various papers

Social Policy Association - Guidelines

Social Research Association – Ethical Guidelines

om

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 Ethics Committee

Administrator ethics-cci@port.ac.uk

CCi Ethics & Combined Protocol Application Version 3.0 January 2016 David Carpenter – University Ethics Advisor

P a g e | 3

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 must be 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.

2 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

2 Forms can be accessed from www.port.ac.uk/research/ethics

CCi Ethics & Combined Protocol Application Version 3.0 January 2016 David Carpenter – University Ethics Advisor

P a g e | 4

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 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.

CCi Ethics & Combined Protocol Application Version 3.0 January 2016 David Carpenter – University Ethics Advisor

P a g e | 5

Faculty of Creative and Cultural Industries

Application for Ethical Review – Staff and Postgraduate Research Students

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

CCi Ethics Committee for ethical review. You may find it helpful to complete all sections before deleting the notes; this will help you to check that you have met all requirements.

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 comparator 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: Projected date of study completion (fully written up):

CCi Ethics & Combined Protocol Application Version 3.0 January 2016 David Carpenter – University Ethics Advisor

P a g e | 6

2.

Applicant Details: Please complete either 2.1 or 2.2 as appropriate

2.1 Principal Investigator (Member of staff –personally or as a supervisor of a taught student)

Name:

Telephone:

Title /Role:

Email:

Department:

2.2 Principal Investigator (PGRS)

Name:

Course of study:

Title /Role: Department:

Telephone: Email:

First Supervisor’s Name: Telephone:

Names and contact details of any other supervisors (if relevant)

Email:

Supervisors will have to confirm to ethics-cci@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 ethics-cci@port.ac.uk

, a separate email confirming that this protocol (version and date) is ready to be submitted to CCi 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

4.

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?

Research Sites

Please add details of where the research will take place; if permissions are contingent on ethical approval please give further explanation. 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.

CCi Ethics & Combined Protocol Application Version 3.0 January 2016 David Carpenter – University Ethics Advisor

P a g e | 7

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 (You might find it easier to return to section 6 after you have completed later sections)

7.

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 language that non-academics as well as academics can understand.

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. You should give a brief explanation of how you plan to deal with the issues you have identified.

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 .

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.

CCi Ethics & Combined Protocol Application Version 3.0 January 2016 David Carpenter – University Ethics Advisor

P a g e | 8

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

CCi Ethics & Combined Protocol Application Version 3.0 January 2016 David Carpenter – University Ethics Advisor

P a g e | 9

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. b. c. on the request of the participant. on the decision of the researcher or supervisor [if appropriate]. 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

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.

CCi Ethics & Combined Protocol Application Version 3.0 January 2016 David Carpenter – University Ethics Advisor

P a g e | 10

10.

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: please include the criteria you will use to identify your sample

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.

CCi Ethics & Combined Protocol Application Version 3.0 January 2016 David Carpenter – University Ethics Advisor

P a g e | 11

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.

CCi Ethics & Combined Protocol Application Version 3.0 January 2016 David Carpenter – University Ethics Advisor

P a g e | 12

10.5 Obtaining Consent

This section should be used to address issues relating to the consent of individual participants; if you need the consent of any organisation please address this in 10.6, below.

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 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.

CCi Ethics & Combined Protocol Application Version 3.0 January 2016 David Carpenter – University Ethics Advisor

P a g e | 13

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 Collection and Analysis

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.

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.?

CCi Ethics & Combined Protocol Application Version 3.0 January 2016 David Carpenter – University Ethics Advisor

P a g e | 14

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 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 3 rd link below). Paper records may be scanned and originals destroyed. 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

CCi Ethics & Combined Protocol Application Version 3.0 January 2016 David Carpenter – University Ethics Advisor

P a g e | 15

11.5 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 areto be linkedanonymised please explain the arrangements here.

11.6 Organisational Data

Organisational data should be treated in much the same way as personal data. It is recognised that some organisational data are in the public domain in which case they need only be appropriately referenced.

Some data, however, will be confidential for commercial or other reasons; please make your management plans clear if this is to be the case. Please explain how you will ensure confidentiality including storage and access arrangements. Where will the data be stored? Who will have access to them? If the organisation wishes to remain anonymous please explain the strategy you will deploy.

11.7 Security Sensitive Data

It is recognised that some research requires access to security sensitive or other data which might be deemed as controversial, for example pornographic material, but which can nevertheless be lawfully accessed. There is useful UUK guidance regarding security sensitive research. The University does not offer a safe store as suggested; you should however, make it clear that you are accessing these materials for legitimate research purposes. It is important for the University to be aware of access to any sensitive documents, for example terrorist manuals, so that police or other enquiries can be addressed; whilst it is lawful to hold such material for research purposes it would be unlawful to pass it on to other individuals or organisations. If you intend to use materials of this nature you should provide a simple bibliography on a google doc giving access to denise.teasdsale@port.ac.uk

(Research Governance Manager) and david.carpenter@port.ac.uk

(University Ethics Adviser). If there are any enquiries or investigations it will be a straightforward matter of confirming a legitimate situation.

CCi Ethics & Combined Protocol Application Version 3.0 January 2016 David Carpenter – University Ethics Advisor

P a g e | 16

12.

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 bibliography here; this should include references needed to support the research proposal.

CCi Ethics & Combined Protocol Application Version 3.0 January 2016 David Carpenter – University Ethics Advisor

P a g e | 17

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)

Date Version No.

Consent Form(s) (list if necessary)

Invitation Letter

Advertisement

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 to the Ethics Committee

Other – please describe

CCi Ethics & Combined Protocol Application Version 3.0 January 2016 David Carpenter – University Ethics Advisor

P a g e | 18

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 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.

CCi Ethics & Combined Protocol Application Version 3.0 January 2016 David Carpenter – University Ethics Advisor

P a g e | 19

Download