The Research Ethics Committee has reviewed the above application and would wish to make the following comments:
C1 – No detail is given about what application and its UI are being tested. Without such detail it is impossible to evaluate how intrusive (or otherwise) the
questionnaire might be. Further, this information is needed to evaluate how justified the inclusion of under-18s is in the first place — could the objectives of
the study be achieved by surveying adults only?
How will participants ‘test’ this app? The questionnaire provided asks participants to provide feedback following their use of an app, but there is no
information given here about what the app does or how it will be made available to the participants for testing prior to the issue of the questionnaire.
Further, the questionnaire is very generic. Without the information about the function of the application, it is impossible to evaluate the ethical aspects of the
proposed questionnaire.
Questionnaire – Questions 8 and 9 refer to a ‘1 to 5 scale’ but do not clarify if 1 or 5 is ‘good’ or ‘bad’. The committee suggest this clarification is added to these questions
to ensure the collected data can be interpreted correctly.
C4 – This is not detailed enough. More clarity is needed, in particular because underage participants are supposed to be surveyed.
C15 – Is the ‘final report’ mentioned here the dissertation to be submitted by the researcher? Please clarify.
C18 – Is this correct — what specific mechanism will be used for online survey?
D1 – is this the total number of participants, or the number in each category?
D3 – This answer identifies three different types of participant: admin, teacher, student. How many of each type of participant will there be? Why is the total
number of participants 10? Further explanation is needed here to justify the stated total number of participants and to clarify how many of each type of
participant there will be.
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D4 – There is no clarity about the organisation where research will be conducted. What will be the arrangements for selecting participants? Will it be
outsourced to the “organisation”, with a compulsion element, or will it be entirely voluntary?
Should ‘requested’ be ‘required’ here? These words mean different things. Why are the stated age ranges important? The reason this ethics review is
flagged as medium risk is due to the inclusion of participants under the age of 18. Nowhere in this application does it explain what the ‘mobile app’ is that
participants will be answering questions about, or why it is important to include vulnerable participants under the age of 18. More detail needs to be provided
about the study in answer to section C1 and in response to D4, D5 and D8.
D7 – To re-iterate, the available information is not enough to evaluate whether the inclusion of vulnerable participants is justified.
D10 – Please provide the name of the organisation in this answer and in answer to D11 (presumably it is Sterling Study Ltd).
D11 – The committee is not sure whether parental consent can be outsourced to the “organisation”; it is recommended that the procedure (information sheet
and consent form) need to undergo Brunel ethics review.
D12 – More detail should be provided about the specific arrangements that will be put in place.
D14 – Who will be doing the “approaching” — the applicant or the “organisation”? If the latter, the answers to D14 and D15 seem inconsistent. In either case, significantly
more detail has to be provided about the arrangements.
D15 – I believe the answer here should be ‘yes’ given other answers on this form.
D17 – This contradicts the answer in D14. A substantive answer is needed here. If you are recruiting participants for this research, then this answer cannot be ‘NA’.
D18 – Again, a substantive answer is needed. Presumably there is a relation between the researcher and the “organisation”. The answer to this question
cannot be ‘NA’. Either there is a relationship between the researcher and the participants, or there is not. If the latter, then the answer should clearly state
that there is no relationship.
D19 – How can this be guaranteed if recruitment is outsourced to the “organisation”?
Participant Information Sheet – You uploaded a copy of the questionnaire instead of the PIS there. Please refer to the Participant Information Template and
Guidance notes, which will help you. You will find the link to the template and guidance notes when you click the information (i) icon under A18.
This contradicts the previous answer, and the need to obtain parents’/guardians’ consent for underage participants.
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D26 – You need to give your participants the option of withdrawing from the study and withdrawing their data. It might be beneficial to give them a deadline,
especially if the data is truly anonymised you will have no means of identifying which data is theirs.
D29 – It is not clear whether the identity of the respondents will be retained. It is recommended setting up the online questionnaire in such a way the the
identity of the responders (beyond the role as teacher, parent, etc.) is not ever available to the researcher or retained in any form. If the personal data is
indeed needed to be collected for this study, then please state this here as this will be an important measure to ensure the confidentiality of participants’
data.
D30 – A substantive answer is needed given that a subset of participants will be under 18. This question cannot be answered with ‘NA’. The BREO guidance notes
for this question state:
When considering interviewing children or employees (among others), it may not be possible to guarantee absolute confidentiality. The following statement
is offered as a guide: “All information collected about you during the course of the study will be kept strictly confidential. Our procedures for handling,
processing, storage and destruction of data are compliant with the Data Protection Act 2018; however, if evidence of harm or misconduct comes to light,
then, in line with research guidelines, confidentiality will have to be broken. We will tell you at the time if we think we need to do this, and let you know what
will happen next.”
In exceptional circumstances, where there is sufficient evidence to raise serious concern about the safety or interests of participants, or about others who
may be threatened by a participant’s behaviour, it may be necessary to inform appropriate third parties without the prior consent of the participant. This
should only be done after consultation with the Supervisor or a senior researcher, unless the delay caused by seeking this advice would involve a serious
risk to life or health.
D31 – This may not be consistent with the University assessment procedures. The data has to be retained for as long as necessary to allow for assessment
and consideration of possible appeals.
D32 – A substantive answer is needed. Given that the subject of research is apparently a proprietary app with a small and possibly not entirely voluntary user
base (if the use of the app is routine in the “organisation”), the participants in the survey may have a vested interest in learning about the outcomes of the
study.
E1 – The possibility for psychological harm to minors is impossible to evaluate without additional information about the the purpose and the function of the
app.
G1 – Is this certain? Would the “organisation” be interested in obtaining positive reviews of its app, and if so, outsourcing recruitment to it may present a
conflict of interest.
J1 – Please amend both proposed start and end date of your study, allowing adequate time for your resubmission to be reviewed. Please be advised that
under no circumstance can research involving human participants commence prior to the date of final ethical approval.
Consent Form – You must give your participants a Consent Form depending on the type of your research activity.
1. For Online Questionnaires/Surveys you will need to use the ‘Online Consent Template’. The template must form the first page of your
Questionnaire/Survey.
2. For Interviews (in person or vis skype etc.), Focus Groups, observations etc., you will need to give your participants the ‘Consent Form Template’ to
complete/sign prior to commencing your testing.
Both templates are available from Help section in BREO.
In the light of the above, please note that the revisions/information required must be provided, and approved, before the study can commence.
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Please make the relevant changes to your original BREO application and resubmit, along with any amended documentation.
In order that your research is not unduly delayed, it is in your best interests to resubmit your application as soon as possible (preferably within the next
10 days). Please note that applications awaiting changes for longer than three months will be archived, and a new one will need to be submitted.