Canvas 8 Group 22 Note To Applicants It Is

canvas 8 group 22 note to applicants: it is important for you to include all relevant information about your research in this application f

Canvas 8 Group 22
note to applicants: it is important for you to include all relevant
information about your research in this application form as your
ethical approval will be based on this form. Therefore anything not
included will not be part of any ethical approval.
You should read the Ethics Application Guidelines and have them
available as you complete this form.
APPLICATION FORM
SECTION A APPLICATION FOR ETHICAL REVIEW: HIGH RISK
A1
Project Title:  
Date of Submission:  
Proposed Data Collection Start Date:  
UCL Ethics Project ID Number:  
Proposed Data Collection End Date:  
Is this application for continuation of a research project that
already has ethical approval? For example, a preliminary/pilot study
has been completed and this is an application for a follow-up project?
If yes, please provide the information requested below.
Project ID for the previous study:  
A2
Principal Researcher
Please note that a student – undergraduate, postgraduate or research
postgraduate cannot be the Principal Researcher for Ethics purposes.
Full Name:  
Position Held:  
Name and Address of Department:  
Email:  
Telephone:  
Fax:  
Declaration To be Signed by the Principal Researcher
*
I have met with and advised the student on the ethical aspects of
this project design (applicable only if the Principal Researcher
is not also the Applicant).
*
I understand that it is a UCL requirement for both students &
staff researchers to undergo Disclosure and Barring Service (DBS)
Checks when working in controlled or regulated activity with
children, young people or vulnerable adults. The required DBS
Check Disclosure Number(s) is:  
*
I have obtained approval from the UCL Data Protection Officer
stating that the research project is compliant with the General
Data Protection Regulation 2018. My Data Protection Registration
Number is:  
*
I am satisfied that the research complies with current
professional, departmental and university guidelines including
UCL’s Risk Assessment Procedures and insurance arrangements.
*
I undertake to complete and submit the ‘Continuing Review Approval
Form’ on an annual basis to the UCL Research Ethics Committee.
*
I will ensure that changes in approved research protocols are
reported promptly and are not initiated without approval by the
UCL Research Ethics Committee, except when necessary to eliminate
apparent immediate hazards to the participant.
*
I will ensure that all adverse or unforeseen problems arising from
the research project are reported in a timely fashion to the UCL
Research Ethics Committee.
*
I will undertake to provide notification when the study is
complete and if it fails to start or is abandoned.
SIGNATURE:
DATE:  
A3
Applicant(s) Details (if Applicant is not the Principal Researcher
e.g. student details):
Full Name:  
Position Held i.e.undergraduate/bachelor or masters project (if so,
provide course title/number, PhD, staff led research project which may
involve one or more students:  
Name and Address of Department:  
Email:  
Telephone:  
Fax:  
Full Name:  
Position Held:  
Name and Address of Department:  
Email:  
Telephone:  
Fax:  
A4
Sponsor/ Other Organisations Involved and Funding
a.
Sponsor: UCL Other institution
If your project is sponsored by an institution other than UCL please
provide details:  
b.
Other Organisations: If your study involves another organisation,
please provide details. Evidence that the relevant authority has
given permission should be attached or confirmation provided that
this will be available upon request.  
c.
Funding: What are the sources of funding for this study and will
the study result in financial payment or payment in kind to the
department or College? If study is funded solely by UCL this
should be stated, the section should not be left blank.  
A5
Signature of Head of Department [or Chair of your Departmental
Research Ethics Committee/Departmental Ethics Lead]
(This must not be the same signature as the Principal Researcher)
A.
I have discussed this project with the principal researcher who is
suitably qualified to carry out this research and I approve it.
I am satisfied that [please highlight as appropriate]:
1.
Data Protection registration:
*
has been satisfactorily completed
*
has been initiated
*
is not required
2.
a risk assessment:
*
has been satisfactorily completed
*
has been initiated
3.
appropriate insurance arrangements are in place and appropriate
sponsorship [funding] has been approved and is in place to
complete the study. Yes No
4.
a Disclosure and Barring Service check(s):
*
has been satisfactorily completed
*
has been initiated
*
is not required
Links to details of UCL's policies on the above can be found at:
http://ethics.grad.ucl.ac.uk/procedures.php
**If any of the above checks are not required please clarify why
below.
 
PRINT NAME:  
SIGNATURE:
DATE:  
SECTION B DETAILS OF THE PROJECT
**It is essential that Sections B1 and B2 are completed in simple
understandable lay language that a non-expert could understand or you
risk your project being rejected
B1
Please provide a brief summary of the project in simple lay person’s
prose outlining the intended value of the project, giving necessary
scientific background. (max 500 words).
 
B2
Briefly characterise in simple lay person’s prose the research
protocol, type of procedure and/or research methodology (e.g.
observational, survey research, experimental). Give details of any
samples or measurements to be taken (max 500 words).
 
Attach any questionnaires, psychological tests, etc. (a standardised
questionnaire does not need to be attached, but please provide the
name and details of the questionnaire together with a published
reference to its prior usage).
B3
Where will the study take place (please provide name of
institution/department)?
If the study is to be carried out overseas, what steps have been taken
to secure research and ethical permission in the study country?
Is the research compliant with Data Protection legislation in the
country concerned or is it compliant with the General Data Protection
Regulation 2018?
 
B4
Have collaborating departments whose resources will be needed been
informed and agreed to participate?
Attach any relevant correspondence.
 
B5
How will the results be disseminated, including communication of
results with research participants?
 
B6
Please outline any ethical issues that might arise from the proposed
study and how they are be addressed. Please note that all research
projects have some ethical considerations so do not leave this section
blank.
 
SECTION C DETAILS OF PARTICIPANTS
C1
Participants to be studied
C1a. Number of volunteers:
 
Upper age limit:
 
Lower age limit:
 
C1b. Please justify the age range and sample size:
 
C2
Accessing/Using Pre-Collected Data:
If you are using data or information held by a third party, please
explain how you will obtain this. You should confirm that the
information has been obtained in accordance with the General Data
Protection Regulation 2018.
 
C3
Will the research include children or vulnerable adults such as
individuals with
a learning disability or cognitive impairment or individuals in a
dependent or unequal relationship? Yes No
How will you ensure that participants in these groups are competent to
give consent to take part in this study? If you have relevant
correspondence, please attach it.
 
C4
Will payment or any other incentive, such as gift service or free
services, be made to any research participant?
Yes No
If yes, please specify the level of payment to be made and/or the
source of the funds/gift/free service to be used.
 
Please justify the payment/other incentive you intend to offer.
 
C5
Recruitment
(i) Describe how potential participants will be identified:
 
(ii) Describe how potential participants will be approached:
 
(iii) Describe how participants will be recruited:
 
C6
Will the participants participate on a fully voluntary basis? Yes No
Will UCL students be involved as participants in the research project?
Yes No
If yes, care must be taken to ensure that they are recruited in such a
way that they do not feel any obligation
to a teacher or member of staff to participate.
Please state how you will bring to the attention of the participants
their right to withdraw from the study without penalty?
 
C7
CONSENT
Please describe the process you will use when seeking and obtaining
consent.
 
A copy of your participant information sheet(s) and consent form(s)
must be attached to this application. For your convenience proformas
are provided in Appendix I. These should be filled in and modified as
necessary.
In cases where it is not proposed to obtain the participants informed
consent, please explain why below.
 
C8
Will any form of deception be used that raises ethical issues? If so,
please explain.
 
C9
Will you provide a full debriefing at the end of the data collection
phase? Yes No
If ‘No’, please explain why below.
 
C10
Information Sheets And Consent Forms: Appendix I
A poorly written Information Sheet(s) and Consent Form(s) that lack
clarity and simplicity frequently delay ethics approval of research
projects. The wording and content of the Information Sheet and Consent
Form must be appropriate to the age and educational level of the
research participants and clearly state in simple non-technical
language what the participant is agreeing to. Use the active voice
e.g. “we will book” rather than “bookings will be made”. Refer to
participants as “you” and yourself as “I” or “we”. An appropriate
translation of the Forms should be provided where the first language
of the participants is not English. If you have different participant
groups you should provide Information Sheets and Consent Forms as
appropriate (e.g. one for children and one for parents/guardians)
using the templates provided in Appendix I. Where children are of a
reading age, a written Information Sheet should be provided. When
participants cannot read or the use of forms would be inappropriate, a
description of the verbal information to be provided should be given.
Where possible please ensure that you trial the forms on an
age-appropriate person before you submit your application.
RISKS AND BENEFITS to
the researcher and the researched
SECTION D: APPROPRIATE SAFEGUARDS, DATA STORAGE AND SECURITY
SECTIO
D1
Will the research involve the collection and/or use of personal data?
Yes No
Personal data is data which relates to a living individual who can be
identified from that data OR from the data and other information that
is either currently held, or will be held by the data controller (the
researcher).
This includes:
*
any expression of opinion about the individual and any intentions
of the data controller or any other person toward the individual.
*
sensor, location or visual data which may reveal information that
enables the identification of a face, address, etc (some postcodes
cover only one property).
*
combinations of data which may reveal identifiable data, such as
names, email/postal addresses, date of birth, ethnicity,
descriptions of health diagnosis or conditions, computer IP
address (if relating to a device with a single user).
If yes, is the research collecting or using special category data as
defined by the GDPR 2018, for example data:
*
which reveals racial or ethnic origin, political opinions,
religious or philosophical beliefs, trade union membership ;
*
data concerning health (the physical or mental health of a
person, including the provision of health care services) ;
*
data concerning sex life or sexual orientation ; or
*
genetic or biometric data processed to uniquely identify a
natural person.
*
data which might be considered sensitive in some countries,
cultures or contexts?
Note that if you intend to process ‘special category’ information you
will need an ‘additional’ legal basis for processing that particular
data and further safeguards will need to be put in place.
If yes, state whether explicit ethical informed consent will be sought
for its use and what data management measures are in place to
adequately manage and protect the data.
 
D2
During the Project (including the write up and dissemination period)
State what types of data will be generated from this project (i.e.
transcripts, videos, photos, audio tapes, field notes, etc).
 
How will data be stored, including where and for how long? This
includes all hard copy and electronic data on laptops, share drives,
usb/mobile devices.
 
Who will have access to the data, including advisory groups and during
transcription?
 
D3
Will personal data be processed or be sent outside of the European
Economic Area (EEA)*?
If yes, please confirm that there are adequate levels of protection in
compliance with the General Data Protection Regulation 2018 and state
what these arrangements are below.
 
D4
After the Project
What data will be stored and how will you keep it secure?
 
Where will the data be stored and who will have access?
 
Will the data be securely deleted?
If yes, please state when will this occur:
 
D5
Will the data be archived for use by other researchers? Yes No
If Yes, please describe provide further details including whether
researchers outside the EEA will be given access.
 
SECTION E: DETAILS OF RISKS AND BENEFITS to the researcher and the
researched
E1
Please state briefly any precautions being taken to protect the health
and safety of researchers and others associated with the project (as
distinct from the research participants).
 
E2
Will these participants participate in any activities that may be
potentially stressful or harmful in connection with this research? Yes
No
If Yes, please describe the nature of the risk or stress and how you
will minimise and monitor it.
 
E3
Will group or individual interviews/questionnaires raise any topics or
issues that might be sensitive, embarrassing or upsetting for
participants?
If Yes, please explain how you will deal with this.
 
E4
Please describe any expected benefits to the participant.
 
E5
Specify whether the following procedures are involved:
Any invasive procedure(s) Yes No
Physical contact Yes No
Any procedure(s) that may cause mental distress Yes No
Please state briefly any precautions being taken to protect the health
and safety of the research participants.
 
E6
Does the research involve the use of drugs? Yes No
If Yes, please name the drug/product and its intended use in the
research and then complete Appendix II
 
Does the project involve the use of genetically modified materials?
Yes No
If Yes, has approval from the Genetic Modification Safety Committee
been obtained for work? Yes No
If Yes, please quote the Genetic Modification Reference Number:  
E7
Will any non-ionising radiation be used on the research
participant(s)? Yes No
If Yes, please complete Appendix III.
E8
Are you using a medical device in the UK that is CE-marked and is
being used within its product indication? Yes No
If Yes, please complete Appendix IV.
CHECKLIST
Documents to be Attached to Application Form (if applicable) Tick if
attached
Section B: Details of the Project
*
Questionnaire(s) / Psychological Tests
*
Relevant correspondence relating to involvement of collaborating
department/s and agreed participation in the research i.e.
approval letters
to gatekeepers seeking permission to do research on their premises/
in their company etc.
Section C: Details of Participants
*
Parental/guardian consent form for research involving
participants under 18
*
Participant/s information sheet
*
Participant/s consent form/s
*
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Appendix I: Information Sheet(s) and Consent Form(s)
Appendix II: Research Involving the Use of Drugs
*
Relevant correspondence relating to agreed arrangements for
dispensing
with the pharmacy
*
Written confirmation from the manufacturer that the drug/substance
has
has been manufactured to GMP
*
Proposed volunteer contract
*
Full declaration of financial or direct interest
*
Copies of certificates: CTA etc…
Appendix III: Use of Non-Ionising Radiation
Appendix IV: Use of Medical Devices
Updated October 2019
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