Application for Ethical Approval of Research Involving Human Participants
This application form must be completed for any research involving human participants conducted in or by
the University by masters and undergraduate students. ‘Human participants’ are defined as including living
human beings, human beings who have recently died (cadavers, human remains and body parts), embryos
and foetuses, human tissue and bodily fluids, and human data and records (such as, but not restricted to
medical, genetic, financial, personnel, criminal or administrative records and test results including scholastic
achievements). Research must not commence until written approval has been received (from departmental
Director of Research/Ethics Officer, Faculty Ethics Sub-Committee (ESC) or the University’s Ethics
Committee). This should be borne in mind when setting a start date for the project. Ethical approval cannot
be granted retrospectively and failure to obtain ethical approval prior to data collection will mean that these
data cannot be used.
Applications must be made on this form, and submitted electronically, to your departmental Director of
Director/Ethics Officer. A signed copy of the form should also be submitted. Applications will be assessed
by the department Director of Research/Ethics Officer in the first instance, and may then passed to the ESC,
and then to the University’s Ethics Committee. A copy of your research proposal and any necessary
supporting documentation (e.g. consent form, recruiting materials, etc) should also be attached to this form.
A full copy of the signed application will be retained by the department/school for 6 years following
completion of the project. The signed application form cover sheet (two pages) will be sent to the Research
Governance and Planning Manager in the REO as Secretary of the University’s Ethics Committee.
1.
Title of project:
2.
Principal Investigator (i.e. name of student)
Name:
3.
Department:
Name of supervisor(s):
Name:
Department:
4.
Proposed start date of research (note ethical
approval cannot be granted retrospectively):
5.
Probable duration:
6.
Will this project be externally funded?
Yes
/ No
If Yes,
7.
What is the source of the funding?
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8.
If external approval for this research has been given, then only this cover sheet needs to be submitted
External ethics approval obtained (attach evidence of approval)
Yes
/ No
Declaration of Principal Investigator:
The information contained in this application, including any accompanying information, is, to the best of my
knowledge, complete and correct. I/we have read the University’s Guidelines for Ethical Approval of
Research Involving Human Participants and accept responsibility for the conduct of the procedures set out in
this application in accordance with the guidelines, the University’s Statement on Safeguarding Good
Scientific Practice and any other conditions laid down by the University’s Ethics Committee. I/we have
attempted to identify all risks related to the research that may arise in conducting this research and
acknowledge my/our obligations and the rights of the participants.
Signature(s): ...................................................................................................………………………….…..
Name(s) in block capitals: ......................................................................................………………………..
Date: ……………………………………………………………………………………………………….
Supervisor’s recommendation (Student Projects only):
I have read and approved the quality of both the research proposal and this application.
Supervisor’s signature: ..…………………………………………………………………………….…….
Outcome:
The departmental Director of Research (DoR) / Ethics Officer (EO) has reviewed this project and considers
the methodological/technical aspects of the proposal to be appropriate to the tasks proposed. The DoR / EO
considers that the investigator(s) has/have the necessary qualifications, experience and facilities to conduct
the research set out in this application, and to deal with any emergencies and contingencies that may arise.
This application falls under Annex B and is approved on behalf of the ESC
This application is referred to the ESC because it does not fall under Annex B
This application is referred to the ESC because it requires independent scrutiny
Signature(s): .......................................................................................…………………..…….…….…….
Name(s) in block capitals: ..................................................................................……..………….……….
Department: ………………………………………………………………………..……………….……
Date: ……………………………………………………………………………………………………..
The application has been approved by the ESC
The application has not been approved by the ESC
The application is referred to the University Ethics Committee
Signature(s): .......................................................................................…………………………………..
Name(s) in block capitals: …..................................................................................…………………….
Faculty: ……………………….…………………………………...……………………………………
Date: …………………………….………………………………………………………………………
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Details of the Project
1.
Brief outline of project (This should include the purpose or objectives of the research, brief
justification, and a summary of methods but should not include theoretical details. It needs to be
understandable to a lay person, i.e. in everyday language that is free from jargon, and the
reviewer must be able to understand what participants will be asked to do.).
Participant Details
2.
Will the research involve human participants? (indicate as appropriate)
Yes
No
Note: Under no circumstances should participants be contacted before ethical approval of this
project has been granted.
3.
Who are the participants?
4.
How will they be recruited? (If any recruiting materials are to be used, e.g. advertisement or letter
of invitation, please provide copies).
5.
Will participants be paid or reimbursed?
Yes
/ No
If so, how will they be paid?
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6.
Could participants be considered:
(a)
to be vulnerable (e.g. children, mentally-ill)?
Yes
/ No
(b)
to feel obliged to take part in the research?
Yes
/ No
If the answer to either of these is yes, please explain how the participants could be considered
vulnerable and why vulnerable participants are necessary for the research.
Informed Consent
7.
Will the participant’s consent be obtained for involvement in the research orally or in writing? 1
(If in writing, please attach an example of written consent for approval):
Yes
No
If in writing, please tick to confirm that you have attached an example of written consent
Consent should be obtained before data is collected. How will consent be obtained and recorded?
If you are obtaining consent orally, explain why. Who will be giving consent? Please indicate at
what stage in the data collection process consent will be obtained. If consent is not possible,
explain why. Please note that, if you are using an on-line questionnaire, consent may be assumed
on submission of the questionnaire but you need to inform participants that this is the case and
provide them with information about the research and their rights before they start to complete the
questionnaire.
Please attach a participant information sheet where appropriate.
Have you reviewed the information provided by the REO on participant
information and consent?
Yes
/ No
1
If the participant is not capable of giving informed consent on their own behalf or is below the age of consent, then consent
must be obtained from a carer, parent or guardian. However, in the case of incompetent adults, the law in the United Kindom
does not recognize proxy consent by a relative. In addition, the University Ethics Committee is not able to provide ethical
approval for such research. It needs to be approved by a Health Research Authority National Research Ethics Service
Research Ethics Committee.
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Confidentiality / Anonymity
8.
If the research generates personal data, describe the arrangements for maintaining anonymity
and confidentiality. For example you might be using participant numbers or pseudonyms. If
you are not maintaining anonymity and confidentially, please explain your reasons for not doing
so.
Data Access, Storage and Security
9.
Describe the arrangements for storing and maintaining the security of any personal data
collected as part of the project. For example: Will data be secured electronically or in
hardcopy? Will you be using password protection, encryption, locked filing cabinets? Please
provide details of all those who will have access to the data.
10.
It is a requirement of the Data Protection Act 1998 to ensure individuals are aware of how
information about them will be managed. Please tick the box to confirm that participants will be
informed of the data access, storage and security arrangements described above. If relevant, it
is appropriate for this to be done via the participant information sheet
11.
Further guidance about the collection of personal data for research purposes and compliance
with the Data Protection Act can be accessed at the following weblink. Please tick the box to
confirm that you have read this guidance
(http://www.essex.ac.uk/records_management/policies/data_protection_and_research.aspx)
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Risk and Risk Management2
12.
Are there any potential risks (e.g. physical, psychological, social, legal or economic) to
participants or subjects associated with the proposed research?
Yes
No
If Yes,
Please provide full details and explain what risk management procedures will be put in place to
minimise the risks:
13.
Are there any potential risks to researchers as a consequence of undertaking this proposal that
are greater than those encountered in normal day-to-day life?
Yes
No
If Yes,
Please provide full details and explain what risk management procedures will be put in place to
minimise the risks:
14.
Will the research involve individuals below the age of 18 or individuals of 18 years and over
with a limited capacity to give informed consent?
Yes
No
If Yes, a Disclosure and Barring Service disclosure (DBS check) may be required.3
2
Advice on risk assessment is available from the University’s Health and Safety Advisers (email safety@essex.ac.uk; tel 2944)
and on the University’s website at www.essex.ac.uk/ohsas/risk_assessment.
3
Advice on the Disclosure and Barring Service and requirement for checks is available: (1) for staff from Employment
Compliance Manager in Human Resources (email lauren@essex.ac.uk; tel 3508) and on the University’s website at
http://www.essex.ac.uk/hr/policies/docs/CRBdocumentpolicy.pdf; (2) for students from the University’s Academic Section.
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11.
Are there any other ethical issues that have not been addressed which you would wish to bring
to the attention of the Faculty Ethics Sub-Committee and/or University Ethics Committees.
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