Proforma - Research Ethics Committee - Application

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Research Ethics Committee (REC)
Application for Ethical Approval
Please note: this application form has been created for electronic completion and therefore contains
check-boxes and drop-down lists for your responses.
All items on this form require a response in order to allow the REC to fully scrutinise the
research.
Researcher Details
Lead Researcher
First Name:
Surname:
FAS:
Primary dept.
/ area (please FoE:
select from
drop-down
lists):
FHSC:
Please select from the drop down list
Please select from the drop down list
Please select from the drop down list
Other:
Staff / Doctoral Student? Please select from the drop down list (if student, supervisors should be included
in the next field)
Names & affiliations of research team / supervisory team
Please note that any ethical approval granted on the basis of this application covers only the
original study for which ethical approval was sought (unless advised otherwise by the relevant
ethics committee at the time of approval).
If a study is extended or changed and / or further use of samples or data from a study already
completed is required, it advisable to contact the Research & Enterprise Support Office and the ethics
committee from which your original approval was granted.
Research & Enterprise Support Office
Project Details
Title:
Start date of project:
End date of project:
Source of funding for the project:
Research Method: Please select from the drop down list
Detail of other / mixed methods:
Risk Assessment
Has a risk assessment been carried out?
YES
NO
Please detail the reasons below
Details if no risk assessment has been carried out (max 500 characters):
If no risk assessment has been carried out, by which date do you intend to conduct one?
Do your data collection and research methods include any of the following? Please tick all that apply.
Administering drugs or other substances
(please specify below)
Deception (excluding blind research
design) (please specify below)
Blood sample (via needle insertion)
Use of distressing images, video or other
media (please specify below)
Blood sample (not via needle insertion)
Other physically or psychologically
invasive method (please specify below)
Collection of other bodily tissues, secretions
or excretions (please specify below)
Non-invasive
Please provide details of the invasive method(s), as requested above (max 500 characters):
Research Subjects:
Please select from the drop down list
Other:
Are research subjects EHU Staff / Student?
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Please select from the drop down list
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Research & Enterprise Support Office
Location of project:
Please select from the drop down list
Other:
Could the location present any risks to either the researcher(s) or to third parties (e.g. the general public,
research subjects, etc.)?
YES
NO
If yes, please provide details (max 500 characters):
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Research & Enterprise Support Office
Ethical Approval Information
Has this proposal been through external or parallel ethical approval processes?
YES
NO
Details (max 500 characters or attach separate sheet):
Is this proposal an extension of a project that has previously undergone ethical approval procedures?
YES
NO
Details (max 500 characters or attach separate sheet):
Does this proposal require a specific ethical approval action (e.g. letter, facility) to be produced to support
the project?
YES
NO
Details (max 500 characters or attach separate sheet):
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Research & Enterprise Support Office
Outline of the Project & Ethical Issues
Please attach your research proposal.
Proposals should include details under the categories listed below. They can be presented in a
submission written specifically for this document or consist of other written documents that outline the
project (e.g. to external funders), as long as a cover sheet clearly specifies upon where each of the
categories listed are elaborated.
Submissions should include such detail as to allow readers to gain a clear understanding of the
applicants’ attention to ethical issues and problems.
Categories:
Title of project / aims and objective of the project
Outline of the project
Methodology and outline of methods and analysis
Identification of research participants
Timescales and staging of the project
Budget and logistics / sources of funding
Specific ethical considerations / risk assessment
Relevant supporting documents (e.g. consent forms, information sheets, invitation letters)
Confirmation that EHU policies & procedures have been followed (e.g. risk assessment, health &
safety protocol)
Processes by which ethical review will be in place throughout the project
Details of research staff
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Research & Enterprise Support Office
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Research & Enterprise Support Office
Research Ethics Committee (REC)
Approval Form
Applicant’s Signature (lead researcher if more than one applicant)
Date
Comments from Head of Department / Area or Research Degree Supervisor
(max 600 characters)
HoD / Research Degree Supervisor Name
HoD / Research Degree Supervisor Signature
Date
The completed, signed form should be returned to:
FAS: Your Departmental Research Ethics Committee (DREC) Secretary
FHSC: Victoria Kelly
FoE: Julie Kirby
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Research & Enterprise Support Office
Comments from Departmental and / or Faculty REC Chair (max 600 characters)
Departmental / Faculty REC Chair Name
Departmental / Faculty REC Chair Signature
Date
Approved by DREC / FREC?
Is the below decision that of DREC or FREC: Please select from the drop-down list
YES
NO: Re-submit to DREC / FREC
NO: Re-submit for Chair’s Approval
NO: Refer to FREC (DRECs only)
NO: Refer to UREC
NO: Rejected
Please note: if rejected, the applicant has the right to lodge an appeal with UREC as per the Framework
for Research Ethics.
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Research & Enterprise Support Office
Only if referred to UREC from Faculty REC:
Comments from UREC Chair (max 600 characters)
UREC Chair Name
UREC Chair Signature
Date
Approved by UREC?
YES
NO
Administration
Committee / Sub-Committee Date
Minute Reference
Approval Date
Further action, where needed (max 600 characters)
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Research & Enterprise Support Office
Document updated September 2013
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