Biomedical and Scientific Research Ethics Committee (BSREC)
Application Form for Ethical Approval of Substantial Amendment
SECTION 1. PROJECT DETAILS
1.1 Project Title:
1.2 BSREC Reference:
SECTION 2. APPLICANT DETAILS
2.1 RESEARCHER
Researcher’s Title:
Researcher’s Forename:
Researcher’s Surname:
Researcher’s Faculty/School and Department:
Researcher’s Status:
Undergraduate Student
Taught Postgraduate Student
Research Postgraduate Student
Staff
Other
Please specify:
If Student:
Name of course/qualification:
If Staff:
Researcher’s Post:
2.2 RESEARCHER’S CONTACT DETAILS
BSREC Application form for Ethical Approval of Substantial Amendment; version number: 02; version date: 23Feb16
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Warwick e-mail address:
Daytime telephone number:
Postal address:
2.3 SUPERVISOR - COMPLETE FOR ALL STUDENT PROJECTS
Supervisor’s Title:
Supervisor’s Forename:
Supervisor’s Surname:
Supervisor’s Post:
Supervisor’s Faculty/School and Department:
Supervisor’s Warwick e-mail address:
Supervisor’s daytime telephone number:
SECTION 3. SUMMARY OF SUBSTANTIAL AMENDMENT
Guidance notes for completing this section:
 Briefly summarise the main changes proposed in this amendment;
 Explain the purpose of the changes and their significance for the study;
 Highlight all amendments in the supporting document(s) so that they can easily be
identified.
What changes to the research design or methodology are proposed? (e.g. a changed
research strategy; the inclusion of a new group of participants/population; or an addition to
the content of the study in some way):
What specific ethical issues are raised by the changes, and how are they addressed:
What changes to the research team are proposed:
SECTION 4. DETAILS OF AMENDED DOCUMENTS SUBMITTED
Document Title
Version
Date
BSREC Application form for Ethical Approval of Substantial Amendment; version number: 02; version date: 23Feb16
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SECTION 5. SIGNATURES AND DECLARATIONS
5.1 RESEARCHER/APPLICANT
I undertake to abide by the University of Warwick’s Research Code of Practice in
undertaking this study.
I understand that I must not implement substantial amendments to a previously
approved study until I have received approval from the relevant Research Ethics
Committee of the University of Warwick.
I understand that any changes that I would like to make to this study after receiving
approval from BSREC must follow BSREC procedures as detailed on the BSREC web
pages.
Name of Researcher:
Signature: ……………………………………………………………………
Date:
NB: The applicant must post a signed copy of this form to: BSREC Administrator, A010, Medical School Building, Warwick
Medical School, University of Warwick, Coventry, CV4 7AL.
5.2 SUPERVISOR AUTHORISATION FOR STUDENT PROJECTS
I confirm that I have read this application and will be acting as the student researcher’s
supervisor for this amended project.
The amendment is viable and the student has the appropriate skills to undertake the
amended research.
I understand that substantial amendments to research and related projects with human
participants must not be implemented without approval from the relevant research
ethics committee of the University of Warwick.
Name of Supervisor:
Signature: ……………………………………………………………………
Date:
NB: An e-mail from the Academic Supervisor that states the above, in lieu of a wet ink signature on this form, may be sent to:
bsrec@warwick.ac.uk
BSREC Application form for Ethical Approval of Substantial Amendment; version number: 02; version date: 23Feb16
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