Biomedical and Scientific Research Ethics Committee (BSREC):
Application Form for Research Ethical Approval
SECTION 1. APPLICANT DETAILS
1.1 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:
1.2 RESEARCHER’S CONTACT DETAILS
Warwick e-mail address:
Daytime telephone number:
Postal address:
1.3 SUPERVISOR (COMPLETE FOR ALL STUDENT PROJECTS)
BSREC Application Form for Ethical Approval; version number: 03; Version date: 23Feb16
1
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 2. PROJECT DETAILS
2.1 Project Title:
2.2 Estimated Start Date of Project:
2.3 Estimated Completion Date of Project:
2.4 Sponsoring Organisation:
(for University of Warwick staff and students,
undertaking non-commercial projects, this will be
the University of Warwick)
2.5 Funder:
(e.g. unfunded student project, unfunded
Departmental project, Medical Research Council
(MRC), Economic & Social Research Council
(ESRC), EU)
2.6 TYPE OF PROJECT
Is the project:
Primary Research
Research limited to the use of previously collected identifiable data
Research limited to the use of previously collected anonymised
data
Clinical Audit
Service evaluation or Development
Please specify:
2.7 LINKS WITH OTHER BSREC APPLICATIONS
Is the project linked to any other BSREC application? Yes
If yes, detail:
Project title:
Chief Investigator:
BSREC Reference (if known):
Nature of linkage:
2.8 LOCATION
BSREC Application Form for Ethical Approval; version number: 03; Version date: 23Feb16
2
Will any part of the project be undertaken overseas? Yes
State all of the locations at which the project will be undertaken, whether in the UK or overseas
e.g. public place, school (a), school (b) etc., in researcher’s office:
2.9 PARTICIPANTS
State the total number of planned participants:
BREAKDOWN OF PARTICIPANTS
Where applicable, state the breakdown of participants by type and number of each type of
participant, e.g. children, parents, teachers, etc.:
Type of Participant:
Number:
SECTION 3. RISK AND ETHICAL CONSIDERATIONS CHECKLIST
Complete the checklist ticking ‘Yes’ or ‘No’ to all questions.
Note that, where you have ticked ‘Yes’ to a question below, you will need to specifically address the
ethical issues raised by that point in the study protocol.
Yes
A
Does the study involve participants who are particularly vulnerable or unable
to give informed consent or in a dependent position (e.g. children, your own
students, over-researched groups, people with learning difficulties, people with
mental health problems, young offenders, people in care facilities, prisoners)?
B
Will participants be taking part in the study without their consent or knowledge at
the time, or will deception of any sort be involved (e.g. covert observation of
people in non-public places)?
C
Is there a risk that the highly sensitive nature of the subject might lead to
disclosures from the participant concerning their involvement in illegal activities
BSREC Application Form for Ethical Approval; version number: 03; Version date: 23Feb16
No
3
or other activities that represent a threat to themselves or others (e.g. sexual
activity, drug use, or professional misconduct)?
D
Could the study induce psychological distress or anxiety, or produce
humiliation, or cause harm, or lead to negative consequences beyond the
risks encountered in normal life?
E
Does the study involve substantial physical exertion?
F
Does the study involve the administration of any substance?
G
Does the study involve physically intrusive procedures, use of bodily
materials or human tissue, or DNA/RNA analysis?
H
Is any reward, apart from travelling and other expenses, to be given to
participants?
I
Does the study involve collaboration with any company or organisation
external to the University of Warwick?
J
Could the proposal give rise to researchers having any conflicts of interest?
K
Will the researchers go to any areas where their safety may be compromised?
L
Will pregnant women be participants in the study?
SECTION 4. SIGNATURES AND DECLARATIONS
4.1 RESEARCHER/APPLICANT
I undertake to abide by the University of Warwick’s Research Code of Practice in undertaking this
study.
I understand that BSREC grants ethical approval for projects, and that the seeking and obtaining
of all other necessary approvals and permissions prior to starting the project is my responsibility.
I understand that I must not begin research and related projects with human participants until I
have received full 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:
Send a signed copy of the form to the BSREC Administrator, A010, Medical School Building, Warwick Medical School, University of Warwick,
Coventry, CV4 7AL. bsrec@warwick.ac.uk
BSREC Application Form for Ethical Approval; version number: 03; Version date: 23Feb16
4
4.2 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 project.
The proposal is viable and the student has the appropriate skills to undertake the research.
Participant recruitment procedures, including the Information Leaflet(s) to be provided and the
process for obtaining informed consent, are appropriate, and the ethical issues arising from the
project have been addressed in the protocol.
I understand that BSREC grants ethical approval for projects, and that the seeking and obtaining
of all other necessary approvals and permissions prior to starting the project is the responsibility
of the student.
I understand that research and related projects with human participants must not commence
without full 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 signature on this form, may be sent to: bsrec@warwick.ac.uk
BSREC Application Form for Ethical Approval; version number: 03; Version date: 23Feb16
5