Research Governance and Ethics Committee (RGEC)
Application Form
Section A – Project Summary (to be completed for ALL projects)
1. Title of Project:
1.1 Is the project
a:
PhD/MD/ProfD/MPhil study
BSc/BA/MSc/MA study*
(please highlight or tick
box)
UG student project
Module 404 Individual
Research Project (IRP)
Clinical Elective Project
Staff Research
Other
1.2 Is the project a student research being conducted overseas?
Y/N
If yes, please ensure the researcher completes and submits an Overseas Travel Safety and
Security Risk Assessment (OTSSRA) Form, signed by their Supervisor, with this application and
completes the Section 2 (page 2) of this form.
1.3 *For student research projects please specify below the name of the course the student is
enrolled on:
1.4 Name of Principal Investigator / Supervisor:
School/Division:
Contact Details – Email:
Telephone:
1.5 Names of all Researchers/Students:
Contact Details – Email:
Telephone:
1
BSMS RGEC Application Form (July 2012)
This section to be completed for projects conducted overseas only:
2. Is this application for a self-generated project or an established project?
2.1 Is there ongoing ethical approval already in place for this project?
YES/NO
(If so please submit evidence with this application).
2.2 Name of Research Ethics Committee or other body which has approved this project:
2.3 Does this ethical approval cover the student’s involvement in this project?
2.4 Please describe the contribution of the student to the overarching project (in no more than
250 words):
2.5 Who will be Supervising the student in the field?
Name of the Field Supervisor:
Institution/Organisation:
Contact Details – Email:
2.6 What are the sponsorship and insurance arrangements for this project?
2
BSMS RGEC Application Form (July 2012)
To be completed for ALL projects:
(please do not omit or remove any of the following sections)
3. Does this project require NRES approval? *
Yes
No
* Please answer this question. If you are unsure please consult the NRES algorithm
www.nres.nhs.uk/applications/approval-requirements/ethical-review-requirements/ or contact Caroline
Brooks, BSMS Research Administrator, who will be able to advise you.
3.1 Proposed start date:
dd/mm/yyyy
Proposed completion date:
dd/mm/yyyy
3.2 Please indicate in the box below whether the request is for:
Sponsorship (for studies applying to
NRES for ethical approval)
Governance and Ethical Approval (for studies
proposed by University staff/students; studies
utilising BSMS premises; studies proposed by
BSMS staff/students taking place overseas)
Governance (for projects proposed by external personnel and reviewed by an external Ethics
Committee requesting permission to access BSMS staff/students for research purposes)
3.3 Please provide a summary of the project written in language accessible for a non-expert
audience (approximately 350 words)
3
BSMS RGEC Application Form (July 2012)
4
BSMS RGEC Application Form (July 2012)
Section A continued
4. Risk Assessment (Please tick or highlight the appropriate boxes)
Will the study involve:
Causing participants physical damage, harm or more than minimal pain
Yes
No
Manual handling of participants, vigorous physical exercise, or physical
activity from which there is a likelihood of accidents occurring?
Yes
No
Physiological interventions or procedures outside of standard practice These might include the administration of drugs or other substances;
taking bodily samples or human tissue (e.g. blood, saliva, biopsy or urine)
from participants; use of probes or other equipment to measure or
monitor bodily performance
Yes
No
Psychological interventions or procedures outside of standard practice These might include techniques such as hypnotherapy, psychometric
testing
Yes
No
Exposure of participants to hazardous or toxic materials, such as
radioactive materials
Yes
No
Inducing psychological stress, anxiety or humiliation
Yes
No
Questioning of participants regarding sensitive topics, such as beliefs,
painful reflections or traumas, experience of violence or abuse, illness,
sexual behaviour, illegal or political behaviour, or their gender or ethnic
status
Yes
No
Children under 16
Yes
No
Incapacitated adults and/or people with learning disabilities or mental
health problems
Yes
No
Groups where permission of a gatekeeper is normally required for access
to its members, for example specific patient groups, traditional
communities or school pupils?
Yes
No
Access to records of personal or confidential information?
Yes
No
Storage and analysis of tissue samples
Yes
No
Have you considered the possibility that your investigations might
uncover unexpected and possibly clinically relevant findings?
Yes
No
A heavily researched population e.g. BSMS students
Yes
No
Any other risk not identified above
Yes
No
4.1 If you have answered ‘Yes’ to any of the above questions please describe the
safeguards and monitoring procedure.
5
BSMS RGEC Application Form (July 2012)
Section B – Project Proposal and Protocol (to be completed for ALL projects)
Please complete the template below ensuring you answer all the questions
comprehensively. Your protocol should also be included in this template.
5. What is the purpose of this study? Please clearly state the aims of the study or hypothesis to
be tested.
6. What is the methodology?
7. What sort of participants will be involved? (i.e. how many, gender, ages)
7.1 If vulnerable and disadvantaged groups (i.e. children, incapacitated adults, populations in
low income countries) will be involved please give full details and outline the steps that will be
taken to protect them.
7.2 What are the inclusion/exclusion criteria?
7.3 Please state the rationale for your participant choice.
7.4 Please state the rationale for the number of participants to be recruited (please note it is
unethical to recruit either more, or less, participants than required to adequately power a study).
8. How will participants be identified and recruited?
Please specify all channels which you intend to use to advertise to potential participants. If
recruiting via email circulation lists, or University intranets, please be specific and state which
ones will be used, for e.g. University of Brighton “Uni Info” email circulation list.
9. What measures will be taken to ensure confidentiality, privacy and data protection?
Data should be secured against unauthorised access and comply with data protection
legislation. Where possible the data should be anonymised, where this is not possible
confidentiality should be maintained.
10. What is your procedure for obtaining informed consent? If it is not possible to obtain
informed consent, full reasons must be given.
6
BSMS RGEC Application Form (July 2012)
11. What are the risks to participants, and how will these be managed?
11.1 What are the risks to researchers, and how will these be managed?
12. Will participants be reimbursed for expenses or given any inducements?
If so, please give details.
13. How, where and when will the data be collected?
Please include a copy of any questionnaire that will be used, or sample questions (e.g. a topic
guide), in structured or semi-structured interviews.
14. What facilities will be needed and who will provide them?
15. How will the results be analysed and by whom?
16. What are the expected benefits of the research to participants or researchers?
17. What means of dissemination will be used?
17.1 What arrangements will be made for giving the participants access to the results?
17.2 What results/end points are to be measured/noted?
18. How will this project be funded?
List all sources of funds e.g. grants, commercial sponsorship, school’s funds etc.
19. Has the project been subjected to scientific or peer review and benefited from Patient and
Public Involvement (PPI) in the design where applicable? If ‘Yes’ please give details or submit
the report with this form.
20. Do any researchers have any financial interests in this research or its outcomes or any
relevant affiliations?
7
BSMS RGEC Application Form (July 2012)
If ‘Yes’ please give details and include an appropriate comment on the Participant Information
Sheet.
8
BSMS RGEC Application Form (July 2012)