RESEARCH PROPOSAL APPLICATION
WESTERN HEALTH
General Application
Please attach completed checklist with each copy of your application. Please ensure all
items are marked either X or NA.
Short title of proposal:
______________________________________________
[
]
Student project – undergraduate, graduate, postgraduate
[ ] All questions have been answered in the space provided on the form or in the
number
of lines allowed (See attached is not acceptable)
[
]
There are 7 copies of the application
[
]
Each copy of the application is signed by applicant
[
]
Copies of the budget are attached to each copy of the application
[
]
Questionnaires, chart audit forms, covering letters are attached to each copy of the
application.
[ ] One copy of full protocol with signature of local investigator, is attached (if
relevant)
[
]
Consent document is attached to each copy of application
[ ] Consent has been assessed at a reading level of ______ (must be less than
grade 6).
I have verified that the above information is correct:
Printed name of Principal Investigator:
Signature of Principal Investigator:
WESTERN HEALTH RESEARCH ETHICS BOARD
General Application Form
Please complete the application in bold or a font which can be easily distinguished from
the application form.
Forward 7 copies of the checklist, application, budget, consent form and any other
documents (questionnaires, scripts, etc.) for review by the Western Health Research
Ethics Board to the Regional Research Coordinator/Planner, Western Health, Western
Memorial Health Clinic, P.O. Box 2005, A2H 6J7, Phone: 634-4306. All documents
must be received at least two weeks prior to the meeting date. The REB meets the first
Wednesday of every month.
A. Personnel, Timeline and Setting
1.

Investigators, Research Staff and Sponsor Information:
Principal Investigator:
Last Name
(Dr./Mr./Ms.)
[
[
[
[

First Name
Title
]
Faculty
]
Employee of Western Health
]
Undergraduate, graduate, postgraduate student- Supervisor:
________________
]
Other: [please specify]
Mailing Address:
Internal:
Department
Site
OR
External:
Street # and Name
P.O. Box
City / Town
Postal Code

Telephone Number:

Fax Number:

Pager Number:

Email Address:

Co-investigators:

Local contact (name and contact information) if principal investigator is external:

Supervisor:
Address:
Telephone Number:
Email:

Study Coordinator (if relevant):
Address:
Telephone Number:
Email:

Funding provided by (if relevant):
Address:
Telephone Number:
Email:
2.
3.

Title of study

Title:


Assigned Protocol number by REB ( if relevant):
Date of protocol (if relevant):
Study timeline:
Proposed start date [at least 2 months from date of submission]:
M/D/Y

Anticipated completion date: M/D/Y
Indicate below if:
[ ] course project
4.
Setting of study and data sources:

Setting – Please specify the institutions and/or communities involved:
(e.g. Sir Wilfred Grenfell College, Bonne Bay Health Centre, Burgeo, etc)

Check relevant data sources:
(a) Patients [ ]
(b) Health providers [ ]
(c) Health records [ ]
(d) Pre-existing Dataset [ ] [Please give name of data holder with contact
information]:
(e) Residents in Community [ ]
(f) Other: [please specify]
B. Objectives, Background, Implementation, Analysis of Study
5.
Objectives:
Provide a numbered list of the main research objectives of the study in plain language
[no more than 15 lines]
6.
Introduction to the study:
Please answer the following in no more than 20 lines.
 What previous work has been done in this area?
 What is the rationale for this study?
 Why are you doing this study?
 Why is this research important?
 What contributions could it make?
7.
Research interventions and/or modes of data collection:

List any interventions which would not be part of a participant’s daily life.

List questionnaires, information sheets, covering letters, telephone or face to face
interview scripts/outlines or chart audit forms to be used
8.
Description of study:
Give a brief description of the study, including interventions and outcome measures in
plain language [no more than 20 lines]. Describe briefly what the patient will be asked
to do.
9.
Sample size: [if measuring statistical differences/equivalencies]
Give the basis – power, alpha, difference to be detected, etc., for the choice of sample
size (See guidelines).
C. Participants, Consent, Protection of Privacy
10.
Participants:
[
[
[
[
] Adults
] Children under 19
] Persons incompetent to give consent
] vulnerable populations
If including children, incompetent adults or persons in protected or vulnerable
populations, please justify their inclusion in the research study.



Number of participants at this site:
Will pregnant women be excluded?
[ ] Yes
Is this a part of a national/international study?
[ ] Yes
 If yes, what is the total number of participants at all sites.
[ ] No
[ ] No



If yes, where is the main study site?
Will contact be made with potential participants?
No
Only records will be accessed
No
[ ] Yes
[ ]
[ ] Yes
[ ]
[Please specify the means of contact – letter, telephone, advertisement, etc.]

If yes, who will make the first contact to provide information about the study?
[
[
[
11.
] Attending physician
] Investigator
] Other: [Please specify]
Consent process:

Who will obtain the consent?

Explain the procedure you will use to obtain consent.

How will the research team ensure ongoing consent?
13.

14.

Risks, discomforts and inconveniences:
What risks, discomforts or inconveniences are involved?
Benefits:
Are there any immediate benefits for participants, including controls?
15.
Privacy and confidentiality:
Any chart/record review requiring identifiers linked to personal health information
OR requiring subsequent transfer of information to persons outside the research
team OR requiring subsequent record linkage will require review by the REB.
The following privacy protections are required by REB:
 No names, addresses, telephone numbers are recorded on paper or requested in
data files.
 All members of the research team have signed an oath of confidentiality
 All paper abstract forms and printouts of electronic files are kept in secure
storage
 All computer files pertaining to the study are password protected.
List below the names of all personnel who can access the identities associated with the
personal health information being collected about study participants:
D. Dissemination of Results, Payment, Budget, Conflict of Interest,
Disposition of Data
16.
Dissemination of research results:
Explain the plan for sharing research results with participants, relevant agencies or
communities and the research community.
17.

Payments:
Do you intend to reimburse participants for expenses incurred?[ ] Yes
[ ] No
o For what expenses?
o Explain how this will be handled by the research team.
o Will there be any payment to clinical investigators for referral of patients:
[ ] Yes
[ ] No
Amount per patient: $
18.
Budget:
Not Applicable [ ]
Please attach a copy of the budget to each application including the source of funding

19.
Source of funding:
Potential conflict of interest:

Does any investigator have direct or indirect financial interests in any device, drug,
intervention being using in this study?
[ ] Yes
[ ] No

Does any investigator function as an advisor, employee, officer, director or consultant
for any funder?
[ ] Yes
[ ] No

Will any investigator receive an honorarium or other benefits from any funder (apart
from fees for service)? indirect financial or other benefit?
[ ] Yes
[ ] No
If the answer is yes to any of the above questions, please describe and explain how that
conflict is being managed to ensure participant rights and welfare are not affected.
20.

Ownership, storage and destruction of data:
Western Health requires the retention of study data for a period of five years
after the date of the publication of research findings. Please indicate below the
intended storage and whether the destruction of the data and material will take
place after the study.
(a)
(b)
(c)
(d)
Please give the anticipated date of destruction:
In what form/s will the data be retained, e.g., frozen samples, computer
tapes, paper?
Where will the data be stored? Give the exact location.
Who will be the data guardian?
Contact information:

Will any form of identifier –e.g. name, postal code, study code, be retained?[ ]Yes[
]No

If yes, please describe the identifiers to be retained and give the rationale for their
retention.
E. Requirement for Other Approvals, Signatures
21.
Concurrent submissions or approvals:
Has this proposal been submitted to another REB?
[
] Yes [
If already approved, please include one copy of approval/s
Signature of Principal Investigator:
Date:
Signature of undergraduate/graduate/postgraduate student (if applicable):
Signature of supervisor:
______________________________________________
] No