January 2014
General Application for Research Ethics Review
Forward 1 copy of the checklist and application, the consent form, if applicable and any
other documents (questionnaires, scripts, etc.) for screening to the Ethics Office via email to
[email protected]
When the application is accepted for review, the review committee requires 15 copies of the
application and attachments. Double sided printing is preferred; please ensure that
application packages are provided as an individual complete set containing a copy of each
document to be reviewed. Ethics Office staff will not assume responsibility for assembling
application packages. Send the hard copies to:
Ethics Office
Health Research Ethics Authority
Suite 200, 95 Bonaventure Avenue
St. John’s, NL
A1B 2X5
Phone: 709-777-6974
Fax: 709-777-8776
A schedule of submission timelines and the meeting dates of the HREB is posted on the
HREB website: www.hrea.ca
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January 2014
Application to the Health Research Ethics Board (HREB)
General Research
The application timelines and process
A schedule of submission timelines and the meeting dates is posted on the HREA web site at http://www.hrea.ca
One copy of the application form and consent form (if applicable) are to be submitted not later than noon on Wednesday two weeks prior to
the HREB meeting to be considered for review. Electronic submissions are preferred but faxed or hard copies will be accepted. An
electronic submission is to be sent directly to [email protected]; faxed copies should be sent to 709-777-8776 and mailed copies
to the address below. New applications will be acknowledged and assigned an HREB Reference Number. All correspondence from this
point should reference the assigned number. Applications will be screened by the Ethics Office . You will be advised via email if modifications
to the application are required and provided direction regarding submission of your application package. Final approval will not be granted
until all documentation is received.
1. Full committee review will require the following application package
ONE electronic version and ONE paper copy of the following documents:

Research proposal/protocol

If you intend to use one of the commonly used questionnaires listed on the HREA web site, please provide the title of the
questionnaire on the HREB application and submit one copy only; this copy will be given to the primary reviewer.
ONE electronic version and 15 paper copies of the following documents in collated sets to include:

Application form (one signed copy; electronic signatures are accepted)

Budget (if applicable)

Consent forms (if applicable) with a completed checklist (Please date the version submitted)

Advertisements for recruitment (if applicable) (Please date the version submitted)

Telephone scripts (if applicable) (Please date the version submitted)

Study- specific questionnaires, surveys etc(if applicable) (Please date the version submitted)
When submitting 15 copies -double sided printing is preferred; and please ensures that application packages are provided as an individual
complete set containing a copy of each document for review. Staff of the Ethics Office will not assume responsibility for assembling
application packages.
2. Expedited/Delegated Review will require the following application package
ONE electronic version and 1 paper copy of the following documents including:

Research proposal/protocol

Application form (one signed copy; electronic signatures are accepted)

Budget (if applicable)

Consent forms (if applicable) (Please date the version submitted)

Advertisements for recruitment (if applicable) (Please date the version submitted)

Telephone scripts (if applicable) (Please date the version submitted)

Study specific questionnaires, surveys etc (if applicable) (Please date the version submitted)
If you intend to use one of the commonly used questionnaires listed on the HREA web site, please provide the title of the
questionnaire on the HREA application and submit one copy only; this copy will be given to the primary reviewer
Applications must be submitted directly to [email protected] and hard copies forwarded to
Ethics Office
Health Research Ethics Authority
Suite 200, 2nd Floor, Bonaventure Place
95 Bonaventure Avenue
St. John's, NL, A1B 2X5
T: 709-777-6974
F: 709-777-8776
www.hrea.ca
Applications not meeting the above requirements will not be accepted for review by the committee
Please remove this instruction sheet from your application before submitting to HREA
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January 2014
HEALTH RESEARCH ETHICS BOARD
General Application Form
One copy of the completed checklist must be attached to each copy of your application
Title of proposal: (insert title here)
To ensure assignment of your application to the appropriate reviewer, please check ALL of the following
that apply to your research :
quantitative
qualitative
genetics
CHECKLIST .
Please ensure all items are checked
YES
The latest version of the application form has been used. (January 2014)
All questions have been answered in the number of lines allowed (‘See attached’ is not acceptable)
One copy of the application is signed by Principal Investigator (electronic signature is acceptable)
One electronic copy of the application package has been sent to [email protected]
One copy of the full research proposal/protocol is submitted
One copy of the TCPS Tutorial Certificate of Completion if a first time applicant
One copy of a current curriculum vitae for the principal investigator if a first time applicant
A copy of the consent document, if applicable, is attached to each copy of the application
A copy of study specific questionnaires, chart audit forms, surveys, recruitment advertisements,
covering letters etc. are attached to each copy of the application. Only one copy of standard
questionnaires (EROTC, SF36 et al.) is required.
A copy of the budget is attached to each copy of the application
This project includes a genetics component
The Addendum for DNA/tissue Consent is included, if relevant
Secondary use of data/tissue: One copy of the data./tissue request letter listing all variables requested
from the data custodian. If the study involves only health records, a pre-existing dataset or archived
specimens, please submit your application on the ‘Secondary Use of Data/Chart Audit Application
Form’.
Storage of Tissue form included if relevant
This is a student project - undergraduate, graduate, postgraduate
The Guidelines for Completing Applications and the Guidelines for Preparation of a Standard Consent
Form have been read
The consent form has been assessed at a reading level of ______________ (must be less than grade 9
I assume full responsibility for this research study and verify that the information provided in this
application is accurate and complete.
Printed name of Principal Investigator
Signature of Principal Investigator
Date
Printed name of Academic Supervisor
Signature of Academic Supervisor
Date
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January 2014
HEALTH RESEARCH ETHICS BOARD
General Application Form
A. Personnel, Timeline and Setting
1.
Investigators, Research Staff and Sponsor Information:

Principal Investigator:
Last Name
First Name
Title (Dr./ Mr./ Ms.)
Affiliation of Principal Investigator
[ ]
Faculty
[ ]
Employee of a Health Authority
[ ] Eastern Health
[ ] Western Health
[ ] Central Health
[ ] Labrador Grenfell Health
[ ]
Undergraduate, graduate, postgraduate student
[ ]
Community researcher

Information for Principal Investigator and Key Contact Person if not PI
Principal Investigator
Complete mailing address:
Key Contact Persons [if applicable]
Complete mailing address:
Telephone number:
Fax number:
Pager number:
Email address:
Telephone number:
Fax number:
Pager number:
Email address:

Supervisor: (if relevant)
Address:
Telephone Number:
Email:

Research Coordinator (if relevant):
Address:
Telephone Number:
Email:
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January 2014

Funding provided by (if relevant):
Address:
Telephone Number:
Email:
2.
3.



4.
Title of study

Title:


Protocol number (if relevant):
Date of protocol (if relevant):
See HREB website for protocol template
Study timeline:
Anticipated completion date:
Deadline for ethics approval: M/D/Y
Indicate below if:
[ ] course project
Setting of study and data sources:

Setting – Please list the institutions, organizations and/or communities involved (e.g. Eastern HealthJaneway Hospital; Western Health-Sir Thomas Roddick Hospital; NL Diabetes Association; Twillingate;
Grand Falls)

Check relevant data sources:
Primary sources:
[ ] Patients
[ ] Health providers
[ ] Residents in the community
Secondary sources (If using only secondary sources, please use the Secondary Use of Data/Chart Audit
Application)
[ ] Health records
[ ] Pre-existing dataset
[ ] Archived specimens
Please give name/s and location of data custodian/s:
[ ] Other: [please specify]
If using data previously collected for another purpose (secondary use of data) copies of the letter requesting
information which describes in detail the information sought (list of variables, etc..) must be attached to the
application.
B. Objectives, Background, Implementation, Analysis of Study
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January 2014
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 including the rationale for the study and a brief summary of previous
work in this area in no more than 20 lines. :
7.
Blood or other biological samples: collection and use
Not Applicable [ ]

List the samples, blood and other biological tissues, to be used in the study, the frequency of sampling and
the amount of sample.

Will any samples now archived by a health care institution be used in the study? [ ] Yes
If yes, please attach
A copy of your letter requesting access
[ ] No
Will any samples be sent outside the province?
[ ] Yes [ ] No
If yes, please explain. (See Section 13 of the HREB Policy Manual at www.hrea.ca)
8.

Blood or other biological samples: retention and storage.
Not Applicable [ ]
Will any blood or other biological samples be kept after completion of the study? [ ] Yes [ ] No
If yes,




Why are the samples being retained? What specific research question is being addressed?
You must include in the consent form information about future uses (e.g. cancer research,
research on respiratory disease); unspecified ‘future research’ is not acceptable
For how long will sample be kept?
Where are the samples being stored?

Please name the data custodian
_________________________
 Can samples be withdrawn?
[ ] Yes
[If yes, please describe the process for withdrawal]
9.
[ ] No
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. Include copies of each with each copy of the application; if standard
questionnaires are being used – SF36, EROTC, etc. [see list on HREB website] include one copy only.
10.
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 participant will be asked to do. Attach one copy of the protocol.
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January 2014
11.
Sample size:
Quantitative studies: Give the basis – power, alpha, difference to be detected, etc., for the choice of sample size
(See guidelines).
Qualitative studies:
Give the rationale for the number of participants to be included in the study.
C. Participants
12.
Participants:
[
[
[
[
[
]
]
]
]
]
Adults
Children under 18
Pregnant women
Persons incompetent to give consent
Protected or vulnerable populations. Please specify.
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:
Is this a part of a national/international study?
[ ] Yes
 If yes, what is the total number of participants at all sites.
 If yes, where is the main study site?
[ ] No
D. Protection of Privacy: recruitment, consent, safeguards, retention of data
Adherence to privacy legislation and policy requires the researcher’s attention to the collection, access,
storage, disclosure of information and its retention and destruction. Please see the Application Guidelines
13.
Recruitment and first contact
[Normally, first contact should be made by a person known to the potential participant. See Application
Guidelines]



Please describe in detail the means you will use to identify eligible participants.
Will contact be made with potential participants?
[ ] Yes
[ ] No[
If yes, who will make the first contact to provide information about the study?

Please specify the means of contact [check all that apply]
[ ] in person
[ ] letter
[ ] telephone
[ ] advertisement
[ ] poster
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January 2014
[ ] other, please specify:
[Copies of letters, telephone scripts, ads, posters must be attached to each copy of the application]
*Reminder: If the study involves only health records, a pre-existing dataset or archived specimens,
please submit your application on the ‘Secondary Use of Data/Chart Audit Application Form’.
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Consent process:
Special consideration is required if the study involves children, incompetent persons, or persons in protected or
vulnerable populations. If applicable, describe in detail how proxy, parental and/or community consent will be
obtained. See HREB Guidelines for Consent at www.hrea.ca
The Principal Investigator is the person ultimately responsible for the consent process.

Who will obtain the consent?

Explain, in detail – setting, timing, person approaching and persons to be approached - the procedure you will
use to obtain consent.

Describe the potential risks, discomforts and inconveniences for the participant
Risks:
Discomforts:
Inconveniences:
[In the case of experimental studies, potential participants must understand that comparison interventions are
considered to be in equipoise and no benefits to an individual or group can be guaranteed.]
15.
Safeguards for participant confidentiality and information
The protection of the privacy and confidentiality of all research participants and their information is the
responsibility of all members of the research team. This pertains to any personal health information
collected from identified participants or their records.
Any chart/record review requiring identifiers linked with 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 full HREB.
The following privacy protections are recommended. Please check those currently in place for this study. If you
are planning exceptions for these protections please provide, in detail, the rationale for this decision.
Organizational safeguards that will be the responsibility of the Principal Investigator:
[ ] All members of the research team will be briefed on their responsibility for privacy protection
[ ] All members of the research team will sign an oath of confidentiality
[ ] As a general principle, no names, addresses, telephone numbers will be recorded on paper or
requested in datafiles
[ ] Any data-sharing agreements between the researcher and other researchers and/or institutions will be
signed prior to providing or obtaining access to data
[ ] Consequences for breach of confidentiality will be clearly stipulated to the research team
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January 2014
Technological safeguards:
[ ] All computer files pertaining to the study will be password protected
Physical safeguards:
[ ] All paper abstract forms and printouts of electronic files will be kept in secure storage – limited number
of storage areas, limited access rooms, locked filing cabinets
List below the names of ALL members of the research team who will know the identities associated with the
information collected from/about participants:
16.
Retention of data:
How long will the data be stored?
Where will the data be stored? Give exact location:
Who will be the data custodian?
Name:
Contact information:
List any identifiers – name, postal code, study code, to be retained and give the rationale for retention.
NOTE for researchers affiliated with MUN: Memorial University requires the retention of data for a period of five years after the
date of publication of research findings.
E. Dissemination of Results, Publication. Reimbursements, Payments, Budget,
Potential Conflict of Interest
17.

18.
Dissemination of research results:
Explain the plan for sharing research results with participant, relevant agencies or communities and the
research community:
Reimbursements/Payments/Honoraria/Lottery Opportunity :

Do you intend to reimburse participants for expenses incurred?
For what expenses?
[ ] Yes [ ] No

Will there be any payment for referral of patient participants?
[ ] Yes [ ] No
Amount per patient: $

Do you intend to provide a gift, honorarium, lottery opportunity to participants?
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[ ] yes[ ] No
January 2014
If yes, please describe.
At what point in the study would this be offered?
19.
Budget:
Not Applicable [ ]
Please attach a copy of the budget to each application including the source of funding

Source of funding:

For MUN faculty only:
Will the budget be administered through the University Finance Office?[ ] Yes
20.
[ ] No
Potential conflict of interest:

Does any investigator have direct or indirect financial interests in any device, drug, and/or intervention being
used in this study?
[ ] Yes
[ ] No

Does any investigator function as an advisor, employee, officer, director or consultant for the funder/s?
[ ] Yes
[ ] No

Will any investigator receive an honorarium or other benefits from the funder/s (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.
21.

Publication :
The investigator must be free to publish within 6 months after submitting the manuscript to the
sponsor for review. Publication of the full study must be assumed no longer than 1 year after the
completion of the study.
NOTE: Additional Requirements
The use of personnel and/or resources of any Health Authority or health care institution or health agency
in NL requires approval of that institution, authority or agency. The Principal Investigator is responsible
for obtaining these approvals.
I request the Health Research Ethics Board (HREB) to act as the research ethics board of record for the above study. I will:



Conduct the study according to applicable laws, regulations and guidelines
Conduct the study consistent with applicable ethical norms
Conduct the study according to the approved protocol and consent form/s
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January 2014





Accept the authority of, and abide by, the decisions of the HREB as the board of record
Comply with HREB requirements, including timely filing of documents as required by the HREB and provide access
to study documents for any random or for cause monitoring by the HREA
Ensure there will be no changes to the research without prior HREB review and approval, except where necessary to
eliminate an immediate hazard to subjects
Report immediately to the HREB any unanticipated problems in the research, significant deviations from the study
protocol, or changes increasing the risk to subjects or affecting significantly the conduct of the study.
Report promptly to the HREB all adverse reactions that are both serious and unexpected and new information that
may affect the participants’ willingness to participate in the research
I assume full responsibility for this research study and verify that the information provided in this application is
accurate and complete.
_______________________________________
Printed name of Principal Investigator
_______________________________________
Signature of Principal Investigator
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