RESEARCH ETHICS BOARD APPLICATION FORM FOR
PROSPECTIVE STUDIES INVOLVING MINIMAL RISK
(E.G.; SURVEYS, QUALITY OF LIFE QUESTIONNAIRES, NON-INVASIVE PROCEDURES)
Submit one copy of the application, protocol and applicable study documentation for review.
Please ensure that all questions are answered in full. Only complete applications will be accepted.
PROTOCOL TITLE:
PROTOCOL #
For office use only
PRIMARY CHEO SITE INVESTIGATOR
(ONE ONLY):
DIVISION OR PSU
TELEPHONE
EMAIL
My signature confirms that, as site investigator:

I assume full responsibility for the research as outlined in this application.

I will maintain copies of all pertinent information related to the research activities in this project, including
copies of the informed consent agreements obtained from all participants.

I will notify the REB of any developments in the project including an annual report, reports of adverse events,
reports of subject recruitment, reports of any study amendments, and a study termination report.

I will notify the REB if one of the investigators leaves the Hospital, the Research Institute, or the project. I will
also notify the REB if my contract with the study sponsor changes in any way.

If there is a signed contract agreement with the study sponsor, indicate if your access to the research data or right
to publish local results is limited in any way.
_____________________________________________________________________________________
_____________________________________________________________________________________
Primary CHEO Site investigator Signature:
Date:
NAME OF THE CHEO RESEARCH COORDINATOR:
NAME
DIVISION OR PSU
TELEPHONE
EMAIL
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Application Form - Prospective Study involving Minimal Risk – DECEMBER 2013
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PROSPECTIVE STUDIES INVOLVING MINIMAL RISK (E.G.; SURVEYS, QUALITY OF LIFE
QUESTIONNAIRES, NON-INVASIVE PROCEDURES) – CONT’D
FUNDING OR SPONSORING AGENCY:
Study both funded and initiated by an Industry (Pharmaceutical or other), specify company name and contact
information to be invoiced:
________________________________________________________________________________________
_________________________________________________________________________________________
A fee of $3,000.00 Canadian will be charged for the review (not approval) of any research project partially or fully
funded by private industry, and is applied whether the study is submitted to full Board or expedited review. Major
amendments will be charged an additional $500.00 Canadian each. Consideration will be made for exemption from
the review fee, on a case-by-case basis. Requests for an exemption must be made in writing to the Chair, CHEO
Research Ethics Board.
Study funded by CHEO Internal Cost Centre (either research or hospital-based)
Study funded by External Granting Agency: Please indicate name of agency: __________________________
Study will be carried out without additional expenditure.
SUMMARY OF RESEARCH PROTOCOL
Provide a synopsis and description of the ethical considerations as well as a brief description of the proposed
research (approximately one page) which includes the following information:
 Rationale and hypotheses
 Study design and methods
 Subject selection
 Specify the number of participants drawn from CHEO and other centres
 Delineate the outcomes to be measured and analyzed
 Anticipated benefits/harms and how these will be addressed
 Data fields (if any) to be abstracted from the patient’s health record. (Should not collect name, medical record
number and postal code should not be used, etc.)
Informed consent documents and any advertisement notices must be appended to the application.
LIST OF STUDY DOCUMENTATION SUBMITTED TO THE REB PERTAINING TO THIS SUBMISSION:
DOCUMENT
DATE
PROTOCOL
AMENDMENT
NUMBER
DOCUMENT
VERSION
NUMBER
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Application Form - Prospective Study involving Minimal Risk – DECEMBER 2013
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PRIVACY & CONFIDENTIALITY STATEMENT:
In the event that a breach in privacy occurs, the investigator must immediately notify the hospital’s privacy officer and
the REB.
In conducting research, the investigator agrees that the personal health information (PHI) collected in this study will not:
 Be used for future projects without prior approval of the Research Ethics Board.
 Be published in such a way that could reasonably allow others to identify the patient whose personal health information is
being researched.
 Be disclosed except as required or permitted by law.
General safeguards for the storage of research data:
Personal Health Information must not be released externally and should be stored securely at all times. Subject ID codes
based on name, medical record number and postal code should not be used. Variables that can be identifying of the person
either alone or in combination must similarly be avoided. Instead, subjects should be coded with a study number that is not
identifying of the individual. If needed, the hospital unique number can be linked to the study subject number in a separate
password-protected and encrypted document. This further decreases the risk of personal information becoming accessible should
the information be lost or stolen.
In addition, the following web link allows investigators to do a quick assessment of re-identification risk. The model underlying
this tool is based on an analysis of the Canadian census and was developed by Dr. Khaled El-Emam, Canada Research Chair in
Electronic Health Information. http://www.ehealthinformation.ca/rebwizard/ca
All research records pertaining to studies that fall under Health Canada Division 5 regulations should be retained for 25 years
after closure. All other studies should retain records for 5 to 7 years after the study closure, unless otherwise approved by the
REB. Long term electronically stored information should be verified or validated for accessibility and correctness every 2 to 3
years.
Information stored on mobile/portable devices:
Mobile devices (e.g., laptops, USB keys, PDAs) that contain study information should be stored securely. Study data stored on
these devices should be de-identified as much as possible. Electronic files stored on mobile devices should also be passwordprotected, and encrypted.
For additional information on the encryption and safeguarding personal health information, refer to the guidance issued by the
Ontario Information and Privacy Commissioner. http://www.ipc.on.ca/images/Resources/up-fact_12e.pdf
Data Sharing
If personal health information must be released externally, a data sharing agreement must be signed between the health
information custodian (Dr. Martin Osmond, CEO RI & scientific director; Vice-president Research, CHEO) and the external
investigators. A copy of the signed data sharing agreement should be submitted to the REB for our files. A sample Data
Sharing Agreement and Risk analysis is included on the CHEO RI Website. The REB recommends the template developed by
Dr. Khaled El-Emam from the Electronic Health Information Laboratory (eHIL). This template can be customized for use in
different contexts.
For clinical drugs trials, the terms of data sharing are generally specified in the contract with the Sponsor. These contractual
terms must be consistent with the conditions set out by the eHIL data sharing agreement.
For more information, consult the following relevant CHEO policies.
Investigators must comply with the following CHEO policies in conducting research:
Privacy and Confidentiality of Patient Personal Health Information
http://cheonet/data/1/rec_docs/12663_Admin_010_Privacy-Confidentiality_-June_15,_2010.doc
Access to and Disclosure of Patient Health Information
http://cheonet/data/1/rec_docs/3242_HREC%20067%20Access%20to%20and%20Disclosure%20of%20Patient%20Health%20I
nformation.doc
Acceptable Use of Information Systems
http://cheonet/data/1/rec_docs/12232_IS_153_Acceptable_use_of_information_systems.pdf
Access Control to Information Systems
http://cheonet/data/1/rec_docs/12233_IS_160_Access_Control_to_Information_Systems.doc
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Application Form - Prospective Study involving Minimal Risk – DECEMBER 2013
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PROSPECTIVE STUDIES INVOLVING MINIMAL RISK
(E.G.; SURVEYS, QUALITY OF LIFE QUESTIONNAIRES, NON-INVASIVE PROCEDURES) – CONT’D
RESOURCE IMPLICATIONS AND SCIENTIFIC MERIT OF PROJECT
If one of the individuals below is also an investigator in this project, the authorization of their next immediate
manager/director must be obtained. Investigators should provide resource managers with sufficient time to review the
protocols and the possible impact of the study on their service (outside of routine, clinical care).
For prospective studies involving minimal risk (e.g.; Surveys, Quality of Life Questionnaires, Non-Invasive
Testing/Procedures), the appropriate authorization from the Clinical Director or Director of Research Program
responsible for the staff or the clinical population is required.
An application will only be considered complete when all necessary authorizations have been obtained.
POSITION
PRINT NAME
SIGNATURE
TELEPHONE
DATE
Clinical
Director
Director of Research
Program
My signature above attests that I am satisfied that within the scope of my profession:
 The investigator is in good standing at the Children's Hospital of Eastern Ontario or CHEO Research Institute, and
that they have the credentials/expertise to conduct the research being proposed in this application
 Any clinical services provided through this research protocol meet minimal standards for the provision of care.
 The proposed research has sufficient quality and merit to warrant the implementation of this project.
SIGNATURES: Authorization must be obtained for all personnel directly or indirectly involved in the study
(i.e. Laboratory, Nursing, Biomedical Engineering and Allied Health).
POSITION
PRINT NAME
SIGNATURE
TELEPHONE
DATE
Director Biomedical
Engineering
(For Clinical Device Trials)
Other Resource Managers
(Please specify)
Other Resource Managers
(Please specify)
My signature above attests to the following:
My Department or Service has the resources (e.g.; materials, equipment, personnel and patient population) to support
this research.
Send to:
Mrs. Sharon Haig, Ethics Coordinator, Research Ethics Board
Children’s Hospital of Eastern Ontario
Room R1134, Research Institute 2
401 Smyth Road, Ottawa, Ontario, K1H 8L1
Telephone: (613) 737-7600, ext. 3272
This page must be included with your submission.
Application Form - Prospective Study involving Minimal Risk – DECEMBER 2013
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