Fillable SMUREB Form1C May62019 (Saint Mary's University, Halifax)

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SMUREB Form1C May62019 (Saint Mary's University, Halifax)

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FOR OFFICE USE ONLY
SMU REB #:
DATE RECEIVED:
APPLICATION FOR ETHICS REVIEW OF RESEARCH INVOLVING HUMANS
Form 1 C- Faculty/Student/Staff Research Already Cleared at Another Canadian REB
REQUIREMENTS/GUIDANCE
Some research projects involving multiple locations or colleagues require multi-site ethics review. If you already have research ethics clearance from another
Canadian REB, submit all of the following documents along with the Form 1 C application (verus a Form 1):
1. A complete submission consists of 1 copy of the following documents:
(a) Signed original SMU REB Form 1 C by all SMU affiliated researchers,
(b) The Informed Consent Form/Script,
(c) The application form and all relating research documents (I.e.: surveys, questionnaires, scales, scripts, draft interview questions, invitation letters, letters of
support, feedback forms, debriefing forms, advertisements and other research tools as new, adapted or standardized instruments.)
2. The REB clearance certificate/letter issued by the other Canadian REB,
3. 1 copy of all corresponding material with the other Canadian REB. This involves all the communication between the Principal Investigator of the research and
the other Canadian REB Office and Chair. (Documentation of communication between the other Canadian REB Chair requesting clarifications, the Principal
Investigator's responsonses to the REB Chair, including all updated final research documents that were cleared.)
INSTRUCTIONS
This application form has been revised to facilitate the application and review process. It is designed to be completed electronically, please use the space
provided to provide the information requested. Please do not skip items, answer "n/a" if the question does not apply to your research, do not leave items blank.
SECTION A
GENERAL INFORMATION
Faculty
Student
Staff
(Choose one only)
2. Title of the Research:
3. Type of Research:
Choose one
4. (a) Start date:
Note: Engaging with participants (e.g., recruitment) is generally considered to be the beginning of the study.
(b) End date:
Note: The research is completed when all data has been collected from participants, no further contact will be made with them, and all data are recorded and
stored in accordance with the provisions of the approved application.
CONTACTS (Include all individuals who will have contact with participants and/or access to participant data.)
For Student research, begin with listing the Faculty Supervisor.
For Faculty and Staff research, begin with listing the Faculty/Staff Principal Investigator.
Role
Choose one
Name:
Institution:
Choose one
Institutional Status:
Choose one
Department:
Phone #:
Alternate Phone #:
Email:
Alternate Email:
Page 1 of 4
5.
Role
Choose one
Name:
Institution:
Choose one
Institutional Status:
Choose one
Department:
Phone #:
Alternate Phone #:
Email:
Alternate Email:
Role
Choose one
Name:
Institution:
Choose one
Institutional Status:
Choose one
Department:
Phone #:
Alternate Phone #:
Email:
Alternate Email:
Role
Choose one
Name:
Institution:
Choose one
Institutional Status:
Choose one
Department:
Phone #:
Alternate Phone #:
Email:
Alternate Email:
(Include additional members in "Additional Information" section.)
FUNDING
6.
Funded
Funding pending
Unfunded
Tri-Council Agency:
SSHRC
NSERC
CIHR
Internal (Specify):
Other (Specify):
Grant Number:
Grant Name:
Funding Period:
From: (dd/mmm/yyyy)
To: (dd/mmm/yyyy)
Grant title if different from Question 2:
Page 2 of 4
SECTION B
OTHER CANADIAN REB APPROVAL
7. Name of the other Canadian REB that has provided clearance:
8. Current REB clearance period (dd/mmm/yyyy - dd/mmm/yyyy):
From:
To:
File No.:
9. Required documentation checklist:
Ensure required documents are attached to your application. Applications that are missing required documents will not be reviewed.
copy of REB clearance certificate/letter
copy of clarifications requested from the REB (of the protocol, consenting process, other research study relating documents)
copy of answers provided by the Principal Investigator to the clarifications requested by the REB (of protocol, consent
process, other research study relating documents, etc.)
copy of final versions of all study related documents to be used by SMU researchers
Comments:
SCHOLARLY REVIEW
1. Please describe any scholarly review that this proposed research has been subjected to (if any).
ADDITIONAL INFORMATION:
Page 3 of 4
SECTION C
CERTIFICATION
My signature confirms the following responsibilities:
INITIAL RESEARCH ETHICS REVIEW CLEARANCE REQUIRMENTS:
I will ensure that all procedures performed under the project will be conducted in accordance with the SMU REB's approved protocol and consenting process, the
Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2, 2014) and all relevant Saint Mary's University, provincial, national and
international policies and regulations that govern research involving human participants. Recruitment of participants will not start until the SMU REB and
contract/agreement have been approved by the appropriate research institute official(s).
CONTINUING REVIEW REPORTING REQUIREMENTS:
ADVERSE EVENTS: I am familiar with the Policy on Adverse Events and will respond to such an event immediately and report it to the REB no later than one
business day.
MODIFICATIONS: Deviations from the initially approved protocol, that alter the risks to participants and are implemented without research ethics approval
constitute a violation of the TCPS 2 and Saint Mary's University Policy. Any deviations from the project as originally approved will be submitted as a Modification
to Previously Approved Project (Form 2) to the REB for approval prior to its implementation.
YEARLY RENEWAL: Research studies are approved for one year after which approval is automatically suspended. 30 days prior to expiry, I will submit an Annual
Renewal Request for Previously Approved Projects (Form 3) to the Office of Research Ethics to extend the research ethics approval if needed.
CLOSURE: I will notify the Office of Research Ethics when the study is completed by submitting a Completion of Research request (Form 5).
FUNDING: I will notify the Office of Research Ethics if/when funding circumstances for this study change so the Office of Research Ethics can clear the release of
my research funds.
CONTACT INFORMATION: I will notify the Office of Research Ethics if/when applicant contact information changes or new members are added to the research
team.
NON-COMPLIANCE: I understand that the REB is obligated to report and turn over any cases in which a research protocol does not hold a valid Certificate of
Ethical Acceptability/Continuation to the Dean of Graduate Studies and Research under the provision of the Saint Mary's University Policy on Integrity and
Research and Scholarship and Procedures for Reporting and Investigating Scholarly Misconduct.
SMU REB APPROVAL DOCUMENTS: I will retain a copy of the Certificate for Research Ethics Clearance/Continuation for Research Involving Humans for my
records.
FACULTY SUPERVISOR
I have reviewed and approve the scientific merit of the research and this ethics protocol submission and will review and approve all forthcoming requests to the
REB. I will provide the necessary training and supervision to the student investigator throughout the project. I will ensure that the level of risk inherent to the
project is managed by the level of research experience that the student investigator has combined with an extent of oversight that will be provided by me.
_____________________________
*Signature of Faculty Supervisor
(Type name)
Date (dd/mmm/yyyy)
PRINCIPAL INVESTIGATOR
_____________________________
*Signature of
Choose role
(Type name)
Date (dd/mmm/yyyy)
CO-INVESTIGATOR
_____________________________
*Signature of
Choose role
INSTRUCTIONS
Date (dd/mmm/yyyy)
_____________________________
*Signature of
Choose role
(Type name)
_____________________________
*Signature of
Choose role
(Type name)
Date (dd/mmm/yyyy)
Date (dd/mmm/yyyy)
_____________________________
*Signature of
Choose role
(Type name)
Date (dd/mmm/yyyy)
_____________________________
*Signature of
Choose role
(Type name)
Date (dd/mmm/yyyy)
* Original signature required
Page 4 of 4
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SMUREB Form1C May62019 (Saint Mary's University, Halifax)

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Completed 30 July 2020

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