Fillable SMUREB Form3 (St. Mary's University)

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SMUREB Form3 (St. Mary's University)

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FOR OFFICE USE ONLY
SMU REB #:
DATE RECEIVED:
ANNUAL RENEWAL REQUEST FORM
Form 3- Faculty/Student/Staff
Research ethics approval is valid for 1 year, followed by automatic suspension. If approval is not renewed on time, research activity
must cease immediately and will have implications for administration of funds and compliance with the REB and University Integrity
policy. No option exists for retroactive approval.
INSTRUCTIONS: Send request to ethics.continuingreview@smu.ca (only)
1) 30 days prior to the expiry date of the approval, please send Form 3 to ethics.continuingreview@smu.ca (only);
2) Requests involving student protocols must be submitted by the Faculty Supervisor;
3) Original signature is not required for electronic submissions;
4) All information requested is material to the ethics review. It is required that all fields be completed;
5) Incomplete submissions will not be processed and will be returned to sender.
1. TITLE OF RESEARCH PROJECT
a) SMU REB File #:
Choose one
Type of Research:
Choose one
b) Title of Research:
c) Original Approval Date:
From: (dd/mmm/yyyy)
To: (dd/mmm/yyyy)
d) Last Approval Period:
From: (dd/mmm/yyyy)
To: (dd/mmm/yyyy)
e) Have there been any unreported changes to the study protocol, consent process or supporting
documents since the most recent (original, modification or annual renewal) approval?
Yes
No
If yes, submit a MODIFICATION REQUEST FORM Form 2 along this request. Revised procedures may not be used until approval is confirmed.
2. FUNDING STATUS*
a)
Funded
Funding pending
Unfunded
b)
NSERC
Tri-Council Agency:
SSHRC
CIHR
c)
Internal (Specify):
d)
Other (Specify):
e)
Grant Number:
f)
Grant Name:
To: (dd/mmm/yyyy)
g)
Funding Period:
From: (dd/mmm/yyyy)
N/A
h)
Grant title if different from Question 2:
Page 1 of 5
* All fields relating to funding must be filled out so the REB can grant the necessary permission to release the research funds upon approval.
Any changes to funding must be reported to the REB.
3. INVESTIGATOR CONTACTS
For Student research, begin with listing the Faculty Supervisor. For Faculty and Staff research, begin with listing the Faculty/Staff Principal Investigator.
a)
Role
Choose one
Name:
Institution:
Choose one
Institutional Status:
Choose one
Department:
Phone #:
Alternate Phone #:
Email:
Alternate Email:
b)
Role
Choose one
Name:
Institution:
Choose one
Institutional Status:
Choose one
Department:
Phone #:
Alternate Phone #:
Email:
Alternate Email:
c)
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 at the end of the form.
Yes
d) Have there been any changes in research personnel who interact with participants and/or
have access to personal data?
No
4. STUDY STATUS
a) When did recruitment begin?
(dd-mmm-yyyy)
b) What is the anticipated date of completion for this study, if available?
(dd-mmm-yyyy)
c) What is the current status of the study? Please elaborate. (i.e., no recruitment has occured yet at this time,
participants are currently being recruited, are actively participating, research participant involvement has been
completed, the study is in between phases, on hold, final analysis is in progress, the study involves secondary data
analysis only.)
Page 2 of 5
5. PARTICIPANTS
d) Number of participants recruited for the study:
e) Number of participants yet to be recruited for the study:
f) Number of participants currently in the study:
g) Number of participants completed the study:
h) Number of participants voluntarily withdrawn from the study, and provide the reasons for withdrawal:
i) Number of participants the researcher withdrew from the study, and provide the reason for withdrawal:
j) Have there been any participant complaints of feedback about the research from
participants? If yes, please describe.
Yes
No
k) Since original approval, have any participants experienced any adverse events as a result of
their participation in the study?
Yes
No
If there have been adverse events, please describe these in detail and how the situations were resolved.
N/A
l) If there have been adverse events, what procedures/safeguards are now in place to protect the
participants from these risks?
N/A
Page 3 of 5
m) Is there any new information available about the study that needs to be communicated to
participants? As well, would such new information change the rationale or the risk/benefit ratio for
this study?
Yes
No
n) Throughout the course of this study and/or arising from direct interaction with your participants,
have there been any indicators to show ways in which potential benefits to participants could be
increased? If yes, please describe.
Yes
No
o) Since the last approval, have there been any changes in the conflict of interest information
provided to the REB? If yes, please describe.
Yes
No
p) Since the last REB approval, have there been any changes to how or where personally
identifiable information will be collected/protected/managed and/or disseminated?
Yes
No
N/A
6. ADDITIONAL INFORMATION
Page 4 of 5
7. AGREEMENT
I have read the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2), Saint Mary's University
REB Procedures for Completing Requests for Ethics Review and the Senate Policy on Ethical Conduct for Research Involving
Humans and agree to comply with the policies and procedures outlined therein. In the case of student research, as faculty
supervisor, my signature indicates that I have read and approved the request, deem the project scientifically valid and agree to
provide continuing and thorough supervision of the student(s). 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 and that the research will be conducted in accordance with the SMU REB's appoved protocol, and consenting process.
FACULTY SUPERVISOR
_____________________________
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
(Type name)
Date (dd/mmm/yyyy)
_____________________________
Signature of
Choose role
(Type name)
Date (dd/mmm/yyyy)
_____________________________
Signature of
Choose role
(Type name)
Date (dd/mmm/yyyy)
_____________________________
Signature of
Choose role
(Type name)
Date (dd/mmm/yyyy)
Page 5 of 5
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Completed 21 July 2020

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