My signature confirms the following responsibilities:
PRE RESEARCH ETHICS APPROVAL 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, 2010) 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).
POST RESEARCH ETHICS APPROVAL 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
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 Senate 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: Protocols are approved for one year after which approval is 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
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 of Ethical Acceptability/Continuation for Research Involving Humans for my records.
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
* Original signature required