Signature Page –Prospective Minimal RiskApplication

Title of Research Study:
Primary CHEO Site Investigator
My signature below indicates that:
General Conduct
  • I am responsible for complying with the decisions and responsibilities set out by the REB. In addition, I am responsible for complying with all applicable regulations
  • I will personally conduct or supervise the described investigation(s)
  • I and any research staff are appropriately qualified by education, training and experience to assume responsibility for the proper conduct of the research and for protection of human research participants
  • I have the adequate resources to properly conduct the research and conducts the research following written SOPs
  • I will obtain REB approval before engaging in research involving human participants
  • I have signed all necessary documentation, as applicable,
  • I will comply with the institutional privacy and confidentiality conditions
  • I will advise the REB and appropriate organizational officials immediately if mine or members of the research team’s medical license or hospital privileges are suspended, restricted or revoked and/or our qualifications otherwise no longer be appropriate
  • I will ensure that the personal health information collected in this study will:
  • Be encoded in a way that would not be identifying of the individual. Codes based on name, medical record number and postal code are not permitted. Variables that can be identifying of the person either alone or in combination will similarly be avoided.
  • Be stored securely in locked areas and access will be restricted to the names listed above. Any personal health information that leaves the site for any reason will be de-identified, password-protected and encrypted. Data will be destroyed at the conclusion of the study,
  • Not be used to contact or attempt to contact patients whose personal information is being researched unless the patients’ express written consent is obtained first,
  • Not be published in a way that could reasonably allow others to identify the patient whose personal health information is being researched,
  • Immediately notify the REB in writing if the investigator becomes aware of any breach of confidentiality or security,
  • Be disclosed except as required or permitted by law.
Conflict of Interest
  • I have declared all real, potential, or perceived conflicts of interest at the time of the initial application, and as they arise

Primary CHEO Site Investigator continued…
My signature below indicates that:
Research Ethics Requirements
  • I or my research staff will secure informed consent from participants when required, using the most current informed consent document(s) approved by the REB (as applicable)
  • I will conduct the research in compliance with the approved research and applicable reporting criteria will be followed (i.e., deviations, serious, unexpected adverse events and privacy breaches, unexpected finding or new research that could affect the risk/benefit ratio of the research)
  • I will ensure that no changes in the approved research will be initiated without REB review and approval, except where necessary to eliminate an immediate hazard(s) to the participant(s)
  • I will ensure that accurate and complete records are maintained
Initial Application
  • I have answered the questions and completed the application form, and take responsibility for the content of the application form and applicable study documentation.
Ongoing/Continuing Review Requirements
  • I will file an annual renewal report, or more frequent reports if required by the REB, and it will be submitted prior to the expiration of REB approval,
  • I will advise the REB of any changes in Researchers
  • I will report to the REB any premature termination or suspension of the research
  • I will notify the Board when the research is complete.

P.I Print Name: / Signature: / Date:
Secondary CHEO Co-Investigator(s)
My signature below attests to the following:
  • I have read the research protocol and agree to conductthe research project as described in this application.

Name
/ Division Or PSU / Telephone / Email
1.
Signature:
2.
Signature:
3.
Signature:
4.
Signature:
Research Coordinator(s)
My signature below attests to the following:
  • I have read the research protocol and agree to conductthe research project as described in this application.

Name
/ Division Or PSU / Telephone / Email
1.
Signature:
Authorizations to conduct research
If one of the individuals below is also an investigator on this project, the authorization of the next immediate manager/director/supervisor within the authority gradientmust be obtained.
Investigators should provide signatories sufficient time to review the protocols An application will only be considered complete when all necessary authorizations have been obtained.
Resource Implications of the Research Project
My signature below attests to the following:
  • My Department or Service has the resources (e.g.; materials, equipment, personnel, space, and patient population) to support this research.
  • The application is considered to be feasible and appropriate.

Position / Print Name / Signature / Telephone / Date
Patient Service Unit (PSU)
Operations Director
Clinical or Program Director
(as applicable)

N.B.: If for any reason you wish to revoke your authorization of the submission, please notify the researcher and the REB.
Cont’d

Authorizations from
Division Headand (as applicable) director of research
My signature below attests that I am satisfied that:
  • The investigator has the relevant training and experience to conduct the research. I have reviewed a current version of the investigator’s CV.
  • The investigator has the appropriate credentials to conduct the research; including, as appropriate, a valid licence with the relevant RHPA College.
  • The investigator-physician maintains active admitting privileges (as appropriate)
  • Any clinical service provided through this research meets minimal standards for the provision of care.

Position / Print Name / Signature / Telephone / Date
Division Head
(For physicians)
Professional Practice Leader
Allied Health Professionals
Director of Research Program (if applicable)

N.B.: If for any reason you wish to revoke your authorization of the submission, please notify the researcher and the REB.

Authorizations for
Clinical Services provided within the context of research
(e.g., the dispensing of drugs, the use of medical devices, etc.)
My signature below attests to the following:
  • My Department or Service has the resources (e.g.; materials, equipment, personnel and patient population) to support this research.
  • (As applicable) the clinical services provided through this research protocol meetminimal standards for the provision of care (e.g., dispensing of drugs, maintenance or training of personnel for medical equipment)

Position / Print Name / Signature / Telephone / Date
Laboratory
(For studies involving this service)
Director of Medical Imaging
(For studies involving this service)
Director Biomedical Engineering
Other Resource Managers (Please specify)

N.B.: If for any reason you wish to revoke your authorization of the submission, please notify the researcher and the REB.

Signature Page –Prospective Minimal Risk Application–January 2017Page 1 of 6