Protocol Submission

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Applications for Research with Human Participants

Requirements for submission of a complete protocol:?
  • Tri-Council Policy Statement(TCPS2)?Certificate of Completion - All project team members?-?TCPS website to create account and complete training. Must use Nipissing e-mail address.?
  • Participant Information Letter/Consent - if required
  • Confidentiality Forms - if required
  • Recruitment Posters/Adverts - if required
  • Additional Certifications/Approvals - if required

*REB will not review incomplete protocols. It is the responsibility of the applicant, and also of the faculty supervisor in the case of students, to submit protocols that are complete. If your protocol has any missing or incomplete information, it will be returned to you to complete prior to review. In all cases, the Principal Investigator (PI) is required to make the official submission of a?protocol, in doing so the PI has confirmed all information within the application is accurate and believes the application to be ready for review.?

Types of Reviews:

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MINIMAL RISK STUDIES:?such?studies will be eligible for Delegate Review (2 reviewers, 1 chair).

? ? ? ? ? TIMELINE: allow up to 4 weeks AFTER submission for the Research Ethics Board to respond with a decision. Refer to the Delegated Review Process.

ABOVE MINIMAL RISK STUDIES: may require Full Board Review (reviewed by all REB members, 1 chair).

? ? ? ? ? TIMELINE: allow a minimum of 6 to 8 weeks after submission for the REB to respond with a decision.

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Events for Research with Human Participants:
  • Renewals
  • Modifications
  • Report on Adverse Events
  • Final Reports

*If minor in nature,?events are reviewed by the REB Chair.

TIMELINE: allow up to 1 week AFTER submission for a response with decision on any event?

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