Minimal Risk - WordPress.com
1 PI initiates Ethics application 4 2 3 Receiving REB notifies involved REBs Participating REBs confirm Risk level & BoR 5 Participating REBs complete proportionate/ site specific reviews BoR drafts provisos and shares with REBs 6 9 7 YES YES 5.1 1.1 Study meets minimal risk criteria? PI completes Cover Sheet & attaches to ethics application NO BoR notifies participating REBs as requested BoR receives response from PI BoR sends provisos to PI Follow Above Minimal Risk Model BoR delivers CoA package to PI REBs issue CoAs with same date and send to BoR Proviso responses complete? NO BoR confirms date & issues Certificate of Approval 10.1 8 REBs share provisos with BoR or notify of acceptance of BoR decision 11 10 12 BoR shares all approved research related documents with participating REBs Board of Record (BoR) Decision Criteria If the study involves a Health Authority, the Board of Record will be the REB representing that Health Authority If there is more than one Health Authority involved, the BoR will be the primary location where the research will take place or, if all things are equal, the Health Authority where the PI holds their primary appointment If no Health Authority is involved, the BoR will be the REB representing the institution where the PI holds their primary appointment. In the event that the majority of research will take place in an institution other than that of the PI’s primary appointment, the BoR may be the REB that represents the institution where the research will take place. If Northern Health would be considered the BoR under these guidelines, UNBC will by default be the BoR as agreed between Northern Health and UNBC. Continuing Review 1 PI submits continuing review activity to BoR 3 2 Does the continuing review activity require REB consultation? YES 2.1 Last updated May 14, 2015 BoR consults with affected REBs NO BoR processes continuing review activity 4 BoR issues acknowledgement or Certificate/s of Approval (as appropriate) 5 BoR shares all approved research related documents with participating REBs
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