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h0h?uCJOJQJ^JaJh0h35CJOJQJaJhOdh!5OJQJaJhOdh?u5OJQJaJh0h*5CJOJQJaJhOdh?uCJOJQJaJ3jh0hOdOJQJU\^JaJmHnHu$jh0hOdOJQJU\aJ*j;h0hOdOJQJU\aJrrrrrssssssssAsDso[H5$h0h=CJOJPJQJ^JaJ$h0hCJOJPJQJ^JaJ'h0h?u5CJOJPJQJ^JaJ/j)h0h?uCJOJQJU^JaJ h0h?uCJOJQJ^JaJ)jh0h?uCJOJQJU^JaJ'h0h5CJOJPJQJ^JaJ h0hCJOJQJ^JaJ)jh0hCJOJQJU^JaJ/jh0hCJOJQJU^JaJDsrssstsusvssst t tttt,tկq`H`6#h0h@-6CJOJQJ^JaJ.jh%va5B*OJQJUmHnHphu h0hCJOJQJ^JaJ3jh0hOdOJQJU\^JaJmHnHu*jh0hOdOJQJU\aJh0hOdOJQJ\aJ$jh0hOdOJQJU\aJ$h0h?uCJOJPJQJ^JaJ$h0hCJOJPJQJ^JaJ-h0h=B*CJOJPJQJ^JaJph,t2tNtTtlt|tvʹgS;S/jh0hCJOJQJU^JaJ'h0h5CJOJPJQJ^JaJ/jh0hCJOJQJU^JaJ h0hCJOJQJ^JaJ)jh0hCJOJQJU^JaJU#h0h?u5CJOJQJ^JaJ h0h?uCJOJQJ^JaJ h0h@-CJOJQJ^JaJ#h0h@-6CJOJQJ^JaJ#h0h36CJOJQJ^JaJRB that involve one or more of the following: harm to research participants; exposing research participants to a significant risk of substantive harm; compromising the privacy and confidentiality of research participants; damage caused to scientific integrity of the research data that has been collected; willful or knowing non-compliance on the part of the investigator; adversely impacting ethical principles)?  FORMCHECKBOX  No  FORMCHECKBOX  Yes - Explain why the event is Serious Non-Compliance:  FORMTEXT        If the event is Non-Compliance, is the event Continuing Non-Compliance (repeated pattern of non-compliance by an individual investigator or research staff member either on a single protocol or multiple protocols)?  FORMCHECKBOX  No  FORMCHECKBOX  Yes - Explain why the event is Continuing Non-Compliance:  FORMTEXT       C. Full Board Review Note: All VA study UP s require a Full Board Review  FORMCHECKBOX  Requires Full Board Review  FORMCHECKBOX  Does not require Full Board Review  Unanticipated Problem Reviewer Determination - Continued Designated Reviewer Recommendation(s) for Full Board: Select the required action(s) below:  FORMCHECKBOX  Suspension of enrollment of new participants  FORMCHECKBOX  Suspension of research procedures in currently enrolled participants  FORMCHECKBOX  Suspension of the research  FORMCHECKBOX  Termination of the research  FORMCHECKBOX  Notification of participants when such information may relate to current participants willingness to continue to take part in the research or there is a risk to the health or safety of the past or current participants  FORMCHECKBOX  Provide additional information to past participants  FORMCHECKBOX  Require current participants to be re-consented to protocol with the changes in the informed consent  FORMCHECKBOX  Request additional information or clarification from the PI, sponsor and/or data safety monitoring committee  FORMCHECKBOX  Accept report as submitted pending amendment with consent form changes  FORMCHECKBOX  Require additional monitoring by the IRB  FORMCHECKBOX  Monitoring of the consent process  FORMCHECKBOX  Require a change in the continuing review period  FORMCHECKBOX  Request a for-cause audit, if not already done, and/or a follow-up audit  FORMCHECKBOX  Request further inquiry into other protocols utilizing the experimental drug/device/intervention or procedure in question  FORMCHECKBOX  Request further inquiry into PIs other active protocols  FORMCHECKBOX  Determine if a detailed plan for safe withdrawal of participants from the research must be developed to protect the rights and welfare of participants  FORMCHECKBOX  Use of data should not be permitted  FORMCHECKBOX  Require changes to corrective action plan  FORMCHECKBOX  Require IRB education for:  FORMCHECKBOX  PI  FORMCHECKBOX  Key Personnel  FORMCHECKBOX  Amendment submission required to make required changes to the following documents:  FORMCHECKBOX  Protocol  FORMCHECKBOX Consent  FORMCHECKBOX Add key personnel  FORMCHECKBOX  Other  FORMCHECKBOX  Require that appropriate federal regulatory agencies, accrediting bodies, sponsors, and institutional officials be notified of any unanticipated adverse reactions or unanticipated events involving risks to participants or others according to the IRB policies: 13-1, 13-2, 13-5, 15-1 and 15-3.  FORMCHECKBOX  VA  FORMCHECKBOX  DoD  FORMCHECKBOX  OHRP  FORMCHECKBOX  FDA  FORMCHECKBOX  AAHRPP  FORMCHECKBOX  Sponsor  FORMCHECKBOX  Other:  FORMTEXT       Designated Reviewer Determinations (When event is not referred to Full Board)  FORMCHECKBOX  Note the occurrence of the Unanticipated Problem, but take no action (for minor violations)  FORMCHECKBOX  Require that this plan be submitted to the IRB for review and approval  FORMCHECKBOX  Additional information needed from PI  FORMCHECKBOX  Other:  FORMTEXT      Reviewer s Signature: ______________________________________________________ Date: _______________________ Printed Name:  FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       Comments:  FORMTEXT       Full Board IRB Determination: IRB meeting date:  FORMTEXT       IRB#:_ FORMTEXT      ___________ Non-Compliance: Is the event Non-Compliance (failure to comply with all federal regulations, including Veteran s Administration regulations and guidance, state and local requirements, WSU Policy and determinations of the IRB)?  FORMCHECKBOX  No  FORMCHECKBOX  Yes - If different than the UP Reviewer s determination, explain why the event is Non-Compliance:  FORMTEXT       If the event is Non-Compliance, is the event Serious Non-Compliance (failure to comply with all federal regulations, including Veterans Administration regulations and guidance, state, and local requirements, WSU Policy and determinations of the IRB that involve one or more of the following: harm to research participants; exposing research participants to a significant risk of substantive harm; compromising the privacy and confidentiality of research participants; damage caused to scientific integrit   "$.0246PƳubJb8#h0h@-6CJOJQJ^JaJ.jh%va5B*OJQJUmHnHphu$h0hCJOJPJQJ^JaJ3jh0hOdOJQJU\^JaJmHnHu*jh0hOdOJQJU\aJh0hOdOJQJ\aJ$jh0hOdOJQJU\aJ$h0h?uCJOJPJQJ^JaJ'h0h5CJOJPJQJ^JaJ$h0hCJOJPJQJ^JaJPVrx ȵ}hW?hW+W'h0h5CJOJPJQJ^JaJ/j{h0hCJOJQJU^JaJ h0hCJOJQJ^JaJ)jh0hCJOJQJU^JaJ h0h?uCJOJQJ^JaJ$h0h?uCJOJPJQJ^JaJ'h0h?u5CJOJPJQJ^JaJ$h0h?uCJOJPJQJ^JaJ$h0h@-CJOJPJQJ^JaJ#h0h@-6CJOJQJ^JaJ#h0h36CJOJQJ^JaJ:<>@H~٭o\N8\*jgh0hOdOJQJU\aJh0hOdOJQJ\aJ$jh0hOdOJQJU\aJ.jh%va5B*OJQJUmHnHphu$h0h*CJOJPJQJ^JaJ$h0hCJOJPJQJ^JaJ'h0h5CJOJPJQJ^JaJ/jh0hCJOJQJU^JaJ h0hCJOJQJ^JaJ)jh0hCJOJQJU^JaJxz!" d$IfgdUA $IfgdOd d$Ifgd3 $Ifgd3d$If^gdOd $Ifgd vxz|Ƕo]M?*)jh0h3CJOJQJU^JaJhUACJOJQJ^JaJh0h35CJOJQJaJ#hUAhUA5CJOJQJ^JaJ,hUAhUA5B* CJOJQJ^JaJph&hUA5B* CJOJQJ^JaJphhOdh35OJQJaJhOdhw5OJQJaJ h0hOd5B*OJQJphh3OJQJ\aJ$jh0hOdOJQJU\aJ3jh0hOdOJQJU\^JaJmHnHu |!"#$1\]zi^M<1h9h?uOJQJ h9h?u5B*OJQJph h9h[;5B*OJQJphh0h?uOJQJ h0h!5B*OJQJph h0h35B*OJQJphhUACJOJQJ^JaJ/jUh0h3CJOJQJU^JaJ hOdh3CJOJQJ^JaJ)jh0h3CJOJQJU^JaJ/jh0h3CJOJQJU^JaJ h0h3CJOJQJ^JaJ"#$]^P}ttdddd$If`gd?u $Ifgd?u $Ifgd?uqkd$$Ifl    *+ t0    644 lap ytga ]^i  OPQ_ijufNf/jh9h?uCJOJQJU^JaJh9h?uCJOJQJaJ/j`h9h?uCJOJQJU^JaJ)jh9h?uCJOJQJU^JaJ h9h?uCJOJQJ^JaJ h9hwCJOJQJ^JaJh9h?uOJQJh9h`5OJQJh9h35OJQJh9h|j5OJQJh9h?u5OJQJ_`ap}~m\Dm\/jh9hG;CJOJQJU^JaJ h9hG;CJOJQJ^JaJ)jh9hG;CJOJQJU^JaJ/j8h9h?uCJOJQJU^JaJ/jh9h?uCJOJQJU^JaJh9h?uCJOJQJaJ h9h?uCJOJQJ^JaJ)jh9h?uCJOJQJU^JaJ/jLh9h?uCJOJQJU^JaJ}V.j=   {d$If^`gd,d$If^`gd?ud$If^`gdG;d$If^gd?ud$If^gdN{8d$If^8`gd?ud$If^`gd?uVWefg./=˺˺|d|||L||/jh9h?uCJOJQJU^JaJ/jh9h?uCJOJQJU^JaJ h9h?uCJOJQJ^JaJ)jh9h?uCJOJQJU^JaJ/j$h9hN{CJOJQJU^JaJ h9hN{CJOJQJ^JaJ)jh9hN{CJOJQJU^JaJh9hGrCJOJQJaJ h9hGrCJOJQJ^JaJ=>?jkyz{r]rE]r/jrh9hG;CJOJQJU^JaJ)jh9hG;CJOJQJU^JaJ h9hG;CJOJQJ^JaJ/jh9haCJOJQJU^JaJ h9haCJOJQJ^JaJ)jh9haCJOJQJU^JaJ h9h?uCJOJQJ^JaJ)jh9h?uCJOJQJU^JaJ/jh9h?uCJOJQJU^JaJ=>LMN  # 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FORMCHECKBOX  No  FORMCHECKBOX  Yes - If different than the UP Reviewers determination, explain why the event is Serious Non-Compliance:  FORMTEXT       If the event is Non-Compliance, is the event Continuing Non-Compliance (repeated pattern of non-compliance through multiple individual findings of non-compliance by an individual investigator or research staff member either on a single protocol or multiple protocols)?  FORMCHECKBOX  No  FORMCHECKBOX  Yes - If different than the UP Reviewer s determination, explain why the event is Continuing Non-Compliance:  FORMTEXT       Reviewer Recommendation(s):  FORMCHECKBOX  Accept reviewer recommendation(s) as presented  FORMCHECKBOX  Accept reviewer recommendation(s) with modifications  FORMCHECKBOX  Reviewer recommendation(s) not accepted IRB Recommendation(s) or Comment(s)  FORMTEXT        FORMCHECKBOX  Use of datattttttttttttu%u5u6u7u8uBuo\I;h9hOdOJQJ\aJ$jh9hOdOJQJU\aJ$h9hOdCJOJPJQJ^JaJ$h9h@-CJOJPJQJ^JaJ$h9hCJOJPJQJ^JaJ/jh9hCJOJQJU^JaJ'h9h5CJOJPJQJ^JaJ h9hCJOJQJ^JaJ)jh9hCJOJQJU^JaJ/jjh9hCJOJQJU^JaJBuCuv v vv(v.vJvhv~vvvvv׽תs_sL;* h9h/CJOJQJ^JaJ h9h@-CJOJQJ^JaJ$h9h@-CJOJPJQJ^JaJ'h9h@-5CJOJPJQJ^JaJ$h9h@-CJOJPJQJ^JaJ#h9h36CJOJQJ^JaJ#h9h@-6CJOJQJ^JaJ$h9hCJOJPJQJ^JaJ3jh9hOdOJQJU\^JaJmHnHu$jh9hOdOJQJU\aJ*jVh9hOdOJQJU\aJvRw&x(x*xFxHxJxLxPxbxdxxxxxx,y@y`yby˶yayNyN;$h9h@-CJOJPJQJ^JaJ$h9hCJOJPJQJ^JaJ/jDh9hCJOJQJU^JaJ'h9h5CJOJPJQJ^JaJ/jh9hCJOJQJU^JaJ h9hCJOJQJ^JaJ)jh9hCJOJQJU^JaJ$h9h@-CJOJPJQJ^JaJ h9h@-CJOJQJ^JaJ h9h`CJOJQJ^JaJbydyfyzy|y~yyyyyyyyyyyyޮޛss`K: h9hgCJOJQJ^JaJ)jh9hgCJOJQJU^JaJ$h9hV,CJOJPJQJ^JaJ'h9h35CJOJPJQJ^JaJ'h9hV,5CJOJPJQJ^JaJ$h9h3CJOJPJQJ^JaJ3jh9hOdOJQJU\^JaJmHnHu*jh9hOdOJQJU\aJ$jh9hOdOJQJU\aJh9hOdOJQJ\aJyyyyy z&z(z*z,zFzHzJzLzNzjzqqaQa<+ h9he`CJOJQJ^JaJ)jh9he`CJOJQJU^JaJh9hgCJOJQJ\aJh9he`CJOJQJ\aJ'h9h35CJOJPJQJ^JaJ'h9he`5CJOJPJQJ^JaJ'h9hV,5CJOJPJQJ^JaJ'h9h=~"5CJOJPJQJ^JaJ h9hgCJOJQJ^JaJ)jh9hgCJOJQJU^JaJ/j2h9hgCJOJQJU^JaJjzlznzpz|zzzzzzzzzzzzzz{{{.{0{2{4{N{P{qqYqqIh9he`CJOJQJ\aJ/jh9he`CJOJQJU^JaJ'h9h35CJOJPJQJ^JaJ'h9h+)5CJOJPJQJ^JaJ'h9hV,5CJOJPJQJ^JaJ'h9he`5CJOJPJQJ^JaJ h9he`CJOJQJ^JaJ)jh9he`CJOJQJU^JaJ/jh9he`CJOJQJU^JaJP{R{T{x{z{|{~{{{{{{{{{{{{{{۳|bT@'h9ht5CJOJPJQJ^JaJh9hOJQJ\aJ3jh9hOdOJQJU\^JaJmHnHu*jh9hOdOJQJU\aJh9hOdOJQJ\aJ$jh9hOdOJQJU\aJ'h9h*5CJOJPJQJ^JaJ'h9hV,5CJOJPJQJ^JaJ'h9h35CJOJPJQJ^JaJ h9hgCJOJQJ^JaJ{{N:Sv dd[$\$gd! !P'xgd*gdOd ^`gd9d^`gd, d^gd,dgd,d^`gd, ^`gd{{{{{|!"#NO]^_~ɐٿ٧ُw_/jh9htCJOJQJU^JaJ/jnh9htCJOJQJU^JaJ/jh9htCJOJQJU^JaJ/jh9htCJOJQJU^JaJU/j h9htCJOJQJU^JaJ h9htCJOJQJ^JaJ)jh9htCJOJQJU^JaJ is not permitted  FORMCHECKBOX  Require changes to corrective action plan  FORMCHECKBOX  Require IRB education for:  FORMCHECKBOX  PI  FORMCHECKBOX  Key Personnel  FORMCHECKBOX  Amendment submission required to make required changes to the following documents:  FORMCHECKBOX  Protocol  FORMCHECKBOX Consent  FORMCHECKBOX Add key personnel  FORMCHECKBOX  Other:  FORMTEXT       IRB Chair Signature_____________________________________________________ Required Reporting for VA Studies: See Q#7 for VA status. These studies have special requirements see VA Reporting Policy. Required Reporting for DoD, and DoE Studies: Thesɐʐː ./0:;IJKSTbcdvwyaN$jh9htOJQJU\aJ/j2h9htCJOJQJU^JaJ/jh9htCJOJQJU^JaJ/jFh9htCJOJQJU^JaJ/jh9htCJOJQJU^JaJ h9htCJOJQJ^JaJ)jh9htCJOJQJU^JaJ/jZh9htCJOJQJU^JaJ  46Ȯu]H6H6H6#hlB* CJOJQJ^JaJphH)hlhlB* CJOJQJ^JaJphH/h0h*5>*B* CJOJQJ^JaJphH'h0h5CJOJPJQJ^JaJ'h0ht5CJOJPJQJ^JaJ!ht5CJOJPJQJ^JaJ3jh9htOJQJU\^JaJmHnHu$jh9htOJQJU\aJ*jh9htOJQJU\aJh9htOJQJ\aJ6rғĜǜ̜ۜ͜ꮙؗ~vrvrvrvrfWfWfWHWHheh8CJOJQJaJhehm"CJOJQJaJh[;CJOJQJaJhCjhCU1hJgh*B* CJOJQJ^JaJmH phHsH U)h!5>*B* CJOJQJ^JaJphH/h0h*5>*B* CJOJQJ^JaJphH#hlB* CJOJQJ^JaJphH#h!B* CJOJQJ^JaJphH)h0h*B* CJOJQJ^JaJphHe studies have special requirements. See IRB Reporting of Unanticipated Problems, suspensions and terminations, continuing non-compliance policy.     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