ࡱ> ] τbjbj 8ee.K8 8 }}}}}8Qb&(!BE!$i!|a~a~a~a~a~a~a$cfai}}!!!}!}!a}}4 b$$$}!j}}|a$}!|a$$2TXT/a|!RPV.ha!b0Qb~VJwh9"6wh\Xwh}X}!}!$}!}!}!}!}!aao#}!}!}!Qb}!}!}!}!wh}!}!}!}!}!}!}!}!}!8 C:  WSU IRB Reviewer Reportable Event Guide I. Project Information WSU IRB NumberTitle of ProjectEvent SiteReviewer Name  II. Preliminary Report Evaluation The reviewer must answer each of the following questions.YESNO Is the reported event or problem serious? FORMCHECKBOX  FORMCHECKBOX Is the reported event or problem unanticipated?  FORMCHECKBOX  FORMCHECKBOX  Is the reported event or problem related or probably related to participation in the research?  FORMCHECKBOX  FORMCHECKBOX Note: Related means the event or problem may reasonably be regarded as caused by, or probably caused by the research. If a determination that it is related or probably related cannot be made at this time without additional information check the box below:  FORMCHECKBOX  Additional information required for the convened IRB to make a determination Specify the additional information required to make a determination in the Comment section below. a. Does the reported event or problem place participants or others at a substantially greater risk of harm (including physical, psychological, economic, social, or legal harm) than was previously known or recognized? FORMCHECKBOX  FORMCHECKBOX b. Were actions taken in response to the reported event or problem? Answer one of the following as applicable: If yes, were the actions appropriate? c. If no, are any actions warranted to eliminate apparent immediate hazards to subjects? If yes, note actions in comment section.  FORMCHECKBOX   FORMCHECKBOX   FORMCHECKBOX   FORMCHECKBOX   FORMCHECKBOX   FORMCHECKBOX Does this project continue to meet criteria for IRB approval?  FORMCHECKBOX   FORMCHECKBOX Comments:  FORMCHECKBOX  Event/Problem doesnt meet any prompt reporting category and should be withdrawn and  FORMCHECKBOX  Submitted at time of continuing review, or  FORMCHECKBOX  Does not require to be submitted for IRB review.  III. Full Board Reviewer Recommendations The reviewer must make one or more of the following recommendations for consideration by the IRB. (Check all that apply)  FORMCHECKBOX  No further action is required.  FORMCHECKBOX  The protocol needs to be modified per the comments indicated in the comment section below.  FORMCHECKBOX  Modify the information disclosed during the consent process. If this box is checked, also check one of the boxes below:  FORMCHECKBOX  Previously enrolled participants do not require notification.  FORMCHECKBOX  Previously enrolled participants must be notified. If this box is checked, please specify: a. Method of notification (e.g., re-consent with modified informed consent, information letter):  FORMTEXT       b. Timeline for notification (enter suggested notification timeline: e.g., contact participant by phone and send information letter within 30 days):  FORMTEXT       c. Method for documentation of notification (e.g., copy of informed consent documents to IRB at continuing review)?  FORMTEXT        FORMCHECKBOX  Provide additional information to current participants. If this box is checked, also check method of notification:  FORMCHECKBOX  Reconsent with modified informed consent document.  FORMCHECKBOX  Information letter.  FORMCHECKBOX  Other:  FORMTEXT        FORMCHECKBOX  Modify the continuing review schedule as specified below.  FORMCHECKBOX  Monitor the research. Provide comments below on how this should be done, i.e., request an audit by WSU IRB Office).  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