ࡱ> fie Kbjbj 1R+6 8,lD8r(^7777777$:M=7u:!:!:!7s8&&&:!F7&:!7&& 5|6ЬV!R578085=!=$6=6,g 0 "&  eg g g 77d$g g g 8:!:!:!:!=g g g g g g g g g :  IRB#  FORMTEXT       SAINT LOUIS UNIVERSITY Institutional Review Board 3556 Caroline St., Room 110 %% phone: (314) 977-7744 %%fax: (314)977-7730 Emergency Treatment Form Emergency use means the use of a test article on a human subject in a life-threatening/severely debilitating situation in which no standard acceptable treatment is available, and in which there is not sufficient time to obtain IRB approval [21 CFR 56.102(d)]. The emergency use provision in the FDA regulations [21 CFR 56.104(c)] is an exemption from prior review and approval by the IRB provided that such emergency use is reported to the IRB within 5 working days. The exemption allows for one emergency use of a test article without prospective IRB review. FDA regulations require that any subsequent use of the test article at the institution must have prospective IRB review and approval. Data pertaining to a patient treated on an emergency basis are not to be used for research purposes. For additional information please refer to the HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/guidelines_emergency_use.doc"Guidance for Emergency Use of a Test Article. Investigator: Date of Treatment:: Department: Test article used: E-Mail: Phone: IND/IDE number:  Provide justification for the use of the experimental drug, device or procedure and any alternatives:  FORMTEXT       Check as appropriate:  FORMCHECKBOX  Test article is exempt from IRB review under NCI Class C IND Evidence must be provided by investigator.  FORMCHECKBOX  Emergency use of the test article without prospective IRB approval is appropriate because all of the following are true: FDA Regulations:  FORMCHECKBOX Subject has a life threatening/severely debilitating condition necessitating the use of the test article. (Note that having an ultimately fatal condition does not constitute a life threatening condition.) Explain:  FORMTEXT        FORMCHECKBOX No standard acceptable treatment is available.  FORMCHECKBOX There is not sufficient time to obtain full IRB approval. Explain: FORMTEXT        FORMCHECKBOX This is the HYPERLINK "https://www.slu.edu/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/previous_emergent_test_articles.docx"first and only emergency use of this test article. If not, explain: FORMTEXT        FORMCHECKBOX This report is being submitted within 5 working days of the use. If not, explain: FORMTEXT       Submit supporting materials (e.g. from the manufacturer of the test article) if available. Informed Consent Requirements:  FORMCHECKBOX  The emergency treatment has not yet taken place and consent will be obtained prior to the treatment. Physicians should use the HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/emergency_treatment_consent_template.docx"91Ů Emergency Use template for obtaining consent when possible.  FORMCHECKBOX  The emergency treatment has already taken place and consent was obtained from the participant prior to the treatment. Attach an unsigned copy of the consent form or certify in writing below that the criteria for the exception to informed consent were met Exception from informed consent The treating physician is required to obtain informed consent of the subject or the subjects legally authorized representative unless both the treating physician and a physician who is not otherwise participating in the use certify in writing the following [ HYPERLINK "http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=50.23" 21 CFR 50.23(a)]:  FORMCHECKBOX  The emergency treatment has already taken place and consent was waived. The following signatures document that it was determined by the PI and a non-affiliated physician that the emergency situation met all of the following required criteria for waiver as outlined in HYPERLINK "http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=50.23"21 CFR 50.23 (a)(1-4):  FORMCHECKBOX The human subject is confronted by a life-threatening situation necessitating the use of the test article.  FORMCHECKBOX Informed consent cannot be obtained from the subject because of an inability to communicate with, or obtain legally effective consent from, the subject.  FORMCHECKBOX Time is not sufficient to obtain consent from the subject's legal representative.  FORMCHECKBOX There is no available alternative method of approved or generally recognized therapy that provides an equal or greater likelihood of saving the life of the subject. If the treating physician determined that immediate use of the test article was required to preserve the life of the subject and time was not sufficient to obtain the independent determination required in HYPERLINK "http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=50.23"21 CFR 50.23 (a)(1-4), federal regulations allow the determination to be made by a non-affiliated physician within five working days of the treatment. I certify that all of the above criteria were met. ________________________________________ Consulting Physician Date Emergency use is FDA-regulated, so data related to this emergency treatment may be reported to a sponsor and the FDA. Data may not be used for the treating physicians own prospective research. Please note that  "$&02468df 6 8 : l n # ` xrg^X^O^h~hDaJ h*aJh~h[aJh^[h[CJ aJ h[CJ h^[h[5CJ aJ h[5>*CJhfh\Hw5>*CJhfh[5>*CJ hodhodhn;hn;5CJaJh\Hw5CJ aJ hodh[5CJ aJ hodCJjhIfpUmHnHujhIfpUhIfpjhIfpUh[hod468f8 : l n $Ifgde?gdD$a$gdagda$a$gda$a$` C H s  Ź}pdXL<hDh_4[5@OJQJ^Jh4 B* CJaJphhDB* CJaJphh4 B* CJaJphh99^h^[0JCJaJ&jthaB* CJUaJphhaB* CJaJph jh99^B* CJUaJphh~h^[CJaJh~h^[5CJaJh~h[5CJaJh~h[56CJaJh~hDCJaJh~h[CJaJh~h[5aJ :FHJLX`jrBlpr☇ymm^WSWKjh`Uhod h~h[h~h_4[B* CJaJphhD@OJQJ^Jh~@OJQJ^JaJ hDhD@OJQJ^JaJ#h~hD5@OJQJ^JaJhDhD5@OJQJ^Jh_4[@OJQJ^Jh~@OJQJ^Jh~hD5@OJQJ^JhDhD@OJQJ^JhDh_4[@OJQJ^J Jqd[ $Ifgde? $Ifgde?kd$$Ifs 0_(_ ``0(4 saspJL`rnaPG $Ifgde? =$If^=gde? $IfgdDkd$$Ifs4 0_(_ ``0(4 sasf4ppPNF=N5 & Fgddh^hgd` & Fgd^[kd$$Ifs4 F/ _(/ 0  ```0(    4 sasf4pr56bcqrst/Ez̪ТԏyuynjuhIfp hIfphIfph* hIfph`j\hVUhVjhVUhIfph`56>*hIfph`6h`hd5jh`Ujth`Uh}Ihdh~ h~h[jh`UmHnHujh`Ujh`Uh`)4ab`bBDh^hgd9XN & Fgd9XN ^gdIfp 0^`0gd``gddh^hgdd  .02&8:NPR\^bdJL{mdh9hIfp0Jj h9haUhajh9h9U h9hIfpjhIfpUjhn;UmHnHuj,hn;Ujhn;Uhn;jhIfpUjDhIfpUh[jhIfpUmHnHujhIfpUjhIfpUhIfp'Lpr^`tvx@˸˭ߢtjYtLhbbhn;OJQJ^J!j) hn;OJQJU^Jhn;OJQJ^Jjhn;OJQJU^JhOOJQJ^J hn;5 h9XNh}I h9XNhodjhIfpUmHnHuj hIfpUjA hIfpUjhIfpUhIfp jh9hIfpUmHnHuj h9hIfpUjh9hIfpU h9hIfpD:G[\|} 0^`0gdod *L^L`gd9XN$a$ 0d^`0gd9XN  ^ `gd9XN `d^``gd9XNgdn; & Fgd}I  !:<AW[\  !"EGHIWXYZ˾{mcRmNh}I!j`hn;OJQJU^Jhn;OJQJ^Jjhn;OJQJU^Jh(hQ)5h9XNh|5h9XNh|0J5h9XNhQ)0J5h9XNhn;0J5j h9XNha5U ha5jh9XNh(5Uh9XNhn;5 hQ)5hOOJQJ^Jhbbhn;OJQJ^Jh@hn;5\ h@hn;GZ[\{   Z]ĹϭϭĞtn`VhIfpOJQJ^JjhIfpOJQJU^J h[CJh9XNh[0JCJaJ#jh9XNhe?CJUaJh9XNhoICJaJjh9XNhoICJUaJh9XNh}I5CJaJh9XNh}ICJaJh9XNh[CJaJh9XNh[5CJaJ h}I5CJ h9XNh}I h}I5hlVh}I5h}IOJQJ^J BTvwx ŻŭziPz?izi!h9XNhodB*OJQJ^Jph0jph9XNhIfpB*OJQJU^Jph!h9XNhIfpB*OJQJ^Jph*jh9XNhIfpB*OJQJU^Jphh9XNhod0J5\!jYh9XNhod5U\jh9XNhod5U\h9XNhod5\ h9XNhodh9XNOJQJ^JhodOJQJ^JjhIfpOJQJU^J!jhIfpOJQJU^J !!!!!""JJJJK hh]h^hgdn;gdIgdn;$a$gdn;gdod 0^`0gdod  Px 4 #\'*p(^(gdq,-. ѯѯ}vovaWFa!jHh9XNhod5U\h9XNhod5\jh9XNhod5U\ h9XNhq h9XNhod0jh9XNhIfpB*OJQJU^Jph0j\h9XNhIfpB*OJQJU^Jph!h9XNhIfpB*OJQJ^Jph!h9XNhodB*OJQJ^Jph*jh9XNhIfpB*OJQJU^Jph0jh9XNhIfpB*OJQJU^Jph !!!!!!!""""""R#k###H>III0J1J2J[J\JJJJ˿ynj\nSnyKh9XNhn;6h9XNh|0Jj_h9XNhaUhajh9XNh(U h9XNh|U h9XNhn; h9XNhIhn;5CJ\hn;5>*CJ\h9XNh[5>*CJaJh9XNhn;5>*CJaJh9XNh[5CJaJ&hbbhod5CJOJQJ\^JaJ h9XNhodjh9XNhod5U\h9XNhod0J5\FDA regulations require that any subsequent use of the test article at the institution (91Ů) undergo prospective IRB review and approval. Physicians should carefully consider the likelihood of future use of the test article and submit an IRB Application for review and approval if subsequent use is reasonably likely. Also note that 91Ů IRB requires a status of treatment update via the HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/emergency_treatment_status_closure_form.doc"Emergency Treatment Status Update/Closure form every six months until the treatment is complete. 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