ࡱ> Y bjbj[[ n9 \9 \-Jjjj~~~8|2~d  "> #!# yd{d{d{d{d{d{d$gDjdj-#"@"-#-#d d%%%-#8 j yd%-#yd%%XR] `Aܐs#jZ6edd0dZj$jl]]jjj_d-#-#%-#-#-#-#-#dd%-#-#-#d-#-#-#-#j-#-#-#-#-#-#-#-#-#> :  Office Use ONLY Date: Appendix D IRB Request for Research Involving Pregnant Women, Neonates, Fetuses Pregnant women, neonates, and fetuses are a special group of research participants, classified as a vulnerable population and protected under the Common Rule  HYPERLINK "http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html" \l "subpartc" 45 CFR 46 Subpart B. Intentional inclusion of these populations require IRB full board review. See the IRB website for full board deadlines and meetings. Email this typed and signed form with your initial protocol application (or Modification Request) as a separate file titled: LASTNAME.Appendix D.Pregnant Women.DATE to  HYPERLINK "mailto:irb@seattleu.edu" irb@seattleu.edu. Section 1: Information Principal Investigator (Last name, First)Project Title Section 2: Pregnant Women and/or Fetuses ( Subpart B requires that the following conditions be met for pregnant women and/or fetuses. Check the corresponding box for each statement to indicate understanding and intention to comply. Where indicated, provide a brief statement explaining how the protocol complies with or supports the condition/finding. Where scientifically appropriate, preclinical studies, including studies on pregnant animals, and clinical studies, including studies on nonpregnant women, have been conducted and provide data for assessing potential risks to pregnant women and fetuses [45 CFR 46.204(a)]. FORMCHECKBOX  Yes FORMCHECKBOX  NoThe risk (potentially greater than minimal) to the fetus is caused solely by interventions or procedures that hold out the prospect of direct benefit for the woman or the fetus OR: The risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge which cannot be obtained by any other means [45 CFR 46.204(b)]. FORMCHECKBOX  Yes FORMCHECKBOX  NoExplain how study risks will be mitigated to ensure the least possible risks for achieving the objectives of the research [45 CFR 46.204(c)].>> If the research offers possible direct benefit to the pregnant woman, to both the pregnant woman and the fetus, or offers no possible benefit for either (when risk to the fetus is not greater than minimal and the research aims to develop important biomedical knowledge that cannot be obtained in any other way), the womans consent will be obtained in accord with informed consent provisions of subpart A. [45 CFR 46.204(d)]. FORMCHECKBOX  Yes FORMCHECKBOX  NoIf the research offers possible direct benefit only to the fetus, then the consent of the pregnant woman and the father is obtained in accord with the informed consent provisions of subpart A, except the fathers consent may be waived due to unavailability, incompetence, temporary incapacity, or if the pregnancy resulted from rape or incest. [45 CFR 46.204(e)]. FORMCHECKBOX  Yes FORMCHECKBOX  NoBriefly explain how individuals providing consent under number (4) or (5) above will be fully informed regarding the reasonably foreseeable impact of the research on the fetus or neonate [45 CFR 46.204(f)].>> Explain how assent and permission for minors (as defined in Sec. 46.402(a)) who are pregnant will be obtained in accord with the provisions of subpart D of 45 CFR 46.204(g).>> No incentives, monetary or otherwise, may be offered to terminate a pregnancy [45 CFR 46.204(h)]. FORMCHECKBOX  Agreed FORMCHECKBOX  NoIndividuals engaged in the research will have no part in any decisions as to the timing, method, or procedures used to terminate a pregnancy [45 CFR 46.204(i). FORMCHECKBOX  Agreed FORMCHECKBOX  NoIndividuals engaged in the research will have no part in determining the viability of a neonate [45 CFR 46.204(j)]. FORMCHECKBOX  Agreed FORMCHECKBOX  No     IRB Request for Research Involving Pregnant Women, Neonates, Fetuses: Page  PAGE 2 Last Revised: January 2018 SU Institutional Review Board Admin 201, 206-296-2585 irb@seattleu.edu  *1=PȸreXeK;.hnP5CJOJQJaJ he'hp0w5CJOJQJaJ h"[5CJOJQJaJ hRA5CJOJQJaJ h6 5CJOJQJaJ hEsh6 5OJQJ\aJhN]>*OJQJ\aJh.h6 >*OJQJ\aJh6 5OJQJ\aJh)h6 5OJQJhYh6 >*OJQJ\aJh6 h6 OJQJ\aJ(jhrhH;OJQJUmHnHu(jhrh6 OJQJUmHnHu rs  & Fhd$If^h`gd & Fhd$If^h`gd6 gd;gd6 <x<gdN] $ <da$gd6 Pqrs   k l m  u[K;-hN]B*OJQJ\phhh/90J5OJQJ\hhL=0J5OJQJ\2jhh6 5B*OJQJU\ph#hh6 5B*OJQJ\ph,jhh6 5B*OJQJU\ph hhL=B*OJQJ\ph hh8B*OJQJ\ph#hh/95B*OJQJ\phhrh8Y5CJOJQJaJ he'hh5CJOJQJaJ h/95CJOJQJaJ    & * + Q R l  Ϳ{mbYMYMb>b>jh^hOJQJUh^h5OJQJh5OJQJh^hOJQJhB*OJQJ\ph#h^h>*B*OJQJ\phhN]5B*OJQJ\ph#h^h5B*OJQJ\ph h^hB*OJQJ\phhh6 OJQJ\]#hN]hN]6B*OJQJ\phhN]B*OJQJ\ph# *hN]hN]B*OJQJ\ph     ) , 1 2 3 ȼtdWJW;,h8h8tCJOJQJaJh8h:CJOJQJaJhh2UOJQJaJhh:OJQJaJh8h8t5CJOJQJaJh(h"v":OJQJaJh(h8tOJQJaJhaaF5:CJOJQJaJ"h(hu$w5:CJOJQJaJhh"[5OJQJhh8Y5OJQJhh6 OJQJ\]hhRAOJQJ\]jh^hOJQJUh^h0JOJQJ   2 3 j]PE8 dd$Ifgd; d$Ifgd; d($Ifgd;  Pgd8  (&d P gd8kd$$Ifl'8(  t 0644 l` ap yt6 3 4 B C k^^ dd$Ifgd;kd$$Ifl40Y ' s 064 laf4pytmW3 4 ; A B C D E F R o p q r 񳣑pXC.)hhR5;CJOJQJ\^JaJ)h7PQhR5;CJOJQJ\^JaJ/ jPh7PQhR5;CJOJQJ\^JaJ"hZ0<hZ0<5:CJOJQJaJhR5:CJOJQJaJ"h(hu$w5:CJOJQJaJhHfah25CJOJQJaJh6 h6 CJOJQJaJh8h8tCJOJQJaJh8h:5CJOJQJaJh8h8t5CJOJQJaJhrh8tCJOJQJaJC D E F p kfUJ  dgdZ0<  $d N gd;gd6 kd$$Ifl40Y ' s 064 laf4pytmW ? 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