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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 woman’s 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 father’s 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=PëÖȸ¬Ÿ�‚reXeK;.hnP‰5�CJOJQJaJ hÌe'hp0w5�CJOJQJaJ hç"[5�CJOJQJaJ hçRA5�CJOJQJaJ h6 5�CJOJQJaJ hEsh6 5�OJQJ\�aJhN]>*OJQJ\�aJh.h6 >*OJQJ\�aJh6 5�OJQJ\�aJh®)èh6 5�OJQJhYõh6 >*OJQJ\�aJh6 h6 OJQJ\�aJ(jh×r†hH;ØOJQJUmHnHu(jh×r†h6 OJQJUmHnHu rs í ñäßßÚÚì & F„h„òþ¤d$If^„h`„òþgd؇ & F„h„òþ¤d$If^„h`„òþgd6 gdÃ;Ígd6 Æ<¤x¤<gdN] $ Æ<¤da$gd6 Pqrs˜   k l m  € � ‚ „ òâÒÀ¯ž‡u[‡K;‡¯-hN]B*OJQJ\�phh؇h/9Ç0J5�OJQJ\�h؇hL=0J5�OJQJ\�2�jh؇h6 5�B*OJQJU\�ph#h؇h6 5�B*OJQJ\�ph,jh؇h6 5�B*OJQJU\�ph h؇hL=B*OJQJ\�ph h؇h«8ªB*OJQJ\�ph#h؇h/9Ç5�B*OJQJ\�phh×r†h8Y5�CJOJQJaJ hÌe'hŒh°5�CJOJQJaJ h/9Ç5�CJOJQJaJ „ Í Ï   & * + Q R l  ˆ › œ ª ¯ ³ ´ Ù Ú íßÍ¿®œ�œ®{®m®bYMYMb>b>jh½^œh؇OJQJUh½^œh؇5�OJQJh؇5�OJQJh½^œh؇OJQJh؇B*OJQJ\�ph#h½^œh؇>*B*OJQJ\�phhN]5�B*OJQJ\�ph#h½^œh؇5�B*OJQJ\�ph h½^œh؇B*OJQJ\�phh؇h6 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