{"id":2893,"date":"2026-06-10T16:57:15","date_gmt":"2026-06-10T16:57:15","guid":{"rendered":"https:\/\/in.nau.edu\/research\/?page_id=2893"},"modified":"2026-08-15T02:33:11","modified_gmt":"2026-08-15T02:33:11","slug":"pregnant-women","status":"publish","type":"page","link":"https:\/\/in.nau.edu\/research\/research-compliance\/human-research-protection-program\/guidance\/pregnant-women\/","title":{"rendered":"Pregnant women"},"content":{"rendered":"<div class=\"nau-block nau-block-left-nav-top-bound\">\n    \t<button id=\"left-nav-toggle-btn\" onclick=\"toggleNav();\">\n\t\tON THIS PAGE \n\t\t<i id=\"chevron-icon\" class=\"fas fa-solid fa-chevron-down\"><\/i>\n\t<\/button>\n\t<div id=\"left-nav-menu-track\">\n\t\t<div id=\"left-nav-wrapper\">\n\t\t\t<div class=\"rfi-above-anchor-tags\">\n\t\t\t\t<div class=\"ri-container\">\n\t\t\t\t\t<a href=\"https:\/\/nau.edu\/admissions\/request-information\/\" id=\"request-info\" class=\"btn bg-true-blue left-nav-menu-bottom-button display-mobile\">Request info&nbsp;&nbsp;<\/a>\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t\t<div id=\"left-nav-menu\">\n\t\t\t\t<div class=\"menu-section menu-section-links\"><h6 class=\"hidden-mobile left-nav-list-header\">ON THIS PAGE<\/h6><ul class=\"left-nav-menu-list left-nav-automatic on-this-page\"><\/ul><div class=\"ri-container\"><a href=\"https:\/\/nau.edu\/admissions\/request-information\/\" id=\"request-info\" class=\"btn bg-true-blue left-nav-menu-bottom-button display-mobile\">Request info&nbsp;&nbsp;<\/a><\/div><\/div>\t\t\t\t\t\t\t\t<div class=\"menu-section backcolor\">\n\t\t\t\t\t<div class=\"header\">\n\t\t\t\t\t\tHOW CAN WE HELP?\t\t\t\t\t<\/div>\n\t\t\t\t\t<ul class=\"responsive-icons\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><a href=\"tel:928-523-9551\"><img decoding=\"async\" src=\"https:\/\/in.nau.edu\/wp-content\/themes\/nau-marketing-2021\/img\/icon-phone.svg\" alt=\"Telephone:\"> 928-523-9551<\/a>\n\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t\t\t\t\t<li><a href=\"mailto:IRB@nau.edu\"><img decoding=\"async\" src=\"https:\/\/in.nau.edu\/wp-content\/themes\/nau-marketing-2021\/img\/icon-email.svg\" alt=\"Email:\"><span class=\"left-nav-email\"> IRB&#8203;@nau.edu <\/span><\/a><\/li>\n\t\t\t\t\t<\/ul>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\n\t\t\t<\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div>\n\n<section class=\"nau-block left-nav-section\"><header class=\"entry-header\"><div class=\"breadcrumb\"><ol class=\"breadcrumbs\"><li><a href=\"https:\/\/stage.in.nau.edu\">IN<\/a><span class=\"breadcrumb-chevron\" aria-hidden=\"true\">&gt;<\/span><\/li><li><a href=\"https:\/\/in.nau.edu\/research\">NAU Research<\/a><span class=\"breadcrumb-chevron\" aria-hidden=\"true\">&gt;<\/span><\/li><li class=\"current\">Pages<\/li><\/ol><\/div><h1 class=\"entry-title text-left \">Pregnant women<\/h1><hr class=\"h1-hr  text-left \" role=\"none\"><\/header><!-- .entry-header --><\/section><!-- <section class=\"nau-block left-nav-section grid-md-12\">\n    <header class=\"entry-header\">\n        <h1 class=\"entry-title text-left \" tabindex=\"0\" id=\"h1-first\">Dummy H1<\/h1>\n        <hr class=\"h1-hr  text-left \" role=\"none\">\n    <\/header>\n<\/section> -->\n\n<section class=\"nau-block left-nav-section grid-md-12\">\n    <div class=\"page-content\">\n        \n\n<h2 class=\"wp-block-heading\">When does human research involve pregnant women?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Research involves pregnant women when the researcher is able to confirm that a woman is pregnant, either by self-disclosure by the subject, proof of missed menses, or a positive pregnancy test. These studies are not considered to involve pregnant women.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The Office for Human Research Protections (OHRP) current position is that an investigator does not have an obligation to ascertain whether any of the women involved in a research study are pregnant. Just because a project involves women who may become pregnant (also known as \u201cwomen of childbearing potential\u201d), it does not mean the project involves pregnant women. If the research does not require disclosure of pregnancy status, then the researcher is not obligated to determine whether a woman is or may be pregnant.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">For example, a\u00a0<strong>federally-<\/strong>funded or supported research\u00a0survey of undergraduates would not require the investigator to ascertain whether any of the potential respondents is pregnant and exclude them in order to avoid having to comply with the Subpart B requirements. If the investigator does happen to know that a subject is pregnant, however, then the provisions of\u00a0<a href=\"https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/regulations\/45-cfr-46\/common-rule-subpart-b\/index.html\" target=\"_blank\" rel=\"noreferrer noopener\">45 CFR 46 subpart B<\/a>\u00a0apply, and the\u00a0biomedical\u00a0knowledge provision requirement is triggered where there is no prospect of direct benefit for the woman or fetus, as per\u00a0<a href=\"https:\/\/www.ecfr.gov\/current\/title-45\/subtitle-A\/subchapter-A\/part-46\/subpart-B\/section-46.204\" target=\"_blank\" rel=\"noreferrer noopener\">46.204(b)<\/a>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Requirements for inclusion of pregnant women in human research<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Investigators must provide protocol specific justification to the IRB, so that the IRB may make a determination that the enrollment of pregnant women in the research is justified.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Definitions <\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/www.ecfr.gov\/current\/title-45\/subtitle-A\/subchapter-A\/part-46\/subpart-B\/section-46.202\" target=\"_blank\" rel=\"noreferrer noopener\">45 CFR \u00a746.202<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Pregnancy\u00a0encompasses the period of time from implantation until delivery. A woman shall be assumed to be pregnant if she exhibits any of the pertinent presumptive signs of pregnancy, such as missed menses, until the results of a pregnancy test are negative or until delivery.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Categories of research involving pregnant women<\/h2>\n\n\n\n<ol class=\"wp-block-list\">\n<li>Federally funded minimal risk research or has prospect of direct benefit to the woman or the fetus (<a href=\"https:\/\/www.ecfr.gov\/current\/title-45\/subtitle-A\/subchapter-A\/part-46\/subpart-B\/section-46.204\" target=\"_blank\" rel=\"noreferrer noopener\">45 CFR \u00a746.204<\/a>).<\/li>\n\n\n\n<li>The research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of pregnant women, fetuses or neonates and contact the HSPP office (<a href=\"https:\/\/www.ecfr.gov\/current\/title-45\/subtitle-A\/subchapter-A\/part-46\/subpart-B\/section-46.207\" target=\"_blank\" rel=\"noreferrer noopener\">45 CFR \u00a746.207<\/a>).<\/li>\n<\/ol>\n\n\n\n<p class=\"wp-block-paragraph\"><em>Version 2019-8<\/em><\/p>\n\n\n    <\/div>\n<\/section>\n\n<div class=\"nau-block nau-block-left-nav-bottom-bound\">\n\n<\/div>","protected":false},"excerpt":{"rendered":"","protected":false},"author":105,"featured_media":3100,"parent":2599,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"ring_central_script_selection":"","footnotes":""},"class_list":["post-2893","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/in.nau.edu\/research\/wp-json\/wp\/v2\/pages\/2893","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/in.nau.edu\/research\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/in.nau.edu\/research\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/in.nau.edu\/research\/wp-json\/wp\/v2\/users\/105"}],"replies":[{"embeddable":true,"href":"https:\/\/in.nau.edu\/research\/wp-json\/wp\/v2\/comments?post=2893"}],"version-history":[{"count":4,"href":"https:\/\/in.nau.edu\/research\/wp-json\/wp\/v2\/pages\/2893\/revisions"}],"predecessor-version":[{"id":5537,"href":"https:\/\/in.nau.edu\/research\/wp-json\/wp\/v2\/pages\/2893\/revisions\/5537"}],"up":[{"embeddable":true,"href":"https:\/\/in.nau.edu\/research\/wp-json\/wp\/v2\/pages\/2599"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/in.nau.edu\/research\/wp-json\/wp\/v2\/media\/3100"}],"wp:attachment":[{"href":"https:\/\/in.nau.edu\/research\/wp-json\/wp\/v2\/media?parent=2893"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}