{"id":2721,"date":"2016-07-28T15:44:22","date_gmt":"2016-07-28T19:44:22","guid":{"rendered":"https:\/\/www.bu.edu\/research\/?page_id=2721"},"modified":"2023-06-05T12:50:43","modified_gmt":"2023-06-05T16:50:43","slug":"human-subjects-training","status":"publish","type":"page","link":"https:\/\/www.bu.edu\/research\/ethics-compliance\/human-subjects\/human-subjects-training\/","title":{"rendered":"Human Subjects Training"},"content":{"rendered":"<p>The Charles River Campus (CRC) IRB requires all individuals involved in human subjects research to complete training in human subjects protection via the Collaborative Institutional Training Initiative (CITI) Program which must be completed by both the Principal Investigator and all study staff listed on the protocol before the protocol can be approved. This training includes an initial certification course and subsequent recertification every three years.<\/p>\n<h2 id=\"who-is-required-to-take-the-training\">Who is required to take the training?<\/h2>\n<h3 id=\"required\">Required<\/h3>\n<ul>\n<li>All study staff with human subjects\u2019 responsibilities (interactions\/interventions with study participants, or access to their identifiable data, images, biospecimens) are required to complete this CITI training.<\/li>\n<\/ul>\n<h3 id=\"not-required\">Not Required<\/h3>\n<ul>\n<li>BU CRC Staff who are performing their non-research job responsibilities (e.g., radiology technicians, phlebotomists, physical therapists, etc.). These individuals are not considered research personnel if they will be conducting the same services\/practices that they conduct in their day-to-day jobs.<\/li>\n<li>Investigators not affiliated with BU who are collaborating with BU investigators on a BU research study, and who will be covered under the review of their own IRB.<\/li>\n<\/ul>\n<h2 id=\"training-requirements\">Training Requirements<\/h2>\n<p><strong>All study staff must complete one of the following courses:<\/strong><\/p>\n<p>\u2022 &nbsp;Human Subjects Protection Training: Social and Behavioral Focus<br \/>\n\u2022 &nbsp;Human Subjects Protection Training: Biomedical Focus<\/p>\n<div class=\"bu_collapsible_container \" aria-live=\"polite\" data-customize-animation=\"false\"><h4 class=\"bu_collapsible\" aria-expanded=\"false\"tabindex=\"0\" role=\"button\">Additional training requirements<\/h4><div class=\"bu_collapsible_section\" style=\"display: none;\"><br \/>\n<strong>NIH-Funded Clinical Trials:<\/strong><\/p>\n<p>NIH-funded Investigators and clinical trial site staff who are responsible for the conduct, management and oversight of NIH-funded clinical trials are additionally required to take the <em>Good Clinical Practice (GCP)<\/em> course.<\/p>\n<p style=\"padding-left: 30px;\">\u2022\t<em>Please note that the &#8220;GCP \u2013 Social and Behavioral Research Best Practices for Clinical Research&#8221; course may not substitute for the Human Subjects Protection Training requirement.<\/em><\/p>\n<p><strong>Optional Modules:<\/strong> If the research involves working with one of the following populations, you will need to complete additional modules, which can be found under &#8220;Optional Modules&#8221; within the Human Subjects Protection Training course:<\/p>\n<p style=\"padding-left: 30px;\"><strong>Research with Children:<\/strong><br \/>\n\u2022\tResearch with Children (ID 507)<br \/>\n\u2022\tIf applicable: Research in Public Elementary and Secondary Schools (ID 508)<br \/>\n<strong>Research with Prisoners:<\/strong><br \/>\n\u2022\tResearch with Prisoners (ID 506)<br \/>\n<strong>International Research:<\/strong><br \/>\n\u2022\tInternational Research (ID 509)<br \/>\n\u2022\tInternational Studies (ID 971)<\/p>\n<p><\/div>\n<\/div>\n\n<h2 id=\"citi-training-instructions\">CITI Training Instructions<\/h2>\n<p>For instructions with screenshots, please click <a href=\"\/research\/files\/2020\/04\/CITI-Instructions-with-pictures.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">here<\/a>.<\/p>\n<div class=\"bu_collapsible_container \" aria-live=\"polite\" data-customize-animation=\"false\"><h4 class=\"bu_collapsible\" aria-expanded=\"false\"tabindex=\"0\" role=\"button\">New CITI Users<\/h4><div class=\"bu_collapsible_section\" style=\"display: none;\"><\/p>\n<ol>\n<li>Go to <a href=\"https:\/\/www.citiprogram.org\">https:\/\/www.citiprogram.org<\/a><\/li>\n<li>Click the \u201cRegister\u201d icon on the top left corner of your screen<\/li>\n<li>This will bring you to the \u201cLearner Registration\u201d page. In the text box provided, type \u201cBoston University\u201d. Select the \u201cBoston University (Charles River Campus)\u201d option (the other option is \u201cBoston University Medical Campus\/Boston Medical Center\u201d which is for the Medical Campus).<\/li>\n<li>Next, you must agree to the terms of service and affirm your affiliation with Boston University (Charles River Campus). Once you have done so, click on the \u201cContinue\u201d button.<\/li>\n<li>Complete all the fields in the registration form and then click on \u201cNext.\u201d<\/li>\n<li>In the \u201cSelect Curriculum\u201d page, select the following:\n<p style=\"padding-left: 30px;\">Question 1: Everyone must select \u201cHuman Research Courses\u201d<br \/>\n\u2022\tIf your study is an NIH-Funded Clinical Trial, you will also need to select \u201cGood Clinical Practice\u201d course<br \/>\n\u2022\tAfter selecting the appropriate course(s), click \u201cNext\u201d<br \/>\nQuestion 2: Select \u201cbasic\u201d<br \/>\nQuestion 3: The Boston University Charles River Campus IRB will accept either of the following courses:<br \/>\n\u2022\t&nbsp;Human Subjects Protection Training: Social &amp; Behavioral Focus<br \/>\n\u2022\t&nbsp;Human Subjects Protection Training: Biomedical Focus<\/p>\n<\/li>\n<\/ol>\n<p><\/div>\n<\/div>\n\n<div class=\"bu_collapsible_container \" aria-live=\"polite\" data-customize-animation=\"false\"><h4 class=\"bu_collapsible\" aria-expanded=\"false\"tabindex=\"0\" role=\"button\">Existing CITI Users<\/h4><div class=\"bu_collapsible_section\" style=\"display: none;\"><\/p>\n<ol>\n<li>Go to <a href=\"https:\/\/www.citiprogram.org\">https:\/\/www.citiprogram.org<\/a><\/li>\n<li>Log into your existing CITI account using the username and password you previously registered with. This should take you to the Welcome screen of your CITI account.<\/li>\n<li>Under Institution Courses, next to \u201cWould you like to affiliate with another institution,\u201d click on \u201cAdd An Affiliation\u201d.<\/li>\n<li>In the text box provided, type \u201cBoston University\u201d. Select the \u201cBoston University (Charles River Campus)\u201d option (the other option is \u201cBoston University Medical Campus\/Boston Medical Center\u201d which is for the Medical Campus).<\/li>\n<li>Next, you must agree to the terms of service and affirm your affiliation with Boston University (Charles River Campus). Once you have done so, click on the \u201cContinue\u201d button.<\/li>\n<li>Complete all the fields in the registration form and then click on \u201cNext.\u201d<br \/>\nIn the \u201cSelect Curriculum\u201d page, select the following:<\/p>\n<p style=\"padding-left: 30px;\">Question 1:    Everyone must select \u201cHuman Research Courses\u201d<br \/>\n\u2022\tIf your study is an NIH-Funded Clinical Trial, you will also need to select \u201cGood Clinical Practice\u201d course<br \/>\n\u2022\tAfter selecting the appropriate course(s), click \u201cNext\u201d<br \/>\nQuestion 2:    Select \u201cbasic\u201d<br \/>\nQuestion 3:    The Boston University Charles River Campus IRB will accept either of the following courses:<br \/>\n\u2022\tHuman Subjects Protection Training: Social &amp; Behavioral Focus<br \/>\n\u2022\tHuman Subjects Protection Training: Biomedical Focus<\/p>\n<\/li>\n<\/ol>\n<p><\/div>\n<\/div>\n\n<div class=\"bu_collapsible_container \" aria-live=\"polite\" data-customize-animation=\"false\"><h4 class=\"bu_collapsible\" aria-expanded=\"false\"tabindex=\"0\" role=\"button\">Locating Optional Modules<\/h4><div class=\"bu_collapsible_section\" style=\"display: none;\"><\/p>\n<ol>\n<li>Log into your CITI Profile<\/li>\n<li>Click the \u201ccourses\u201d tab at the top of your screen<\/li>\n<li>Under \u201cBoston University\u201d, you will see another section that lists your \u201cCompleted Courses\u201d. Under this subsection, you will see your (completed) course titled \u201cHuman Subjects Protection Training: Social and Behavioral Focus\u201d.<\/li>\n<li>Under this box that is for the \u201cHuman Subjects Protection Training: Social and Behavioral Focus\u201d course, you will see that blue button that says \u201cReview Course\u201d. Click on this button.<\/li>\n<li>This will bring you to the list of modules that you have completed in order to complete this specific course. If you begin to scroll down, you will see the list of \u201cRequired Modules\u201d, all of which you were required to complete to obtain your CITI certification.<\/li>\n<li>At the end of this list, you will see another list titled \u201cOptional Modules\u201d. Continue to scroll until you see the specific module you wish to complete.<\/li>\n<li>Once you have located this module, there will be a box that either says \u201cReview\u201d or \u201cStart\u201d depending on whether or not you have previously completed this module<\/li>\n<\/ol>\n<p><\/div>\n<\/div>\n\n<h2 id=\"course-modules\">Course Modules<\/h2>\n<div class=\"bu_collapsible_container \" aria-live=\"polite\" data-customize-animation=\"false\"><h4 class=\"bu_collapsible\" aria-expanded=\"false\"tabindex=\"0\" role=\"button\">Human Subjects Protection Training: Social &amp; Behavioral Focus<\/h4><div class=\"bu_collapsible_section\" style=\"display: none;\"><\/p>\n<li>Belmont Report and Its Principles (ID 1127)<\/li>\n<li>HIPAA and Research Data Security at Boston University (CRC) (ID 17347)<\/li>\n<li>Conflicts of Interest in Human Subjects Research (ID 17464)<\/li>\n<li>Students in Research (ID 1321)<\/li>\n<li>History and Ethical Principles &#8211; SBE (ID 490)<\/li>\n<li>Defining Research with Human Subjects &#8211; SBE (ID 491)<\/li>\n<li>The Federal Regulations &#8211; SBE (ID 502)<\/li>\n<li>Assessing Risk &#8211; SBE (ID 503)<\/li>\n<li>Informed Consent &#8211; SBE (ID 504)<\/li>\n<li>Privacy and Confidentiality &#8211; SBE (ID 505)<\/li>\n<li>Unanticipated Problems and Reporting Requirements in Social and Behavioral Research (ID 14928)<\/li>\n<li>Conflicts of Interest in Research Involving Human Subjects (ID 488)<\/li>\n<li>Boston University (ID 13950)<\/li>\n<p><\/div>\n<\/div>\n\n<div class=\"bu_collapsible_container \" aria-live=\"polite\" data-customize-animation=\"false\"><h4 class=\"bu_collapsible\" aria-expanded=\"false\"tabindex=\"0\" role=\"button\">Human Subjects Protection Training: Biomedical Focus<\/h4><div class=\"bu_collapsible_section\" style=\"display: none;\"><\/p>\n<li>Belmont Report and Its Principles (ID 1127)<\/li>\n<li>Avoiding Group Harms- U.S. Research Perspectives (ID 14080)<\/li>\n<li>Populations in Research Requiring Additional Considerations and\/or Protections (ID 16680)<\/li>\n<li>HIPAA and Research Data Security at Boston University (CRC) (ID 17347)<\/li>\n<li>Conflicts of Interest in Human Subjects Research (ID 17464)<\/li>\n<li>History and Ethics of Human Subjects Research (ID 498)<\/li>\n<li>Basic Institutional Review Board (IRB) Regulations and Review Process (ID 2)<\/li>\n<li>Informed Consent (ID 3)<\/li>\n<li>Social and Behavioral Research (SBR) for Biomedical Researchers (ID 4)<\/li>\n<li>Records-Based Research (ID 5)<\/li>\n<li>Vulnerable Subjects &#8211; Research Involving Workers\/Employees (ID 483)<\/li>\n<li>Hot Topics (ID 487)<\/li>\n<p><\/div>\n<\/div>\n\n<p>*Please note that it is the responsibility of the Principal Investigator to ensure that all study staff have completed the required training and that it is up to date.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Charles River Campus (CRC) IRB requires all individuals involved in human subjects research to complete training in human subjects protection via the Collaborative Institutional Training Initiative (CITI) Program which must be completed by both the Principal Investigator and all study staff listed on the protocol before the protocol can be approved. This training includes [&hellip;]<\/p>\n","protected":false},"author":11959,"featured_media":0,"parent":420,"menu_order":20,"comment_status":"closed","ping_status":"closed","template":"page-templates\/chapter-navigation.php","meta":[],"_links":{"self":[{"href":"https:\/\/www.bu.edu\/research\/wp-json\/wp\/v2\/pages\/2721"}],"collection":[{"href":"https:\/\/www.bu.edu\/research\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.bu.edu\/research\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.bu.edu\/research\/wp-json\/wp\/v2\/users\/11959"}],"replies":[{"embeddable":true,"href":"https:\/\/www.bu.edu\/research\/wp-json\/wp\/v2\/comments?post=2721"}],"version-history":[{"count":54,"href":"https:\/\/www.bu.edu\/research\/wp-json\/wp\/v2\/pages\/2721\/revisions"}],"predecessor-version":[{"id":46989,"href":"https:\/\/www.bu.edu\/research\/wp-json\/wp\/v2\/pages\/2721\/revisions\/46989"}],"up":[{"embeddable":true,"href":"https:\/\/www.bu.edu\/research\/wp-json\/wp\/v2\/pages\/420"}],"wp:attachment":[{"href":"https:\/\/www.bu.edu\/research\/wp-json\/wp\/v2\/media?parent=2721"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}