{"id":2764,"date":"2025-11-06T12:17:11","date_gmt":"2025-11-06T18:17:49","guid":{"rendered":"https:\/\/uwm.edu\/safety-assurances\/?page_id=2764"},"modified":"2026-04-03T10:04:12","modified_gmt":"2026-04-03T15:04:12","slug":"frequently-asked-questions","status":"publish","type":"page","link":"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-review-board\/frequently-asked-questions\/","title":{"rendered":"Frequently Asked Questions"},"content":{"rendered":"\n<div class=\"uwm-l-row\">\n<div class=\"uwm-l-col\">\n<h2 class=\"wp-block-heading\" id=\"h-general-information\">General Information<\/h2>\n\n\n\n<div class=\"uwm-p-accordion\" data-accordion-prefix-classes=\"uwm\" data-accordion-cool-selectors=\"1\"><button class=\"uwm-p-accordion--toggle-button size-p-md\">Expand All<\/button>\n<div class=\"uwm-p-accordion--header\">1. What is the Institutional Review Board (IRB)?<\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>Federal regulations and UW-Milwaukee policy requires research involving human subjects to be reviewed and approved by the Institutional Review Board (IRB). There is currently one UWM IRB registered under a Federalwide Assurance (FWA) with the Department of Health and Human Services. The IRB reviews research conducted by UWM faculty, staff, or students. The IRB is comprised of UWM faculty, staff, students, and community representatives.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\">2. What is a Federalwide Assurance (FWA)?<\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>An FWA is a document that designates the IRB that will review and oversee the research. It also specifies the ethical principles under which the research will be conducted and names the individuals who will be responsible for the proper conduct of the research. UWM has its own FWA (FWA00006171) for research conducted at UWM. Under the FWA, the IRB is also charged with the responsibility for assuring that human subject research conducted under the auspices of UWM (e.g., investigators and facilities) is conducted in compliance with federal law.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\">3. What ethical principles guide the IRB?<\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>The IRB is guided by three basic principles set forth in the Belmont Report:<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>Respect for Persons:<\/strong> Treating subjects with dignity and autonomy while affording those with diminished autonomy with additional protections. A key part of this is informed consent.<\/li>\n\n\n\n<li><strong>Beneficence:<\/strong> An obligation to not harm subjects; to maximize benefits and minimize possible harms.<\/li>\n\n\n\n<li><strong>Justice:<\/strong> Fairness in the selection of research subjects; fairness in the distribution of benefits and risks.<\/li>\n<\/ol>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\">4. What qualifies for IRB review?<\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>The criteria to determine whether a project requires IRB review and approval is based on it being (1) \u201cresearch\u201d defined as: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge\u201d&nbsp;<strong>and<\/strong>&nbsp;the project involves (2) \u201chuman subjects\u201d defined as: a living individual about whom an investigator conducting research obtains (a) data through intervention or interaction with the individual, or (b) identifiable private information.<\/p>\n\n\n\n<p>Once a project is determined to be \u201cresearch involving human subjects,\u201d UWM must also be engaged in the research in one or more of the following capacity: (1) research conducted by UWM faculty (any percent time appointment, including adjunct and non-salary), students, and staff under UWM auspices; (2) research conducted by affiliated faculty under UWM auspices; or (3) non-UWM personnel using UWM equipment.<\/p>\n\n\n\n<p>Visit the \u201cDo You Need to Submit to the IRB?\u201d section of the&nbsp;<a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-review-board\/submission\/\">Submission<\/a>&nbsp;page&nbsp;for detailed instructions.<\/p>\n\n\n\n<p>Determining when a Quality Improvement project requires UWM IRB review can be complicated. Please refer to #9 below for more information.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\">5. Do I need IRB review\/approval if I am not affiliated with UWM but would like to conduct research at UWM or use UWM subjects?<\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>If you intend to use certain facilities or equipment (e.g., psychology and exercise physiology lab), or have subjects perform physical activities on UWM premises, IRB review\/approval may be needed, please contact the IRB office for details. Certain activities (e.g., interviewing or surveying students in the Union) would not need UWM IRB review.&nbsp;Visit the \u201cDo You Need to Submit to the IRB?\u201d section of the&nbsp;<a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-review-board\/submission\/\">Submission<\/a>&nbsp;page&nbsp;for detailed information and a link to our Determination form.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\">6<strong>. I am required to conduct a research project for my class assignment, do I need IRB review?<\/strong><\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>This type of research does not need approval if the data collected from the research project will not go beyond the classroom setting. For instance, if a student is required to design and conduct interviews for her research methods course, IRB review would not be required. However, if they plan to use that data for a larger project (PhD dissertation), that would constitute generalizable knowledge, then IRB review is required. Visit the \u201cDo You Need to Submit to the IRB?\u201d section of the&nbsp;<a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-review-board\/submission\/\">Submission<\/a>&nbsp;page for detailed information and a link to our Determination form.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\">7<strong>. What about anthropological and ethnographic research?<\/strong><\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>These types of research will need to be submitted to the IRB if it involves \u201ca systematic investigation\u2026designed to develop or contribute to generalizable knowledge.\u201d Although these types of studies take place in natural settings, IRB review is necessary to ensure that the human subjects are not harmed. Visit the\u00a0<a href=\"https:\/\/americananthro.org\/institutional-review-boards-and-anthropology\/\">American Anthropological Association<\/a> for their statement on IRB review.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\">8. <strong>What about oral history projects?<\/strong><\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>Oral History projects may or may not meet the definition of research.&nbsp; Review the \u201cDo You Need to Submit to the IRB?\u201d section of the&nbsp;<a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-review-board\/submission\/\">Submission<\/a>&nbsp;page for detailed information and a link to our Determination form.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\">9<strong>. When do Quality Improvement projects require IRB approval?<\/strong><\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>If a quality improvement or quality assurance project meets the definition of research then it would need to be submitted and approved by the IRB.&nbsp;Visit the \u201cDo You Need to Submit to the IRB?\u201d section of the&nbsp;<a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-review-board\/submission\/\">Submission<\/a>&nbsp;page for detailed information and a link to our Determination form and feel free to contact the IRB office if further clarification is needed.&nbsp;The IRB staff have also put together a brief&nbsp;<a href=\"https:\/\/uwm.edu\/irb\/wp-content\/uploads\/sites\/127\/2024\/01\/Determination-of-UWM-IRB-Review-Guidance-August-2014-updated-links.pdf\">Determination Guide (PDF)<\/a>&nbsp;for guidance.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\">10<strong>. What is Exempt, Expedited, and Full Board Review?<\/strong><\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>There are three types of IRB review (Exempt, Expedited, and Full Board). Even though the Principal Investigator identifies the type of review when s\/he completes the New Study Form, the IRB makes the final determination.&nbsp;Visit the <a href=\"http:\/\/www.hhs.gov\/ohrp\/policy\/checklists\/decisioncharts.html\">HHS Office for Human Research Protections Decision Chart<\/a> for more information.<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>Exempt<\/strong>: Under federal regulations, certain types of research may be exempt from IRB review if the study involves no more than \u201cminimal risk\u201d and falls into one or more of six categories.&nbsp;Visit the <a href=\"http:\/\/www.hhs.gov\/ohrp\/humansubjects\/guidance\/45cfr46.html#46.101\">HHS Office for Human Research Protections<\/a> for exemption categories. The New Study Submission Form also identifies the six categories. Exempt status must be determined by the IRB, so a new study submission and approval letter from the IRB are required.<\/li>\n\n\n\n<li><strong>Expedited:<\/strong>&nbsp;The IRB may use an expedited review procedure when the research involves no more than minimal risk to the subjects and where the only involvement of human subjects will be in one or more of the expedited categories.&nbsp;Visit the <a href=\"http:\/\/www.hhs.gov\/ohrp\/policy\/expedited98.html\">HHS Office for Human Research Protections<\/a> for expedited categories. The New Study Submission Form also identifies the categories.<\/li>\n\n\n\n<li><strong>Full Board:<\/strong>&nbsp;Submissions that are neither exempt nor expedited are sent to the Full Board for review.<\/li>\n<\/ol>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\">11<strong>. Who can be a Principal Investigator (PI)?<\/strong><\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>Under current UWM guidelines, only faculty and staff are allowed to be the Principal Investigator. Students may be listed as \u201cStudent PI.\u201d<\/p>\n<\/div><\/div>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-training-related-to-human-subjects-research\">Training Related to Human Subjects Research<\/h2>\n\n\n\n<div class=\"uwm-p-accordion\" data-accordion-prefix-classes=\"uwm\" data-accordion-cool-selectors=\"1\"><button class=\"uwm-p-accordion--toggle-button size-p-md\">Expand All<\/button>\n<div class=\"uwm-p-accordion--header\"><strong>12. Is training required?<\/strong><\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>Human Subjects Research Training provides information on the rules, regulations, and ethical principles governing research involving human subjects and is required for all Principal Investigators, Student Principal Investigators, and strongly recommended for research personnel interacting (consenting, recruiting, data collecting, etc.) with research participants. The IRB may require non-PIs to complete the training. Visit the&nbsp;&#8220;Human Subjects Research Training \/ CITI&#8221; section of the <a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-review-board\/training\">Training<\/a> page for additional information.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\"><strong>13. How do I complete human subjects training?<\/strong><\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>Visit the &#8220;Human Subjects Research Training \/ CITI&#8221; section of the UWM IRB\u2019s <a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-review-board\/training\">Training<\/a> page&nbsp;and follow the detailed instructions for completing the CITI training.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\"><strong>14. Does the IRB track those who complete Human Subjects research training?<\/strong><\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>Yes. If you have completed CITI training and have listed your institution as UWM then the IRB will automatically receive an electronic notice once certification is complete. If you list your UWM email address in CITI, the training information is also automatically pulled into I-Manager.<\/p>\n\n\n\n<p>If you have completed the CITI training under a different institution, please email the IRB office (<a href=\"mailto:irbinfo@uwm.edu\">irbinfo@uwm.edu<\/a>) a copy of your completion certificate that includes the list of modules you completed and quiz scores). If the modules you completed are similar enough to the ones UWM requires, we will accept this training instead of requiring you to do the UWM-specific training.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\"><strong>15. What if I am not UWM faculty, staff, or student but have completed or want to complete the CITI training?<\/strong><\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>Register for and complete the CITI training using your current institution and email the IRB office a copy of your completion certificate.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\"><strong>16. How do I complete or report previous completion of human subjects training if I am not UWM faculty, staff, or student?<\/strong><\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>If you have completed the CITI training under a different institution, please email the IRB office (<a href=\"mailto:irbinfo@uwm.edu\">irbinfo@uwm.edu<\/a>) a copy of your completion certificate that includes the list of modules you completed and quiz scores). If the modules you completed are similar enough to the ones UWM requires, we will accept this training instead of requiring you to do the UWM-specific training.<\/p>\n<\/div><\/div>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-submitting-a-study-for-review\">Submitting a Study for Review<\/h2>\n\n\n\n<div class=\"uwm-p-accordion\" data-accordion-prefix-classes=\"uwm\" data-accordion-cool-selectors=\"1\"><button class=\"uwm-p-accordion--toggle-button size-p-md\">Expand All<\/button>\n<div class=\"uwm-p-accordion--header\"><strong>17. I&#8217;ve determined that my study requires IRB review, now what?<\/strong><\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>Begin by reviewing the&nbsp;Visit the \u201cStep-by-Step New Study Submission Instructions\u201d section of the&nbsp;<a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-review-board\/submission\/\">Submission<\/a>&nbsp;page. Create an I-Manager account, if you don\u2019t already have one. To create an account, log in with your PantherID. An account will automatically be created. You will ultimately need to complete the IRB Application Form in I-Manager and create study documents (e.g., Consent Forms). Submit all relevant study materials (survey instrument, interview questions, recruitment flyers, consent forms, etc.) to the IRB via&nbsp;<a href=\"https:\/\/irbmanager.becirb.com\/Login.aspx?clientid=uwm\">I-Manager<\/a>.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\"><strong>18. This study is being conducted at multiple sites, is IRB approval needed from them as well?<\/strong><\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>Typically, yes, if the other site has an IRB. Visit the &#8220;IRB Reliance (Deferral) Requests&#8221; section of the&nbsp;<a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-review-board\/forms\">Forms<\/a>&nbsp;page for more information about the potential for arranging single IRB review in these cases.<\/p>\n\n\n\n<p>If the other institution does NOT have an IRB, then we can usually oversee the study on that institution\u2019s behalf. If there is federal funding, an Institutional Authorization Agreement or Individual Investigator Agreement will be required. Contact the IRB office with questions about how to proceed in these situations.<\/p>\n\n\n\n<p>Please factor in the extra time that may be needed from other IRBs or institutional permissions when planning your project. For example, projects involving the use of ionizing radioactive materials or radiation producing devices (e.g., x-rays) located here on the UWM campus require separate review and approval from the&nbsp;<a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/radiation-safety\/\">Radiation Safety Program<\/a>. Research conducted at Milwaukee Public Schools requires MPS review and approval. Advocate Aurora Health Care and Children\u2019s Wisconsin also have additional institutional requirements that need to be fulfilled in addition to IRB review and approval. All of these take time.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\"><strong>19. When is informed consent necessary?<\/strong><\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>All research subjects must give their express consent to participate in a research study. Consent is a necessary element for all research studies, even exempt research. Consent is only considered valid if the subjects are given enough information to allow them to weigh the study\u2019s risks and benefits and if the information is told to them in terms that they can understand. Subjects always have the right to decline or even withdraw from any study.<\/p>\n\n\n\n<p>Under certain circumstances, informed consent or parts of it may be waived or modified (e.g., information letters). However, the default should be to obtain informed consent, and waivers are permitted only when there is sufficient justification to satisfy the IRB that obtaining consent is not feasible for your project.<\/p>\n\n\n\n<p>The IRB Staff has put together some helpful hints on the informed consent process and different types of consent in the&nbsp;<a href=\"https:\/\/uwm.edu\/irb\/wp-content\/uploads\/sites\/127\/2024\/01\/UWM-IRB-Consent-helpful-hints_FINAL_updated-link.pdf\">IRB Consent Guidance Document (PDF)<\/a>.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\"><strong>20. What do I need to know about data confidentiality?<\/strong><\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>An important risk for many studies reviewed by the IRB is breach of confidentiality. The IRB will ask you to specifically tell us how you are securing the data you will be collecting as part of your study. Visit the&nbsp;<a href=\"https:\/\/uwm.edu\/irb\/wp-content\/uploads\/sites\/127\/2024\/01\/UWM-IRB-Data-Confidentiality-Guidance.pdf\">Data Confidentiality Guidance (PDF)<\/a>&nbsp;document for recommendations on data confidentiality measures you may want to consider. The&nbsp;<a href=\"https:\/\/uwm.edu\/itsecurity\/\">University IT security department<\/a> is another resource.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\"><strong>21. What do I need to know if I am doing internet-based research?<\/strong><\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>Internet-based research involves collecting data from internet-based resources. This can involve websites, chat rooms, message forums, Facebook, virtual reality spaces, etc. There are a variety of issues to consider if you are doing internet-based research.&nbsp;The starting point is to determine if your project involves human subjects based on the OHRP\u2019s definition of human subject:&nbsp;\u201cA living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information\u201d.&nbsp;To provide some explanation for how the IRB thinks about this in relation to internet research and answers to other questions around internet-based research, please refer to the&nbsp;<a href=\"https:\/\/uwm.edu\/irb\/wp-content\/uploads\/sites\/127\/2024\/01\/OnlineResearch_V2.pdf\">Guidance on Internet-based Research document (PDF)<\/a>.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\"><strong>22. When can I begin my research?<\/strong><\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>Remember, no research-related activities may begin until the IRB has given your research project full approval, meaning that all revisions or conditions are complete and the researcher has received an official approval letter. This includes screening subjects or mailing out questionnaires. Certain research feasibility activities are permissible (e.g., gathering institutional or other appropriate permissions, gauging participant interest), please contact the IRB staff for specific directions.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\"><strong>23. What are Revisions\/Conditions requested by the IRB?<\/strong><\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>After the Principal Investigator submits a study and the study has been reviewed, the IRB may ask for revisions or place conditions on the study before final approval is granted. For example, the IRB may request revisions to the consent form after the IRB staff, designated IRB reviewers, or the Full Board reviews the study.<\/p>\n\n\n\n<p>After you have made the required changes and resubmitted your study, you will be notified by email with a formal letter attached that your protocol is approved.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\"><strong>24. Can I begin my study when I receive a Conditional Approval or Revisions Requested letter?<\/strong><\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>No. Study activities (e.g., recruiting, enrolling, etc.) may not begin until final approval is granted.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\"><strong>25. After I receive IRB approval, is there anything else I need to know?<\/strong><\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>Once IRB approval is granted, the following require future submissions to the IRB:<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>Continuing Review:<\/strong> For some Expedited and all Full Board studies, the IRB must conduct continuing review of research on an annual basis. This means that if your research study will not be complete (including data analysis &amp; writing up of results) within that time, the IRB must review your study and give continuing approval.<\/li>\n\n\n\n<li><strong>Modifications \/ Amendments:<\/strong> Modifications to the planned research may affect the treatment of human subjects and therefore must be reviewed and approved by the IRB prior to their implementation. Visit \u201cSubmitting Modifications \/ Amendments\u201d for additional FAQs.<\/li>\n\n\n\n<li><strong>Reportable Event:<\/strong> Principal investigators are responsible for the timely reporting of adverse events or noncompliance to the IRB. Visit Question #34 below \u201cWhat is a Reportable Event\u201d for additional FAQs.<\/li>\n<\/ol>\n<\/div><\/div>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-after-approval-annual-reports-to-the-irb\">After Approval: Annual Reports to the IRB<\/h2>\n\n\n\n<div class=\"uwm-p-accordion\" data-accordion-prefix-classes=\"uwm\" data-accordion-cool-selectors=\"1\"><button class=\"uwm-p-accordion--toggle-button size-p-md\">Expand All<\/button>\n<div class=\"uwm-p-accordion--header\"><strong>26. What is Continuing Review?<\/strong><\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>Once a study receives IRB approval, federal regulations require an annual review of certain research studies no less than once per year. This review must take place on or before the anniversary date of when the research study was last reviewed, regardless of when the research study actually started. If you plan to continue research past the date of IRB expiration, continuing review and approval from the IRB is required. Any data collected, or research activities conducted without IRB approval is in non-compliance with both institutional and federal regulations.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\"><strong>27. Who needs continuing approval?<\/strong><\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>Continuing review is required for all Full Board and some Expedited studies. You will receive automated notifications in advance of the expiration date giving you instructions about what to do to keep your study open (either submit a continuing review, if required, or provide an email update of your study status).<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\"><strong>28. What do I need to do in order to get continuing approval?<\/strong><\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>Continuing review submissions are made by completing and submitting a continuing review x-form in I-Manager. You will receive automated notices beginning 45 days before the date of IRB expiration with instructions for submitting.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\"><strong>29. When should I file the submission?<\/strong><\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>The recommended timeframe is approximately ~30 days before the date of IRB expiration.&nbsp;Please note that the IRB Staff will review the continuing review documents shortly after they are submitted but that an approval letter will not be sent out until within days of the expiration date so as to keep the approval dates consistent from year to year.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\"><strong>30. My study went past the expiration date, what do I do?<\/strong><\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>STOP all research activities immediately! There is no grace period. Only if the IRB determines that the continuation of the subjects in the research activity (i.e., medical or psychological treatment\/intervention) presents a prospect of direct benefit, may individual subjects continue in the research as the investigator seeks IRB re-approval for the study (contact the IRB office). Expiration of IRB approval (unless the offense is repeated) will not be reported to OHRP as a suspension of IRB approval under DHHS regulations.<\/p>\n\n\n\n<p>If your IRB approval lapses:<\/p>\n\n\n\n<ol style=\"list-style-type:lower-alpha\" class=\"wp-block-list\">\n<li>If you are done with the study, then there is no need to do anything. The IRB automatically closes your study if it has not received a submission by your study\u2019s IRB expiration date.<\/li>\n\n\n\n<li>If you plan to continue research, then you must apply for IRB approval by submitting a Continuing Review Form or provide the requested update.<\/li>\n<\/ol>\n<\/div><\/div>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-after-approval-making-changes-to-the-study\">After Approval: Making Changes to the Study<\/h2>\n\n\n\n<div class=\"uwm-p-accordion\" data-accordion-prefix-classes=\"uwm\" data-accordion-cool-selectors=\"1\"><button class=\"uwm-p-accordion--toggle-button size-p-md\">Expand All<\/button>\n<div class=\"uwm-p-accordion--header\"><strong>31. What are Modifications or Amendments?<\/strong><\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>Once a study receives IRB approval, any changes to the research project must be approved by the IRB before implementation. For instance, changes to the study title, principal investigator, informed consent document, and study design all require prior authorization from the IRB.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\"><strong>32. What do I need to do in order to get my modification\/amendment approved?<\/strong><\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>Visit the &#8220;Amendment and Continuing Review Submissions&#8221; section of the <a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-review-board\/submission\/\">Submissions<\/a>&nbsp;page for instructions. Remember to use track changes to clearly indicate the requested changes in these documents so that the IRB can readily identify the changes.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\"><strong>33. Can I submit a Modifications\/Amendment request at the same time as the Continuing Review?<\/strong><\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>Yes, however, you must submit a separate Amendment and Continuing Review x-form. You cannot request changes in the Continuing Review.<\/p>\n<\/div><\/div>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-after-approval-something-happened-to-one-of-my-participants\">After Approval: Something Happened to One of My Participants<\/h2>\n\n\n\n<div class=\"uwm-p-accordion\" data-accordion-prefix-classes=\"uwm\" data-accordion-cool-selectors=\"1\"><button class=\"uwm-p-accordion--toggle-button size-p-md\">Expand All<\/button>\n<div class=\"uwm-p-accordion--header\"><strong>34. What is a Reportable Event?<\/strong><\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>The IRB is responsible for on going monitoring of the safety and welfare of human subjects. Part of this monitoring is on-going review and assessment of reportable events related to participation in the research.<\/p>\n\n\n\n<p>One type of reportable event is an Adverse Event (AE), which are any occurrences that may present itself during the conduct of a research study that ultimately harms the subject. AEs may either be related or unrelated to the research. Remember, some adverse events are required to be reported to the IRB within 10 working days.<\/p>\n\n\n\n<p>Submit a reportable event to the IRB by completing and submitting a Reportable Event x-form.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\"><strong>35. What do I do if a subject needs medical care?<\/strong><\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>UWM generally does not provide research participants with reimbursement for medical expenses incurred as a result of their participation. Thus, participants are responsible for their own medical care. Sometimes, however, medical situations can and do arise.<\/p>\n\n\n\n<p>For Emergencies: Dial 9-911 (on campus) or 911 (off campus).<br>For Non-Emergencies: If the individual needs basic First Aid, contact the UWM Police Department at x4627. If the individual does not need First Aid but may need some additional care, ask the injured person if he or she would like assistance a health care provider of his or her choice. If the injured person is a student, he or she may be entitled to services at the Norris Health Center. Ask the student if he or she would like assistance contacting Norris at x4716.<\/p>\n\n\n\n<p>After the incident has occurred: The PI must complete a General Incident Report Form. If you have questions about this requirement, contact the Risk Manager at <a href=\"tel:414-229-5079\">414-229-5079<\/a>. You must complete this Form whether or not the injured person wants you to do so, even if the injuries are very minor.<\/p>\n\n\n\n<p>If this event was not an anticipated risk identified in the protocol and consent form, it must be reported to the IRB as a Reportable Event. When in doubt, contact the IRB office for guidance.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\"><strong>36. What if I enrolled more subjects than the IRB approved?<\/strong><\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>Please contact the IRB office to discuss and we can give you guidance on how to report this and what the next steps are.<\/p>\n<\/div><\/div>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-definitions\">Definitions<\/h2>\n\n\n\n<p><strong>Research:<\/strong>&nbsp;Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. (45 CFR46.102(d))<\/p>\n\n\n\n<p><strong>Human Subject:<\/strong>&nbsp;Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains:<\/p>\n\n\n\n<p>(1) Data through&nbsp;<strong>intervention<\/strong>&nbsp;or&nbsp;<strong>interaction<\/strong>&nbsp;with the individual, or<br>(2) Identifiable&nbsp;<strong>private information<\/strong>.<\/p>\n\n\n\n<p><strong>Intervention<\/strong>&nbsp;includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject\u2019s environment that are performed for research purposes.&nbsp;<strong>Interaction<\/strong>&nbsp;includes communication or interpersonal contact between investigator and subject.&nbsp;<strong>Private information<\/strong>&nbsp;includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. (45CFR46.102(f))<\/p>\n\n\n\n<p><strong>Minimal Risk:<\/strong>&nbsp;Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. (45CFR46.102(i))<\/p>\n<\/div>\n\n\n\n<div class=\"uwm-l-col uwm-l-col--4 uwm-l-offset--1\"><div class=\"content_block\" id=\"custom_post_widget-3987\"><nav aria-label=\"Sidebar\" class=\"uwm-p-navigation-list uwm-p-navigation-list--gold-border \"><div class=\"uwm-p-navigation-list--title\"><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/\">Research Compliance<\/a><\/div><ul><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/animal-care-program\/\">Animal Care Program<\/a><\/li><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-biosafety-committee\/\">Institutional Biosafety Committee<\/a><\/li><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-review-board\/\">Institutional Review Board (Human Subjects)<\/a><ul><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-review-board\/training\/\">Training<\/a><\/li><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-review-board\/submission\/\">Study Submission<\/a><\/li><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-review-board\/i-manager\/\">I-Manager<\/a><\/li><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-review-board\/meeting-dates\/\">Meeting Dates<\/a><\/li><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-review-board\/member-roster\/\">Member Roster<\/a><\/li><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-review-board\/standard-operating-procedures\/\">Standard Operating Procedures<\/a><\/li><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-review-board\/resources\/\">Resources<\/a><\/li><li><a class=\"current\" href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-review-board\/frequently-asked-questions\/\"><span aria-current=\"page\">Frequently Asked Questions<\/span><\/a><\/li><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-review-board\/events\/\">Events<\/a><\/li><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-review-board\/irb-reliance-requests\/\">IRB Reliance Requests<\/a><\/li><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-review-board\/forms\/\">Forms<\/a><\/li><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-review-board\/contact\/\">Contact<\/a><\/li><\/ul><\/li><\/ul><\/nav><\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":639,"featured_media":0,"parent":2730,"menu_order":7,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":"","uwm_wg_additional_authors":[1282,1523,1524]},"class_list":["post-2764","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Safety &amp; 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