{"id":2853,"date":"2025-11-10T11:25:25","date_gmt":"2025-11-10T17:25:25","guid":{"rendered":"https:\/\/uwm.edu\/safety-assurances\/?page_id=2853"},"modified":"2026-02-26T12:25:27","modified_gmt":"2026-02-26T18:25:27","slug":"biosafety-protocol-submissions","status":"publish","type":"page","link":"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-biosafety-committee\/biosafety-protocol-submissions\/","title":{"rendered":"Biosafety Protocol Submissions"},"content":{"rendered":"\n<div class=\"uwm-l-row\">\n<div class=\"uwm-l-col\">\n<p class=\"default\">UWM uses an online system called I-Manager for all protocol submission to the Institutional Biosafety Committee (IBC).<\/p>\n\n\n\n<p>All research and teaching activities at UWM that involve recombinant or synthetic nucleic acid molecules or any other biohazardous materials must be submitted to the IBC prior to beginning the work. IBC approvals are valid for 3 years, after which point continuing projects must be renewed and re-reviewed. The committee\u2019s review ensures that all use of biologically hazardous materials in UWM research and teaching laboratories is conducted safely and ethically.<\/p>\n\n\n\n<div class=\"uwm-u-flex uwm-u-flex--wrap uwm-u-flex--left\">\n<a class=\"uwm-c-button uwm-u-mr-20 uwm-u-mb-20\" href=\"https:\/\/uwm.my.irbmanager.com\/Login.aspx?clientid=uwm\" rel=\"\">Access I-Manager<\/a>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-authorized-personnel-that-can-submit-a-biosafety-protocol\">Authorized Personnel That Can Submit a Biosafety Protocol<\/h2>\n\n\n\n<p>All biosafety protocols must designate a single individual as Principal Investigator (PI; for research protocols) or Lead Course Instructor (LCI; for teaching protocols). This individual is ultimately responsible for ensuring the compliance and safety of all activities described in the protocol. Only those individuals with supervisory authority, such as professors, instructors, and lab managers, may serve as PI or LCI on a biosafety protocol. <\/p>\n\n\n\n<p>Other individuals, such as graduate students and postdoctoral scholars, may initiate biosafety protocol submissions, complete protocol content, and serve as co-investigators on projects. However, an appropriate PI or LCI must still be responsible for the overall content and approve of its submission.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-managing-protocol-submissions\">Managing Protocol Submissions<\/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\">New Protocols<\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>All use of recombinant or synthetic nucleic acid molecules or other biohazardous materials for research or teaching purposes requires submission of a Biosafety Protocol to the IBC. These protocols must be reviewed and approved by the Biosafety Program and, in most cases, the IBC before work can begin.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-before-you-submit\">Before You Submit<\/h3>\n\n\n\n<ol class=\"wp-block-list\">\n<li>Make sure all required training is up-to-date.&nbsp;Review the training requirements on the Biosafety Program\u2019s website.<\/li>\n\n\n\n<li>Make sure your lab locations have a recent biosafety inspection on file. You can check your latest inspection records in&nbsp;<a href=\"https:\/\/labcliq.com\/login.cfm\">LabCliq<\/a>. You can <a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-biosafety-committee\/contact\/\">contact us<\/a> if you have questions or need to schedule a new inspection.<\/li>\n<\/ol>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-submission-instructions\">Submission Instructions<\/h3>\n\n\n\n<ol class=\"wp-block-list\">\n<li><a href=\"https:\/\/uwm.my.irbmanager.com\/Login.aspx?clientid=uwm\" target=\"_blank\" rel=\"noreferrer noopener\">Log in to I-Manager<\/a><\/li>\n\n\n\n<li>If prompted, select \u201cIBC Biosafety\u201d from the Project Type Switchboard<\/li>\n\n\n\n<li>From your home page, click \u201cStart xForm\u201d in the left-hand Actions menu<\/li>\n\n\n\n<li>Select the appropriate form type for your submission<\/li>\n\n\n\n<li>Fill in all relevant information on all pages of the form, using the dropdown menu at the top of the form and\/or the \u201cNext\u201d button to progress through the form<\/li>\n\n\n\n<li>If you\u2019d like to exit the form to return at a later time, click \u201cSave for Later\u201d. You can then return to the saved draft from your I-Manager home page by clicking the \u201cx unsubmitted\u201d link in the xForms table<\/li>\n\n\n\n<li>When all information is complete, submit the form. Note that if the submitter is not the PI or LCI, the form will first be sent to the PI or LCI for signature before it is submitted to the IBC.<\/li>\n<\/ol>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\">Amendments<\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>Any changes to existing Biosafety Protocols must be submitted to the IBC for review. Depending on the changes made, Amendments may be reviewed administratively by the IBC Administrator or may be sent to a committee for review.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-minor-amendments\">Minor Amendments<\/h3>\n\n\n\n<p>In general, minor amendments can be reviewed and approved by the IBC Administrator. They are typically handled within 1-2 business days. Examples of minor amendments include:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Adding or removing personnel<\/li>\n\n\n\n<li>Adding or removing locations<\/li>\n\n\n\n<li>Adding lines or strains of a previously approved organism (e.g., adding HeLa cells to a protocol that has already been approved for HEK cells)<\/li>\n\n\n\n<li>Any changes that do not alter the recommended containment level of the experiments and do not require review under NIH Guidelines<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-major-amendments\">Major Amendments<\/h3>\n\n\n\n<p>Major amendments are those that significantly alter the scope, risk, or compliance requirements for a study. They are assigned to either Administrative Review, Subcommittee Review, or Full Committee Review using the same criteria as new submissions. Examples of major amendments include:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Adding a new animal species, infectious agent, or transgene<\/li>\n\n\n\n<li>Any changes resulting in a change in relevant NIH Guidelines sections<\/li>\n\n\n\n<li>Any changes resulting in a change of containment level<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-amendment-instructions\">Amendment Instructions<\/h3>\n\n\n\n<p><em>Note: If you need to make changes to a study within 6 months of the study expiration date, it is recommended that you submit a full Renewal in lieu of an Amendment if you expect the study to continue past the expiration date.<\/em><\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><a href=\"https:\/\/uwm.my.irbmanager.com\/Login.aspx?clientid=uwm\" target=\"_blank\" rel=\"noreferrer noopener\">Log in to I-Manager<\/a><\/li>\n\n\n\n<li>If prompted, select \u201cIBC Biosafety\u201d from the Project Type Switchboard<\/li>\n\n\n\n<li>Scroll to the bottom of the screen to find your \u201cMy Studies\u201d table. Click the Study link for the protocol you would like to modify<\/li>\n\n\n\n<li>Navigate to the &#8220;Reference xForms&#8221; table. In the left-hand Actions column, select the &#8220;Copy&#8221; icon.<\/li>\n\n\n\n<li>If prompted, select \u201cCopy for Amendment or Renewal\u201d<\/li>\n\n\n\n<li>On the Amendment Header page, select the \u201cModification of Approved Protocol\u201d option<\/li>\n\n\n\n<li>Modify any information in the subsequent pages as needed<\/li>\n\n\n\n<li>If you\u2019d like to exit the form to return at a later time, click \u201cSave for Later\u201d. You can then return to the saved draft from your I-Manager home page by clicking the \u201cx unsubmitted\u201d link in the xForms table<\/li>\n\n\n\n<li>When all information is complete, submit the form. Note that if the submitter is not the PI or LCI, the form will first be sent to the PI or LCI for signature before it is submitted to the IBC.<\/li>\n<\/ol>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\">Renewals<\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>All research and teaching protocols are approved for 3 years. After the initial approval, 3-Year Renewals are required for any protocols that are not being closed. It is recommended that Renewals be submitted within 6 months of a protocol\u2019s overall expiration date.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-renewal-instructions\">Renewal instructions<\/h3>\n\n\n\n<ol class=\"wp-block-list\">\n<li><a href=\"https:\/\/uwm.my.irbmanager.com\/Login.aspx?clientid=uwm\" target=\"_blank\" rel=\"noreferrer noopener\">Log in to I-Manager<\/a><\/li>\n\n\n\n<li>If prompted, select \u201cIBC Biosafety\u201d from the Project Type Switchboard<\/li>\n\n\n\n<li>Scroll to the bottom of the screen to find your \u201cMy Studies\u201d table. Click the Study link for the protocol you would like to renew<\/li>\n\n\n\n<li>Scroll to the \u201cReference xForms\u201d table. In the left-hand Actions column, click the \u201cCopy\u201d icon<\/li>\n\n\n\n<li>Select \u201cCopy for Amendment or Renewal\u201d<\/li>\n\n\n\n<li>On the Amendment Header page, select the \u201c3-Year Renewal\u201d option<\/li>\n\n\n\n<li>Review all pages of the form to ensure information is still accurate, and make any updates needed<\/li>\n\n\n\n<li>If you\u2019d like to exit the form to return at a later time, click \u201cSave for Later\u201d. You can then return to the saved draft from your I-Manager home page by clicking the \u201cx unsubmitted\u201d link in the xForms table<\/li>\n\n\n\n<li>When all information is complete, submit the form. Note that if the submitter is not the PI or LCI, the form will first be sent to the PI or LCI for signature before it is submitted to the IBC.<\/li>\n<\/ol>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\">Protocol Closure<\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>If not renewed, all research and teaching protocols are automatically closed after their 3-year approval window has ended. To close a protocol before the approval window is over, <a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-biosafety-committee\/contact\/\">contact us<\/a>, and make sure to&nbsp;include the protocol number in the email subject line to request protocol closure.<\/p>\n<\/div><\/div>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-the-review-process\">The Review Process<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-initial-review\">Initial Review<\/h3>\n\n\n\n<p>After being signed by the PI\/LCI and submitted, all IBC protocols are initially reviewed by the Biosafety Program for completeness and clarity. If there are significant issues with your submission, such as missing information or attachment errors, these issues will be noted and the protocol returned to you for updates. After resolving any major issues, the information provided in your protocol will be used to determine which type of review your protocol requires:&nbsp;full committee,&nbsp;subcommittee, or&nbsp;administrative review.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-administrative\">Administrative<\/h3>\n\n\n\n<p>Administrative review is assigned to any submissions that are exempt from the NIH Guidelines&nbsp;and&nbsp;are low risk (e.g., BSL-1).<\/p>\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\">Biosafety Officer Review<\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>The submission will be reviewed by the Biosafety Officer. This review will include a check of training records for all personnel involved in the study, up-to-date lab inspections, and the clarity &amp; appropriateness of all uses of biological materials.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\">Required Revisions<\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>If changes to the submission are required, these revisions will be noted in the protocol form and the protocol form will be returned to the submitter in I-Manager. The submitter will receive an email indicating that their submission has been returned for changes and including a link to access the protocol form. Once changes are made, the protocol will need to be signed by the PI or LCI again before re-submission.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\">Approval<\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>After all required revisions from the Biosafety Officer are resolved, the protocol will be registered as Approved. An approval letter will be emailed to the Submitter and PI or LCI and will be attached to the protocol in I-Manager.<\/p>\n<\/div><\/div>\n<\/div>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-subcommittee\">Subcommittee<\/h3>\n\n\n\n<p>Subcommittee review is assigned to any submissions that are exempt from the NIH Guidelines&nbsp;and&nbsp;are low-moderate risk.<\/p>\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\">Assignment to Subcommittee Reviewers<\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>After initial review, the IBC Administrator will assign the protocol to a subcommittee of the IBC for review. This review occurs asynchronously via I-Manager.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\">Subcommittee Review<\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>Subcommittee members will review the submission within 2 weeks and provide any notes that must be addressed before approval. Each subcommittee member will also submit one of the following decisions for the protocol:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Approved:&nbsp;Approved as is, no changes required<\/li>\n\n\n\n<li>Minor Modifications:&nbsp;Conditionally approved, with full approval granted after required revisions are adequately addressed<\/li>\n\n\n\n<li>Tabled:&nbsp;Major revisions required; resubmission requires review by subcommittee or full committee<\/li>\n\n\n\n<li>Denied:&nbsp;Not approved; resubmission not permitted<\/li>\n<\/ul>\n\n\n\n<p>Based on subcommittee member decisions, the Biosafety Officer will summarize required updates and recommend a decision on the protocol. If subcommittee member decisions are in disagreement, a subcommittee meeting may be convened before a decision is provided to the PI\/LCI. The Submitter and PI\/LCI will be notified of the subcommittee\u2019s decision via email through I-Manager.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\">Required Revisions<\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>If a decision of \u201cMinor Modifications\u201d or \u201cTabled\u201d is provided, the Submitter will receive access to the protocol in I-Manager and must make the revisions noted by the subcommittee before re-submission. After re-submission, protocols returned for Minor Modifications will be reviewed by the Biosafety Officer, while Tabled protocols will be reassigned to the appropriate committee for additional review.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\">Approval<\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>After all required revisions and\/or additional reviews are resolved, the protocol will be registered as Approved. An approval letter will be emailed to the Submitter and PI or LCI and will be attached to the protocol in I-Manager.<\/p>\n<\/div><\/div>\n<\/div>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-full-committee\">Full Committee<\/h3>\n\n\n\n<p>Full committee review is required for all research that is not exempt from the NIH Guidelines and\/or involves moderate or high risk activities (e.g., Biosafety Level 2 containment or higher).<\/p>\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\">Assignment to Full Committee Meeting<\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>After initial review, the IBC Administrator will assign the protocol to the full IBC for review and will add the protocol to the next available IBC meeting agenda. Protocols must be received two weeks in advance to be considered at the next IBC meeting.<\/p>\n\n\n\n<div class=\"uwm-u-flex uwm-u-flex--wrap uwm-u-flex--left\">\n<a class=\"uwm-c-button uwm-u-mr-20 uwm-u-mb-20\" href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-biosafety-committee\/ibc-meetings\/\" rel=\"\">Upcoming IBC Meeting Schedule<\/a>\n<\/div>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\">Full Committee Review<\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>IBC members will review the submission at the next available IBC full committee meeting. The PI\/LCI will be invited to attend the review to provide context and answer any questions from the IBC. During the meeting, IBC members will vote on a decision for the protocol:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Approved:&nbsp;Approved as is, no changes required<\/li>\n\n\n\n<li>Minor Modifications:&nbsp;Conditionally approved, with full approval granted after required revisions are adequately addressed<\/li>\n\n\n\n<li>Tabled:&nbsp;Major revisions required; resubmission requires review by subcommittee or full committee<\/li>\n\n\n\n<li>Denied:&nbsp;Not approved; resubmission not permitted<\/li>\n<\/ul>\n\n\n\n<p>The Submitter and PI\/LCI will be notified of the IBC\u2019s decision via email through I-Manager.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\">Required Revisions<\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>If a decision of \u201cMinor Modifications\u201d or \u201cTabled\u201d is provided, the Submitter will receive access to the protocol in I-Manager and must make the revisions noted by the IBC before re-submission. After re-submission, protocols returned for Minor Modifications will be reviewed by the Biosafety Officer, while Tabled protocols will be reassigned to the appropriate committee for additional review.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"uwm-p-accordion--header\">Approval<\/div><div class=\"uwm-p-accordion--panel\"><div class=\"uwm-p-accordion--panel-inner uwm-u-clear\">\n<p>After all required revisions and\/or additional reviews are resolved, the protocol will be registered as Approved. An approval letter will be emailed to the Submitter and PI or LCI and will be attached to the protocol in I-Manager.<\/p>\n<\/div><\/div>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-biosafety-program-guidelines\">Biosafety Program Guidelines<\/h2>\n\n\n\n<p>You can learn more about <a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/safety-health\/biosafety\/\">UWM\u2019s Biosafety Program<\/a>, including requirements for working with a range of different biohazardous materials.<\/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><ul><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-biosafety-committee\/members\/\">Members<\/a><\/li><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-biosafety-committee\/biohazardous-materials\/\">Biohazardous Materials<\/a><\/li><li><a class=\"current\" href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-biosafety-committee\/biosafety-protocol-submissions\/\"><span aria-current=\"page\">Biosafety Protocol Submissions<\/span><\/a><\/li><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-biosafety-committee\/ibc-meetings\/\">IBC Meetings<\/a><\/li><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-biosafety-committee\/resources\/\">Resources<\/a><\/li><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-biosafety-committee\/frequently-asked-questions\/\">Frequently Asked Questions<\/a><\/li><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-biosafety-committee\/contact\/\">Contact<\/a><\/li><\/ul><\/li><li><a href=\"https:\/\/uwm.edu\/safety-assurances\/programs\/research-compliance\/institutional-review-board\/\">Institutional Review Board (Human Subjects)<\/a><\/li><\/ul><\/nav><\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1652,"featured_media":0,"parent":2728,"menu_order":2,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":"","uwm_wg_additional_authors":[1282,1523,1524]},"class_list":["post-2853","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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