{"id":897,"date":"2022-11-28T07:26:15","date_gmt":"2022-11-28T07:26:15","guid":{"rendered":"https:\/\/az.research.umich.edu\/medschool\/document\/updating-irb-applications-when-researchers-leave-u-m\/"},"modified":"2026-04-15T09:05:10","modified_gmt":"2026-04-15T13:05:10","slug":"updating-irb-applications-when-researchers-leave-u-m","status":"publish","type":"document","link":"https:\/\/az.research.umich.edu\/medschool\/guidance\/updating-irb-applications-when-researchers-leave-u-m\/","title":{"rendered":"Updating IRB applications When Researcher(s) Leave U-M"},"template":"","categories":[24],"tags":[79,77],"content-type":[41],"topic":[66],"update-type":[98],"class_list":["post-897","document","type-document","status-publish","hentry","category-institutional-review-boards-irbmed","tag-principal-investigator","tag-regulatory","content-type-guidance","topic-investigator-study-team-responsibilities","update-type-new-resource"],"acf":{"use_legacy_editor":true,"updated_date":"2022-11-28 12:15:00","update_notice":false,"author":"IRBMED","summary":"When a researcher (aka study team member) listed in an active (not Terminated or Withdrawn in eResearch) IRB application is leaving the University of Michigan, follow this guidance to update the corresponding IRB applications. Notify IRBMED early in the process for guidance if this document does not address your questions.\r\n\r\nMost commonly:\r\n<ul>\r\n \t<li><strong>Principal Investigator (PI) exits<\/strong>: <a href=\"https:\/\/documentation.its.umich.edu\/node\/1300\">amend to identify a new PI<\/a> or submit <a href=\"https:\/\/documentation.its.umich.edu\/node\/1504\">a termination report<\/a> to close U-M activity.<\/li>\r\n \t<li><strong>Co-investigator, research staff, etc. exits<\/strong>: amend to remove throughout the application.<\/li>\r\n \t<li><strong>Data\/samples transfer<\/strong>: notify the IRB whether any data\/samples will be transferred from U-M, with or without identifiers. Initiate <a href=\"https:\/\/orsp.umich.edu\/policies-procedures\/data-sharing-and-use-agreements\">Data Sharing\/Use Agreement (DUA)<\/a> and\/or <a href=\"https:\/\/innovationpartnerships.umich.edu\/resource\/mta-incoming\/\">Material Transfer Agreement (MTA)<\/a> in <a href=\"https:\/\/orsp.umich.edu\/unfunded-agreement-types\">eResearch Proposal Management<\/a> and link to these <a href=\"https:\/\/documentation.its.umich.edu\/node\/1250\">as Support in IRB application Section 02<\/a>.<\/li>\r\n<\/ul>\r\nSee Section II below for detailed scenarios, and Section III\u00a0for detailed guidance on information to include in Amendments and Terminations.\r\n\r\nFor guidance on many other \u201coff-boarding\u201d tasks for exiting researchers, consult\r\n<ul>\r\n \t<li><a href=\"https:\/\/umhealth.sharepoint.com\/sites\/MSA\/SitePages\/u-m-resources-researchers.aspx\">Faculty Offboarding Checklist<\/a> <em>(level-2 login required)<\/em> from MM Regulatory Affairs<\/li>\r\n \t<li><a href=\"https:\/\/research.umich.edu\/resource\/?_research_phase=research-onboarding-offboarding-checklist\">Research Offboarding Checklist<\/a> from UM Office for the Vice-President of Research<\/li>\r\n<\/ul>","button_links":[{"button_link":""}],"related_content":[883,873],"legacy_path":"updating-irb-applications-when-researchers-leave-u-m","legacy_node_id":1647,"legacy_related_nids":"1533, 1019","legacy_content_section":[{"legacy_section_type":"heading","legacy_heading":"I. Planning","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area","legacy_heading":"","legacy_subheading":"","legacy_section_text":"The exiting researcher can view their list of active IRB applications when they login to <a href=\"https:\/\/documentation.its.umich.edu\/node\/1407\">their eResearch account<\/a>\u00a0(\u201cApproved\u201d\u00a0and \u201cExempt and Not Regulated.\u201d Alternatively, the study team can reach out to IRBMED for this list of IRB applications.\r\n\r\nEvaluate whether the exiting researcher will have any ongoing collaboration (conducting any study-related activities, including data analysis) with the impacted IRB applications (see Section II\u00a0below).\r\n\r\nActive study participants (subjects) will need to be informed of any changes to study contact information. <strong>Note<\/strong>: These notifications require IRBMED approval before disseminating any materials.\r\n\r\nAlong with IRBMED, the study team may need to work with or alter other supporting units, such as:\r\n<table style=\"width: 93.4561%;height: 343px\" border=\"1\" cellspacing=\"1\" cellpadding=\"1\">\r\n<thead>\r\n<tr style=\"height: 25px\">\r\n<th style=\"height: 25px\" scope=\"col\">IF<\/th>\r\n<th style=\"height: 25px\" scope=\"col\">THEN notify\/alert<\/th>\r\n<\/tr>\r\n<\/thead>\r\n<tbody>\r\n<tr style=\"height: 76px\">\r\n<td style=\"height: 76px\">The IRB application is externally funded, and the PAF\/AWD needs to be updated<\/td>\r\n<td style=\"height: 76px\">Funding agency and\/or Sponsor<\/td>\r\n<\/tr>\r\n<tr style=\"height: 50px\">\r\n<td style=\"height: 50px\">The exiting researcher is the IND\/IDE holder<\/td>\r\n<td style=\"height: 50px\"><a href=\"mailto:MICHRMIAP@med.umich.edu?subject=exiting%20researcher%20who%20is%20IND\/IDE%20holder\">MICHR MIAP<\/a><\/td>\r\n<\/tr>\r\n<tr style=\"height: 25px\">\r\n<td style=\"height: 25px\">U-M is the coordinating center<\/td>\r\n<td style=\"height: 25px\">Participating site<\/td>\r\n<\/tr>\r\n<tr style=\"height: 25px\">\r\n<td style=\"height: 25px\">U-M is a participating site<\/td>\r\n<td style=\"height: 25px\">Coordinating center<\/td>\r\n<\/tr>\r\n<tr style=\"height: 30px\">\r\n<td style=\"height: 30px\">U-M is the Single IRB<\/td>\r\n<td style=\"height: 30px\"><a href=\"mailto:irbmedreliance@umich.edu?subject=exiting%20researcher%20on%20study%20with%20U-M%20as%20sIRB\">IRBMED Single IRB team<\/a> and IRBMED staff owner<\/td>\r\n<\/tr>\r\n<tr style=\"height: 25px\">\r\n<td style=\"height: 25px\">Ceded application<\/td>\r\n<td style=\"height: 25px\">External IRB<\/td>\r\n<\/tr>\r\n<tr style=\"height: 87px\">\r\n<td style=\"height: 87px\">Transfer of data\/samples from U-M<\/td>\r\n<td style=\"height: 87px\"><a href=\"https:\/\/orsp.umich.edu\/find-research-administrator-blue-pages\">Primary research administrator<\/a> of your unit; <a href=\"https:\/\/medresearch.umich.edu\/office-research\/about-office-research\/our-units\/data-office-clinical-translational-research\/data-biospecimen-sharing\">Data Office<\/a> or <a href=\"https:\/\/orsp.umich.edu\/policies-procedures\/data-sharing-and-use-agreements\">ORSP<\/a> (for Data Use Agreements) and\/or <a href=\"mailto:MichiganMTA@umich.edu?subject=exiting%20researcher%20question%20regarding%20transfer%20of%20materials%20from%20U-M\">Innovation Partnerships<\/a> (for Material Transfer Agreements)<\/td>\r\n<\/tr>\r\n<\/tbody>\r\n<\/table>\r\n&nbsp;","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"heading","legacy_heading":"II. Common scenarios when a researcher is leaving U-M","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area","legacy_heading":"","legacy_subheading":"","legacy_section_text":"Contact IRBMED at your earliest opportunity if your specific scenario is not listed below.","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area_with_subheading","legacy_heading":"","legacy_subheading":"Closing the project at U-M","legacy_section_text":"<ol style=\"list-style-type: lower-alpha\">\r\n \t<li>Create\u00a0and submit <a href=\"https:\/\/documentation.its.umich.edu\/node\/1504\">a termination report<\/a> in eResearch<\/li>\r\n \t<li>See below for general instructions when submitting the Termination.<\/li>\r\n \t<li>Do not Amend to remove the exiting researcher.<\/li>\r\n<\/ol>","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area_with_subheading","legacy_heading":"","legacy_subheading":"Closing the project at U-M and moving it to the new institution","legacy_section_text":"<ol style=\"list-style-type: lower-alpha\">\r\n \t<li>Consult with the IRB at the new institution and apply for IRB approval<\/li>\r\n \t<li>Keep the IRB application at U-M open until the IRB application at the new institution is approved<\/li>\r\n \t<li>Once the IRB approval from the new institution is obtained, <a href=\"https:\/\/documentation.its.umich.edu\/node\/1504\">terminate<\/a> the U-M IRB application appropriately. See below for general instructions when submitting the Termination.<\/li>\r\n \t<li><strong>Note<\/strong>: an Amendment to change the PI is not usually required for this scenario if the IRB approval from the new institution can be obtained before the appointment at U-M ends. If any delay in this transition process is expected, submit an Amendment to <a href=\"https:\/\/documentation.its.umich.edu\/node\/1300\">identify a new PI at U-M<\/a> to ensure an appropriate transition.<\/li>\r\n<\/ol>","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area_with_subheading","legacy_heading":"","legacy_subheading":"Exiting researcher will NOT be involved with research activities at U-M","legacy_section_text":"<ol style=\"list-style-type: lower-alpha\">\r\n \t<li>Create and submit an Amendment to remove the exiting researcher<\/li>\r\n \t<li>If the exiting researcher is the PI, <a href=\"https:\/\/documentation.its.umich.edu\/node\/1300\">identify the new PI<\/a> with this Amendment. The new PI will be able to submit the Amendment. Also, consider keeping the exiting PI as a Co-I until their last day to ensure a smooth transition. They can be fully removed after the final date with U-M. If no new PI will take over, close the project (see above).<\/li>\r\n \t<li>See below for general instructions when submitting the Amendments.<\/li>\r\n<\/ol>","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area_with_subheading","legacy_heading":"","legacy_subheading":"Exiting researcher WILL be involved with research activities at U-M","legacy_section_text":"<strong>Option A<\/strong>\r\n<ol style=\"list-style-type: lower-alpha\">\r\n \t<li>Consult with the IRB at the new institution and apply for IRB approval for the ongoing research activities<\/li>\r\n \t<li>Submit an Amendment to remove the exiting researcher. Add the new institution as a participating site in Section 03-1. Upload IRB approval from the new institution when available.<\/li>\r\n \t<li>If the study is currently federally funded, adding a new site might trigger <a href=\"\/medschool\/guidance\/single-irb-sirb-and-cooperative-multi-site-research\/\">\"single IRB\" requirements<\/a> depending on the activities done at the new site.<\/li>\r\n<\/ol>\r\n<strong>Option B<\/strong>\r\n\r\nIf there is no IRB at the new institution and\/or if the exiting researcher would like to continue under U-M IRB oversight\r\n<ol style=\"list-style-type: lower-alpha\">\r\n \t<li>Reach out to IRBMED as soon as possible<\/li>\r\n \t<li>Clarify whether the exiting researcher will have an adjunct appointment with U-M<\/li>\r\n \t<li>If there will be an adjunct appointment that supports ongoing research activities at U-M, an Amendment to update the role to \u201cother\u201d is usually required. As the adjunct appointments are usually temporary, the IRB application will need to be updated when the adjunct appointment ends. The IRB staff might consider adding a Manage Action Item (MAI) in eResearch for tracking purposes.<\/li>\r\n \t<li>If there will NOT be an adjunct appointment, an Amendment to update the role will be needed.\r\n<ol>\r\n \t<li>Remove the exiting researcher from their current role (PI or Co-I, etc.);<\/li>\r\n \t<li>Re-list them in the role of \u201cother\u201d (for external study team members).<\/li>\r\n \t<li>Follow all steps from IRBMED\u2019s guidance on <a href=\"\/medschool\/guidance\/external-non-um-study-team-members\">external study team members<\/a> in the Amendment (completing an external collaborator checklist and uploading it in the IRB application, etc.)<\/li>\r\n<\/ol>\r\n<\/li>\r\n<\/ol>","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"heading","legacy_heading":"III. Instructions for IRB submissions (Amendments &amp; Terminations)","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area_with_subheading","legacy_heading":"","legacy_subheading":"For Amendments or Terminations","legacy_section_text":"Include the following relevant details.\r\nFor Amendments, include these details in the Amendment coversheet.\r\nFor Terminations, include these details within the Termination report (1.2 free text field).\r\n<ol style=\"list-style-type: lower-alpha\" start=\"1\">\r\n \t<li><strong>Brief Background<\/strong>:\u201cEffective <em>_____ <\/em>, Dr. <em>ABC<\/em> is leaving U-M. He\/she have an adjunct appointment with U-M. The purpose of this submission is to \u2026. the exiting researcher\u00a0<strong>\/\u00a0<\/strong>terminate the IRB application at U-M\u00a0<em>etc.<\/em>\u201d<\/li>\r\n \t<li><strong>Status of Data and\/or Materials<\/strong>:<strong>EITHER<\/strong><em>\u201c<\/em> No data or materials will be transferred outside the U-M. The exiting researcher will not have access to any data and\/or materials.\u201d<strong>OR<\/strong>\r\n\r\n\u201cThe data and\/or materials collected in this IRB application may be transferred outside the U-M. Possible transfer outside U-M already reflected in approved informed consent document(s). We are currently working on appropriate data\/material transfer agreements. We affirm that no data\/material will leave U-M until appropriate agreements are finalized. Here is the UFA ID for data use agreements: \u2026\u201d<\/li>\r\n \t<li><strong>Status of participants<\/strong>: Provide additional details related to the status of the participants (how many are active, will they need to be notified, etc.) in the Amendment cover sheet question regarding possible re-consent.<\/li>\r\n \t<li><strong>Review the table in Section I<\/strong> and provide additional information regarding the other units as applicable<\/li>\r\n \t<li><strong>Review the table in Section II<\/strong> and identify the specific scenario<\/li>\r\n<\/ol>\r\nNOTE: Amendment and Termination should not <strong>both <\/strong>be prepared.","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area_with_subheading","legacy_heading":"","legacy_subheading":"For Amendments only","legacy_section_text":"When editing the IRB application:\r\n<ol style=\"list-style-type: lower-alpha\" start=\"1\">\r\n \t<li><strong>Changing the exiting researcher role<\/strong>:\r\n<ol>\r\n \t<li>Update <a href=\"https:\/\/documentation.its.umich.edu\/node\/1251\">Section 01 (study team members)<\/a><\/li>\r\n \t<li>Open the <a href=\"https:\/\/documentation.its.umich.edu\/node\/1495\">Printer Friendly Version<\/a> of the IRB application and use \u2018Ctrl+Find\u2019 to find any sections where the study team member leaving U-M is listed. <a href=\"https:\/\/az.research.umich.edu\/medschool\/resource\/eresearch-cross-reference-table\/\">eResearch Cross-Reference Table<\/a> may be of use.<\/li>\r\n<\/ol>\r\n<\/li>\r\n \t<li><strong>Revising the study documents<\/strong>:\r\n<ol>\r\n \t<li>For investigator-initiated studies, <a href=\"\/medschool\/policies\/statement-practice-document-revision-guidance-naming-convention-and-version\/\">update the study protocol<\/a> to remove\/replace the exiting researcher.<\/li>\r\n \t<li>If the enrollment or re-consenting is still open, <a href=\"\/medschool\/policies\/statement-practice-document-revision-guidance-naming-convention-and-version\/\">update the informed consent documents and the recruitment documents<\/a> to remove\/replace the exiting researcher.<\/li>\r\n \t<li>Scan through the application to identify any other subject-facing materials and update them as appropriate.<\/li>\r\n \t<li>As always in eResearch, <strong>do not<\/strong> delete the whole <a href=\"https:\/\/documentation.its.umich.edu\/node\/1079\">document \u2018stacks\u2019<\/a>: rather, \u2018Upload Revision.\u2019<\/li>\r\n<\/ol>\r\n<\/li>\r\n \t<li><strong>Update <a href=\"https:\/\/documentation.its.umich.edu\/node\/1250\">Section 02 (funding and UFA(s))<\/a><\/strong> as needed.<\/li>\r\n<\/ol>","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area_with_subheading","legacy_heading":"","legacy_subheading":"For Exempt\/Not Regulated IRB applications","legacy_section_text":"<ol style=\"list-style-type: lower-alpha\" start=\"1\">\r\n \t<li><strong>Termination\u00a0<\/strong>\r\n<ol>\r\n \t<li>Exempt studies: Termination is a separate, simpler process that can be completed by any study team member with Edit rights. See ITS step-by-step guide \u201c<a href=\"https:\/\/documentation.its.umich.edu\/node\/1503\">Creating a Termination<\/a> - Submit a request for terminating an exempt study.\u201d<\/li>\r\n \t<li>Not Regulated projects: There is no eResearch function to terminate. Therefore, send a <a href=\"https:\/\/documentation.its.umich.edu\/node\/1488\">Post Correspondence<\/a> (select IRBMED as a recipient) with the details outlined in Section III heading \u201cFor Amendments or Terminations\u201d above.<\/li>\r\n<\/ol>\r\n<\/li>\r\n \t<li><strong>Amendment<\/strong>\r\n<ol>\r\n \t<li>An Amendment is not generally required for Exempt\/Not Regulated IRB applications unless changes could impact the previously issued Exempt\/Not Regulated determinations. The study team changes typically will not impact the Exempt\/Not Regulated determination. If the study team would like to keep the IRB application current, <a href=\"https:\/\/documentation.its.umich.edu\/node\/1263\">submit an Amendment<\/a> for the changes related to study team membership.<\/li>\r\n \t<li>Tips: See also <a href=\"https:\/\/az.research.umich.edu\/medschool\/guidance\/exempt-human-subjects-research\/\">Exempt Human Subjects Research<\/a>, heading \u201cWhat is an Exemption?,\u201d\u00a0subheading \u201cHow are Exempt studies regulated?\u201d<\/li>\r\n<\/ol>\r\n<\/li>\r\n<\/ol>","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null}],"update_notice_type":[98],"update_notice_start":"2022-11-28 07:15:00","update_notice_end":"2023-01-31 14:30:00","update_notice_text_blocks":[{"update_notice_text":"<p>This new document harmonizes IRBMED requirements and suggestions for when study team members in IRB applications leave U-M. Detailed guidance is included.<\/p>"}],"global_contact_block":false,"contact_name":"","contact_email":"","contact_additional_info":"Contact us at <a href=\"mailto:irbmed@umich.edu?subject=Q%20from%20Res%20A-Z%20page\">irbmed@umich.edu<\/a> or 734-763-4768 \/ (Fax 734-763-1234)\r\n2800 Plymouth Road, Ann Arbor, MI 48109-2800\r\n\r\nA <a href=\"https:\/\/medresearch.umich.edu\/office-research\/about-office-research\/our-units\/institutional-review-boards-irbmed\/irbmed-contacts-roster#irbmed-staff\">list of IRBMED staff<\/a> is available at our website.\r\n\r\nEdited By: <a href=\"mailto:larkspur@umich.edu\">larkspur@umich.edu<\/a>\r\nLast Updated: April 15, 2026 8:55AM","global_contact_block_select":null},"_links":{"self":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/897","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document"}],"about":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/types\/document"}],"version-history":[{"count":4,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/897\/revisions"}],"predecessor-version":[{"id":1976,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/897\/revisions\/1976"}],"acf:term":[{"embeddable":true,"taxonomy":"update-type","href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/update-type\/98"}],"acf:post":[{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/873"},{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/883"}],"wp:attachment":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/media?parent=897"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/categories?post=897"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/tags?post=897"},{"taxonomy":"content-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/content-type?post=897"},{"taxonomy":"topic","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/topic?post=897"},{"taxonomy":"update-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/update-type?post=897"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}