{"id":881,"date":"2019-06-25T10:53:42","date_gmt":"2019-06-25T10:53:42","guid":{"rendered":"https:\/\/az.research.umich.edu\/medschool\/document\/single-irb-sirb-and-cooperative-multi-site-research\/"},"modified":"2026-04-08T10:15:03","modified_gmt":"2026-04-08T14:15:03","slug":"single-irb-sirb-and-cooperative-multi-site-research","status":"publish","type":"document","link":"https:\/\/az.research.umich.edu\/medschool\/guidance\/single-irb-sirb-and-cooperative-multi-site-research\/","title":{"rendered":"Single IRB (sIRB) and Cooperative Multi-Site Research"},"template":"","categories":[24],"tags":[77,37],"content-type":[41],"topic":[42,40,30,92],"update-type":[97],"class_list":["post-881","document","type-document","status-publish","hentry","category-institutional-review-boards-irbmed","tag-regulatory","tag-sponsor","content-type-guidance","topic-application-types","topic-clinical-research","topic-clinical-trial","topic-single-irb-sirb","update-type-information-only"],"acf":{"use_legacy_editor":true,"updated_date":"2023-06-19 10:00:00","update_notice":false,"author":"IRBMED","summary":"<strong>sIRB Timing, Fees and Budgeting<\/strong>\r\n<ul>\r\n \t<li>When requesting IRBMED to be the reviewing sIRB, contact IRBMED as soon as possible but at least 8 weeks prior to the grant application due date. \u00a0See section \u201cIRBMED as the sIRB (accepting oversight)\u201d of this guidance for additional instruction.<\/li>\r\n \t<li>When requesting IRBMED to cede oversight to an external IRB, complete an eResearch application \u201cRequest Review by non-U-M IRB\u201d (i.e., ceding application) at least 3 weeks prior to the grant application due date.<\/li>\r\n \t<li>IRBMED fees are charged to each <em>new <\/em>industry-sponsored contract with required IRBMED review. Detailed budgeting information is available at the <a href=\"\/medschool\/guidance\/irbmed-review-fees\/\">IRB Review Fees<\/a> informational page.<\/li>\r\n<\/ul>\r\nCooperative research projects involving more than one institution are expected to follow a single IRB (sIRB) model as required by the Common Rule or by contract.\r\n\r\nRoles and responsibilities of participating sites in multi-site research are defined in this guidance.\r\n<ol style=\"list-style-type: upper-roman\">\r\n \t<li>Single IRB Policies<\/li>\r\n \t<li>IRBMED Accepts IRB Oversight (sIRB) and Associated Fees<\/li>\r\n \t<li>IRBMED Cedes IRB Oversight to an External IRB<\/li>\r\n \t<li>U-M as a Coordinating Center<\/li>\r\n \t<li>Single IRB Fees and Budgeting<\/li>\r\n \t<li>Downloadable Multi-site Research Job Aids (including MiCORES)<\/li>\r\n<\/ol>","button_links":null,"related_content":[889],"legacy_path":"single-irb-sirb-and-cooperative-multi-site-research","legacy_node_id":1520,"legacy_related_nids":"1585","legacy_content_section":[{"legacy_section_type":"heading","legacy_heading":"I. Federal Single IRB Policies\/Regulations","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":"Since 2018 (NIH policy) and 2020 (HHS regulations) applicable federally-sponsored multisite research projects using the same research protocol are required to utilize a sIRB review model for all participating institutions.\r\n\r\n<a href=\"https:\/\/www.federalregister.gov\/documents\/2017\/01\/19\/2017-01058\/federal-policy-for-the-protection-of-human-subjects#h-201\"><strong>Revised Common Rule Regulations<\/strong><\/a><strong>, effective January 20, 2020<\/strong>\r\n<ul style=\"list-style-type: circle\">\r\n \t<li>Applies to: All sites in the United States participating in a federally funded multi-site research study following the Common Rule requirements, including those funded by NIH.<\/li>\r\n \t<li>Exceptions: Cooperative research for which more than single IRB review is required by law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe); or research for which any Federal department of agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate.<\/li>\r\n<\/ul>\r\n<a href=\"https:\/\/grants.nih.gov\/grants\/guide\/notice-files\/NOT-OD-16-094.html\"><strong>NIH Policy<\/strong><\/a><strong>, effective January 25, 2018<\/strong>\r\n<ul style=\"list-style-type: circle\">\r\n \t<li>Applies to: Domestic sites of NIH funded studies where each site will conduct the same protocol involving non-exempt human subjects research, whether supported by grants, cooperative agreements contracts or the NIH Intramural Research Program.\u00a0 It does not apply to Foreign Sites, career development (K), research training (T) or fellowship awards (F) and noncompeting continuation awards.<\/li>\r\n \t<li>Exceptions: VA sites; international sites; sites involving tribal nations.<\/li>\r\n \t<li><a href=\"https:\/\/grants.nih.gov\/grants\/policy\/faq_single_IRB_policy_research.htm\">NIH FAQ's on the Single IRB Policy for Multi-Site Research<\/a><\/li>\r\n<\/ul>","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. IRBMED Accepts IRB Oversight (sIRB) and Associated Fees","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":"If requesting IRBMED to be the reviewing sIRB, contact IRBMED via <a href=\"https:\/\/umich.corefacilities.org\/service_center\/show_external\/5567\/umich_irbmed\">MiCORES<\/a> as soon as possible but at least 8 weeks prior to the grant application due date to seek authorization to commit IRBMED to this effort.\r\n\r\nCompletion of a request form in <a href=\"https:\/\/umich.corefacilities.org\/service_center\/show_external\/5567\/umich_irbmed\">MiCORES<\/a> using the Single IRB Review Core (\u201csIRB Core\u201d)\u00a0is required.\u00a0The sIRB Core provides a single location where researchers can request that IRBMED be the sIRB of record for proposed multi-site human research. Initiate a request using the \u201cU-M to be the Single IRB-of-Record\u201d form. During the review of the information provided, the IRBMED will determine if it is appropriate for IRBMED to serve as the sIRB for the proposed project.\u00a0 Evaluation criteria include:\r\n<ul style=\"list-style-type: circle\">\r\n \t<li>Study design<\/li>\r\n \t<li>What entity\/individual holds any associated IND\/IDE<\/li>\r\n \t<li>The number and location of participating sites<\/li>\r\n<\/ul>\r\nIf it is determined that IRBMED\u00a0will not\u00a0serve as the sIRB, the research investigators should consider whether another participating site will serve as sIRB or whether an independent IRB should be considered. \u00a0As applicable IRBMED will then provide a letter of support to rely on the external IRB for inclusion with the grant proposal.\u00a0\u00a0Commercial IRB options will also be discussed.\r\n\r\nIf agreeing to be sIRB under a federal award, IRBMED will prepare a budget estimate for any applicable direct costs associated with its review of the multi-site components of the research.\u00a0 Estimates are based on the number of sites and expected complexity of study oversight.\r\n\r\nContact\u00a0<a href=\"mailto:irbmedreliance@umich.edu\">irbmedreliance@umich.edu<\/a>\u00a0with any questions","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":"Fees for Multi-site Research when IRBMED is the Single IRB (sIRB)","legacy_section_text":"Use of a single IRB model (sIRB) may be required by grant or contract for multi-site research.\u00a0 IRBMED must be informed of this requirement at the time of grant application or contract negotiation in order to assess the circumstances, prepare a budget for inclusion in the grant\/contract, and execute Reliance Agreements between institutions.\u00a0 When IRBMED agrees to function as the sIRB for the research, IRBMED will charge the following fee:\r\n<ul>\r\n \t<li>$62.66\/hour as work is completed on the project<\/li>\r\n<\/ul>\r\nThis fee structure dates to July 1, 2021.","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":"Variations based on Granting Agency","legacy_section_text":"<strong>NIH Grant Proposals <\/strong>\r\n\r\nFor NIH\u00a0applicants, the single IRB plan is no longer required at the time of submission but a budget must be provided. However, the grant applicant must provide a statement naming the sIRB of record in the Just-in-Time submission prior to award. \u00a0Provide IRBMED the information as indicated above.\r\n\r\n<strong>AHRQ Grant Proposals<\/strong>\r\n\r\nFor AHRQ applicants, if this is a research project that involves more than one institution and that will be conducted in the United States, a single IRB plan must be prepared unless review by a sIRB would be prohibited by a federal, tribal, or state law, regulation, or policy. The single IRB plan will be developed by IRBMED. \u00a0Provide IRBMED the information as indicated above.\r\n\r\n<strong>Other Federal Agency Requirements <\/strong>\r\n\r\nCheck the specific requirements associated with the grant application. Provide IRBMED the information as indicated above.\r\n\r\n<strong>Non-federal Grant\/Contract Proposals for IRBMED as sIRB <\/strong>\r\n\r\nIRBMED will evaluate whether it will serve as sIRB on a study-specific basis. Provide IRBMED the information as indicated above.","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":"link_button","legacy_heading":"","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":[{"legacy_button":{"title":"Companion piece for institutions participating in SMART IRB agreement","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/12\/res_irbmed_Smart-IRB-Guidance-Companion-Piece.docx","target":"_blank"},"legacy_import_link":true},{"legacy_button":{"title":"Companion Piece for Institutions Not Participating in Smart IRB Agreement","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/12\/res_irbmed_Non-Smart-IRB-Guidance-Companion-Piece.docx","target":""},"legacy_import_link":true}]},{"legacy_section_type":"heading","legacy_heading":"III. IRBMED Cedes Oversight to an External IRB","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":"<strong>Ceding to an Independent (i.e., commercial IRB) under an existing Master Service Agreement.\u00a0 <\/strong>\r\n\r\nU-M maintains Master Service Agreements with Advarra, Western IRB (WCG or WIRB), Ethical and Independent IRB (E&amp;I), and NCI CIRB.\u00a0 No advance notification is necessary to initiate ceding of IRB review to these organizations.\u00a0 Complete the Ceding Application in eResearch.\r\n\r\nU-M research teams must complete the \"Request Review by a Non-UM IRB\" (Ceding) Application within eResearch to receive an Acknowledgement letter and complete the independent IRBs application. \u00a0Study teams must receive the U-M Acknowledgement letter\u00a0<strong>and\u00a0<\/strong>the independent IRB approval notice before beginning any research related activities.\r\n\r\n<strong>Ceding under the SMART IRB Agreement (e.g., ceding to an academic IRB)<\/strong>\r\n\r\nCeding to an external (academic) IRB under the SMART IRB agreement requires submission of the eResearch ceding application.\u00a0 Also, provide SMART IRB Letter of Acknowledgement and\/or the local context form from the external IRB. \u00a0IRBMED will assess the appropriateness of ceding to this IRB for the designated study.\u00a0 Unless mandated by policy, the IRBMED cannot guarantee its willingness to rely on an external IRB.","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":"link_button","legacy_heading":"","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":[{"legacy_button":{"title":"SMART IRB Guidance Companion Piece","url":"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/12\/res_irbmed_Smart-IRB-Guidance-Companion-Piece.docx","target":"_blank"},"legacy_import_link":true}]},{"legacy_section_type":"text_area","legacy_heading":"","legacy_subheading":"","legacy_section_text":"<strong>Ceding under No Prior Agreement <\/strong>\r\n\r\nSubmit an eResearch ceding application for IRBMED to consider a request to cede outside of a Master Services Agreement or SMART IRB agreement.\u00a0 These ceding requests will be assessed on a study-specific basis.","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":"IV. U-M as a Coordinating Center","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":"A coordinating center is an entity that agrees to be responsible for coordinating administrative and\/or collection activities for data, clinical protocols, or biospecimens associated with a multi-site research project.\r\n\r\nWhen U-M is the coordinating center, the study team will complete a Multi-Site Research Application type in eResearch. \u00a0The\u00a0<a href=\"https:\/\/hrpp.umich.edu\/wp-content\/uploads\/sites\/4\/2024\/10\/csp_pg205.sirb_eresearch_application_instructions_2023_june.pdf\">IRB Application instructions<\/a>\u00a0for Multi-site Research provide specific guidance for completing the application.\r\n\r\n<em>Note: Unless required by federal regulations, if U-M performs only coordinating center activities it does not necessarily require that IRBMED follow a sIRB model and\/or provide IRB oversight for all participating sites.<\/em>","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":"V. Fees and Budgeting for Industry-Sponsored Research","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":"Background","legacy_section_text":"IRBMED review fees are charged to industry sponsored contracts to underwrite a portion of the administrative costs necessary to conduct IRB review, issue IRB Board approvals, and maintain oversight of a research study.\u00a0 Even with this limited recovery, the Medical School continues to heavily subsidize the costs of these reviews.","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":"Industry-Sponsored Research","legacy_section_text":"IRBMED fees are charged to each sponsor for new industry-sponsored contracts with required IRBMED review.\r\n<p class=\"rteindent1\"><em><u>IRBMED Reviews U-M as a Participating Site<\/u><\/em><\/p>\r\n<p class=\"rteindent1\">A <strong>one-time <\/strong>IRBMED review fee of <strong>$3750<\/strong> is required to be negotiated and recovered as a standard, fixed fee amount for the university to provide the review of the initial submission, amendments, adverse events, and continuing reviews\/termination for a study.\u00a0The fee is standard for all applicable agreements and studies will not be accepted by the university to move forward without this recovery.<\/p>\r\n<p class=\"rteindent1\"><em><u>IRBMED Oversight is Ceded to a Commercial IRB<\/u><\/em><\/p>\r\n<p class=\"rteindent1\">A <strong>one-time<\/strong> IRBMED review fee of <strong>$1300<\/strong> is required to be negotiated and recovered as a standard, fixed fee amount for the university to provide administrative review, finalization of study materials, and compliance functions related to studies ceded to commercial IRBs.\u00a0The fee is standard for all applicable agreements and studies will not be accepted by the university to move forward without this recovery.<\/p>\r\n<p class=\"rteindent1\">More information about the fee structure for qualifying studies and budgeting for these fees is located at <a href=\"\/medschool\/guidance\/irbmed-review-fees\/\">IRBMED Review Fees<\/a>.<\/p>","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":"Contacts","legacy_section_text":"<ul>\r\n \t<li>IRBMED review \u2013\u00a0<a href=\"mailto:irbmedreliance@umich.edu?subject=Questions%20related%20to%20IRB%20Review%20fees\">IRBMED<\/a><\/li>\r\n \t<li>Contract negotiation \u2013 <a href=\"https:\/\/research.medicine.umich.edu\/our-units\/clinical-trials-support-office\/clinical-trials-support-units\">Clinical Trials Support Units<\/a><\/li>\r\n \t<li>General sponsor applicability and reflecting IRBMED Fees\/recovery in your sponsored project budget\u2013 <a href=\"mailto:msgrants@umich.edu?subject=Questions%20related%20to%20IRB%20Review%20fees\">Grant Services &amp; Analysis Office<\/a><\/li>\r\n<\/ul>","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":"VI. Downloadable Multi-Site Research Job Aids (including MiCORES)","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":"Multi-site Research Documents for Study Teams: see \"Resources and References\" heading at <a href=\"https:\/\/hrpp.umich.edu\/coordinated-services-practices-csp\/\">IRB Coordinated Services and Practices<\/a> page\r\n\r\n<a href=\"https:\/\/its.umich.edu\/academics-research\/research\/eresearch\/micores\">MiCORES Support page<\/a>","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":[97],"update_notice_start":"2023-06-19 07:45:00","update_notice_end":"2023-08-18 15:00:00","update_notice_text_blocks":[{"update_notice_text":"<p>The linked&nbsp;<a href=\"\/node\/1585\/\">IRB Review Fees<\/a>&nbsp;page has been moved and is no longer password-protected.&nbsp;IRBMED&nbsp;hourly fees have been updated at that page.<\/p>"}],"global_contact_block":false,"contact_name":"","contact_email":"","contact_additional_info":"Contact us at\u00a0<a href=\"mailto:irbmed@umich.edu\">irbmed@umich.edu<\/a>\u00a0or 734-763-4768 \/ (Fax 734-763-1234)\r\n2800 Plymouth Road, Ann Arbor, MI 48109-2800\r\n\r\nA list of IRBMED staff is available at\u00a0the <a href=\"https:\/\/medresearch.umich.edu\/office-research\/about-office-research\/our-units\/institutional-review-boards-irbmed\/irbmed-contacts-roster\">UMMS Office of Research webpage<\/a>.\r\n\r\nEdited <a href=\"mailto:larkspur@umich.edu\">larkspur@umich.edu<\/a>\r\nLast Updated: April 8, 2026 10:15AM","global_contact_block_select":null},"_links":{"self":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/881","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\/881\/revisions"}],"predecessor-version":[{"id":1953,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/881\/revisions\/1953"}],"acf:term":[{"embeddable":true,"taxonomy":"update-type","href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/update-type\/97"}],"acf:post":[{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/889"}],"wp:attachment":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/media?parent=881"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/categories?post=881"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/tags?post=881"},{"taxonomy":"content-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/content-type?post=881"},{"taxonomy":"topic","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/topic?post=881"},{"taxonomy":"update-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/update-type?post=881"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}