{"id":771,"date":"2018-05-08T07:37:41","date_gmt":"2018-05-08T07:37:41","guid":{"rendered":"https:\/\/az.research.umich.edu\/medschool\/document\/international-research\/"},"modified":"2026-03-06T15:04:07","modified_gmt":"2026-03-06T20:04:07","slug":"international-research","status":"publish","type":"document","link":"https:\/\/az.research.umich.edu\/medschool\/guidance\/international-research\/","title":{"rendered":"International Research"},"template":"","categories":[24],"tags":[],"content-type":[41],"topic":[81],"update-type":[],"class_list":["post-771","document","type-document","status-publish","hentry","category-institutional-review-boards-irbmed","content-type-guidance","topic-international-research"],"acf":{"use_legacy_editor":true,"updated_date":"2026-03-06 15:00:00","update_notice":false,"author":"IRBMED","summary":"In order for UM researchers to conduct a <a class=\"gtip\" href=\"\/medschool\/glossary\/research\">research<\/a> project outside of the U.S., the foreign host hospital\/research center must negotiate an International Assurance Agreement with the Office of International Activities (OIA) in the <a class=\"gtip\" href=\"\/medschool\/glossary\/office-human-research-protection-ohrp\">Office of Human Research Protections (OHRP)<\/a> in the federal <a class=\"gtip\" href=\"\/medschool\/glossary\/department-health-and-human-services-dhhs\">Department of Health and Human Services (DHHS<\/a>). Consult the following OHRP website to see if your host institution already has an <a class=\"gtip\" href=\"\/medschool\/glossary\/assurance\">assurance<\/a> agreement on file:\u00a0<a href=\"https:\/\/ohrp.cit.nih.gov\/search\/search.aspx?styp=bsc\">https:\/\/ohrp.cit.nih.gov\/search\/search.aspx?styp=bsc<\/a>\r\n\r\nThe OIA will require the foreign host hospital\/research center have or set up an <a class=\"gtip\" href=\"\/medschool\/glossary\/institutional-review-board-irb\">IRB<\/a> or similar committee to review the research project. In some situations, the local health ministry or institutional ethics committee serves in this capacity.","button_links":null,"related_content":"","legacy_path":"international-research","legacy_node_id":313,"legacy_related_nids":"","legacy_content_section":[{"legacy_section_type":"heading","legacy_heading":"IRBMED Guidelines","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":"In addition to the local review at the location the <a class=\"gtip\" href=\"\/medschool\/glossary\/research\">research<\/a> is conducted, the <a class=\"gtip\" href=\"\/medschool\/glossary\/institutional-review-board-medical-school-irbmed\">IRBMED<\/a> must also review the project. The onus is on the <a class=\"gtip\" href=\"\/medschool\/glossary\/investigator\">investigator<\/a> to provide IRBMED with the same level of information that would be required for an investigation conducted here at UM, and provide information regarding the local research context.\u00a0<em>The extent of the information to be provided depends upon the <a class=\"gtip\" href=\"\/medschool\/glossary\/risk\">risks<\/a> of the project to subjects.<\/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":"text_area_with_subheading","legacy_heading":"","legacy_subheading":"Required for All International Studies","legacy_section_text":"<ul>\r\n \t<li>Foreign host <a class=\"gtip\" href=\"\/medschool\/glossary\/institutional-review-board-irb\">IRB<\/a>\/ethics committee's approval letter\r\n<ul>\r\n \t<li>Copy of the original (electronic version is acceptable) and, if not in English, an English translation of the approval letter<\/li>\r\n<\/ul>\r\n<\/li>\r\n \t<li><a class=\"gtip\" href=\"\/medschool\/glossary\/informed-consent-document-icd-or-informed-consent-form-icf\">Informed consent documents<\/a> in local language and English translation (indicate the language expertise of writer(s)\/translator(s))<\/li>\r\n \t<li>General information regarding local <a class=\"gtip\" href=\"\/medschool\/glossary\/research\">research<\/a> context\r\n<ul>\r\n \t<li>EXAMPLES:\r\n<ul>\r\n \t<li>Local laws\/customs (e.g. proxy, minor consent, age of majority)<\/li>\r\n \t<li>Racial\/ethnic\/socio-economic demographics<\/li>\r\n \t<li>Literacy rates among potential subjects<\/li>\r\n \t<li>Healthcare status of community\/subjects<\/li>\r\n \t<li>Relevant political issues (e.g. war, civil unrest)<\/li>\r\n \t<li>Religious\/Cultural customs<\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>\r\n<\/li>\r\n \t<li>Allow 10 weeks for review<\/li>\r\n<\/ul>\r\nRecommended for Studies Involving Greater than <a class=\"gtip\" href=\"\/medschool\/glossary\/minimal-risk-0\">Minimal Risk<\/a>\r\n<ul>\r\n \t<li><a class=\"gtip\" href=\"\/medschool\/glossary\/site\">Site<\/a> information: size of hospital or clinic<\/li>\r\n \t<li>Supervision and training of research personnel<\/li>\r\n \t<li>English translations of particularly relevant policies and procedures of local site (safety monitoring\/data security)<\/li>\r\n \t<li>IRBMED may also request contact information for on-site <a class=\"gtip\" href=\"\/medschool\/glossary\/investigator\">investigators,<\/a> or local authorities, or other additional information.<\/li>\r\n \t<li>Contact IRBMED prior to submission of application (email\u00a0<a href=\"mailto:irbmed@umich.edu\">irbmed@umich.edu<\/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":"Web Resources","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":"<ul>\r\n \t<li><a href=\"https:\/\/ohrp.cit.nih.gov\/efile\/Default.aspx\">Assurances and IRB Registration<\/a><\/li>\r\n \t<li><a>Declaration of Helsinki<\/a><\/li>\r\n \t<li><a href=\"https:\/\/cioms.ch\/publications\/product\/international-ethical-guidelines-for-health-related-research-involving-humans\/\">International Ethical Guidelines for Human Subject Research<\/a> - Council for International Organizations of Medical Sciences<\/li>\r\n \t<li><a href=\"https:\/\/www.ich.org\/page\/efficacy-guidelines\">ICH-GCP Efficacy Guidelines<\/a> -\u00a0E6 Good Clinical Practice <\/li>\r\n \t<li><a href=\"https:\/\/www.hhs.gov\/ohrp\/international\/index.html\">Miscellaneous International Resources at DHHS Office of Human Research Protections (OHRP)<\/a>\u00a0(including the\u00a0<em>International Compliation of Human Research Standards, a document listing relevant laws, regulations, and guidelines for many countries<\/em>)<\/li>\r\n \t<li><a href=\"https:\/\/tdr.who.int\/publications\/m\">WHO-TDR publications<\/a>: \"Operational guidelines for ethics committees that review biomedical research\"\r\n<\/li>\r\n \t<li>NIAID\u00a0<a href=\"https:\/\/clinregs.niaid.nih.gov\/index.php\">ClinRegs<\/a>: aggregating clinical research regulations from around the globe (selected countries only)<\/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}],"update_notice_type":[],"update_notice_start":"","update_notice_end":"","update_notice_text_blocks":null,"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\n\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: March 6, 2026 3:00PM\r\n\r\n&nbsp;\r\n\r\n&nbsp;","global_contact_block_select":null},"_links":{"self":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/771","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":1,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/771\/revisions"}],"predecessor-version":[{"id":1917,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/771\/revisions\/1917"}],"wp:attachment":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/media?parent=771"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/categories?post=771"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/tags?post=771"},{"taxonomy":"content-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/content-type?post=771"},{"taxonomy":"topic","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/topic?post=771"},{"taxonomy":"update-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/update-type?post=771"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}