{"id":883,"date":"2019-11-06T10:40:38","date_gmt":"2019-11-06T10:40:38","guid":{"rendered":"https:\/\/az.research.umich.edu\/medschool\/document\/external-non-um-study-team-members\/"},"modified":"2026-03-04T17:16:43","modified_gmt":"2026-03-04T22:16:43","slug":"external-non-um-study-team-members","status":"publish","type":"document","link":"https:\/\/az.research.umich.edu\/medschool\/guidance\/external-non-um-study-team-members\/","title":{"rendered":"External (non-UM) Study Team Members"},"template":"","categories":[24],"tags":[57],"content-type":[41],"topic":[81,66,92],"update-type":[98,94],"class_list":["post-883","document","type-document","status-publish","hentry","category-institutional-review-boards-irbmed","tag-study-teams","content-type-guidance","topic-international-research","topic-investigator-study-team-responsibilities","topic-single-irb-sirb","update-type-new-resource","update-type-review-recommended"],"acf":{"use_legacy_editor":true,"updated_date":"2025-11-21 10:30:00","update_notice":true,"author":"IRBMED","summary":"","button_links":null,"related_content":[881,768],"legacy_path":"external-non-um-study-team-members","legacy_node_id":1533,"legacy_related_nids":"1520, 310","legacy_content_section":[{"legacy_section_type":"heading","legacy_heading":"Overview","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":"Institutional Review Boards have a role in assessing an investigator\u2019s (or, a study team member\u2019s) qualification in conducting the human subject<\/a> research activities proposed in a protocol<\/a> or an IRB application. IRBMED review and approval process includes evaluating study team members\u2019 qualifications and appropriate U-M affiliation(s).\u00a0 IRBMED oversight applies to the study team members affiliated with U-M in accordance with IRBMED jurisdiction (outlined in U-M IRB Standard Operating Procedures<\/a>). For study team members that are not affiliated with U-M, appropriate IRB oversight must be established prior to conducting any human subject research activities. IRBMED may choose to extend its oversight to study team members not otherwise affiliated with an institution having an IRB<\/strong> or whose institution is not otherwise a performance site<\/strong> in the research. This guidance outlines the current IRBMED process to identify these external study team members, document them in the IRB application, and work with IRBMED in establishing appropriate IRB oversight.\r\n\r\nSee also U-M Human Research Protection Program (HRPP)\u00a0Operations Manual<\/a> Part 5 (particularly, IV. UNAFFILIATED INVESTIGATORS)","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":"Process","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":"External Collaborators: <\/strong>The study team members who are not affiliated with \u00a0University of Michigan (U-M) but are conducting non-exempt\u00a0research\u00a0with human participants\u00a0on behalf of the U-M.\u00a0 Their institution or organization is not otherwise a performance site.\r\n\r\nNOTE:<\/strong> Generally, Active Emeritus Faculty, Adjunct Faculty, Visiting Faculty, Visiting Scholars, Visiting Graduate Students, International Visiting Scholars and Volunteers vetted through Volunteer services<\/a>\u00a0count as affiliated with U-M during the term of their\u00a0sponsorship<\/a>\/appointment. Contact your IRB\u00a0(IRBMED <\/a>or HSBS<\/a>) for confirmation.","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":"I. Identifying external (non-UM) study team members","legacy_section_text":"Section 01 of the IRB application (eResearch Regulatory Management<\/a>) is designed to capture information regarding the study team members. The non-UM study team members are usually identified in various ways:\r\n
    \r\n \t
  1. The U-M study team self-identifies an individual as an external collaborator.<\/li>\r\n \t
  2. A study team member is listed with a Friend Account<\/a><\/li>\r\n \t
  3. A study team member is pre-identified with \u201cOther\u201d as the study team role<\/li>\r\n \t
  4. A study team member is not<\/em> a student and has no<\/em> Appointment Department<\/a> selected<\/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":"media","legacy_heading":"","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"media-full","legacy_media_file":1381,"legacy_media_url":"https:\/\/az.research.umich.edu\/sites\/default\/files\/media\/embedded\/res_irbmed_study-team-listing-eRRM-1.3.png","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":"II. IRB Oversight","legacy_section_text":"Generally, the human subject research activities performed by an external study team member are overseen by the institution they are affiliated with.\r\n