{"id":857,"date":"2018-05-23T08:54:49","date_gmt":"2018-05-23T08:54:49","guid":{"rendered":"https:\/\/az.research.umich.edu\/medschool\/document\/certification-preparatory-research\/"},"modified":"2026-02-23T11:24:38","modified_gmt":"2026-02-23T16:24:38","slug":"certification-preparatory-research","status":"publish","type":"document","link":"https:\/\/az.research.umich.edu\/medschool\/guidance\/certification-preparatory-research\/","title":{"rendered":"Certification Preparatory to Research"},"template":"","categories":[24],"tags":[],"content-type":[41],"topic":[42,43,45,66],"update-type":[],"class_list":["post-857","document","type-document","status-publish","hentry","category-institutional-review-boards-irbmed","content-type-guidance","topic-application-types","topic-eresearch-regulatory-management-errm","topic-hipaa-protected-health-information","topic-investigator-study-team-responsibilities"],"acf":{"use_legacy_editor":true,"updated_date":"2020-08-31 14:45:00","update_notice":false,"author":"IRBMED","summary":"Review of data and\/or biospecimens preparatory to <a class=\"gtip\" href=\"\/medschool\/glossary\/research\">research<\/a> are not regulated under the\u00a0<a href=\"https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/regulations\/45-cfr-46\/index.html\">Common Rule<\/a>\u00a0<strong>if any data obtained is not used for future research.<\/strong>\u00a0\u00a0However, if you or any member of the study team will be accessing\u00a0<a href=\"https:\/\/az.research.umich.edu\/medschool\/guidance\/protected-health-information-phi\">Protected Health Information (PHI)<\/a>\u00a0to assess the feasibility of a research project (for example, determining whether there are enough potential subjects in order to pursue the research project), the activities must comply with\u00a0<a class=\"gtip\" href=\"\/medschool\/glossary\/hipaa\">HIPAA<\/a> Privacy Rule.\r\n\r\n<a href=\"https:\/\/az.research.umich.edu\/medschool\/guidance\/hipaa\">HIPAA Privacy Rule<\/a> permits access to PHI as part of\u00a0<a href=\"https:\/\/privacyruleandresearch.nih.gov\/pr_08.asp#8e\">Activities Preparatory to Research<\/a><strong>\u00a0if<\/strong>\u00a0the researcher provides appropriate representations (or assurances) to the\u00a0<a href=\"https:\/\/az.research.umich.edu\/medschool\/glossary\/covered-entity\">covered entity<\/a>.\u00a0These representations are recorded in the\u00a0<a href=\"http:\/\/eresearch.umich.edu\">eResearch\u00a0<\/a>Regulatory Management (eRRM) system.","button_links":null,"related_content":[744,745,752],"legacy_path":"certification-preparatory-research","legacy_node_id":418,"legacy_related_nids":"","legacy_content_section":[{"legacy_section_type":"heading","legacy_heading":"Required representations (assurances)","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":"<ol>\r\n \t<li>The use or disclosure is requested solely to review <a class=\"gtip\" href=\"\/medschool\/glossary\/protected-health-information-phi\">PHI<\/a> as necessary to prepare a research <a class=\"gtip\" href=\"\/medschool\/glossary\/protocol\">protocol<\/a> or for similar purposes preparatory to research (<a href=\"http:\/\/eresearch.umich.edu\">eResearch<\/a> application question\u00a0<a href=\"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/12\/res_irbmed_eResearch.Application.Section25-3.2011.06.03_0.pdf\">25-3<\/a>.<strong>1<\/strong>),<\/li>\r\n \t<li>The PHI will not be removed from the covered entity in the course of review, (eResearch\u00a0<a href=\"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/12\/res_irbmed_eResearch.Application.Section25-3.2011.06.03_0.pdf\">25-3<\/a>.<strong>2<\/strong>) and<\/li>\r\n \t<li>The PHI for which use or access is requested is necessary for the research (eResearch\u00a0<strong>1.8<\/strong>).<\/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":"Process for application","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":"To request \u201cCertification for pre-review of clinical data\u201d from\u00a0Privacy Board, complete a new application in\u00a0<a href=\"http:\/\/eresearch.umich.edu\">eResearch<\/a>\u00a0Regulatory Management (<a href=\"http:\/\/www.umich.edu\/~eresinfo\/rm.html\">eRRM<\/a>). Fill out system-required sections, including:\r\n<ul>\r\n \t<li>Question\u00a0<strong>1.8<\/strong>\u00a0(project summary): explain the purpose of the project, and why this requires access to <a class=\"gtip\" href=\"\/medschool\/glossary\/protected-health-information-phi\">PHI.<\/a><\/li>\r\n \t<li>Section<strong>\u00a001-1<\/strong>: \u201cActivities Not Regulated\u2026\u201d;<\/li>\r\n \t<li>Section\u00a0<strong>04-1<\/strong>: \u201cPre-review of Clinical Data Sets\u201d;<\/li>\r\n \t<li>Section\u00a0<a href=\"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/12\/res_irbmed_eResearch.Application.Section25-3.2011.06.03_0.pdf\">25-3<\/a>: provide required assurances.<\/li>\r\n<\/ul>\r\nOnce completed and submitted, the application will be reviewed by IRBMED Staff for clarity and completeness, then assigned to an IRBMED Board reviewer\u00a0for determination.","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\n2800 Plymouth Road, Ann Arbor, MI 48109-2800\r\n<p>A <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.<\/p>\r\n\r\nEdited By: <a href=\"mailto:larkspur@umich.edu\">larkspur@umich.edu<\/a>\r\nLast Updated: February 23, 2026 11:25AM","global_contact_block_select":null},"_links":{"self":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/857","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\/857\/revisions"}],"predecessor-version":[{"id":1886,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/857\/revisions\/1886"}],"acf:post":[{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/752"},{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/745"},{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/744"}],"wp:attachment":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/media?parent=857"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/categories?post=857"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/tags?post=857"},{"taxonomy":"content-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/content-type?post=857"},{"taxonomy":"topic","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/topic?post=857"},{"taxonomy":"update-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/update-type?post=857"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}