{"id":709,"date":"2022-03-16T06:51:53","date_gmt":"2022-03-16T06:51:53","guid":{"rendered":"https:\/\/az.research.umich.edu\/medschool\/glossary\/medschool-glossary-invasive-procedures\/"},"modified":"2024-12-04T22:12:34","modified_gmt":"2024-12-04T22:12:34","slug":"invasive-procedures","status":"publish","type":"glossary","link":"https:\/\/az.research.umich.edu\/medschool\/glossary\/invasive-procedures\/","title":{"rendered":"Invasive Procedures"},"template":"","class_list":["post-709","glossary","type-glossary","status-publish","hentry"],"acf":{"glossary_term_description":"An\u00a0<a href=\"https:\/\/medlineplus.gov\/ency\/article\/002384.htm\">invasive procedure<\/a>\u00a0is one in which the body is \"invaded\", or entered by a needle, tube, device, or scope.\r\n\r\nSome procedures routinely employed in clinical practice that are \"minimally invasive\" can be deemed to pose <a class=\"gtip\" href=\"\/medschool\/glossary\/minimal-risk-0\">minimal <\/a>physical <a class=\"gtip\" href=\"\/medschool\/glossary\/risk\">risk <\/a>to research participants: most commonly, <a href=\"\/medschool\/guidance\/blood-draw-guidance\">blood draw<\/a> by venipuncture or specimen collection by nasopharyngeal\u00a0swab. Risk determination <a href=\"https:\/\/az.research.umich.edu\/medschool\/document\/evaluating-risks-participants\/\">depends also on other contextual features<\/a> of the study.\r\n\r\n<a class=\"gtip\" href=\"\/medschool\/glossary\/office-human-research-protection-ohrp\">OHRP<\/a>'s\u00a0Secretary\u2019s Advisory Committee on Human Research Protections\u00a0(<a href=\"https:\/\/www.hhs.gov\/ohrp\/sachrp-committee\/index.html\">SACHRP<\/a>) offers suggested examples of \"minimally invasive\" procedures in a\u00a0<a href=\"https:\/\/www.hhs.gov\/ohrp\/sachrp-committee\/recommendations\/attachment-a-december-12-2017\/index.html\">12\/2017 Recommendation<\/a> on revisions to the list of \"<a href=\"\/medschool\/guidance\/expedited-review\">Expedited categories<\/a>\":\r\n<p class=\"rteindent1\"><strong>4. Prospective collection of biological specimens, excluding blood, for research purposes by minimally invasive means<\/strong> and not requiring sedation for research purposes.<\/p>\r\n<p class=\"rteindent1\"><strong>Examples:<\/strong> <strong>(a)<\/strong> tissues from non-facial, non-genital skin punch biopsy with allowable local anesthesia and limited to 2mm in diameter and not requiring sutures; <strong>(b)<\/strong> Specimens collected\u00a0 by swab (nasal, oral, urethral, vaginal, rectal); <strong>(c)<\/strong> teeth if routine patient care indicates a need for extraction.<\/p>\r\nSACHRP recommendations are\u00a0<strong>not<\/strong> regulation-level, <strong>nor<\/strong>\u00a0current official guidance from OHRP, but are often considered a reasonable basis for institutional guidance and policy.","glossary_related_terms":[617,708,338],"legacy_glossary_node_id":1639,"legacy_related_terms":"878, 1638, 568"},"_links":{"self":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/glossary\/709","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/glossary"}],"about":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/types\/glossary"}],"acf:post":[{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/glossary\/338"},{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/glossary\/708"},{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/glossary\/617"}],"wp:attachment":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/media?parent=709"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}