{"id":430,"date":"2011-04-14T14:04:02","date_gmt":"2011-04-14T18:04:02","guid":{"rendered":"http:\/\/www.marshall.edu\/ori\/?page_id=430"},"modified":"2019-03-12T16:35:12","modified_gmt":"2019-03-12T20:35:12","slug":"research-termsdefinitions-s","status":"publish","type":"page","link":"https:\/\/www.marshall.edu\/ori\/office-of-research-integrity\/human-subject-research\/research-termsdefinitions\/research-termsdefinitions-s\/","title":{"rendered":"Research Terms\/Definitions &#8211; S"},"content":{"rendered":"<p style=\"\"><a href=\"https:\/\/www.marshall.edu\/ori\/human-subject-research\/research-termsdefinitions\" target=\"_self\">Return to Directory<\/a><\/p>\n<p><strong>Serious Adverse Event (AE) or Serious Problem &#8211;<\/strong> Defined as an adverse event that results in death, a life-threatening experience, inpatient hospitalization, prolongation of hospitalization, persistent or significant disability or incapacity, congenital anomaly, or birth defect.<\/p>\n<p style=\"\">1) A serious problem in research is one that results in:<\/p>\n<p style=\"\">(a) Substantive harm or damage (or risk of substantive harm or damage) to the rights, or welfare of research subjects, research staff, or others; or<\/p>\n<p style=\"\">(b) Substantive harm or damage (or risk of substantive harm or damage) to the safety or welfare of laboratory animals.<\/p>\n<p style=\"\">2) An adverse event or problem in research is also considered serious when medical, surgical, behavioral, social, or other intervention is needed to prevent preceding subparagraphs.<\/p>\n<p><strong>SOP:\u00a0 Standard Operating Procedures <\/strong>&#8211; Detailed, written procedures for the uniform performance of a function. These must be consistent with the \u201cCommon Rule\u201d and federal regulations and policies pertaining to research compliance and protection of human subjects.\u00a0 (Federal regulations tell \u201cwhat\u201d to do, but not \u201chow\u201d to do it.\u00a0 individual institutions SOP outline the \u201chow\u201d to do research at that institution.)<\/p>\n<p><strong>Suspended Protocols:<\/strong>\u00a0 Suspension of IRB approval. An action taken by the IRB to temporarily or permanently withdraw approval for some or all research activities short of permanently withdrawing approval for all research activities.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Return to Directory Serious Adverse Event (AE) or Serious Problem &#8211; Defined as an adverse event that results in death, a life-threatening experience, inpatient hospitalization, prolongation of hospitalization, persistent or significant disability or incapacity, congenital anomaly, or birth defect. 1) A serious problem in research is one that results in: (a) Substantive harm or damage<\/p>\n","protected":false},"author":15,"featured_media":0,"parent":101,"menu_order":19,"comment_status":"closed","ping_status":"closed","template":"page-sidebar-right.php","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-430","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.marshall.edu\/ori\/wp-json\/wp\/v2\/pages\/430","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.marshall.edu\/ori\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.marshall.edu\/ori\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.marshall.edu\/ori\/wp-json\/wp\/v2\/users\/15"}],"replies":[{"embeddable":true,"href":"https:\/\/www.marshall.edu\/ori\/wp-json\/wp\/v2\/comments?post=430"}],"version-history":[{"count":0,"href":"https:\/\/www.marshall.edu\/ori\/wp-json\/wp\/v2\/pages\/430\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/www.marshall.edu\/ori\/wp-json\/wp\/v2\/pages\/101"}],"wp:attachment":[{"href":"https:\/\/www.marshall.edu\/ori\/wp-json\/wp\/v2\/media?parent=430"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}