{"id":434,"date":"2023-08-17T04:47:24","date_gmt":"2023-08-17T04:47:24","guid":{"rendered":"https:\/\/research.iium.edu.my\/irec\/?page_id=434"},"modified":"2023-08-17T04:55:59","modified_gmt":"2023-08-17T04:55:59","slug":"major-protocol-deviation","status":"publish","type":"page","link":"https:\/\/research.iium.edu.my\/irec\/?page_id=434","title":{"rendered":"Major Protocol Deviation"},"content":{"rendered":"<div data-colibri-id=\"434-c1\" class=\"style-737 style-local-434-c1 position-relative\">\n  <!---->\n  <div data-colibri-component=\"section\" data-colibri-id=\"434-c2\" id=\"custom\" class=\"h-section h-section-global-spacing d-flex align-items-lg-center align-items-md-center align-items-center style-738 style-local-434-c2 position-relative\">\n    <!---->\n    <!---->\n    <div class=\"h-section-grid-container h-section-boxed-container\">\n      <!---->\n      <div data-colibri-id=\"434-c3\" class=\"h-row-container gutters-row-lg-2 gutters-row-md-2 gutters-row-0 gutters-row-v-lg-2 gutters-row-v-md-2 gutters-row-v-2 style-739 style-local-434-c3 position-relative\">\n        <!---->\n        <div class=\"h-row justify-content-lg-center justify-content-md-center justify-content-center align-items-lg-stretch align-items-md-stretch align-items-stretch gutters-col-lg-2 gutters-col-md-2 gutters-col-0 gutters-col-v-lg-2 gutters-col-v-md-2 gutters-col-v-2\">\n          <!---->\n          <div class=\"h-column h-column-container d-flex h-col-lg-auto h-col-md-auto h-col-auto style-740-outer style-local-434-c4-outer\">\n            <div data-colibri-id=\"434-c4\" class=\"d-flex h-flex-basis h-column__inner h-px-lg-2 h-px-md-2 h-px-2 v-inner-lg-2 v-inner-md-2 v-inner-2 style-740 style-local-434-c4 position-relative\">\n              <!---->\n              <!---->\n              <div class=\"w-100 h-y-container h-column__content h-column__v-align flex-basis-100 align-self-lg-start align-self-md-start align-self-start\">\n                <!---->\n                <div data-colibri-id=\"434-c5\" class=\"h-text h-text-component style-741 style-local-434-c5 position-relative h-element\">\n                  <!---->\n                  <!---->\n                  <div class=\"\">\n                    <ul>\n                      <li>The deviation has harmed or posed a significant or substantive risk of harm to a research participant (this is also an unanticipated problem). Examples: A research participant received the wrong treatment or incorrect dose, A research\n                        participant met withdrawal criteria during the research project but was not withdrawn, A research participant received an excluded concomitant medication.<\/li>\n                      <li>The deviation compromises the scientific integrity of the data collected for the research project. Examples: A research participant was enrolled but does not meet the protocol&#8217;s eligibility criteria.<\/li>\n                      <li>Failure to treat research participants per protocol procedures that specifically relate to primary efficacy outcomes (if it involves patient safety, it meets the first category above).<\/li>\n                      <li>Changing the protocol without prior IRB approval (except where necessary to eliminate an apparent immediate hazard to the participant).<\/li>\n                      <li>Inadvertent loss of samples or data.<\/li>\n                      <li>The deviation is a willful or knowing breach of human subjects&#8217; research protection regulations, policies, or procedures on the part of the investigator(s). Examples: Failure to obtain informed consent prior to initiation of research\n                        project-related procedures, Falsifying research or medical records.<\/li>\n                      <li>Performing tests or procedures beyond the individual&#8217;s professional scope or privilege status (credentialing).<\/li>\n                      <li>The deviation involves a serious or continuing noncompliance with federal, state, local, or University human subjects research protection regulations, policies, or procedures. Examples: Working under an expired professional license\n                        or certification,Failure to follow federal and\/or local regulations and intramural research or University policies, Repeated minor deviations, The deviation is inconsistent with the IREC\u2019s research, medical, or ethical principles.<\/li>\n                      <li>A breach of confidentiality.<\/li>\n                      <li>Inadequate or improper informed consent procedure.<\/li>\n                    <\/ul>\n                  <\/div>\n                <\/div>\n              <\/div>\n            <\/div>\n          <\/div>\n        <\/div>\n      <\/div>\n    <\/div>\n  <\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>The deviation has harmed or posed a significant or substantive risk of harm to a research participant (this is also an unanticipated problem). Examples: A research participant received the wrong treatment or incorrect dose, A research participant met withdrawal criteria during the research project but was not withdrawn, A research participant received an excluded concomitant [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-templates\/full-width-page.php","meta":{"footnotes":""},"_links":{"self":[{"href":"https:\/\/research.iium.edu.my\/irec\/index.php?rest_route=\/wp\/v2\/pages\/434"}],"collection":[{"href":"https:\/\/research.iium.edu.my\/irec\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/research.iium.edu.my\/irec\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/research.iium.edu.my\/irec\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/research.iium.edu.my\/irec\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=434"}],"version-history":[{"count":1,"href":"https:\/\/research.iium.edu.my\/irec\/index.php?rest_route=\/wp\/v2\/pages\/434\/revisions"}],"predecessor-version":[{"id":443,"href":"https:\/\/research.iium.edu.my\/irec\/index.php?rest_route=\/wp\/v2\/pages\/434\/revisions\/443"}],"wp:attachment":[{"href":"https:\/\/research.iium.edu.my\/irec\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=434"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}