{"id":1628,"date":"2024-05-21T02:21:38","date_gmt":"2024-05-21T02:21:38","guid":{"rendered":"https:\/\/research.iium.edu.my\/irec\/?page_id=1628"},"modified":"2024-05-21T03:05:56","modified_gmt":"2024-05-21T03:05:56","slug":"requirement-for-informed-consent-form-icf","status":"publish","type":"page","link":"https:\/\/research.iium.edu.my\/irec\/?page_id=1628","title":{"rendered":"Requirement for Informed Consent Form (ICF)"},"content":{"rendered":"<div data-colibri-id=\"1628-c1\" class=\"style-1437 style-local-1628-c1 position-relative\">\n  <!---->\n  <div data-colibri-component=\"section\" data-colibri-id=\"1628-c2\" id=\"custom\" class=\"h-section h-section-global-spacing d-flex align-items-lg-center align-items-md-center align-items-center style-1438 style-local-1628-c2 position-relative\">\n    <!---->\n    <!---->\n    <div class=\"h-section-grid-container h-section-boxed-container\">\n      <!---->\n      <div data-colibri-id=\"1628-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-1439 style-local-1628-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-1440-outer style-local-1628-c4-outer\">\n            <div data-colibri-id=\"1628-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-1440 style-local-1628-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=\"1628-c5\" class=\"h-global-transition-all h-heading style-1441 style-local-1628-c5 position-relative h-element\">\n                  <!---->\n                  <div class=\"h-heading__outer style-1441 style-local-1628-c5\">\n                    <!---->\n                    <!---->\n                    <h1 class=\"\">Requirement for Informed Consent Form (ICF)<\/h1>\n                  <\/div>\n                <\/div>\n              <\/div>\n            <\/div>\n          <\/div>\n        <\/div>\n      <\/div>\n      <div data-colibri-id=\"1628-c9\" 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-1445 style-local-1628-c9 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-1446-outer style-local-1628-c10-outer\">\n            <div data-colibri-id=\"1628-c10\" 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-1446 style-local-1628-c10 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=\"1628-c12\" class=\"h-text h-text-component style-1448 style-local-1628-c12 position-relative h-element\">\n                  <!---->\n                  <!---->\n                  <div class=\"\">\n                    <p>An Informed Consent Form (ICF) is a crucial document in ethical research or medical practices.<\/p>\n                    <p>\n                      <a href=\"https:\/\/www.research.chop.edu\/services\/what-do-i-need-to-know-about-consent-and-how-do-i-write-a-consent-form\" target=\"_blank\" class=\"customize-unpreviewable\" rel=\"noopener\">It\u2019s not just a document, but a process that ensures participants are fully informed before they decide to volunteer in any type of research projects<\/a>.<\/p>\n                    <p>Here\u2019s a simple explanation:<\/p>\n                    <ol>\n                      <li>\n                        <a href=\"https:\/\/www.research.chop.edu\/services\/what-do-i-need-to-know-about-consent-and-how-do-i-write-a-consent-form\" target=\"_blank\" class=\"customize-unpreviewable\" rel=\"noopener\"><strong>Purpose<\/strong>: The ICF tells you why the research or medical procedure is being done<\/a>.<\/li>\n                      <li>\n                        <a href=\"https:\/\/www.research.chop.edu\/services\/what-do-i-need-to-know-about-consent-and-how-do-i-write-a-consent-form\" target=\"_blank\" class=\"customize-unpreviewable\" rel=\"noopener\"><strong>Procedures<\/strong>: It explains what will happen during the research or procedure, and what you, as a participant, need to do<\/a>.<\/li>\n                      <li>\n                        <a href=\"https:\/\/www.research.chop.edu\/services\/what-do-i-need-to-know-about-consent-and-how-do-i-write-a-consent-form\" target=\"_blank\" class=\"customize-unpreviewable\" rel=\"noopener\"><strong>Risks and Benefits<\/strong>: The ICF will outline any potential risks or benefits that may come from participating<\/a>.<\/li>\n                      <li>\n                        <a href=\"https:\/\/research.iium.edu.my\/irec?page_id=1168\" target=\"_blank\" rel=\"noopener\"><strong>Rights<\/strong>: It informs you that participation is voluntary and you can withdraw at any time without penalty<\/a>.<\/li>\n                    <\/ol>\n                    <p>The language used in the ICF should be understandable to the participants.\n                      <a href=\"https:\/\/www.singhealthdukenus.com.sg\/research\/rice\/Documents\/Glossary%20of%20lay%20terms%20%5B2016-07-26%5D.pdf\" target=\"_blank\" class=\"customize-unpreviewable\" rel=\"noopener\">Any technical or medical terms should be explained using common or lay terminology<\/a>.\n                      <a href=\"https:\/\/irb.ufl.edu\/irb01\/forms\/glossary.html\" target=\"_blank\" class=\"customize-unpreviewable\" rel=\"noopener\">For example, a term like \u201canemia\u201d would be explained as a &#8220;decreased number of red blood cells&#8221;<\/a>.<\/p>\n                    <p>\n                      <a href=\"https:\/\/www.research.chop.edu\/services\/what-do-i-need-to-know-about-consent-and-how-do-i-write-a-consent-form\" target=\"_blank\" class=\"customize-unpreviewable\" rel=\"noopener\">Remember, the goal of an ICF is to ensure that you are fully aware and understand what you\u2019re agreeing to when participating in a study or procedure<\/a>. If you have any questions or something isn\u2019t clear, you should feel comfortable\n                      asking for more information.\n                      <br>\n                      <br>* IREC will only accept Informed Consent Form that fulfill the above criteria.<\/p>\n                    <p>\n                      <br>\n                    <\/p>\n                  <\/div>\n                <\/div>\n              <\/div>\n            <\/div>\n          <\/div>\n          <div class=\"h-column h-column-container d-flex h-col-lg-auto h-col-md-auto h-col-auto style-1447-outer style-local-1628-c11-outer\">\n            <div data-colibri-id=\"1628-c11\" 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-1447 style-local-1628-c11 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=\"1628-c13\" class=\"d-block style-1449 style-local-1628-c13 position-relative h-element\">\n                  <!---->\n                  <div class=\"h-image__frame-container-outer\">\n                    <div class=\"h-image__frame-container\">\n                      <!---->\n                      <!---->\n                      <img decoding=\"async\" loading=\"lazy\" width=\"1134\" height=\"898\" src=\"https:\/\/research.iium.edu.my\/irec\/wp-content\/uploads\/2024\/05\/cropped-R.jpeg\" class=\"wp-image-1631 style-1449-image style-local-1628-c13-image\" srcset=\"https:\/\/research.iium.edu.my\/irec\/wp-content\/uploads\/2024\/05\/cropped-R.jpeg 1134w, https:\/\/research.iium.edu.my\/irec\/wp-content\/uploads\/2024\/05\/cropped-R-300x238.jpeg 300w, https:\/\/research.iium.edu.my\/irec\/wp-content\/uploads\/2024\/05\/cropped-R-1024x811.jpeg 1024w, https:\/\/research.iium.edu.my\/irec\/wp-content\/uploads\/2024\/05\/cropped-R-768x608.jpeg 768w\" sizes=\"(max-width: 1134px) 100vw, 1134px\" alt=\"\" \/>\n                      <div class=\"h-image__frame h-hide-lg h-hide-md h-hide-sm style-1449-frameImage style-local-1628-c13-frameImage\"><\/div>\n                    <\/div>\n                  <\/div>\n                <\/div>\n              <\/div>\n            <\/div>\n          <\/div>\n        <\/div>\n      <\/div>\n      <div data-colibri-id=\"1628-c23\" 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-1458 style-local-1628-c23 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-1459-outer style-local-1628-c24-outer\">\n            <div data-colibri-id=\"1628-c24\" 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-1459 style-local-1628-c24 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=\"1628-c26\" class=\"h-global-transition-all h-heading style-1461 style-local-1628-c26 position-relative h-element\">\n                  <!---->\n                  <div class=\"h-heading__outer style-1461 style-local-1628-c26\">\n                    <!---->\n                    <!---->\n                    <h3 class=\"\">Research that requires Informed Consent<\/h3>\n                  <\/div>\n                <\/div>\n                <div data-colibri-id=\"1628-c31\" class=\"h-text h-text-component style-1466 style-local-1628-c31 position-relative h-element\">\n                  <!---->\n                  <!---->\n                  <div class=\"\">\n                    <ol>\n                      <li>Questionnaire\/Survey<\/li>\n                      <li>Interview<\/li>\n                      <li>Physical\/Medical Assessment<\/li>\n                      <li>Clinical Trials<\/li>\n                      <li>Human tissue sampling<\/li>\n                    <\/ol>\n                    <p>\n                      <br>\n                    <\/p>\n                    <p>\n                      <br>\n                    <\/p>\n                  <\/div>\n                <\/div>\n              <\/div>\n            <\/div>\n          <\/div>\n          <div class=\"h-column h-column-container d-flex h-col-lg-auto h-col-md-auto h-col-auto style-1460-outer style-local-1628-c25-outer\">\n            <div data-colibri-id=\"1628-c25\" 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-1460 style-local-1628-c25 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=\"1628-c27\" class=\"h-global-transition-all h-heading style-1462 style-local-1628-c27 position-relative h-element\">\n                  <!---->\n                  <div class=\"h-heading__outer style-1462 style-local-1628-c27\">\n                    <!---->\n                    <!---->\n                    <h3 class=\"\">Research that may not require Informed Consent<\/h3>\n                  <\/div>\n                <\/div>\n                <div data-colibri-id=\"1628-c32\" class=\"h-text h-text-component style-1467 style-local-1628-c32 position-relative h-element\">\n                  <!---->\n                  <!---->\n                  <div class=\"\">\n                    <ol>\n                      <li>Covert Observations<\/li>\n                      <li>Retrospective (need ensure no identification will be recorded)<\/li>\n                      <li>Case study<\/li>\n                      <li>Experimental (using non-identifiable human tissue)<\/li>\n                    <\/ol>\n                    <p>\n                      <br>\n                    <\/p>\n                    <p>\n                      <br>\n                    <\/p>\n                  <\/div>\n                <\/div>\n              <\/div>\n            <\/div>\n          <\/div>\n        <\/div>\n      <\/div>\n      <div data-colibri-id=\"1628-c33\" 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-1468 style-local-1628-c33 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-1469-outer style-local-1628-c34-outer\">\n            <div data-colibri-id=\"1628-c34\" 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-1469 style-local-1628-c34 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=\"1628-c35\" class=\"h-x-container style-1470 style-local-1628-c35 position-relative h-element\">\n                  <!---->\n                  <div class=\"h-x-container-inner style-dynamic-1628-c35-group style-1470-spacing style-local-1628-c35-spacing\"><span class=\"h-button__outer style-1471-outer style-local-1628-c36-outer d-inline-flex h-element\"><a h-use-smooth-scroll=\"true\" href=\"https:\/\/research.iium.edu.my\/irec\/?page_id=1168\"  data-colibri-id=\"1628-c36\" class=\"d-flex w-100 align-items-center h-button justify-content-lg-center justify-content-md-center justify-content-center style-1471 style-local-1628-c36 position-relative\"><!----><!----> <span>informed consent form (ICF) template\/guideline<\/span><\/a>\n                    <\/span>\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>Requirement for Informed Consent Form (ICF) An Informed Consent Form (ICF) is a crucial document in ethical research or medical practices. It\u2019s not just a document, but a process that ensures participants are fully informed before they decide to volunteer in any type of research projects. Here\u2019s a simple explanation: Purpose: The ICF tells you [&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\/1628"}],"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=1628"}],"version-history":[{"count":3,"href":"https:\/\/research.iium.edu.my\/irec\/index.php?rest_route=\/wp\/v2\/pages\/1628\/revisions"}],"predecessor-version":[{"id":1647,"href":"https:\/\/research.iium.edu.my\/irec\/index.php?rest_route=\/wp\/v2\/pages\/1628\/revisions\/1647"}],"wp:attachment":[{"href":"https:\/\/research.iium.edu.my\/irec\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1628"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}