{"id":1266,"date":"2022-09-27T15:19:10","date_gmt":"2022-09-27T15:19:10","guid":{"rendered":"https:\/\/nsec.nacosti.go.ke\/?page_id=1266"},"modified":"2022-10-09T09:09:00","modified_gmt":"2022-10-09T09:09:00","slug":"kenya","status":"publish","type":"page","link":"https:\/\/nsers.nacosti.go.ke\/?page_id=1266","title":{"rendered":"Kenya"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"1266\" class=\"elementor elementor-1266\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-2e1218d6 elementor-section-height-min-height elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-id=\"2e1218d6\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-ce245a\" data-id=\"ce245a\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap\">\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-6073b0d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6073b0d\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-8af99ab\" data-id=\"8af99ab\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-54d78bd elementor-widget elementor-widget-text-editor\" data-id=\"54d78bd\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>Overview<\/strong><\/p><p>As per the\u00a0<a href=\"https:\/\/pharmacyboardkenya.org\/files\/?file=Guidelines%20for%20Conduct%20of%20Clinical%20Trials%20in%20Kenya%202nd%20Revision.pdf\">G-KenyaCT<\/a>, the\u00a0<a href=\"https:\/\/www.nacosti.go.ke\/nacosti\/Docs\/2021\/Guidelines%20for%20Biomedical%20Research.pdf\">G-ECBiomedRes<\/a>, and\u00a0<a href=\"https:\/\/www.nacosti.go.ke\/faqs\/\">KEN-30<\/a>, Kenya requires an independent review of research through a\u00a0<a href=\"https:\/\/www.nacosti.go.ke\/\">National Commission for Science, Technology and Innovation (NACOSTI)<\/a>-accredited ethics committee (EC) in one (1) of the local institutions charged with the responsibility of conducting research in human participants.\u00a0<a href=\"https:\/\/research-portal.nacosti.go.ke\/researcher\/AccreditedInstitutions\/View\/T01.html\">KEN-25<\/a>\u00a0provides a list of the accredited institutional ECs.<\/p><p>As delineated in the\u00a0<a href=\"https:\/\/www.nacosti.go.ke\/nacosti\/Docs\/QUICK%20DOWNLOADS\/Guidelines%20for%20Accreditation%20of%20IERC(1).pdf\">G-ECAccred<\/a>, NACOSTI will issue a certificate of accreditation to accredited institutional ECs, which is effective for three (3) years from the date of NACOSTI notification. All accredited ECs must submit annual reports to NACOSTI by July 31st for review and monitoring. Applications for renewal of accreditation should be made six (6) months before expiry of the accreditation period. Failure to renew accreditation or failure to maintain the appropriate standards for continuity of accreditation will mean that the accredited status of the EC will lapse at the end of the current accreditation period. Accreditation must be terminated if the accredited committee fails to maintain the required standards. See the\u00a0<a href=\"https:\/\/www.nacosti.go.ke\/nacosti\/Docs\/QUICK%20DOWNLOADS\/Guidelines%20for%20Accreditation%20of%20IERC(1).pdf\">G-ECAccred<\/a>\u00a0for detailed instructions and\u00a0<a href=\"https:\/\/www.nacosti.go.ke\/nacosti\/Docs\/QUICK%20DOWNLOADS\/Application%20form%20for%20IERC%20(2).docx\">KEN-10<\/a>\u00a0for the application form required for institutional EC accreditation.<\/p><p><strong>Ethics Committee Composition<\/strong><\/p><p>As delineated in the\u00a0<a href=\"https:\/\/www.nacosti.go.ke\/nacosti\/Docs\/QUICK%20DOWNLOADS\/Guidelines%20for%20Accreditation%20of%20IERC(1).pdf\">G-ECAccred<\/a>, institutional ECs should consist of at least seven (7) members, or an odd number above seven (7). The\u00a0<a href=\"https:\/\/www.nacosti.go.ke\/nacosti\/Docs\/2021\/Guidelines%20for%20Biomedical%20Research.pdf\">G-ECBiomedRes<\/a>\u00a0states that these members should be multidisciplinary and multisectoral in composition, collectively encompass relevant scientific expertise, balanced age and gender distribution, and include laypersons representing community interests and concerns. Per the\u00a0<a href=\"https:\/\/www.nacosti.go.ke\/nacosti\/Docs\/QUICK%20DOWNLOADS\/Guidelines%20for%20Accreditation%20of%20IERC(1).pdf\">G-ECAccred<\/a>, the composition should meet the following requirements:<\/p><ul><li>At least one (1) member with knowledge and understanding of Kenyan law<\/li><li>At least one-third of the members must be female and one-third must be male<\/li><li>At least one (1) member who is unaffiliated with the institution<\/li><li>At least two (2) members must have research expertise and experience, one (1) of whom must be in the health field<\/li><li>At least one (1) member must be a lay member<\/li><li>For ECs reviewing clinical research, at least two (2) members must be clinicians, one (1) of whom is currently in active practice or clinical research<\/li><li>Reflect the regional and ethnic diversity of the people of Kenya<\/li><\/ul><p>The chairperson must also have some basic training and\/or experience in bioethics and leadership. All EC appointments are the responsibility of the institution\u2019s administrative head. See the\u00a0<a href=\"https:\/\/www.nacosti.go.ke\/nacosti\/Docs\/QUICK%20DOWNLOADS\/Guidelines%20for%20Accreditation%20of%20IERC(1).pdf\">G-ECAccred<\/a>\u00a0and the\u00a0<a href=\"https:\/\/www.nacosti.go.ke\/nacosti\/Docs\/2021\/Guidelines%20for%20Biomedical%20Research.pdf\">G-ECBiomedRes<\/a>\u00a0for detailed institutional EC requirements.<\/p><p><strong>Terms of Reference, Review Procedures, and Meeting Schedule<\/strong><\/p><p>Per\u00a0<a href=\"https:\/\/www.nacosti.go.ke\/nacosti\/Docs\/2021\/Guidelines%20for%20Biomedical%20Research.pdf\">G-ECBiomedRes<\/a>, ECs need to have independence from political, institutional, professional and market influences. As delineated in the\u00a0<a href=\"https:\/\/www.nacosti.go.ke\/nacosti\/Docs\/QUICK%20DOWNLOADS\/Guidelines%20for%20Accreditation%20of%20IERC(1).pdf\">G-ECAccred<\/a>, the\u00a0<a href=\"https:\/\/www.nacosti.go.ke\/nacosti\/Docs\/2021\/Guidelines%20for%20Biomedical%20Research.pdf\">G-ECBiomedRes<\/a>, and the\u00a0<a href=\"https:\/\/www.nacosti.go.ke\/nacosti\/Docs\/Information%20Centre\/The-Science-Technology-and-Innovation-Regulations-2014.pdf\">STI-Regs<\/a>, institutional ECs must operate within written standard operating procedures (SOPs) which delineate the EC\u2019s process for conducting reviews. Per the\u00a0<a href=\"https:\/\/www.nacosti.go.ke\/nacosti\/Docs\/QUICK%20DOWNLOADS\/Guidelines%20for%20Accreditation%20of%20IERC(1).pdf\">G-ECAccred<\/a>, SOPs should include but are not limited to information on EC scope, responsibility, and objectives, institutions served, committee functions, terms and conditions of member appointment, business procedures including meeting schedules and types of reviews, documentation, recordkeeping, and archiving procedures, quorum requirements, communication procedures, and complaint process and dispute resolution procedures. Per the\u00a0<a href=\"https:\/\/www.nacosti.go.ke\/nacosti\/Docs\/QUICK%20DOWNLOADS\/Guidelines%20for%20Accreditation%20of%20IERC(1).pdf\">G-ECAccred<\/a>\u00a0and the\u00a0<a href=\"https:\/\/www.nacosti.go.ke\/nacosti\/Docs\/Information%20Centre\/The-Science-Technology-and-Innovation-Regulations-2014.pdf\">STI-Regs<\/a>, these documents must be provided to NACOSTI.<\/p><p>Per the\u00a0<a href=\"https:\/\/www.nacosti.go.ke\/nacosti\/Docs\/QUICK%20DOWNLOADS\/Guidelines%20for%20Accreditation%20of%20IERC(1).pdf\">G-ECAccred<\/a>, the quorum for NACOSTI-accredited EC meetings must be:<\/p><ul><li>At least 50 percent of the membership must form the quorum;<\/li><li>A lay person must be present in all meetings; and<\/li><li>For ECs reviewing clinical research, at least two (2) members must be clinicians, one (1) of whom is currently in active practice or clinical research.<\/li><\/ul><p>The\u00a0<a href=\"https:\/\/www.nacosti.go.ke\/nacosti\/Docs\/2021\/Guidelines%20for%20Biomedical%20Research.pdf\">G-ECBiomedRes<\/a>\u00a0also defines quorum requirements:<\/p><ul><li>The minimum number of members required to compose a quorum (e.g., more than half the members)<\/li><li>The professional qualifications requirements (e.g., physician, lawyer, statistician, paramedical, or layperson) and the distribution of those requirements over the quorum; no quorum should consist entirely of members of one (1) profession or one (1) gender; a quorum should include at least one (1) member whose primary area of expertise is in a non-scientific area, and at least one (1) member who is independent of the institution\/research site<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>KENYA Overview As per the\u00a0G-KenyaCT, the\u00a0G-ECBiomedRes, and\u00a0KEN-30, Kenya requires an independent review of research through a\u00a0National Commission for Science, Technology [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"class_list":["post-1266","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/nsers.nacosti.go.ke\/index.php?rest_route=\/wp\/v2\/pages\/1266","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nsers.nacosti.go.ke\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/nsers.nacosti.go.ke\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/nsers.nacosti.go.ke\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/nsers.nacosti.go.ke\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=1266"}],"version-history":[{"count":0,"href":"https:\/\/nsers.nacosti.go.ke\/index.php?rest_route=\/wp\/v2\/pages\/1266\/revisions"}],"wp:attachment":[{"href":"https:\/\/nsers.nacosti.go.ke\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1266"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}