{"id":22853,"date":"2018-05-01T21:19:37","date_gmt":"2018-05-01T21:19:37","guid":{"rendered":"https:\/\/portal-hgps.azurewebsites.net\/sobre-hgps\/gerencia-de-investigacion\/"},"modified":"2021-05-10T18:25:06","modified_gmt":"2021-05-10T18:25:06","slug":"gerencia-de-investigacion","status":"publish","type":"page","link":"https:\/\/hgps.org.do\/en\/sobre-hgps\/gerencia-de-investigacion\/","title":{"rendered":"Research Management"},"content":{"rendered":"<section class=\"l-section wpb_row us_custom_9b36ddac height_medium\"><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row type_default valign_top\"><div class=\"vc_col-sm-8 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div id=\"ultimate-heading-138269e8ac60e1713\" class=\"uvc-heading ult-adjust-bottom-margin ultimate-heading-138269e8ac60e1713 uvc-5945\" data-hspacer=\"line_only\"  data-halign=\"center\" style=\"text-align:center\"><div class=\"uvc-main-heading ult-responsive\"  data-ultimate-target='.uvc-heading.ultimate-heading-138269e8ac60e1713 h2'  data-responsive-json-new='{\"font-size\":\"\",\"line-height\":\"\"}' ><h2 style=\"font-weight:normal;margin-bottom:10px;\">Comit\u00e9 de \u00c9tica de la investigaci\u00f3n HGPS (CEI-HGPS)<\/h2><\/div><div class=\"uvc-heading-spacer line_only\" style=\"margin-bottom:20px;height:2px;\"><span class=\"uvc-headings-line\" style=\"border-style:solid;border-bottom-width:2px;border-color:#00abc6;width:300px;\"><\/span><\/div><\/div><div class=\"wpb_text_column\" ><div class=\"wpb_wrapper\"><p class=\"p1\"><span class=\"s1\">Functions of the Ethics Committee of the HGPS research (CEI-HGPS)<\/span><\/p>\n<p class=\"p1\"><span class=\"s1\">The Ethics Committee of the HGPS Research (CEI-HGPS) evaluates the ethical, methodological and legal aspects of clinical trials with drugs and other biomedical research studies, in order to protect the fundamental rights and freedoms of people who participate in them.<\/span><\/p>\n<p class=\"p1\"><span class=\"s1\">Our CEI-HGPS is recognized by the National Council of Bioethics in Health (CONABIOS), an organization of the Dominican state responsible for ensuring ethical aspects in the health sector. It is about confirming that certain practices or treatments do not violate the ethical principles and the dignity of the patients.<\/span><\/p>\n<\/div><\/div><div class=\"w-tabs style_default switch_click accordion has_scrolling type_togglable title_atleft icon_chevron iconpos_right\"><div class=\"w-tabs-sections\"><div class=\"w-tabs-sections-h\"><div class=\"w-tabs-section\" id=\"1548132371552-27300b8b-7fb9\"><button class=\"w-tabs-section-header\" aria-controls=\"content-1548132371552-27300b8b-7fb9\"><div class=\"w-tabs-section-header-h\"><div class=\"w-tabs-section-title\">goals<\/div><div class=\"w-tabs-section-control\"><\/div><\/div><\/button><div class=\"w-tabs-section-content\" id=\"content-1548132371552-27300b8b-7fb9\" aria-expanded=\"false\"><div class=\"w-tabs-section-content-h i-cf\"><div class=\"wpb_text_column\" ><div class=\"wpb_wrapper\"><p>Evaluar que los Protocolos de Investigaci\u00f3n presentados por los servicios del Hospital y\/o la industria farmac\u00e9utica sean apropiados desde el punto de vista t\u00e9cnico y \u00e9tico. En el aspecto t\u00e9cnico, se eval\u00faa la calidad metodol\u00f3gica para definir si los procedimientos e instrumentos planteados son adecuados para medir lo que se pretende con la investigaci\u00f3n. Para ello se analiza una serie de variables que incluye los antecedentes, justificaci\u00f3n, la hip\u00f3tesis, los c\u00e1lculos estad\u00edsticos, etc.<\/p>\n<p>Revisar que los aspectos \u00e9ticos de la investigaci\u00f3n, est\u00e9n centrados en el cuidado de los sujetos que participan en ella y en la protecci\u00f3n de sus derechos.<\/p>\n<p>Assess the potential risks to which the participants in the research are exposed.<\/p>\n<p>To certify that the patients selected to participate in the research have not been exploited due to their sociocultural characteristics, low income, membership of minority groups or low cultural level.<\/p>\n<p>Verify that the document by which the patient agrees to participate in the investigation, the Informed Consent, has been formalized complying with all the relevant requirements (freedom, autonomy, right to refuse, etc.).<\/p>\n<p>It will monitor the clinical trial from its beginning until the receipt of the final report.<\/p>\n<\/div><\/div><\/div><\/div><\/div><div class=\"w-tabs-section\" id=\"1548132371569-5c6a11b5-1769\"><button class=\"w-tabs-section-header\" aria-controls=\"content-1548132371569-5c6a11b5-1769\"><div class=\"w-tabs-section-header-h\"><div class=\"w-tabs-section-title\">General Operating Regulations<\/div><div class=\"w-tabs-section-control\"><\/div><\/div><\/button><div class=\"w-tabs-section-content\" id=\"content-1548132371569-5c6a11b5-1769\" aria-expanded=\"false\"><div class=\"w-tabs-section-content-h i-cf\"><div class=\"wpb_text_column\" ><div class=\"wpb_wrapper\"><p>The members of the Research Ethics Committee will respect the principle of confidentiality regarding the documentation of the protocol and the identity of the patients.<\/p>\n<p>For their decisions to be valid, the participation of half plus one of their members is required.<\/p>\n<p>When there is a Research Commission or an Ethics Committee, the presence of a member of each of them will be necessary for the decisions to be valid.<\/p>\n<p>When evaluating surgical procedures, diagnostic techniques or medical products, you will have an expert in the procedure or technology to be evaluated.<\/p>\n<p>When it deems it appropriate, it will seek the advice of experts from outside the Research Ethics Committee.<\/p>\n<p>El investigador de un ensayo cl\u00ednico no podr\u00e1 participar en la evaluaci\u00f3n de su propio protocolo aun cuando sea miembro del Comit\u00e9.<\/p>\n<p>It must be guaranteed that the protocol evaluated by a Research Ethics Committee is identical to that sent to CONABIOS.<\/p>\n<p>There must be a communication with the researchers that allows them to know the occurrence of fatal, serious or unexpected adverse events.<\/p>\n<p>There will be specific work procedures, periodicity of meetings and maximum response time, which should be public.<\/p>\n<p>Las reuniones y los asistentes quedar\u00e1n reflejados en el acta correspondiente.<\/p>\n<p><strong>\u00a0<\/strong><\/p>\n<\/div><\/div><\/div><\/div><\/div><div class=\"w-tabs-section\" id=\"1548132440215-a2f97595-29f0\"><button class=\"w-tabs-section-header\" aria-controls=\"content-1548132440215-a2f97595-29f0\"><div class=\"w-tabs-section-header-h\"><div class=\"w-tabs-section-title\">Requisitos para someter un protocolo de la investigaci\u00f3n al CEI-HGPS<\/div><div class=\"w-tabs-section-control\"><\/div><\/div><\/button><div class=\"w-tabs-section-content\" id=\"content-1548132440215-a2f97595-29f0\" aria-expanded=\"false\"><div class=\"w-tabs-section-content-h i-cf\"><div class=\"wpb_text_column\" ><div class=\"wpb_wrapper\"><ul>\n<li>Carta de presentaci\u00f3n dirigida al Dr. Pavel Rodriguez Uceta, presidente del Comit\u00e9 de \u00c9tica de Investigaci\u00f3n del Hospital General de la Plaza de la Salud.<\/li>\n<li>Presentar el protocolo impreso en su idioma original y en traducci\u00f3n fidedigna del idioma espa\u00f1ol.<\/li>\n<li>Diez (10) copias digitales en CD en traducci\u00f3n fidedigna del idioma espa\u00f1ol.<\/li>\n<li>Guarantee of the sponsoring institution.<\/li>\n<li>Guarantee of the executing institution.<\/li>\n<li>Designar un investigador principal, responsable del protocolo ante el CONABIOS.<\/li>\n<li>Curriculum of the involved researchers.<\/li>\n<li>All documents must be original.<\/li>\n<li>Escr\u00edbenos para informaci\u00f3n adicional <a href=\"mailto:comitedeeticaadministrativo@hgps.org.do\">comitedeeticaadministrativo@hgps.org.do<\/a><\/li>\n<\/ul>\n<\/div><\/div><\/div><\/div><\/div><div class=\"w-tabs-section\" id=\"1548132482818-1409c234-efd2\"><button class=\"w-tabs-section-header\" aria-controls=\"content-1548132482818-1409c234-efd2\"><div class=\"w-tabs-section-header-h\"><div class=\"w-tabs-section-title\">Miembros del CEI-HGPS<\/div><div class=\"w-tabs-section-control\"><\/div><\/div><\/button><div class=\"w-tabs-section-content\" id=\"content-1548132482818-1409c234-efd2\" aria-expanded=\"false\"><div class=\"w-tabs-section-content-h i-cf\"><div class=\"wpb_text_column\" ><div class=\"wpb_wrapper\"><p>Dr. Pavel Rodr\u00edguez Uceta\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Presidente<\/p>\n<p>Dra. Dolores Mej\u00eda\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Secretaria<\/p>\n<p>Dr. Nepomuceno Mejia\u00a0 Miembro<\/p>\n<p>Dr. Dagoberto Almanzar Miembro<\/p>\n<p>Lic. Emmanuel Almonte Miembro<\/p>\n<p>Lic. Gilda Tolari\u00a0\u00a0 Miembro<\/p>\n<p>Sor. Teresa Torres Miembro<\/p>\n<p>Dr. Jesus Antonio Echavarr\u00eda U. \u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 \u00a0Miembro<\/p>\n<p>Dra. Ann S\u00e1nchez Miembro<\/p>\n<\/div><\/div><\/div><\/div><\/div><div class=\"w-tabs-section\" id=\"1548132519933-54382c12-ce97\"><button class=\"w-tabs-section-header\" aria-controls=\"content-1548132519933-54382c12-ce97\"><div class=\"w-tabs-section-header-h\"><div class=\"w-tabs-section-title\">National Regulations for Biomedical Research<\/div><div class=\"w-tabs-section-control\"><\/div><\/div><\/button><div class=\"w-tabs-section-content\" id=\"content-1548132519933-54382c12-ce97\" aria-expanded=\"false\"><div class=\"w-tabs-section-content-h i-cf\"><div class=\"wpb_text_column\" ><div class=\"wpb_wrapper\"><p class=\"p1\"><span class=\"s1\">On October 21, 2004, through Administrative Regulation No. 004-2004, of Dr. Sabino Baez, Secretary of State for Public Health and Social Assistance, the National Bioethics Committee (CONABI) was transformed into the National Bioethics Council in Health (CONABIOS).<\/span><\/p>\n<p class=\"p1\"><span class=\"s1\">On November 22, 2004, through Administrative Resolution No. 004-A of Dr. Sabino Baez, Secretary of State for Public Health and Social Assistance, the powers of CONABIOS were extended to regulate investigations in the Dominican Republic, establishing the following:<\/span><\/p>\n<p class=\"p1\"><span class=\"s1\"><b>FIRST:<\/b>\u00a0The National Council of Bioethics in Health (CONABIOS) is empowered to recognize, approve, reject, supervise, evaluate and suspend, temporarily or definitively, any research or study carried out with human beings at a national level, in order to guarantee that they comply with scientific, methodological and bioethical principles, both nationally and internationally.<\/span><\/p>\n<p class=\"p1\"><span class=\"s1\"><b>SECOND:<\/b> All research carried out on human beings, its protocol must undergo a process of evaluation and approval by the National Council of Bioethics in Health (CONABIOS), prior to its implementation 60 days before the scheduled date for its start and Supervision by this Council, during the execution phase which will monitor compliance with scientific rigor and the bioethical principles that support it, having the faculty and responsibility to suspend it temporarily or definitively if irregularities and \/ or dangers of health risks are proven and the welfare of the participating subjects.<\/span><\/p>\n<p class=\"p1\"><span class=\"s1\"><b>THIRD<\/b>: It is understood that any provision or resolution contrary to this, will be without effect of full right.<\/span><\/p>\n<p class=\"p1\"><span class=\"s1\">Consequently, the National Council of Bioethics in Health (CONABIOS), in its capacity as an agency dependent on the Ministry of Public Health and Social Assistance, is the official authority of the Dominican Republic in the area of regulation of biomedical research.<\/span><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><div class=\"vc_col-sm-4 wpb_column vc_column_container\"><div class=\"vc_column-inner us_custom_c3c31ab9\"><div class=\"wpb_wrapper\"><div id=\"ultimate-heading-355469e8ac60e6796\" class=\"uvc-heading ult-adjust-bottom-margin ultimate-heading-355469e8ac60e6796 uvc-8426\" data-hspacer=\"line_only\"  data-halign=\"center\" style=\"text-align:center\"><div class=\"uvc-main-heading ult-responsive\"  data-ultimate-target='.uvc-heading.ultimate-heading-355469e8ac60e6796 h4'  data-responsive-json-new='{\"font-size\":\"\",\"line-height\":\"\"}' ><h4 style=\"font-weight:normal;margin-bottom:10px;\">Preguntas e informaci\u00f3n adicional:<\/h4><\/div><div class=\"uvc-heading-spacer line_only\" style=\"margin-bottom:20px;height:2px;\"><span class=\"uvc-headings-line\" style=\"border-style:solid;border-bottom-width:2px;border-color:#00abc6;width:300px;\"><\/span><\/div><\/div><div class=\"uavc-list-icon uavc-list-icon-wrapper ult-adjust-bottom-margin\"><ul class=\"uavc-list\"><li><div class=\"uavc-list-content\" id=\"list-icon-wrap-9838\">\n<div class=\"uavc-list-icon\" data-animation=\"\" data-animation-delay=\"03\" style=\"margin-right:10px;\"><div class=\"ult-just-icon-wrapper\"><div class=\"align-icon\" style=\"text-align:center;\">\n<div class=\"aio-icon none\"  style=\"font-size:22px;display:inline-block;\">\n\t<i class=\"Defaults-phone\"><\/i>\n<\/div><\/div><\/div>\n<\/div><span  data-ultimate-target='#list-icon-wrap-9838 .uavc-list-desc'  data-responsive-json-new='{\"font-size\":\"\",\"line-height\":\"\"}'  class=\"uavc-list-desc ult-responsive\" style=\"\">\n<h4 style=\"padding-bottom: 0; margin-bottom: 0; font-size: 20px;\">Call us at<\/h4>\n<p><a href=\"tel:809-565-7477\">809-565-7477<\/a> Ext. 7051<\/span><\/div><\/li><li><div class=\"uavc-list-content\" id=\"list-icon-wrap-2071\">\n<div class=\"uavc-list-icon\" data-animation=\"\" data-animation-delay=\"03\" style=\"margin-right:10px;\"><div class=\"ult-just-icon-wrapper\"><div class=\"align-icon\" style=\"text-align:center;\">\n<div class=\"aio-icon none\"  style=\"font-size:22px;display:inline-block;\">\n\t<i class=\"Defaults-envelope-o\"><\/i>\n<\/div><\/div><\/div>\n<\/div><span  data-ultimate-target='#list-icon-wrap-2071 .uavc-list-desc'  data-responsive-json-new='{\"font-size\":\"\",\"line-height\":\"\"}'  class=\"uavc-list-desc ult-responsive\" style=\"\">\n<h4 style=\"padding-bottom: 0; margin-bottom: 0; font-size: 20px;\">Write to us<\/h4>\n<p><a href=\"mailto:comitedeeticaadministrativo@hgps.org.do\">comitedeeticaadministrativo@hgps.org.do<\/a><\/span><\/div><\/li><\/ul><\/div><\/div><\/div><\/div><\/div><\/div><\/section>","protected":false},"excerpt":{"rendered":"Comit\u00e9 de \u00c9tica de la investigaci\u00f3n HGPS (CEI-HGPS) Funciones del Comit\u00e9 de \u00c9tica de la investigaci\u00f3n HGPS (CEI-HGPS) El\u00a0Comit\u00e9 de \u00e9tica de la Investigaci\u00f3n HGPS (CEI-HGPS) eval\u00faa los aspectos \u00e9ticos, metodol\u00f3gicos y legales de los ensayos cl\u00ednicos con medicamentos y de otros estudios de investigaci\u00f3n biom\u00e9dica, con el fin de proteger los derechos y libertades...","protected":false},"author":1,"featured_media":0,"parent":22804,"menu_order":61,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"_links":{"self":[{"href":"https:\/\/hgps.org.do\/en\/wp-json\/wp\/v2\/pages\/22853"}],"collection":[{"href":"https:\/\/hgps.org.do\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/hgps.org.do\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/hgps.org.do\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/hgps.org.do\/en\/wp-json\/wp\/v2\/comments?post=22853"}],"version-history":[{"count":9,"href":"https:\/\/hgps.org.do\/en\/wp-json\/wp\/v2\/pages\/22853\/revisions"}],"predecessor-version":[{"id":27042,"href":"https:\/\/hgps.org.do\/en\/wp-json\/wp\/v2\/pages\/22853\/revisions\/27042"}],"up":[{"embeddable":true,"href":"https:\/\/hgps.org.do\/en\/wp-json\/wp\/v2\/pages\/22804"}],"wp:attachment":[{"href":"https:\/\/hgps.org.do\/en\/wp-json\/wp\/v2\/media?parent=22853"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}