{"id":227,"date":"2022-08-26T03:49:50","date_gmt":"2022-08-26T03:49:50","guid":{"rendered":"https:\/\/vinuni.edu.vn\/research\/?post_type=resource_opportunity&#038;p=227"},"modified":"2025-11-24T12:05:12","modified_gmt":"2025-11-24T05:05:12","slug":"vinuniversity-statement-on-the-use-of-human-subjects-in-research","status":"publish","type":"resource_opportunity","link":"https:\/\/vinuni.edu.vn\/research\/resource_opportunity\/vinuniversity-statement-on-the-use-of-human-subjects-in-research\/","title":{"rendered":"Applying for Ethical Review"},"content":{"rendered":"<p><i>&#8220;Use of Human Participants in Research: VinUni must ensure that the rights and interests of human participants involved in VinUni research are protected, that research is conducted with appropriate informed consent, and that the benefits of any research involving such participants outweighs the risks to them and others. Any research that involves research with human participants must be reviewed and approved by an ethical review board duly constituted with the appropriate expertise and authority to review, approve, require amendments to, or deny the research. Such research is subject to regular monitoring for continued compliance with the approved protocols.&#8221;<\/i><\/p>\n<p>Excerpt form <a id=\"menur36t\" class=\"fui-Link ___1q1shib f2hkw1w f3rmtva f1ewtqcl fyind8e f1k6fduh f1w7gpdv fk6fouc fjoy568 figsok6 f1s184ao f1mk8lai fnbmjn9 f1o700av f13mvf36 f1cmlufx f9n3di6 f1ids18y f1tx3yz7 f1deo86v f1eh06m1 f1iescvh fhgqx19 f1olyrje f1p93eir f1nev41a f1h8hb77 f1lqvz6u f10aw75t fsle3fq f17ae5zn\" title=\"https:\/\/dataroom.vingroup.net\/08.document-detail\/default.aspx?webserverrelativeurl=https:\/\/dataroom.vingroup.net\/sites\/dr-vbtd\/vuni&amp;listid=181dc075-ef28-49d5-88f4-e18126823408&amp;itemids=35\" href=\"https:\/\/policy.vinuni.edu.vn\/all-policies\/regulations-for-research-activity-management\/\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"Link VinUniversity Regulations on Research Activities\">VinUniversity Research Management Policies and Procedures<\/a>\u00a0(VinGroup login required).<\/p>\n<p><strong>Review and Approval by the Committee for the Ethical Review of Studies that Involve Human Subjects<\/strong><\/p>\n<p>VinUniversity has partnered with VinMec Company for the ethical review of studies conducted by VinUniversity faculty, staff and students. For an excellent introduction of the Vinmec ERC and the regulations that govern studies involving human subjects in Vietnam, refer to <a href=\"https:\/\/vinuni.edu.vn\/research\/wp-content\/uploads\/2022\/08\/Slide-Vinmec-ERC-final.pdf\" target=\"_blank\" rel=\"noopener\">[This presentation]<\/a> by the Chair of the Vinmec ERC, Dr. Cuong.<\/p>\n<p><strong>How to apply to review and approval?<\/strong><\/p>\n<p><strong>If this is the applicants\u2019 first time seeking IRB\u2019s approval, they should send to the RMO<\/strong><\/p>\n<p><strong>1) certified application form<\/strong>\u00a0(a\u00a0<a id=\"menur370\" class=\"fui-Link ___1q1shib f2hkw1w f3rmtva f1ewtqcl fyind8e f1k6fduh f1w7gpdv fk6fouc fjoy568 figsok6 f1s184ao f1mk8lai fnbmjn9 f1o700av f13mvf36 f1cmlufx f9n3di6 f1ids18y f1tx3yz7 f1deo86v f1eh06m1 f1iescvh fhgqx19 f1olyrje f1p93eir f1nev41a f1h8hb77 f1lqvz6u f10aw75t fsle3fq f17ae5zn\" title=\"https:\/\/vinuni.edu.vn\/research\/wp-content\/uploads\/2024\/10\/expedited-review-protocol-form-for-vinuniversity.docx\" href=\"https:\/\/vinuni.edu.vn\/research\/wp-content\/uploads\/2024\/10\/Expedited-Review-Protocol-form-for-VinUniversity.docx\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"Link shortened form\">shortened form<\/a>\u00a0if the study involves no more than minimal risks to participants and a\u00a0<a id=\"menur373\" class=\"fui-Link ___1q1shib f2hkw1w f3rmtva f1ewtqcl fyind8e f1k6fduh f1w7gpdv fk6fouc fjoy568 figsok6 f1s184ao f1mk8lai fnbmjn9 f1o700av f13mvf36 f1cmlufx f9n3di6 f1ids18y f1tx3yz7 f1deo86v f1eh06m1 f1iescvh fhgqx19 f1olyrje f1p93eir f1nev41a f1h8hb77 f1lqvz6u f10aw75t fsle3fq f17ae5zn\" title=\"https:\/\/vinuni.edu.vn\/research\/wp-content\/uploads\/2024\/10\/expedited-review-protocol-form-for-vinuniversity.docx\" href=\"https:\/\/vinuni.edu.vn\/research\/wp-content\/uploads\/2022\/08\/ERC-CHECKLIST-FOR-FULL-REVIEW.docx\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"Link full form\">full form<\/a>\u00a0if it involves more than minimal risks and thus requiring full review).<\/p>\n<p><strong>2) consent form<\/strong>\u00a0(if used, and translated into Vietnamese if it involves VNM participants) &#8211; \u00a0Please use the\u00a0<a id=\"menur376\" class=\"fui-Link ___1q1shib f2hkw1w f3rmtva f1ewtqcl fyind8e f1k6fduh f1w7gpdv fk6fouc fjoy568 figsok6 f1s184ao f1mk8lai fnbmjn9 f1o700av f13mvf36 f1cmlufx f9n3di6 f1ids18y f1tx3yz7 f1deo86v f1eh06m1 f1iescvh fhgqx19 f1olyrje f1p93eir f1nev41a f1h8hb77 f1lqvz6u f10aw75t fsle3fq f17ae5zn\" title=\"https:\/\/vinuni.edu.vn\/research\/wp-content\/uploads\/2022\/08\/template-short-consent.docx\" href=\"https:\/\/vinuni.edu.vn\/research\/wp-content\/uploads\/2022\/08\/Template-Short-Consent.docx\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"Link Short Consent Template\u00a0\">Short Consent Template\u00a0<\/a>or the\u00a0<a id=\"menur379\" class=\"fui-Link ___1q1shib f2hkw1w f3rmtva f1ewtqcl fyind8e f1k6fduh f1w7gpdv fk6fouc fjoy568 figsok6 f1s184ao f1mk8lai fnbmjn9 f1o700av f13mvf36 f1cmlufx f9n3di6 f1ids18y f1tx3yz7 f1deo86v f1eh06m1 f1iescvh fhgqx19 f1olyrje f1p93eir f1nev41a f1h8hb77 f1lqvz6u f10aw75t fsle3fq f17ae5zn\" title=\"https:\/\/vinuni.edu.vn\/research\/wp-content\/uploads\/2022\/08\/template-long-consent.doc\" href=\"https:\/\/vinuni.edu.vn\/research\/wp-content\/uploads\/2022\/08\/Template-Long-Consent.doc\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"Link Long Consent Template.\u00a0\">Long Consent Template.\u00a0<\/a>If they choose to use another form, please ensure that it covers all the points outlined in the VinUni template.<\/p>\n<p><strong>3) verified CV(s)<\/strong><\/p>\n<p><strong>4) Project-specific documents<\/strong>\u00a0such as research proposals, questionnaire surveys, interview forms, etc.<\/p>\n<p>There are specific requirements for these documents as noted in the table below:<\/p>\n<table>\n<tbody>\n<tr>\n<td>IRB application form (either shortened or full form)<\/td>\n<td>Two versions:<\/p>\n<ul>\n<li>One version in MS Word<\/li>\n<li>One verified and scanned version (signed by the appropriate representative, sealed with VinUni\u2019s seal, scanned)<\/li>\n<\/ul>\n<p>RMO will <strong>first review<\/strong> the IRB Application Form. If the form is complete and valid, RMO will arrange for the required signature and VinUni&#8217;s seal before the package is submitted.<\/td>\n<\/tr>\n<tr>\n<td>Consent form<\/td>\n<td>MS Word or PDF format<\/td>\n<\/tr>\n<tr>\n<td>Verified CV of the research team<\/td>\n<td>\n<ul>\n<li>For faculty: Signed by HR, sealed with VinUni\u2019s seal, scanned<\/li>\n<li>For students: (i) A CV; (ii) Official Enrollment Certification Letter from Registrar and scanned<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n<tr>\n<td>Project-specific documents<\/td>\n<td>MS Word or PDF format<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<p>Submit all documents in soft copy to the Research Management Office at <a id=\"menur37c\" class=\"fui-Link ___1q1shib f2hkw1w f3rmtva f1ewtqcl fyind8e f1k6fduh f1w7gpdv fk6fouc fjoy568 figsok6 f1s184ao f1mk8lai fnbmjn9 f1o700av f13mvf36 f1cmlufx f9n3di6 f1ids18y f1tx3yz7 f1deo86v f1eh06m1 f1iescvh fhgqx19 f1olyrje f1p93eir f1nev41a f1h8hb77 f1lqvz6u f10aw75t fsle3fq f17ae5zn\" title=\"mailto:research@vinuni.edu.vn\" href=\"mailto:research@vinuni.edu.vn\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"Link research@vinuni.edu.vn\">research@vinuni.edu.vn<\/a>. No need to send hard copies of these documents, unless required later by the committee.<\/p>\n<p><strong>Request for amendment approval?<\/strong><\/p>\n<ul>\n<li>Fill out the form: <a id=\"menur37f\" class=\"fui-Link ___1q1shib f2hkw1w f3rmtva f1ewtqcl fyind8e f1k6fduh f1w7gpdv fk6fouc fjoy568 figsok6 f1s184ao f1mk8lai fnbmjn9 f1o700av f13mvf36 f1cmlufx f9n3di6 f1ids18y f1tx3yz7 f1deo86v f1eh06m1 f1iescvh fhgqx19 f1olyrje f1p93eir f1nev41a f1h8hb77 f1lqvz6u f10aw75t fsle3fq f17ae5zn\" title=\"https:\/\/vinuni.edu.vn\/research\/wp-content\/uploads\/2024\/10\/request-for-amendment-approval.docx\" href=\"https:\/\/vinuni.edu.vn\/research\/wp-content\/uploads\/2024\/10\/Request-for-Amendment-Approval.docx\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"Link Request for Amendment Approval\">Request for Amendment Approval<\/a> and <a id=\"menur37i\" class=\"fui-Link ___1q1shib f2hkw1w f3rmtva f1ewtqcl fyind8e f1k6fduh f1w7gpdv fk6fouc fjoy568 figsok6 f1s184ao f1mk8lai fnbmjn9 f1o700av f13mvf36 f1cmlufx f9n3di6 f1ids18y f1tx3yz7 f1deo86v f1eh06m1 f1iescvh fhgqx19 f1olyrje f1p93eir f1nev41a f1h8hb77 f1lqvz6u f10aw75t fsle3fq f17ae5zn\" title=\"https:\/\/vinuni.edu.vn\/research\/wp-content\/uploads\/2022\/08\/details-of-changes.docx\" href=\"https:\/\/vinuni.edu.vn\/research\/wp-content\/uploads\/2022\/08\/Details-of-Changes.docx\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"Link Details of Changes\">Details of Changes<\/a><\/li>\n<li>Submit all documents to the Research Management Office at VinUniversity at <a id=\"menur37l\" class=\"fui-Link ___1q1shib f2hkw1w f3rmtva f1ewtqcl fyind8e f1k6fduh f1w7gpdv fk6fouc fjoy568 figsok6 f1s184ao f1mk8lai fnbmjn9 f1o700av f13mvf36 f1cmlufx f9n3di6 f1ids18y f1tx3yz7 f1deo86v f1eh06m1 f1iescvh fhgqx19 f1olyrje f1p93eir f1nev41a f1h8hb77 f1lqvz6u f10aw75t fsle3fq f17ae5zn\" title=\"mailto:research@vinuni.edu.vn\" href=\"mailto:research@vinuni.edu.vn\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"Link research@vinuni.edu.vn\">research@vinuni.edu.vn<\/a><\/li>\n<\/ul>\n<p>Remark:<\/p>\n<ul>\n<li>Under normal circumstances, the RMO aims to send out applications to the IRB for approval twice a month, usually at the beginning and middle of the month.<\/li>\n<li>Expected decision time:\n<ul>\n<li>Expedited reviews: 2-3 weeks<\/li>\n<li>Full reviews: 4 -5 weeks<\/li>\n<\/ul>\n<\/li>\n<li>The RMO staff will conduct a preliminary review of the study to ensure that it meets the VinUni requirements and convey its recommendation to the Vinmec-VinUni ERC for approval.<\/li>\n<\/ul>\n<p><strong>What does approval mean?<\/strong><\/p>\n<ul>\n<li>Vinmec-VinUni ERC will issue the final approval: a stamped and signed letter of approval from the Chair of the ERC. No other approvals can be accepted.<\/li>\n<li>Approvals cannot be given retroactively (if researchers conducted any research activities including contacting participants, collecting or analyzing data, before the ERC issued its final approval, those data and activities will be considered unapproved research and cannot be used).<\/li>\n<\/ul>\n<p><strong>IRB Requirements for External Partners<\/strong><\/p>\n<ul>\n<li>For research activities involving human subjects conducted by VinUni partners, partners are encouraged to follow the IRB review process.<\/li>\n<li>If a partner already has IRB approval from an external institution, they should provide the approval letter and related documents to RMO. RMO will then consult the Vinmec\u2013VinUni IRB to determine whether an internal review is still required.<\/li>\n<\/ul>\n<p>For any questions about this process or about your study, contact <a id=\"menur37o\" class=\"fui-Link ___1q1shib f2hkw1w f3rmtva f1ewtqcl fyind8e f1k6fduh f1w7gpdv fk6fouc fjoy568 figsok6 f1s184ao f1mk8lai fnbmjn9 f1o700av f13mvf36 f1cmlufx f9n3di6 f1ids18y f1tx3yz7 f1deo86v f1eh06m1 f1iescvh fhgqx19 f1olyrje f1p93eir f1nev41a f1h8hb77 f1lqvz6u f10aw75t fsle3fq f17ae5zn\" title=\"mailto:research@vinuni.edu.vn\" href=\"mailto:research@vinuni.edu.vn\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"Link research@vinuni.edu.vn\">research@vinuni.edu.vn<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>VinUni must ensure that the rights and interests of human participants involved in VinUni research are protected, that research is conducted with appropriate informed consent, and that the benefits of any research involving such participants outweighs the risks to them and others.<\/p>\n","protected":false},"featured_media":0,"template":"","resource_opportunities":[6],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v19.6.1 - 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