{"id":145548,"date":"2026-08-13T17:01:38","date_gmt":"2026-08-13T09:01:38","guid":{"rendered":"https:\/\/www.curtin.edu.au\/research\/?page_id=145548"},"modified":"2026-08-14T09:25:07","modified_gmt":"2026-08-14T01:25:07","slug":"human-ethics","status":"publish","type":"page","link":"https:\/\/www.curtin.edu.au\/research\/research-integrity-and-ethics\/human-ethics\/","title":{"rendered":"Human ethics"},"content":{"rendered":"<mimas-block \n        block-name=\"cards\"\n        data-segment=\"dom\">\n\n    \n<div class=\"block-heading\"\n     data-segment=\"dom\"\n     data-style=\"\"\n     data-align=\"default\"\n>\n\n                                <h2 class=\"block-heading__title \" id=\"conducting-research-about-people-and-their-data\">Conducting research about people and their data<\/h2>\n            \n                        \n                                <div class=\"block-heading__content\"><p>Any research conducted with or about people, their data, or their tissue is considered Human research, according to the <a href=\"https:\/\/www.nhmrc.gov.au\/about-us\/publications\/national-statement-ethical-conduct-human-research-2025\">National Statement on Ethical Conduct in Human Research<\/a> 2025 (the National Statement), and requires ethical approval prior to commencing research. Human participation includes the involvement of human participants in the following activities:<\/p>\n<ul>\n<li>surveys, interviews or focus groups;<\/li>\n<li>psychological, physiological or medical testing or treatments;<\/li>\n<li>having their personal documents or other materials accessed;<\/li>\n<li>observation by researchers;<\/li>\n<li>collection and use of their body organs, tissues or fluids (e.g. skin, blood, urine, saliva, hair, bones, tumour and other biopsy specimens) or their exhaled breath, and;<\/li>\n<li>their information (in individually identifiable, re-identifiable or non-identifiable form) as part of an existing published or unpublished source or database being accessed.<\/li>\n<\/ul>\n<p>At Curtin, ethics applications are submitted and managed through a platform called <a href=\"https:\/\/infoed.curtin.edu.au\/\">InfoEd<\/a>. Curtin Staff and Students can log in using the Curtin Single Sign On (SSO) to access the application platform, as well as information and user guides on using the system, via the Help drop down menu.<\/p>\n<p>These pages have been designed to provide guidance on the Human Ethics processes at Curtin. If you have any suggestions or feedback, please feel free to<a href=\"mailto:roc-ethics@curtin.edu.au?subject=Website%20Feedback\"> email us. <\/a><\/p>\n<p>Curtin research staff are also required to complete the Research Integrity Training module through iPerform.<\/p>\n<p>Higher Degree by Research (HDR) students are required to complete the Research Integrity and HDR Essentials through Blackboard*<\/p>\n<p>We host Drop-in Sessions during semesters where you can come along and speak to one of our team about anything ethics related. If you would like to speak to one of our friendly team for assistance with your ethics application, you can book an appointment for an in-person or Microsoft Teams meeting via our <a href=\"https:\/\/bookings.cloud.microsoft\/book\/Ethicsoffice@curtin.onmicrosoft.com\/?ismsaljsauthenabled\">Bookings page.<\/a><\/p>\n<\/div>\n            \n            \n                <\/div>\n\n        <div class=\"card-grid\"\n         data-card-size=\"small\"         data-card-count=\"3\"\n         data-card-background=\"gray\">\n                    <div  id=\"ethics-applications\" class=\"card\" data-type=\"\" aria-label=\"ethics-applications\"><div class=\"inner\"><div class=\"card__title\"><h3>Ethics applications<\/h3><\/div><div class=\"card__content\"><p>What you need to know about applying for ethics approval from who needs ethics approval, risk categories, supporting documents, approval time frames, and HREC committee meetings and more!<\/p><\/div><ul class=\"card__links\"><li><a\n    href=\"https:\/\/curtin.edu.au\/research\/research-integrity-and-ethics\/human-ethics\/ethics-applications\"\n    class=\"ico-link--arrow\"\n    target=\"_top\" aria-label=\"Learn more\">Learn more<\/a><\/li><\/ul><\/div><\/div>                    <div  id=\"reporting-requirements\" class=\"card\" data-type=\"\" aria-label=\"reporting-requirements\"><div class=\"inner\"><div class=\"card__title\"><h3>Reporting requirements<\/h3><\/div><div class=\"card__content\"><p>Once you have received approval, there are requirements for annual progress reporting, notifying us of changes to your research, and when your research has completed &#8211; find out more here. <\/p><\/div><ul class=\"card__links\"><li><a\n    href=\"https:\/\/www.curtin.edu.au\/research\/research-integrity-and-ethics\/human-ethics\/reporting-requirements\/\"\n    class=\"ico-link--arrow\"\n    target=\"_top\" aria-label=\"Learn more\">Learn more<\/a><\/li><\/ul><\/div><\/div>                    <div  id=\"help-and-resources\" class=\"card\" data-type=\"\" aria-label=\"help-and-resources\"><div class=\"inner\"><div class=\"card__title\"><h3>Help and resources<\/h3><\/div><div class=\"card__content\"><p>Handy information including links to policies, FAQs and more<\/p><\/div><ul class=\"card__links\"><li><a\n    href=\"https:\/\/curtin.edu.au\/research\/research-integrity-and-ethics\/human-ethics\/resources\"\n    class=\"ico-link--arrow\"\n    target=\"_top\" aria-label=\"Learn more\">Learn more<\/a><\/li><\/ul><\/div><\/div>            <\/div>\n<\/mimas-block>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-8f761849 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-8f761849 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\"><\/div>\n<\/div>\n\n\n<mimas-block \n        block-name=\"accordion\"\n        role=\"complementary\"\n        aria-label=\"Accordion content\"\n        data-segment=\"all\">\n\n                \n<div class=\"block-heading\"\n     data-segment=\"dom\"\n     data-style=\"\"\n     data-align=\"default\"\n>\n\n                                <h2 class=\"block-heading__title \" id=\"clinical-trials\">Clinical Trials<\/h2>\n            \n                        \n                                <div class=\"block-heading__content\"><p>Curtin uses the\u00a0<a href=\"http:\/\/www.icmje.org\/about-icmje\/faqs\/clinical-trials-registration\/\">WHO \/ ICMJE 2008 de<\/a><a href=\"http:\/\/www.icmje.org\/about-icmje\/faqs\/clinical-trials-registration\/\" target=\"_blank\" rel=\"noreferrer noopener\">f<\/a><a href=\"http:\/\/www.icmje.org\/about-icmje\/faqs\/clinical-trials-registration\/\">inition of a clinical trial<\/a>. That is, any research study that prospectively assigns human participants or groups of humans to one or more health related interventions to evaluate the effects on health outcomes.<\/p>\n<p>For assistance in designing and conducting clinical trials please contact <a href=\"mailto:ROC-clinicaltrials@curtin.edu.au\">ROC-clinicaltrials@curtin.edu.au<\/a> or +61 8 9266 9292<\/p>\n<\/div>\n            \n            \n                <\/div>\n\n                    <div class=\"accordion\" aria-labelledby=\"accordion-title-What-is-an-intervention?\">\n            <button type=\"button\" class=\"accordion__heading\" aria-controls=\"What-is-an-intervention?\" aria-expanded=\"false\">\n            <div class=\"title\" id=\"accordion-title-What-is-an-intervention?\">What is an intervention?<\/div>\n            <div class=\"icon\"><\/div>\n        <\/button>\n        <div class=\"accordion__content\" id=\"What-is-an-intervention?\" aria-hidden=\"true\">\n                    <p>\u2018Intervention\u2019\u00a0refers to manipulation of the participants or the participants\u2019 environment for the purpose of modifying one or more of the study outcomes.\u00a0 The intervention may be a drug, medical device, surgical procedure, diagnostic or screening procedure, a health service change, or a psychological, educational or behavioural strategy.<\/p>\n<p>Interventional studies characteristically involve comparison of one or more interventional groups with a control group.<\/p>\n\n        \n                            \n                    <\/div>\n<\/div>\n                    <div class=\"accordion\" aria-labelledby=\"accordion-title-Training-for-clinical-trials\">\n            <button type=\"button\" class=\"accordion__heading\" aria-controls=\"Training-for-clinical-trials\" aria-expanded=\"false\">\n            <div class=\"title\" id=\"accordion-title-Training-for-clinical-trials\">Training for clinical trials<\/div>\n            <div class=\"icon\"><\/div>\n        <\/button>\n        <div class=\"accordion__content\" id=\"Training-for-clinical-trials\" aria-hidden=\"true\">\n                    <p>The Association of Clinical Research Professionals offers a free online\u00a0<a href=\"https:\/\/acrpnet.org\/learning\/courses\/introduction-clinical-trials\" target=\"_blank\" rel=\"noopener\">Introduction to Clinical Trials course<\/a>.\u00a0This one-hour course outlines how medical products are developed and how clinical trial\u00a0participants are protected.<\/p>\n<p>The Therapeutic Goods Administration\u2019s\u00a0<a href=\"http:\/\/www.tga.gov.au\/university-student-educational-materials\" target=\"_blank\" rel=\"noopener\">university student education materials<\/a>\u00a0contain more information on the regulation of therapeutic goods (drugs and medical devices) in Australia.<\/p>\n\n        \n                            \n                    <\/div>\n<\/div>\n                    <div class=\"accordion\" aria-labelledby=\"accordion-title-Clinical-trials-using-therapeutic-goods\">\n            <button type=\"button\" class=\"accordion__heading\" aria-controls=\"Clinical-trials-using-therapeutic-goods\" aria-expanded=\"false\">\n            <div class=\"title\" id=\"accordion-title-Clinical-trials-using-therapeutic-goods\">Clinical trials using therapeutic goods<\/div>\n            <div class=\"icon\"><\/div>\n        <\/button>\n        <div class=\"accordion__content\" id=\"Clinical-trials-using-therapeutic-goods\" aria-hidden=\"true\">\n                    <p>Clinical trials involving therapeutic goods, whether drugs or devices, that are not yet entered on the Australian Register of Therapeutic Goods (ARTG) are subject to regulation by the Therapeutics Goods Administration (TGA). These regulations also apply to use of a registered or listed product in a clinical trial beyond the conditions of its marketing approval. There are two schemes under which such trials may be conducted: the Clinical Trial Notification (CTN) scheme and the Clinical Trial Approval (CTA) scheme. The <a href=\"https:\/\/www.tga.gov.au\/publication\/australian-clinical-trial-handbook\" target=\"_blank\" rel=\"noopener\">Australian Clinical Trial Handbook<\/a>\u00a0contains guidance on conducting clinical trials in Australia using unapproved therapeutic goods.<\/p>\n<p>All CTNs must be submitted online via the TGA Business Services (TBS) system. Curtin\u2019s Ethics Office submits CTNs on behalf of\u00a0 researchers.<\/p>\n\n        \n                            \n                    <\/div>\n<\/div>\n                    <div class=\"accordion\" aria-labelledby=\"accordion-title-Good-Clinical-Practice-and-ISO-14155\">\n            <button type=\"button\" class=\"accordion__heading\" aria-controls=\"Good-Clinical-Practice-and-ISO-14155\" aria-expanded=\"false\">\n            <div class=\"title\" id=\"accordion-title-Good-Clinical-Practice-and-ISO-14155\">Good Clinical Practice and ISO 14155<\/div>\n            <div class=\"icon\"><\/div>\n        <\/button>\n        <div class=\"accordion__content\" id=\"Good-Clinical-Practice-and-ISO-14155\" aria-hidden=\"true\">\n                    <p>Clinical trials must be conducted in accordance with the\u00a0<a href=\"https:\/\/www.tga.gov.au\/resources\/publication\/corporate-reports\/ich-guideline-good-clinical-practice\">International Council on Harmonisation (ICH) Guideline for Good Clinical Practice (GCP)<\/a>.\u00a0GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve human participants.<\/p>\n<p>Free online GCP training is\u00a0available at:<\/p>\n<ul>\n<li><a href=\"https:\/\/wahtn.org\/platforms\/research-education-training-program\/\" target=\"_blank\" rel=\"noopener\">Western Australian Health Translation Network Research Education and Training Program<\/a>\u00a0\u2013 \u00a0register to access the\u00a0GCP online training module<\/li>\n<\/ul>\n<p>This course meets the\u00a0<a href=\"http:\/\/www.transceleratebiopharmainc.com\/gcp-training-attestation\/\" target=\"_blank\" rel=\"noopener\">minimum criteria for ICH GCP investigator site personnel training<\/a>\u00a0identified by TransCelerate Biopharma.<\/p>\n<p>Medical device trials must be conducted according to ISO 14155:2011 Clinical Investigation of Medical Devices for Human Subjects (available through the\u00a0<a href=\"https:\/\/uniskills.library.curtin.edu.au\/academic-writing\/finding-information\/specific-resources\/\" rel=\"noopener\">Curtin Library<\/a>). \u00a0This standard is harmonised with the Good Clinical Practice guidelines.<\/p>\n\n        \n                            \n                    <\/div>\n<\/div>\n                    <div class=\"accordion\" aria-labelledby=\"accordion-title-Resources-available-from-Curtin-Library\">\n            <button type=\"button\" class=\"accordion__heading\" aria-controls=\"Resources-available-from-Curtin-Library\" aria-expanded=\"false\">\n            <div class=\"title\" id=\"accordion-title-Resources-available-from-Curtin-Library\">Resources available from Curtin Library<\/div>\n            <div class=\"icon\"><\/div>\n        <\/button>\n        <div class=\"accordion__content\" id=\"Resources-available-from-Curtin-Library\" aria-hidden=\"true\">\n                    <p><a href=\"https:\/\/catalogue.curtin.edu.au\/discovery\/fulldisplay?context=L&amp;vid=61CUR_INST:CUR_ALMA&amp;search_scope=MyInst_and_CI&amp;tab=Everything&amp;lang=en&amp;docid=alma9933321480001951\" rel=\"noopener\">Fundamentals of Clinical Trials<\/a>\u00a0provides further detail on the fundamental concepts of designing and managing clinical trials.<\/p>\n<p><a href=\"https:\/\/catalogue.curtin.edu.au\/discovery\/fulldisplay?context=L&amp;vid=61CUR_INST:CUR_ALMA&amp;search_scope=MyInst_and_CI&amp;tab=Everything&amp;lang=en&amp;docid=alma9938537519801951\" rel=\"noopener\">Clinical Research Manual: Practical Tools and Templates for Managing Clinical Research<\/a>\u00a0contains practical advice on conducting\u00a0clinical trials.<\/p>\n<p><a href=\"https:\/\/catalogue.curtin.edu.au\/discovery\/fulldisplay?context=L&amp;vid=61CUR_INST:CUR_ALMA&amp;tab=Everything&amp;lang=en&amp;docid=alma9939081521001951\" rel=\"noopener\">A Clinical Trials Manual from the Duke Clinical Research Institute: Lessons from a Horse Named Jim<\/a>\u00a0contains practical advice on conducting clinical trials.<\/p>\n<p><a href=\"https:\/\/catalogue.curtin.edu.au\/discovery\/fulldisplay?context=L&amp;vid=61CUR_INST:CUR_ALMA&amp;search_scope=MyInst_and_CI&amp;tab=Everything&amp;lang=en&amp;docid=alma9938503921301951\" rel=\"noopener\">Conducting Clinical Research: A Practical Guide for Physicians, Nurses, Study Coordinators, and Investigators<\/a>\u00a0contains practical advice on conducting clinical trials.<\/p>\n<p><a href=\"https:\/\/catalogue.curtin.edu.au\/discovery\/fulldisplay?context=L&amp;vid=61CUR_INST:CUR_ALMA&amp;search_scope=MyInst_and_CI&amp;tab=Everything&amp;lang=en&amp;docid=alma9938503921501951\" rel=\"noopener\">Business Administration for Clinical Trials: Managing Research, Strategy, Finance, Regulation, and Quality<\/a>\u00a0contains information about the business operations related to clinical trials.<\/p>\n\n        \n                            \n                    <\/div>\n<\/div>\n        \n<\/mimas-block><\/div>\n<\/div>\n\n\n    <mimas-block \n        block-name=\"articles\"\n        role=\"complementary\"\n        aria-label=\"articles content\"\n        data-segment=\"all\"\n        data-bg=\"gray\">\n\n        \n\n                    <div class=\"article\">\n                                                                \n                <img decoding=\"async\" src=\"https:\/\/www.curtin.edu.au\/research\/wp-content\/uploads\/2026\/08\/Research-students-150x150.jpg\"\n                     alt=\"Drop in sessions\"\n                     srcset=\"https:\/\/www.curtin.edu.au\/research\/wp-content\/uploads\/2026\/08\/Research-students-150x150.jpg 150w, https:\/\/www.curtin.edu.au\/research\/wp-content\/uploads\/2026\/08\/Research-students-740x370.jpg 740w, https:\/\/www.curtin.edu.au\/research\/wp-content\/uploads\/2026\/08\/Research-students-768x512.jpg 768w, https:\/\/www.curtin.edu.au\/research\/wp-content\/uploads\/2026\/08\/Research-students-1000x500.jpg 1000w, https:\/\/www.curtin.edu.au\/research\/wp-content\/uploads\/2026\/08\/Research-students.jpg 1150w, https:\/\/www.curtin.edu.au\/research\/wp-content\/uploads\/2026\/08\/Research-students.jpg 1150w, https:\/\/www.curtin.edu.au\/research\/wp-content\/uploads\/2026\/08\/Research-students-480x240.jpg 480w, https:\/\/www.curtin.edu.au\/research\/wp-content\/uploads\/2026\/08\/Research-students-1150x630.jpg 1150w, https:\/\/www.curtin.edu.au\/research\/wp-content\/uploads\/2026\/08\/Research-students-1150x760.jpg 1150w\"\n                     sizes=\"(min-width: 2560px) 2560px, (min-width: 1920px) 1920px, (min-width: 1440px) 1440px, (min-width: 1024px) 1024px, (min-width: 768px) 768px\" loading=\"lazy\">\n\n                <article class=\"article__content\">\n                    \n                                            <h2 class=\"h3\">Drop in sessions<\/h2>\n                    \n                                            <p><p class=\"wp-block-paragraph\"><span style=\"font-size: 14pt;\">Whether you\u2019re preparing an ethics application, navigating InfoEd or have questions about the research ethics process, the Research Office Ethics Team is here to help.<\/span><\/p>\n<p class=\"wp-block-paragraph\"><span style=\"font-size: 14pt;\"><strong>When:\u00a0<\/strong><\/span><\/p>\n<ul class=\"wp-block-list\">\n<li><span style=\"font-size: 14pt;\">Tuesdays, 11am<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Wednesdays, 1pm<\/span><\/li>\n<li><span style=\"font-size: 14pt;\">Between weeks 4\u201314 (11 August\u201321 October 2026) &#8211; <\/span>Please note, there are no sessions on September 29 and 30.<\/li>\n<\/ul>\n<p class=\"wp-block-paragraph\"><span style=\"font-size: 14pt;\"><strong>Where: <\/strong><\/span><span style=\"font-size: 14pt;\">Graduate Research School,\u00a0<\/span><span style=\"font-size: 14pt;\">Building 101, Level 1 (Public entrance opposite Curtin Health Services)<\/span><\/p>\n<p><span style=\"font-size: 18.6667px;\">If these times don&#8217;t suit, or if you would like a Teams meeting, you can <a href=\"https:\/\/outlook.office.com\/book\/Ethicsoffice@curtin.onmicrosoft.com\/?ismsaljsauthenabled\">book an appointment with the Ethics team!<\/a><\/span><\/p>\n<\/p>\n                    \n                                                \n                <ul class=\"article__links\">\n                    <li>\n                        <a\n    href=\"https:\/\/www.curtin.edu.au\/news\/oasis-news\/need-help-with-ethics-applications-drop-in-and-chat-with-the-ethics-team\/\"\n    class=\"ico-link--arrow button--deep-blue filled\"\n    target=\"_top\" aria-label=\"Learn more\">Learn more<\/a>                    <\/li>\n                <\/ul>\n            \n                        <\/article>\n            <\/div>\n        <\/mimas-block>\n\n\n\n\n<mimas-block full-width=\"gray\"\n             block-name=\"help-support\" \n             role=\"complementary\" class=\"hs\"\n             aria-label=\"Help and Support\"\n             data-segment=\"all\">\n    \n                    <div class=\"hs__head\">\n            <h2 id=\"contact-the-ethics-team\">Contact the ethics team<\/h2>\n        <\/div>\n\n        <div class=\"hs__body\">\n                            <a href=\"mailto:roc-ethics@curtin.edu.au\" class=\"button button--blue\" data-btn-opt=\"default\" title=\"roc-ethics@curtin.edu.au\"\n                   target=\"_top\"><span class=\"ico ico-email\" style=\"--icon:url(https:\/\/www.curtin.edu.au\/research\/wp-content\/themes\/mimas\/src\/img\/icons\/ico-email.svg)\" aria-hidden='true'>\n                                <\/span><span>roc-ethics@curtin.edu.au<\/span><\/a>\n                            <a href=\"tel:0061892669223\" class=\"button button--blue\" data-btn-opt=\"default\" title=\"08 9266 9223\"\n                   target=\"_top\"><span class=\"ico ico-telephone\" style=\"--icon:url(https:\/\/www.curtin.edu.au\/research\/wp-content\/themes\/mimas\/src\/img\/icons\/ico-telephone.svg)\" aria-hidden='true'>\n                                <\/span><span>08 9266 9223<\/span><\/a>\n                            <a href=\"https:\/\/outlook.office.com\/book\/Ethicsoffice@curtin.onmicrosoft.com\/?ismsaljsauthenabled\" class=\"button button--blue\" data-btn-opt=\"default\" title=\"Book an appointment\"\n                   target=\"_top\"><span class=\"ico ico-calendar\" style=\"--icon:url(https:\/\/www.curtin.edu.au\/research\/wp-content\/themes\/mimas\/src\/img\/icons\/ico-calendar.svg)\" aria-hidden='true'>\n                                <\/span><span>Book an appointment<\/span><\/a>\n                    <\/div>\n\n        <div class=\"hs__footer\">\n            \n        <\/div>\n    \n    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