{"id":14258,"date":"2021-12-02T14:28:48","date_gmt":"2021-12-02T06:28:48","guid":{"rendered":"https:\/\/www.curtin.edu.au\/students\/essentials\/higher-degree-by-research\/ethics-safety\/human-research-ethics\/"},"modified":"2025-10-09T15:08:17","modified_gmt":"2025-10-09T07:08:17","slug":"human","status":"publish","type":"page","link":"https:\/\/www.curtin.edu.au\/students\/essentials\/higher-degree-by-research\/ethics-safety\/human\/","title":{"rendered":"Human research ethics"},"content":{"rendered":"\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1000\" height=\"500\" src=\"https:\/\/www.curtin.edu.au\/wp-content\/uploads\/sites\/8\/2021\/12\/DSC_2021-1000x500.jpg\" alt=\"\" class=\"wp-image-15738\" srcset=\"https:\/\/www.curtin.edu.au\/students\/wp-content\/uploads\/sites\/8\/2021\/12\/DSC_2021-1000x500.jpg 1000w, https:\/\/www.curtin.edu.au\/students\/wp-content\/uploads\/sites\/8\/2021\/12\/DSC_2021-740x370.jpg 740w, https:\/\/www.curtin.edu.au\/students\/wp-content\/uploads\/sites\/8\/2021\/12\/DSC_2021-480x240.jpg 480w, https:\/\/www.curtin.edu.au\/students\/wp-content\/uploads\/sites\/8\/2021\/12\/DSC_2021-1260x630.jpg 1260w, https:\/\/www.curtin.edu.au\/students\/wp-content\/uploads\/sites\/8\/2021\/12\/DSC_2021-1520x760.jpg 1520w, https:\/\/www.curtin.edu.au\/students\/wp-content\/uploads\/sites\/8\/2021\/12\/DSC_2021-1920x960.jpg 1920w\" sizes=\"auto, (max-width: 1000px) 100vw, 1000px\" \/><\/figure>\n\n\n\n<p>Human research is conducted with or about people, or their data or tissue. This research must comply with the&nbsp;<a href=\"https:\/\/www.nhmrc.gov.au\/about-us\/publications\/national-statement-ethical-conduct-human-research-2007-updated-2018\" target=\"_blank\" rel=\"noreferrer noopener\">National Statement on Ethical Conduct in Research 2007 (updated 2018).<\/a><\/p>\n\n\n<mimas-block \n        block-name=\"cards\"\n        data-segment=\"dom\">\n\n    \n\n        <div class=\"card-grid\"\n         data-card-size=\"standard\"         data-card-count=\"2\"\n         data-card-background=\"gray\">\n                    <div  id=\"\" class=\"card\" data-type=\"\" aria-label=\"\"><div class=\"inner\"><div class=\"card__title\"><h3><\/h3><\/div><div class=\"card__content\"><p>All research on humans conducted on Curtin campuses or by Curtin students or staff must be approved by the Curtin Human Research Ethics Committee before it can commence.<\/p><\/div><\/div><\/div>                    <div  id=\"\" class=\"card\" data-type=\"\" aria-label=\"\"><div class=\"inner\"><div class=\"card__title\"><h3><\/h3><\/div><div class=\"card__content\"><p>Research can only be conducted within the approved timelines, so if your approval has expired you cannot continue with your research. Non-compliance with these requirements represents research misconduct which will be investigated.<\/p><\/div><\/div><\/div>            <\/div>\n<\/mimas-block>\n\n\n\n<h2 class=\"wp-block-heading\">Applying for human research ethics approval<\/h2>\n\n\n\n<p>Before applying for approval, you must complete the SOL Research Integrity Professional Development Program.&nbsp;Students can access this via Blackboard, and staff can access this via iPerform.<\/p>\n\n\n<mimas-block \n        block-name=\"accordion\"\n        role=\"complementary\"\n        aria-label=\"Accordion content\"\n        data-segment=\"all\">\n\n                \n\n                    <div class=\"accordion\" aria-labelledby=\"accordion-title-Application-process\">\n            <button type=\"button\" class=\"accordion__heading\" aria-controls=\"Application-process\" aria-expanded=\"false\">\n            <div class=\"title\" id=\"accordion-title-Application-process\">Application process<\/div>\n            <div class=\"icon\"><\/div>\n        <\/button>\n        <div class=\"accordion__content\" id=\"Application-process\" aria-hidden=\"true\">\n                    <p>If you are applying for ethics approval for a new project,\u00a0<a href=\"https:\/\/infoed.curtin.edu.au\/\" rel=\"noopener\">log into\u00a0InfoEd<\/a> using your Curtin credentials, create a new record, and go through the process for New Human Protocol in Human Ethics Development\u009d.<\/p>\n<ul>\n<li><strong>Note for students:<\/strong>\u00a0In the Chief Investigator screen you must delete your name and add your supervisor&#8217;s name. Add yourself as co-investigator and click save to be able to go back into the system and see the form. If you are a staff member but submitting as a student make sure you use your student credentials.<\/li>\n<\/ul>\n<p>Your application will be submitted to the Ethics Support Officer for your faculty. If you are not from one of the four faculties, or you&#8217;re from the Sarawak Campus, your application will be submitted to the\u00a0Science and Engineering Ethics Support Officer.<\/p>\n<p>On submitting your application the Ethics Support Officer will triage your application to either\u00a0<strong>Negligible risk<\/strong>,\u00a0<strong>Low risk<\/strong>\u00a0or\u00a0<strong>Non-low risk<\/strong>.<\/p>\n<ul>\n<li><strong>Negligible risk process:<\/strong><br \/>\nYour application will be assessed by the Ethics Office.<\/li>\n<li><strong>Low risk process:<br \/>\n<\/strong>Your application will be sent to one reviewer in your school to review your project.<\/li>\n<li><strong>Non-low risk process<\/strong><strong>:<br \/>\n<\/strong>If your project has been peer reviewed (i.e. has candidacy or has grant approval from a funding body that uses a peer review process) the application will be assessed by the Human Research Ethics Committee (HREC) only.<\/li>\n<\/ul>\n<p>If your project has not been peer reviewed it will be assessed by the Advisory Committee to the HREC first. Once your project has approval from the Advisory Committee it will then be assessed by the HREC.<\/p>\n\n        \n                            \n                    <\/div>\n<\/div>\n                    <div class=\"accordion\" aria-labelledby=\"accordion-title-Application-deadlines-for-non-low-risk-submissions\">\n            <button type=\"button\" class=\"accordion__heading\" aria-controls=\"Application-deadlines-for-non-low-risk-submissions\" aria-expanded=\"false\">\n            <div class=\"title\" id=\"accordion-title-Application-deadlines-for-non-low-risk-submissions\">Application deadlines for non-low risk submissions<\/div>\n            <div class=\"icon\"><\/div>\n        <\/button>\n        <div class=\"accordion__content\" id=\"Application-deadlines-for-non-low-risk-submissions\" aria-hidden=\"true\">\n                    <p><a href=\"https:\/\/infoed.curtin.edu.au\/\">Log on to InfoEd<\/a> where HREC meeting dates and applications deadlines can be found under the help tab. If you can&#8217;t access InfoEd email <a href=\"mailto:infoed@curtin.edu.au\">infoed@curtin.edu.au<\/a> for support.<\/p>\n\n        \n                            \n                    <\/div>\n<\/div>\n                    <div class=\"accordion\" aria-labelledby=\"accordion-title-Previously-approved-projects\">\n            <button type=\"button\" class=\"accordion__heading\" aria-controls=\"Previously-approved-projects\" aria-expanded=\"false\">\n            <div class=\"title\" id=\"accordion-title-Previously-approved-projects\">Previously-approved projects<\/div>\n            <div class=\"icon\"><\/div>\n        <\/button>\n        <div class=\"accordion__content\" id=\"Previously-approved-projects\" aria-hidden=\"true\">\n                    <p>If your project has already been approved by another Human Research Ethics Committee (HREC), you may qualify for reciprocal ethics approval through Curtin.\u00a0<a href=\"https:\/\/infoed.curtin.edu.au\/\" rel=\"noopener\">Log into\u00a0InfoEd<\/a>, create a new record, and complete a reciprocal application form. Along with your reciprocal application form, please upload:<\/p>\n<ul>\n<li>A completed copy of the lead HREC ethics application form,<\/li>\n<li>A copy of the lead HREC ethics approval letter,<\/li>\n<li>A copy of any amendments\/adverse events\/progress reports as approved by the lead HREC after ethics approval\u00a0was granted.<\/li>\n<\/ul>\n<p><strong>Note for students:<\/strong>\u00a0in the Chief Investigator screen you must delete your name and add your supervisor&#8217;s name. Add yourself as co-investigator and click save to be able to go back into the system and see the form. If you are a staff member but submitting as a student make sure you use your student credentials.<\/p>\n<p>Your application will be reviewed by the Team Lead, Ethics.<\/p>\n\n        \n                            \n                    <\/div>\n<\/div>\n                    <div class=\"accordion\" aria-labelledby=\"accordion-title-InfoEd-ethics-application-system\">\n            <button type=\"button\" class=\"accordion__heading\" aria-controls=\"InfoEd-ethics-application-system\" aria-expanded=\"false\">\n            <div class=\"title\" id=\"accordion-title-InfoEd-ethics-application-system\">InfoEd ethics application system<\/div>\n            <div class=\"icon\"><\/div>\n        <\/button>\n        <div class=\"accordion__content\" id=\"InfoEd-ethics-application-system\" aria-hidden=\"true\">\n                    <p><a href=\"https:\/\/infoed.curtin.edu.au\/\" rel=\"noopener\">Log into\u00a0InfoEd<\/a>\u00a0using your Curtin credentials to apply for ethics approval and access submission forms.<\/p>\n<p>If you can&#8217;t access InfoEd email\u00a0<a href=\"mailto:infoed@curtin.edu.au\" target=\"_blank\" rel=\"noopener\">infoed@curtin.edu.au<\/a>\u00a0for support.<\/p>\n\n        \n                            \n                    <\/div>\n<\/div>\n                    <div class=\"accordion\" aria-labelledby=\"accordion-title-Test-the-InfoEd-system\">\n            <button type=\"button\" class=\"accordion__heading\" aria-controls=\"Test-the-InfoEd-system\" aria-expanded=\"false\">\n            <div class=\"title\" id=\"accordion-title-Test-the-InfoEd-system\">Test the InfoEd system<\/div>\n            <div class=\"icon\"><\/div>\n        <\/button>\n        <div class=\"accordion__content\" id=\"Test-the-InfoEd-system\" aria-hidden=\"true\">\n                    <p>If you want to play with the system to understand how it works, log into the\u00a0<a href=\"https:\/\/infoedtest.curtin.edu.au\/\" rel=\"noopener\">InfoEd test environment<\/a>. Information you put in here will not be uploaded to the production environment.<\/p>\n<p>If you are a student and cannot access the test environment,\u00a0email the <strong>ethics support officer<\/strong> in your faculty\u00a0for a generic username and password.<\/p>\n\n        \n                            \n                    <\/div>\n<\/div>\n        \n<\/mimas-block>\n\n\n<h2 class=\"wp-block-heading\">Maintaining your human research ethics approval<\/h2>\n\n\n\n<p>To comply with your ethics approval and ensure ongoing approval of a research study, all existing applicants must submit annual reports, then a completion report when the research has finished.<\/p>\n\n\n\n<p><a href=\"https:\/\/infoed.curtin.edu.au\/\">Log into&nbsp;InfoEd<\/a>&nbsp;to submit annual and completion reports, make changes to the project (through an amendment request) and submit information on reportable events.<\/p>\n\n\n<mimas-block \n        block-name=\"accordion\"\n        role=\"complementary\"\n        aria-label=\"Accordion content\"\n        data-segment=\"all\">\n\n                \n\n                    <div class=\"accordion\" aria-labelledby=\"accordion-title-Changing-your-study\">\n            <button type=\"button\" class=\"accordion__heading\" aria-controls=\"Changing-your-study\" aria-expanded=\"false\">\n            <div class=\"title\" id=\"accordion-title-Changing-your-study\">Changing your study<\/div>\n            <div class=\"icon\"><\/div>\n        <\/button>\n        <div class=\"accordion__content\" id=\"Changing-your-study\" aria-hidden=\"true\">\n                    <p>If your study has to be changed in any way you must submit an amendment request prior to implementing any changes, and you must report any events such as protocol deviations, serious adverse events or unanticipated problems as soon as possible after they occur.<\/p>\n\n        \n                            \n                    <\/div>\n<\/div>\n                    <div class=\"accordion\" aria-labelledby=\"accordion-title-Annual-reports\">\n            <button type=\"button\" class=\"accordion__heading\" aria-controls=\"Annual-reports\" aria-expanded=\"false\">\n            <div class=\"title\" id=\"accordion-title-Annual-reports\">Annual reports<\/div>\n            <div class=\"icon\"><\/div>\n        <\/button>\n        <div class=\"accordion__content\" id=\"Annual-reports\" aria-hidden=\"true\">\n                    <p>You must submit an annual report every year on the anniversary of approval in accordance with the\u00a0<a href=\"https:\/\/www.nhmrc.gov.au\/about-us\/publications\/national-statement-ethical-conduct-human-research-2007-updated-2018\" target=\"_blank\" rel=\"noopener\">NH&amp;MRC National Statement on Ethical Conduct in Human Research<\/a>.\u00a0<strong>Failure to submit an annual report means your project does not have current approval<\/strong>. Your project will approved for an additional 12 months once your annual report has been approved.<\/p>\n\n        \n                            \n                    <\/div>\n<\/div>\n                    <div class=\"accordion\" aria-labelledby=\"accordion-title-Completion-report\">\n            <button type=\"button\" class=\"accordion__heading\" aria-controls=\"Completion-report\" aria-expanded=\"false\">\n            <div class=\"title\" id=\"accordion-title-Completion-report\">Completion report<\/div>\n            <div class=\"icon\"><\/div>\n        <\/button>\n        <div class=\"accordion__content\" id=\"Completion-report\" aria-hidden=\"true\">\n                    <p>You must submit a completion report on completion of the project in accordance with the\u00a0<a href=\"https:\/\/www.nhmrc.gov.au\/about-us\/publications\/national-statement-ethical-conduct-human-research-2007-updated-2018\" target=\"_blank\" rel=\"noopener\">NH&amp;MRC National Statement on Ethical Conduct in Human Research<\/a>.<\/p>\n\n        \n                            \n                    <\/div>\n<\/div>\n                    <div class=\"accordion\" aria-labelledby=\"accordion-title-Auditing-program\">\n            <button type=\"button\" class=\"accordion__heading\" aria-controls=\"Auditing-program\" aria-expanded=\"false\">\n            <div class=\"title\" id=\"accordion-title-Auditing-program\">Auditing program<\/div>\n            <div class=\"icon\"><\/div>\n        <\/button>\n        <div class=\"accordion__content\" id=\"Auditing-program\" aria-hidden=\"true\">\n                    <p>All ongoing projects which have human research ethics approval from Curtin may be audited in accordance with the\u00a0<a href=\"https:\/\/www.nhmrc.gov.au\/about-us\/publications\/national-statement-ethical-conduct-human-research-2007-updated-2018\" target=\"_blank\" rel=\"noopener\">NH&amp;MRC National Statement on Ethical Conduct in Human Research<\/a>.<\/p>\n<p>Projects are audited to ensure research is conducted ethically, legally, safely and in compliance with the protocol and conditions approved by the Human Research Ethics Committee.<\/p>\n<p>Projects are selected to be audited based on:<\/p>\n<ul>\n<li>Request by the Human Research Ethics Committee<\/li>\n<li>Risk<\/li>\n<li>Random selection<\/li>\n<li>A complaint<\/li>\n<\/ul>\n<p>If your project has been selected to be audited you will be contacted by the Clinical Research Monitor who will provide you with more details.<\/p>\n\n        \n                            \n                    <\/div>\n<\/div>\n        \n<\/mimas-block>\n\n\n<h3 class=\"wp-block-heading\">Reportable events<\/h3>\n\n\n\n<p>A reportable event is any event that must be reported to the Curtin Ethics Office. Reportable events may include protocol deviations, serious adverse event or an unanticipated problem.<\/p>\n\n\n<mimas-block \n        block-name=\"accordion\"\n        role=\"complementary\"\n        aria-label=\"Accordion content\"\n        data-segment=\"all\">\n\n                \n\n                    <div class=\"accordion\" aria-labelledby=\"accordion-title-Protocol-deviation\">\n            <button type=\"button\" class=\"accordion__heading\" aria-controls=\"Protocol-deviation\" aria-expanded=\"false\">\n            <div class=\"title\" id=\"accordion-title-Protocol-deviation\">Protocol deviation<\/div>\n            <div class=\"icon\"><\/div>\n        <\/button>\n        <div class=\"accordion__content\" id=\"Protocol-deviation\" aria-hidden=\"true\">\n                    <p>A deviation is a departure from the HREC approval protocol procedures and\/or regulatory guidelines.<\/p>\n<p>A deviation is considered major if it:<\/p>\n<ul>\n<li>Increases the risk or decreases the benefit,<\/li>\n<li>Affects the safety, rights or welfare,<\/li>\n<li>Affects the integrity of the study design or data, or<\/li>\n<li>Compromises the ethical acceptability of the study.<\/li>\n<\/ul>\n<p>If this event does not meet one of these criteria, report this event in your annual report.<\/p>\n\n        \n                            \n                    <\/div>\n<\/div>\n                    <div class=\"accordion\" aria-labelledby=\"accordion-title-Serious-adverse-events\">\n            <button type=\"button\" class=\"accordion__heading\" aria-controls=\"Serious-adverse-events\" aria-expanded=\"false\">\n            <div class=\"title\" id=\"accordion-title-Serious-adverse-events\">Serious adverse events<\/div>\n            <div class=\"icon\"><\/div>\n        <\/button>\n        <div class=\"accordion__content\" id=\"Serious-adverse-events\" aria-hidden=\"true\">\n                    <p>An adverse event is any unforeseen or unexpected outcomes that have a negative impact on participants, researchers or Curtin&#8217;s reputation. Adverse events can apply to interventional studies using new drugs or devices, but also to research with interventions such as behavioural modifications. People participating in qualitative research may also experience adverse events that meet the above definition.<\/p>\n<p>Adverse events are considered serious if any of the following outcomes occur:<\/p>\n<ul>\n<li>Death<\/li>\n<li>Life threatening<\/li>\n<li>Requires inpatient hospitalisation or prolongation of existing hospitalisation<\/li>\n<li>Results in congenital anomaly\/birth defect<\/li>\n<li>Results in persistent or significant disability or incapacity.<\/li>\n<\/ul>\n<p>If the adverse event does not result in any of the above outcomes, but still needs to be reported immediately (rather than in the annual report) because it potentially changes the risk-benefit profile of the study, it should be reported as an unanticipated problem.<\/p>\n\n        \n                            \n                    <\/div>\n<\/div>\n                    <div class=\"accordion\" aria-labelledby=\"accordion-title-Unanticipated-problems\">\n            <button type=\"button\" class=\"accordion__heading\" aria-controls=\"Unanticipated-problems\" aria-expanded=\"false\">\n            <div class=\"title\" id=\"accordion-title-Unanticipated-problems\">Unanticipated problems<\/div>\n            <div class=\"icon\"><\/div>\n        <\/button>\n        <div class=\"accordion__content\" id=\"Unanticipated-problems\" aria-hidden=\"true\">\n                    <p>An unanticipated problem is any unforeseen issues that have arisen in your research project. This may relate to an individual or multiple individuals.<\/p>\n<p>An unanticipated event needs to meet the following three criteria:<\/p>\n<ul>\n<li>Increase the risk of harm,<\/li>\n<li>Is unexpected, and<\/li>\n<li>Is caused by, or related to, the study.<\/li>\n<\/ul>\n<p>If this event does not meet these three criteria, report this event in your annual report.<\/p>\n\n        \n                            \n                    <\/div>\n<\/div>\n        \n<\/mimas-block>\n\n\n<h3 class=\"wp-block-heading\">Amendments<\/h3>\n\n\n\n<p>If your study has changed in any way you must submit an amendment request. Amendments to the protocol must not be acted on until approval has been given by the Human Research Office.<\/p>\n\n\n\n<p>Protocol amendments may be defined as&nbsp;<strong>major<\/strong>&nbsp;or&nbsp;<strong>minor<\/strong>.<\/p>\n\n\n<mimas-block \n        block-name=\"accordion\"\n        role=\"complementary\"\n        aria-label=\"Accordion content\"\n        data-segment=\"all\">\n\n                \n\n                    <div class=\"accordion\" aria-labelledby=\"accordion-title-Major-amendments\">\n            <button type=\"button\" class=\"accordion__heading\" aria-controls=\"Major-amendments\" aria-expanded=\"false\">\n            <div class=\"title\" id=\"accordion-title-Major-amendments\">Major amendments<\/div>\n            <div class=\"icon\"><\/div>\n        <\/button>\n        <div class=\"accordion__content\" id=\"Major-amendments\" aria-hidden=\"true\">\n                    <p>Major amendments are defined as changes to the protocol which substantially changes the study design or analysis plan and potentially alter the risk-benefit profile of the study. For example:<\/p>\n<ul>\n<li>Change in the primary hypothesis<\/li>\n<li>Change to the design of the study<\/li>\n<li>Additional outcomes or exposures<\/li>\n<li>Use of additional linkages to other databases.<\/li>\n<\/ul>\n\n        \n                            \n                    <\/div>\n<\/div>\n                    <div class=\"accordion\" aria-labelledby=\"accordion-title-Minor-amendments\">\n            <button type=\"button\" class=\"accordion__heading\" aria-controls=\"Minor-amendments\" aria-expanded=\"false\">\n            <div class=\"title\" id=\"accordion-title-Minor-amendments\">Minor amendments<\/div>\n            <div class=\"icon\"><\/div>\n        <\/button>\n        <div class=\"accordion__content\" id=\"Minor-amendments\" aria-hidden=\"true\">\n                    <p>Minor amendments are defined as changes to the protocol that do not have an impact on the main aims and outcomes of the study. An example is administrative changes to the protocol (e.g. a change in contact details).<\/p>\n\n        \n                            \n                    <\/div>\n<\/div>\n        \n<\/mimas-block>\n\n\n<h2 class=\"wp-block-heading\">Clinical trials<\/h2>\n\n\n\n<p>Curtin uses the&nbsp;<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\n\n<mimas-block \n        block-name=\"accordion\"\n        role=\"complementary\"\n        aria-label=\"Accordion content\"\n        data-segment=\"all\">\n\n                \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>&#8216;Intervention&#8217;\u00a0refers to manipulation of the participants or the participants&#8217; 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=\"http:\/\/www.acrpnet.org\/MainMenuCategory\/Education\/Featured-Courses\/eLearning\/Introduction-to-Clinical-Trials.aspx\" 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>For a brief introduction to the clinical trials environment in Australia, you may refer to the NHMRC&#8217;s\u00a0<a href=\"https:\/\/www.australianclinicaltrials.gov.au\/resources\" target=\"_blank\" rel=\"noopener\">clinical trial eLearning modules<\/a>.\u00a0These modules consist of three 45 minute videos providing an introduction to the clinical trials environment in Australia, ethical issues relating to clinical research and research governance processes relating to clinical research.<\/p>\n<p>The Therapeutic Goods Administration&#8217;s\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-drugs-or-devices\">\n            <button type=\"button\" class=\"accordion__heading\" aria-controls=\"Clinical-trials-using-therapeutic-drugs-or-devices\" aria-expanded=\"false\">\n            <div class=\"title\" id=\"accordion-title-Clinical-trials-using-therapeutic-drugs-or-devices\">Clinical trials using therapeutic drugs or devices<\/div>\n            <div class=\"icon\"><\/div>\n        <\/button>\n        <div class=\"accordion__content\" id=\"Clinical-trials-using-therapeutic-drugs-or-devices\" 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).\u00a0These regulations also apply to use of a registered or listed product in a clinical trial beyond the conditions of its marketing approval.\u00a0There are two schemes under which such trials may be conducted: the Clinical Trials Notification (CTN) scheme and the Clinical Trials Exemption (CTX) scheme.\u00a0The\u00a0<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&#8217;s Ethics Office submits CTNs on researchers&#8217; behalf once the clinical trial has received ethics and institutional approval.<\/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=\"http:\/\/www.tga.gov.au\/publication\/note-guidance-good-clinical-practice\" target=\"_blank\" rel=\"noopener\"><em>Note for Guidance on Good Clinical Practice\u00a0<\/em>(CPMP\/ICH135\/95 &#8211; Annotated with TGA Comments)<\/a>, the Good Clinical Practice (GCP) guidelines adopted in Australia. GCP is an\u00a0international ethical and scientific quality standard\u00a0for 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&#8211; \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=\"http:\/\/libguides.library.curtin.edu.au\/c.php?g=202368&amp;p=1332371\" 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=\"http:\/\/catalogue.curtin.edu.au\/primo_library\/libweb\/action\/display.do?tabs=detailsTab&amp;ct=display&amp;fn=search&amp;doc=CUR_ALMA51110937220001951&amp;indx=1&amp;recIds=CUR_ALMA51110937220001951&amp;recIdxs=0&amp;elementId=0&amp;renderMode=poppedOut&amp;displayMode=full&amp;frbrVersion=&amp;dscnt=0&amp;fctN=facet_frbrgroupid&amp;submit=Go&amp;rfnGrp=frbr&amp;frbg=319973188&amp;fctV=319973188&amp;tab=default_tab&amp;dstmp=1443755223729&amp;frbrRecordsSource=Primo+Local&amp;cs=frb&amp;lastPagIndx=&amp;lastPag=&amp;frbrSrt=date&amp;_ga=1.243425741.950571408.1443743729&amp;vl(freeText0)=Fundamentals%20of%20Clinical%20Trials&amp;vid=CUR_ALMA\" 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=\"http:\/\/link.library.curtin.edu.au\/p?pid=CUR_ALMA51134513160001951\" 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=\"http:\/\/catalogue.curtin.edu.au\/primo_library\/libweb\/action\/display.do?tabs=detailsTab&amp;ct=display&amp;fn=search&amp;doc=CUR_ALMA51130743810001951&amp;indx=1&amp;recIds=CUR_ALMA51130743810001951&amp;recIdxs=0&amp;elementId=0&amp;renderMode=poppedOut&amp;displayMode=full&amp;frbrVersion=&amp;dscnt=0&amp;scp.scps=scope%3A%28cur_digitool_marc%29%2Cscope%3A%28CUR_ALMA_whc%29%2Cscope%3A%28CUR_ALMA_jbsc%29%2Cscope%3A%28CUR_ALMA%29%2Cscope%3A%28cur_digitool_dc%29%2Cscope%3A%28cur_libguides%29%2Cprimo_central_multiple_fe&amp;frbg=&amp;tab=default_tab&amp;dstmp=1444960484216&amp;srt=rank&amp;mode=Basic&amp;&amp;dum=true&amp;tb=t&amp;vl(1UIStartWith0)=contains&amp;vl(642582820UI0)=any&amp;vl(freeText0)=A%20clinical%20trials%20manual%20from%20the%20Duke%20Clinical%20Research%20Institute%20lessons%20from%20a%20horse%20named%20Jim&amp;vid=CUR_ALMA\" 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=\"http:\/\/link.library.curtin.edu.au\/p?pid=CUR_ALMA21130743630001951\" 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=\"http:\/\/catalogue.curtin.edu.au\/primo_library\/libweb\/action\/display.do?tabs=detailsTab&amp;ct=display&amp;fn=search&amp;doc=CUR_ALMA51130743850001951&amp;indx=1&amp;recIds=CUR_ALMA51130743850001951&amp;recIdxs=0&amp;elementId=0&amp;renderMode=poppedOut&amp;displayMode=full&amp;frbrVersion=&amp;dscnt=0&amp;scp.scps=scope%3A%28cur_digitool_marc%29%2Cscope%3A%28CUR_ALMA_whc%29%2Cscope%3A%28CUR_ALMA_jbsc%29%2Cscope%3A%28CUR_ALMA%29%2Cscope%3A%28cur_digitool_dc%29%2Cscope%3A%28cur_libguides%29%2Cprimo_central_multiple_fe&amp;frbg=&amp;tab=default_tab&amp;dstmp=1444693229722&amp;srt=rank&amp;mode=Basic&amp;&amp;dum=true&amp;tb=t&amp;vl(1UIStartWith0)=contains&amp;vl(642582820UI0)=any&amp;vl(freeText0)=business%20administration%20for%20clinical%20trials&amp;vid=CUR_ALMA\" 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>\n\n\n<p>For assistance in designing and conducting clinical trials please contact&nbsp;<a href=\"mailto:ROC-clinicaltrials@curtin.edu.au\" target=\"_blank\" rel=\"noreferrer noopener\">ROC-clinicaltrials@curtin.edu.au<\/a>&nbsp;or <a href=\"tel:+61892669292\" target=\"_blank\" rel=\"noreferrer noopener\">+61 8 9266 9292<\/a>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Training and guides for human research ethics<\/h2>\n\n\n<mimas-block \n        block-name=\"accordion\"\n        role=\"complementary\"\n        aria-label=\"Accordion content\"\n        data-segment=\"all\">\n\n                \n\n                    <div class=\"accordion\" aria-labelledby=\"accordion-title-Resources-for-human-research-ethics\">\n            <button type=\"button\" class=\"accordion__heading\" aria-controls=\"Resources-for-human-research-ethics\" aria-expanded=\"false\">\n            <div class=\"title\" id=\"accordion-title-Resources-for-human-research-ethics\">Resources for human research ethics<\/div>\n            <div class=\"icon\"><\/div>\n        <\/button>\n        <div class=\"accordion__content\" id=\"Resources-for-human-research-ethics\" aria-hidden=\"true\">\n                    <p>If you have questions about how to submit a human ethics application, or would like to make an appointment to discuss your application, please contact the Research Ethics Office at\u00a0<a href=\"mailto:ROC-ethics@curtin.edu.au\" target=\"_blank\" rel=\"noopener\">ROC-ethics@curtin.edu.au<\/a>\u00a0or\u00a0<a href=\"tel:(08) 9266 9223\" target=\"_blank\" rel=\"noopener\">(08) 9266 9223<\/a>.<\/p>\n<p><strong>To view or download Infoed instruction guides<\/strong><\/p>\n<ol>\n<li>Log into\u00a0<a href=\"https:\/\/infoed.curtin.edu.au\/\" rel=\"noopener\">InfoEd<\/a><\/li>\n<li>Click on\u00a0<strong>Help<\/strong><\/li>\n<li>Hover your cursor over\u00a0<strong>Human Ethics<\/strong><\/li>\n<li>Click on the chosen guide to open it in a new browser window<\/li>\n<\/ol>\n\n        \n                            \n                    <\/div>\n<\/div>\n        \n<\/mimas-block>\n\n\n<h3 class=\"wp-block-heading\">Guides<\/h3>\n\n\n<mimas-block \n        block-name=\"accordion\"\n        role=\"complementary\"\n        aria-label=\"Accordion content\"\n        data-segment=\"all\">\n\n                \n\n                    <div class=\"accordion\" aria-labelledby=\"accordion-title-Good-research-practice-guidelines-and-templates\">\n            <button type=\"button\" class=\"accordion__heading\" aria-controls=\"Good-research-practice-guidelines-and-templates\" aria-expanded=\"false\">\n            <div class=\"title\" id=\"accordion-title-Good-research-practice-guidelines-and-templates\">Good research practice guidelines and templates<\/div>\n            <div class=\"icon\"><\/div>\n        <\/button>\n        <div class=\"accordion__content\" id=\"Good-research-practice-guidelines-and-templates\" aria-hidden=\"true\">\n                    <ul>\n<li><a href=\"https:\/\/www.curtin.edu.au\/wp-content\/uploads\/sites\/8\/2021\/12\/PIF-template_V7_12FEB2019.docx\" target=\"_blank\" rel=\"noopener\">Participant Information Form Template [.docx 76kB]<\/a><\/li>\n<li><a href=\"https:\/\/www.curtin.edu.au\/wp-content\/uploads\/sites\/8\/2021\/12\/CF-template_V6_12FEB2019.docx\" target=\"_blank\" rel=\"noopener\">Participant Consent Form Template [.docx 66kB]<\/a><\/li>\n<li><a href=\"https:\/\/www.curtin.edu.au\/wp-content\/uploads\/sites\/8\/2021\/12\/PICF-checklist-V1-12JAN20151.pdf\" target=\"_blank\" rel=\"noopener\">Participant Information and Consent Form Checklist\u00a0[.pdf 289kB]<\/a><\/li>\n<li><a href=\"https:\/\/www.curtin.edu.au\/wp-content\/uploads\/sites\/8\/2021\/12\/tips-for-writing-in-plain-english-V1.pdf\" target=\"_blank\" rel=\"noopener\">Tips for writing in plain English\u00a0[.pdf 59kB]<\/a><\/li>\n<li><a href=\"https:\/\/www.curtin.edu.au\/wp-content\/uploads\/sites\/8\/2021\/12\/WWC-for-researchers-v1.1.pdf\" target=\"_blank\" rel=\"noopener\">Working with children check for researchers\u00a0[.pdf 41kB]<\/a><\/li>\n<li><a href=\"https:\/\/www.curtin.edu.au\/wp-content\/uploads\/sites\/8\/2021\/12\/payments-in-research-V1.pdf\" target=\"_blank\" rel=\"noopener\">Payments in research\u00a0[.pdf 98kB]<\/a><\/li>\n<\/ul>\n\n        \n                            \n                    <\/div>\n<\/div>\n                    <div class=\"accordion\" aria-labelledby=\"accordion-title-Ethics-application-practice-form\">\n            <button type=\"button\" class=\"accordion__heading\" aria-controls=\"Ethics-application-practice-form\" aria-expanded=\"false\">\n            <div class=\"title\" id=\"accordion-title-Ethics-application-practice-form\">Ethics application practice form<\/div>\n            <div class=\"icon\"><\/div>\n        <\/button>\n        <div class=\"accordion__content\" id=\"Ethics-application-practice-form\" aria-hidden=\"true\">\n                    <p><a href=\"https:\/\/www.curtin.edu.au\/wp-content\/uploads\/sites\/8\/2021\/12\/human-research-ethics-application-practice-form.pdf\" target=\"_blank\" rel=\"noopener\">Human Research Ethics Application Practice Form [.pdf 455kB]<\/a><\/p>\n\n        \n                            \n                    <\/div>\n<\/div>\n        \n<\/mimas-block>\n\n\n<p>If you need assistance with these guides or human research ethics please email your faculty officer down below.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"HRE-Contact\">The Human Research Ethics Committee and faculty officers<\/h2>\n\n\n<mimas-block \n        block-name=\"cards\"\n        data-segment=\"dom\">\n\n    \n\n        <div class=\"card-grid\"\n         data-card-size=\"standard\"         data-card-count=\"2\"\n         data-card-background=\"gray\">\n                    <div  id=\"human-research-ethics-committee\" class=\"card\" data-type=\"\" aria-label=\"human-research-ethics-committee\"><div class=\"inner\"><div class=\"card__title\"><h3>Human Research Ethics Committee<\/h3><\/div><div class=\"card__content\"><p>The Human Research Ethics Committee (HREC) is constituted and operates in accordance with the National Health and Medical Research Council National Statement on Ethical Conduct in Human Research (2007) including all updates. <\/p><p><a href=\"https:\/\/about.curtin.edu.au\/governance\/research-standards\/\" rel=\"noopener\" target=\"_blank\"> View the Constitution and committee members here<\/a>.<\/p><\/div><\/div><\/div>                    <div  id=\"contact-the-ethics-team\" class=\"card\" data-type=\"\" aria-label=\"contact-the-ethics-team\"><div class=\"inner\"><div class=\"card__title\"><h3>Contact the Ethics team<\/h3><\/div><div class=\"card__content\"><p>The Human Research Ethics Office is responsible for managing and facilitating the ethical review process for research involving humans.<\/p><p>Contact us on <a href=\"mailto:ROC-ethics@curtin.edu.au\" rel=\"noopener\" target=\"_blank\">ROC-ethics@curtin.edu.au<\/a>  for general enquiries or <a href=\"mailto:HREC@curtin.edu.au\" rel=\"noopener\" target=\"_blank\">HREC@curtin.edu.au<\/a>  or phone <a href=\"tel:92669223\" rel=\"noopener\" target=\"_blank\">9266 9223<\/a>.<\/p><\/div><\/div><\/div>            <\/div>\n<\/mimas-block>\n","protected":false},"excerpt":{"rendered":"<p>Human research is conducted with or about people, or their data or tissue. This research [&hellip;]<\/p>\n","protected":false},"author":369,"featured_media":0,"parent":12331,"menu_order":3,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_oasis_is_in_workflow":0,"_oasis_original":0,"_oasis_task_priority":"","footnotes":""},"tags":[],"class_list":["post-14258","page","type-page","status-publish","hentry"],"acf":[],"publishpress_future_action":{"enabled":false,"date":"2026-04-16 14:22:23","action":"change-status","newStatus":"draft","terms":[],"taxonomy":"post_tag","extraData":[]},"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"_links":{"self":[{"href":"https:\/\/www.curtin.edu.au\/students\/wp-json\/wp\/v2\/pages\/14258","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.curtin.edu.au\/students\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.curtin.edu.au\/students\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.curtin.edu.au\/students\/wp-json\/wp\/v2\/users\/369"}],"replies":[{"embeddable":true,"href":"https:\/\/www.curtin.edu.au\/students\/wp-json\/wp\/v2\/comments?post=14258"}],"version-history":[{"count":6,"href":"https:\/\/www.curtin.edu.au\/students\/wp-json\/wp\/v2\/pages\/14258\/revisions"}],"predecessor-version":[{"id":40009,"href":"https:\/\/www.curtin.edu.au\/students\/wp-json\/wp\/v2\/pages\/14258\/revisions\/40009"}],"up":[{"embeddable":true,"href":"https:\/\/www.curtin.edu.au\/students\/wp-json\/wp\/v2\/pages\/12331"}],"wp:attachment":[{"href":"https:\/\/www.curtin.edu.au\/students\/wp-json\/wp\/v2\/media?parent=14258"}],"wp:term":[{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.curtin.edu.au\/students\/wp-json\/wp\/v2\/tags?post=14258"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}