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Regulations & Policies for Research Involving Human Participants
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data-drupal-link-system-path="node/1349">Overview</a> </span> </li> <li class="menu__item menu__item-title--institutional-strategic-initiatives-isi-2024--2025-funding-program" id="menu-name--main__institutional-strategic-initiatives-isi-2024-2025-funding-program_secureinstitutional-strategic-initiatives-isi-2024-2025-funding-program"> <span class="menu__link--wrapper"> <a href="/secure/institutional-strategic-initiatives-isi-2024-2025-funding-program" class="menu__link" data-drupal-link-system-path="node/1925">Institutional Strategic Initiatives (ISI) 2024 & 2025 Funding Program</a> </span> </li> <li class="menu__item menu__item-title--initiatives-resources--news" id="menu-name--main__initiatives-resources-news_httpsisiutorontoca"> <span class="menu__link--wrapper"> <a href="https://isi.utoronto.ca/" class="menu__link">Initiatives, Resources & News</a> </span> </li></ul> </li> <li class="menu__item is-parent menu__item--expanded menu__item-title--equity-diversity--inclusion" id="menu-name--main__equity-diversity-inclusion_group"> <span class="menu__link--wrapper is-parent__wrapper"> <a href="#group" class="menu__link">Equity, Diversity & Inclusion</a> </span> <ul class="menu is-child even menu-level-2"> <li class="menu__item menu__item-title--overview" id="menu-name--main__overview_equity-diversity-inclusionequity-diversity-inclusion"> <span class="menu__link--wrapper"> <a href="/equity-diversity-inclusion/equity-diversity-inclusion" class="menu__link" data-drupal-link-system-path="node/843">Overview</a> </span> </li> <li class="menu__item menu__item-title--resources-updates-news--events" id="menu-name--main__resources-updates-news-events_httpsediriutorontoca"> <span class="menu__link--wrapper"> <a href="https://ediri.utoronto.ca/" class="menu__link">Resources, Updates, News & Events</a> </span> </li></ul> </li> <li class="menu__item is-parent menu__item--expanded menu__item-title--training-resources--facilities" id="menu-name--main__training-resources-facilities_group"> <span class="menu__link--wrapper is-parent__wrapper"> <a href="#group" class="menu__link">Training, Resources & Facilities</a> </span> <ul class="menu is-child even menu-level-2"> <li class="menu__item menu__item-title--overview" id="menu-name--main__overview_training-resourcestraining-resources"> <span class="menu__link--wrapper"> <a href="/training-resources/training-resources" class="menu__link" data-drupal-link-system-path="node/488">Overview</a> </span> </li> <li class="menu__item menu__item-title--centre-for-research--innovation-support" id="menu-name--main__centre-for-research-innovation-support_training-resourcescentre-research-innovation-support"> <span class="menu__link--wrapper"> <a href="/training-resources/centre-research-innovation-support" class="menu__link" data-drupal-link-system-path="node/899">Centre for Research & Innovation Support</a> </span> </li> <li class="menu__item 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id="menu-name--main__discoverresearch_training-resourcesdiscoverresearch"> <span class="menu__link--wrapper"> <a href="/training-resources/discoverresearch" class="menu__link" data-drupal-link-system-path="node/1619">DiscoverResearch</a> </span> </li> <li class="menu__item menu__item-title--toronto-research-data-centre" id="menu-name--main__toronto-research-data-centre_rdc"> <span class="menu__link--wrapper"> <a href="/rdc" class="menu__link" data-drupal-link-system-path="node/1877">Toronto Research Data Centre</a> </span> </li> <li class="menu__item menu__item-title--scinet" id="menu-name--main__scinet_training-resources-facilitiesscinet"> <span class="menu__link--wrapper"> <a href="/training-resources-facilities/scinet" class="menu__link" data-drupal-link-system-path="node/836">SciNet</a> </span> </li> <li class="menu__item menu__item-title--institutional-core-facilities" id="menu-name--main__institutional-core-facilities_training-resources-facilitiesinstitutional-core-facilities"> <span class="menu__link--wrapper"> <a href="/training-resources-facilities/institutional-core-facilities" class="menu__link" data-drupal-link-system-path="node/1919">Institutional Core Facilities</a> </span> </li></ul> </li> <li class="menu__item is-parent menu__item--expanded menu__item--active-trail menu__item-title--ethics-in-human-research" id="menu-name--main__ethics-in-human-research_group"> <span class="menu__link--wrapper is-parent__wrapper"> <a href="#group" class="menu__link">Ethics in Human Research</a> </span> <ul class="menu is-child even menu-level-2"> <li class="menu__item menu__item-title--overview" id="menu-name--main__overview_ethics-human-researchethics-human-research"> <span class="menu__link--wrapper"> <a href="/ethics-human-research/ethics-human-research" class="menu__link" data-drupal-link-system-path="node/849">Overview</a> </span> </li> <li class="menu__item menu__item-title--when-do-i-need-a-human-ethics-protocol" id="menu-name--main__when-do-i-need-a-human-ethics-protocol_ethics-human-researchwhen-do-i-need-human-ethics-protocol"> <span class="menu__link--wrapper"> <a href="/ethics-human-research/when-do-i-need-human-ethics-protocol" class="menu__link" data-drupal-link-system-path="node/850">When Do I Need a Human Ethics Protocol?</a> </span> </li> <li class="menu__item menu__item-title--submit-a-human-ethics-protocol" id="menu-name--main__submit-a-human-ethics-protocol_ethics-human-researchsubmit-human-ethics-protocol"> <span class="menu__link--wrapper"> <a href="/ethics-human-research/submit-human-ethics-protocol" class="menu__link" data-drupal-link-system-path="node/851">Submit a Human Ethics Protocol</a> </span> </li> <li class="menu__item menu__item-title--protocol-submission-deadlines--who-to-submit-to-human-research" id="menu-name--main__protocol-submission-deadlines-who-to-submit-to-human-research_ethics-human-researchprotocol-submission-deadlines-who-submit-human-research"> <span class="menu__link--wrapper"> <a href="/ethics-human-research/protocol-submission-deadlines-who-submit-human-research" class="menu__link" data-drupal-link-system-path="node/852">Protocol Submission Deadlines & Who to Submit to (Human Research)</a> </span> </li> <li class="menu__item menu__item-title--research-ethics-boards" id="menu-name--main__research-ethics-boards_ethics-human-researchresearch-ethics-boards"> <span class="menu__link--wrapper"> <a href="/ethics-human-research/research-ethics-boards" class="menu__link" data-drupal-link-system-path="node/884">Research Ethics Boards</a> </span> </li> <li class="menu__item menu__item-title--how-to-amend-a-protocol" id="menu-name--main__how-to-amend-a-protocol_ethics-human-researchhow-amend-protocol"> <span class="menu__link--wrapper"> <a href="/ethics-human-research/how-amend-protocol" class="menu__link" data-drupal-link-system-path="node/853">How to Amend a Protocol</a> </span> </li> <li class="menu__item menu__item-title--when-and-how-to-submit-renewals-protocol-completions-adverse-events-and-protocol-deviation-reports" id="menu-name--main__when-and-how-to-submit-renewals-protocol-completions-adverse-events-and-protocol-deviation-reports_ethics-human-researchwhen-how-submit-renewals-protocol-completions-adverse-events-protocol"> <span class="menu__link--wrapper"> <a href="/ethics-human-research/when-how-submit-renewals-protocol-completions-adverse-events-protocol" class="menu__link" data-drupal-link-system-path="node/1743">When and How to Submit Renewals, Protocol Completions, Adverse Events and Protocol Deviation Reports</a> </span> </li> <li class="menu__item menu__item-title--post-approval-review-par-program---human-ethics" id="menu-name--main__post-approval-review-par-program-human-ethics_ethics-human-researchpost-approval-review-par-program-human-ethics"> <span class="menu__link--wrapper"> <a href="/ethics-human-research/post-approval-review-par-program-human-ethics" class="menu__link" data-drupal-link-system-path="node/854">Post-Approval Review (PAR) Program - Human Ethics</a> </span> </li> <li class="menu__item menu__item--active-trail menu__item-title--regulations--policies-for-research-involving-human-participants" id="menu-name--main__regulations-policies-for-research-involving-human-participants_ethics-human-researchregulations-policies-research-involving-human-participants"> <span class="menu__link--wrapper"> <a href="/ethics-human-research/regulations-policies-research-involving-human-participants" class="menu__link is-active" data-drupal-link-system-path="node/855" aria-current="page">Regulations & Policies for Research Involving Human Participants</a> </span> </li> <li class="menu__item menu__item-title--schedule-an-ethics-consultation" id="menu-name--main__schedule-an-ethics-consultation_ethics-human-researchschedule-ethics-consultation"> <span class="menu__link--wrapper"> <a href="/ethics-human-research/schedule-ethics-consultation" class="menu__link" data-drupal-link-system-path="node/856">Schedule an Ethics Consultation</a> </span> </li> <li class="menu__item menu__item-title--determine-if-a-protocol-qualifies-for-delegated-review" id="menu-name--main__determine-if-a-protocol-qualifies-for-delegated-review_ethics-human-researchdetermine-if-protocol-qualifies-delegated-review"> <span class="menu__link--wrapper"> <a href="/ethics-human-research/determine-if-protocol-qualifies-delegated-review" class="menu__link" data-drupal-link-system-path="node/857">Determine If a Protocol Qualifies for Delegated Review</a> </span> </li> <li class="menu__item menu__item-title--international-legal--ethical-requirements" id="menu-name--main__international-legal-ethical-requirements_ethics-human-researchinternational-legal-ethical-requirements"> <span class="menu__link--wrapper"> <a href="/ethics-human-research/international-legal-ethical-requirements" class="menu__link" data-drupal-link-system-path="node/858">International Legal & Ethical Requirements</a> </span> </li> <li class="menu__item menu__item-title--ethics-review-of-course-based-research" id="menu-name--main__ethics-review-of-course-based-research_ethics-human-researchethics-review-course-based-research"> <span class="menu__link--wrapper"> <a href="/ethics-human-research/ethics-review-course-based-research" class="menu__link" data-drupal-link-system-path="node/859">Ethics Review of Course-based Research</a> </span> </li> <li class="menu__item menu__item-title--human-ethics-principles--guidelines" id="menu-name--main__human-ethics-principles-guidelines_ethics-human-researchhuman-ethics-principles-guidelines"> <span class="menu__link--wrapper"> <a href="/ethics-human-research/human-ethics-principles-guidelines" class="menu__link" data-drupal-link-system-path="node/860">Human Ethics Principles & Guidelines</a> </span> </li> <li class="menu__item menu__item-title--activities-exempt-from-human-ethics-review" id="menu-name--main__activities-exempt-from-human-ethics-review_ethics-human-researchactivities-exempt-human-ethics-review"> <span class="menu__link--wrapper"> <a href="/ethics-human-research/activities-exempt-human-ethics-review" class="menu__link" data-drupal-link-system-path="node/861">Activities Exempt from Human Ethics Review</a> </span> </li></ul> </li> <li class="menu__item is-parent menu__item--expanded menu__item-title--ethics-in-animal-research--teaching" id="menu-name--main__ethics-in-animal-research-teaching_group"> <span class="menu__link--wrapper is-parent__wrapper"> <a href="#group" class="menu__link">Ethics in Animal Research & Teaching</a> </span> <ul class="menu is-child even menu-level-2"> <li class="menu__item menu__item-title--overview" id="menu-name--main__overview_ethics-animal-research-teachingethics-animal-research-teaching"> <span class="menu__link--wrapper"> <a href="/ethics-animal-research-teaching/ethics-animal-research-teaching" class="menu__link" data-drupal-link-system-path="node/863">Overview</a> </span> </li> <li class="menu__item menu__item-title--when-do-i-need-an-animal-use-protocol" id="menu-name--main__when-do-i-need-an-animal-use-protocol_ethics-animal-research-teachingwhen-do-i-need-animal-use-protocol"> <span class="menu__link--wrapper"> <a href="/ethics-animal-research-teaching/when-do-i-need-animal-use-protocol" class="menu__link" data-drupal-link-system-path="node/864">When Do I Need an Animal Use Protocol?</a> </span> </li> <li class="menu__item menu__item-title--protocol-review-process---animal-ethics" id="menu-name--main__protocol-review-process-animal-ethics_ethics-animal-research-teachingprotocol-review-process-animal-ethics"> <span class="menu__link--wrapper"> <a href="/ethics-animal-research-teaching/protocol-review-process-animal-ethics" class="menu__link" data-drupal-link-system-path="node/865">Protocol Review Process - Animal Ethics</a> </span> </li> <li class="menu__item menu__item-title--protocol-submission-deadlines--who-to-submit-to-animal-research--teaching" id="menu-name--main__protocol-submission-deadlines-who-to-submit-to-animal-research-teaching_ethics-animal-research-teachingprotocol-submission-deadlines-who-submit-animal-research-teaching"> <span class="menu__link--wrapper"> <a href="/ethics-animal-research-teaching/protocol-submission-deadlines-who-submit-animal-research-teaching" class="menu__link" data-drupal-link-system-path="node/866">Protocol Submission Deadlines & Who to Submit to (Animal Research & Teaching)</a> </span> </li> <li class="menu__item menu__item-title--submit-an-animal-use-protocol" id="menu-name--main__submit-an-animal-use-protocol_ethics-animal-research-teachingsubmit-animal-use-protocol"> <span class="menu__link--wrapper"> <a href="/ethics-animal-research-teaching/submit-animal-use-protocol" class="menu__link" data-drupal-link-system-path="node/867">Submit an Animal Use Protocol</a> </span> </li> <li class="menu__item menu__item-title--pedagogical-merit-review-for-animals-in-teaching" id="menu-name--main__pedagogical-merit-review-for-animals-in-teaching_ethics-animal-research-teachingpedagogical-merit-review-animals-teaching"> <span class="menu__link--wrapper"> <a href="/ethics-animal-research-teaching/pedagogical-merit-review-animals-teaching" class="menu__link" data-drupal-link-system-path="node/868">Pedagogical Merit Review for Animals in Teaching</a> </span> </li> <li class="menu__item menu__item-title--field-work-requirements" id="menu-name--main__field-work-requirements_ethics-animal-research-teachingfield-work-requirements"> <span class="menu__link--wrapper"> <a href="/ethics-animal-research-teaching/field-work-requirements" class="menu__link" data-drupal-link-system-path="node/869">Field Work Requirements</a> </span> </li> <li class="menu__item menu__item-title--peer-review-for-scientific-merit" id="menu-name--main__peer-review-for-scientific-merit_ethics-animal-research-teachingpeer-review-scientific-merit"> <span class="menu__link--wrapper"> <a href="/ethics-animal-research-teaching/peer-review-scientific-merit" class="menu__link" data-drupal-link-system-path="node/870">Peer Review for Scientific Merit</a> </span> </li> <li class="menu__item menu__item-title--standard-operating-procedures-sops--guidelines---animal-ethics" id="menu-name--main__standard-operating-procedures-sops-guidelines-animal-ethics_ethics-animal-research-teachingstandard-operating-procedures-sops-guidelines-animal-ethics"> <span class="menu__link--wrapper"> <a href="/ethics-animal-research-teaching/standard-operating-procedures-sops-guidelines-animal-ethics" class="menu__link" data-drupal-link-system-path="node/871">Standard Operating Procedures (SOPs) & Guidelines - Animal Ethics</a> </span> </li> <li class="menu__item menu__item-title--controlled-drug-exemptions--biosafety-permits" id="menu-name--main__controlled-drug-exemptions-biosafety-permits_ethics-animal-research-teachingcontrolled-drug-exemptions-biosafety-permits"> <span class="menu__link--wrapper"> <a href="/ethics-animal-research-teaching/controlled-drug-exemptions-biosafety-permits" class="menu__link" data-drupal-link-system-path="node/872">Controlled Drug Exemptions & Biosafety Permits</a> </span> </li> <li class="menu__item menu__item-title--mandatory-animal-user-training" id="menu-name--main__mandatory-animal-user-training_ethics-animal-research-teachingmandatory-animal-user-training"> <span class="menu__link--wrapper"> <a href="/ethics-animal-research-teaching/mandatory-animal-user-training" class="menu__link" data-drupal-link-system-path="node/873">Mandatory Animal User Training </a> </span> </li> <li class="menu__item menu__item-title--post-approval-review-par-program---animal-ethics" id="menu-name--main__post-approval-review-par-program-animal-ethics_ethics-animal-research-teachingpost-approval-review-par-program-animal-ethics"> <span class="menu__link--wrapper"> <a href="/ethics-animal-research-teaching/post-approval-review-par-program-animal-ethics" class="menu__link" data-drupal-link-system-path="node/874">Post-Approval Review (PAR) Program - Animal Ethics</a> </span> </li> <li class="menu__item menu__item-title--general-information-about-animals-in-research--teaching" id="menu-name--main__general-information-about-animals-in-research-teaching_ethics-animal-research-teachinggeneral-information-about-animals-research-teaching"> <span class="menu__link--wrapper"> <a href="/ethics-animal-research-teaching/general-information-about-animals-research-teaching" class="menu__link" data-drupal-link-system-path="node/875">General Information About Animals in Research & Teaching</a> </span> </li> <li class="menu__item menu__item-title--animal-care-committees" id="menu-name--main__animal-care-committees_ethics-animal-research-teachinganimal-care-committees"> <span class="menu__link--wrapper"> <a href="/ethics-animal-research-teaching/animal-care-committees" class="menu__link" data-drupal-link-system-path="node/883">Animal Care Committees</a> </span> </li></ul> </li> <li class="menu__item is-parent menu__item--expanded menu__item-title--research-integrity" id="menu-name--main__research-integrity_group"> <span class="menu__link--wrapper is-parent__wrapper"> <a href="#group" class="menu__link">Research Integrity</a> </span> <ul class="menu is-child even menu-level-2"> <li class="menu__item menu__item-title--overview" id="menu-name--main__overview_research-integrityresearch-integrity"> <span class="menu__link--wrapper"> <a href="/research-integrity/research-integrity" class="menu__link" data-drupal-link-system-path="node/766">Overview</a> </span> </li> <li class="menu__item menu__item-title--statement-on-research-integrity" id="menu-name--main__statement-on-research-integrity_research-integritystatement-research-integrity"> <span class="menu__link--wrapper"> <a href="/research-integrity/statement-research-integrity" class="menu__link" data-drupal-link-system-path="node/1736">Statement on Research Integrity</a> </span> </li> <li class="menu__item menu__item-title--submit-a-research-integrity-complaint" id="menu-name--main__submit-a-research-integrity-complaint_research-integritysubmit-research-integrity-complaint"> <span class="menu__link--wrapper"> <a href="/research-integrity/submit-research-integrity-complaint" class="menu__link" data-drupal-link-system-path="node/767">Submit a Research Integrity Complaint</a> </span> </li> <li class="menu__item menu__item-title--summary-of-research-misconduct-complaints-addressed-by-u-of-t" id="menu-name--main__summary-of-research-misconduct-complaints-addressed-by-u-of-t_research-integritysummary-research-misconduct-complaints-addressed-u-t"> <span class="menu__link--wrapper"> <a href="/research-integrity/summary-research-misconduct-complaints-addressed-u-t" class="menu__link" data-drupal-link-system-path="node/768">Summary of Research Misconduct Complaints Addressed by U of T</a> </span> </li></ul> </li> <li class="menu__item is-parent menu__item--expanded menu__item-title--honours--awards" id="menu-name--main__honours-awards_group"> <span class="menu__link--wrapper is-parent__wrapper"> <a href="#group" class="menu__link">Honours & Awards</a> </span> <ul class="menu is-child even menu-level-2"> <li class="menu__item menu__item-title--overview" id="menu-name--main__overview_honours-awardshonours-awards"> <span class="menu__link--wrapper"> <a href="/honours-awards/honours-awards" class="menu__link" data-drupal-link-system-path="node/755">Overview</a> </span> </li> <li class="menu__item menu__item-title--presidents-impact-award--academy" 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<div class="block__content"> <div class="pagetitle-share-block-wrp"> <h1 class="pg-title">Regulations & Policies for Research Involving Human Participants</h1> <div class="share-tools-wrp"> <span>Share:</span> <a class="email-link" href="#mailto" title="Email Link"></a> <a class="copy-link" href="#copy" onclick="return false;" title="Copy Link"> <span class="tooltip">Copied!</span> </a> </div> </div> </div></div> </div> <div data-id="quicklinks-block" class="l-bl block block-config-provider--quicklinks-block block-plugin-id--quicklinks-block"> <div class="block__inner"> <div class="block__content"> <div class="quick-links-wrp"> <div> <span>On this page:</span> </div> <ul class="quick-links"> <!-- Append links using javascript--> </ul> </div></div></div> </div> <div data-id="entity-fieldnodefield-page-section-1" class="l-bl block block-config-provider--ctools-block block-plugin-id--entity-field-nodefield-page-section-1"> <div class="block__inner"> <div class="block__content"><div class="field field-node--field-page-section-1 field-formatter-entity-reference-revisions-entity-view field-name-field-page-section-1 field-type-entity-reference-revisions field-label-hidden has-single"><div class="field__items"><div class="field__item"><div class="paragraph paragraph--type-lc-2cols-50-50 paragraph--view-mode-default"> <div class="field field-paragraph--field-lo-2cols-50-50-col1 field-formatter-entity-reference-revisions-entity-view field-name-field-lo-2cols-50-50-col1 field-type-entity-reference-revisions field-label-hidden has-single"><div class="field__items"><div class="field__item"><div class="paragraph paragraph--type-lo-expandable-bluelight paragraph--view-mode-default"> <div class="equalheights clearfix text-formatted field field-paragraph--field-lo-expandable-bl-title field-formatter-text-default field-name-field-lo-expandable-bl-title field-type-text field-label-hidden has-single"><div class="field__items"><div class="field__item"><p>What do I need before I can begin?</p> </div></div> </div> <div class="field field-paragraph--field-lo-expandable-bl-content field-formatter-entity-reference-revisions-entity-view field-name-field-lo-expandable-bl-content field-type-entity-reference-revisions field-label-hidden has-single"><div class="field__items"><div class="field__item"><div class="paragraph paragraph--type-text paragraph--view-mode-default"> <div class="clearfix text-formatted field field-paragraph--field-text-demo field-formatter-text-default field-name-field-text-demo field-type-text-long field-label-hidden has-single"><div class="field__items"><div class="field__item"><p>Please review the <a href="http://www.pre.ethics.gc.ca/eng/policy-politique_tcps2-eptc2_2018.html">Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans</a> and read U of T’s <a href="https://governingcouncil.utoronto.ca/media/4368/view">Policy on Research Involving Human Subjects</a> and <a href="https://governingcouncil.utoronto.ca/media/4402/view">Policy on Ethical Conduct in Research</a>.</p> </div></div> </div> </div> </div></div> </div> </div> </div></div> </div> </div> </div></div> </div> </div></div> </div> <div data-id="entity-fieldnodefield-page-section-2" class="l-bl block block-config-provider--ctools-block block-plugin-id--entity-field-nodefield-page-section-2"> <div class="block__inner"> <div class="block__content"><div class="field field-node--field-page-section-2 field-formatter-entity-reference-revisions-entity-view field-name-field-page-section-2 field-type-entity-reference-revisions field-label-hidden has-multiple"><div class="field__items"><div class="field__item"><div class="paragraph paragraph--type-title-icon-line paragraph--view-mode-default"> <div class="clearfix text-formatted field field-paragraph--field-title-icon-line__title field-formatter-text-default field-name-field-title-icon-line__title field-type-text field-label-hidden has-single"><div class="field__items"><div class="field__item"><h2>Overview</h2> </div></div> </div> </div> </div><div class="field__item"><div class="paragraph paragraph--type-text paragraph--view-mode-default"> <div class="clearfix text-formatted field field-paragraph--field-text-demo field-formatter-text-default field-name-field-text-demo field-type-text-long field-label-hidden has-single"><div class="field__items"><div class="field__item"><p>Research involving human participants is subject to a range of regulations and policies. The research methodology, types of data to be collected and how, the participant population and the location/jurisdiction all affect what regulations and policies researchers must adhere.</p> </div></div> </div> </div> </div><div class="field__item"><div class="paragraph paragraph--type-title-icon-line paragraph--view-mode-default"> <div class="clearfix text-formatted field field-paragraph--field-title-icon-line__title field-formatter-text-default field-name-field-title-icon-line__title field-type-text field-label-hidden has-single"><div class="field__items"><div class="field__item"><h2>Clinical Trials</h2> </div></div> </div> </div> </div><div class="field__item"><div class="paragraph paragraph--type-text paragraph--view-mode-default"> <div class="clearfix text-formatted field field-paragraph--field-text-demo field-formatter-text-default field-name-field-text-demo field-type-text-long field-label-hidden has-single"><div class="field__items"><div class="field__item"><p>A ‘clinical trial’ is a research study where human participants are prospectively assigned to one or more interventions to evaluate the effects of these interventions on health-related outcomes.</p> <p>All studies meeting the definition of clinical trial must be registered through an internationally recognized Clinical Trial Registration database. For example, <a href="http://www.clinicaltrials.gov">ClinicalTrials.gov</a> or the <a href="http://www.isrctn.org">ISRCTN Registry</a>.</p> <p>In addition to the <a href="http://www.pre.ethics.gc.ca/eng/policy-politique_tcps2-eptc2_2018.html">Tri-Council Policy Statement (TCPS 2)</a>, clinical trial researchers should follow the <a href="https://about.citiprogram.org/wp-content/uploads/2018/05/GCP-ICH-Revisions-Resource.pdf">International Council for Harmonisation: Good Clinical Practice (E6) guidelines</a>.</p> </div></div> </div> </div> </div><div class="field__item"><div class="paragraph paragraph--type-title-icon-line paragraph--view-mode-default"> <div class="clearfix text-formatted field field-paragraph--field-title-icon-line__title field-formatter-text-default field-name-field-title-icon-line__title field-type-text field-label-hidden has-single"><div class="field__items"><div class="field__item"><h2>Health Canada-Regulated Clinical Trials</h2> </div></div> </div> </div> </div><div class="field__item"><div class="paragraph paragraph--type-text paragraph--view-mode-default"> <div class="clearfix text-formatted field field-paragraph--field-text-demo field-formatter-text-default field-name-field-text-demo field-type-text-long field-label-hidden has-single"><div class="field__items"><div class="field__item"><p>Clinical trials that involve testing of new drugs, devices or natural health products, or those previously approved in new populations may require registration with Health Canada.</p> <p>Health Canada-regulated clinical trials must be sponsored by a third party to be conducted at U of T. The sponsor is required to ensure compliance with Health Canada regulations throughout all aspects of the clinical trial, including submitting a clinical trial application (CTA), providing sufficient and ongoing monitoring of the project, and assuming responsibility for any adverse or unanticipated events.</p> <p>U of T cannot act as the sponsor for Health Canada-regulated clinical trials.</p> <p>Health Canada requirements for drug, device and natural health product clinical trials can be found below.</p> <ul> <li>Drugs: <a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/clinical-trials/clinical-trial-sponsors-applications.html">Guidance Document for Clinical Trial Sponsors: Clinical Trial Application</a>s</li> <li>Devices: <a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/investigational-testing-authorizations-guidance.html">Applications for Medical Device Investigational Testing Authorizations Guidance Document</a></li> <li>Natural Health Products: <a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/clinical-trials.html">Clinical Trials For Natural Health Products</a></li> </ul> </div></div> </div> </div> </div><div class="field__item"><div class="paragraph paragraph--type-title-icon-line paragraph--view-mode-default"> <div class="clearfix text-formatted field field-paragraph--field-title-icon-line__title field-formatter-text-default field-name-field-title-icon-line__title field-type-text field-label-hidden has-single"><div class="field__items"><div class="field__item"><h2>Cannabis</h2> </div></div> </div> </div> </div><div class="field__item"><div class="paragraph paragraph--type-text paragraph--view-mode-default"> <div class="clearfix text-formatted field field-paragraph--field-text-demo field-formatter-text-default field-name-field-text-demo field-type-text-long field-label-hidden has-single"><div class="field__items"><div class="field__item"><p>To obtain, possess and use cannabis for research purposes the researcher(s) must obtain a permit from Environmental Health and Safety. For further details, see the <a href="https://ehs.utoronto.ca/cannabis-research/">Cannabis Research</a> page.</p> <p>If the research falls under the definition of clinical trial, Health Canada regulations for drugs will apply and a third-party sponsor is required. Please see the Clinical Trials section on this page for further information.</p> </div></div> </div> </div> </div><div class="field__item"><div class="paragraph paragraph--type-title-icon-line paragraph--view-mode-default"> <div class="clearfix text-formatted field field-paragraph--field-title-icon-line__title field-formatter-text-default field-name-field-title-icon-line__title field-type-text field-label-hidden has-single"><div class="field__items"><div class="field__item"><h2>Personal Health Information</h2> </div></div> </div> </div> </div><div class="field__item"><div class="paragraph paragraph--type-text paragraph--view-mode-default"> <div class="clearfix text-formatted field field-paragraph--field-text-demo field-formatter-text-default field-name-field-text-demo field-type-text-long field-label-hidden has-single"><div class="field__items"><div class="field__item"><p>Collection and/or use of personal health information must be compliant with <a href="https://www.ontario.ca/laws/statute/04p03">Ontario’s Personal Health Information Protection Act (PHIPA)</a>. This includes research involving collection of personal health information (PHI) directly from participants as well as secondary use of PHI collected for other (e.g. clinical) purposes.</p> </div></div> </div> </div> </div><div class="field__item"><div class="paragraph paragraph--type-title-icon-line paragraph--view-mode-default"> <div class="clearfix text-formatted field field-paragraph--field-title-icon-line__title field-formatter-text-default field-name-field-title-icon-line__title field-type-text field-label-hidden has-single"><div class="field__items"><div class="field__item"><h2>Personal Information</h2> </div></div> </div> </div> </div><div class="field__item"><div class="paragraph paragraph--type-text paragraph--view-mode-default"> <div class="clearfix text-formatted field field-paragraph--field-text-demo field-formatter-text-default field-name-field-text-demo field-type-text-long field-label-hidden has-single"><div class="field__items"><div class="field__item"><p>Research involving collection and/or use of personal information originally collected for a non-research purpose by a public institution in Ontario (e.g. university, hospital or government) must be compliant with <a href="https://www.ontario.ca/laws/statute/90f31">Ontario’s Freedom of Information and Protection of Privacy Act</a>, in particular Part III – Protection of Individual Privacy.</p> <p>The standard for maintaining privacy described in the Act should be applied for all personal information collected or used in research. Also see <a href="/media/132/download">Data Security Standards for Personally Identifiable and Other Confidential Data in Research</a>.</p> </div></div> </div> </div> </div><div class="field__item"><div class="paragraph paragraph--type-title-icon-line paragraph--view-mode-default"> <div class="clearfix text-formatted field field-paragraph--field-title-icon-line__title field-formatter-text-default field-name-field-title-icon-line__title field-type-text field-label-hidden has-single"><div class="field__items"><div class="field__item"><h2>Research with First Nations, Metis or Inuit Populations</h2> </div></div> </div> </div> </div><div class="field__item"><div class="paragraph paragraph--type-text paragraph--view-mode-default"> <div class="clearfix text-formatted field field-paragraph--field-text-demo field-formatter-text-default field-name-field-text-demo field-type-text-long field-label-hidden has-single"><div class="field__items"><div class="field__item"><p><a href="http://www.pre.ethics.gc.ca/eng/tcps2-eptc2_2018_chapter9-chapitre9.html">Chapter 9 of TCPS 2</a> provides ethical guidance for research that involves Indigenous participants and/or communities. First National research should also comply with <a href="https://fnigc.ca/ocap-training/">OCAP®</a>, which involves four principles: ownership, control, access and possession.</p> </div></div> </div> </div> </div><div class="field__item"><div class="paragraph paragraph--type-title-icon-line paragraph--view-mode-default"> <div class="clearfix text-formatted field field-paragraph--field-title-icon-line__title field-formatter-text-default field-name-field-title-icon-line__title field-type-text field-label-hidden has-single"><div class="field__items"><div class="field__item"><h2>International Research</h2> </div></div> </div> </div> </div><div class="field__item"><div class="paragraph paragraph--type-text paragraph--view-mode-default"> <div class="clearfix text-formatted field field-paragraph--field-text-demo field-formatter-text-default field-name-field-text-demo field-type-text-long field-label-hidden has-single"><div class="field__items"><div class="field__item"><p>Research that is funded by a United States (US) government agency, or in collaboration with a US institution must comply with and be reviewed in consideration of US regulations, such as the <a href="https://www.govinfo.gov/content/pkg/FR-2018-06-19/pdf/2018-13187.pdf">US Health and Human Services Policy for the Protection of Human Research Subjects</a>, in addition to Canadian regulations. Research that may involve research participants from the European Union may require compliance with the <a href="https://ec.europa.eu/research/participants/data/ref/h2020/grants_manual/hi/ethics/h2020_hi_ethics-data-protection_en.pdf">General Data Protection Regulation (GDPR)</a>.</p> </div></div> </div> </div> </div><div class="field__item"><div class="paragraph paragraph--type-title-icon-line paragraph--view-mode-default"> <div class="clearfix text-formatted field field-paragraph--field-title-icon-line__title field-formatter-text-default field-name-field-title-icon-line__title field-type-text field-label-hidden has-single"><div class="field__items"><div class="field__item"><h2>School Boards</h2> </div></div> </div> </div> </div><div class="field__item"><div class="paragraph paragraph--type-text paragraph--view-mode-default"> <div class="clearfix text-formatted field field-paragraph--field-text-demo field-formatter-text-default field-name-field-text-demo field-type-text-long field-label-hidden has-single"><div class="field__items"><div class="field__item"><p>All research to be conducted in schools must have administrative consent/permission prior to recruitment. Some school boards, including the Toronto District School Board, require protocol review by their Research Committee before gaining administrative permission. Please contact the school board to be involved with your research for further information.</p> </div></div> </div> </div> </div><div class="field__item"><div class="paragraph paragraph--type-title-icon-line paragraph--view-mode-default"> <div class="clearfix text-formatted field field-paragraph--field-title-icon-line__title field-formatter-text-default field-name-field-title-icon-line__title field-type-text field-label-hidden has-single"><div class="field__items"><div class="field__item"><h2>Faculty, Staff & Students of U of T</h2> </div></div> </div> </div> </div><div class="field__item"><div class="paragraph paragraph--type-text paragraph--view-mode-default"> <div class="clearfix text-formatted field field-paragraph--field-text-demo field-formatter-text-default field-name-field-text-demo field-type-text-long field-label-hidden has-single"><div class="field__items"><div class="field__item"><p>Researchers who wish to conduct research with students, staff and faculty at the University of Toronto or gain access to data about them must follow the <a href="https://www.provost.utoronto.ca/planning-policy/guideline-on-the-surveying-of-u-of-t-students-faculty-librarians-staff-and-alumni-by-u-of-t-researchers/">Guidelines and Procedures Regarding Access to University of Toronto Faculty, Students and Staff for Research Purposes</a>.</p> </div></div> </div> </div> </div><div class="field__item"><div class="paragraph paragraph--type-title-icon-line paragraph--view-mode-default"> <div class="clearfix text-formatted field field-paragraph--field-title-icon-line__title field-formatter-text-default field-name-field-title-icon-line__title field-type-text field-label-hidden has-single"><div class="field__items"><div class="field__item"><h2>Forms & Downloads</h2> </div></div> </div> </div> </div><div class="field__item"><div class="paragraph paragraph--type-text paragraph--view-mode-default"> <div class="clearfix text-formatted field field-paragraph--field-text-demo field-formatter-text-default field-name-field-text-demo field-type-text-long field-label-hidden has-single"><div class="field__items"><div class="field__item"><ul> <li><a href="https://governingcouncil.utoronto.ca/media/4368/view">Policy on Research Involving Human Subjects</a></li> <li><a href="https://governingcouncil.utoronto.ca/media/4402/view">Policy on Ethical Conduct in Research</a></li> <li><a href="https://about.citiprogram.org/wp-content/uploads/2018/05/GCP-ICH-Revisions-Resource.pdf">International Council for Harmonisation: Good Clinical Practice (E6) guidelines</a></li> <li><a href="/media/132/download">Data Security Standards for Personally Identifiable and Other Confidential Data in Research</a></li> <li><a href="https://www.govinfo.gov/content/pkg/FR-2018-06-19/pdf/2018-13187.pdf">US Health and Human Services Policy for the Protection of Human Research Subjects</a></li> </ul> </div></div> </div> </div> </div><div class="field__item"><div class="paragraph paragraph--type-title-icon-line paragraph--view-mode-default"> <div class="clearfix text-formatted field field-paragraph--field-title-icon-line__title field-formatter-text-default field-name-field-title-icon-line__title field-type-text field-label-hidden has-single"><div class="field__items"><div class="field__item"><h2>VPRI Role</h2> </div></div> </div> </div> </div><div class="field__item"><div class="paragraph paragraph--type-text paragraph--view-mode-default"> <div class="clearfix text-formatted field field-paragraph--field-text-demo field-formatter-text-default field-name-field-text-demo field-type-text-long field-label-hidden has-single"><div class="field__items"><div class="field__item"><ul> <li>Provide policy and procedural advice and guidance to researchers in the planning and execution of their research to ensure compliance with all of the relevant regulations and policies</li> </ul> </div></div> </div> </div> </div></div> </div> </div></div> </div> <div data-id="entity-fieldnodefield-page-section-3" class="l-bl block block-config-provider--ctools-block block-plugin-id--entity-field-nodefield-page-section-3"> <div class="block__inner"> <div class="block__content"><div class="field field-node--field-page-section-3 field-formatter-entity-reference-revisions-entity-view field-name-field-page-section-3 field-type-entity-reference-revisions field-label-hidden has-multiple"><div class="field__items"><div class="field__item"><div class="paragraph paragraph--type-title-icon-line paragraph--view-mode-default"> <div class="field field-paragraph--field-title-icon-line__icon field-formatter-image field-name-field-title-icon-line__icon field-type-image field-label-hidden has-single"><figure class="field-type-image__figure image-count-1"><div class="field-type-image__item"> <img loading="lazy" src="/sites/default/files/2019-09/circle-at-blue_37.png" width="88" height="88" alt="" typeof="foaf:Image" /> </div> </figure></div> <div class="clearfix text-formatted field field-paragraph--field-title-icon-line__title field-formatter-text-default field-name-field-title-icon-line__title field-type-text field-label-hidden has-single"><div class="field__items"><div class="field__item"><h2>VPRI Contact</h2> </div></div> </div> </div> </div><div class="field__item"><div class="paragraph paragraph--type-lc-2cols-50-50 paragraph--view-mode-default"> <div class="field field-paragraph--field-lo-2cols-50-50-col1 field-formatter-entity-reference-revisions-entity-view field-name-field-lo-2cols-50-50-col1 field-type-entity-reference-revisions field-label-hidden has-single"><div class="field__items"><div class="field__item"><div class="paragraph paragraph--type-staff paragraph--view-mode-default"> <div class="field field-paragraph-field-staff-taxonomy field-entity-reference-type-taxonomy-term field-formatter-entity-reference-entity-view field-name-field-staff-taxonomy field-type-entity-reference field-label-visually_hidden"><h3 class="field__label visually-hidden">Staff</h3><div class="field__items"><div class="field__item"> <span class="field__item-wrapper"> <article about="/taxonomy/term/248" id="taxonomy-term-248" class="taxonomy-term taxonomy-term--view-mode-default vocabulary-staff-contact"> <div class="border"> <h3 class="taxonomy-term__title"><div class="field field-taxonomy-term--name field-formatter-string field-name-name field-type-string field-label-hidden has-single"><div class="field__items"><div class="field__item">Director, Human Research Ethics</div></div> </div> </h3> <div class="taxonomy-term__content"> <div class="field field-taxonomy-term--field-title field-formatter-string field-name-field-title field-type-string field-label-hidden has-single"><div class="field__items"><div class="field__item">Director, Human Research Ethics</div></div> </div> <div class="field field-taxonomy-term-field-department field-entity-reference-type-taxonomy-term field-formatter-entity-reference-label field-name-field-department field-type-entity-reference field-label-hidden"><div class="field__items"><div class="field__item"> <span class="field__item-wrapper">Research Oversight & Compliance Office (ROCO)</span> </div></div> </div> <div class="field field-taxonomy-term--field-email field-formatter-email-mailto field-name-field-email field-type-email field-label-hidden has-single"><div class="field__items"><div class="field__item"><a href="mailto:roco@utoronto.ca">roco@utoronto.ca</a></div></div> </div> </div> </div> </article> </span> </div></div> </div> </div> </div></div> </div> </div> </div><div class="field__item"><div class="paragraph paragraph--type-title-icon-line paragraph--view-mode-default"> <div class="field field-paragraph--field-title-icon-line__icon field-formatter-image field-name-field-title-icon-line__icon field-type-image field-label-hidden has-single"><figure class="field-type-image__figure image-count-1"><div class="field-type-image__item"> <img loading="lazy" src="/sites/default/files/2019-09/circle-reduce-blue_22.png" width="88" height="88" alt="" typeof="foaf:Image" /> </div> </figure></div> <div class="clearfix text-formatted field field-paragraph--field-title-icon-line__title field-formatter-text-default field-name-field-title-icon-line__title field-type-text field-label-hidden has-single"><div class="field__items"><div class="field__item"><h2>Other Resources</h2> </div></div> </div> </div> </div><div class="field__item"><div class="paragraph paragraph--type-lc-2cols-50-50 paragraph--view-mode-default"> <div class="field field-paragraph--field-lo-2cols-50-50-col1 field-formatter-entity-reference-revisions-entity-view field-name-field-lo-2cols-50-50-col1 field-type-entity-reference-revisions field-label-hidden has-single"><div class="field__items"><div class="field__item"><div class="paragraph paragraph--type-text paragraph--view-mode-default"> <div class="clearfix text-formatted field field-paragraph--field-text-demo field-formatter-text-default field-name-field-text-demo field-type-text-long field-label-hidden has-single"><div class="field__items"><div class="field__item"><p><a class="color-secondary-no-txt-decor" href="https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/investigational-testing-authorizations-guidance.html"><span class="hs4">Applications for Medical Device Investigational Testing Authorizations Guidance Document ></span></a> </p> </div></div> </div> </div> </div></div> </div> <div class="field field-paragraph--field-lo-2cols-50-50-col2 field-formatter-entity-reference-revisions-entity-view field-name-field-lo-2cols-50-50-col2 field-type-entity-reference-revisions field-label-hidden has-single"><div class="field__items"><div class="field__item"><div class="paragraph paragraph--type-text paragraph--view-mode-default"> <div class="clearfix text-formatted field field-paragraph--field-text-demo field-formatter-text-default field-name-field-text-demo field-type-text-long field-label-hidden has-single"><div class="field__items"><div class="field__item"><p><a class="color-secondary-no-txt-decor" href="https://www.provost.utoronto.ca/planning-policy/guideline-on-the-surveying-of-u-of-t-students-faculty-librarians-staff-and-alumni-by-u-of-t-researchers/"><span class="hs4">Guidelines and Procedures Regarding Access to University of Toronto Faculty, Students and Staff for Research Purposes ></span></a> </p> </div></div> </div> </div> </div></div> </div> </div> </div><div class="field__item"><div class="paragraph paragraph--type-lc-2cols-50-50 paragraph--view-mode-default"> <div class="field field-paragraph--field-lo-2cols-50-50-col1 field-formatter-entity-reference-revisions-entity-view field-name-field-lo-2cols-50-50-col1 field-type-entity-reference-revisions field-label-hidden has-single"><div class="field__items"><div class="field__item"><div class="paragraph paragraph--type-text paragraph--view-mode-default"> <div class="clearfix text-formatted field field-paragraph--field-text-demo field-formatter-text-default field-name-field-text-demo field-type-text-long field-label-hidden has-single"><div class="field__items"><div class="field__item"><p><a class="color-secondary-no-txt-decor" href="http://www.pre.ethics.gc.ca/eng/policy-politique_tcps2-eptc2_2018.html"><span class="hs4">Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2) ></span></a> </p> </div></div> </div> </div> </div></div> </div> <div class="field field-paragraph--field-lo-2cols-50-50-col2 field-formatter-entity-reference-revisions-entity-view field-name-field-lo-2cols-50-50-col2 field-type-entity-reference-revisions field-label-hidden has-single"><div class="field__items"><div class="field__item"><div class="paragraph paragraph--type-text paragraph--view-mode-default"> <div class="clearfix text-formatted field field-paragraph--field-text-demo field-formatter-text-default field-name-field-text-demo field-type-text-long field-label-hidden has-single"><div class="field__items"><div class="field__item"><p><a class="color-secondary-no-txt-decor" href="https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/clinical-trials/clinical-trial-sponsors-applications.html"><span class="hs4">Guidance Document for Clinical Trial Sponsors: Clinical Trial Applications ></span></a> </p> </div></div> </div> </div> </div></div> </div> </div> </div><div class="field__item"><div class="paragraph paragraph--type-lc-2cols-50-50 paragraph--view-mode-default"> <div class="field field-paragraph--field-lo-2cols-50-50-col1 field-formatter-entity-reference-revisions-entity-view field-name-field-lo-2cols-50-50-col1 field-type-entity-reference-revisions field-label-hidden has-single"><div class="field__items"><div class="field__item"><div class="paragraph paragraph--type-text paragraph--view-mode-default"> <div class="clearfix text-formatted field field-paragraph--field-text-demo field-formatter-text-default field-name-field-text-demo field-type-text-long field-label-hidden has-single"><div class="field__items"><div class="field__item"><p><a class="color-secondary-no-txt-decor" href="https://www.ontario.ca/laws/statute/90f31"><span class="hs4">Ontario’s Freedom of Information and Protection of Privacy Act (FIPPA) ></span></a> </p> </div></div> </div> </div> </div></div> </div> <div class="field field-paragraph--field-lo-2cols-50-50-col2 field-formatter-entity-reference-revisions-entity-view field-name-field-lo-2cols-50-50-col2 field-type-entity-reference-revisions field-label-hidden has-single"><div class="field__items"><div class="field__item"><div class="paragraph paragraph--type-text paragraph--view-mode-default"> <div class="clearfix text-formatted field field-paragraph--field-text-demo field-formatter-text-default field-name-field-text-demo field-type-text-long field-label-hidden has-single"><div class="field__items"><div class="field__item"><p><a class="color-secondary-no-txt-decor" href="https://www.ontario.ca/laws/statute/04p03"><span class="hs4">Ontario’s Personal Health Information Protection Act (PHIPA) ></span></a> </p> </div></div> </div> </div> </div></div> </div> </div> </div><div class="field__item"><div class="paragraph paragraph--type-lc-2cols-50-50 paragraph--view-mode-default"> <div class="field field-paragraph--field-lo-2cols-50-50-col1 field-formatter-entity-reference-revisions-entity-view field-name-field-lo-2cols-50-50-col1 field-type-entity-reference-revisions field-label-hidden has-single"><div class="field__items"><div class="field__item"><div class="paragraph paragraph--type-text paragraph--view-mode-default"> <div class="clearfix text-formatted field field-paragraph--field-text-demo field-formatter-text-default field-name-field-text-demo field-type-text-long field-label-hidden has-single"><div class="field__items"><div class="field__item"><p><a class="color-secondary-no-txt-decor" href="https://ec.europa.eu/research/participants/data/ref/h2020/grants_manual/hi/ethics/h2020_hi_ethics-data-protection_en.pdf"><span class="hs4">European Union General Data Protection Regulation (GDPR) ></span></a> </p> </div></div> </div> </div> </div></div> </div> <div class="field field-paragraph--field-lo-2cols-50-50-col2 field-formatter-entity-reference-revisions-entity-view field-name-field-lo-2cols-50-50-col2 field-type-entity-reference-revisions field-label-hidden has-single"><div class="field__items"><div class="field__item"><div class="paragraph paragraph--type-text paragraph--view-mode-default"> <div class="clearfix text-formatted field field-paragraph--field-text-demo field-formatter-text-default field-name-field-text-demo field-type-text-long field-label-hidden has-single"><div class="field__items"><div class="field__item"><p><a class="color-secondary-no-txt-decor" href="https://fnigc.ca/"><span class="hs4">First Nations Information Governance Centre ></span></a> </p> </div></div> </div> </div> </div></div> </div> </div> </div><div class="field__item"><div class="paragraph paragraph--type-lc-2cols-50-50 paragraph--view-mode-default"> <div class="field field-paragraph--field-lo-2cols-50-50-col1 field-formatter-entity-reference-revisions-entity-view field-name-field-lo-2cols-50-50-col1 field-type-entity-reference-revisions field-label-hidden has-single"><div class="field__items"><div class="field__item"><div class="paragraph paragraph--type-text paragraph--view-mode-default"> <div class="clearfix text-formatted field field-paragraph--field-text-demo field-formatter-text-default field-name-field-text-demo field-type-text-long field-label-hidden has-single"><div class="field__items"><div class="field__item"><p><a class="color-secondary-no-txt-decor" href="https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/clinical-trials.html"><span class="hs4">Clinical Trials For Natural Health Products ></span></a> </p> </div></div> </div> </div> </div></div> </div> <div class="field field-paragraph--field-lo-2cols-50-50-col2 field-formatter-entity-reference-revisions-entity-view field-name-field-lo-2cols-50-50-col2 field-type-entity-reference-revisions field-label-hidden has-single"><div class="field__items"><div class="field__item"><div class="paragraph paragraph--type-text paragraph--view-mode-default"> <div class="clearfix text-formatted field field-paragraph--field-text-demo field-formatter-text-default field-name-field-text-demo field-type-text-long field-label-hidden has-single"><div class="field__items"><div class="field__item"><p><a class="color-secondary-no-txt-decor" href="http://www.isrctn.com/"><span class="hs4">ISRCTN registry ></span></a> </p> </div></div> </div> </div> </div></div> </div> </div> </div><div class="field__item"><div class="paragraph paragraph--type-lc-2cols-50-50 paragraph--view-mode-default"> <div class="field field-paragraph--field-lo-2cols-50-50-col1 field-formatter-entity-reference-revisions-entity-view field-name-field-lo-2cols-50-50-col1 field-type-entity-reference-revisions field-label-hidden has-single"><div class="field__items"><div class="field__item"><div class="paragraph paragraph--type-text paragraph--view-mode-default"> <div class="clearfix text-formatted field field-paragraph--field-text-demo field-formatter-text-default field-name-field-text-demo field-type-text-long field-label-hidden has-single"><div class="field__items"><div class="field__item"><p><a class="color-secondary-no-txt-decor" href="https://clinicaltrials.gov/"><span class="hs4">Clinicaltrials.gov ></span></a> </p> </div></div> </div> </div> </div></div> </div> <div class="field field-paragraph--field-lo-2cols-50-50-col2 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