{"id":1761,"date":"2023-04-03T12:46:21","date_gmt":"2023-04-03T16:46:21","guid":{"rendered":"https:\/\/mrctcenter.org\/return-of-individual-results\/?page_id=1761"},"modified":"2024-07-15T18:07:21","modified_gmt":"2024-07-15T18:07:21","slug":"case-studies","status":"publish","type":"page","link":"https:\/\/mrctcenter.org\/return-of-individual-results\/resources\/case-studies\/","title":{"rendered":"Case Studies"},"content":{"rendered":"

[vc_row][vc_column][vc_empty_space][vc_column_text]The MRCT Center has worked with stakeholders to develop case studies that show (1) different ways to get started returning individual research results, (2) how common roadblocks in the IRR process have been overcome, and (3) how thoughtful planning early on has enabled success with IRR.<\/p>\n

Contact us<\/a> <\/strong>if you would like to contribute a case study.[\/vc_column_text][vc_empty_space][\/vc_column][\/vc_row][vc_row][vc_column width=”1\/4″][vc_single_image image=”1904″ img_size=”full” onclick=”custom_link” img_link_target=”_blank” link=”https:\/\/mrctcenter.org\/resource\/returning-individual-research-results-and-data-digging-deeper-webinar-series\/”][\/vc_column][vc_column width=”3\/4″][vc_column_text]On May 2, 2023, the MRCT Center presented a webinar about these case studies, “Returning Individual Research Results and Data to Participants: Experience from the Field.” To watch this webinar and see related resources, click here.<\/strong><\/a><\/p>\n

Given the interest and questions that the May webinar generated, we offered a 3-part summer webinar series about the specific ethical, operational, and technical challenges to returning individual research results and data to participants.<\/p>\n

The Digging Deeper series explored Pfizer’s Participant Data Return Solution, IRB\/HRPP Responsibilities, and Returning Genetic\/Genomic Secondary Findings. To view resources from these webinars, click here<\/strong><\/a>.[\/vc_column_text][vc_empty_space][\/vc_column][\/vc_row][vc_row][vc_column width=”1\/6″][vc_single_image image=”1766″ img_size=”large” onclick=”custom_link” css=”.vc_custom_1683042591922{background-color: #1e73be !important;border-radius: 2px !important;}” link=”https:\/\/mrctcenter.org\/return-of-individual-results\/wp-content\/uploads\/sites\/7\/2023\/05\/IRR-Case-Study-1-with-CC-license.pdf”][\/vc_column][vc_column width=”2\/3″][vc_column_text]<\/p>\n

Supporting Participant Decision-Making in Genetic Testing Studies<\/a><\/h4>\n

This case study shares an example of how one institution created an educational tool to support decision-making for potential participants in a genetic testing study.[\/vc_column_text][\/vc_column][vc_column width=”1\/6″][vc_btn title=”Download” color=”primary” i_icon_fontawesome=”fas fa-arrow-alt-circle-down” add_icon=”true” link=”url:https%3A%2F%2Fmrctcenter.org%2Freturn-of-individual-results%2Fwp-content%2Fuploads%2Fsites%2F9%2F2023%2F05%2FIRR-Case-Study-1-with-CC-license.pdf”][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text][\/vc_column_text][vc_empty_space height=”10px”][\/vc_column][\/vc_row][vc_row][vc_column width=”1\/6″][vc_single_image image=”1768″ img_size=”large” onclick=”custom_link” link=”https:\/\/mrctcenter.org\/return-of-individual-results\/wp-content\/uploads\/sites\/7\/2023\/05\/IRR-Case-Study-2-with-CC-license.pdf”][\/vc_column][vc_column width=”2\/3″][vc_column_text]<\/p>\n

Returning Routine Lab Results to Participants During a Clinical Trial<\/a><\/h4>\n

This case study demonstrates how an industry sponsor operationalized returning routine laboratory results to participants during an ongoing, multi-site clinical trial.[\/vc_column_text][\/vc_column][vc_column width=”1\/6″][vc_btn title=”Download” color=”primary” i_icon_fontawesome=”fas fa-arrow-alt-circle-down” add_icon=”true” link=”url:https%3A%2F%2Fmrctcenter.org%2Freturn-of-individual-results%2Fwp-content%2Fuploads%2Fsites%2F9%2F2023%2F05%2FIRR-Case-Study-2-with-CC-license.pdf”][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text][\/vc_column_text][vc_empty_space height=”10px”][\/vc_column][\/vc_row][vc_row][vc_column width=”1\/6″][vc_single_image image=”1769″ img_size=”large” onclick=”custom_link” link=”https:\/\/mrctcenter.org\/return-of-individual-results\/wp-content\/uploads\/sites\/7\/2023\/05\/IRR-Case-Study-3-with-CC-license.pdf”][\/vc_column][vc_column width=”2\/3″][vc_column_text]<\/p>\n

Responsibly Returning Secondary Findings<\/a><\/h4>\n

This case details the experience of a research team returning secondary findings to participants in a genetic testing study.[\/vc_column_text][\/vc_column][vc_column width=”1\/6″][vc_btn title=”Download” color=”primary” i_icon_fontawesome=”fas fa-arrow-alt-circle-down” add_icon=”true” link=”url:https%3A%2F%2Fmrctcenter.org%2Freturn-of-individual-results%2Fwp-content%2Fuploads%2Fsites%2F9%2F2023%2F05%2FIRR-Case-Study-3-with-CC-license.pdf”][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text][\/vc_column_text][vc_empty_space height=”10px”][\/vc_column][\/vc_row][vc_row][vc_column width=”1\/6″][vc_single_image image=”1767″ img_size=”large” onclick=”custom_link” link=”https:\/\/mrctcenter.org\/return-of-individual-results\/wp-content\/uploads\/sites\/7\/2023\/05\/IRR-Case-Study-4-with-CC-license.pdf”][\/vc_column][vc_column width=”2\/3″][vc_column_text]<\/p>\n

Returning Non-Validated Test Results<\/a><\/h4>\n

This case study describes how an IRB navigated returning results of a new COVID-19 assay from a non-CLIA-certified lab during a public health emergency.[\/vc_column_text][\/vc_column][vc_column width=”1\/6″][vc_btn title=”Download” color=”primary” i_icon_fontawesome=”fas fa-arrow-alt-circle-down” add_icon=”true” link=”url:https%3A%2F%2Fmrctcenter.org%2Freturn-of-individual-results%2Fwp-content%2Fuploads%2Fsites%2F9%2F2023%2F05%2FIRR-Case-Study-4-with-CC-license.pdf”][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text][\/vc_column_text][vc_empty_space height=”10px”][\/vc_column][\/vc_row][vc_row][vc_column width=”1\/6″][vc_single_image image=”1806″ img_size=”large” onclick=”custom_link” link=”https:\/\/mrctcenter.org\/return-of-individual-results\/wp-content\/uploads\/sites\/7\/2023\/04\/IRR-Pfizer-Case-Study_FINAL_5.pdf”][\/vc_column][vc_column width=”2\/3″][vc_column_text]<\/p>\n

Implementing a Robust, Scalable Participant Data Return Solution<\/a><\/h4>\n

This case study outlines how an industry sponsor designed an initiative to return clinical trial data to participants.[\/vc_column_text][\/vc_column][vc_column width=”1\/6″][vc_btn title=”Download” color=”primary” i_icon_fontawesome=”fas fa-arrow-alt-circle-down” add_icon=”true” link=”url:https%3A%2F%2Fmrctcenter.org%2Fwp-content%2Fuploads%2F2023%2F04%2FIRR-Pfizer-Case-Study_FINAL_5.pdf”][\/vc_column][\/vc_row][vc_row disable_element=”yes”][vc_column][vc_empty_space][vc_column_text]The MRCT Center has worked with stakeholders to develop case studies that (1) show different ways to get started returning individual research results, (2) how common roadblocks in the IRR process have been overcome, and (3) how thoughtful planning early on has enabled success with IRR[\/vc_column_text][\/vc_column][\/vc_row][vc_row disable_element=”yes”][vc_column][vc_empty_space][vc_column_text]The MRCT Center has worked with stakeholders to develop case studies that (1) show different ways to get started returning individual research results, (2) how common roadblocks in the IRR process have been overcome, and (3) how thoughtful planning early on has enabled success with IRR[\/vc_column_text][\/vc_column][\/vc_row][vc_row disable_element=”yes”][vc_column width=”1\/4″][vc_column_text]\"\"[\/vc_column_text][\/vc_column][vc_column width=”1\/4″][vc_column_text]<\/p>\n

Supporting Participant Decision-Making in Genetic Testing Studies<\/h4>\n

This case study shares an example of how one institution created an educational tool to support decision-making for potential participants in a genetic testing study.[\/vc_column_text][\/vc_column][vc_column width=”1\/4″][vc_btn title=”DOWNLOAD PDF” style=”outline-custom” outline_custom_color=”#68184b” outline_custom_hover_background=”#68184b” outline_custom_hover_text=”#ffffff” link=”url:https%3A%2F%2Fmrctcenter.org%2Freturn-of-individual-results%2Fwp-content%2Fuploads%2Fsites%2F9%2F2023%2F03%2FIRR-2023-03-07-Supporting-Participant-Decision-Making-FINAL1.pdf”][\/vc_column][\/vc_row][vc_row disable_element=”yes”][vc_column][vc_separator border_width=”2″][vc_row_inner][vc_column_inner width=”1\/4″][vc_column_text]IRB Policy and Training around IRR – New<\/span><\/strong>[\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/4″][vc_column_text]How an IRB created its own policy around IRR and provided education and resources to researchers.[\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/4″][vc_column_text]<\/p>\n

    \n
  • IRBs\/HRPPs<\/li>\n<\/ul>\n

    [\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/4″][vc_btn title=”DOWNLOAD PDF” style=”outline-custom” outline_custom_color=”#68184b” outline_custom_hover_background=”#68184b” outline_custom_hover_text=”#ffffff”][\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner width=”1\/4″][vc_column_text]IRB Policy and Training around IRR – New<\/span><\/strong>[\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/4″][vc_column_text]How an IRB created its own policy around IRR and provided education and resources to researchers.[\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/4″][vc_column_text]<\/p>\n

      \n
    • IRBs\/HRPPs<\/li>\n<\/ul>\n

      [\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/4″][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row disable_element=”yes”][vc_column][vc_separator border_width=”2″][vc_row_inner][vc_column_inner width=”1\/4″][vc_column_text]A Patient Engagement Pilot Initiative to Provide Patients with Access to Data During a Clinical Trial – Updated<\/span><\/strong>[\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/4″][vc_column_text]Conducting a pilot to demonstrate feasibility of IRR at an industry sponsor.[\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/4″][vc_column_text]<\/p>\n

        \n
      • Sponsors<\/li>\n
      • Study Teams<\/li>\n<\/ul>\n

        [\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/4″][vc_btn title=”DOWNLOAD PDF” style=”outline-custom” outline_custom_color=”#68184b” outline_custom_hover_background=”#68184b” outline_custom_hover_text=”#ffffff”][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row disable_element=”yes”][vc_column][vc_separator border_width=”2″][vc_row_inner][vc_column_inner width=”1\/4″][vc_column_text]HER2 Negative Metastatic Breast Cancer<\/strong>[\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/4″][vc_column_text]Returning actionable findings when ICF did not mention IRR.[\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/4″][vc_column_text]<\/p>\n

          \n
        • IRBs\/HRPPs\/ECs<\/li>\n
        • Study staff<\/li>\n
        • Investigators<\/li>\n
        • Sponsors<\/li>\n<\/ul>\n

          [\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/4″][vc_btn title=”DOWNLOAD PDF” style=”outline-custom” outline_custom_color=”#68184b” outline_custom_hover_background=”#68184b” outline_custom_hover_text=”#ffffff”][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row]<\/p>\n<\/section>","protected":false},"excerpt":{"rendered":"

          [vc_row][vc_column][vc_empty_space][vc_column_text]The MRCT Center has worked with stakeholders to develop case studies that show (1) different ways to get started returning individual research results, (2) how common roadblocks in the IRR process have been overcome, and (3) how thoughtful planning early on has enabled success with IRR. Contact us if you would like to contribute a […]<\/p>\n","protected":false},"author":5,"featured_media":0,"parent":781,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"template-sub.php","meta":{"footnotes":""},"class_list":["post-1761","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"\nCase Studies - Return of Individual Research Results<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/mrctcenter.org\/return-of-individual-results\/resources\/case-studies\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Case Studies\" \/>\n<meta property=\"og:description\" content=\"[vc_row][vc_column][vc_empty_space][vc_column_text]The MRCT Center has worked with stakeholders to develop case studies that show (1) different ways to get started returning individual research results, (2) how common roadblocks in the IRR process have been overcome, and (3) how thoughtful planning early on has enabled success with IRR. 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