{"id":37,"date":"2018-11-26T20:30:19","date_gmt":"2018-11-27T01:30:19","guid":{"rendered":"https:\/\/dev.mrctcenter.org\/health-literacy\/?page_id=37"},"modified":"2018-11-26T20:30:19","modified_gmt":"2018-11-27T01:30:19","slug":"principles-of-health-literacy-in-clinical-research","status":"publish","type":"page","link":"https:\/\/dev.mrctcenter.org\/health-literacy\/introduction\/principles-of-health-literacy-in-clinical-research\/","title":{"rendered":"Principles of Health Literacy in Clinical Research"},"content":{"rendered":"

[vc_row][vc_column][vc_empty_space][vc_column_text]<\/p>\n

These principles of health literacy provide a basis from which to adopt and integrate health literacy practices into clinical research.<\/h1>\n

[\/vc_column_text][\/vc_column][\/vc_row][vc_row css=”.vc_custom_1571578269218{margin-top: -50px !important;}”][vc_column width=”1\/2″][vc_column_text css=”.vc_custom_1571578324864{margin-top: 0px !important;}”]They are intended to support clinical research stakeholders, like sponsors and funders, investigators and study teams, and institutional review boards\/ethics committees in their communications with potential, enrolled, and past participants.[\/vc_column_text][\/vc_column][vc_column width=”1\/2″ css=”.vc_custom_1571578309427{margin-top: -25px !important;}”][vc_row_inner css=”.vc_custom_1569976163539{margin-top: 20px !important;margin-right: 20px !important;margin-bottom: 20px !important;margin-left: 20px !important;border-top-width: 1px !important;border-right-width: 1px !important;border-bottom-width: 1px !important;border-left-width: 1px !important;padding-top: 0px !important;padding-right: 0px !important;padding-bottom: 0px !important;padding-left: 0px !important;background-color: #99ccff !important;border-left-style: none !important;border-right-style: none !important;border-top-style: none !important;border-bottom-style: none !important;}”][vc_column_inner css=”.vc_custom_1569976195676{padding-bottom: 25px !important;}”][vc_column_text css=”.vc_custom_1569975833504{padding-left: 10px !important;}”]Review the Principles below then click\u00a0here<\/a>\u00a0to find out how you can integrate health literacy into your role.[\/vc_column_text][vc_btn title=”LEARN MORE” style=”custom” custom_background=”#003366″ custom_text=”#ffffff” size=”lg” align=”center” link=”url:https%3A%2F%2Fdev.mrctcenter.org%2Fhealth-literacy%2Fintroduction%2Fhealth-literacy-into-action%2F|||”][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row full_width=”stretch_row_content”][vc_column][vc_column_text css=”.vc_custom_1571604917849{padding-top: 10px !important;padding-right: 5px !important;padding-bottom: 10px !important;padding-left: 5px !important;background-color: #efefef !important;}”]<\/p>\n

Principles of Health Literacy in Clinical Research<\/h2>\n

[\/vc_column_text][\/vc_column][\/vc_row][vc_row css=”.vc_custom_1552748748640{padding-right: 20px !important;}”][vc_column width=”1\/6″][vc_row_inner][vc_column_inner][vc_single_image image=”707″ img_size=”75×75″ alignment=”center”][\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column width=”5\/6″][vc_tta_accordion style=”flat” shape=”square” color=”white” c_icon=”chevron” active_section=”0″ no_fill=”true” collapsible_all=”true” css=”.vc_custom_1564170799687{border-top-width: 1px !important;border-right-width: 1px !important;border-bottom-width: 1px !important;border-left-width: 1px !important;border-left-color: #dbdbdb !important;border-left-style: solid !important;border-right-color: #dbdbdb !important;border-right-style: solid !important;border-top-color: #dbdbdb !important;border-top-style: solid !important;border-bottom-color: #dbdbdb !important;border-bottom-style: solid !important;border-radius: 2px !important;}”][vc_tta_section title=”All clinical research communications should be clear and easy to understand.” tab_id=”1552748172474-54729343-9006″][vc_column_text]Voluntary and informed clinical research participation is an ethical requirement. Clear communication respects autonomy and empowers decisions that are in line with personal values.\u00a0 All communication with potential, enrolled and past participants should be clearly designed to support understanding and informed decision-making.[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row][vc_row css=”.vc_custom_1552748778114{padding-right: 20px !important;}”][vc_column width=”1\/6″][vc_row_inner][vc_column_inner][vc_single_image image=”701″ img_size=”75×75″ alignment=”center”][\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column width=”5\/6″][vc_tta_accordion style=”flat” shape=”square” color=”white” c_icon=”chevron” active_section=”0″ collapsible_all=”true” css=”.vc_custom_1564170855189{border-top-width: 1px !important;border-right-width: 1px !important;border-bottom-width: 1px !important;border-left-width: 1px !important;border-left-color: #dbdbdb !important;border-left-style: solid !important;border-right-color: #dbdbdb !important;border-right-style: solid !important;border-top-color: #dbdbdb !important;border-top-style: solid !important;border-bottom-color: #dbdbdb !important;border-bottom-style: solid !important;border-radius: 2px !important;}”][vc_tta_section title=”Clear communication is necessary throughout the clinical research life cycle.” tab_id=”1552748608603-62821f75-0a91″][vc_column_text]Health literacy applies to the entire clinical trial life cycle \u2013 from the point of learning about research and gaining access to study information, through the recruitment and consent process, during the on-study period, to trial results reporting. Clear communication can benefit participants any time clinical research information is presented and discussed.[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row][vc_row css=”.vc_custom_1552748778114{padding-right: 20px !important;}”][vc_column width=”1\/6″][vc_row_inner][vc_column_inner][vc_single_image image=”702″ img_size=”75×75″ alignment=”center”][\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column width=”5\/6″][vc_tta_accordion style=”flat” shape=”square” color=”white” c_icon=”chevron” active_section=”0″ collapsible_all=”true” css=”.vc_custom_1564170870467{border-top-width: 1px !important;border-right-width: 1px !important;border-bottom-width: 1px !important;border-left-width: 1px !important;border-left-color: #dbdbdb !important;border-left-style: solid !important;border-right-color: #dbdbdb !important;border-right-style: solid !important;border-top-color: #dbdbdb !important;border-top-style: solid !important;border-bottom-color: #dbdbdb !important;border-bottom-style: solid !important;border-radius: 2px !important;}”][vc_tta_section title=”All clinical research stakeholders share an ongoing responsibility for ensuring research communication is clear and easy to understand.” tab_id=”1552748781545-77b4e3c8-b0bd”][vc_column_text]Sponsors and funders, investigators and study teams, institutional review boards and ethics committees, as well as participants, caregivers, and their community, all play important roles in developing clear clinical research communications. The clarity of clinical research communication will improve when stakeholders work together to foster understanding, support transparent dialog, and respond to the information needs of the participant population.[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row][vc_row css=”.vc_custom_1552748778114{padding-right: 20px !important;}”][vc_column width=”1\/6″][vc_row_inner][vc_column_inner][vc_single_image image=”703″ img_size=”75×75″ alignment=”center”][\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column width=”5\/6″][vc_tta_accordion style=”flat” shape=”square” color=”white” c_icon=”chevron” active_section=”0″ no_fill=”true” collapsible_all=”true” css=”.vc_custom_1564170898220{border-top-width: 1px !important;border-right-width: 1px !important;border-bottom-width: 1px !important;border-left-width: 1px !important;border-left-color: #dbdbdb !important;border-left-style: solid !important;border-right-color: #dbdbdb !important;border-right-style: solid !important;border-top-color: #dbdbdb !important;border-top-style: solid !important;border-bottom-color: #dbdbdb !important;border-bottom-style: solid !important;border-radius: 2px !important;}”][vc_tta_section title=”Clinical research communications should be developed by partnering with the intended audience(s).” tab_id=”1552748909676-26617e31-b1d3″][vc_column_text]Clinical research stakeholders should be sensitive to the vulnerability of potential, enrolled, and past participants, and open to learning from the participant community as research partners. Participants, their caregivers, and their community should all be included in the process of developing and reviewing clinical research information.\u00a0 Stakeholders should engage with the intended audience(s) to learn from them, co-develop communications with them, and solicit feedback before, during and after the clinical research study, from study design to the reporting of research results.\u00a0 This engagement increases the likelihood that the way information is communicated meets the population\u2019s needs and is understandable and actionable.[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row][vc_row css=”.vc_custom_1552748778114{padding-right: 20px !important;}”][vc_column width=”1\/6″][vc_row_inner][vc_column_inner][vc_single_image image=”704″ img_size=”75×75″ alignment=”center”][\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column width=”5\/6″][vc_tta_accordion style=”flat” shape=”square” color=”white” c_icon=”chevron” active_section=”0″ no_fill=”true” collapsible_all=”true” css=”.vc_custom_1564170914776{border-top-width: 1px !important;border-right-width: 1px !important;border-bottom-width: 1px !important;border-left-width: 1px !important;border-left-color: #dbdbdb !important;border-left-style: solid !important;border-right-color: #dbdbdb !important;border-right-style: solid !important;border-top-color: #dbdbdb !important;border-top-style: solid !important;border-bottom-color: #dbdbdb !important;border-bottom-style: solid !important;border-radius: 2px !important;}”][vc_tta_section title=”Cultural respect is an integral part of communicating appropriately about clinical research.” tab_id=”1552748959052-dc917bc7-7e8b”][vc_column_text]All clinical research communication should be sensitive to cultural differences in order to better support autonomy and informed decision making. In the context of developing research communications, culture should be considered broadly, and go beyond country of origin to include race, ethnicity, sex, gender identity, sexual orientation, physical ability, disability, geography, and so on.\u00a0 Considering what culture means to different groups, and engaging in training on cultural humility and methods like teach-back, can lead to communication that is more likely to meet the information needs of the intended audience, especially given the power imbalance that is inherent within the context of medicine, research, and illness.[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row][vc_row css=”.vc_custom_1552748778114{padding-right: 20px !important;}”][vc_column width=”1\/6″][vc_row_inner][vc_column_inner][vc_single_image image=”705″ img_size=”75×75″ alignment=”center”][\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column width=”5\/6″][vc_tta_accordion style=”flat” shape=”square” color=”white” c_icon=”chevron” active_section=”0″ no_fill=”true” collapsible_all=”true” css=”.vc_custom_1564170914776{border-top-width: 1px !important;border-right-width: 1px !important;border-bottom-width: 1px !important;border-left-width: 1px !important;border-left-color: #dbdbdb !important;border-left-style: solid !important;border-right-color: #dbdbdb !important;border-right-style: solid !important;border-top-color: #dbdbdb !important;border-top-style: solid !important;border-bottom-color: #dbdbdb !important;border-bottom-style: solid !important;border-radius: 2px !important;}”][vc_tta_section title=”Clinical research materials for participants should integrate health literacy practices, including plain language, numeracy, visualization and design techniques, and cultural considerations.” tab_id=”1565834598170-c6a37e13-6b78″][vc_column_text]Written, printed, and electronic media clinical research communications, including any standard templates and boilerplates, should incorporate the concepts of plain language, numeracy, readability, reader-friendly document design, and visual aids like infographics to augment the recipient’s ability to understand.[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row][vc_row css=”.vc_custom_1552748778114{padding-right: 20px !important;}”][vc_column width=”1\/6″][vc_row_inner][vc_column_inner][vc_single_image image=”706″ img_size=”75×75″ alignment=”center”][\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column width=”5\/6″][vc_tta_accordion style=”flat” shape=”square” color=”white” c_icon=”chevron” active_section=”0″ no_fill=”true” collapsible_all=”true” css=”.vc_custom_1564170948284{border-top-width: 1px !important;border-right-width: 1px !important;border-bottom-width: 1px !important;border-left-width: 1px !important;border-left-color: #dbdbdb !important;border-left-style: solid !important;border-right-color: #dbdbdb !important;border-right-style: solid !important;border-top-color: #dbdbdb !important;border-top-style: solid !important;border-bottom-color: #dbdbdb !important;border-bottom-style: solid !important;border-radius: 2px !important;}”][vc_tta_section title=”Clinical research materials for participants should be evaluated to ensure the intended audience(s) can understand the information.” tab_id=”1552749072900-50b7ebc5-1106″][vc_column_text]Health literacy evaluation methods increase the likelihood that the audience will be able to understand and act on the clinical research information presented to them. These methods include some combination of testing for readability, piloting study materials and research processes, and performing usability testing with members of the potential participant community.[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row][vc_row css=”.vc_custom_1552748778114{padding-right: 20px !important;}”][vc_column width=”1\/6″][vc_row_inner][vc_column_inner][vc_single_image image=”1193″ img_size=”75×75″ alignment=”center”][\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column width=”5\/6″][vc_tta_accordion style=”flat” shape=”square” color=”white” c_icon=”chevron” active_section=”0″ no_fill=”true” collapsible_all=”true” css=”.vc_custom_1564170948284{border-top-width: 1px !important;border-right-width: 1px !important;border-bottom-width: 1px !important;border-left-width: 1px !important;border-left-color: #dbdbdb !important;border-left-style: solid !important;border-right-color: #dbdbdb !important;border-right-style: solid !important;border-top-color: #dbdbdb !important;border-top-style: solid !important;border-bottom-color: #dbdbdb !important;border-bottom-style: solid !important;border-radius: 2px !important;}”][vc_tta_section title=”In-person communication with the intended audience should encourage dialogue and confirm understanding.” tab_id=”1565207141670-500087ca-c965″][vc_column_text]All stakeholders should develop a plan that allows for multiple conversations with participants and gives them the time needed to process the information provided and ask questions. To this end, using scripts that clearly explain common terminology and key takeaways can help to ensure that the communicators share consistent information with each participant.\u00a0 Researchers and their study teams should also use interactive methods like teach-back to confirm understanding at all points of the clinical trial life cycle that involve sharing and collecting information, not just when obtaining informed consent.[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row][vc_row css=”.vc_custom_1552748778114{padding-right: 20px !important;}”][vc_column width=”1\/6″][vc_row_inner][vc_column_inner][vc_single_image image=”1194″ img_size=”75×75″ alignment=”center”][\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column width=”5\/6″][vc_tta_accordion style=”flat” shape=”square” color=”white” c_icon=”chevron” active_section=”0″ no_fill=”true” collapsible_all=”true” css=”.vc_custom_1564170948284{border-top-width: 1px !important;border-right-width: 1px !important;border-bottom-width: 1px !important;border-left-width: 1px !important;border-left-color: #dbdbdb !important;border-left-style: solid !important;border-right-color: #dbdbdb !important;border-right-style: solid !important;border-top-color: #dbdbdb !important;border-top-style: solid !important;border-bottom-color: #dbdbdb !important;border-bottom-style: solid !important;border-radius: 2px !important;}”][vc_tta_section title=”All clinical research stakeholders should support the development and implementation of organizational policies that integrate health literacy into clinical research.” tab_id=”1565207140342-8bd6c02d-8c78″][vc_column_text]Organizational policies and funding mechanisms, announcements and conditions should support health literacy processes being integrated into all aspects of clinical research, including study design and development. Corporate, non-profit, and academic sponsors and funders should specify that health literacy concepts be incorporated into all participant-facing communications, including recruitment materials, consents, research summaries, and templates.\u00a0 Institutional review boards and ethics boards should promote the inclusion of health literacy best practice in all participant-facing materials they review.[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row][vc_row css=”.vc_custom_1552748778114{padding-right: 20px !important;}”][vc_column width=”1\/6″][vc_row_inner][vc_column_inner][vc_single_image image=”1195″ img_size=”75×75″ alignment=”center”][\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column width=”5\/6″][vc_tta_accordion style=”flat” shape=”square” color=”white” c_icon=”chevron” active_section=”0″ no_fill=”true” collapsible_all=”true” css=”.vc_custom_1564170948284{border-top-width: 1px !important;border-right-width: 1px !important;border-bottom-width: 1px !important;border-left-width: 1px !important;border-left-color: #dbdbdb !important;border-left-style: solid !important;border-right-color: #dbdbdb !important;border-right-style: solid !important;border-top-color: #dbdbdb !important;border-top-style: solid !important;border-bottom-color: #dbdbdb !important;border-bottom-style: solid !important;border-radius: 2px !important;}”][vc_tta_section title=”Integration of health literacy into clinical research requires proactive planning to develop, test, modify, and confirm understanding of clinical research communications.” tab_id=”1565207138814-047b9cfa-60fe”][vc_column_text]A true commitment to developing clear research information and engaging in meaningful study-related conversations is reflected in the adoption of health literacy practices throughout an organization\u2019s clinical research infrastructure. In many cases, integrating health literacy is a matter of enhancing processes that are already in place.\u00a0 All clinical research stakeholders and their organizations should optimize their workflows to include developing, testing, modifying, and confirming understanding of research communications and be open to continuously improving their processes[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][vc_column][vc_column_text css=”.vc_custom_1613101573177{padding-top: 20px !important;padding-right: 20px !important;padding-bottom: 20px !important;padding-left: 20px !important;background-color: #99ccff !important;}”]<\/p>\n

Download a PDF of the Health Literacy in Clinical Research Principles<\/a><\/strong><\/p>\n

[\/vc_column_text][\/vc_column][\/vc_row][vc_row full_width=”stretch_row” css=”.vc_custom_1570383127645{background-color: #efefef !important;}”][vc_column width=”1\/3″][vc_single_image image=”1458″ img_size=”full” alignment=”right” css=”.vc_custom_1570377183283{margin-right: 50px !important;}”][\/vc_column][vc_column width=”2\/3″ css=”.vc_custom_1571664847735{margin-left: 30px !important;padding-right: 50px !important;}”][vc_column_text]<\/p>\n

We welcome your feedback! <\/span><\/strong>Our health literacy site is always evolving and we encourage visitor input to help us enhance and improve this important resource.<\/span><\/strong><\/h3>\n

[\/vc_column_text][vc_column_text]<\/p>\n

Please email MRCT@bwh.harvard.edu <\/a>with recommendations of additional resources that support health literacy integration into clinical research.<\/span><\/strong><\/h3>\n

[\/vc_column_text][\/vc_column][\/vc_row]<\/p>\n<\/section>","protected":false},"excerpt":{"rendered":"

[vc_row][vc_column][vc_empty_space][vc_column_text] These principles of health literacy provide a basis from which to adopt and integrate health literacy practices into clinical research. [\/vc_column_text][\/vc_column][\/vc_row][vc_row css=”.vc_custom_1571578269218{margin-top: -50px !important;}”][vc_column width=”1\/2″][vc_column_text css=”.vc_custom_1571578324864{margin-top: 0px !important;}”]They are intended to support clinical research stakeholders, like sponsors and funders, investigators and study teams, and institutional review boards\/ethics committees in their communications with potential, enrolled, […]<\/p>\n","protected":false},"author":5,"featured_media":0,"parent":32,"menu_order":2,"comment_status":"closed","ping_status":"closed","template":"template-sub.php","meta":{"footnotes":""},"class_list":["post-37","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/dev.mrctcenter.org\/health-literacy\/wp-json\/wp\/v2\/pages\/37"}],"collection":[{"href":"https:\/\/dev.mrctcenter.org\/health-literacy\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/dev.mrctcenter.org\/health-literacy\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/dev.mrctcenter.org\/health-literacy\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/dev.mrctcenter.org\/health-literacy\/wp-json\/wp\/v2\/comments?post=37"}],"version-history":[{"count":0,"href":"https:\/\/dev.mrctcenter.org\/health-literacy\/wp-json\/wp\/v2\/pages\/37\/revisions"}],"up":[{"embeddable":true,"href":"https:\/\/dev.mrctcenter.org\/health-literacy\/wp-json\/wp\/v2\/pages\/32"}],"wp:attachment":[{"href":"https:\/\/dev.mrctcenter.org\/health-literacy\/wp-json\/wp\/v2\/media?parent=37"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}