{"id":878,"date":"2019-06-11T22:20:31","date_gmt":"2019-06-12T02:20:31","guid":{"rendered":"https:\/\/mrctcenter.org\/health-literacy\/?page_id=878"},"modified":"2019-06-11T22:20:31","modified_gmt":"2019-06-12T02:20:31","slug":"consent-guide","status":"publish","type":"page","link":"https:\/\/mrctcenter.org\/health-literacy\/tools\/overview\/consent-guide\/","title":{"rendered":"Consent Guide"},"content":{"rendered":"<section class=\"wpb-content-wrapper\"><p>[vc_row][vc_column][vc_row_inner][vc_column_inner][vc_column_text]<\/p>\n<h1><strong>Applying\u00a0Health Literacy to Informed Consents for Research:<\/strong><\/h1>\n<p>Quick Tips for Clearly Explaining the Requirements<\/p>\n<p><strong>Adapted from original material created by: <\/strong>Christopher R. Trudeau, JD[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_column_text css=&#8221;.vc_custom_1571229243482{margin-top: -50px !important;}&#8221;]<img loading=\"lazy\" decoding=\"async\" class=\"alignright wp-image-1583\" src=\"https:\/\/mrctcenter.org\/health-literacy\/wp-content\/uploads\/sites\/3\/2019\/10\/best-practice-resources-consent-guide-2.jpg\" alt=\"consent guide\" width=\"500\" height=\"500\" srcset=\"https:\/\/mrctcenter.org\/health-literacy\/wp-content\/uploads\/sites\/3\/2019\/10\/best-practice-resources-consent-guide-2.jpg 800w, https:\/\/mrctcenter.org\/health-literacy\/wp-content\/uploads\/sites\/3\/2019\/10\/best-practice-resources-consent-guide-2-300x300.jpg 300w, https:\/\/mrctcenter.org\/health-literacy\/wp-content\/uploads\/sites\/3\/2019\/10\/best-practice-resources-consent-guide-2-150x150.jpg 150w, https:\/\/mrctcenter.org\/health-literacy\/wp-content\/uploads\/sites\/3\/2019\/10\/best-practice-resources-consent-guide-2-768x768.jpg 768w, https:\/\/mrctcenter.org\/health-literacy\/wp-content\/uploads\/sites\/3\/2019\/10\/best-practice-resources-consent-guide-2-250x250.jpg 250w\" sizes=\"(max-width: 500px) 100vw, 500px\" \/><\/p>\n<p>Creating consent materials that people can understand involves not only thinking about the content needed, but also how that content will be worded, ordered, and presented. Consent form content is always important, yet due to recent regulatory changes that emphasize clarity, consent forms will be reviewed more closely by Institutional Review Boards\/Ethics Committees (IRB\/ECs), government regulators, and, sometimes, even in courts.<\/p>\n<p>Using health literacy best practices, we can do more with consent forms than simply ensuring regulatory compliance.<\/p>\n<p>Find out how to:<\/p>\n<ul>\n<li>Prepare to Create a Clear Informed Consent Form<\/li>\n<li>Draft the Content in Plain Language<\/li>\n<\/ul>\n<p>[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1571182902241{padding-top: 20px !important;padding-right: 20px !important;padding-bottom: 20px !important;padding-left: 20px !important;background-color: #99ccff !important;}&#8221;]Note: Unless quoting specific regulations that refer to \u201csubjects,\u201d we will use the preferred term \u201cparticipant\u201d to describe individuals who decide to join a research study.[\/vc_column_text][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row_content&#8221;][vc_column][vc_column_text css=&#8221;.vc_custom_1571584965157{padding-top: 10px !important;padding-right: 10px !important;padding-bottom: 10px !important;padding-left: 10px !important;background-color: #efefef !important;}&#8221;]<\/p>\n<h2 style=\"text-align: center\">Preparing to Create a Clear Informed Consent Form<\/h2>\n<p>[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text]Creating any health communication takes planning and preparation.<\/p>\n<p>This section outlines the steps needed to create consent forms for research that not only comply with regulations but also present the content in ways that participants are more likely to understand. Many of these steps are, of course, applicable to the creation of all consent forms in any country, although country-specific regulations would need to be considered.\u00a0 Here we will use the US regulatory framework by way of example.<\/p>\n<ul>\n<li><strong>Step One<\/strong> \u2013 Address the Three Pillars of Consent: Purpose, Audience, and Process<\/li>\n<li><strong>Step Two<\/strong> \u2013 Determine the Legal Requirements for Consent<\/li>\n<li><strong>Step Three<\/strong> \u2013 Create a Preliminary Outline of Needed Requirements<\/li>\n<li><strong>Step Four<\/strong> \u2013 Plan Your Design Strategy<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row_content&#8221;][vc_column][vc_column_text css=&#8221;.vc_custom_1571584975697{padding-top: 10px !important;padding-right: 10px !important;padding-bottom: 10px !important;padding-left: 10px !important;background-color: #efefef !important;}&#8221;]<\/p>\n<h2 style=\"text-align: center\"><strong>Step One \u2013 Address the Three Pillars of Consent: Purpose, Audience, and Process<\/strong><\/h2>\n<p>[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column css=&#8221;.vc_custom_1571187168379{margin-bottom: 0px !important;}&#8221;][vc_column_text]Consent forms are not transactional documents like other contracts \u2013 they are tools to help facilitate an informed choice of whether or not to join a study. At Step One you must determine Purpose, Audience and Process.[\/vc_column_text][vc_tta_accordion style=&#8221;flat&#8221; shape=&#8221;square&#8221; color=&#8221;white&#8221; c_icon=&#8221;chevron&#8221; active_section=&#8221;0&#8243; no_fill=&#8221;true&#8221; collapsible_all=&#8221;true&#8221; css=&#8221;.vc_custom_1571186976214{padding-top: 20px !important;padding-bottom: 20px !important;}&#8221;][vc_tta_section title=&#8221;Purpose: What are the goals for this consent form?&#8221; tab_id=&#8221;1571182455801-75d992eb-b604&#8243;][vc_column_text]Purpose helps keep you focused when creating a consent form &#8211; it is one of the pillars that help you decide what to include and how to explain the information clearly.<\/p>\n<p>Purposes of consent for research:<\/p>\n<ul>\n<li>Describe the study so that participants are aware of what to expect and can make more autonomous, informed decisions about whether they (or their children) should participate<\/li>\n<li>Provide a framework to support meaningful consent discussions<\/li>\n<li>Comply with regulatory requirements<\/li>\n<li>Insulate researchers, institutions, and sponsors from liability.<\/li>\n<\/ul>\n<p>[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1571189223777{padding-top: 20px !important;padding-right: 20px !important;padding-bottom: 20px !important;padding-left: 20px !important;background-color: #99ccff !important;}&#8221;]One study found that \u201cfactors of the consent discussion that were associated with a decreased likelihood of enrollment included . . . the presentation of complex information in a limited amount of time.\u201d [Hallinan, et al, 2016.] <a href=\"https:\/\/www.thehastingscenter.org\/irb_article\/barriers-to-change-in-the-informed-consent-process-a-systematic-literature-review\/\" target=\"_blank\" rel=\"noopener\">https:\/\/www.thehastingscenter.org\/irb_article\/barriers-to-change-in-the-informed-consent-process-a-systematic-literature-review\/<\/a>[\/vc_column_text][vc_column_text]Consent forms provide information to<\/p>\n<ul>\n<li><strong>Potential and enrolled participants<\/strong> \u2013 who are seeking clear information to help them decide whether to join and to guide them once they decide to join;<\/li>\n<li><strong>IRB reviewers<\/strong> \u2013 who not only review for regulatory compliance but also advocate for ethical treatment of and protect participants;<\/li>\n<li><strong>Sponsors &amp; funding agencies<\/strong> \u2013 who are increasingly concerned with issues of health literacy and participant understanding due to organizational policy and changing regulations;<\/li>\n<li><strong>Investigators and research staff<\/strong> \u2013 who often are tasked with discussing and obtaining consent from study participants; and<\/li>\n<li><strong>The general public<\/strong> \u2013 especially now that many consent forms are available on clinicaltrials.gov.<\/li>\n<\/ul>\n<p>Defining all of your consent purposes during the planning process can guide you in making key choices about what to include, where you will include it, and how you will clearly convey the message so that people are able to make informed, autonomous decisions about whether to take part in a research study.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1571182710595{padding-top: 20px !important;padding-right: 20px !important;padding-bottom: 20px !important;padding-left: 20px !important;background-color: #99ccff !important;}&#8221;]For example, a participant experiencing something new, like a rash, can look back at the consent form to see if it might be a known risk of the study intervention.[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][vc_tta_accordion style=&#8221;flat&#8221; shape=&#8221;square&#8221; color=&#8221;white&#8221; c_icon=&#8221;chevron&#8221; active_section=&#8221;0&#8243; no_fill=&#8221;true&#8221; collapsible_all=&#8221;true&#8221; css=&#8221;.vc_custom_1571187199608{margin-top: -50px !important;padding-top: 20px !important;padding-bottom: 20px !important;}&#8221;][vc_tta_section title=&#8221;Audience: Who are your audiences for this consent form?&#8221; tab_id=&#8221;1571187038036-fe6e2191-c138&#8243;][vc_column_text]Before you start writing the consent form, consider the audiences. Clearly, potential and enrolled study participants are your primary audience. But, as noted above, many others see and can be informed by your consent form, including family members of the participant.<\/p>\n<p>When thinking about your primary audience \u2013 study participants \u2013 think about what you know about them. Are they young adults? Do most come from a particular cultural background? Are there other medical or social factors that may impact the group? The underlying idea here is that understanding the needs of your study population and addressing possible health literacy challenges will serve all audiences better. <a href=\"https:\/\/mrctcenter.org\/health-literacy\/tools\/overview\/cultural-considerations\/\">You can learn more about cultural considerations in clinical research here<\/a><\/p>\n<p>Another, often overlooked, audience for consent forms are research staff. \u00a0Clear consent forms, with explanations of legal and medical terms, will help research staff by ensuring consistency in educating participants about the study and in obtaining their informed consent.[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1571183202305{padding-top: 20px !important;padding-right: 20px !important;padding-bottom: 20px !important;padding-left: 20px !important;background-color: #99ccff !important;}&#8221;]Involve people from your study population as you develop the study protocol and the consent form to help ensure that you are meeting their informational needs and designing materials for a study that people will want to join.[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][vc_tta_accordion style=&#8221;flat&#8221; shape=&#8221;square&#8221; color=&#8221;white&#8221; c_icon=&#8221;chevron&#8221; active_section=&#8221;0&#8243; no_fill=&#8221;true&#8221; collapsible_all=&#8221;true&#8221; css=&#8221;.vc_custom_1571187215379{margin-top: -50px !important;padding-top: 20px !important;padding-bottom: 20px !important;}&#8221;][vc_tta_section title=&#8221;Process: What is the process for obtaining consent?&#8221; tab_id=&#8221;1571187057084-008c2cd2-47ce&#8221;][vc_column_text]Consent is more than just a form \u2013 it is a process. The consent process begins the moment you start soliciting people to be in the study and ends only after you will no longer use the participant\u2019s information or biospecimens for further research. Thus, it is important to think about this early and create a plan for consenting participants that considers the following:<\/p>\n<ul>\n<li>How will potential participants be educated about the study?<\/li>\n<li>When will they be educated about the study?<\/li>\n<li>When will they receive the consent form?<\/li>\n<li>How will they receive the consent form (electronically or in print)?<\/li>\n<li>How long will they have to read and consider the form?<\/li>\n<li>Who will be there to guide them through the consent process?<\/li>\n<li>To whom should they ask questions about the study?<\/li>\n<li>What additional information or materials might help them make an informed decision?<\/li>\n<li>How can I encourage and support them to ask questions?<\/li>\n<li>When will they be expected to sign the consent form?<\/li>\n<\/ul>\n<p>In all cases, as you plan the consent process, be sure that it includes (1) a plan for participant education and (2) includes some opportunity for one-on-one interaction with a member of the study team to answer questions and facilitate understanding.<\/p>\n<p>The best way to do facilitate understanding is by using a technique called <strong>teach-back<\/strong>. This involves participants demonstrating knowledge by \u201cteaching\u201d what they learn back to the person that explained it. <a href=\"https:\/\/mrctcenter.org\/health-literacy\/tools\/overview\/interactive-techniques\/#teachback\">For more on teach-back click here.<\/a>[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row_content&#8221;][vc_column][vc_column_text css=&#8221;.vc_custom_1571584985387{padding-top: 10px !important;padding-right: 10px !important;padding-bottom: 10px !important;padding-left: 10px !important;background-color: #efefef !important;}&#8221;]<\/p>\n<h2 style=\"text-align: center\"><strong>Step Two \u2013 Determine the Legal Requirements for Consent<\/strong><\/h2>\n<p>[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text]The second step is to determine what is legally required to be included in your consent form. Once you figure out those \u201cmust haves,\u201d you can then better consider how to organize and explain those concepts in the form[\/vc_column_text][vc_tta_accordion style=&#8221;flat&#8221; shape=&#8221;square&#8221; color=&#8221;white&#8221; c_icon=&#8221;chevron&#8221; active_section=&#8221;0&#8243; no_fill=&#8221;true&#8221; collapsible_all=&#8221;true&#8221; css=&#8221;.vc_custom_1571187862623{padding-top: 20px !important;padding-bottom: 20px !important;}&#8221;][vc_tta_section title=&#8221;Participant Understanding Requirements of the US Federal Regulations&#8221; tab_id=&#8221;1571183560546-fb2c5098-9aee&#8221;][vc_column_text]To better facilitate informed consent decision-making, the US federal regulations (<a href=\"https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/regulations\/revised-common-rule-regulatory-text\/index.html\" target=\"_blank\" rel=\"noopener\">Revised Common Rule<\/a>) now require that consent forms \u201cbegin with <strong>a concise and focused presentation<\/strong> of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research.\u201d ([<a href=\"https:\/\/www.ecfr.gov\/cgi-bin\/retrieveECFR?gp=&amp;SID=83cd09e1c0f5c6937cd9d7513160fc3f&amp;pitd=20180719&amp;n=pt45.1.46&amp;r=PART&amp;ty=HTML#se45.1.46_1116\" target=\"_blank\" rel=\"noopener\">46.116(a)(5)(i)]<\/a>) This requirement will aid in focusing consent forms and processes to the goal of assisting a participant in their decision making.<\/p>\n<p>Facilitating participant understanding is the goal of the informed consent documents and processes in all settings, in all languages, and in all countries; local regulations will apply and may be less explicit than the US federal regulations. Nevertheless, the goal of informed consent is comprehension.[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row][vc_row][vc_column][vc_tta_accordion style=&#8221;flat&#8221; shape=&#8221;square&#8221; color=&#8221;white&#8221; c_icon=&#8221;chevron&#8221; active_section=&#8221;0&#8243; no_fill=&#8221;true&#8221; collapsible_all=&#8221;true&#8221; css=&#8221;.vc_custom_1571187875668{margin-top: -50px !important;padding-top: 20px !important;padding-bottom: 20px !important;}&#8221;][vc_tta_section title=&#8221;Mandatory and As-Needed Requirements of the Updated Common Rule&#8221; tab_id=&#8221;1571187292960-4671f0d6-4545&#8243;][vc_column_text]When considering the consent requirements, it helps to keep notes on what US requirements must be included in the consent form. This will help you plan and organize the content in your consent form, and it will help ensure that you do not forget something you planned on including.<\/p>\n<p>Use the following chart which is based on the US requirements to help you keep track of the elements that must be included in your consent forms.\u00a0 This list can be adapted for any country.\u00a0 Use it before writing and when checking drafts.[\/vc_column_text][vc_btn title=&#8221;Download the Consent Guide Checklist&#8221; style=&#8221;flat&#8221; shape=&#8221;square&#8221; color=&#8221;primary&#8221; size=&#8221;lg&#8221; align=&#8221;center&#8221; button_block=&#8221;true&#8221; link=&#8221;url:https%3A%2F%2Fmrctcenter.org%2Fhealth-literacy%2Fwp-content%2Fuploads%2Fsites%2F2%2F2019%2F10%2FMRCT-consent-guide-checklist-1.docx||target:%20_blank|&#8221; css=&#8221;.vc_custom_1571591364047{background-color: #0066bf !important;}&#8221;][vc_single_image image=&#8221;1738&#8243; img_size=&#8221;full&#8221; onclick=&#8221;custom_link&#8221; img_link_target=&#8221;_blank&#8221; link=&#8221;https:\/\/mrctcenter.org\/health-literacy\/wp-content\/uploads\/sites\/3\/2019\/10\/MRCT-consent-guide-checklist-1-2.docx&#8221;][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row][vc_row][vc_column][vc_tta_accordion style=&#8221;flat&#8221; shape=&#8221;square&#8221; color=&#8221;white&#8221; c_icon=&#8221;chevron&#8221; active_section=&#8221;0&#8243; collapsible_all=&#8221;true&#8221; css=&#8221;.vc_custom_1571187879482{margin-top: -50px !important;padding-top: 20px !important;padding-bottom: 20px !important;}&#8221;][vc_tta_section title=&#8221;Research Any Other Legal Requirements&#8221; tab_id=&#8221;1571187291729-f0f166ea-0f01&#8243;][vc_column_text]The next step is to determine if there are any state-specific or industry-specific requirements that relate to your study. While some states and industries have no such laws, other states do. Plus, laws are constantly changing, so research these before beginning to write the consent form. The best place to start is by checking with compliance or regulatory oversight personnel \u2013 e.g. IRBs, CTSAs, Offices of Research Protections, Industry Regulators, etc.<\/p>\n<p>In addition, for multi-regional clinical trials, considering the international legal and regulatory requirements is essential.\u00a0 <a href=\"https:\/\/www.hhs.gov\/ohrp\/sites\/default\/files\/2019-International-Compilation-of-Human-Research-Standards.pdf\" target=\"_blank\" rel=\"noopener\">The International Compilation of Human Research Standards\u00a0&#8211; PDF<\/a>\u00a0is a listing of over 1,000 laws, regulations, and guidelines on human research participant protections in 131 countries and from many international organizations. These standards are maintained and updated annually by the US Office of Human Research Protection (OHRP).[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row_content&#8221;][vc_column][vc_column_text css=&#8221;.vc_custom_1571584992937{padding-top: 10px !important;padding-right: 10px !important;padding-bottom: 10px !important;padding-left: 10px !important;background-color: #efefef !important;}&#8221;]<\/p>\n<h2 style=\"text-align: center\"><strong>Step Three \u2013 Create an Outline of Needed Requirements<\/strong><\/h2>\n<p>[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text]After researching the legally required content for the consent form, Step Three is to create an outline of the content to include. Except for the addition of key information at the beginning of the consent form, you do not have to follow the exact order of requirements as listed in the federal regulations.[\/vc_column_text][vc_tta_accordion style=&#8221;flat&#8221; shape=&#8221;square&#8221; color=&#8221;white&#8221; c_icon=&#8221;chevron&#8221; active_section=&#8221;0&#8243; no_fill=&#8221;true&#8221; collapsible_all=&#8221;true&#8221; css=&#8221;.vc_custom_1571187892701{padding-top: 20px !important;padding-bottom: 20px !important;}&#8221;][vc_tta_section title=&#8221;What requirements should you put first as key information?&#8221; tab_id=&#8221;1571184023250-f2acd0a1-9c4a&#8221;][vc_column_text]For US federally funded trials, the Revised Common Rule now mandates that consent forms \u201cbegin with <strong>a concise and focused presentation<\/strong> of the key information.\u201d Since this is a new requirement, deciding what to include is not always easy nor need it be consistent from trial to trial. It will vary based on your purpose and audience.<\/p>\n<p>The Revised Common Rule states that the following things <strong>may<\/strong> be key information in many studies:<\/p>\n<ul>\n<li>That consent is for research and participation is voluntary<\/li>\n<li>The purpose, duration, and procedures of the study<\/li>\n<li>Any reasonably foreseeable risks or discomforts of joining the study<\/li>\n<li>Any alternatives to the study that might be advantageous to the participant<\/li>\n<li>Any benefits to the participants or others<\/li>\n<\/ul>\n<p>While these five things are listed, you should be flexible in determining what amounts to key information for your specific study. \u00a0\u00a0In <a href=\"https:\/\/www.hhs.gov\/ohrp\/sachrp-committee\/recommendations\/attachment-c-november-13-2018\/index.html\" target=\"_blank\" rel=\"noopener\">an appendix to its guidance<\/a>, SACHRP (the Secretary\u2019s Advisory Committee on Human Research Protection) created the following list of questions to help you determine what might be key information for your study:<\/p>\n<ul>\n<li>What are the main reasons a subject will want to join this study?<\/li>\n<li>What are the main reasons a subject will not want to join this study?<\/li>\n<li>What is the research the question the study is trying to answer? Why is it relevant to the subject?<\/li>\n<li>What aspects of research participation or this particular study are likely to be unfamiliar to a prospective subject, diverge from a subject\u2019s expectations, or require special attention?<\/li>\n<li>What information about the subject is being collected as part of this research?<\/li>\n<li>What are the types of activities that subjects will do in the research?<\/li>\n<li>What impact will participating in this research have on the subject outside of the research? For example, will it reduce options for standard treatments?<\/li>\n<li>How will the subjects\u2019 experience in this study differ from treatment outside the study?<\/li>\n<li>In what ways will this research be novel?<\/li>\n<\/ul>\n<p>These questions can help you choose the key information for your specific study, but involving people who are like the ones you expect to enroll in the study when creating and assessing the consent form is the best way to further refine the consent. You can do this by:<\/p>\n<p>(1) discussing with people from your intended participant population what might be important to them before you even create the form<\/p>\n<p>(2) usability testing a draft version of the form with these individuals and then making changes in later drafts that are consistent with what you learn. <a href=\"https:\/\/mrctcenter.org\/health-literacy\/tools\/overview\/usability-testing\" target=\"_blank\" rel=\"noopener\">Click here to learn more about usability testing.<\/a>[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1571189316087{padding-top: 20px !important;padding-right: 20px !important;padding-bottom: 20px !important;padding-left: 20px !important;background-color: #99ccff !important;}&#8221;]Don\u2019t forget: the consent form should \u201cassist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research.\u201d ([<a href=\"https:\/\/www.ecfr.gov\/cgi-bin\/retrieveECFR?gp=&amp;SID=83cd09e1c0f5c6937cd9d7513160fc3f&amp;pitd=20180719&amp;n=pt45.1.46&amp;r=PART&amp;ty=HTML#se45.1.46_1116\" target=\"_blank\" rel=\"noopener\">46.116(a)(5)(i)]<\/a>)[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row][vc_row][vc_column][vc_tta_accordion style=&#8221;flat&#8221; shape=&#8221;square&#8221; color=&#8221;white&#8221; c_icon=&#8221;chevron&#8221; active_section=&#8221;0&#8243; no_fill=&#8221;true&#8221; collapsible_all=&#8221;true&#8221; css=&#8221;.vc_custom_1571187908841{margin-top: -50px !important;padding-top: 20px !important;padding-bottom: 20px !important;}&#8221;][vc_tta_section title=&#8221;How should you organize the other requirements?&#8221; tab_id=&#8221;1571187671088-effce354-66bf&#8221;][vc_column_text]There is no definite answer for this, so keep in mind the goal \u2013 to facilitate understanding. The following tips will help you do so:<\/p>\n<ul>\n<li><strong>Rank what is most important to participants <\/strong>\u2013 This is what will drive most of your decisions. You can categorize things by thinking about what participants must do, risk, or undergo to be in the study. While many are hesitant to try and predict what potential research participants might think is important, trying to put yourself into that mindset, and talking with others outside the medical profession will help you make better ranking decisions.<\/li>\n<li><strong>Put more important information before less important information <\/strong>(in the document, on pages, and in sections) \u2013 people are less likely to overlook something if it is at the beginning.<\/li>\n<li><strong>Put related content close together<\/strong> \u2013 This seems self-explanatory, but you will often see related information scattered throughout longer documents. When the material is not close together, there is a real risk that the participant will not be able to process all of the information in a way that helps make complex decisions.<\/li>\n<\/ul>\n<p>[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1571184384970{padding-top: 20px !important;padding-right: 20px !important;padding-bottom: 20px !important;padding-left: 20px !important;background-color: #99ccff !important;}&#8221;]For example, if you are conducting a study where there is a real risk that the patient may suffer complications, explaining who will pay for the medical treatment if complications arise will be extremely important to most patients. It would, arguably, be more important than if significant results will be provided or if the researcher stands to gain financially.[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row_content&#8221;][vc_column][vc_column_text css=&#8221;.vc_custom_1571585001221{padding-top: 10px !important;padding-right: 10px !important;padding-bottom: 10px !important;padding-left: 10px !important;background-color: #efefef !important;}&#8221;]<\/p>\n<h2 style=\"text-align: center\"><strong>Step Four \u2013 Plan Your Design Strategy<\/strong><\/h2>\n<p>[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text]Once you have an outline to help organize the content you will include in your consent form, Step Four is to plan your initial design strategy. \u00a0Sometimes it is helpful to do this even earlier in the process, especially if you have to make significant choices up front, like whether this consent will be electronic or in print. Determining if this consent will be electronic or in print is the one of the most important factors in determining your design strategy. Whether you use color, the size and page limitations of your consent, and whether you use graphics, media, or other non-text features are all factors that are directly impacted by this decision.<\/p>\n<p>Whatever the medium, there are a number of things that help foster a clear, user-focused design \u2013 so you should plan for these before you begin writing a draft:<\/p>\n<ul>\n<li>Use at least 12-point font (probably larger)<\/li>\n<li>Use plenty of white space<\/li>\n<li>Include table, charts, and graphics<\/li>\n<li>Consider a color scheme with subtle shifts of color to make different sections stand out<\/li>\n<li>Save enough space for Signature Boxes and Other Logistical Requirements<\/li>\n<li>Find models of good consent forms to use as a starting point <a href=\"https:\/\/mrctcenter.org\/health-literacy\/tools\/overview\/casestudies\/#case1\">You can find one example here<\/a><\/li>\n<li>Plan time to engage members of your target audience for user-testing and feedback<\/li>\n<\/ul>\n<p>[\/vc_column_text][vc_column_text css=&#8221;.vc_custom_1571184512021{padding-top: 20px !important;padding-right: 20px !important;padding-bottom: 20px !important;padding-left: 20px !important;background-color: #99ccff !important;}&#8221;]<strong>Note: <\/strong>When using color, be sure to account for participants who are colorblind. Watch out for greens and reds, or any other contrast that makes the content harder to see or read.[\/vc_column_text][\/vc_column][\/vc_row][vc_row full_width=&#8221;stretch_row_content&#8221;][vc_column][vc_column_text css=&#8221;.vc_custom_1571189713090{padding-top: 10px !important;padding-right: 10px !important;padding-bottom: 10px !important;padding-left: 10px !important;background-color: #efefef !important;}&#8221;]<\/p>\n<h2 style=\"text-align: center\">Drafting the Content in Plain Language<\/h2>\n<p>[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text]After diligently planning and preparing to draft a consent form, writing a draft is much easier. Keep your audience in mind as you start writing the content <a href=\"https:\/\/mrctcenter.org\/health-literacy\/tools\/overview\/plain-language\/\">using plain language principles<\/a>. Let the participants\u2019 need to understand drive your writing decisions. Make sure to check with your IRB\/EC to find out if there\u2019s an institutional template you should be using.[\/vc_column_text][vc_tta_accordion style=&#8221;flat&#8221; shape=&#8221;square&#8221; color=&#8221;white&#8221; spacing=&#8221;10&#8243; c_icon=&#8221;chevron&#8221; active_section=&#8221;0&#8243; no_fill=&#8221;true&#8221; collapsible_all=&#8221;true&#8221;][vc_tta_section title=&#8221;Using a Content Template v. Creating a Consent from Scratch&#8221; tab_id=&#8221;1571184627335-115d3b78-9cc5&#8243;][vc_column_text]If you are not bound by a template, you can find existing templates or consent forms to get ideas on what to say and how to phrase things. But be careful. Most past consent forms are not written health literacy in mind, so alter it to better promote participant understanding using the tips in this guide.<\/p>\n<p>If you must use a specific template, like one from your institution or a sponsor, there are a few reasons why it is still helpful to do your preliminary planning and preparation before turning to the template.<\/p>\n<ul>\n<li><strong>Think about your audience and purpose for creating the consent form so you can better view the existing template from your prospective participant\u2019s point of view.<\/strong> Many templates were not created with a participant\u2019s health literacy needs in mind. Rather, they were created with an eye towards regulatory compliance. Therefore, as you read through the template, ask yourself whether the wording and the organization would foster participant understanding.<\/li>\n<li><strong>Use your pre-planned outline to help you assess whether this template covers what you need to cover<\/strong>. Templates have often been used for years, so your planning may alert you that you either have an older version of the template or that the current version is out of date. Plus, while organizations have recently updated their templates to comply with new clinical trial regulations, make sure you are using the most up-to-date version before you start \u2013 this will save you time and speed up IRB\/EC approval.<\/li>\n<li><strong>Use your initial design strategy to better determine how to fit your study-specific requirements into the existing template<\/strong>. In any case, if you must use a template, remember your primary purpose under the Revised Common Rule is to facilitate the participant\u2019s decision of whether to take part in the study. Let this be your guide as you decide write and organize the content in the template.<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;After the First Draft: Revising &amp; Testing the Consent&#8221; tab_id=&#8221;1571184627408-b476a9a1-600e&#8221;][vc_column_text css=&#8221;.vc_custom_1571184811191{padding-top: 20px !important;padding-right: 20px !important;padding-bottom: 20px !important;padding-left: 20px !important;background-color: #99ccff !important;}&#8221;]<strong>A note about translation:<\/strong> If you plan to consent non-English speakers into your study, translate and back-translate the content to ensure meaning is retained, and then perform usability tested with native speakers of the language.[\/vc_column_text][vc_column_text]After you finish planning and writing the first draft of the consent form, there are still important parts left to make it understandable. You must:<\/p>\n<ul>\n<li>edit the consent form<\/li>\n<li>test it with your audience<\/li>\n<li>revise the form based on the testing<\/li>\n<\/ul>\n<p><strong>Editing <\/strong>before you test helps to ensure that you covered all the needed elements of the consent form Common Rule and followed through on your initial plan for organizing and ordering the information. It also helps to make sure that your headings are consistent and that your consent language follows health literacy best practices. In short, you don\u2019t want to test an unedited draft, you want to reread and polish it to make sure people aren\u2019t distracted when testing it.<\/p>\n<p>One tip for editing effectively is to edit multiple times looking for specific things. If you look for everything in one edit, you will miss a lot. For example, if you do one edit just for the headings, you are more likely to catch every error related to the headings than if you looked for content coverage, headings, word choice, punctuation, etc.<\/p>\n<p><strong>Usability testing <\/strong>with people who are similar to your intended study population will help you spot gaps in content, learn what people think is important, and recognize areas where people may struggle with the writing. <a href=\"https:\/\/mrctcenter.org\/health-literacy\/tools\/overview\/usability-testing\/\">Learn more about usability testing<\/a> .<\/p>\n<p><strong>Revising <\/strong>content is more inclusive than editing content. Revising involves reorganizing content, major rewrites or design changes, and other larger-scale issues. While you may need to revise an early draft of the consent to get it into a form that you can test, it is important to plan on revising content after you test it with your audience. This is when you have actual user input, so your revisions will be much more focused and useful than those revisions you do before testing.<\/p>\n<p>&nbsp;<\/p>\n<p>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Ten General Tips for Writing Clear Consent Content&#8221; tab_id=&#8221;1571184735349-69219a1b-8fb7&#8243;][vc_column_text]<strong>(1)<\/strong> <strong>Keep your words, sentences, and paragraphs short<\/strong> (15-25 words per sentence; 3-5 sentences per paragraph, on average). Use bullets as much as possible. Along those lines, use words with fewer syllabus instead of longer words with more syllabus.<\/p>\n<p><strong>(2) Use high-frequency words<\/strong> that people have likely heard before in their everyday lives.<\/p>\n<p><strong>(3) Carefully consider how you use numbers. <\/strong>This is such an important area that we\u2019ve created a separate <a href=\"https:\/\/mrctcenter.org\/health-literacy\/tools\/overview\/numeracy\/\">page to help further explain it.<\/a><\/p>\n<p><strong>(4) Explain complex terms.<\/strong> If you must use a complicated term, explain it.\u00a0 People will appreciate it even if it makes the document longer. You can do this by:<\/p>\n<ul>\n<li>Using visuals to help explain the term or concept.<\/li>\n<li>Providing a definition or an example using a few short, simple sentences<\/li>\n<li>Using simpler synonyms, if they exist.\n<ul>\n<li><strong>Tip<\/strong>: There are a few plain language dictionaries that can help give you ideas of clearer terms to use. <a href=\"https:\/\/mrctcenter.org\/health-literacy\/tools\/overview\/glossary\/\">You can find some of our favorites here<\/a><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><strong>(5) Use the active voice <\/strong>which is more clear and easy to understand. <a href=\"https:\/\/mrctcenter.org\/health-literacy\/tools\/overview\/plain-language\/#1564763120618-b00dc84c-efde\">You can find some examples here.<\/a>[\/vc_column_text][vc_row_inner][vc_column_inner][vc_column_text]<strong>(6) Avoid nominalizations.<\/strong> Nominalizations arise when you create a noun based off of an existing verb or adjective. When this happens, it generally makes for longer words and longer sentence that often lack a clear action. \u00a0Change the sentence to use the verb or adjective form of the word instead.[\/vc_column_text][vc_column_text]\n<table id=\"tablepress-12\" class=\"tablepress tablepress-id-12\">\n<tbody class=\"row-hover\">\n<tr class=\"row-1 odd\">\n\t<td class=\"column-1\"><b>Nominalization<\/b><\/td><td class=\"column-2\"><b>Verb Form<\/b><\/td>\n<\/tr>\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\">decision<\/td><td class=\"column-2\">decide<\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\">discussion<\/td><td class=\"column-2\">discuss<\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\">removal of<\/td><td class=\"column-2\">remove<\/td>\n<\/tr>\n<tr class=\"row-5 odd\">\n\t<td class=\"column-1\">disagreement<\/td><td class=\"column-2\">disagree<\/td>\n<\/tr>\n<tr class=\"row-6 even\">\n\t<td class=\"column-1\">collection<\/td><td class=\"column-2\">collect<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-12 from cache -->[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner][vc_column_text]<strong>(7) Use informative headings. <\/strong>Informative headings tell the participant what a section will be about and how it relates to them. A great way to make a heading more informative is to phrase it as a question or direction rather than a statement.[\/vc_column_text][vc_column_text]\n<table id=\"tablepress-13\" class=\"tablepress tablepress-id-13\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">Statement<\/th><th class=\"column-2\"><\/th><th class=\"column-3\">Question<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\">Risks<\/td><td class=\"column-2\">vs.<\/td><td class=\"column-3\">What are the risks of being in the study?<\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\">Injury<\/td><td class=\"column-2\">vs.<\/td><td class=\"column-3\">What happens if I get injured?<\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\">Study Procedures<\/td><td class=\"column-2\">vs.<\/td><td class=\"column-3\">What will happen if I join the study?<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-13 from cache -->[\/vc_column_text][\/vc_column_inner][vc_column_inner][vc_column_text]<strong>(8) Break information into shorter chunks of information \u2013 <\/strong>this helps make the information more digestible.<\/p>\n<p><strong>(9) Include enough white space so that text is not overwhelming<\/strong> \u2013 it has to look inviting for people to want to start reading it.<\/p>\n<p><strong>(10) Use clear visuals instead of just words<\/strong> \u2013 we know people learn in different ways, so use images, graphics, and video to help explain topics that are difficult to explain using words.[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row]<\/p>\n<\/section>","protected":false},"excerpt":{"rendered":"<p>[vc_row][vc_column][vc_row_inner][vc_column_inner][vc_column_text] Applying\u00a0Health Literacy to Informed Consents for Research: Quick Tips for Clearly Explaining the Requirements Adapted from original material created by: Christopher R. Trudeau, JD[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_column_text css=&#8221;.vc_custom_1571229243482{margin-top: -50px !important;}&#8221;] Creating consent materials that people can understand involves not only thinking about the content needed, but also how that content will be worded, ordered, and presented. Consent [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":0,"parent":255,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"template-sub.php","meta":{"footnotes":""},"class_list":["post-878","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.0 (Yoast SEO v25.0) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Consent Guide - Health Literacy in Clinical Research<\/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\/health-literacy\/tools\/overview\/consent-guide\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Consent Guide\" \/>\n<meta property=\"og:description\" content=\"[vc_row][vc_column][vc_row_inner][vc_column_inner][vc_column_text] Applying\u00a0Health Literacy to Informed Consents for Research: Quick Tips for Clearly Explaining the Requirements Adapted from original material created by: Christopher R. 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