Welcome to Lesson 7, Managing an Effective Person-Centered Consent Process. We know that each of you work hard to implement a strong consent process, and you know that the process requires more than simply having participants sign a form. This lesson doesn't focus on laws or regulations around consent as many of you already have that knowledge. Rather, this lesson focuses on what should happen during consent, outline what we call a person-centered consent process. As stated by the FDA in this quote, we all know that the consent process is more than a signature, but we are often challenged as to how to make that happen. We've already described person-centered approaches in previous lessons and mentioned the cross-cutting nature of applying person-centered practices along the recruitment process. A person-centered approach is critical throughout the consent process. During the consent process, it's critical that we ensure informed decision-making and assess comprehension. Sometimes in many consent discussions, critical information is omitted or poorly presented. This suboptimal communication may explain in part participant misconceptions and gaps in knowledge about the trials that they have consented to. There are two components in the consent process: one, the written information shared and signed by the participants; and two, the process by which the research team provides the information and answers questions. We have to ensure comprehension throughout the whole process of consent. Understanding participant's readiness, health literacy and comprehension is crucial to the consent process. As we've discussed in previous lessons, culture, values, beliefs, affect the way we think about health, wellness, healing, and delivery of care. We have mentioned also how culture affects how people communicate, understand, and respond to health information. Taking part in a study may influence family's everyday schedules and issues such as childcare and transportation. Some people need to make decision-making processes with their family or even community, so we have to take into account who those family members or community members are. Participation of immigrants or refugees also needs to be considered. A temporary status of immigrants or refugees might make them fear their participation could have a negative effect on their immigration process. Education is also an important cultural issue, especially when it comes to literacy and health literacy, which we're going to talk about in a moment. You may be surprised to learn that patients from minority communities might have different expectations from their healthcare providers. We have evidence that what the researcher does is not necessarily what community members prefer to encourage their comprehension during the consent process. Of particular interest are the vast differences between perceptions of the community versus researchers of the need to talk with other trial participants, the use of video, and the consent form being read to participants. This also underscores the need for different kinds of practices to ensure comprehension, which we're going to talk about later in this lesson. When considering the format of the consent form, the focus on plain language is certainly helpful as our questions and answers in real time. But as you can see here, many community members in the same study, all from minority groups, would also like to see consent summaries in pictures as ways to enhance understanding. Here's some other insights from minority groups. Research honesty was an important motivator for participation. The informed consent process must be a true conversation. Trust must be established between the researcher and the participant. But it's important to know that 60 percent believed that people are occasionally or more than half the time pressured into participation in research. Here's a quote that we'd like you to consider, When someone hands you this document and sits in front of you while you're reading, it's intimidating and it makes you nervous, and you can't really read it well. So, we need time and a properly designated space where we can read and sign it. If they can take it home and read it with a family member, it would be better. This way, they'll feel more comfortable in discussing the document with their family rather than with a stranger. You can say to them, "I can help you. You can do it by yourself or you can take it with you." It's important to give them options because you're not aware of my skills yet. This is a quote from a Spanish speaking person with low literacy skills. The quote about informed consent, illustrates what some participants felt was most important about the process. They also express the need to be given time and space to carefully review the consent form before making a decision about participating in the study. As we reviewed in Lesson 6, decision support includes things like values, family, community, and an entire process of decision support. Once more, we want to talk about informed decision-making, which is another important issue around consent. This time we're talking about the decision of participating in a study or not, whereas in previous lessons, decisions did not necessarily result in signing a consent form. To do this, we want to ensure that participants have knowledge of their condition, their options, benefits, risks, scientific uncertainties. They want to make sure they have realistic expectations of the likelihood of benefits and risks, we want to make sure they’ve been helped to understand their own values or personal importance of benefits, risks and uncertainties. We also want to make sure they have support from others or from resources that we can provide. Remember again that culture, values and beliefs affect the way we think about health, wellness, healing and delivery of care. An important note about culture and consent is that in many cultures, it's common for people to bring their family members or other important people with them, and to make decisions as a family or group. Accounting for this type of group decision-making process can also inform the informed consent process. As we've discussed before, taking part in a study may also influence family's everyday schedules and issues, like childcare and transportation, and all of that might have an impact on long-term participation. Information on the family consequences of participation should also be given during the consent process. Another key issue to consider during the consent process is the issue of English proficiency. As we spoke of in earlier lessons, the demographics in the US are changing, and with it, the variety of languages spoken by people other than English continues to increase. Meaning, there's an increasing percentage of patients who are limited English proficient or LEP. LEP patients are defined as people who don't speak English as their first language and may have a limited ability to speak, read or write in English. Given the statistics on changing demographics, it's clear that the extent of LEP patients seen in a clinical research setting is likely continued to grow. People with LEP are underrepresented in clinical research as we mentioned earlier. Specifically, researchers simply often decide to simply exclude LEP people from enrollment from their study as a way of avoiding problems and hassles related to language barriers. Among the reasons researchers cite for excluding LEP people were difficulties translating study documents and problems with recruiting, training and paying bilingual staff. What do you think could be some of the problems with this? Well, first, one, exclusion of LEP people can limit the generalizability of a research study by excluding people with particular ethnic or cultural differences. Two, intentionally excluding LEP people would be unfair to potential subjects who happened to have LEP as it relates to the principle of justice as discussed in the Belmont Report. Remember we talked about this which requires fair procedures and outcomes in the selection of subjects. Three, intentionally excluding people with LEP may also violate federal research regulations which state that selection of subjects should be equitable. Four, the failure to ensure that LEP persons can effectively participate in or benefit from federally assisted programs and activities such as many of the grants that you all work on may constitute national origin discrimination. With this in mind, there are several key issues related to LEP populations that are important to be aware of in the context of clinical trials. One is that, much like those facing low health literacy, LEP patients may have a harder time reading and understanding health-related information, at the same time IRBs perhaps like yours provide little guidance regarding inclusion of LEP patients in research. So it's incumbent upon you and all of us in the research team to anticipate what potential language access needs might arise in your catchment area, and have the necessary resources available, such as translation and interpreter services to meet these needs. Making consent forms easier to read is not necessarily addressed the linguistic challenges that researchers face when obtaining consent from individuals who speak languages other than English, or who have limited English proficiency, even when using a consent form that has been translated into the target language without determining whether the translation process actually rendered an easy to understand consent form. Institutional Review Boards requirement of conducting back translation procedures to verify translation addresses the issue of content accuracy, but not content comprehension. Many consider back translation as rough and mechanistic assessment of translated text. Forms translated by professional translators should be pre-tested for comprehension with individuals who speak those languages, and who have different levels of literacy and familiarity with research and informed consent. If investigators enroll participants without an IRB approved written translation, the short form written consent document in a language that the subject understands should be used to document that the elements of informed consent were presented orally. Many IRBs will allow the use of the short form, which has specific requirements for its use, usually for the unforeseen needs of an LEP participant. However, IRBs might consider approving the use of the short form in situations where the participant or the legally authorized representative is unable to read due to having low literacy skills or blindness. It's important to understand some key issues about working with interpreters. There have been communication errors associated with using family members or untrained staff as interpreters. Professional interpreters provide more accurate information than ad hoc interpreters, and the use of professional interpreters increases participant and physician satisfaction compared to when we use ad hoc interpreters or no interpreters at all. Other things to keep in mind include the importance of maintaining focus on the participant, and watching for cues of understanding or confusion. Research team members must be aware that trained interpreters needs to comply with confidentiality guidelines. They should also know that family members with their previous knowledge of the participant, and their best interests and how the encounter plays out make highly inaccurate and intrusive interpreters. In addition, patients might be unwilling to disclose crucial health-related information with family members present, especially if that information is of a delicate nature. Using children or minor children to interpret is even more questionable, and may be ethically inappropriate. Remember research staff is still in charge of the consenting process. The interpreter is merely the means of communication with the patient. Where possible, it may be helpful to provide basic training to interpreters, about the basics of clinical trials which can aid in their ability to effectively translate complex trial concepts. Training physicians, and research staff, in interpreter use combining with making it more convenient can actually increase the use of interpreters. Nonetheless, there are some issues about the use of professional interpreters as there is still no mandatory national standards for what constitutes appropriate certification for professional interpreters. It's important to note that even among interpreters who are trained may not understand some nuances about trials. The last key issue during the consent process that we will discuss is related to health literacy. Health literacy has already been introduced in previous lessons. Take a look at the sentence presented here. As you notice, reading it is challenging because the word letters do not appear in the correct order. So you left with trying to read it word by word. In fact, as noted by one researcher, individuals with limited health literacy often read sentences word by word, and doing so can make it more difficult for them to remember information from the beginning to the end of the sentence. The average adult reads at the eighth or ninth grade level, and 20 percent read at the fifth grade level or below. Documents are long and written at a reading level way beyond the capacity of most potential participants. Therefore, to ensure wide understanding, it's best for materials to be written at a fifth or sixth grade level. But reading levels only tell part of the story. What is not participant centered consent? Obviously this quote. This is often heard among research teams using consent as a verb, and the very problematic word subject. Let's talk more about how we can ensure that the process is as person-centered as possible. Not only are we providing information for the potential participant to decide whether or not to participate. In addition, we need to build rapport, we need to be responsive, we need to answer questions and encourage that kind of environment, and we have to assess understanding. Decision support, as described here, provides structured assistance and deliberating on the options and communicating with others that's tailored to the patients decisional needs. The process involves the steps outlined here, and is best used when someone has actively thinking about whether or not to participate in the trial. Supporting empowered and active decision-making is a critical part of the consent process. Empathy is of particular importance in an effective person-centered communication process. Ability to recognize the opportunities and to respond to a patient empathetically, communicating desire to understand can help patients understand and cope effectively with their illnesses and their decision-making process.
