NIH All About Grants Podcast � Language Access

Kosub >> For us to be successful at recruiting the appropriate people into our supported clinical research, researchers must consider a lot of different things when developing their applications and planning their research. This includes thinking about the languages that people speak and accurately communicating information to the participants. Well, join us for this NIH All About Grants podcast, where we're going to talk more about the NIH language access policy.

Announcer >> From the National Institutes of Health in Bethesda, Maryland. This is all about grants.

Kosub >> Well, welcome to the show. I am glad to say we have two guests with us today to talk more about the NIH's language access policy. We have Miss Melissa McGowan She is the deputy director of the Office of Clinical Research within the National Institute on Aging Division of Extramural Activities. And we also have miss Dawn Corbett. She serves as the NIH inclusion Policy officer here at the NIH in the Office of Extramural Research. And I welcome you both to the show.

Corbett >> Thanks, David. Glad to be here.

McGowan >> Glad to be here.

Kosub >> So let's just jump right in. Why is language access so important when we're thinking about clinical research?

Corbett >> Well, David, to start with, language access is a requirement of your NIH grant. So if you're a recipient of federal financial assistance, you're required. If you receive an NIH grant to take reasonable steps to make your program services and activities accessible to individuals with limited English proficiency. But for me, as the NIH inclusion policy officer, I tend to look at language access through the lens of inclusion of women members of racial and ethnic minority groups, and individuals of all ages and research. Any age requires inclusion of all of these groups in research, and the goal of our policies is to have research that's generalizable across populations. So we know that individuals from different backgrounds communicate in different ways, and we need individuals to be able to fully engage in research. So some participants may speak English. Others may have limited English proficiency. Some people may access communication more visually, while others may prefer um to use more auditory communication. And in order to make sure that individuals from various backgrounds and individuals with disabilities are fully included in research, we need to make sure that they understand what's going on in the research throughout the entire study. Um, it's also important for us to think about how participants will access language from the very beginning. When you're designing an NIH trial, and we have some examples of this at NIH. So, for example, the all of US research program has made a concerted effort to include their materials in multiple languages and to hire bilingual staff, and as a result, they've seen higher enrollment of participants from traditionally underrepresented groups.

McGowan >> To just follow up on what Dawn said. From our perspective, when we are looking at our research portfolio, when we're developing and testing new or enhanced interventions, treatments, prevention strategies, we really want to ensure that the work that we are doing, the work that we are funding, is going to be available for the broad spectrum of people in the United States who need those treatment, those prevention strategies. So that's why communication, language access, all of these topics that we're talking about today are so important. Um, across the board.

Kosub >> I'd like to touch on some of those points that were made earlier about thinking about communication across the, you know, throughout the life of the study, the communication between the participants and the research team. Can you all talk more about that and why that communication is so critical?

McGowan >> Yeah, I'm happy to. Um, this is something we think about a lot, um, especially in the Office of Clinical Research. Um, we have done a lot of work thinking about access and inclusion. Um, and what we hear over and over again is that, um, communities want to be engaged in research beyond just being asked to participate. So this kind of community engagement is critical. And part of that includes developing meaningful, sustainable relationships within communities even before a study is designed. And we're thinking about recruiting participants. And that's where the ability to communicate. And some of the things that Dawn was talking about earlier, culturally appropriate message, uh, you know, language access, types of materials. It's so important for that to be part of the research community participant relationship even before, um, you know, those grant applications start to come in.

Corbett >> So, David. I would piggyback on what Melissa said and just, you know, reemphasize that participants should be able to be fully engaged throughout the entire study, including always understanding what they're agreeing to and any procedures that are being performed. And so we often think about this in terms of informed consent. And some folks, when they think of informed consent, think of the informed consent form. But it really goes far beyond this to make sure that participants understand the risks and the benefits of their participation and their right to withdraw from the study at any time, and that they know how to do that and have someone to communicate with in order to do that. Um, we also think about this, you know, in terms of the informed consent document, making sure that that's translated into a language the participant can understand, making sure that recruitment materials are accessible, um, and making sure there's someone that that participant can communicate with throughout the entire study. As they undergo procedures to answer any questions, they have to be available if they want to call to talk about any side effects they may be experiencing and these kinds of things, and also to return meaningful results to the participants in a way that they can understand. So and then I would also touch on the fact that language access is also important to your study integrity. So if participants are able to follow the protocol, for example, if they need to take medication at a certain time or at a certain dose if they need to report certain effects, we need to make sure that they fully understand the study protocol and what they need to do in order to protect the integrity of the study data. This is, of course, also a safety issue, right? If participants don't understand when they're supposed to take a study medication, for example, or the correct dosage, this could present a safety issue for participants. So it's really critical that all participants have access to communication in a way they can understand throughout the entire study.

Kosub >> Yeah, definitely is critical for, you know, ensuring their protection as they participate in these studies, I echo that. Um, you all have both touched on, like the grant application and kind of how it's in there. And Dawn, you even mentioned early on that, you know, it's a requirement as the term and condition of an actual award. Well, can you talk more about kind of how do you weave in language access into a grant application?

Corbett >> Sure. A couple of places where you may address language access in your study application include your inclusion plans and also your human subjects protection plans. Um, so you might address language access when it's relevant to the participation of women members of racial and ethnic minority groups or individuals across the lifespan. So, for example, you may talk about your recruitment materials and which languages they're available in. If you're doing radio advertisements, these kinds of things in several languages, or how your study staff will communicate with children in a way that they can understand, um, what's going on in their experience in doing so. Um, and you can also address language access in the Human Subjects Protection plan. Um, especially as it relates to the adequacy of your protection against risks. Um, so, for example, in the description of your informed consent process, and you're talking when you're talking about strategies for minimizing risks or reporting adverse events, you can address, you know, what kind of access your participants will have, um, to language and language they understand, and how they can report adverse events, for example, if they don't speak English or otherwise may need translation services.

Kosub >> Thanks for that. I mean, I could still see that if a researcher is out there having to translate all these documents and how to get all this information out there, it could be costly or it could be a potential cost to them as part of their grant. Are they allowed to use grant funds for language access?

Corbett >> Yes you can. And so it's really important when you're developing your budget that you think about language access and any resources that you might need in order to make sure that you're able to communicate with your participants. So you can use federal funds to support, for example, language translation of your study materials, including your informed consent forms. Um, and that should be part of the budget that you submit to NIH. Um, if you already have an award and realize maybe you need some additional resources for language access, you also are allowed to rebudget costs within the scope of your grant with prior approval.

Kosub >> If if someone's kind of coming at this new and you know they may not be too familiar with this, like how to make their information accessible or appropriately translated in a different languages. Are there resources that exist? Are there options that people can look at And to learn more about how to ensure that their materials are as accessible to as many communities as possible?

Corbett >> Yeah, we do have language on the OER inclusion website. We have a nice document that kind of compiles different resources across NIH. A number of our ICS have created tools and resources. Our intramural program has some information to help you think through language access in, for example, with informed consent. Um, also our CTSAs um, the Trial Innovation Network has a library where they've shared information on various aspects of recruitment and retention. So I'd encourage you to check those out. Um, our National Institute on Aging also has some great resources. So Melissa, I'll kind of turn it over to you to talk about some additional resources that we have.

McGowan >> Sure. Absolutely. As Dawn said, I know a lot of the institutes and centers have information often already translated into into other languages. And I know, for example, on our Nia website, our Office of Communication and Public Liaison works, you know, really diligently to translate and to disseminate the findings from from some of our research. There is information on our website for a range of audiences. There's information that's already available in English and Spanish and Simplified Chinese. Um, some are designed for, uh, you know, the general public. But as researchers and research teams are building their outreach and recruitment plans, there's a whole host of information that is available that I would just encourage people to look at before you feel like you have to kind of reinvent the wheel and create your own materials. In the Office of Clinical Research. We have a new a new tool that we have developed. It's called Outreach Pro and it is an online materials recruitment generator for Alzheimer's clinical trials. So as a research team, you can go on to this website. You can create materials that either promote your individual study or if you're doing general awareness about brain health, those materials can be tailored to your specific needs. And the beauty of Outreach Pro is that we have done a lot of the formative research. So the messages that are available have been audience tested. Um, and it's really designed to fill a need that we heard from our grantees about needing some additional help when it comes to recruitment activities, recruitment materials, particularly for underrepresented audiences. So in that tool, um, we have messages that were tested with African American, Hispanic, Latino, Asian American, Pacific Islander, uh, audiences, and the materials are available. Some materials are available in English, Spanish, Chinese, um, Tagalog and Hindi. So a wide range of information there. So I hope you take a look at some of our resources available at Outreach Pro Nia. And also NIH has the clinical trials and you website that also has a lot of great information really designed for participants. But I think there's a lot of information there that could be helpful and relevant to researchers as they're thinking about outreach efforts.

Kosub >> Yeah, definitely sounds like there's a lot out there, so no need to recreate the wheel. Definitely check out all those resources. There will be some affiliated with this podcast on the narrative, so check those out as well. Um, Melissa Dawn, this has been great. To learn more about the language access policy here at NIH, how one can fit it into their application. Uh, any final thoughts before we leave? Anything that that we'd like to leave with the audience about this topic?

Corbett >> I would just say that, you know, for the reasons of inclusion, it's really important to know your participants and to know the communities from which you're enrolling. And so this is something you want to think about throughout your study. We do have resources at NIH to help you, and I really encourage you to talk to your program officer. Um, if you have any questions about language access. Um, we're here to help.

McGowan >> Um, and I echo everything that Dawn has said. And, um, David, thanks for having us on to address this, this important topic. And I would just say, um, you know, to be able to engage and communicate with the participants. Participants, um, whom you want to, um, include in your clinical studies. It's all about being able to communicate and engage across the life course of of a research project, because ultimately, I think we're all looking to make sure that the treatments and the prevention strategies that we are testing work for the people who need them most.

Kosub >> Well, here, here I will reecho everything that you guys have been echoing and say that I truly appreciate all of these, all this information and all these resources on language access and, you know, helping people ensure that the the studies that they're going to be developing and considering are going to actually be accessible, and the information is going to be available to all sorts of participants who are relevant for the study population. Definitely go out and check the resources that are available. My name is David Kosub and this has been NIH�s all about grants.