NIH All About Grants Podcast

Inclusion Plans (Part 1): Background and Application Prep


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


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>> Kosub: Hello and welcome to another virtual edition of NIH’s All About Grants podcast. I’m your host David Kosub with the NIH’s  Office of Extramural Research. And today we have the first in a two part series on inclusion plans and inclusion policies here at NIH and in everything you need to know from start to finish, hopefully. and we have with us Ms. Dawn Corbett. She serves as the NIH inclusion policy officer and is also within the NIH Office of Extramural Research. And I welcome you to the show, Dawn.


>> Thanks, David.


>> Kosub: Sure. Sure. So let's just jump right in. And can you tell us a little bit about the history of these inclusion policies?


>> Corbett: Sure. And NIH actually has two inclusion policies. The first one is the inclusion of women and minorities as participants in research involving human subjects. So that policy has actually been on the books since 1994 in its current form, after it was mandated by Congress. And that policy requires that women and members of racial and ethnic minority groups be included in all NIH funded clinical research studies unless there's a compelling rationale for exclusion. And then there some additional requirements for an NIH defined Phase three clinical trials. They have to conduct analyses by sex or gender, race and ethnicity and report on those analyses. And then our second inclusion policy is the NIH policy and guidelines on the inclusion of individuals across the lifespan as participants in research involving human subjects. So this inclusion policy requires inclusion of individuals of all ages and NIH human subjects research unless there are scientific or ethical reasons not to include them. So this policy is more recent. It became effective for applications submitted on or after January 25th, 2019. So it's just been around for a few years and it requires some additional requirements for submission of data in progress reports.


>> Kosub: Thanks for that. and to put a plug in for another podcast, we did one on inclusion across the lifespan too, so check that one out. So inclusion plans. So when you're putting together your application, you have to develop an inclusion plan which is what we're here talking about. Can you tell us what our inclusion plans and kind of like how they fit in?


>> Sure. Inclusion plans are part of your application. you'll be completing a peer just human subjects of clinical trials, information form if you're doing human subjects research and part of that form and section two, there are two attachments one for the inclusion of women and minorities and one for inclusion across the lifespan. So this is the place in your application when you talk about inclusion of these groups.


>> Kosub: So what is actually required to be in these? are these plans and like you mentioned, there's two of them. Like how much space to me do I have in my application for them?


>> Corbett: Well, the good news is there's no page limit. So you can take the space that you need to describe inclusion of these populations in your research. As far as what's required, both plans require that you describe the planned distribution of participants. So in the inclusion of women and minorities plan, you'll be describing your inclusion based on sex or gender and race and ethnicity. And then in your inclusion of across the life span plan, you'll be describing distribution based on age and then you talk about the rationale. So why did you choose this population distribution? And this should really be based on science and ethics and you'll justify any exclusions. So if you're excluding any population, for example, if you're doing a study on prostate cancer and you're excluding people whose sex at birth is female, then you would explain that in this part of the application for the plan on inclusion of women and minorities, you also want to describe proposed outreach programs for recruiting sex or gender, racial and ethnic group members. And then in your inclusion across the Lifespan plan, you'll want to talk a bit about the expertise of the study team. So for example, if you're working with children, do you have pediatric expertise on staff or consultants that you're working with similarly for older adults?


>> Kosub: In that answer you hit on a couple of things I want to ask some questions about perhaps. Could you talk a little bit more about like the recruitment and outreach as part of these plans?


>> Corbett: Sure. So you will want to talk about outreach programs and your inclusion of women and minorities plan. So in this plan, you'll want to talk about things like, you know, are you involving family and communities? You have programs to target these communities. Do you have language resources, plans for participant communication with either sex or gender, race or ethnicity groups? But you won't talk about the details of recruitment and outreach there. You can talk about those details in the recruitment and retention plan, which is another attachment on the page as human subjects of clinical trials information form. That's the place to provide the specifics about how you recruit and retain participants in your study. But you will mention these programs and the inclusion of women and minorities plan.


>> Kosub: And what about as it relates to potential budget implications? like it's not like a participant's going to be compensated for their time or you know, travel or something like that. Is that included in an inclusion plan?


>> Corbett: Not necessarily. You definitely want to think about the budget when you're developing your inclusion plan. It's very important to think about things like, are you going to be paying for transportation or childcare for your participants, which can affect the participants ability to participate and disproportionately affect some groups. So you definitely want to consider that. But the specifics of your budget should be included in the budget terms of your application. So you want to be thinking about inclusion and what resources you may need while you're completing your budget forms. Participant compensation doesn't need to be discussed in the inclusion plan, but again, you'll talk about any strategies for an inclusive study population. So as specific budget items relate to those strategies, you can mention that there.


>> Kosub: Thanks for that clarification. And also jumping back to you had mentioned some exclusions that might be addressed in an inclusion plan. How specific do so I need to be? Can you tell us a little bit more about that?


>> Corbett: Well, you know, the bottom line of both of our inclusion policies is you need to have a good reason for excluding anyone based, be it based on sex or gender, race, ethnicity or age. And you need to provide enough information so that peer review and NIH staff understand that you really do have a good reason for that exclusion and why it's scientifically justified. So in addition to providing that reason, generally you're going to need some evidence to back up your reason. So, for example, if you're stating that the knowledge about the excluded group is already available in another study, you might mention that other study. If you're saying that an age specific study would be preferable to including certain age groups in your study, you need to explain the circumstances that make that so. So describe why it's not preferable to modify your study design to include that group. So this is really where you want to spend some time and provide some thoughtful information so that people really understand why you're excluding that population.


>> Kosub: And you know as we're putting together applications, these inclusion plans involve inclusion tables. Can you tell us more about these? Can you break them down for us?


>> Corbett: Sure. So also on the page as human subjects and clinical trial information form, you're going to be providing an inclusion enrollment report. So these are the inclusion tables that we're talking about. The inclusion enrollment report itself has two tables. The first is for planned enrollment and the second is for cumulative or actual enrollment. So in your planned enrollment, you're going to be providing some basic information about your study, including a title for that enrollment report, whether or not you're using an existing data set or resource. So for example, if you're using samples from a bio repository that have already been collected or you're doing a secondary analysis of data, you would indicate that you're using an existing data set, a resource there. And then you'll also indicate whether your study is recruiting in the U.S. or outside the U.S. There's a domestic or foreign indicator there. And then you report the number of participants that are expected to be in your study broken down by sex or gender, race and ethnicity. One thing to note here, for race and ethnicity, we do use the OMB categories. These are the 1997 OMB categories that are required for use by all federal agencies for collecting and reporting race and ethnicity data. And this helps us ensure there's consistency across the federal government so that we can compare information across databases. So you'll provide that breakdown in the planned enrollment table, and then you may also include in your application your actual enrollment. If you have any actual enrollment at that time, many times you don't in an application because you haven't started rolling yet. But you may, for example, if you are using existing data set of resources. So in that part again you'll provide the demographic information about participants using the same categories. But in this case, it's going to be people that you've already enrolled, and that should be cumulative for the life of your study.


>> Kosub: Thanks for that. We’ll be revisiting the inclusion tables too in our next conversation, which is just a word and talk about reporting and things like that. But before we close out this one on the application, Dawn, do you have any final thoughts you'd like to leave people with about inclusion plans as part of one's application?


>> Corbett: I just encourage you to check out our website for inclusion. We have a lot more resources there to help you as you're developing your inclusion plan and also reach out to your P.O. They're a great resource to talk to if you have any questions.


>> Kosub: Great. You stole my thunder. I was going to invite people to go to the website as well. And so, yes, thank you very much that we greatly appreciate this opportunity to talk more about inclusion plans for applications and we look forward to you joining us in our next conversation as we talk about review and post award. This has been David Kosub with NIH’s all about grants. Thank you.