FAQ from INCLUDE Data Coordinating Center Pre-Application Webinar

Q. I missed the informational webinar on January 17, 2020. Is a recording available?
A. Yes, a recording is available. Please email Valerie Cotton at Valerie.cotton@nih.gov for the link to the recording.

Q. The RFA encourages “applications that propose to use or integrate with existing data platforms, tools, and workspaces to promote interoperability and cross-initiative data sharing and analysis.” What existing data platforms are you referring to?
A. Data platforms that exist for data sharing and knowledge portals, some of which may have a Down syndrome focus, although this is not required. For example, there are existing efforts in the Alzheimer’s research community and in the pediatrics genomics community that have already built some data portals or knowledge bases, so any opportunity to leverage those would be appropriate. You can learn more about existing resources discussed during the Planning a Virtual Down Syndrome Cohort Across the Lifespan Workshop held in September 2019.

Q. It is implicit in the description of the DCC that there will not be a centralized biobank for INCLUDE, but rather a network of smaller biorepositories. Would you confirm that this is the vision for INCLUDE?
A. Yes, we did not want to reinvent the wheel by funding another biorepository since there already are several existing biorepositories that collect and distribute specimens from individuals with Down syndrome. Several of these are listed in the RFA. The data management core would serve as an umbrella linking with those different biorepositories to help investigators identify specimens available through those different biorepositories and to inform the community of opportunities for individuals with Down syndrome to submit samples to these biorepositories.

Q. Can we expect that in the next few years there will be FOAs for 'data generation' or is the DCC only dealing with integrating data from INCLUDE-funded grants?
A. This DCC is tasked with coordinating existing Down syndrome data and data to be generated in the future. We have received feedback from investigators that they are interested in generating more deep datasets to build a prospective cohort, so the NIH will consider this feedback when planning future FOAs. In addition, we have an FOA for “Small Research Grants for Analyses of Down Syndrome-related Research Data for the INCLUDE Project (R03 Clinical Trial Not Allowed; RFA-OD-20-006)” that is open through November 2021. Investigators that respond to this RFA may want to access data available through the INCLUDE DCC.

Q. The Letter of Intent (LOI) due date has passed. Is an LOI required?
A. It is not necessary to submit an LOI, but they are appreciated and can still be accepted after the due date. LOIs are helpful for NIH staff to enable applications to be processed and reviewed quickly. If you have not submitted an LOI and you do plan to apply, we encourage you to submit one as soon as possible.

Q. Is a Protection of Human Subjects section required?
A. If you are proposing activities that your local IRB would consider to meet the definition of human subjects research, then you would need to include a Human Subjects section. You should place it in the Overall component and refer to it in other components as appropriate. If there are other elements that are part of NIH requirements such as data sharing requirements, put them into the Overall component section as well, so you are not repeating this information in other parts of your application.

Q. Is the DCC charged with providing long-term storage of these data? Should this be included in the budget?
A. The DCC is not charged with long-term storage of all these datasets. NIH staff will work with the successful applicant to identify and fund data storage for the INCLUDE project. NIH recognizes that data storage systems to support NIH resources are in flux, and that identifying a long-term data storage solution will require partnership with INCLUDE staff. The DCC should budget to support local or cloud-based compute to meet the goals of the FOA; for instance, data processing and harmonization.

Q. How many components will there be in the DCC application and what will be the allowed page limit for each?
A. The application will consist of four components: an Overall component, an Administrative and Outreach Core, a Data Portal Core, and a Data Management Core. Each is allowed a Research Strategy section of up to 12 pages and each will have a budget section.