Date: September 5, 2018
Time: 2:00 - 3:00 p.m. Eastern
The intent of the pre-application webinar is to provide an overview of the CERA FOA and to address questions from potential applicants. The webinar is optional and not required for application submission. The webinar may conclude before the scheduled time depending on the number of questions.
Prospective applicants are encouraged to submit their questions or comments regarding the RFA to firstname.lastname@example.org by August 29th. Following the webinar, NHGRI will post the slides presented during the Webinar on this website.
Are letters of intent required for this RFA?Letters of intent are not mandatory but are strongly encouraged for this RFA. The information contained in letters of intent allows NHGRI staff to estimate the potential review workload and plan the peer review meeting. Letters of intent are due October 3, 2018 and should be sent to Nicole Lockhart at: email@example.com. Letters of intent should include:
Are single PI/PD applications allowed under this RFA?
Yes. For an application proposing a single PD/PI, that PD/PI is expected to make a minimum commitment of 4 calendar months per year.
Are multi-PI/PD applications allowed under this RFA?
Yes. If multiple PDs/PIs are proposed, at least one PD/PI must have a minimum commitment of 3 calendar months, and any individual serving as a PD/PI must commit at least 1 calendar month of their time.
Are applications from foreign institutions allowed?
No. Applications from foreign institutions are not allowed under this RFA. However, foreign components as defined in the NIH Grants Policy Statement, are allowed.
Are applicants required to apply for both the CERA RFA and the U13 for the ELSI Congress?
No. While applicants can apply for both the CERA RFA and the U13 for the ELSI Congress (see NOT-HG-18-009), it is not required to apply to both funding opportunities. However, the recipients of the CERA award will be expected to work closely with the recipients of the U13 for the ELSI Congress to assist in the planning and implementation of the meeting and to ensure that the ELSI Congress is complementary to any convenings organized by CERA. Applications for the U13 and CERA will be reviewed separately.
Should applications specifically address the use cases described in the RFA?
The use cases included in the RFA are intended as possible, but not exclusive, user needs the Center might address. These use cases are intended to inform possible designs and approaches to CERA. While applicants may address specific use cases within their application as appropriate, they are not required to do so.
Is a data sharing plan required?
All applications, regardless of the amount of direct costs requested for any one year, should include a Data Sharing Plan. To maximize the value of ELSI resources to the research community and to enhance the reproducibility of ELSI research, applicants should propose a data sharing plan and accompanying policy to create a rapid pipeline for resource acquisition and sharing that is consistent with achieving the goals of the Center, and the needs of Center users and contributors.
The data that the Center must be designed to share include, but are not limited to, ELSI publications, resources, measurement instruments, and materials collected by or submitted to the Center, as well as all resources and products generated by the Center itself. All resources and tools developed by the Center including the CERA portal should be portable and easily transferred if needed.
After the initial peer review, NHGRI program staff will conduct an additional administrative review of the plan for sharing ELSI resources, and may negotiate modifications of this plan with the prospective awardee. The final negotiated version of the resource sharing plan will become a term and condition of the award of the cooperative agreement.
Will CERA be required to store primary ELSI data or provide access to such data?
No. CERA will not collect, curate, store or disseminate primary data collected as part of funded NHGRI ELSI grants. However, the Center will be responsible for directing Center portal users to other data repositories and to ELSI researchers who are sharing their data outside of the Center, e.g. through existing repositories and resources.
What is the function of the portal developed by CERA?
The Center will create an open access, user friendly, online portal that provides access to ELSI tools and products. At minimum, the online portal should facilitate the upload of, and access to ELSI resources including a database of ELSI scholarship and its products (e.g., resulting publications, best practices or recommendations; scales; data collection instruments, data dictionaries, and study methods from NHGRI-funded ELSI research; and tools developed for use in clinical genomics or genomic research). The portal should also provide access to all novel products developed by the Center. The portal should include an intuitive interface which allows researchers with different backgrounds and levels of expertise to easily contribute, navigate and locate Center resources. The Center will conduct usability testing for the portal and assess the ongoing needs of actual and potential users. All resources and tools developed by the Center will be designed as non-proprietary and open source employing user interfaces that will allow the upload and download of resources. In addition, all resources and tools should be portable and easily transferred to other institutions as needed.
Will CERA validate or otherwise recommend specific tools and measures for use in ELSI research?
CERA will not validate measures or tools and will not serve as the arbiter of the best measure, tool, or study. Rather, the Center will collect, index, store, and make publicly available data collection instruments, data dictionaries, and study methods from NHGRI-funded ELSI research.
What is meant by the requirement to "ensure a balanced resource and avoid the introduction of bias"?
CERA will identify topics of importance to both genomic and ELSI researchers, provide broad overviews of ELSI scholarship and integrate and synthesize current and existing ELSI research data across disciplines. It is critical that these analyses be designed and carried out using a systematic and inclusive approach to ensure unbiased conclusions that reflect the field of ELSI research broadly and not only the beliefs of CERA investigators. To achieve this goal, CERA should establish a diverse and inclusive environment, including input from groups traditionally underrepresented in research. CERA should also reflect the disciplinary diversity of the ELSI community and partner with outside experts as needed to inform and complete these analytical functions. In addition, the External Scientific Panel will help ensure that the interests, perspectives and needs of the ELSI and genomics communities are considered in an unbiased manner.
What should be included in the outreach and dissemination plan?
The outreach and dissemination plan should include the overall strategy envisioned to help bring ELSI research and Center products to the widening set of potential users. This plan should include innovative strategies to (a) encourage and incentivize ELSI researchers to contribute materials to the Center and participate in other Center activities, (b) connect ELSI researchers more directly to one another and to a broader genetic and genomic audience, (c) ensure that genomic researchers, practitioners, trainees, funders, and policy makers are aware of NHGRI-funded work, past and present, that may inform both research and healthcare, (d) inform the ELSI community about the expanding genomic landscape and (e) train potential users on how to access and utilize Center resources. The Center should include outreach and dissemination activities aimed at researchers across the career development pipeline. Particular emphasis should be given to providing networking opportunities and other resources to trainees and investigators new to ELSI research. Applicants should include costs relevant to outreach and dissemination in their budget justification, including costs associated with travel to relevant national meetings.
Can applicants provide the names of individuals for their proposed external scientific panel or advisory committee?
Applicants should NOT contact potential advisors prior to the review of the application, nor should potential advisors be named in the application or provide letters of support. The External Scientific Panel will be assembled and given its charge in collaboration with NHGRI staff. In addition, naming specific individuals may limit potential individuals eligible for review of applications. Details on a general structure of the proposed advisory committee and the types of expertise that will be represented may be included in the application.
If the annual budget is limited to $1M direct costs each year, why is the total direct costs over the 5-year period only $4.5M?
Initial annual budgets may be smaller and grow in later years as Center functions become fully developed. All increases in budget must be thoroughly justified and no escalation in costs will be provided. The total direct costs across the 5-year funding period is limited to $4.5M.
Will CERA be responsible for organizing the ELSI Congress?
No. Future ELSI Congress meetings will be organized and funded separately through a U13 award (see NOT-HG-18-009). While applicants can apply for both the CERA RFA and the U13 for the ELSI Congress, it is not required. However, the recipients of the CERA award will be expected to work closely with the recipients of the U13 for the ELSI Congress to assist in the planning and implementation of the meeting and to ensure that the ELSI Congress is complementary to any convenings organized by CERA.
How will CERA interact with other NHGRI grantees, including NHGRI Coordinating Centers?
CERA will bring together the research tools and products from across NHGRI-funded ELSI research. The Center will be expected to collaborate effectively with the diverse array of ELSI and genomic researchers to maximize the chances of overall success of the program.
CERA will not replace existing NHGRI Coordinating Centers that meet the needs of specific programs or consortia. However, CERA will provide a central source of ELSI tools, products, and expertise that could be consulted by and coordinated with other NHGRI consortia. CERA will collaborate with relevant NIH programs as well as other US-based and international genomics efforts to serve as a key convener and source of expertise for the larger research and policy communities, as appropriate.
Posted: August 6, 2018