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gLHS Pre-Application Webinar FAQ

On September 6, 2023, the National Human Genome Research Institute hosted a pre-application webinar for the genomics-enabled learning health systems (gLHS) NOFOs: RFA-HG-23-041 and RFA-HG-23-042.  Questions were answered during the webinar.

The following questions were answered during the webinar.

How many implementation interventions should be proposed in our application?


Sites should describe, budget for, and submit three implementation intervention projects. The Network will review implementation projects from all the sites and select three that will be implemented Network-wide.

Are clinical sites allowed to recommend more than four projects in the proposal?


While there exists a broad spectrum of potential projects to consider, we recommend narrowing your focus to the three that, in your assessment, possess the strongest evidence and demonstrate a pronounced requirement for widespread implementation. The Network retains the flexibility to incorporate supplementary projects at a later date.

Could you provide a bit more clarification about the Clinical Trial requirement? The RFA seems to frame the pilot projects as Quality Improvement (QI) research.


The RFA is situated at the intersection of QI and Human Subjects (HS) research. A significant challenge arises from the potential for diverse site interpretations of implementation interventions as either human subjects or quality improvement research. Additionally, the NIH definition of a Clinical Trial has broadened in scope. In light of this, we recommend a cautious approach and advise you to submit your application as a Clinical Trial. The Network and its single IRB may determine that the implementation interventions are QI research at a later stage.

How many proposed projects should fall into the Clinical Trials designation in order to be compliant with the “Clinical Trials Required” component of the U01?


Only one of the proposed projects needs to fall into the clinical trials designation.

Will statistical resources be available through the CC?


Yes, some statistical resources will be available through the CC, but the clinical sites should include them as well. The CC will be expected to provide statistical resources for network-wide projects and analyses, but the clinical sites will be expected to participate actively in these analyses and to conduct independent analyses within their gLHS as appropriate.

Is it appropriate for applicants to name advisory group members, assuming they are all internal?


If an advisory group or groups are envisioned, their proposed roles and expertise should be described. However, potential members should not be named in the application.

How conceptually distinct do the proposed implementation interventions need to be?


Applicants are encouraged to offer a diverse array of implementation interventions that are substantiated by the most robust existing evidence, demonstrating the imperative for broader adoption within health systems to enhance patient care. Applicants should discern and describe distinctions among the proposed projects or justify why more than one conceptually related project is needed.

Given that there seems to be interest in pediatrics, is a pediatrics-focused project required?


A pediatrics-focused project is not a requirement unless the Steering Committee determines that it should be one of the Network-wide projects. All the sites are expected to follow the decisions made by the Steering Committee, so all sites should describe their capabilities for including potential pediatric projects.

Do applicants need to have a learning health system in place to apply?


Yes, given the significant amount of time required to implement a learning health system, applicants should already have, or should demonstrate, the ability to apply a learning health system approach at their institution.

Does our institution need to have genomics already incorporated into our learning health system to apply?


No; however, applicants must demonstrate that they have the capacity and expertise to implement genomics into their existing learning health system.

Will sites be able to work on implementation interventions that are not selected by the Steering Committee?


Site-specific implementation interventions may be possible but cannot be supported by the limited funding provided through this RFA. Sites are welcome to implement and share site-specific interventions and products using their own resources, but these must be a secondary priority to the Network-wide interventions.

Can I apply to this RFA if we are not genomics-enabled yet?


Yes, the applicant should show that their institutions have supported and committed to a learning health system, but not necessarily one that’s already fully implemented. The intention of this RFA is to integrate genomics into the LHS.

Do all the sites have to do the same genomic medicine interventions and measure outcomes in the same way?


Yes, and the Steering Committee will decide what 2-4 interventions that the Network will implement. Each site should propose methods for implementation and outcome measurement that best fit their local environment(s) and describe what flexibilities they might have to adopt network-wide approaches. NHGRI recognizes that while the challenges of implementing a gLHS may be similar across sites, local systems and practices may necessitate some tailored solutions. Methods for measuring uptake and effectiveness of different implementation strategies are expected to be fully or nearly fully automated to minimize burden on ongoing data collection. In the first year, the Network will share approaches to implementation and outcome measurement with the intent to help all the sites improve their processes while facilitating the program’s research.

What are the objectives of the community engagement component?


One objective of community engagement is to involve clinician and community leaders from external institutions, particularly those serving underserved communities without a gLHS, at an early stage in the process of designing the research. They should be selected and empowered to provide valuable insights on the development of tools and resources that can be relevant across a wide range of healthcare settings and resources, including low-resource settings. An additional objective is for these individuals to become familiar with the gLHS approach and bring that knowledge back to their respective institutions for potential future gLHS implementation.

Should we structure the aims around the pilot intervention projects?


No, the purpose of this RFA is to identify and improve approaches for clinical integration of genomic information in a virtuous learning health system cycle of implementation, evaluation, refinement, and re-implementation. The aim of the pilot interventions is to develop, assess, and validate the effectiveness and efficiency of gLHS resources—resources which can then be refined and shared to promote adoption of gLHS among a greater number of healthcare systems. The emphasis is on using the intervention projects to test the robustness of gLHS resources being developed by the Network, rather than making the selected interventions per se the central focus of study.

What level of detail of statistical analyses should applicants provide for the proposed pilot projects?


At least two different aspects require measurement: the adoption of genomic intervention and the varying effectiveness of interventions when adopted. Applicants should define what will constitute a meaningful impact for their proposed interventions and outline their analytic strategy for assessing both adoption and effectiveness, including the power of their proposed design to detect meaningful outcomes.

Should the three proposed pilot projects be new initiatives at our institution, or could we propose something that we are actively doing within our institution?


Either existing or new initiatives, or both, can be proposed, but existing programs must be open to modification as agreed upon by the Network, and measurement of their adoption and effectiveness must be prospective from the time of Network adoption for all Network sites. That is, all implementation and data collection will need to begin anew as part of this collaborative program, and will not include data generated prior to Network-wide implementation.

Last updated: October 24, 2023