eConsult Webinar FAQs

Questions and answers specific to RFA-HG-24-001 (U01 RFA)

Does a “regional” service need to span across multiple states?
No. This RFA defines regional eConsult services as “those providing services to multiple unaffiliated healthcare organizations.” This definition does not include a requirement to include multiple states.

Please note that a specific review criterion is, “How well does the applicant address significant barriers to implementing genomic eConsults in a variety of settings?” For example, “managing provider licensure in multiple states” is a known barrier that applicants can, but are not required to, address.

Can the service use non-physicians, such as genetic counselors, PharmDs, nurses, or PhDs to respond to the eConsult requests?
Perhaps—this funding opportunity does not specify who can or cannot respond to eConsult requests, as this may be determined by institutional or state regulatory policies. Applicants should clearly describe and justify the types of personnel proposed to respond to eConsult requests, and ensure their plans comply with any applicable laws and regulations (such as state licensure laws) that may affect who can respond to eConsult requests.

Can small businesses apply to the U01 funding opportunity?
Yes, small businesses are eligible to apply to the U01; however, only small businesses are eligible to apply to the SBIR/STTR PARs.

Do awardees under the U01 RFA need to utilize the solutions developed under the SBIR/STTR PARs? 
No.

What data should be captured in the EHR and transmitted to the clinician responding to the eConsult request? What are the documentation requirements for the response?
NHGRI is not imposing requirements on how the eConsult service is constructed. Requirements such as data to be captured, transmitted, and documented will depend on the research questions applicants propose to answer through their research and should be clearly defined in their research plan.

Will there be an opportunity to revise and resubmit an U01 application?
No. RFA-HG-24-001 only has a single receipt date.

Should eConsults for any particular specialty (such as pharmacogenetics, cancer, and teratogens) be included in the service?
Yes. Services should have plans for who will answer eConsult requests from the full breadth of specialties that utilize genomic medicine. We would expect that a service would receive pharmacogenetic, cancer, and teratogen eConsult requests, as well as many other types. Thus, services should plan for how those will be handled and how the requesting provider will receive a response.

For any specialty, it may be that there is a better resource that already exists. For example, although teratogenic exposures have traditionally been the part of genetics services, the national MotherToBaby resource already exists and information can be given to the requesting provider for how to utilize this existing service. Similar, the National Cancer Institute’s PDQ® Cancer Information for Health Professionals provides some information on cancer genetics. Applicants should describe resources to which they may refer clinicians to minimize duplication of effort and maximize efficiency. 

Can this service be limited to pediatrics or adult only?
No.

Regarding the requirement for 1000 eConsults – is this from outside of the health system or does it include consults from within health system?
This requirement includes those from inside and outside of the applicant’s health system. It is expected that a substantial portion will come from outside of their own health system. Applicants should clearly define the proportions from outside the health system that they anticipate and describe how those proportions will promote the broader application or generalization of the proposed service. 

Do we need to name the clinicians that would be providing eConsult services or can we say generally the topics that would be covered?
A specific review criterion is, “Did the applicant(s) describe adequate plans for obtaining sufficient numbers of consultants with expertise to address the breadth of expected eConsult requests?” While reviewers won’t expect applicants to explain every detail, they will need sufficient detail to assess the scientific merit of the proposed research. Applicants can consider including the names of clinicians who they expect will answer substantial numbers of eConsults and provide letters of support from those clinicians.

Can funds be used for marketing?
Yes. The funding opportunity notes that applicants will need to “provide outreach to potential users” although it doesn’t use the term “marketing.”

What kind of tool development do you envision to support this long term? 
The tools developed will likely vary by site. For example, some sites may need to develop tools for managing clinician’s licenses in multiple states, or provide triage guidelines, templates for common referrals, or education. 

How many awards do you anticipate funding?
2-3 U01s will likely be funded.

Should the IT platform be included in the grant’s budget? 
Yes, an applicant would need to include any IT needs in their budget. U01 applicants can partner with a small business through PAR-24-106 & PAR-24-107 to develop some of the IT infrastructure. However, they should have contingency plans in case their partner small business doesn’t get funded.

Should non-affiliated sites be named (and included as sub-sites) as part of the proposal?
The application should be clear which sites/practices/providers will be covered by the regional service. For example, a service covering a whole state would not need to name each individual practice in the state. However, they may want to name some of the large institutions, such as the state’s major unaffiliated healthcare systems, and obtain letters of support from them.

Besides sites and key consultants, is there anyone who could be named as part of the proposal?
Depending on the applicant’s plans, they may want to name and obtain letters of support from anyone who is providing critical elements of the project, such as IT infrastructure or marketing services.

Is the expectation that the cost of genetic testing is covered under usual medical care? 
Yes. eConsult services do not directly interact with the patient and do not order genetic tests. Testing (and the cost associated with it) is part of usual medical care.

Is billing required? Can we provide this service free to the clinician?
Billing is not required. However, a focus of this research is how to create sustainable services. Thus, data should be collected to evaluate the impact of, and subsequently justify, providing this service free. Applicants should consider how they would justify maintaining free services to their organization’s leadership once the project period is over, particularly for providers and organizations that not affiliated with their healthcare system.

Can services bill providers, patients, or insurance?
This will likely depend on the local providers, patients, and insurance. Each service will need to figure out what is the best way to finance their program. Please note, however, part of the goal of this research is to figure out how to provide eConsults to those in lower-resource settings. Billing procedures that create or increase barriers to these populations will not meet the aims of this RFA.

Can awardees submit IRBs through their own institutions, or will a single IRB be required?
NIH cannot make the determination if a single IRB will be required until after the awardees are selected. One we know the research questions and outcomes each site will examine; a decision will be made. For more information on when a single IRB is required, please see Single IRB For Multi-Site or Cooperative Research.

If an applicant will have more than one site, do they need to use a single IRB?
Multi-site non-exempt human subjects research conducting the same research protocol may be subject to the NIH Single IRB policy. For more information, please see Single IRB For Multi-Site or Cooperative Research.

Can a person be a collaborator on more than one application to the NOFO?
Yes. There are no rules that prohibit a person to be a collaborator on more than one project. If both awards are selected, please be aware that their total effort (for these and other projects) cannot exceed 12 calendar months.