HEAL Initiative: Development and validation of virtual assessments to study children and caregivers in their natural environment (R01- Basic Experimental Studies with Humans Required) | RFA DA 23 055

Frequently Asked Questions (FAQs)

What is this NIH funding opportunity about?

This NIH HEAL Initiative funding opportunity (RFA-DA-23-055) supports research projects that develop and validate virtual (remote, technology-enabled) assessment tools to study children and their caregivers in real-world, everyday settings. The intent is to enable reliable, scientifically validated measurement outside of clinics or labs.

What is the main goal of the funded research?

The core goal is to create remote measures that can capture sociocultural, biobehavioral, and environmental factors that help explain how substance use risk, substance use exposure, and substance use disorders emerge and change over time in children and caregiving contexts.

What does NIH mean by "virtual assessments" in this FOA?

"Virtual assessments" refers to remote, technology-enabled measurement approaches that can be deployed in participants' natural environments. Examples mentioned include smartphone-based surveys, ecological momentary assessment (EMA), wearable or sensor-informed measures, video-based observations, passive data capture, and other telehealth-compatible approaches.

Is the goal just to turn existing paper questionnaires into digital surveys?

No. The FOA emphasizes that the intent is not simply to digitize existing questionnaires. The focus is on developing measures that are demonstrably valid for the constructs they claim to assess and feasible for repeated use with children and caregivers in everyday settings.

Why does the FOA emphasize real-world, everyday settings?

The program aims to support assessment approaches that work outside the clinic or lab so researchers can observe and measure relevant mechanisms as families go about normal routines, rather than relying only on in-person visits or retrospective self-reports.

What kinds of factors or mechanisms should the virtual tools measure?

The FOA highlights mechanisms across multiple levels, including:

• Sociocultural influences (for example, stressors, family and community context, cultural factors, and social determinants)
• Biobehavioral processes (such as affect, stress physiology proxies, sleep, behavior patterns, and caregiver-child interactions)
• Environmental conditions (including household- and neighborhood-level exposures)

What research outcomes is NIH trying to improve through this program?

By validating these virtual measures, the program aims to strengthen research on developmental trajectories and pathways related to substance use and related outcomes by capturing day-to-day influences that traditional approaches can miss.

What grant mechanism is used for this opportunity?

This opportunity uses the NIH R01 grant mechanism.

What does "Basic Experimental Studies with Humans Required" indicate?

This categorization indicates that applications may include studies where humans are prospectively assigned to conditions to examine fundamental mechanisms, measurement performance, or behavioral processes. The description notes this may be the case even if the work is not a clinical efficacy trial.

What does NIH appear to prioritize for competitiveness under this FOA?

Based on the description, competitive projects should be expected to include rigorous study designs, careful attention to ethics and participant protections (especially because children are involved), and strong plans to demonstrate reliability, validity, and generalizability of the virtual assessment tools.

What kinds of evidence are projects generally expected to produce?

Because the purpose is measure development and validation, projects would typically be expected to show that the virtual tools:

• Produce consistent results (reliability)
• Accurately reflect underlying constructs (validity)
• Function well across relevant populations and settings (generalizability and feasibility for repeated use)

Who can apply (in general terms)?

Eligibility is broad and includes many types of U.S.-based entities, including government entities, educational institutions, nonprofits, and for-profit organizations, as well as small businesses (as specifically listed in the FOA summary provided).

Are state and local governments eligible to apply?

Yes. The eligible applicant types listed include state, county, city, township, and special district governments.

Are independent school districts eligible?

Yes. Independent school districts are explicitly listed as eligible.

Are colleges and universities eligible?

Yes. Eligible entities include public and state-controlled institutions of higher education and private institutions of higher education.

Are tribal governments and tribal organizations eligible?

Yes. Federally recognized Native American tribal governments are listed as eligible, and tribal organizations that are not federally recognized are also included as eligible applicant types.

Are nonprofits eligible, and is 501(c)(3) status required?

Nonprofits are eligible both with or without 501(c)(3) status (as described in the information provided), as long as they meet the relevant category conditions noted in the eligibility summary.

Are for-profit organizations eligible?

Yes. For-profit organizations (other than small businesses) are listed as eligible, and small businesses are also listed separately as eligible.

Are faith-based or community-based organizations eligible?

Yes. Faith-based or community-based organizations are explicitly noted among additional eligible applicant types.

Are U.S. territories or possessions eligible?

Yes. U.S. territories or possessions are explicitly listed among eligible applicant types.

Can non-U.S. (non-domestic) organizations apply?

No. Non-domestic (non-U.S.) entities are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible to apply as applicants.

Are any international activities allowed at all under this opportunity?

Yes, the summary states that "foreign components" (as defined by the NIH Grants Policy Statement) are allowed. This means certain project activities may occur outside the U.S. under NIH rules, even though the applicant organization must be domestic.

What agency and initiative are associated with this opportunity?

The opportunity is released by the National Institutes of Health (NIH) and is part of the HEAL Initiative.

What activity areas does this opportunity relate to?

The opportunity is described as relating to health and education activity areas.

What CFDA numbers are associated with this FOA?

The CFDA numbers listed are 93.213, 93.273, and 93.279.

What was the closing date listed for this funding opportunity?

The original closing date shown for the FOA was February 7, 2023.

Is there an award ceiling listed in the provided information?

Yes. The record lists an award ceiling of $500,000.

Who are the intended participants for the assessment tools developed under this FOA?

The tools are intended for studying children and their caregivers, with an emphasis on capturing mechanisms and influences in day-to-day life.

What makes this opportunity different from traditional in-clinic research assessments?

The emphasis is on remote measurement in natural environments, enabling repeated and potentially more immediate capture of relevant mechanisms, rather than relying mainly on in-person visits or retrospective reports.

What broader impact is NIH aiming for with these virtual assessment tools?

The program aims to improve the quality and reach of research methods used to study substance use-related developmental processes in children and caregivers by enabling robust, validated, real-world measurement.