Opportunity Information: Apply for PA 13 167

  • The National Institutes of Health in the education health sector is offering a public funding opportunity titled "Innovative Research Methods Prevention and Management of Symptoms in Chronic Illness (R21)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.361 Nursing Research 93.393 Cancer Cause and Prevention Research 93.399 Cancer Control.
  • This funding opportunity was created on Mar 29, 2013 and posted on Mar 29, 2013.
  • Applicants must submit their applications by May 7, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Each selected applicant is eligible to receive up to $200,000.00 in funding.
  • Eligible applicants include: Native American tribal governments (Federally recognized) Independent school districts Small businesses Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Special district governments Others (see text field entitled Additional Information on Eligibility for clarification) Private institutions of higher education For profit organizations other than small businesses State governments Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education County governments.
  • Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
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Opportunity Summary:

The National Institutes of Health (NIH) funding opportunity titled "Innovative Research Methods Prevention and Management of Symptoms in Chronic Illness (R21)" (Funding Opportunity Number PA-13-167) was a discretionary grant program designed to push clinical symptom-management research beyond the traditional randomized controlled trial (RCT) model. The main goal was to encourage practical, innovative study designs that better reflect real-world clinical decision-making and that can produce stronger, more actionable evidence for preventing or managing symptom burden in chronic illness. Rather than simply testing a single, fixed intervention against a control condition, the opportunity emphasized methods that can adapt to patient differences over time and clarify which treatment strategies work best, for whom, and under what circumstances.

A central motivation behind the announcement was the recognition that symptom management in chronic illness is complicated by highly variable treatment responses across patients, along with familiar research challenges like keeping participants engaged over time (retention) and getting consistent follow-through with treatment plans (adherence). Standard RCTs can struggle to address these realities because they often assume uniform treatment effects and rely on one-time randomization to a static intervention. NIH signaled interest in study designs that can better capture the dynamic, individualized nature of symptom trajectories and symptom treatment, especially when symptoms fluctuate, patients respond differently, or clinical adjustments are routinely made in practice.

One of the highlighted examples of the kind of approach NIH wanted to see is the Sequential Multiple Assignment Randomized Trial (SMART) design. SMART studies allow participants to be randomized more than once, typically at key decision points, based on predefined rules and on how well a person is responding to an initial intervention. This makes it possible to build and test adaptive or dynamic treatment regimens, where the type, dose, intensity, or combination of intervention components can change over time in response to patient progress toward a symptom-related goal. NIH noted that SMART designs had been used successfully in areas such as alcohol, depression, and HIV, but were not widely applied in symptom management trials, and this opportunity aimed to help close that gap. The pragmatic appeal is that it resembles how care is actually delivered: clinicians reassess, switch approaches, add components, or step up/step down intensity when patients are not improving as expected.

In practical terms, NIH was seeking R21 exploratory/developmental projects that would apply these newer clinical research designs to symptom prevention and management in chronic illness. The expectation was not simply novelty for its own sake, but methods that have a clear rationale for improving the evidence base by dealing directly with heterogeneity of response, engagement problems, and adherence challenges. Projects could involve tailoring intervention components to individual characteristics (such as baseline symptom severity, comorbidities, or risk factors) or to intermediate outcomes observed during the study (such as early improvement, side effects, or failure to meet symptom reduction targets). By allowing multiple randomizations guided by predetermined decision rules, applicants could evaluate sequences of care and identify which adaptive strategies best alter the course of symptom burden over time.

From an administrative standpoint, this was an NIH grant opportunity with an award ceiling listed at $200,000 and no cost-sharing or matching requirement. It was posted March 29, 2013, and the original and final closing date was May 7, 2016, with an archive date of June 7, 2016. The program fell under health and education-related activity categories and included CFDA numbers 93.361 (Nursing Research), 93.393 (Cancer Cause and Prevention Research), and 93.399 (Cancer Control), reflecting relevance to both nursing-focused symptom science and cancer-related symptom and control research, among other chronic illness contexts.

Eligibility was broad and included many common applicant types such as state, county, city/township governments, federally recognized tribal governments, tribal organizations, public and private institutions of higher education, nonprofit organizations (including 501(c)(3) and certain non-501(c)(3) entities), independent school districts, special district governments, public housing authorities/Indian housing authorities, and for-profit organizations (with small businesses explicitly listed as eligible, along with other for-profit entities). Additional eligible applicants included a wide set of mission-driven and capacity-building institutions and organizations, such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American and Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based/community-based organizations and eligible federal agencies. Foreign institutions were not eligible, and foreign components (as defined under NIH policy) were not allowed, including non-U.S. components of U.S. organizations.

The full announcement was hosted by NIH (link provided in the notice: http://grants.nih.gov/grants/guide/pa-files/PA-13-167.html), and NIH’s Office of Extramural Research (OER) webmaster contact was provided for access or linking problems (FBOWebmaster@OD.NIH.GOV). Overall, the opportunity was aimed at accelerating more flexible, adaptive, and clinically realistic experimentation in symptom prevention and management for chronic illness, with the broader intent of producing treatment strategies that can be personalized and sustained in real-world care settings.

Frequently Asked Questions (FAQs)

What is the name of this NIH funding opportunity?

The funding opportunity is titled "Innovative Research Methods Prevention and Management of Symptoms in Chronic Illness (R21)."

What is the Funding Opportunity Number (FON)?

The Funding Opportunity Number is PA-13-167.

What type of grant mechanism is this?

This opportunity uses the NIH R21 exploratory/developmental grant mechanism.

What is the main purpose of this opportunity?

The purpose is to push clinical symptom-management research beyond traditional randomized controlled trials (RCTs) by encouraging innovative, practical study designs that better reflect real-world clinical decision-making and produce more actionable evidence for preventing or managing symptom burden in chronic illness.

Why was NIH encouraging alternatives to traditional RCTs in this program?

NIH highlighted that symptom management in chronic illness involves highly variable patient responses, fluctuating symptom trajectories, and common research challenges such as retention (keeping participants engaged over time) and adherence (consistent follow-through with treatment plans). Standard RCTs can struggle in these conditions because they often assume uniform treatment effects and rely on one-time randomization to a fixed intervention.

What kinds of study designs was NIH interested in supporting?

NIH was interested in innovative clinical research designs that can adapt to patient differences over time and clarify what treatment strategies work best, for whom, and under what circumstances. A key emphasis was on methods that reflect how clinicians adjust care in real practice.

Does the opportunity focus on adaptive or dynamic treatment approaches?

Yes. The opportunity emphasized adaptive or dynamic treatment regimens where the type, dose, intensity, or combination of intervention components can change over time in response to patient progress toward a symptom-related goal.

What is a SMART design, and why was it highlighted?

SMART stands for Sequential Multiple Assignment Randomized Trial. It allows participants to be randomized more than once at key decision points based on predefined rules and how well a participant responds to an initial intervention. NIH highlighted SMART as an example of an approach that can build and test adaptive treatment regimens and mirror real-world clinical adjustments (such as switching, adding components, or stepping intensity up or down).

In what fields had SMART designs already been used successfully, according to NIH?

NIH noted SMART designs had been used successfully in areas such as alcohol, depression, and HIV, but were not widely applied in symptom management trials.

What research topic area does this opportunity support?

The focus is on prevention and management of symptoms in chronic illness, with an emphasis on reducing symptom burden and generating evidence that can guide clinically realistic, personalized strategies.

What specific research challenges did NIH want applicants to address?

NIH specifically called attention to heterogeneity of treatment response (patients responding differently), retention problems (participants dropping out or disengaging over time), and adherence challenges (difficulty maintaining consistent participation in treatment plans).

How could interventions be tailored in projects proposed under this opportunity?

Projects could tailor intervention components based on individual characteristics (for example, baseline symptom severity, comorbidities, or risk factors) and/or intermediate outcomes observed during the study (for example, early improvement, side effects, or failure to meet symptom reduction targets).

Did NIH expect novelty for its own sake?

No. The emphasis was on innovative methods with a clear rationale for improving the evidence base, particularly by directly addressing variable responses, engagement/retention issues, and adherence challenges.

What is the maximum award amount listed for this opportunity?

The award ceiling listed was $200,000.

Is cost-sharing or matching required?

No. The opportunity stated there was no cost-sharing or matching requirement.

When was this opportunity posted?

It was posted on March 29, 2013.

What were the application closing dates?

The original closing date and the final closing date were both May 7, 2016.

When was the opportunity archived?

The archive date was June 7, 2016.

What activity categories did this program fall under?

The program fell under health and education-related activity categories.

Which CFDA numbers were associated with this opportunity?

The CFDA numbers listed were 93.361 (Nursing Research), 93.393 (Cancer Cause and Prevention Research), and 93.399 (Cancer Control).

Who was eligible to apply?

Eligibility was broad and included state, county, and city/township governments; federally recognized tribal governments; tribal organizations; public and private institutions of higher education; nonprofit organizations (including 501(c)(3) and certain non-501(c)(3) entities); independent school districts; special district governments; public housing authorities/Indian housing authorities; for-profit organizations (including small businesses and other for-profit entities); faith-based/community-based organizations; eligible federal agencies; and a range of designated capacity-building and mission-driven institutions.

Which types of designated institutions were explicitly included as eligible?

Eligible institutions explicitly included Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American and Native American Pacific Islander Serving Institutions (AANAPISIs).

Are foreign institutions eligible to apply?

No. Foreign institutions were not eligible.

Are foreign components allowed in an application?

No. Foreign components (as defined under NIH policy) were not allowed, including non-U.S. components of U.S. organizations.

Where was the full announcement posted?

The full announcement was hosted by NIH at http://grants.nih.gov/grants/guide/pa-files/PA-13-167.html.

Who should be contacted for access or linking problems with the announcement?

The notice listed the NIH Office of Extramural Research (OER) webmaster contact for access or linking problems: FBOWebmaster@OD.NIH.GOV.

What was the broader intent behind the research methods focus?

The broader intent was to accelerate flexible, adaptive, clinically realistic experimentation in symptom prevention and management for chronic illness, with the goal of producing treatment strategies that can be personalized and sustained in real-world care settings.

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