NIDCD Low Risk Clinical Trials in Communication Disorders (R01 Clinical Trial Required) | PAR 21 063

Opportunity Information: Apply for PAR 21 063

The NIDCD Low Risk Clinical Trials in Communication Disorders opportunity (PAR-21-063) is an NIH R01 grant announcement designed to support investigator-initiated clinical trials focused on communication disorders. The main goal is to move the field toward better ways to diagnose, prevent, or treat disorders affecting hearing, balance, smell, taste, voice, speech, and language by funding clinical trials that are carefully designed, feasible, and well executed. While the announcement sits within the NIH clinical trials framework, it is specifically aimed at studies that can be conducted safely and efficiently under an R01 mechanism, without the added complexity that comes with higher-risk intervention testing.

A central requirement is that proposed studies must qualify as low risk clinical trials and must meet all of the FOA's defining criteria. In practical terms, that means the trial has to fit within the FOA's budget limits, must not require FDA oversight, must not be intended to formally establish efficacy in the way a definitive, pivotal trial would, and must pose low risk for physical or psychological harm to participants. This makes the FOA a good fit for early-stage or exploratory clinical testing, optimization studies, feasibility work, or other trials that are meaningful and hypothesis-driven but not positioned as the final word on whether an intervention works.

The FOA also explicitly welcomes certain studies that NIH classifies as Basic Science Experimental Studies involving Humans (BESH). These are projects that meet NIH's definition of a clinical trial because they involve prospective assignment to conditions and measurement of outcomes in humans, but they are still considered basic research because they are designed to understand fundamental mechanisms rather than to test a treatment for clinical benefit. By allowing low risk BESH studies, NIDCD is signaling that it is open to mechanistic human experimentation in communication sciences, as long as it meets the same low-risk expectations and fits the R01 scope.

Applicants are advised to propose only one clinical trial per R01 application under this announcement. That guidance reflects the complexity of planning, powering, and managing a trial even when it is low risk, and it helps keep the application focused on a single, well-justified design with clear endpoints, recruitment and retention plans, and an appropriate analytic approach.

For studies that do not meet the low-risk criteria or that rise to a higher level of operational or participant risk, NIDCD directs applicants to a companion cooperative agreement mechanism (U01) described as a separate FOA (referenced in the text as PAR-21-XXX) for clinical trials in communication disorders. The mention of a cooperative agreement is important because it suggests a different oversight model and closer NIH involvement for trials that are more complex, higher risk, or otherwise not appropriate for the low-risk R01 pathway.

Eligibility is broad and includes many types of U.S. organizations and governments, such as state, county, city, township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses); small businesses; and other eligible entities. The FOA also calls out additional eligible applicants and organizational categories, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, non-U.S. (foreign) organizations, regional organizations, and U.S. territories or possessions. This wide eligibility range is meant to encourage strong proposals from varied research settings and communities, including those that are often underrepresented in clinical research infrastructure.

Key administrative details included in the source information are that the sponsoring agency is the National Institutes of Health (NIH), the activity category is Health, and the CFDA/Assistance Listing number is 93.173. The funding instrument is a grant under the R01 mechanism, and the opportunity is listed as discretionary. The award ceiling is stated as $500,000, and the original closing date provided in the source data is 2024-01-07 (noting that NIH opportunities often have recurring due dates or updated cycles, so applicants typically verify current deadlines and any reissuances). Overall, this FOA is best understood as NIDCD's pathway for rigorously designed, human-subjects clinical trials in communication disorders that remain low risk, do not require FDA oversight, and are not positioned as definitive efficacy trials, while still producing results that can meaningfully guide subsequent research and clinical development.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIDCD Low Risk Clinical Trials in Communication Disorders (R01 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.173.
• This funding opportunity was created on 2020-12-11.
• Applicants must submit their applications by 2024-01-07. (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 $500,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for PAR 21 063

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