The purpose of this Funding Opportunity Announcement (FOA) is to encourage investigator initiated clinical trial applications to the National Institute on Deafness and Other Communications Disorders (NIDCD) in communication disorders (hearing, balance, taste, smell, voice, speech and language) with the goal of producing clinical findings for interventions that have significant clinical use and public health impact. The clinical trial should be hypothesis-driven and produce research data/evidence that are necessary to inform core scientific, design, implementation and clinical issues essential to advance scientific knowledge and the development of intervention(s) for subsequent clinical trials.
The NIH defines a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html)
This FOA is specifically intended for a low risk clinical trial that meets ALL the following criteria:
- Does not require FDA oversight such as those requiring Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications. For example, clinical trials involving utilization of a licensed product/device for an approved dose, population, and indication may not require an IND or IDE
- Potential of the intervention to cause physical or psychological harm is low. For example, risks that are no greater than those encountered in routine medical care or procedures
- Intends to gather scientific data/evidence to inform subsequent studies but not aimed or sufficiently powered to directly change health policy or standard of care and is not an NIH defined Phase III Clinical Trial (https://humansubjects.nih.gov/glossary).
- Meets the budget limits specified in Section II, Award Budget
Clinical trials that require FDA oversight, exceed this FOA’s budget limits,, are intended to formally establish efficacy (NIH-defined Phase III clinical trial) or where the potential risks to cause physical or psychological harm is high are referred to the companion U01 FOA PAR-18-340, NIDCD Cooperative Agreement for Clinical Trials in Communication Disorders.
Deadlines: standard dates and standard AIDS dates apply
Filed Under: Funding Opportunities