U.S. flag
				An official website of the United States government
					Here's how you know
        Here's how you know
		U.S. Department of Health & Human Services
			|

			National Institutes of HealthDot gov**Official websites use .gov**
						
						A **.gov** website belongs to an official government organization in the United States.
			Https**Secure .gov websites use HTTPS**
						
            A **lock** (A locked padlock)
            or **https://** means you've safely connected to the .gov website. Share sensitive information only on official, secure websites.  **
Menu
NIDCD Employee Intranet | A–Z Index | En Español


    close

        
        
                      Home
      
    
              Health Info
      
                
  
          **Health Info**
          
    
              Hearing, Ear Infections, and Deafness
      
    
              Balance
      
    
              Taste and Smell
      
    
              Voice, Speech, and Language
      
    
              Información en español
      
    
              Statistics
      
    
              Health Resources
      
    
              Clinical Studies
      
    
              Adult Hearing Health Care
      
    
              Research
      
                
  
          **Research**
          
    
              Extramural Research
      
    
              Intramural Research
      
    
              Building a Diverse Scientific Workforce
      
    
              Scientific Workshop and Meeting Reports
      
    
              Clinical Studies
      
    
              Global Health
      
    
              Grants & Funding
      
                
  
          **Grants & Funding**
          
    
              Types of Grants and Funding
      
    
              How to Apply for a Grant
      
    
              All NIDCD Funding Opportunities
      
    
              The BRAIN Initiative and the NIDCD
      
    
              Training
      
                
  
          **Training**
          
    
              About NIDCD's Research Training Program
      
    
              Types of Research Training Funding Opportunities
      
    
              Research Training in NIDCD Laboratories (Intramural)
      
    
              More Training Resources
      
    
              News & Events
      
                
  
          **News & Events**
          
    
              NIDCD News
      
    
              Grantee News
      
    
              Multimedia
      
    
              Events
      
    
              Sign up. Stay informed.
      
    
              About Us
      
                
  
          **About Us**
          
    
              Messages from the NIDCD Director
      
    
              Mission
      
    
              Strategic Plans
      
    
              NIDCD History and Milestones
      
    
              Organizational Structure and Staff
      
    
              Job Opportunities
      
    
              Congressional Testimony and the NIDCD Budget
      
    
              Advisory Groups and Review Committees
      
    
              Contact Us
      
    
              Get Involved Breadcrumb
    Home
              Research
              Clinical Studies
              Clinical Studies: Information For Researchers And Health Professionals
  
      Know What Funding Opportunities Are Available


In alignment with NIH efforts to enhance stewardship over clinical trials, NIDCD has redefined the scope of R01 and U01 clinical trials applications to address risks in terms of safety, complexity, fiscal investment, and direct scientific/public health impact. The cooperative agreement U01 mechanism continues to be most appropriate for higher-risk clinical trials, which will benefit from the substantial scientific and programmatic involvement of an NIDCD Project Scientist. The Project Scientist will provide scientific/technical expertise and, in partnership with the Principal Investigator (PI), will be involved in protocol development; study implementation; and ensuring timely progress, protocol adherence, data quality, and participant safety.NIDCD has two primary funding opportunities for clinical trials.NIDCD Low Risk Clinical Trials in Communication Disorders (R01 - Clinical Trial Required) PAR-24-051NIDCD Cooperative Agreement for Clinical Trials in Communication Disorders (U01 - Clinical Trial Required) PAR-24-050Stand-alone independent clinical trials cannot be proposed as part of the research plan in a fellowship (F) application. See NIDCD Fellowships: Frequently Asked Questions for details.The risk criteria for applying to the R01 or U01 mechanism are below:Award TypeR01    (if ALL of the criteria below are met)U01    (if ANY of the criteria below are met)**FDA oversight of the intervention**Does not require FDA oversight, e.g., for investigational new drug (IND) or investigational device exemption (IDE) applications. Example: clinical trials involving use of a licensed product/device for an approved dose, population, and indication may not require an IND or IDE.Requires FDA oversight, e.g., for investigational new drug (IND) or investigational device exemption (IDE) applications.**Anticipated risks to participants**Potential of the intervention to have safety risks to participants is low. Example: risks that are no greater than those encountered in routine medical care or procedures.Has the potential to have higher safety risks to participants, for example:Use of a non-routine intervention.Use of an unlicensed product/device, e.g., does not have FDA approval.Use of a licensed product/device for an unapproved indication or unapproved population, e.g., not within the FDA approved product label.**Study goals**Intends to gather scientific data/evidence to inform subsequent studies, but is not aimed or sufficiently powered to directly change health policy or standard of care and is not an NIH-defined Phase III clinical trial.NIH-defined Phase III clinical trial:    An NIH-defined Phase III clinical trial is a broadly-based, prospective Phase III clinical investigation, usually involving several hundred or more human subjects, for the purpose of evaluating an experimental intervention in comparison with a standard or controlled intervention or comparing two or more existing treatments. Often the aim of such investigation is to provide evidence leading to a scientific basis for consideration of a change in health policy or standard of care. The definition includes pharmacologic, non-pharmacologic, and behavioral interventions given for disease prevention, prophylaxis, diagnosis, or therapy. Community trials and other population-based intervention trials are also included.**Annual direct costs**Application budgets are limited to less than $500,000 in direct costs in any year.Applications exceeding the annual direct costs of $700,000 or more, in certain cases, may also be a criterion.
    Last Updated Date:
      December 21, 2023
              Related Topics
    
      
            Administrative Supplements for Continuity of Biomedical and Behavioral Research Among First-Time Recipients of NIH Research Project Grant Awards
Clinical Trials Program Contacts
    
      Trinh Ly, M.D. COVID-19
                              Accessibility
                              Contact Us
                              Free Publications
                              Freedom of Information Act
                              Privacy
                              Site Map
                              Syndication
                              Vulnerability Disclosure
                              Website Policies
                              Subscribe to NIDCD Email Updates 


    Follow Us:
                                                Facebook
                
                                                X

              31 Center Drive, MSC 2320, Bethesda, MD USA 20892-2320

              800-241-1044

                nidcdinfo@nidcd.nih.gov

          U.S. Department of Health and Human Services
                National Institutes of Health
                USA.gov—Government Made Easy