NIDCD Low Risk Clinical Trials in Communication Disorders (R01 Clinical Trial Required)

The NIDCD is committed to identifying effective interventions for the diagnosis, prevention, or treatment of communication disorders by supporting well-designed and well-executed clinical trials. This funding opportunity announcement (FOA) supports investigator initiated low risk clinical trials addressing the mission and research interests of NIDCD. Clinical trials must meet ALL the following criteria: meet the budget limits of this FOA, not require FDA oversight, are not intended to formally establish efficacy and have low risks to potentially cause physical or psychological harm. This FOA also supports low risk trials determined to be Basic Science Experimental Studies involving Humans (BESH). These studies fall within the NIH definition of a clinical trial and also meet the definition of basic research. It is advisable that only one clinical trial be proposed in each NIDCD Clinical Trials in Communication Disorders R01 application. High risk clinical trials not meeting all the criteria above are referred companion U01 FOA PAR-21-XXX, NIDCD Cooperative Agreement for Clinical Trials in Communication Disorders.

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); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession.