Mechanistic Ancillary Studies to Ongoing Interventional Clinical Trials (R01)


This Funding Opportunity Announcement (FOA) solicits applications that propose to conduct time-sensitive mechanistic ancillary studies related to the NIAMS mission in conjunction with privately or publicly funde, ongoing interventional clinical trials. The ongoing parent project has to be an interventional clinical trial that can provide a cohort of well-characterized patients, infrastructure, data, and biological samples. Applications submitted in response to this FOA will undergo an accelerated review and award process. Each application must include a clear description of the ancillary studys mechanistic rationale and premise, and a timeline to demonstrate that the parent project has adequate time left to accommodate the proposed ancillary study. In addition, applicants must justify the time-sensitive nature of the ancillary study and the need for an expedited review and award process. Applicants must also document permission from the parent project to use the patient cohorts, data, and biological materials. The objective of this FOA is to provide a flexible mechanism to leverage established resources and maximize the return on existing investments in parent projects. Successful ancillary studies will enhance the scientific content and value of the parent projects, improve the research communitys understanding of a disease or organ system in the NIAMS portfolio, and thus may identify novel targets for diagnosis, treatment, and prevention of disease.

General information about this opportunity
Last Known Status
Program Number
Federal Agency/Office
Agency: Department of Health and Human Services
Office: National Institutes of Health
Type(s) of Assistance Offered
Who is eligible to apply/benefit from this assistance?
Applicant Eligibility
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 allowed.
What is the process for applying and being award this assistance?
Other Assistance Considerations
Formula and Matching Requirements
This program does not have cost sharing or matching requirements.
Who do I contact about this opportunity?
Headquarters Office
NIH OER Webmaster
Website Address
E-mail Address
Financial Information
Range and Average of Financial Assistance
Awards up to $300,000.00


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