NIAID Clinical Trial Implementation Grant (R01)
Deadline: May 12, 2017; September 13, 2017 January 12, 2018; May 14, 2018; September 13, 2018; January 14, 2019; May 13, 2019
Amount: Application budgets are not limited but need to reflect the actual needs of the proposed project. Maximum period is 5 years.
Encourages applications for implementation of investigator-initiated, hypothesis-driven, non-high-risk clinical trials that are considered a high priority by NIAID. Investigators are encouraged to visit the NIAID website for additional information about the research mission and high-priority research areas of the NIAID (http://www3.niaid.nih.gov/about/whoWeAre/planningPriorities/). Only one clinical trial may be proposed in each NIAID Clinical Trial Implementation (R01) Grant application. For HIV-related clinical trials, NIAID encourages projects that integrate biomedical and behavioral interventions; studies that explore pathogenesis of HIV infection within the trial are also encouraged.
- A clinical trial is defined by NIH 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." - See more at: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html
- A high-risk clinical trial is defined by the NIAID as having one or more of the following attributes:
- provision of a non-routine intervention, that is, an intervention or non-routine use of an intervention that would not otherwise be provided for the condition under study in the local facility where the study is being conducted;
- administration of an unlicensed product; or
- administration of a licensed product for an unapproved indication.
- Companion FOA's
- NIAID Clinical Trial Planning (R34) Grants, supporting planning activities for investigator-initiated clinical trials - http://grants.nih.gov/grants/guide/pa-files/PAR-16-272.html
- NIAID Clinical Trial Implementation (U01) Cooperative Agreement, supporting implementation of high-risk clinical trials - http://grants.nih.gov/grants/guide/pa-files/PAR-16-270.html
- NIAID SBIR Phase II Implementation Cooperative Agreement (U44), supporting small business concerns for hypothesis-driven, milestone-driven clinical trials - http://grants.nih.gov/grants/guide/pa-files/PAR-16-271.html