What is a U01 clinical trial?
The NIAID Clinical Trial Implementation Cooperative Agreement (U01, Clinical Trial Required) is for principal investigators (PIs) implementing a high-risk clinical trial. Applications must include project milestones, and NIAID staff have substantial scientific involvement during the award.
What is a U44?
Scope. The NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44) program supports implementation of clinical trials from small business concerns (SBCs) that propose clinical trials in research areas that are well matched with the mission and goals of the NIAID.
When conducting human subjects research that is funded by niaid the investigator must abide by the?
All clinical research supported by NIAID must comply with applicable Parts of U.S. Code of Federal Regulations, Title 45, Part 46 “Protection of Human Subjects.” All clinical trials supported by NIAID shall comply with ICH and GCP guidelines.
What is a UM1 grant?
The grant, called a UM1, is a 5-year grant that funds investigator-initiated clinical trials. The grants support the NCI’s Experimental Therapeutics Clinical Trials Network (ETCTN), whose purpose is to encourage early phase clinical trials of innovative cancer therapies.
What is a U44 NIH grant?
Resources. U44. Cooperative Agreements. Small Business Innovation Research (SBIR) Cooperative Agreements – Phase II. To support in-depth development of R&D ideas whose feasibility has been established in Phase I and that are likely to result in commercial products or services.
Where is IRB?
IRBs are administered on a federal level by the Office for Human Research Protections (OHRP), an office within the Department of Health and Human Services.
Do you need preliminary data for R21?
R21 Pros and Cons Pros: Allows you to introduce novel scientific ideas, model systems, tools, agents, targets, and technologies that have the potential to substantially advance biomedical research. Preliminary data are not required for an R21 application.