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Application Process

Seminar.

Understand the seven steps of the CTSI Translational Pilot Studies Program application process.

1) RFP 2) LOIs 3) Proposals 4) Review 5) Funding 6) Prior Approval 7) Account and Tracking

NIH's National Center for Advancing Translational Sciences (NCATS) Prior Approval

Human Subjects Research (HSR)

  • There are two categories in which HSR can be considered:
Category 1 Category 2
Clinical Trials Minimal Risk
Greater than Minimal Risk Exempt
  • HSR studies that fall under Category 1 require entry of the study into the eRA Human Subjects System (HSS) and official notification from NCATS of NCATS’ Prior Approval before the project can begin. HSR studies that fall under Category 2 require entry of the study into the eRA HSS and email notification to NCATS before the study can begin.

Correspondence regarding prior approval or notification is between NCATS and UB’s Sponsored Projects Services office, as the Authorized Organizational Official.

  • Any studies involving HSR must complete required sections within the ASSIST Human Subjects System (HSS). Required HSS sections are dependent on whether a project is Category 1 or 2, as provided in the NCATS New Projects with Human Subjects Research Addendum and Instructions found here. 

Investigators will work with the CTSI Senior Research Administrator, who is responsible for entering the required information into HSS. Once a study record is complete, UB’s Sponsored Projects Services office is responsible for submitting the HSS study record.

Animal Subjects Research (ASR)

  • Studies involving AS require official notification from NCATS of NCATS' Prior Approval. 

Correspondence regarding prior approval is between NCATS and UB’s Sponsored Projects Services office, as the Authorized Organizational Official.

  • IACUC-approved documentation is required, as provided in NCATS CTSA Program Instructions for Submitting Prior Approval Requests for Planned Research Involving Live Vertebrate Animals found here. 

Non-HSR or Non-AS

  • Prior approval is not required for research that does not involve human or animal subjects.

Foreign Components

  • Studies involving any foreign component require NCATS Prior Approval. Upon receiving approval for the foreign component, the study may then be submitted for prior approval for human or animal subject research.