Understanding the CTSI Pilot Studies Program in 7 Steps

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

(1) Clinical Trials

(2) Greater than Minimal Risk

- Category 2

(1) Minimal Risk

(2) Exempt

• For HSR studies that fall under Category 1, NCATS prior approval is required before the project can begin. For HSR studies that fall under Category 2, NCATS notification is required before the project 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 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 (AS)

• For studies involving AS, NCATS prior approval is required before the project can begin.

- 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.