Application Process

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, formal receipt of approval from NCATS following prior approval submission is required before the project can begin. For HSR studies that fall under Category 2, NCATS prior approval submission is required before the project can begin.

- All prior approval correspondence with NCATS is carried out by UB’s Sponsored Projects Services office as the Authorized Organizational Official.

• Any studies involving HSR must work with the CTSI Senior Research Administrator and CTSI Quality Assurance Specialist to 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. 

Animal Subjects Research (AS)

• For studies involving AS, formal receipt of approval from NCATS following prior approval submission is required before the project can begin.

- All prior approval correspondence with NCATS is carried out by 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 submission is not required for research that does not involve human or animal subjects.