Institutional Review Board

MISSION STATEMENT

The name of the board is the Touro University California Institutional Review Board (hereafter referred to as the "TUC IRB").

The Mission of the TUC IRB is

  • to promote the welfare and rights of human research participants
  • to facilitate excellence in human research and
  • to provide timely and high quality education, review and monitoring for human research projects.

OBJECT

To safeguard the rights and welfare of human research subjects, the TUC IRB adheres unequivocally to the principles of The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects in Research by the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research. These guidelines are codified in the Code ofFederal Regulations Title 45 Part 46 Subpart A, which are the uniform set of regulations that function as the Federal Policy for the Protection of Human Subjects and is informally known as the “Common Rule”.

Concerning research involving human subjects, the function of the TUC IRB is to ensure observance of (1) the guidelines established by the 1974 Belmont Report, (2) the terms of the Federal Policy for the Protection of Human Subjects, published in the Federal Register, Vol. 56, No. 117, June 18, 1991, and (3) the policies of the TUC campus administration, including but not restricted to the TUC Office of Research. Based on these criteria, the TUC IRB will review all research activity conducted by or in collaboration with TUC faculty, students, or staff that directly, or indirectly, involves human subjects whether federally supported or non-federally supported.

AUTHORITY

The TUC IRB is established under and pursuant to the Federalwide Assurance (FWA) (#FWA0009823), between Touro University and the U.S. Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) as a registered institutional review board (IRB Registration # IRB00004515) under Title 45 Code of Federal Regulations (CFR) Part 46, Subparts A, B, C, & D of the U.S. Department of Health & Human Services (DHHS) Regulations http://www.hhs.gov/ohrp/humansubjects/

With regard to all human research to which the FWA applies (except research exempted or waived in accordance with sections 101 (b) or 101 (i) of 45 CFR Part 46), the TUC IRB is empowered to:

1)   Review all funded and unfunded research by faculty, students, or staff that involves the use of human subjects, prior to the beginning of the research.

2)   Determine the type of review process (exempt, expedited, or full board) the research requires based on decision guidelines outlined by the OHRP: http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html

3)   Disapprove, recommend modification, or approve research proposals based upon consideration of the protection of human subjects.

4)   Suspend or terminate a research project.

5)   Require progress reports and perform such monitoring, as it deems necessary.

Last Updated: 6/17/15