State Center IRB
All IRBs that review human subjects research conducted or supported by HHS, and that are designated under assurances of compliance approved for federal wide use by OHRP under 45 CFR 46.103(a), must be registered with OHRP. The Ïã¸ÛÁùºÏ²Ê¹ÙÍø complies and registered with OHRP.
What is an IRB?
Institutional Review Boards (IRBs) are established to review research studies, ensuring they align with ethical standards, institutional policies, and applicable regulations, while providing adequate protection for research participants. IRBs, also known as Independent Review Boards or Ethics Review Committees, play a vital role in safeguarding participants from research-related risks and ensuring ethical treatment. This oversight is essential for maintaining public trust in research, supporting the responsible advancement of science, and promoting the common good.
Board membership represents a wide range of disciplines and includes a member from outside Ïã¸ÛÁùºÏ²Ê¹ÙÍø; the IRB gives individualized attention to the numerous projects proposed across our colleges and populations.
Investigators who endeavor to conduct research with State Center student or employee populations must have prior dated and written approval from the IRB before any research activities can begin with human subjects. Some research activities may be exempt from ongoing IRB oversight, but eligibility for exemption must be predetermined by an IRB.
Employees, students, and external researchers may be eligible to conduct research at The District if their proposed studies meet standards of ethics, integrity, and if they align and uphold Ïã¸ÛÁùºÏ²Ê¹ÙÍø's mission, vision, and values, and demonstrate a clear benefit to The District. To demonstrate this, proposals and supporting documentation must be submitted to the State Center IRB for consideration through the following types of reviews:
Research proposals for Exempt consideration will comply with the categories listed on the U.S. Health and Human Services (HHS) Office of Human Research Protections (OHRP) webpage, and will not include sensitive populations further outlined by OHRP, such as, but not limited to, pregnant or nursing women and fetuses, research with children, or research targeted to prisoner populations. Proposed research procedures for some Exempt categories may not identify subjects in a way that places them at risk of liability or cause other damage or harm to the subject's financial standing or employability, or could expose a sensitive aspect of a subject's behavior.
Research proposals for Expedited consideration will present no more than minimal risk to human subjects and will use only the procedures listed in the categories for Expedited research on the OHRP webpage. defines minimal risk to mean that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Proposed research procedures may not identify subjects in a way that places them at risk of liability or other damage or harm as described on the OHRP webpage for Expedited research.
Site Authorization
For research proposals where an external IRB reviews a protocol that seeks to gather data from Ïã¸ÛÁùºÏ²Ê¹ÙÍø populations, you will need to submit a Site Authorization form and supporting documentation for consideration. All Site Authorization requests involving or pertaining to students or employees conducted by individuals or groups outside of Ïã¸ÛÁùºÏ²Ê¹ÙÍø may be subject to State Center IRB review regardless of external protocol determination (exempt, expedited, or full review) at the discrimination of the State Center IRB Chair.
Full Review
Research proposals for Full Review by IRB involve more than minimal risk to subjects as defined previously, and/or involve subjects in protected groups. For a full list of research considerations requiring Full Review, contact the State Center IRB.
Human Research Protections (HRP) Training
State Center IRB requires HRP training for consideration of all protocol submission types and site authorization requests. Many academic institutions subscribe to the Collaborative Institutional Training Initiative (CITI) Program and State Center IRB accepts CITI program course completion certificates as proof of HRP training. If you do not have access to a CITI program, the State Center IRB accepts completion certificates from the OHRP’s free (minimum Lesson 1 and Lesson 2). HRP training certifications expire and need to be renewed at least every three years.
If you are interested in conducting research at Ïã¸ÛÁùºÏ²Ê¹ÙÍø, for forms, and/or more information on State Center IRB processes, please submit your inquiries to: irb@scccd.edu
