Resources

Find all documents related to the Institutional Review Board and human subjects review below.

This document houses all procedures for anyone involved in the submission, review, approval, and administration of human subjects research.

IRB Procedures*
Summary of Changes*

 

*Initial submissions of human subjects research that is not funded, or that is not funded by an agency that has adopted the Common Rule (45 CFR 46) will be reviewed according to the Final Rule, which was published on January 19, 2017. Human subjects research that proposes to be funded by, or is funded by, a federal or other agency that has adopted the Common Rule will be reviewed according to the pre-2018 rule until July 19, 2018, upon which the Final Rule will be in effect.

The manuals are condensed procedures specific to one's role in human subjects research or review.

Investigators - please view the Procedures document
IRB Member Manual
Department/College Student Research Review Committee Manual

If you are looking for guidance on submitting an application through Cayuse IRB, view the Quick Guides below for short application submission instructions.

These Quick Guides provide snapshot guidance and videos to help you navigate the Cayuse IRB system when making a submission or approving someone else's application. 

Investigator Submissions
Faculty Advisor/ Co-Investigator Certify a Submission

Below are templates for you to use when creating an informed consent form. Exempt templates should only be used for exempt research, and the IRB will make the final determination.

See Review Categories for information regarding exempt, expedited, and full board review.

Exempt Research
Regulated (Expedited/Full Board) Research

Updates are posted annually to inform the campus of new or updated policies or procedures related to research integrity and compliance in the Office of Research, Innovation, and Economic Development.

Fall 2017

There are two options for external investigators to consider:

Cooperative Research Agreements should only be considered when a CSUS affiliate will be working with the external investigator to conduct research (i.e. collecting informed consent, collecting data (identifiable or not), and/or analyzing identifiable data.) Please see Cooperative Research on our Submit page.

External Investigators do not need an agreement if their only purpose is to recruit subjects from our campus (whether subjects are students, faculty, and/or staff). CSUS affiliates may assist an external investigator in connecting potential participants with researchers as this is not considered to be engaging in the research. Please see External Investigators on our Submit page.

 

The federal policy is administered by the Health and Human Services' (HHS) Office of Human Research Protection (OHRP). The policy guides all IRBs in the United States that review research funded by Public Health Services (PHS) and many other agencies. It also guides IRBs who do not recieve funding if they have pledged to use this policy for human subjects research regardless of funding.

OHRP Regulations (45 CFR 46)
OHRP Decision Trees
The Belmont Report
Office of Human Research Protection (OHRP)

If you are a participant in research and have questions about your rights in research, please visit our Participant Rights page.

The Office of Human Research Protections has a new Research Participation page that can be viewed here: https://www.hhs.gov/ohrp/education-and-outreach/about-research-participation/index.html#

Questions?

Leah Vargas
Research Integrity and Compliance Officer
Research, Innovation, and Economic Development
leah.vargas@csus.edu
(916) 278-5674
Hornet Bookstore, Suite 3400