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

If you would like information that is specific to your role, please see the Manuals tab below.

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
Exempt Online Research
Regulated Online Research
Regulated Behavioral, Social, Educational Research
Regulated Clinical Research
Parental Consent/Child Assent

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 Affairs.

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#

If you would like to report activity that you believe to be non-compliant with federal regulation, state and local law, or university policies and you would like to submit this confidentially, please click here. The content of the report is confidential and will be maintained to the highest level permitted by law.

Questions?

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