Protection of Human Subjects

The Institutional Review Board (IRB; formerly Human Subjects in Research Committee [HSRC]) at Chico State is responsible for ensuring the ethical conduct of human subjects research conducted by university faculty, staff, and students. The IRB is primarily responsible for the review and continuous monitoring of human subjects protocols to ensure adequate protection of subjects and compliance with university policy and federal regulations governing the ethical and responsible conduct of research. Chico State holds a Federalwide Assurance (#FWA00001655) issued by the Office of Human Research Protections (OHRP) and follows the principles of the Belmont Report and guidance from the Federal Policy for the Protection of Human Subjects (also known as the “Revised Common Rule”).

All human subjects research conducted at Chico State, regardless of funding source or regardless of the institution that reviewed the research, is subject to institutional, local, and state (including tribal law), and federal policies and regulations and must be submitted to and approved by the IRB prior to initiation. Only those activities that constitute human subjects research require IRB review and approval. If you are unsure if your project requires IRB review or not, please submit an application through Cayuse. The IRB is responsible for making that determination. If the IRB determines that your project does not meet the federal definition of human subjects research, you will receive an official decision letter via email from Cayuse indicating that determination.

Depending on the nature of the research, submissions may be exempt from full board review. Importantly, “exempt” does not mean that the research can proceed in the absence of IRB review and approval. If a submission meets any of the criteria for exemption from full board review as defined in 45 CFR 46, it will be reviewed by the IRB Chair or designated IRB member.

Submissions that do not qualify for an exemption may still qualify for expedited review. “Expedited” does not mean that the submission is reviewed on a shorter timeline. If a submission meets any of the criteria for an expedited review as defined by the Office of Human Research Protections, it will be reviewed by the IRB Chair or designated IRB member.

Submissions not meeting the criteria for exempt or expedited review are reviewed by the IRB during monthly convened meetings (see calendar below). Decisions about which level of review is most appropriate for a submission are made by the IRB Chair.

The IRB is comprised of scientists, non-scientists, and community members with diverse backgrounds to provide a comprehensive review of the proposed research. IRB members are required to complete ethics training in human subjects research and are appointed at the recommendation of the Chair and serve one-year, renewable terms. To support the IRB on behalf of the university, Sharon Ruggirello serves as the IRB Coordinator and works in consultation with the IRB, Chair, and Compliance Officer. Sharon is happy to answer general questions regarding the protection of human subjects and can be reached at irb@csuchico.edu.

Human Subjects Research Required Training Update (January 30, 2023)

We are pleased to announce some important changes to the campus CITI Program. 

The Collaborative Institutional Training Initiative (CITI Program) is an online program dedicated to serving the training needs of colleges and universities, healthcare institutions, and governmental agencies, as they foster the integrity and professional advancement of their learners. Here at Chico State, we utilize the CITI Training program for a multitude of different research compliance training including:

• Research Involving Human Subjects
• Research Involving Vertebrate Animals
  
• Research Involving Gene Therapy, Recombinant or Synthetic DNA
  
• Responsible Conduct of Research
  

For additional details, please review the full announcement. All inquiries regarding the protection of human subjects should be direct to Sharon Ruggirello at irb@csuchico.edu.

Update on the Institutional Review Board’s (IRB) Transition to Cayuse (August 30, 2021)

Cayuse IRB Application Submissions

All applications to the IRB are now submitted through the Cayuse Research Suite. New applications submitted using the PDF form will not be accepted.

Staff and faculty have access to Cayuse through their Portal ID. All students who would like access to Cayuse are required to complete the online request form. The request form is located on the right side of this page under the blue button: “Request to Add Personnel to Cayuse”. Please allow 48-72 hours to be added to the system.

Please note that protocols approved by the IRB prior to today’s date will not be integrated into Cayuse. Principal Investigators conducting research under these “legacy” protocols are asked to continue to submit requests for amendments or extensions using the PDF forms available on the IRB website.

If you have any questions, please contact Sharon Ruggirello.

Announcing Required Human Ethics Training (August 26, 2021)

Effective August 26, 2021, all Key Personnel listed on IRB submissions will be required to have completed the appropriate CITI training coursework prior to initiation of the review process (PDF). Key Personnel is defined as any Principal Investigator, other investigators, and research personnel conducting human subjects research that are:

1. directly involved in conducting research (i.e., interacting and/or intervening) with human subjects; and/or
2. directly involved with handling private information and/or personally identifiable data related to human subjects during the course of a research project.

Please visit the CITI Program website for instructions on how to register and complete the training. All inquiries regarding the protection of human subjects should be direct to Sharon Ruggirello at irb@csuchico.edu.

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• Student Research Activities

  Graduate and Undergraduate Students are encouraged to seek guidance from their graduate coordinator or faculty advisor in completing the human subjects research application. Students involved in data collection and research activities must be under the guidance, supervision and ultimate responsibility of a Chico State faculty or staff member.

• Deadlines and Meeting Dates
  

  Please note: Exempt and expedited protocols are reviewed on a rolling basis, year-round. Only protocols requiring full committee review are subject to the dates described below!

  Deadline dates for submission of protocols to be reviewed by the full board are set two weeks before each meeting. Meetings are usually held on the third Friday of each month during the fall and spring semester. Please plan accordingly to ensure enough time for revision and resubmission of your application before the proposed start date of your research. Deadlines and meeting dates for the upcoming academic year are as follows:
  

  Protocol Submission Dates for 2022-2023

  Protocol Deadlines (electronically)	Meeting Dates
  September 2, 2022	September 16, 2022
  October 7, 2022	October 21, 2022
  November 4, 2022	November 18, 2022
  February 3, 2023	February 17, 2023
  March 3, 2023	March 24, 2023
  April 7, 2023	April 21, 2023

  Summer Protocol Submissions

  Researchers may continue to submit protocols during June and July on a rolling basis. Protocols that are determined to meet exemption or expedited review criteria will be reviewed as they are received. Some research activities may require full board review, especially those that involve vulnerable populations or that may present greater than minimal risk to participants. These protocols may not be reviewed until the first IRB full board meeting in September. Deadlines for full committee meetings will resume in the fall semester as noted in the table above.

• Human Subjects Protocol Forms

  For new IRB applications:

  Cayuse Research Suite(opens in new window)
  
  For legacy IRB applications (approved prior to August 30, 2021):
  
  Human Subjects Amendment (PDF)
  Human Subjects Extension Request (PDF)
  Human Subject Post Data Collection (PDF)
  

• Policies

  Chico State EM 93-004: Human Subjects Policy
  HHS Policy for the Protection of Human Research Subjects (PDF)