Protection of Human Subjects

Update on Transition to Cayuse (June 11, 2021)

Beginning July 1, 2021, the Institutional Review Board (IRB) will begin transitioning to Cayuse for online protocol submission and management. While human subjects researchers will be allowed to submit their protocols through the Cayuse system beginning July 1, the IRB will not require protocol submissions using the new system until the fall (effective date TBD). For up-to-date information regarding the transition to Cayuse, please visit the Cayuse informational website(opens in new window). Protocols approved before July 1, 2021, will not be transferred to the Cayuse system. Principal Investigators conducting research under these “legacy” protocols should continue to use the PDF forms (available below) until the closing of their project.

Announcing Required Human Ethics Training (June 11, 2021)

Effective August 18, 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. 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.

The Institutional Review Board (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 an activity does not meet criteria for human subjects research, an IRB submission is not required. If you are unsure whether your activity constitutes human subjects research, you may use the National Institutes of Health Decision Tool.

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, Chico State Enterprises (CSE) provides the administration of the IRB. CSE staff member Sharon Ruggirello serves as the IRB Coordinator and works in consultation with the IRB Chair to provide educational offerings such as seminars or workshops. Sharon is happy to answer general questions regarding the protection of human subjects and can be reached at irb@csuchico.edu.

• 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 2020-2021

  Protocol Deadlines (electronically)	Meeting Dates
  September 3, 2021	September 17, 2021
  October 2, 2021	October 15, 2021
  November 6, 2021	November 20, 2021
  February 4, 2022	February 18, 2022
  March 4, 2022	March 25, 2022
  April 1, 2022	April 15, 2022

  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

  Requirements For Human Subjects in Research (PDF)
  Human Subjects Checklist (PDF)
  Human Subjects FAQ (PDF)
  Human Subjects Application (PDF)
  Human Subjects Amendment (PDF)
  Human Subjects Extension Request (PDF)
  Human Subject Informed Consent Form (PDF)
  Human Subject Informed Online Consent Form (PDF)
  Human Subject Oral Consent (PDF)
  Human Subject Post Data Collection (PDF)
  Digital Signature Instructions (PDF)
  Cayuse Research Suite(opens in new window)

• Policies

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