Protection of Human Subjects

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The 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 HSRC 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 “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 HSRC prior to initiation. Although Principal Investigators are encouraged to use the online determination tool to identify whether the planned activities meet the definition of research (Is My Activity Research?), decisions about whether planned activities constitute research are made by the HSRC Chair. Activities that do not meet the definition of research do not require HSRC review and approval to proceed as planned.

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 HSRC review and approval. If a submission meets the criteria for exemption from full board review, it is reviewed by the HSRC Chair or other designee. Similarly, submissions may qualify for expedited review. “Expedited” does not mean that the submission is reviewed on a shorter timeline. Expedited reviews are also conducted by the HSRC Chair (or another designee). Submissions not meeting the criteria for exempt or expedited review are reviewed by the HSRC during monthly convened meetings (see HSRC Calendar below). Although Principal Investigators are encouraged to identify which level of review is most appropriate for their research, decisions about which level of review a submission will receive are made by the HSRC Chair.

The HSRC is comprised of scientists, non-scientists, and community members with diverse backgrounds to provide a comprehensive review of the proposed research. HSRC members are required to complete ethics training in human subjects research. HSRC members are appointed at the recommendation of the Chair and serve one-year, renewable terms. To support the HSRC on behalf of the university, Chico State Enterprises (CSE) provides the administration of the HSRC. CSE staff member Sharon Ruggirello serves as the HSRC Coordinator and works in consultation with the HSRC 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.

NOTE: As of August 01, 2019, all researchers and faculty advisors involved in human subjects research are encouraged to complete online ethics training through the CITI Program. This training should be completed before application submission. Please visit the CITI Program website for instructions on how to register and complete the training.

All inquires regarding the protection of human subjects should be direct to Sharon Ruggirello 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 CSUC 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 4, 2020	September 18, 2020
  October 2, 2020	October 16, 2020
  November 6, 2020	November 20, 2020
  February 5, 2021	February 19, 2021
  March 5, 2021	March 19, 2021
  April 2, 2021	April 16, 2021

  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 HRSC 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)
• Policies

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