Protection of Human Subjects

UPDATED PROCEDURES FOR IN-PERSON HUMAN SUBJECTS RESEARCH

December 9, 2021
Debra Larson, Provost and Vice President for Academic Affairs

Colleagues,

On April 27, 2021, a multi-step process for resuming or initiating in-person human subjects research suspended due to COVID-19 was announced. Since returning to campus for the fall 2021 semester, many of the procedures required for researchers to apply for an exception to the suspension have become obsolete. As a result, guidance for in-person human subjects research has lagged behind guidance surrounding a safe return to campus.

Therefore, in consultation with the Chico State Pandemic Management Team and in accordance with local, state, and federal best practices for mitigating the spread of COVID-19, we have developed new guidance that will allow us to safely lift the suspension on in-person human subjects research. Effective today, December 9, 2021, the following procedures are required to be in place whenever researchers come into contact with human subjects for research purposes:

• Identify and Implement Feasible Alternatives to In-Person Activities: Researchers are still encouraged to identify procedures to avoid or minimize contact with human subjects. For example, if interviews can feasibly be conducted via Zoom or other remote methods (e.g., phone), researchers are encouraged to pursue these alternatives. Modifications to existing studies that reduce COVID-19 risk do not require IRB review and approval prior to their implementation.
• Perform Daily Symptom Monitoring Prior to In-Person Activities: Leading up to any face-to-face interaction with human subjects, members of the study team should monitor their health on a daily basis for symptoms of COVID-19. Subjects should be contacted via phone or e-mail prior to face-to-face meetings to confirm the absence of COVID-19 symptoms. If members of the study team or human subjects scheduled for face-to-face procedures experience COVID-19 symptoms or come into close contact with someone who tests positive for COVID-19, in-person activities involving these individuals must be cancelled. Response protocols on the university’s Coronavirus/COVID-19 Information website should be followed in these cases.
• Wear Face Coverings: Members of the study team are required to wear masks or other suitable face coverings when indoors and interacting face-to-face with one another and all human subjects. If in-person research activities are scheduled for outdoor settings, face coverings are only required if physical distancing of at least six feet is not possible; otherwise, face coverings are not required.
• Wash Hands and Sanitize Research Equipment: Members of the study team and any human subjects should practice good hygiene and wash or sanitize their hands prior to any physical contact. Shared research equipment should be disinfected following use and prior to any interactions involving human subjects (e.g., computer).

If you have any questions or concerns related to this guidance, please contact Dr. Patrick S. Johnson (IRB Chair) at psjohnson@csuchico.edu or Sharon Ruggirello (IRB Coordinator) at irb@csuchico.edu.

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

During the summer break, the IRB began transitioning to the Cayuse Research Suite for online protocol submission and management. Effective immediately, all human subjects research applications are required to be submitted through Cayuse. New applications submitted using the PDF form will not be accepted. Please visit the IRB website for additional information.

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.

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.

If you have any questions, please contact Sharon Ruggirello at irb@csuchico.edu.

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. 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

  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)