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Institutional Review Board

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We are open and ready to support you!

As we continue to monitor and meet established safety guidelines in response to the novel coronavirus (COVID-19) outbreak, our offices are still open and operating in a virtual format. You can reach us by phone at (909) 537-7588 or via email at mgillesp@csusb.edu. We will respond as quickly as possible. Please keep a close watch for new announcements. Many of them, as well as several resources, can be found on CSUSB’s dedicated COVID-19/Coronavirus Information web page.

Thank you and stay safe.

Important Announcements

IRB Update on Human Subjects Research and COVID-19; 07-02-2020, 9:00 AM

Recommencement of In-Person Research: At this time, the IRB strongly recommends no in-person research for human participants. However, if you wish to commence or start new in-person research, there are some required precautions you will need to address. The IRB will only consider new applications, modification requests, or renewals if investigators have adequately demonstrated that they will minimize the risk of COVID-19 to participants. Below are items you must consider and include in your IRB application.

  • How will social distancing be maintained between researcher and participants as well as among participants when applicable?
  • What process will be used for contact tracing (i.e., identifying researchers or participants who may have come into contact with an infected person during the research process, and identifying who these individuals subsequently interacted with)?
  • What process will be used for screening researchers and participants for COVID-19 (e.g., using screening questionnaires)? See the example screening tool below..
  • What procedures will be followed to decontaminate hard surfaces, research equipment, soft surfaces, clothing, and personal protective equipment (PPE)?
  • How will you determine if your participants are at high risk of contracting COVID-19 and what measures will be taken to reduce their risk of participating in your research?
  • Will other measures be taken to reduce the spread of COVID-19 within research spaces (e.g., improving ventilation, opening outside doors and windows to increase air circulation, conducting research in larger spaces, using sneeze guards to separate people)?
  • If your research poses risks to individuals with lung, heart, clotting, or other health consequences associated with COVID-19, what measures will you take to reduce those risks (e.g., excluding participants who were previously diagnosed with COVID-19)?

Reviews of protocols will begin July 20, 2020. Once you have received IRB approval you need to obtain administration approval. It is CSUSB policy that you must obtain both IRB and administration approval to continue in-person research. Once your in-person research commences, you must continue to follow the newly approved protocol that includes COVID-19 restrictions to be considered compliant with federal regulations. Any IRB approval for in-person research is potentially temporary and changes may occur due to federal, state, local, and/or CSU directives.

IRB Update on Human Subjects Research and COVID-19; 05-29-2020, 9:30 AM

Primary Investigators Update: The CSUSB Institutional Review Board issued this statement that all Primary Investigators (PI) on IRB protocols must be faculty or full-time staff members of CSUSB. Protocols involving students or student projects must have the faculty advisor listed as the PI. All other co-investigators (including students) should be listed as co-investigators. This new policy will be implemented immediately for new submissions but will not affect any protocols already approved.

Recommencement of Research: At this time, no in-person research can resume due to a lack of clear government and CSU guidelines for human subject research. The IRB Chair and Vice-Chair will attend a CSU webcast on June 9th and is hopeful for some guidance in the following weeks. In the meantime, the IRB will not review any new applications involving in-person human subjects research until we have received clear guidance from the Chancellor’s and Governor’s Offices regarding the recommencement of such research.

COVID-19 preparations: As we start to plan for in-person research resuming, you as an investigator should start thinking about how you will protect participants in your research from COVID-19 risks. As you prepare for your research to resume, you should start to consider how you will minimize the risk of COVID-19 to your participants. Below is a list of questions that you might consider to help guide your preparations as they pertain to your research.

  • How will social distancing be maintained between researcher and participants as well as among participants when applicable?
  • What process will be used for contact tracing (i.e., identifying researchers or participants who may have come into contact with an infected person during the research process, and identifying who these individuals subsequently interacted with)?
  • What process will be used for screening researchers and participants for COVID-19 (e.g., using screening questionnaires)?
  • What procedures will be followed to decontaminate hard surfaces, research equipment, soft surfaces, clothing, and personal protective equipment (PPE)?
  • How will you determine if your participants are at high risk of contracting COVID-19 and what measures will be taken to reduce their risk of participating in your research?
  • Will other measures be taken to reduce the spread of COVID-19 within research spaces (e.g., improving ventilation, opening outside doors and windows to increase air circulation, conducting research in larger spaces, using sneeze guards to separate people)?
  • If your research poses risks to individuals with lung, heart, clotting, or other health consequences associated with COVID-19, what measures will you take to reduce those risks (e.g., excluding participants who were previously diagnosed with COVID-19)?

Data storage: As a reminder, if you change the location of where your data is being securely stored because of COVID-19, you will need to make a modification via Cayuse to your approved IRB protocol, unless you are moving your data electronically to the CSUSB secure google drive. If the change is to a location other than the google drive and is due to COVID-19, please indicate that information in the modification request form. If you plan to return your data to the original location following the lifting of COVID-19 restrictions, please indicate that intention on your modification as well. Giving that info ahead of time will prevent you from having to submit an additional modification once you return to campus.

IRB Update on Human Subjects Research and COVID-19; 03-24-2020, 9:00 AM

Dear Colleagues,

To receive an in-person research continuation approval, please submit a statement of justification for why the benefits of continuing your research outweigh the risks of potentially exposing participants to COVID-19. This justification should be emailed to the IRB compliance officer (Michael Gillespie, mgillesp@csusb.edu). In-person research that is continued without the approval of the IRB will be regarded as non-compliant and reported to the Federal Office for Human Research Protections.  This policy is in effect until both the Office of Research and the IRB at CSUSB notify the campus that in-person research can recommence. Investigators can, however, submit a continuation request to the IRB for sites outside of San Bernardino located in geographical areas for which social-distancing advisements have been lifted by major health agencies and governmental organizations. These requests can be sent directly to the IRB via email.

As per the previous IRB communication on human subjects research and COVID-19, modifications to research protocols due to the virus must be first approved by the IRB through Cayuse. Before submitting a modification request, make sure to indicate in the Cayuse form’s description box whether you are requesting permanent or temporary changes. If you state the changes are temporary, you will not need to submit a modification request to return to your original in-person protocol, once in-person restrictions are lifted by the CSUSB IRB.

Thank you for your cooperation,

Donna Garcia, IRB Chair (dmgarcia@csusb.edu)

Nicole Dabbs, IRB Vice-Chair (ndabbs@csusb.edu)

Michael Gillespie, IRB Research Compliance Officer (mgillesp@csusb.edu)

IRB Statement on Human Subjects Research and COVID-19; 03-16-2020, 1:48 PM

Due to the rapidly evolving concerns and risks related to the COVID-19 outbreak, the CSUSB Institutional Review Board (IRB) requests that study investigators 1) take proactive measures to evaluate new physical and mental health risks posed to participants because of the virus, and 2) limit transmission of the virus by delaying or otherwise modifying person-to-person interactions. In particular, the IRB requests that research involving immunocompromised, elderly, or other at-risk participants or group meetings or appointments is delayed or uses alternative interactions via electronic means if possible. If investigators are experiencing symptoms associated with the illness (fever, cough, and shortness of breath) or have visited a geographical area that has experienced an outbreak of the virus, they must avoid all physical interactions with participants. Investigators whose research involves human biological samples need to handle those samples with extra care (see CDC website). If any participants are exposed to COVID-19 in the course of a study, they must be informed immediately and advised to self-isolate. The IRB must then be promptly notified (within 24 hours) of the exposure and actions taken to notify affected participants.

All new potential or actual COVID-19 related risks posed to participants must be promptly reported to the IRB and the related research must be discontinued (unless the risks caused by the discontinuation exceed those presented by COVID-19) until the IRB has reevaluated and approved recommencement. For the purpose of protecting participants, investigators may suspend most research activities without first consulting the IRB. Investigators, however, are required to report the suspension of research if the suspension might affect the health or well-being of participants (e.g., removal of access to health-related treatments). Before any changes are made to existing research or recruitment processes, a modification request must be submitted to the IRB through Cayuse. The IRB will prioritize processing risk change and protocol modification requests that are intended to protect the well-being of participants. 

(§46.108 (a)(3)(iii))

Your Institutional Review Board

Donna Garcia, IRB Chair

Nicole Dabbs, IRB Vice-Chair

Michael Gillespie, Research Compliance Officer

Welcome

The California State University, San Bernardino Institutional Review Board (IRB) mission is to assure, both in advance and by periodic review, appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group peer review process to review research protocols and related materials (e.g., informed consent documents, surveys, interview questions, and protocol design) to ensure the protection of the rights and welfare of human subjects of research. This is in accordance with federal regulations in the Federal Office of Human Research Protections CFR Title 45 Part 46 and the Federal Food and Drug Administration Title 21 Part 50 and Part 56.

The ethical responsibility of institution’s IRB is to ensure, regardless of whether the research is subject to the U.S. Federal Policy for the Protection of Human Subjects (also known as the Common Rule), it will be guided by a statement of principles governing the institution in the discharge of its responsibilities for protecting the rights and welfare of human subjects of research conducted at or sponsored by the institution. The requirements of our federal mandate further assure students, faculty, staff, and external researchers operate within the requirements of Federalwide Assurance of Compliance with the U.S. Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP). The CSUSB IRB OHRP Federal Assurance number is FWA00004865.

Researchers (students, staff, faculty, administrators) should attend the meeting when their IRB application is being reviewed by the full board committee. Attending the meeting will facilitate the approval of your IRB application so you can address any concerns and clarifications the board has regarding your protocol. Those who would like to attend IRB meetings to view the IRB process are also invited to attend. We would request that you please notify the Research Compliance Officer at 909-537-7588 or mgillesp@csusb.edu to provide seating arrangements.

Please plan to submit your protocols accordingly and with due diligence especially if your IRB application is directly tied to grant-related funding and agency approval. Your attention to detail is important in order to facilitate IRB review of your application protocol in a timely, thorough, and efficient manner. Please note the IRB does not meet during the summer to review bull board applications (protocols) as CSUSB faculty on the RB committee are unavailable to meet to conduct a meeting and hold an IRB quorum as required by OHRP federal regulations.

Thank you,

Institutional Review Board