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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.

Announcements

Important Announcements with COVID-19

IRB Update on Human Subjects Research and COVID-19; 07-13-2020, 9:00 AM

Renewing Protocols during COVID-19: If you have an IRB application that is about to expire that involves in-person research and you want to keep open although you don’t plan to collect data with the new COVID-19 restrictions, the IRB advises you to submit the renewal and state that you 1) want to keep the application open, 2) do not plan to collect data at this time, and 3) will submit a modification for COVID-19 related restrictions if you plan to continue with data collection. If you have an IRB application that is about to expire that involves in-person research, you want to keep open and you plan on collecting data; the IRB advises you to submit your renewal with explanations on how you will address the COVID-19 related concerns listed below.

Important Announcements Regarding PIs

IRB Update on Human Subjects Research and COVID-19; 07-13-2020, 9:00 AM

Primary Investigators Update (for more information): The CSUSB Institutional Review Board voted during the Spring 2020 term that all primary investigators (PIs) on IRB protocols must be faculty or full-time staff members of CSUSB. Protocols involving students or student projects must have the faculty advisor as the PI. All other co-investigators (including students) should be listed as co-investigators. With this change, students can still start an IRB application and fill out all the information, however the PI listed on the application would need to be a CSUSB faculty, staff, or administrator. The PI and all co-PIs would still need to certify the IRB application before it can go under review. This new policy will be implemented immediately for new submissions but will not affect any protocols already approved. This policy change would ensure the application stays tied to the faculty advisor, which would be beneficial for the following reasons:

  1. Data Security: the responsibility of data security should mainly be of the PI and in cases where there are students that come and go on a research project, the IRB agreed that it would be the best if the responsibility of securing the data be on the faculty advisor. Some reasons are obvious, like having physical space to secure data and having more access to online data storage platforms.
  2. Incident Reporting: In the case that an adverse event occurs in a research project, the IRB agrees the responsibility to report the incident should be of the faculty member. The student can assist the faculty member in this reporting but ultimately it would need to be the responsibility of the PI.
  3. Changing the PI: Often there are larger projects where multiple students are involved over time and if a student is the PI and then graduates, it causes logistical problems. We can't transfer over a PI on an application and a new IRB submission would need to occur. 

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