IRB Update on Human Subjects Research and COVID-19; 03-24-2020, 9:00 AM
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, firstname.lastname@example.org). 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 (email@example.com)
Nicole Dabbs, IRB Vice-Chair (firstname.lastname@example.org)
Michael Gillespie, IRB Research Compliance Officer (email@example.com)
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.
Your Institutional Review Board
Donna Garcia, IRB Chair
Nicole Dabbs, IRB Vice-Chair
Michael Gillespie, Research Compliance Officer
The California State University, San Bernardino Institutional Review Boards mission is to assure, both in advance and by periodic review, that 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 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 responsiblity 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 (OHRP, 2014). The requirements of our federal mandate is to further assure students, faculty, staff, and external researchers operate within the requirements of our filing a 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 (student, 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 firstname.lastname@example.org to provide seating arrangements.
Please plan to submit your protocols accordingly and with due dilligence 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 for full board reviews durng the summer as the CSUSB faculty on the IRB committee are unavailable to meet to conduct a meeting and hold an IRB quorum as required by OHRP federal regulations.
Institutional Review Board
NIH Grant Application Policy for Use of Single IRBs
- Notice Update: NIH Policy for Use of Single IRBs for Multi-Site Grant Applications Effective January 25, 2018
- NIH Office of Extramural Research: Single IRB Policy Purpose & Guidelines
Final Common Rule Changes
- Notice Update: Delay of the Revisions to the Final Common Rule Revisions Effective July 19, 2018
- Summary of Final Common Rule Changes (Human Subjects Protections Regulations) Effective January 18, 2018
- New and Revised Definitions Changes to Common Rule
- Department of Health and Human Services (Press Release)
- Federal Register Announcement
- Additional Final Rule Resources from CITI Program