March 16, 2020
The CSUN Committee for Protection of Human Subjects provides the following guidance about human subjects research and operations during the rapidly evolving COVID-19 situation.
Status of the IRB Office
The Research and Sponsored Programs office wants to reassure you that the IRB office remains open and fully operational despite the campus transition away from face-to-face classes. You can continue to contact us anytime at (818) 677-2901 or at email@example.com, and your message will be returned during normal business hours. Additionally, we have plans in place to continue the work of the IRB in the case of a full campus closure. We understand that researchers may need to reach out for assistance in submitting modifications to their IRB protocols or reporting protocol deviations related to the closure of schools, community centers, and other public spaces, and we are available to support you by phone, email, or to schedule a Zoom meeting as needed.
Safety of Research Participants and Personnel
The safety of research participants and study personnel is our highest priority. Please consider postponing, suspending, or modifying planned face-to-face data collection in the near future. If feasible for your research, you may wish to consider submitting a protocol modification to replace in-person data collection with online data collection. Please feel free to reach out for assistance in submitting a modification request. If your research is supported by external funding, please reach out to your grants analyst in the Research and Sponsored Programs office to discuss your particular situation, as Coronavirus-related guidance on project extensions varies by funding agency.
Protocol Deviations and Unanticipated Problems
The IRB committee and staff understand that there may be protocol deviations and unanticipated problems related to the closure of schools, community centers and other public spaces where research may be planned or conducted. These should be reported within one week of the time that the investigator becomes aware of the incident. There are two routes for reporting such incidents to the IRB:
- For projects that have been approved within the Cayuse IRB online submission system, there is an incident report template within Cayuse IRB. If you go into the “Study Details” section of your project and click on the large blue button reading “+ New Submission” a drop down box should appear that allows you to create an incident submission.
- If your project was approved in the older PDF process or if you are unable to initiate an incident report in Cayuse, you may send an email incident report to firstname.lastname@example.org. Please give the IRB number and title of the protocol, and describe to the best of your ability the deviation from the approved protocol or the unanticipated problem that occurred.
When in doubt, please send an email to email@example.com describing your situation. Jennifer and Bianca can help you navigate this process.
Please consult with the CDC, the Los Angeles Department of Public Health, and the CSUN EOC for more information about COVID-19/Novel Coronavirus. We strongly encourage you to follow the recommendations from the CDC, including:
- Washing your hands frequently, with soap and water, for at least 20 seconds.
- Keeping distance between yourself and other people (social distancing).
- Staying home if you are sick.
- Covering coughs and sneezes, disposing of tissues appropriately, and cleaning your hands.
- Cleaning and disinfecting frequently touched surfaces.
Full recommendations can be found at: https://www.cdc.gov/coronavirus/2019-ncov/about/prevention.html
We will be in touch with further information as we receive additional guidance from the federal Office of Human Research Protections, the State of California, and/or the CSU. Stay safe and stay well. The IRB looks forward to continuing to work with you in the future.