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Announcements

Announcements

IRB Member Application for 2021-2022 AY

Call for IRB Member Applications; 05-17-2021, 8:00AM

Call for IRB  Student Member Applications; 04-05-2021, 10:00AM- Filled

 

Important Announcements with COVID-19

IRB: In-Person Research Restart Plan Announcement; 4-12-2021, 9:00AM

The IRB will be accepting new applications or modifications of applications to conduct in-person research during the summer months. If you can still perform your research virtually, you are highly encouraged to continue to do so. In addition to IRB approval, ALL research must be approved by the university. Please consult additional university requirements beyond IRB's human subjects concerns from the Academic Research website (Project Re-Start and Continuity Plan process).

IRB will begin accepting in-person research applications on May 1, 2021, with the actual research start date no earlier than May 24, 2021.

Consider the following prior to submitting your new or modified IRB application for review:

  • Only exempt or expedited studies will be reviewed at this time for in-person research (Full Board does not review over summer)
  • Limit the number of researchers and participants in the research space (recommend one researcher with one participant in a 6-feet radius at one time)
  • Research in the community will be reviewed on an individual basis that do not involve vulnerable populations
  • Consider providing a COVID-19 fact sheet to participants prior and following participation.
  • Investigators must address how participants will be protected (PPE, sanitizing, humidifiers, be outdoors when possible, social distancing, etc.) and the following questions will be asked on the IRB application and will be considered when determining IRB approval.

In addition to IRB requirements, you should also review the following CSUSB Policies related to COVID-19 prior to submitting your new or modified IRB application:

  • It is recommended to view CSUSB’s COVID-19 Prevention Plan where the university outlines how individuals should be protected when on campus (you will also have to submit a plan to risk management using these guidelines after IRB protocol is approved to be able to conduct your research)
  • CSUSB requires all employees and students to self-report positive COVID-19 test using this form
  • University Screening for COVID-19 each day on campus (with or without the COVID-19 vaccine)
    • All individuals with a Coyote ID must fill out the “COVID-19 Daily Health” questions found under MyCoyote and “pass” to be allowed to come to campus, if they do not pass, they should not come to campus

Previous COVID Announcements 

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. 

Previous IRB Announcements

NIH Grant Application Policy for Use of Single IRBs

Notice UpdateNIH 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