RESEARCH WITH HUMAN SUBJECTS
What is the current status of human subjects research at Chapman?
Given the directives from the Orange County Health Department, it has been determined that research activities involving in-person interactions with subjects are suspended until further notice. The only exceptions are if canceling or postponing the activities would either (A) increase the risk to the subject’s safety or well-being or (B) deprive the subject of a potential direct benefit. This is being done to protect research subjects.
What does this pause mean for interactions with enrolled subjects?
Most research activities that involve face-to-face interaction with subjects must stop.
The exceptions are:
1) The research holds the potential for direct benefit to the subject (e.g., investigational drug, devices or surgical procedure) and the interaction is required to deliver that potential direct benefit
2) Collection of safety data (based on clinical judgment of the importance of the visit to detect potential adverse events)
May we continue to collect data and follow up with subjects by telephone when in-person data collection has been paused?
Yes. (Rationale: There is no increased risk to subjects relating to COVID-19.)
May we conduct home visits to collect data in studies with no potential direct benefit to participants?
No. (Rationale: While the real or potential risk to participants of traveling to a research site, and aggregation at the site, are absent from home visits, there may still be real or apparent risk.)
May we enroll new subjects on existing studies?
Only if enrollment is on-line or remote. This should be decided on a study-by-study basis. (Rationale: The risk/benefit ratio for subjects may have changed from the time at which the protocol was reviewed and approved.)
What is the effect of the pause on pending studies?
The IRB will continue to review and approve submissions. For studies that are approvable, but involve in-person interactions with study subjects and do not have the potential for direct benefit, the IRB will approve the study but explicitly note that enrollment cannot start until the pause in research activities is lifted.
RESEARCH WITH ANIMALS
What is the status of animal research and operations at Chapman?
Until further notice, Vivarium operations have been reduced to essential duties to maintain the welfare and safety of animals. Only staff or faculty deemed as essential personnel are permitted to enter or work in the vivarium. If you have any questions on animal welfare in the vivarium, please contact Vanessa Salvary (firstname.lastname@example.org, (714) 516-5504).
What about active protocols or new protocols?
IACUC Administration is fully operational; however, we are practicing social distancing by working remotely and our offices are closed due to the campus closure. In light of this, there may be delays in response and turnaround times as we dedicate efforts to addressing animal welfare issues related to the COVID-19 response – your patience during this challenging time is appreciated. IACUC will continue to review protocols and modifications; however, no animal research activity should commence during the campus closure. If you have any questions regarding approved protocols, please contact Bruce Kennedy at email@example.com.
I have undergraduate student workers on my sponsored project. Since Chapman will be paying students for the time they would have worked during this period, will my project be charged for that cost?
Personnel charges will continue to post to sponsored projects (internal and external awards) as they were originally allocated through ERCRs and/or hiring documents. Sponsored Projects Services will evaluate each sponsor’s allowability of personnel charges where the effort was not expended. If allowable, the personnel charges will remain on the sponsored project budget. If unallowable, SPS will work with each department to identify the appropriate alternative funding source and transfer those personnel charges accordingly.
All non-essential research personnel should report their time according to HR guidance for Fully Remote being sure to mark time worked as they regularly would and time they are unable to work as [Paid Time Non Work] in the time reporting system.
I have travel that I’ve already booked for my project but am now unable to travel due to the current restrictions in place. Since my travel expenses are not refundable, are they allowable on my project?
You will be reimbursed for your travel. The allowability of this type of expense will be evaluated on a case by case basis in comparison with the project sponsor’s guidelines. Please contact SPS for further information and assistance.
I planned on booking travel related to my project in the near future. What should I do?
Given the current circumstances and the fluid travel restrictions being implemented by the government, it is recommended that you postpone booking travel in the near future.
The current circumstances may cause a substantial delay in my project activities. What do I do?
If you’re concerned about a significant delay in your project’s timeline, please contact SPS and we will review your project, including deliverables, and assist in communicating with your sponsor about a possible extension or project modification, if that’s needed.
What do I do if the University closes and I need SPS assistance?
SPS has transitioned to a teleworking environment, along with the majority of the Chapman community. Our team will remain accessible and available to faculty and staff during this temporary shift and can be reached by phone, email, or via Teams. If you need assistance or have further questions, please contact your unit’s SP Analyst, Research Administrator (pre-award), or Contracts & Grants Administrator (post-award).