Interim Guidance by Institutional Review Board (IRB) - approved Human Subjects Research and other research activities involving visits and in-person interactions with participants, subjects or patients at University of California, Riverside (UCR) during COVID-19 Outbreak
-  Effective March 13^th, 2020

Background

This is a follow up to the message from VC RED Torres dated March 11^th to provide specific information related to research involving human subjects. In the context of recent government and campus statements on COVID-19 and the rapidly evolving outbreak, the UCR Office of Research Integrity (ORI) has revised its guidance for human subjects - related research.  This guidance may also be useful to any other researchers, staff, or students on campus. These steps are being implemented to protect researchers, research participants, students, and the larger UCR community from risk of infection with COVID-19, as well as to ensure ongoing access to research which may provide essential support and care to participants and subjects. The situation with the COVID-19 pandemic is very fluid, and we are revising our protocols and best practices. Hence, this guidance may be revised accordingly when appropriate based on new information. It will also be available on the RED coronavirus site.

Please note that all committee/board meetings in ORI will continue but will be done virtually. Most staff in RED office will be working remotely during this time. 

• Please send questions and comments on this guidance to IRB@ucr.edu   
• Please visit the UCR COVID-19 website for FAQs and up-to-date campus communications and announcements

RED Guidance (Effective March 13^th, 2020)[1]

Participant research visits should be performed remotely (e.g., by phone, Skype, Zoom, or other means). RED has created a webpage with instructions on how to use Zoom in case you, your students, or personnel need assistance.  In general, we require treating these visits and activities the same way we are treating classes, conferences, and other events on campus which involve in-person interactions, and hence normally should be postponed or cancelled if they cannot be conducted remotely. More specifically:

Non-Essential Research Visits - Research visits that cannot be performed remotely and are not essential to a participant's health and/or well-being must be postponed until further notice. Currently, the determination of whether or not a research visit is "essential to the health and/or well-being" of a participant should be evaluated by the principal investigator of the research study, the participant, and if relevant, the participant's care provider. The final decision will be made by the PI in consultation with Environmental Health and Safety (EH&S). PIs are strongly encouraged to consider the safety of the research personnel and subjects in making their decisions, keeping in mind that the risks posed by COVID-19 to participants may greatly outweigh in many cases the benefits of a particular study.  The decision will be based on the most current public health guidance related to COVID-19.

Essential Research Visits - Research visits that cannot be performed remotely and are essential to a participant's health and/or well-being may be performed in person, with the following additional guidance:

a)  Research participants should be contacted and screened for fever, cough and flu-like symptoms by research staff prior to the research visit. Those participants who screen positive for symptoms must not participate until all symptoms are gone.

b) Participants should be provided with information regarding the current COVID-19 pandemic and how best to reduce their risk of infection prior to the research visit. This information may be provided in multiple forms suited to the type of contact, including a website link, a telephone script and an in-person handout. See the following CDC COVID-19 link for reference and materials:

https://www.cdc.gov/coronavirus/2019-ncov/index.html.

c) Principal Investigators and their research personnel should assess the risk of the research activities with participants to determine which procedures can be implemented to reduce contact such as increasing disinfection protocols for common use or shared materials (e.g., laptops, keyboards, study materials) and increase social distancing. Environmental Health and Safety can assist in developing standard operating procedures customized for the research activities performed. Contact EH&S for consultation and support - https://ehs.ucr.edu/.



d) Enrollment of new patients on a clinical trial or other human subject-related research should be allowed only if: 1) participation in the trial is essential to a participant's health and/or well-being, as determined as above; or 2) the enrollment and longitudinal participant management can be conducted remotely for the duration of the COVID-19 outbreak.

Training & Changes to IRB Protocol

All study personnel (faculty, staff, and students) should review the UCR COVID-19 webpage and understand the best methods to reduce the risk of infection and receive training regarding proper research participant screening (e.g., masking protocols) and participant triage should a research participant be deemed at risk for COVID-19 infection during an in-person research visit screening. You should contact UCR Environmental Health and Safety office for guidance.

Please note that IRB regulations do allow PI’s to deviate from the approved IRB protocol to remove ‘an immediate hazard’ to participants or subjects. The current situation with COVID-19 would fall into that category of immediate hazard.  You should notify the IRB of the changes made after cessation of the public health emergency by submitting a protocol deviation form for review. For example, changing your visits from in-person interviews to some other method (e.g., Zoom or phone) does not require a prospective amendment to be reviewed and approved but you do have to notify the IRB after the cessation. 

Research Related to COVID-19

Note also that all PIs must have all the necessary compliance approvals prior to performing any coronavirus-related research or work on campus (including helping state and federal agencies screen patients or samples).

Study Sponsors

• Sponsored Programs Administration (SPA) is reviewing questions related to the allowability of costs associated with any disruptions to sponsored projects stemming from COVID-19
• Send questions to your departmental business offices about who should coordinate with the SPA officer
• For a cost to be allowable, it will require consistent treatment across all funding sources
• The federal funding agencies are working on a unified message in this regard, and once published, SPA will share it with the UCR community

The following guidance from VC RED should be practiced by all members of our campus community:



Immediate Measures 

To reduce the potential transmission of the COVID-19 coronavirus (or other colds and flu) in the coming weeks, we ask that campus faculty, staff, and students put in place the following measures:

• Require that all personnel (students, managers, trainees) who are feeling unwell stay home until they no longer have symptoms. Further guidance on personnel policies have already been distributed to campus on March 12^th 2020.
• If your study participants or subjects include those designated as vulnerable to COVID-19 by the CDC (i.e., 65+, chronic medical condition such as diabetes, heart disease, lung conditions, immunocompromised), we strongly advise that you take extreme precautionary measures and only do virtual or phone visits.
• Remind all personnel to practice sanitary measures such as washing hands with soap and water frequently and for at least 20 seconds, using hand sanitizer if handwashing sinks are not available, avoiding touching their face, and covering coughs and sneezes with your elbow. 
• Explore and implement measures to reduce density and allow “social distancing” of students, staff, research personnel, and participants. For example, when possible, increase spacing between students, staff, or have personnel come to the lab/office in shifts.
• Review opportunities for students, volunteers, lab personnel, and support staff to work remotely, even consider modifying and conducting research activities fully remotely in the short term. 
• Increase proactive cleaning and disinfecting of offices, laboratory, and any communal spaces.
• Many scientific conferences and other research community meetings are being cancelled or are permitting remote participation. Limit your research group travel according to the UCR guidelines for travel https://ehs.ucr.edu/coronavirus#information_for_travelers
• Consider cancelling or postponing field research trips or other group travel as they present unique risks because of shared housing, eating meals together, and challenges of “sending someone home” should they become ill during an extended trip.

Finally, we would like to echo the Chancellor’s message once again that it is imperative that all members of the UCR community uphold and respect campus culture and our Principles of Community during this unusual time.

Please feel free to forward this message to anyone in your office, department, or lab who may need to know.

Sincerely,



Derick Fay

IRB-SB Chair

Department of Anthropology

Dr. Mikio Nihira

IRB-Clin Chair

School of Medicine

Rodolfo H. Torres

Institutional Official

Vice Chancellor

Research and Economic Development



Dario Kuzmanović

Assistant Vice Chancellor, Research Integrity

Research and Economic Development