Dear Colleague,
As LLUH is taking precautionary measures to stem the spreading of COVID-19, Research Affairs will be adjusting some of our daily routines accordingly. Continuity of services is our key while also keeping safety top of mind.
Beginning Monday March 16, 2020, we will be implementing social distancing procedures as suggested by the County Department of Public Health. Should you need to meet with anyone in Research Affairs, please do so by phone, email, or Zoom.
Should circumstances warrant it, the Research Affairs staff is prepared to work remotely with no delay in response. Modes of communication include participating in video conferencing with Zoom, email, phone, and/or platforms such as Office 365 – OneDrive, SharePoint. Although we are seeking to maintain physical contact to a minimum, we very much remain open for business and at your service.
For human research:
- Studies where there is a prospect of direct benefit to the human subject that outweigh any additional risk from COVID-19 exposure, (trials with investigational treatment, including drugs and devices) may continue, however, video/telephone visits should be arranged if possible. PLEASE NOTE: Interim clinic/hospital policies/procedures will need to be followed.*
- Studies that involve healthy human subjects whether there is little to no prospect of direct benefit to participants AND subjects are being seen inpatient care areas including clinics, hospitals, etc. should be paused.
- LLUH recommends reviewing research protocols to determine if there are any visits that may be postponed, or done over the phone especially for those subjects that are elderly, immunocompromised and have chronic medical conditions. Discuss options with your sponsor.
- Changes to IRB-approved protocols may occur due to this unprecedented outbreak. According to IRB policy, any changes in IRB-approved research procedures must be reported to the IRB and may not be implemented prior to review and approval by the IRB, except when necessary to eliminate apparent immediate hazards to the subject. This is permitted by both the Common Rule (38 CFR §16.108(a)(3)(iii)) and by FDA regulations (21 CFR §56.108(a)(4)). Any changes that are made should be reported to the IRB within 5 business days.
- The LLUH IRB will continue to meet as scheduled and will remain operational.
*LLUH recommends following any new mandatory clinical screening procedures for research subjects seen in clinics and/or hospitals. This screening does not require IRB approval.
For animal research:
The Animal Care Facility will maintain normal operations.
- Animal Orders - Animal Orders may be placed in iRIS software at https://llu.imedris.net. This system is accessible on and off campus. Animal Care Staff will continue processing and receiving animals; however, these orders may be processed from off-site. The Animal Care Facility cannot guarantee animals will arrive on the preferred delivery date. Questions about any animal order should be emailed to AnimalCare@llu.edu and include the investigator name, protocol number, and order number.
- Procedure Rooms - Procedure and behavior rooms can be accessed by scheduling rooms as usual by FACES online system and by signing out the badge for these rooms from the ACF office.
- Weaning / Separation of Animals - Researchers remain responsible for weaning animals. As necessary to maintain the health and welfare of the animals, Animal Care Staff will wean or separate animals, e.g., separate animals to prevent fighting. When weaning or separating animals, use the Temporary Cage Cards and notify AnimalCare@llu,edu to request a permanent cage card. Temporary cage cards should be available in each animal room. As time permits, Animal Care Staff will print permanent cage cards and notify research staff.
- Drugs - Drugs can be requested through ICR, please remember to alert the ACF staff on when you will be available to receive the drugs.
There is no change in how IACUC and IBC operate. Committee members will be informed when and how the meetings will be conducted.
For those seeking to submit grant proposals:
The Pre Award team will be fully functional; it will be able to submit proposals, assist with budget development, complete supporting documentation, review, and obtain the necessary institutional approvals for submission.
If you are submitting through InfoEd you have the capability of accessing InfoEd from off campus to upload all your documents, prepare your application and approve your submission, if you do not have a login contact a Pre Award team member
If agencies are officially closed, proposals submitted will most likely remain pending in their queue until the agency reopens. Please plan to submit your proposal before the due date.
For an expedited answer to your question call Cindy Dickson at 909-558-4571, x44571; email cdickson@llu.edu or text your question to 909-557-0241.
https://researchaffairs.llu.edu/pre-post-award/pre-award
For those inquiring about their current grant funding:
The Post Award team will continue to be fully functional. All reporting, invoices, and other deliverables will be submitted as usual. Post Award is prepared to utilize Zoom, email, and phone, with little to no delay.
Below is a link from NIH addressing general questions associated with award management that may arise in relation to COVID-19.
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-083.html
Should you have any questions, please feel free to contact us at 909-558-4589 or rapostaward@llu.edu.
For those needing assistance with contracts for industry sponsored projects:
The Industry Relations team will continue to assist with contracts for research collaborations. Should you need to speak with any of our Industry Relations team, please feel free to contact us at 909-558-4831 or racontracts@llu.edu.
Michael R. Samardzija, PhD, JD
Vice President for Research Affairs
LOMA LINDA UNIVERSITY HEALTH
24887 Taylor St., Suite 201, Loma Linda, CA 92354
(909) 951-5920 × Email msamardzija@llu.edu