COVID-19 (Novel Coronavirus)
Agency Guidance and Frequently Asked Questions Relating to Research Awards
The University continues to closely monitor the COVID-19 (novel coronavirus) outbreak. The University maintains a website to provide students, faculty, and staff with updates about the virus and the impact to University operations.
This page is designed to provide timely information regarding the impact to sponsored projects at the University.
If you have a question that is not addressed on this page, please email FS-Compliance@ucdenver.edu.
The Office of Grants and Contracts (OGC) will utilize the email listserv to provide any time-sensitive information. To sign up for the listserv, please visit the GC-UPDATES listserv page.
Federal Agency Guidance
Few federal awarding agencies have provided guidance on the impact to federal awards. This page will be updated as federal agencies release additional information.
Office of Management and Budget (Updated 3/11/2020)
The Office of Management and Budget (OMB) released M-20-11, which enables federal awarding agencies to provide greater flexibility to recipients managing projects related to COVID-19 research. As of this time, these flexibilities do not extend to other awards.
National Science Foundation (Updated 3/9/2020)
The NSF guidance provides answers related to NSF proposals and existing NSF Awards and about participation in NSF merit review panels. The NSF guidance does not alter existing policies for NSF proposals or awards. The guidance emphasizes the need for PIs to work closely with program officers at NSF if their research may be impacted by the outbreak.
The guidance states:
NSF is currently working internally as well as with our federal partners on a number of proposal and award-related issues pertaining to COVID-19. NSF will communicate with the community about these issues and will provide guidance as further information becomes available. In the meantime, please continue to follow all relevant policies and procedures, including those of your organization, and apply those practices consistently.
National Institutes of Health (Updated 3/11/2020)
The only guidance available to date --
Important to note: The NIH guidance on late applications does not currently pertain to the University of Colorado Denver | Anschutz Medical Campus. The late application policy is applicable only to applicants or recipient organizations that are officially closed or unable to submit grant applications.
The NIH Guidance on Travel and Meetings encourages individuals to take adequate precautions to protect their health and safety. The guidance also encourages reconsideration of in-person conferences or large meetings that are not mission critical.
The NIH Extramural Response to Natural Disasters and Other Emergencies guidance identifies NIH procedures during emergencies, and currently only provides the Late Application Policy.
The General Frequently Asked Questions (FAQs) – Proposal Submission and Award Management Related to COVID-19 provides general guidance to NIH recipients.
Our primary concern is the safety of our research participants and the research team members. We understand that the COVID-19 outbreak will affect the continuity and integrity of many research studies. We hope the following guidance is helpful in protecting our participants and staff and minimizing adverse impacts for research.
Changes to eliminate apparent immediate hazards to subjects
Federal regulations allow researchers to make changes to research to eliminate apparent immediate hazards to subjects without IRB approval. COMIRB policies are consistent with this, as are most other IRBs.
Examples of changes to eliminate immediate hazards to subjects in response to COVID-19 include, but are not limited to, cancelling non-essential study visits, conducting phone or telehealth visits visits in lieu of in-person visits, conducting additional screening of current and potential research subjects prior to in-person visits, and temporarily suspending enrollment.
Also, any new screening procedures or other policies implemented by the campus or any of our affiliate health care systems to in response to COVID-19 are not policies or procedures that require IRB approval and do not require COMIRB approval.
Deviations from the Protocol: If researchers deviate from their approved protocol to eliminate apparent immediate hazards to subjects, that does not require COMIRB approval and does not fall under COMIRB 5-day reporting requirements assuming the deviations are considered temporary and are relatively minor. Deviations that are necessary to comply with new policies issued by the University, our affiliate health systems or public health directives also do not require COMIRB approval and do not fall under COMIRB 5-day reporting requirements.
Researchers should document these deviations and submit a single summary report to COMIRB at time of Continuing Review. For research that does not require Continuing Review, submit the summary report with a UAP submission at a reasonable point in the
future (e.g., around the anniversary date of your approval or after university operations return to normal).
If deviations from the protocol are necessary which might result in potential new risks to subjects, these would need to be reported to COMIRB within 5 days. Examples include interruption of study drug prescriptions, or cancellations of study visits critical for subject safety.
Changes to the Protocol: If researchers change their protocol (e.g., to make deviations permanent) to eliminate apparent immediate hazards to subjects, they can do so without prior IRB approval but should report the protocol change to COMIRB within 5 days and submit an amendment for review and approval of the revised protocol. COMIRB will review and approve those amendments quickly but since prior approval is not required, researchers are not out of compliance in the interim.
The conduct of research must otherwise remain in compliance with human subjects regulations, COMIRB policies and the terms of COMIRB’s approval. The following are some examples where prior IRB approval should be obtained.
Informed Consent: If signed consent is required for research participation, changing to verbal consent would not be an acceptable deviation or protocol change without IRB approval. If circumstances make obtaining signed consent impractical, researchers should consider slowing or suspending enrollment. Contact COMIRB if you wish to discuss whether conducting a consent process over the phone is feasible. COMIRB approval would be required before implementing the new consent procedure.
Visit Locations: Carefully consider any changes before implementing them. For example, moving study visits from a clinic to the subject’s home in the current environment would need to involve new screening procedures for the subjects, the household members, and for your research staff. Such a change may also require additional staff training and protective gear, which is in very short supply at this time. Moving study visits from clinical locations to campus non-clinical locations is not advisable. Contact COMIRB if you wish to discuss whether some study procedures could be moved to new locations. COMIRB approval would be required before implementing these changes to make sure risks are minimized.
External IRB: If your research is under the purview of an external IRB, there may be some slight differences in IRB policies but these would not impede a researcher’s responsibility to make immediate changes eliminate apparent immediate hazards to subjects.
New Data and New Objectives: If researchers wish to collect additional data for their studies or add research objectives to approved research in response to COVID-19, an amendment should be submitted to COMIRB for prior approval.
Requirements from Sponsors: If sponsors issue updated protocols, or require evidence of IRB approval of changes, researchers should submit an amendment to COMIRB as usual.
Considering the broad public awareness of COVID-19, COMIRB would not consider the infection of a research subject or research staff member to be an unexpected event which required reporting to the IRB within 5 days. Researchers must remain compliant with other requirements to report adverse events to research sponsors and/or the FDA.
Inaccessible Documents and Data
All staff need to follow university restrictions related to who may be on campus at this time. If you do not have access to a document or data which you think is needed by COMIRB, discuss the issue in a cover letter. That is, tell us what is inaccessible at this time and why your submission might be incomplete. We will complete our review as deemed appropriate for the situation.
Contact us at COMIRB@ucdenver.edu for any questions or assistance. COMIRB remains operational while working remotely. We will be conducting IRB meetings virtually and reviewing research as usual. We are readily available to answer any questions, to consult, and to provide assistance. We are happy to set up conference calls and/or virtual meetings.
SAFETY CONTRIBUTES TO GOOD SCIENCE
Laboratory Housekeeping: Expectations for Cleaning and Disinfection
Protect yourself and others from respiratory virus transmission in the laboratory (i.e. restricted areas requiring badge access), in addition to the standard recommendations for staying home if symptomatic, covering coughs, disposing of paper tissues immediately after use, etc., as responsible members of the university community you should:
|Pipettors||Freezer/refrigerator doors, key pads, locks|
|Centrifuge controls, lids||Shared equipment|
|Sink faucets||Shared computer keyboards|
Tips about the most commonly used disinfectants used in laboratories:
For a complete list of EPA approved disinfectants considered effective against SARS-CoV-2:
FYI: There are just a few brands of wipes approved so far by the EPA. Products listed by EPA may not be available through the university’s “Marketplace” purchasing system.
A company may have products with different active ingredients. For instance, Brand A is associated with bleach products but may also market a product containing a quaternary ammonium. Be sure you know what the active ingredient is for the disinfectant you are using, that it is efficacious against the potential pathogens in your research materials and enveloped viruses, that you use the appropriate contact time.
Remember your freshman chemistry: NEVER mix a product containing chlorine with a product containing ammonia. The resulting release of ammonia gas can be injurious.
For questions about choosing a disinfectant or procedures, for instance, decontaminating sensitive electronic equipment, contact the Biological Safety Division, 303-724-0345.
To date, there is no federal guidance relating to charges to awards for non-refundable travel, conferences, and related expenses due to COVID-19. Costs charged to a federal award must adhere to the applicable cost principles, which require costs to be
allowable, allocable, and necessary for an award. Charging cancellation costs to a federal award does not benefit the project; and, therefore, cannot be charged to a federal award without further guidance from the federal agency. For non-federal awards,
be sure to follow the sponsor’s policy.
NIH (NOT-OD-20-086) is allowing non-refundable travel to be charged to the applicable award, provided the travel would have been allowable.
You should contact the program officer as soon as possible to obtain guidance meeting the terms and conditions of your award.
Due to the nature of this situation, guidance is continually changing. Please reach out to your Post Award Specialist in the Office of Grants and Contracts (OGC) for any assistance. If you have contacted your award’s program officer at a federal agency, please ensure all communication is adequately documented and retained.
In general, yes, provided the employee remains engaged with the project work. Current prior approval requirements regarding disengagement and effort reductions remain in effect. For additional information, please review 2 CFR 200.308(c)(iii).
Yes. Pursuant to the campus’ indirect cost rate agreement with the federal government, sick leave and other paid absences that are permitted under University policy may be charged to the grant. Employees using sick leave must follow University policy.
Costs related to telework are generally considered indirect costs and may not be charged directly to a federal award unless specifically approved by the sponsor. You should discuss your telework needs with your manager.
NIH is allowing for the charging of salaries and benefits during periods when no work is performed due to the effect of COVID-19.
For non-NIH awards, you should contact the grants management officer identified on each of your awards to determine if the agency will allow these charges. Please be sure to notify your OGC Post Award Specialist if you receive written and explicit approval from your agency’s grants management official.
Most federal research awards provide for a one-time no-cost extension (NCE) up to twelve months. This would be an acceptable programmatic justification for an NCE. Prior approval is required for any additional NCEs. Please contact your OGC Post Award Specialists if you have concerns about subrecipient performance. Current prior approval requirements regarding disengagement and effort reductions remain in effect. For additional information, please review 2 CFR 200.308(c)(iii).
Current NIH guidance for COVID-19 only applies to organizations that are closed due to the outbreak. For now, you should plan on meeting all sponsor deadlines. If you have a specific situation, you may want to contact the program officer identified on the funding opportunity announcement.
Each non-federal sponsor maintains its own policy and guidance. You should contact the sponsor directly for guidance. You are also encouraged to relay any information received from the non-federal sponsor to your OGC Post Award Specialist.
On March 16, 2020, NIH released guidance for NIH-funded clinical trials affected by COVID-19. NIH recommends that recipients consult with their IRB and institutions about potential measures to protect participants and research staff. NIH is also providing a no cost extension for up to 12 months. Recipients should contact their NIH grants management official to discuss the need for a no-cost extension. Additionally, NIH is allowing for unanticipated costs be charged to the award, including:
NIH is allowing pre-award costs to be incurred from January 20, 2020 through the public health emergency period and prior to the date of a federal award for all applicants and recipients that have been affected by COVID-19.
NIH understands that many researchers may be unable to work as a result of or related to the effects of COVID-19. If a recipient organization’s policy allows for the charging of salaries and benefits during periods when no work is performed due to the effect of COVID-19, regardless of the funding source, including Federal and non-Federal, then such charges to NIH grant awards will be allowable.
University’s Comments: The University’s policy is that salaries & benefits will be charged to all funding sources as allocated via the HCM system before the COVID-19 disruption. This means we are complying with NIH’s requirements and therefore, salaries/benefits can be charged to NIH grants for this period of time that involves periods of decreased research activity.
Reminder: NIH awarding Institutes/Centers (ICs) may request documentation to confirm the requirements of institutional policies.
Institutions affected by COVID-19 may continue to provide stipend payments to fellows and trainees who may be unable to work as a result of or related to COVID-19. Recipients should notify the assigned grants management official, and provide documentation demonstrating the effect of COVID-19, and how long the institution will be affected.
Non-refundable costs associated with grant-related travel that has been cancelled due to COVID-19 may be charged to the NIH award if they would have otherwise been allowable. See NIH GPS 7.9.1 for detailed information on the allowability of travel expenses.
Conference Registration Fees:
Non-refundable registration fees for conferences, symposiums or seminars that have been cancelled due to COVID19 may be charged to the NIH award if they would have otherwise been allowable (e.g. necessary to accomplish program objectives).
Extension of Post-Award Financial and Other Reporting:
If your institution is unable to complete and submit financial and Research Progress Performance Reports (RPPR) by the scheduled due date, due to the effects of COVID-19, please be sure to contact the assigned grants management and/or program official to let them know the reports will be late.
NIH will accept these late reports but will delay issuing grant awards until the reports are received and accepted by the appropriate Institute or Center (IC).
As a reminder, recipients have rebudgeting authority available under NIH Grants Policy Statement Sec. 18.104.22.168:, which states, “NIH prior approval is not required to rebudget funds for any direct cost item that the applicable cost principles identify as requiring the Federal awarding agency's prior approval, unless the incurrence of costs is associated with or is considered to be a change in scope.”
Recipients that are not under Streamlined Non-competing Application Process (SNAP) have the discretion to carry forward unobligated balances on their active grants for immediate efforts to support activities related to or affected by COVID-19 as long as the charges are allowable costs and are within the scope of the original award.
In addition, affected recipients that have active non-SNAP grant projects may extend the final budget period of the approved project period on active grants one time for a period of up to 12 months without requesting prior approval, by notifying the assigned grants management specialist.
NIH will allow recipients that are affected by COVID-19 to delay submission of any final financial, performance, and other reports required by the terms and conditions of award for the closeout of expired projects, provided that proper notice about the reporting delay is given by the recipient to the agency. This delay may not exceed one year.
When delays occur because the applicant or recipient organization is officially closed or unable to submit grant applications due to the effects of COVID-19, the NIH will consider accepting applications late, on a case-by-case basis, in accordance with the NIH Grants Policy Statement, Section 2.3.9, under the following circumstances: