• Identify procedures and processes that require regular personnel attention (e.g. cell culture maintenance, animal studies).
• Assess and prioritize critical laboratory activities. 
• Identify any research experiments that can be potentially ramped down, curtailed, or delayed, should the need arise.
• Identify personnel who are able to safely perform key activities.
• Ensure that you have access to contact information for your critical staff. 
• Cross-train research staff to fill in for others who may be out sick or unable to come to work.
  • Ensure staff have the appropriate training.
  • Consider documenting step-by-step instructions for crucial tasks.
• Coordinate with colleagues who have similar research activities to identify ways to ensure coverage of key activities and use of supplies, as appropriate.
• Review contingency plans and emergency procedures with researchers and staff. 
• Maintain a sufficient inventory of critical supplies that may be impacted by global shipping delays.
• Consider installing remote control monitoring devices for critical equipment (e.g., -80C freezers, liquid nitrogen storage dewars, incubators), if not already done.
• Communicate significant planned absences and/or lab closures to your Director, Finance & Administration (DFA), business offices, and other key administrative units.

• OLAR has sufficient food, water, and supplies and cross training of staff to cover basic vivarium operations (health monitoring, basic husbandry, and facility maintenance).
• In the event of quarantine or significant staff shortages, only essential functions required to maintain the health and well-being of the animals will be performed, including maintenance of unique genetic lines.
• All biosecurity measures and PPE requirements will remain in effect to protect colony health. Any changes or modifications in standard procedures will be communicated with research staff.
• Research essential functions such as breeding and administration of experimental agents that are not able to be completed by lab staff due to illness or quarantine should be communicated with OLAR as early as possible.  OLAR will assist with these as staff time permits.
• Research personnel are asked to plan for potential phased reductions of research activities with animals. If these reductions are necessary, OLAR will communicate with research staff prior to asking the research community to implement any of these phases.  Phases should include:
  • Delaying the ordering of new research animals
  • Delaying the start of new animal studies
  • Decreasing colony size to minimum maintenance levels, including separating most breeding animals to the minimum required to maintain unique lines
  • Ending research studies early in the vivarium
• Research personnel that are willing to assist OLAR with basic husbandry and colony maintenance are asked to contact OLAR.  OLAR will maintain a list in case OLAR staff levels are significantly reduced.

• For research visits conducted at University-affiliated hospitals and clinics, researchers should be aware of hospital polices regarding COVID-19.
  • For guidance at University of Colorado Hospital, please see https://www.uchealth.org/today/covid-19-coronavirus-recent-updates/
  • For guidance at Children’s Hospital Colorado, please see https://childrenscolorado.sharepoint.com/sites/custom/HospitalNews2019/Pages/EpiAlert_nCoV.aspx
• All research teams are advised to screen all participants for recent travel to areas with ongoing community transmission of COVID-19 and for symptoms of COVID-19 upon arrival/admission for a research visit.  The following screening questions should be asked:
  • Has the participant had close contact with a confirmed COVID-19 patient within the past 14 days?
  • Has the participant traveled to any locations confirmed by the Centers for Disease Control and Prevention to have widespread community transmission of COVID-19 in the past 30 days?   See https://www.cdc.gov/coronavirus/2019-ncov/travelers/index.html for an updated list of areas with widespread community transmission.
  • Does the participant have symptoms of a lower respiratory tract infection (cough, fever, or shortness of breath)?
• If the answer to any of the questions above is yes, a surgical mask should be placed on the participant and the participant should be placed in a private examination room (use a negative pressure room if available) with the door closed.  The study physician, or another physician/advanced practice provider from the research team, should then assess the participant’s risk of COVID-19 and determine the potential risks and benefits of continuing the study visit.
• If the study physician determines:
  • If at least two weeks have passed since leaving an area of widespread transmission or exposure to a known COVID-19 case, and they have no symptoms of a lower respiratory tract infection, then the study visit can continue;
  • If it is less than two weeks since their potential COVID-19 exposure and the participant has no symptoms, the study physician should assess the potential risks and benefits of continuing the research visit versus rescheduling the visit until after the two weeks period, if feasible;
  • If the participant has symptoms of a lower respiratory tract infection the physician should consult the appropriate hospital resources to determine the next steps for evaluation and management: 
    • If the research visit is at a UCHealth facility, the study physician should contact the UCHealth Doc Line (720-848-2828).
    • If the research visit is at Children’s Hospital Colorado, the study physician should call 720-777-0001. 
• Research teams are encouraged to initiate these screening procedures in advance of scheduled research visits and cancel or reschedule visits for persons with current symptoms of a lower respiratory infection.

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)

M-20-11 Administrative Relief for Recipients and Applicants for Federal Financial Assistance Directly Impacted by the Novel Coronavirus (COVID-19)

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)

Frequently Asked Questions (FAQs) About the Coronavirus Disease 2019 (COVID-19) for National Science Foundation (NSF) Proposers and Awardees

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 --

• NIH LATE APPLICATION POLICY Due to Public Health Emergency for United States for 2019 Novel Coronavirus (COVID-19)
• NIH Guidance on Travel and Meetings
• NIH Extramural Response to Natural Disasters and Other Emergencies  
• General Frequently Asked Questions (FAQs) – Proposal Submission and Award Management Related to COVID-19

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.

• NIH is encouraging all recipients that may have delayed financial, progress, or invention reports to promptly contact the NIH official. NIH will accept these late reports; however, grant awards will be delayed until NIH receives and accepts them.
• As of now, nonrefundable travel may not be charged to an award. NIH will provide further guidance as it becomes available.
• NIH does not directly address if travel and accommodations will be reimbursed. For now, University personal should follow the cost principles under section 7 of the NIH Grants Policy Statement.

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.

Limitations

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.

Unanticipated Problems

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 COMIRB

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:

1. Clean and disinfect hard surfaces of laboratory work areas: Daily
   1. Before and after working with any biological materials, especially in the biological safety cabinet (BSC) and laboratory benches
   2.  After any spills
2. Dispose of absorbent pads after one use with biohazardous materials (i.e. human blood/tissue, infectious agents, recombinant nucleic acids, viral vectors, whole animals).
3. Researchers should twice daily wipe down with disinfectant commonly touched surfaces depending upon their use, including but not limited to:

   Door handles	Microscopes
   Pipettors	Freezer/refrigerator doors, key pads, locks
   Centrifuge controls, lids	Shared equipment
   Sink faucets	Shared computer keyboards
   Phones

4. Facilities Management contractors are responsible in public areas for high touch surfaces, such as door handles, elevator buttons, restrooms, water fountains, break rooms/kitchens, etc.
5. Wash your hands with soap and water for 20 seconds:
   1. Immediately after taking off nitrile gloves before leaving laboratory area
   2. After touching commonly shared surfaces without gloves
6. When wearing gloves, remember your gloves are considered “contaminated” and
   1. Do not touch your face, nose, eyes with gloved hands
   2. Do not wear gloves into non-laboratory areas such as break rooms, offices, elevators, etc.
7. Hand sanitizers containing at least 60% alcohol can be used as a “stop-gap” measure until you can wash your hands with soap and water
8. If someone in your research group or laboratory area has tested positive for the SARS-CoV-2 virus, a more rigorous, extensive cleaning and disinfection may be needed.
9. All of these recommendations are considered “best practices” for research laboratories even when there is not a possible pandemic.

Tips about the most commonly used disinfectants used in laboratories:

1. 70% ethanol:
   1. Acceptable for cleaning dust or residues from hard surfaces
   2. In Colorado’s dry climate, it is not considered to be an effective “disinfectant” because it so quickly evaporates that it is hard to obtain a ten minute contact time
   3. It can be used as a “rinse” after using an efficacious disinfectant containing bleach or quaternary ammonias
   4. Dispensing bottle should be clearly labeled
2. Bleach: 10% vs 1%
   1. Household bleach (5.25% sodium hypochlorite ) starts to deteriorate when the bottle is opened;
      1. it maintains an acceptable level of active chlorine for one year so write the date opened on the bottle.
   2. 10% dilution should be made weekly; 1% dilution should be made up daily
      1. Both are effective against enveloped viruses
      2. Bottle should be labeled with concentration, date it was diluted and initials of who performed the dilution
      3. Keep out of heat, sunlight

For a complete list of EPA approved disinfectants considered effective against SARS-CoV-2:

https://www.epa.gov/sites/production/files/2020-03/documents/sars-cov-2-list_03-03-2020.pdf

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.

RESOURCES:

• American Biological Safety Association (ABSA). SARS-CoV-2/COVID-19 Toolbox. https://absa.org/covid19toolbox/. March 6, 2020
  
• American Biological Safety Association (ABSA).COVID-19 Information. https://absa.org/coronavirus/
  
• CDC/NIH. Biosafety in Microbiological and Biomedical Laboratories. 5^th edition. 2009. https://www.cdc.gov/labs/BMBL.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fbiosafety%2Fpublications%2Fbmbl5%2Findex.htm
  
• CDC. Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19).  https://www.cdc.gov/coronavirus/2019-nCoV/lab/lab-biosafety-guidelines.html
  
• CDC. Coronavirus Disease 2019 (COVID-19) Resource Page. https://www.cdc.gov/coronavirus/2019-ncov/
  
• Environmental Protection Agency (EPA). Selected EPA-Registered Disinfectants. https://www.epa.gov/pesticide-registration/selected-epa-registered-disinfectants
  
• Environmental Protection Agency (EPA). Emerging Viral Pathogen Guidance for Antimicrobial Pesticides.  https://www.epa.gov/pesticide-registration/list-n-disinfectants-use-against-sars-cov-2
  
• Kampf, et. al.  Persistence of coronaviruses on inanimate surfaces and their inactivation with biocidal agents. Journal of Hospital Infection 2020; 104: 246-251

The Office of Regulatory Compliance has a webpage with answers to common HIPAA-related questions.

Read FDA’s Guidance on Clinical Trials document at fda.gov.

For non-NIH awards:

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.

For NIH Awards:

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 Awards:

NIH is allowing for the charging of salaries and benefits during periods when no work is performed due to the effect of COVID-19.

Non-NIH Awards:

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:

• Costs incurred to arrange for participants to receive care at their local sites or virtually, rather than the study site, for required visits.
• Supply chain disruptions
• Personnel disruptions due to illness or closure of facilities
• Additional lab testing (e.g. for COVID-19)
• Increased transportation costs

Pre-Award Costs:

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.

Salaries:

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.

Stipends:

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.

Travel:

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).

Source: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-086.html

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).

Source: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-086.html

As a reminder, recipients have rebudgeting authority available under NIH Grants Policy Statement Sec. 8.1.1.2:, 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.

Source: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-086.html

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.

Source: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-086.html

Late applications

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:

• Institutions must submit applications or reports as soon as possible after reopening or resuming operations so that grant applications can be submitted, not to exceed the number of days the institution was officially closed or unable to submit grant applications.
• Institutions must submit a cover letter with the applications with enough detail about the delay so that NIH staff can make a determination whether circumstances justify accepting the application late.
• Institutions need not request advance permission to submit late due to this declared emergency.

Source: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-082.html