COVID-19 Update: March 23, 2020

COVID-19 Update:
1) NIH Flexibilities for Applicants and Awardees;
2) Supplemental Funding Opportunities for COVID-19; and
3) Volunteer Opportunities for Research Staff

Dear CFAR community,

As you are well aware, in the face of this unprecedented COVID-19 pandemic, non-essential clinical research and most web lab research closed last Sunday night at UCSF. The NIH, in recognition of the COVID-19 crisis, has provided guidance on flexibilities for late applications, late progress reports, etc. during this time. We wanted to summarize some of those flexibilities as they are being communicated by the NIH for you here, although we encourage you to be in touch with your program officer and grants management specialist with any questions. The second part of this digest has assembled opportunities to apply for NIH supplements and grants relevant to COVID-19. The third part is to let you know of opportunities for laboratory staff (SRAs, lab techs, CRCs) to contribute to the COVID-19 response at UCSF.

Please let us know how we – as the UCSF-Gladstone CFAR – can assist you in your research during this crisis. We plan to assemble templates of letters for late applications, delayed progress reports, etc. and can help in further exploring grant opportunities for you. We will be meeting with the early stage investigators via Zoom once weekly to answer any clinical questions regarding COVID-19 or questions regarding research opportunities. This pandemic will lead to a multitude of new research questions and the UCSF-Gladstone CFAR will pivot towards helping you and your research programs moving forward.

Thank you for everything you are all doing for the COVID-19 response. We know this is a hard time, and we are here to support you. Please feel free to reach out to any of us if there’s anything we can do to help.

Sincerely,
Monica, Peter, Mallory, and Lauren


Part 1: NIH Flexibilities for Applicants and Awardees
NIH has announced flexibilities for applicants and recipients affected by COVID-19 as well as accompanying FAQs and this helpful YouTube video. Documentation and communication with NIH are key, as research is slowed, impacted, or changes due to the emergency.

Late applications (NOT-OD-20-082)
NIH will accept late applications on a case by case basis not to exceed the number of days the application was unable to be submitted because the recipient organization was officially closed or the PD/PI or other key staff were unable to submit grant applications due to the effects of COVID-19. Prior approval is not needed, but a cover letter must be submitted with the application with enough detail to justify accepting the application late. Since our University closed to non-essential research on March 15, the day prior to the shelter in place mandate in the city of San Francisco, all research relevant to our CFAR investigators has been affected by the COVID-19 response

Late Progress Reports and other FAQs (NOT-OD-20-083)
If grant/contract recipients are not able to submit required progress (RPPR), financial (FFR), or invention reports on time, they should let their grants management official/program officer know ASAP. NIH will accept these reports, but the next year’s award may be delayed until all required reports are submitted.
Many of the other FAQs on this page provide answers about cancelled travel or meeting reimbursement and flexibilities.

Delays in Research Progress and Unanticipated Costs (NOT-OD-20-087)
Delays: NIH understands that delays may occur due to institutional measures to protect participants and research staff. They will allow mid-project period or additional extensions beyond the usually allowed 12-months for projects involving human subjects. Awardees should work with RMS to submit a justification for the extension to NIH. We are currently seeking clarification on whether time on training grants will be extended based on this unprecedented crisis.
Unanticipated Costs: If unanticipated costs are identified, and the project budget doesn’t have funds available to cover those costs, recipients are able to request administrative supplements (PA-18-591) to cover these expenses. Funding will be prioritized for requests that support the safety and welfare of participants and sustain research during any delays. More information on this will be provided in the future.

Other Flexibilities Available (NOT-OD-20-086)
These flexibilities are applicable to NIH applicants and recipients where the entity is conducting research activities related to or affected by COVID-19 (this applies to all of us in the UCSF-Gladstone CFAR). Affected entities are those that have been closed or where business activities have been hindered due to COVID-19 precautionary measures and/or illnesses. Documentation is required which describes the effects along with how long facilities and NIH related research, clinical practices, or instruction was and/or will be affected.
These flexibilities include:

  • pre-award costs
  • prior approval requirement waivers
  • extensions to reporting, closeouts and single audit requirements
  • cost-related expenditures such as salaries and stipends, travel, and conference registration fees, and NIH supported meetings and conferences

The UCSF-Gladstone CFAR will continue to update this digest as more information becomes available. We encourage you to reach out to your program officer and GMS for further information. Rest assured that the NIH is well aware of the impact of this crisis on ongoing research programs. A reassuring statement from the YouTube video the NIH produced on this topic is below:
“We understand with everything else that’s going on right now, getting your application in on time is probably not going to be the first thing on your mind or the easiest thing to do. We put out a guide notice specifically on late applications; you can submit late applications, and you do not need to get pre-approval. All you need to do is submit a brief cover letter that explains why your application is late, and we will take it from there. … We want to be accommodating. We understand the difficulties that you’re dealing with, so we will do everything we possibly can to be flexible and accommodating.”

Part 2: Supplemental Funds for Research on 2019-nCoV
NIH has so far issued three Notices of Special Interest (NOSI) from four Institutes on supplements to current grants to add research on COVID-19. We anticipate that other NIH Institutes will also release additional NOSIs. A brief summary of the available opportunities are listed below, and a more detailed table will be kept updated here with any additions: https://cfar.ucsf.edu/covid-19-supplement-opportunities.

There are two types of supplemental funds available: 1) Urgent Competitive Revisions using PA-18-935, which expand the scope of the parent grant, and 2) Administrative Supplements under PA-18-591, which provide funds for work within the scope of the parent grant. Examples of a change in scope include the addition of human subjects or children to a grant that has not been previously so coded and approved, the addition of vertebrate animals to a grant that has not been previously so coded and approved, or an application that does not involve the parent project study population (e.g., people living with HIV on an HIV grant). The review for any grants involving COVID-19 will be highly streamlined.

There are key differences in topics of interest, eligible activity codes (e.g., R01, K08, R21), amount of funding available, and the period of funding (e.g. 1 or 2 years), depending on the funding mechanism and institute. All investigators interested in submitting an application under any of the below NOSI should plan to discuss their proposed research with NIH program staff ahead of submitting to make sure that the project is responsive.

1. NIAID/NIGMS NOT-AI-20-030
Mechanism: Competitive revisions using PA-18-935 to current NIAID or NIGMS grants (*CFAR note: while this NOSI does not list administrative supplements specifically, we would encourage investigators considering a project that is within scope to refer to this announcement for guidance on administrative supplements to current NIAID/NIGMS awards.)
Eligible activity codes: No listed activity code restrictions.
Topics of interest: Viral natural history, pathogenicity, transmission, as well as projects developing medical countermeasures and suitable animal models for pre-clinical testing of vaccines and therapeutics against 2019-nCoV.
Period: up to 2 years (within parent project period)
Budget: no more than the parent award

2. NHLBI: NOT-HL-20-757
Mechanism: competitive revisions under PA-18-935 and administrative supplements under under PA-18-591 to active NHLBI-funded or co-funded awards only.
Eligible activity codes: Competitive Revision: Only P01, R00, R01, R03, R15, R21, R33, R35, R41, R42, R43, R44, R61, U01, U24, U54, UG3, UH3, UM1; Administrative supplement: Most active NHLBI-awarded or co-funded activity codes including R01, R21, R34, R03, R25, R13, R61, DP1, DP2, K01, K08, K12, K23, K24, K43, K99/R00, P30, P50, P01, PM1, U01, U19, U54, UM1, UM2, F32, D43, D71, T32.
Topics of interest: COVID-19 and on biological effects of SARS-CoV-2, including host response, associations with heart, lung, and blood (HLB) diseases, potential impacts on transfusion safety, and clinical outcomes of infected individuals.
Period: Generally limited to 1 year. Up to 2 years with strong justification.
Budget: No more than parent award

3. NIDA: NOT-DA-20-047
Mechanism: competitive revisions under PA-18-935 and administrative supplements under under PA-18-591. Applications can come from any funding IC as long as the topic is NIDA-specific. Eligible activity codes: No listed activity code restrictions.
Topics of interest: Research collecting and examining data on the risks and outcomes for COVID-19 infection in individuals suffering from substance use disorders.
Period: Up to two years. Must be within parent project period.
Budget: $100k/ year, more if cleared with NIH

UCSF’s Office for Sponsored Research (OSR) has also compiled a list of funding opportunities related to COVID-19, which they are updating here. You should check for updates on that page.

Part 3: Directing your CRCs or SRAS in your laboratory towards helping with the UCSF COVID-19 response
If your clinical research coordinators or staff research associates are at home and would like to contribute to the COVID-19 response, either in helping to recruit for an NIAID-sponsored COVID immunophenotyping project, helping with COVID-19 testing at the BioHub or delivering samples from laboratories to a serology project, please email Lauren Sterling and we can direct you to the right investigator.