Last Updated: August 12, 2020
PCORI is concerned first and foremost for the health and safety of our community, including applicants, awardees, stakeholders, research participants, staff, and all others involved with PCORI. To that end, PCORI is working to assist applicants and awardees in finding solutions that may help address issues related to disruptions associated with COVID-19 (coronavirus). These issues include general guidance, addressing pre-award concerns for applicants, and addressing post-award concerns for awardees.
The answers below are meant to serve as a resource for our research community and are not intended to replace the guidance of your own institutions. Please note that we will update these responses as more information becomes available, given the evolving nature of the situation.
For specific inquiries not addressed below, please contact the following:
- Research Applicants: [email protected]
- Engagement Award Applicants: [email protected]
- Dissemination and Implementation (D&I) Award Applicants: [email protected]
- Contact your assigned PCORI staff person (Program Officer, Program Associate, Contract Administrator and/or Engagement Officer). Please also cc [email protected] (for research awards), [email protected] (for Dissemination and Implementation Awards) or [email protected] (for Engagement Awards)
- If you are unsure who your assigned PCORI staff person is, please email [email protected] (for research awards), [email protected] (for D&I Awards) or [email protected] (for Engagement Awards)
- PCORI will aim to be as flexible and accommodating as possible when responding to administrative and/or research delays due to COVID-19. All responses will prioritize the safety and well-being of research staff and participants. This likely means that in many circumstances, PCORI does not expect advance notice of a change to a research protocol if the change is made to address the health and safety of staff or research participants.
- PCORI requests notification of safety-compelled changes or delays as soon as possible and will attempt to document these to the extent possible given current realities, without placing excessive burden on awardees or research staff.
- As a research funder, PCORI will advise awardees to follow their own organizational policies and notices, including those from Institutional Review Boards for protocol/study modifications for existing study subjects as they relate to COVID-19.
- Projects that can continue should do so. PCORI wants project teams to continue activities when possible and safe. PCORI funds may be used to support safety-mandated and/or other PCORI-approved protocol or workplan modifications, to include personnel effort to work on protocol or workplan revisions, revisions to statistical plans and analyses, re-budget activities, transitioning from in-person to virtual convenings or engagement, and other tasks that are in direct support of the current or revised protocol or workplan.
- Studies that cannot continue may need to suspend research activities. If the Principal Investigator, Institutional Review Board (IRB), or Data and Safety Monitoring Board (DSMB) determines that a research study cannot safely proceed, with or without a protocol modification, PCORI funds may be used to support the suspension of the project. Funds may be used for the research team to conduct interim analyses, submit PCORI-required reports, maintain and store research records, prepare IRB and DSMB materials, and conduct other activities directly related to the suspension of the research activity.
- Costs incurred must be necessary and allocable to the PCORI project. While PCORI aims to be flexible and accommodating, ensuring proper fiduciary stewardship over the public trust fund remains a critical staff function. Whether COVID-19 related or not, costs incurred on PCORI awards must be directly related to, and in support of, the performance of the project and allocable to the award.
- PCORI will not provide guidance or advice about the medical care of patients.
1. I have concerns about travelling to a Merit Review panel, Stakeholder Workshop, or other PCORI-sponsored event. What should I do?
For events scheduled within the next two months, you should have or will soon hear directly from organizers of PCORI meetings about whether these meetings will be canceled, postponed, or held virtually. If you are unsure of the status of your meeting, please contact your meeting organizer, or [email protected] for research awards, or [email protected] for Engagement Awards.
2. I have plans to attend a large scientific gathering. Should I continue to plan on attending?
PCORI recommends first consulting with your organization about its policies and practices. In addition, you may consider reaching out to the organizer or host of the scientific gathering. They are most well-equipped in understanding the guidance at the location of the event. They may have contingency plans if the event is ultimately canceled or relocated, or they might be planning to provide options for virtual participation. We also suggest checking the State Department Travel Advisories website if the gathering involves foreign travel.
1. A meeting or other convening included in my award budget was canceled; however, I have nonrefundable travel, registration, and/or hotel costs. Will PCORI reimburse my institution for these costs?
Consult with your organization about its existing policies and guidance for these costs. If your organization does not have existing guidance, please contact the travel company, institution where you registered, or hotel where you had planned to stay. Many of these institutions will likely provide refunds. If they do not, please contact your PCORI staff person. These requests will be reviewed and adjudicated on a case-by-case basis.
2. Our organization has asked us to work from home if we do not have to be on site to conduct our job responsibilities (such as patient care). Can we purchase laptop computers for our staff who do not have adequate equipment in their homes?
These costs are allowable when the items are not covered by the institution’s indirect cost rate. Awardees should follow institutional policies and guidelines related to the purchase of laptops by sponsored programs. The purchase of home office furniture using PCORI funds is not allowed.
3. The institution will officially close until further notice because of the COVID-19 outbreak. Can the PCORI award be used to pay my employment costs?
PCORI will allow recipients to charge salaries and benefits to currently active awards for work performed to meet the project activities, regardless of the location where those duties are performed (i.e., work from home). Some allowable activities may include data analysis, preparation of articles and papers based on the analysis of the research findings, monitoring subrecipients, preparing protocol modifications, direct charged administrative costs, etc. Additionally, such charges to the award should only be made when the work is performed within the recipient organization’s policies for allowable remote/telework and/or emergency operations.
If project personnel cannot work on active projects, please review the next question, Financial Guidance FAQ #4.
4. Will PCORI pay for the salaries and benefits of researchers and other project personnel unable to work as a result of or related to the effects of COVID-19?
We will review salary and benefits continuation support requests on a case-by-case basis with the Principal Investigator/Project Director/Project Lead.
PCORI recognizes the value of maintaining existing research and project teams and preventing delays in re-initiating research and other projects when it is appropriate to do so. We recognize that supporting research and project teams at their current or reduced effort may present future financial challenges for the budget.
Prior to submitting a salary and benefits continuation request to PCORI, research and project teams should exercise flexibility and consider research and project-related tasks that members can support that will benefit the PCORI award. Some examples of award-related tasks may include data analysis, preparation of articles and papers based on the analysis of the research findings, monitoring subrecipients, preparing protocol modifications and changes to informed consent documents, updating study records and organizing files, developing study-related standard operating procedures, creating data dictionaries, and updating ClinicalTrials.gov information.
Upon receipt of a salary and benefits continuation support request, PCORI staff will work with the Principal Investigator/Project Director/Project Lead to understand the potential impacts to the budget and consider if additional funding may be appropriate in the future for research or project completion.
Awardees approved to charge salaries and benefits when personnel are unable to work due to the interruption of the research project or project activities must maintain records to substantiate the allowability, allocability, and reasonableness of the expenses.
5. Will PCORI allow me to increase the value of a milestone on a firm-fixed-price award?
PCORI will review milestone payments with awardees on a case-by-case basis if non-personnel expenses deviate significantly from the budgeted amount. In all cases, awardees should first demonstrate that internal funds cannot cover the difference.
6. Given organizational closures, community partners in PCORI projects will be unable to continue participating. Is PCORI considering offering hardship funds for community partners——to allow them to continue to function?
Hardship funds are not an allowable direct expense.
7. Will PCORI pay for pre-award spending that exceeds 90 days?
PCORI will allow pre-award spending exceeds 90 days with prior approval from the PCORI Program Office and Contract Administrator.
Pre-Award Questions for Applicants (Including Letter of Intent and Application Submission)
1. My employing institution has asked staff to stay home for an undetermined period of time. How would I request an extension of an upcoming application deadline for the following PCORI Funding Announcements (PFAs)?
- Broad PFAs—Cycle 1 2020 (for Addressing Disparities, Assessment of Options, Communication and Dissemination Research, Improving Healthcare Systems)
- Improving Methods for Conducting Patient-Centered Outcomes Research—Cycle 1 2020
- Engagement Awards (Capacity Building, Dissemination Initiative, Stakeholder Convening Support)
- Limited Competition: Implementation of PCORI-Funded Patient-Centered Outcomes Research Results—Cycle 1 2020
When delays occur because the applicant or recipient organization is officially closed due to a natural disaster or other emergency, or because designated PD/PI(s) or other key staff is/are quarantined or involuntarily unable to come to their work locations, PCORI will consider accepting applications late, with prior approval.
For the Broad and Methods PFAs, while PCORI anticipates the cycle to proceed as planned, applicants with an accepted Letter of Intent (LOI) are eligible to defer submission of their application to Cycle 2 2020, with a deadline of September 1, 2020.
All such deferral requests must be submitted by the Principal Investigator (PI) to [email protected] before the specified submission deadline, cc’ing the Institutional Administrative Official (AO) listed on the application. PCORI will provide a written response within two (2) business days from receipt of such requests. While PCORI requests advance notice, applicants with accepted LOIs for Cycle 1 2020 who are neither able to submit for the Cycle 1 2020 deadline of May 5, 2020, nor able to request advanced approval to defer, will still have the option to defer to Cycle 2 2020.
For all three Engagement Awards funding announcements, we will provide flexibility by moving the LOI deadline from April 1 to May 1. Please review the revised announcements in the Funding Center. Any questions or requests for extensions may be directed to [email protected].
For the Limited Competition: Implementation of PCORI-Funded Patient-Centered Outcomes Research Results PFA, we will be able to consider short application deadline extensions up to three (3) business days, for the Cycle 1 2020 applications (April 7 due date).
For deadline extensions for Cycle 1 2020 D&I applications, PIs should submit requests to [email protected] by April 1, 2020, cc’ing the Institutional AO listed on the application. PCORI will provide a written response within two (2) business days from receipt of such requests. Applicants unable to submit applications in this time frame may also wish to contact us regarding opportunities to submit for the next D&I Limited Competition funding cycle.
2. Are the funding opportunities currently posted on PCORI’s website for Cycle 2 2020 going to change or extend their deadlines due to the current public health crisis?
Due to the current global health epidemic and immediate challenges it presents, we are actively reviewing and assessing the funding cycle timeline for all elements (LOIs and applications) of our PFAs that are slated to open later this year. Please note the following changes:
- The Phased Large Awards for Comparative Effectiveness Research (PLACER) funding announcement will be posted on June 9, 2020, with a Letter of Intent deadline of September 29, 2020, and application deadline of January 12, 2021.
- The Limited Competition for Conducting Rare Disease Research Using PCORnet and The Observational Analyses of Second-Line Pharmacological Agents in Type 2 Diabetes funding announcements will proceed as currently posted.
- For D&I Program cycles: The Cycle 2 Limited Competition: Implementation of PCORI-Funded Patient-Centered Outcomes Research Results and the Implementation of Effective Shared Decision Making Approaches in Practice Settings PFAs will proceed as currently posted.
Please continue to check this website often for additional updates.
3. I am considering submitting an LOI under the Engagement Award: Stakeholder Convening Support mechanism. The site of the meeting has not yet been selected. Should I take into account COVID-19 in conference planning and site selection?
Travel logistics, accessibility, and health and safety considerations of the multi-stakeholder participants should always be the foremost consideration for any multi-stakeholder convening, meeting, and/or conference. Since the COVID-19 threat is still evolving, it is important to consider flexibility and alternative plans (e.g., plans for a virtual meeting) in a proposal to support travel or a conference.
In most cases, PCORI will not support in-person convenings if those meetings occur at this time. Awardees are encouraged to explore virtual meeting capabilities and contingency plans for in-person events. Please contact your PCORI staff person for additional guidance, and continue to check this website for changes or updates.
4. What should I do if an LOI I submitted for Cycle 1 2020 was accepted, but I now need to change some of the information due to COVID-19?
Institutions affected by COVID-19 should notify PCORI of any changes from LOI to application via [email protected]. Changes to the PI, institution, study design, research question, specific aims, or comparators require prior approval by PCORI.
For LOIs submitted to the Cycle 1 D&I Limited Competition PFA, please alert the D&I program regarding any major changes to the proposed project with an email to [email protected] by April 1, 2020. The D&I program will accommodate such changes to the extent possible, confirming within two (2) business days.
Post-Award Questions for Awardees
1. I have a question related to COVID-19's potential impact on my PCORI-funded project. Where can I find more information?
For questions as they pertain to a potential impact on your PCORI-funded award, please contact your PCORI staff person (Program Officer, Program Associate, Contract Administrator, or Engagement Officer) for additional guidance.
In addition, your employing organization is an ideal starting point. In many cases, your institution may have created websites offering information.
2. Given concerns about COVID-19 exposure or transmission, is PCORI recommending or mandating the stopping of ongoing research or closure of research sites?
Decisions about suspending or scaling back research activities are under the control of the awardee institutions and are neither mandated nor prohibited by PCORI. PCORI values the safety and welfare of research staff and human subject participants and understands that institutions may take measures to reduce exposure risks, including suspending ongoing research activities or closing clinics or other sites. Awardees should consult with their institution(s) and/or Institutional Review Boards (IRBs), as appropriate, for their most recent policies and guidelines and when making determinations about human subjects safety.
3. Can I change an element of my PCORI-funded research (examples include but are not limited to: modifying the intervention, comparator, outcome measure, limiting study visits, changing research question(s), assigning flexibilities to study monitoring, adding other variables to capture intervention data, changing an arm of the study, etc.) to continue research activities in the current environment?
Institutions should take all steps necessary to ensure the safety of all human participants and research staff involved in PCORI-funded awards.
If you plan to continue study operations with new patients, any changes to the Population, Intervention(s), Comparator(s), Outcome(s), Timing, or Setting (PICOTS) that affect your PCORI-approved research, this information must be shared with your PCORI staff person (Program Officer, Program Associate, Contract Administrator, or Engagement Officer) as soon as possible with details on the effects of COVID-19 and the related reason for changes. These instances will require PCORI’s review and approval. Such instances will be decided on a case-by-case basis.
4. My study has been placed on-hold due to concerns around COVID-19 and/or our Institutions’ recommendations or requirements to pause all non-essential research. Do we need to inform or seek approval from PCORI first?
If research activities of your PCORI-funded award have been placed on pause, you do not need to obtain PCORI’s approval in advance. Please contact your PCORI staff person as soon as possible to inform them of the pause in research activities. It is likely the Program Officer/Program Associate for your award would like to see supporting documentation from your institution and/or public health authorities as well as any additional documentation from regulatory bodies.
5. What is PCORI’s policy as it relates to delayed milestones, Interim Progress Reports, Final Progress Reports, Final Research Reports, and other award-related deliverables that may be delayed as a result of disruption from COVID-19?
If your institution is unable to complete project activities of your PCORI-funded award by the scheduled due date, please contact your PCORI staff person as soon as possible to apprise them of the delayed deliverables, nature of the delay, and anticipated date of submission to PCORI (if known). PCORI will review these requests on a case-by-case basis.
6. Given the delays to my funded award, will PCORI consider extensions to periods of performance, modifications to milestone schedules, and/or administrative supplements to ensure successful project completion?
Given the fluid situation, PCORI understands that awards might be delayed in completion. It is in the best interest of PCORI and the entire medical community to confront the immediate challenges and impact of the current crisis. In the future, it is anticipated that delays/modifications will be addressed on a case-by-case basis. More information on project/budget modifications will be posted at a later date. To the extent possible, please notify your PCORI staff person as soon as possible of any delays or modifications, along with supporting documentation.
7. One of the participants on my PCORI-funded award has contracted COVID-19 that may be attributable to research participation. Does PCORI want to be made aware?
Awardee institutions must fulfill all reporting obligations relating to any serious unanticipated problems (e.g., serious adverse events, serious safety issues, or other serious problems) relating to the research study that are required by your institution, Data Safety and Monitoring Board (DSMB), IRB, FDA, or other applicable regulatory or oversight body.
As the funder of the research study, PCORI expects to be kept informed of reporting about and actions relating to serious unanticipated problems relating to the research study. Thus, notwithstanding interim reporting obligations, awardee institutions must notify PCORI promptly, but no later than ten (10) days after:
- reporting any serious unanticipated problems (e.g., serious adverse event, serious safety issue, or other serious problem) relating to the research study to the DSMB, IRB, the FDA, or other regulatory or oversight body; and
- any decision, finding, recommendation, action or direction of a DSMB, IRB, the FDA, or any other regulatory body or oversight body relating to any serious unanticipated problems (e.g., serious adverse event, serious safety issue, or other serious problem).
8. Will PCORI accept late invoices for awarded projects?
If your institution is unable to submit financial invoices for your PCORI-funded award by the scheduled due date, please contact [email protected] and your PCORI staff person as soon as possible to inform them of the delayed invoice and anticipated date of submission to PCORI (if known).
9. A meeting or other convening included in my award budget has been canceled; however, I have nonrefundable travel, registration, and/or hotel costs. Will PCORI reimburse my institution for these costs?
PCORI suggests that you first consult with your organization about its existing policies and guidance for these costs. If your organization does not have existing guidance, please contact the travel company, institution where you registered, or hotel where you had planned to stay. Many of these institutions will likely provide refunds. If they do not, please contact your PCORI staff person. These requests will be reviewed on a case-by-case basis.
10. I am involved with a convening or an in-person meeting as a part of activities related to my PCORI project that is taking place in the coming weeks. Should I continue with plans for the meeting?
In most cases, PCORI will not support in-person convenings if those meetings occur at this time. PCORI will make every effort to work with awardees so they can either convert in-person meetings to virtual events, or to postpone or cancel the meeting. Awardees are encouraged to explore virtual meeting capabilities that could be implemented from the originally envisioned location of the event. The host location may recommend contingency plans if the event is ultimately canceled or relocated. Please contact your PCORI staff person for additional guidance and continue to check this website for changes or updates to PCORI guidance for in-person meetings.
11. Our organization has asked us to work from home if we do not have to be on site to conduct our job responsibilities (such as patient care). Can we purchase electronic equipment for our staff who do not have adequate equipment in their homes?
PCORI recognizes the challenges presented by remote work arrangements. PCORI staff are working to address this concern and will update this page soon with more guidance. Please contact your PCORI staff person for additional guidance and continue to check this website for changes or updates to PCORI guidance for purchasing electronic equipment.
Posted: March 20, 2020