• 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.

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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 only 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.

4. Will PCORI pay for the salaries of researchers unable to work as a result of or related to the effects of COVID-19?

PCORI will only allow recipients to charge salaries and benefits to currently active awards for work performed to meet the objectives/needs of the project, regardless of the location where those duties are performed (i.e., work from home).

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.

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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 before May 15, 2020. 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.

12. Will PCORI pay for the salaries of researchers unable to work as a result of or related to the effects of COVID-19?

Maintaining integrity of project teams during this time is a high priority for PCORI. PCORI staff are working to address this concern and will update this page in the near future with more guidance. Please contact your PCORI staff person for additional information and continue to check this website for changes or updates to PCORI guidance.

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