Frequently Asked Questions
- About PCORI FAQs
- Applicant and Awardee FAQs Related to COVID-19 or Other Unexpected Public Health Emergencies
- Budgeting FAQs
- Collecting Data on Costs and Economic Burdens FAQs
- Contract Budget FAQs
- Contract Activation/Execution FAQs
- Engagement FAQs
- Fast-Track Resubmission Process FAQs
- General Awardee FAQs
- Invoicing FAQs
- Letter of Intent FAQs
- Merit Review FAQs
- PCORI Online FAQs
- PCORI's Policy for Data Management and Data Sharing FAQS
- Post-Award Process FAQs
- Rare Disease Research
- Research We Fund FAQs
- Role of the Administrative Official FAQs
- What to Include in the Application FAQs
- Who Can Apply FAQs
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 dedicated to working to assist applicants and awardees find solutions that may help address issues related to disruptions associated with COVID-19 (coronavirus) or other unexpected public health emergencies.
The topics covered within this information include general guidance, pre-award concerns for applicants, and post-award concerns for awardees. The FAQs 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 circumstances warrant.
For specific inquiries not addressed below, please contact the following:
Frequently Asked Questions
- As a research funder, PCORI reminds awardees to follow their own organizational policies and notices, including those from Institutional Review Boards for protocol/study modifications for existing study participants as they relate to COVID-19 or other unexpected public health emergencies.
- PCORI will be responsive, flexible, and as accommodating as possible when responding to administrative and/or research delays due to any unanticipated public health emergency. All responses will prioritize the safety and well-being of research or project staff and participants. 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 or is mandated by the research institution’s IRB. For all other changes to a Research Award, a change request for PCORI approval must be submitted by the awardee at least thirty (30) days in advance of the proposed change. For awardees funded under the Dissemination & Implementation or Engagement Award programs, significant changes to the project plan require the advance mutual written agreement of PCORI and the awardee.
- PCORI requests notification of safety-compelled changes or delays as soon as possible and your PCORI Project Team will document these to the extent possible, without placing excessive burden on awardees or research staff.
- PCORI funds may be used to support safety-mandated and/or other PCORI-accepted protocol or project plan modifications, to include personnel effort to work on protocol or project plan 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. Please discuss with your PCORI Project Team. Keep in mind, these will be reviewed and approved on a case-by-case basis.
- 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 for support during a suspension of the project, if appropriate. 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. These requests will be reviewed and approved on a case-by-case basis.
- Costs incurred must be necessary and allocable to the PCORI project. While PCORI aims to be flexible and accommodating, responsible fiduciary stewardship over PCORI’s public funds remains a critical staff function. Whether related to an unexpected public health emergency 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.
I have concerns about traveling to a Merit Review panel, Stakeholder Workshop, or other PCORI-sponsored event. What should I do?
1. 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 project staff who do not have adequate equipment in their homes?
Awardees should follow PCORI’s Cost Principles, and their own institutional policies and guidelines related to the purchase of laptops and/or equipment by sponsored programs. The purchase of home office furniture using PCORI funds is not allowed.
Please contact your PCORI Project Team for additional guidance.
2. Will PCORI pay for the salaries and benefits of researchers and other project personnel unable to work as a result of any unexpected public health emergency?
PCORI 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 feasible to do so. Additionally, PCORI recognizes that supporting research and project teams at their current or reduced effort may present future financial challenges for the budget. The PCORI Project Team will work with the Principal Investigator and study team to consider the needs and any appropriate options for support, as well as records that will need to be maintained or submitted, in any cases where support is approved.
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 continue to advance progress on the PCORI award, such as data analysis, publication preparation, IRB-related updates, among others.
(Including Letter of Intent and Application Submission)
1. Can I request an extension of an upcoming application deadline for any PCORI Funding Announcements (PFAs)?
PCORI reserves the right to assess and consider late submissions for individual applicants as a result of extenuating circumstances on a case-by-case basis. All extension requests must be submitted to [email protected] within 24 hours of the specified submission deadline by the PI, CC’ing the institutional Administrative Official (AO) listed on the application. PCORI will provide a written response within two business days of receipt of such requests.
For more information about funding application submission guidelines and requesting and extension, please visit this page.
2. 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 an unexpected public health emergency in conference planning and site selection?
Travel logistics, accessibility, and health and safety considerations of the participants should always be a consideration for any convening, meeting, and/or conference.
At this time, PCORI recommends that applicants plan for meetings with a virtual component or option, when practicable. If an applicant opts for a fully in-person meeting, the Workplan and Budget Justification applicant templates in the full proposal must include a plan for activities and costs related to travel and other in-person meeting expenses should issues related to any unanticipated public health emergency interfere with the meeting.
If an applicant proposes a meeting with an in-person component, PCORI expects all applicants to implement appropriate safety protocols consistent with applicable public health authorities and federal, state, and local guidance, laws, and regulations.
1. I have a question related to an unexpected health emergency and its potential impact on my PCORI-funded project. Where can I find more information?
For questions that pertain to potential impacts on your PCORI-funded award, please contact your PCORI Project Team (Program Officer, Program Associate, Contract Administrator, or Engagement Officer) for additional guidance.
In addition, PCORI encourages all investigators to consult with your employing organization as a starting point. In many cases, your institution may have created websites or other internal resources offering information to investigators.
2. If concerns related to COVID-19 or any unanticipated public health emergency exposure or transmission arise, does PCORI recommend or mandate suspending 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 research 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 research participants’ 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 response to an unexpected public health emergency?
Institutions should take all steps necessary to ensure the safety of all human research 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 must be shared with your PCORI Project Team (Program Officer, Program Associate, Contract Administrator, or Engagement Officer) prior to any change being implemented with details on the effects from the unexpected public health emergency and the related reason for changes. Consistent with PCORI contract policies, such instances will require PCORI’s review and approval and will be decided on a case-by-case basis.
4. My study has been placed on hold due to concerns around an unexpected public health emergency and/or our institutions’ recommendations or requirements to pause all nonessential 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 by your research institution, you do not need to obtain PCORI’s approval in advance. Please contact your PCORI Project Team as soon as possible to inform them of the pause in research activities. It is likely that the Project Team for your award will need 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?
If your institution is unable to complete project activities of your PCORI-funded award by the scheduled due date, please contact your PCORI Project Team 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 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?
Delays and/or modifications will be addressed on a case-by-case basis. Please notify your PCORI Project Team 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 Project Team 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 Project Team. 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 months. Should I continue with plans for the meeting?
At this time, PCORI recommends that awardees plan for meetings with a virtual component or option when practicable.
If an awardee chooses to conduct a meeting with an in-person component, PCORI expects all awardees to implement appropriate safety protocols consistent with applicable public health authorities and federal, state, and local guidance, laws, and regulations.
Posted: March 20, 2020; Updated: June 23, 2023
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