FAQs

Frequently Asked Questions regarding CTSI COVID-19 Response

Temporary suspension for Certain Human Subjects Research Studies:
The following FAQs pertain to human subjects research.

  1. Should NIH or other sponsors (government, industry or nonprofit) be notified that select protocol activities or in-person visits of a funded research study will be paused?
  2. How will the pause in my research impact my grant expenditures?
  3. have a progress report due in the near term, and my study is impacted by the pause. Should I include information relating to the pause in my progress report?
  4. My study may be impacted by the pause, which could lead to delays in completing my study by the end of the project period. What should I do?
  5. I am conducting FDA-regulated research for which I am the sponsor of an IND or IDE. Do I need to notify the FDA if I pause my study?
  6. Should I notify the industry sponsor if my research activities are paused on my clinical trial?
  7. I am a PI of an investigational drug/device trial. Do I need to pause my trial?
  8. Will the Clinical Research Unit be open for use to conduct studies that have investigational treatments?
  9. What is the procedure for pausing a study or certain elements of a study?
  10. May we continue to collect data and follow up with subjects by telephone when in-person data collection has been paused?
  11. May we continue conducting telephone screening of potential subjects?
  12. May we conduct home visits to collect data in studies with no potential direct benefit to participants?
  13. Do we need approval from the IRB for communications to study subjects explaining the pause in activities?
  14. May I initiate a new trial that involves a drug or device?
  15. How should I proceed with a study that has no direct benefit to a subject, but is conducted as part of routine clinical care? An example is tissue collection for research studies while a subject is undergoing standard of care surgery.
  16. I have a subcontract with another site in North Carolina. Do I need to pause as well, if the pause applies to my protocol at Wake Forest Baptist Health?
  17. If my study is being conducted off-site, may it continue?
  18. If my study is being conducted entirely during a Wake Forest Baptist Health inpatient admission, may it continue?
  19. How will the pause in research impact studies conducted outside of North Carolina, both domestic and international?
  20. Will the pause or change to the method of data collection be considered a protocol violation?
  21. If I am pausing study procedures, do I need to notify the IRB of Record, for studies relying on an external IRB, in addition to responding to the questions from the Wake Forest Baptist Health IRB?

    Availability of Research Operations

  22. What CTSI services will be available during this period?

    Allowable Costs/Charges/Effort on Sponsored Projects

  23. I was planning to travel to a conference to present my research work supported by my grant, but the conference was canceled due to precautions regarding COVID-19. May I still charge the travel-related costs to the grant?
  24. I’m a PI working remotely from home during self-isolation. Can my effort still be charged to the grant?
  25. What if I am home sick and can’t work on my project? Can my salary still be charged to the grant?
  26. Can I charge trip cancelation insurance to my grant?
  27. I am a PI/researcher, and I am required to work from home as a result of the coronavirus. Would I be able to charge supplies relating to telework (i.e., such as a laptop, printer, office supplies, etc.) to my grant?

    Research-related Travel

  28. I was planning to visit a lab to conduct work/I was planning to meet with a collaborator/I was planning to attend a conference, but cannot because of travel restrictions relating to COVID-19. What should I do?

    Proposal Deadlines

  29. I am self-isolated, quarantined and/or at home caring for a sick family member and am unable to submit my grant by the stated deadline. May I request an extension?
  30. Where can I get more information on sponsor-specific policies concerning disasters and emergencies?

    Research-related Issues

  31. I’m experiencing delayed subject recruitment and/or cancelations of scheduled follow up visits with my study participants and it is negatively affecting the progress of my grant. What should I do?
  32. What is the contingency plan for research animal care?

    Researchers Conducting COVID-19 Research

  33. I was approached by a sponsor/foundation/donor wishing to provide me with funds to conduct research relating to COVID-19. What should I do?
  34. Where can I find funding opportunities related to COVID-19?
  35. I want to conduct COVID-19 research using an emerging pathogen, such as SARS CoV2. What do I need to do?
  36. I would like to receive and/or send materials (i.e., plasma, virus, pathogens, etc.) relating to COVID-19 from or to another organization/collaborator. What should I do?

 

 

Temporary suspension for Certain Human Subjects Research Studies:
The following FAQs pertain to human subjects research.

 

Should NIH or other sponsors (government, industry or nonprofit) be notified that select protocol activities or in-person visits of a funded research study will be paused? 

Yes. OSP will be issuing an initial institutional notification to NIH and other sponsors. After the IRB makes specific protocol determinations, they will be providing OSP with information concerning those protocols that will require a pause and follow-up communications will be sent by OSP for all impacted grants. OSP will notify each PI prior to issuing a follow-up notification to a sponsor.  All communication to external sponsors must be issued from OSP. For questions concerning your NIH- and other government or foundation sponsored studies, please contact your OSP Departmental Contact. (Back to top)

 

How will the pause in my research impact my grant expenditures?

All study-related activities that are not affected by a pause can continue to be charged as normal. Additionally, there should not be a significant disengagement of the PI or other senior key personnel from affected projects. Current prior approval requirements remain in effect. Please contact your OSP Departmental Contact with any questions. (Back to top)

 

I have a progress report due in the near term, and my study is impacted by the pause. Should I include information relating to the pause in my progress report?

Yes. If your study is impacted, your OSP Departmental Contact will provide you with guidance on how and where this should be included in your progress report (i.e., in Section F.2 of a NIH RPPR). (Back to top)

 

My study may be impacted by the pause, which could lead to delays in completing my study by the end of the project period. What should I do?

Most federal sponsors, including NIH, allow for a one-time no cost extension for 12 months at the end of the project. Please discuss your specific project with your OSP Departmental Contact, who will provide guidance on the options available to you.  (Back to top)

 

I am conducting FDA-regulated research for which I am the sponsor of an IND or IDE. Do I need to notify the FDA if I pause my study?

Yes. The FDA will need to be notified. Contact the IND/IDE Navigation Program (ikellypu@wakehealth.edu) for specific guidance and information on the notification process. (Back to top)

 

Should I notify the industry sponsor if my research activities are paused on my clinical trial?

If the study needs to be paused, the sponsor will need to be notified. Contact the OSP Departmental Contact for the notification process. (Back to top)

 

I am a PI of an investigational drug/device trial. Do I need to pause my trial?

Yes, unless it is deemed necessary for the health and well-being of the participants. (Back to top)

 

Will the Clinical Research Unit be open for use to conduct studies that have investigational treatments?

The Clinical Research Unit will remain open only for visits deemed medically necessary. Even then, in an effort to protect our participants and staff, we will require a pre-screening of participants in advance of entry to the unit. 24 hours before the scheduled appointment, study teams should contact participants and ask:

 

  • Have you been contact with someone who was sick in the last 14 days?
  • Do you have a fever, cough, shortness of breath or difficulty breathing?
  • Have you traveled internationally in the last month?

 

If the participant responds negatively to the questions above, you may proceed with the visit.  Do NOT schedule an appointment or have your participant come into the CRU if your participant is symptomatic unless the Clinic Provider/Admitting MD or Infectious Diseases has cleared the patient for an appointment. 

 

Clinical Research Unit staff will screen participants as they check-in for their appointments with the same triage questions. Should there be a concern, staff will provide the patient with a mask and work with the study team to ask the individual to leave the unit, referring them to their primary care provider. (Back to top)

 

What is the procedure for pausing a study or certain elements of a study?

The IRB has sent specific instructions on how a PI should respond to it. The IRB should be notified within 5 days of any change made for safety reasons. The notification should indicate the study, or components of the study, that should remain open and provide a short statement of the risks and benefits in light of the COVID-19 epidemic. The IRB will provide guidance if any additional actions need to be taken after receipt of each notification. (Back to top)

 

 May we continue to collect data and follow up with subjects by telephone when in-person data collection has been paused?

Yes. There is no increased risk to subjects relating to COVID-19. (Back to top)

 

May we continue conducting telephone screening of potential subjects?

Yes. There is no increased risk to subjects relating to COVID-19. (Back to top)

 

May we conduct home visits to collect data in studies with no potential direct benefit to participants?

No. While the real or potential risk to participants of traveling to a research site, and aggregation at the site, are absent from home visits, there may still be real or apparent risk. (Back to top)

 

Do we need approval from the IRB for communications to study subjects explaining the pause in activities?

No. It is not necessary to submit a modification. (Back to top)

 

What if my study doesn’t clearly fall into any of these categories?

Indicate what you think is the ethical basis for pausing or continuing the study in your notification to the IRB. If you state that as the PI, you believe that there is no increased potential or perceived risk from COVID-19, you may continue the study pending IRB review. (Back to top)

 

Will the IRB provide blanket language/approvals?

The wording and language may need to be specific to each study. The guidance is as follows:

Due to the potential or perceived risks of COVID-19, WFBMC has provided guidance to PIs regarding considerations for human subject research studies involving direct subject contact that are not linked directly to the health of the research subjects. PIs should consider whether in-person studies should be paused and contact should be maintained by telephone during this time. If so, remote data collection may continue and in-person visits may resume when the risk of COVID-19 has passed. (Back to top)

 

May we enroll new subjects on existing studies?

This should be decided on a study-by-study basis. The risk/benefit ratio for subjects may have changed from the time at which the protocol was reviewed and approved. (Back to top)

 

May we enroll new subjects while the IRB is making the determination whether to keep enrollment open?

Yes. The presumption is that most PI analyses of risks and benefits will be accepted by the IRB. The IRB will review these case-by-case situations very rapidly. (Back to top)

 

May I initiate a new trial that involves a drug or device?

This will be decided by the IRB on a trial-by-trial basis. The PI should provide a revised risk-benefit statement that explicitly takes the COVID-19 risks into account. (Back to top)

 

How should I proceed with a study that has no direct benefit to a subject, but is conducted as part of routine clinical care? An example is tissue collection for research studies while a subject is undergoing standard of care surgery.

Unless it is deemed necessary for the health and well-being of the participants, these activities should be paused. (Back to top)

 

I have a subcontract with another site in North Carolina. Do I need to pause as well, if the pause applies to my protocol at Wake Forest Baptist Health?

Yes. The same ethical issues relating to the changed risk/benefit ratio that apply to a WFBMC site apply elsewhere. (Back to top)

 

If my study is being conducted off-site, may it continue?

This guidance applies, whether physically at a Wake Forest Baptist Health campus, at a practice site or elsewhere. The same rationale applies regarding the risks relating to COVID-19. (Back to top)

 

If my study is being conducted entirely during a Wake Forest Baptist Health inpatient admission, may it continue?

No, unless it is deemed necessary for the health and well-being of the participants. (Back to top)

How will the pause in research impact studies conducted outside of North Carolina, both domestic and international?

If a study is deemed necessary for the health and well-being of the participants, it may continue.   (Back to top)

 

Will the pause or change to the method of data collection be considered a protocol violation?

You should inform the study sponsor and/or the overall PI of the study of the modified procedures and what documentation requirements will need to be modified (e.g., changes to CRFs, etc.).  (Back to top)

 

If I am pausing study procedures, do I need to notify the IRB of Record, for studies relying on an external IRB, in addition to responding to the questions from the Wake Forest Baptist Health IRB?

Yes, as soon as feasible. The regulations allow implementation of a change to study procedures without prospective IRB approval when it is necessary to avoid imminent hazards to subjects. The IRB of Record will need to approve resumption of study procedures. (Back to top)

 

 

Availability of Research Operations

What CTSI services will be available during this period?

Please click here for a list of all CTSI services with updates about their status during this time. (Back to top)

 

 

Allowable Costs/Charges/Effort on Sponsored Projects

I was planning to travel to a conference to present my research work supported by my grant, but the conference was canceled due to precautions regarding COVID-19. May I still charge the travel-related costs to the grant?

For NIH awards, please refer to NOT-OD-20-086: Flexibilities Available to Applicants and Recipients of Federal Financial Assistance Affected by COVID-19. All travel booked on NIH awards as well as non-NIH awards must continue to follow the WFBMC Travel and Reimbursable Employee Expense Policy, and general cost principles described in the Uniform Guidance for reimbursement from grants.  We will continue to monitor sponsor guidance and update accordingly.  (Back to top)

 

I’m a PI working remotely from home during self-isolation. Can my effort still be charged to the grant?

In general, yes, provided you remain engaged in your project. Current NIH and NSF prior approval requirements regarding disengagement and effort reductions remain in effect. (Back to top)

 

What if I am home sick and can’t work on my project? Can my salary still be charged to the grant?

Yes. Sick leave and other paid absences that are permitted under Wake Forest Baptist Health policy may be charged to the grant. (Back to top)

 

Can I charge trip cancelation insurance to my grant?

Trip cancelation insurance is typically unallowable on grants. However, we are monitoring any additional guidance the federal government may issue related to travel. If you need to travel in the coming months to conduct business for a sponsored project, and you want to purchase trip cancelation insurance, you may reach out to your OSP Departmental Contact to request prior approval from the sponsor to charge this cost to the grant. (Back to top)

 

I am a PI/researcher, and I am required to work from home as a result of the coronavirus. Would I be able to charge supplies relating to telework (i.e., such as a laptop, printer, office supplies, etc.) to my grant?

These types of expenses are considered administrative costs (indirect costs), and generally are not appropriate as a direct cost unless specifically approved by the sponsor. (Back to top)

 

Research-related Travel

I was planning to visit a lab to conduct work/I was planning to meet with a collaborator/I was planning to attend a conference, but cannot because of travel restrictions relating to COVID-19. What should I do?

Wake Forest Baptist Health Travel Policies and restrictions have been shared by leadership via email and are posted here. (Back to top)

 

Proposal Deadlines

I am self-isolated, quarantined and/or at home caring for a sick family member and am unable to submit my grant by the stated deadline. May I request an extension?

 

Most federal agencies, including NIH and NSF, do not grant prior approval for late submissions; however, there are existing policies that address extenuating circumstances. Current NIH guidance can be located at NOT-OD-15-039 and Special Exceptions to NSF's Deadline Date Policy (PAPPG 19-1). We strongly encourage you to discuss your specific situation with both your agency Program Official and your OSP Departmental Contact. Also see:

Where can I get more information on sponsor-specific policies concerning disasters and emergencies?

See NIH Extramural Response to Natural Disasters and Other Emergencies: https://grants.nih.gov/grants/natural_disasters.htm

See NSF: Detailed Guidance on the Coronavirus (COVID-19)

Responses to Natural Disasters: https://www.nsf.gov/naturaldisasters/.
 
(Back to top)

 

Research-related Issues

I’m experiencing delayed subject recruitment and/or cancelations of scheduled follow up visits with my study participants and it is negatively affecting the progress of my grant. What should I do?

For programmatic issues affecting your study, we strongly recommend you speak with your agency Program Official or other sponsor contact.  If any issues should persist, they may need to be reported in future progress reports, or you may need a No Cost Extension to complete your study. Please coordinate any such actions with your OSP Departmental Contact. (Back to top)

 

What is the contingency plan for research animal care?

The Animal Resources Program has a pandemic response as part of our overall disaster plan. Our husbandry and veterinary staff are considered essential employees and will be expected to come in during a disaster. Whenever there is a possibility that there will be a significant reduction of staff or limited access to animals, the ARP identifies staff who would be willing and able to come to or stay in the facility, and work is limited to life supporting procedures only; cage changes and other husbandry procedures that are deemed non-essential to the support of life are delayed as determined by the Attending Veterinarian and the Institutional Animal Care and Use Committee. (Back to top)

Researchers Conducting COVID-19 Research

I was approached by a sponsor/foundation/donor wishing to provide me with funds to conduct research relating to COVID-19. What should I do?

Conducting work relating to COVID-19 requires approval from senior leadership and will require significant attention to review and negotiate the terms of the sponsored award and to assist you in obtaining required institutional approvals (e.g., IRB, IACUC, etc.). You should immediately contact your assigned OSP Administrator, who will then provide you information on next steps. (Back to top)

 

Where can I find funding opportunities related to COVID-19?

NIH Guide for Grants and Contracts - search results for "2019-nCoV"

NSF - Dear Colleague Letter: Provisioning Advanced Cyberinfrastructure to Further Research on the Coronavirus Disease 2019 (COVID-19)
(Back to top)

 

I want to conduct COVID-19 research using an emerging pathogen, such as SARS CoV2. What do I need to do?

Researchers interested in conducting research with emerging pathogens such as SARS CoV2, should contact the Biological Safety staff in EH&S at ehs@wakehealth.edu for guidance and assistance. Contact information can be found at:

 

I would like to receive and/or send materials (i.e., plasma, virus, pathogens, etc.) relating to COVID-19 from or to another organization/collaborator. What should I do?

If you are planning to receive and/or send any material (plasma, virus, etc.) containing, constituting or directly relating to coronavirus research, please contact OSP for assistance. All requests should be directed to Sara Stanley (Sara.Stanley@wakehealth.edu), indicating 'COVID-19 for Coronavirus' in the subject line.

  • When receiving material: The organization/collaborator providing material to Wake Forest provides a Material Transfer Agreement (MTA). Please request a template from the provider organization/collaborator and forward it to OSP for legal review. In the event the provider prefers to use an MTA template from WFBMC, OSP can generate the document.
  • When sending material: OSP will prepare and send a draft MTA to the organization /collaborator for review.

 

OSP may need to consult with the necessary regulatory offices depending on the type of material and nature of the research. OSP will advise you if anything else is needed before the MTA may be signed (e.g., IRB or other institutional approval).  (Back to top)