UD’s Return to Research Under COVID-19

UPDATED: 2/01/2023

Guidelines & Resources

The University of Delaware continues to closely monitor the coronavirus. Visit UD’s Coronavirus webpage frequently for updated information for the entire UD community.

This page provides an overview of UD’s phased-in return to research during the pandemic, in alignment with state and University guidance. We provide researchers with resources for navigating under the “new normal” and address questions you may have in our FAQs. If you are a researcher and have additional questions, please contact UDResearch@udel.edu. For general questions, contact coronavirus@udel.edu.

Research Ramp-Up Phases

Research Currently in Phase 4

We are in Phase 4, with the resumption of all on-campus research. Thanks for your continued patience and collaboration.

PHASE 0

BEGINNING PHASE

Essential Maintenance of Effort
COVID-19 PPE Production

THE RESEARCH COMMUNITY

PHASE 1

EFFECTIVE JUNE 2020

Time-Sensitive Research
Some Field-Based Research

10-15%

OF THE RESEARCH COMMUNITY

PHASE 2

EFFECTIVE JULY 2020

Lab-Based Research Gradual Ramp-Up
All Field Based
Limited Human Subjects Work
Studio Activities: Visual, Art, Design

~33%

OF THE RESEARCH COMMUNITY

PHASE 3

EFFECTIVE AUG 10, 2020

Further Research Gradual Ramp-Up
Some In-Person Human Subjects

~67%

OF THE RESEARCH COMMUNITY

PHASE 4

EFFECTIVE MAY 21, 2021

New Normal
All On-Campus Research Resumes

85-100%

OF THE RESEARCH COMMUNITY

PHASE 0

Essential Maintenance of Effort
COVID-19 PPE Production

THE RESEARCH COMMUNITY

Close Section

PHASE 0

BEGINNING PHASE

Essential Maintenance of Effort
COVID-19 PPE Production

THE RESEARCH COMMUNITY

EXTERNAL CONDITIONS

Governor’s stay at home order in place; travel restrictions. Local/regional COVID-19 cases and hospitalizations increasing; limited COVID-19 testing; limited access to PPE

RESEARCH EFFORTS

PHASE 0. ESSENTIAL WORK: Maintenance of animal and critical cell lines, equipment; activities that directly support state of Delaware requests.
 

  1. Projects that directly address COVID-19 research, and PPE manufacturing and production.
  2. Essential staff only in UD research facilities, comprising < 5% of research and facilities personnel.
  3. Building managers and academic unit leaders prepare movement plans for research buildings and place signage and instructions within buildings. These plans should be broadly shared with researchers and plans should be posted at building entrances.
  4. Centralized procurement of PPE in anticipation of Phase 1 research. Phase 1 PIs prepare for research ramp-up; includes reviewing and revising standard operating procedures (SOPs), making changes to align with physical distancing guidance and the level of support infrastructure available.


PHASE 1

ACTIVE PHASE

Time-Sensitive Research
Some Field-Based Research

10-15%

OF THE RESEARCH COMMUNITY

Close Section

PHASE 1

EFFECTIVE JUNE 2020

Time-Sensitive Research
Some Field-Based Research

10-15%

OF THE RESEARCH COMMUNITY

EXTERNAL CONDITIONS

Governor’s stay at home order and restrictions loosening. Local/regional COVID-19 cases decreasing for 14+ days, hospitalizations flattening; COVID-19 testing availability increasing; identification of new COVID-19 cases with quarantining and contact tracing; limited access to PPE may remain.

RESEARCH EFFORTS

PHASE 1. Time-sensitive and field-based research that can be performed safely with physical distancing and limited support infrastructure, highly-limited return to indoor research spaces. Expectation of ~10-15% of total UD research-related workforce researchers and essential support personnel returning to campus facilities and field-based work. Disruption of effort/data collection causes catastrophic data loss or delays. Seasonal data collection such as outdoor non-human subjects field and agricultural work; long-term longitudinal studies; animal experiments where a delay would result in euthanasia or loss of a colony.

In this limited phase, prioritized research includes:

  1. Prioritize access for graduate students and postdocs close to completion where lack of campus access will jeopardize timely degree or term of appointment completion. Graduate students scheduled to graduate in May or August 2020. Postdoc appointments ending on or before August 31, 2020.
  2. Prioritize research work of
    a) tenure track (not yet tenured) faculty,
    b) sponsored projects with fixed, time-sensitive deliverables and
    c) sponsored projects with no ability to charge salaries/stipends for no-work.

Core facilities resume limited operations to support time-sensitive research within this phase and to prepare for the next phase of research ramp up. For information regarding library access visit the Library, Museums and Press website.

PIs prepare for Phase 2 research ramp-up; includes reviewing and revising SOPs, making changes to align with physical distancing guidance and the level of support infrastructure.

UD establishes self-reporting system for symptom and exposure monitoring via Qualtrics or similar platform.

Research work that can effectively be performed remotely should continue to be done remotely.

 

PHASE 2

Lab-Based Research Gradual Ramp-Up
All Field Based

~33%

OF THE RESEARCH COMMUNITY

Close Section

PHASE 2

EFFECTIVE JULY 2020

Lab-Based Research Gradual Ramp-Up
All Field-Based Research
Limited Human Subjects Work
Studio Activities: Visual, Art, Design

~33%

OF THE RESEARCH COMMUNITY

EXTERNAL CONDITIONS

Further relaxation of executive orders and restrictions. Local/regional COVID-19 cases significantly decreasing for 28+ days, hospitalizations decreasing; COVID-19 testing availability meeting UD needs; Rapid identification of new COVID-19 cases with quarantining and contact tracing; PPE more widely available

RESEARCH EFFORTS

PHASE 2. Gradual expansion of on-site research or studio activities.

  1. Lab-based research ramps up to gradually increase the number of people on campus to ~33% of personnel working simultaneously with strict physical distancing requirements of PPE, no more than 2 people per lab bench, no more than 4 people per 1,000 sq. ft.; shift work and alternate day work schedules recommended. All field-based research can resume consistent with local guidance/conditions. Limited time-sensitive human subjects work may be possible depending on restrictions with prioritization of:

    • Research with significant likelihood of providing direct therapeutic benefit to the study participants, which outweighs the risk of COVID-19 exposure
    • Studies for which in-person research interactions can occur, with no added risk, in the context of a clinical care visit
    • Research with minimal physical contact/proximity with study participants.
  2. Studio activities, such as visual and performing arts and design, will be permitted.
  3. Instructional lab and studio spaces will be available to permit for preparation and redesign of fall semester classes.
  4. Common/gathering areas and multiple cubicle spaces and shared offices remain closed. Desk and group work continues remotely. Research work that can effectively be performed remotely should continue to be done remotely.
  5. Continued use of self-report for symptoms or exposure.

 

PHASE 3

Further Research Gradual Ramp-Up
Some In-Person Human Subjects

~67%

OF THE RESEARCH COMMUNITY

Close Section

PHASE 3

EFFECTIVE AUGUST 10, 2020

Further Research Gradual Ramp-Up
Some In-Person Human Subjects

~67%

OF THE RESEARCH COMMUNITY

EXTERNAL CONDITIONS

Further relaxation of executive orders and restrictions. Local/regional COVID-19 cases minimal, hospitalizations decreasing; COVID-19 testing availability meeting local needs; Rapid identification of new COVID-19 cases with quarantining and contact tracing; PPE fully available.

RESEARCH EFFORTS

PHASE 3. Further expansion of on-site research.

  1. Further gradual relaxing of physical distancing requirements such that 67% of lab personnel are working simultaneously.
  2. An indoor density of, at most, one person per 125 square feet will allow two-thirds of laboratory personnel to be at work simultaneously. More importantly than the square footage, it is critical that work density continues to allow individuals to stay at least 6 feet apart.
  3. Additional in-person clinical/human subjects research and extension/outreach activities are permitted.
  4. Faculty may request access to work in their office on a regular basis. Requests are submitted to their Dean and then to the Provost for approval. If approved, faculty will need to work alone in their office. Additional guidance will be provided to faculty who are approved for access.
  5. Research work that can effectively be performed remotely should continue to be done remotely, including meetings, advising, etc.
  6. Limited access to common spaces consistent with executive order guidance on gathering group sizes in effect. Common spaces may be used in a limited capacity. Specifically, at most, 10 individuals are permitted in a shared space provided the space can accommodate the total number of individuals separated by at least 6 feet. Common spaces may be used for eating/drinking at this time as long as the following are adhered to:
     

    • Before and after eating, you should wash your hands thoroughly to reduce the potential transmission of the virus.
    • If dining on campus, you should wear your mask or face covering until you are ready to eat and then replace it afterward. Eating establishments must meet requirements to allow at least 6 feet of distance between each customer, including lines and seating arrangements. Individuals should not sit facing one another. Employees are encouraged to take food back to their office area or eat outside, if this is reasonable for your situation.
    • Employees should wipe all surfaces, including tables, refrigerator handles, coffee machines, etc. after use in common areas.
  7. Continued use of PPE and social distancing.


PHASE 4

New Normal
All On-Campus Research Resumes

85-100%

OF THE RESEARCH COMMUNITY

Close Section

PHASE 4

EFFECTIVE MAY 21, 2020

New Normal
All On-Campus Research Resumes

85-100%

OF THE RESEARCH COMMUNITY

EXTERNAL CONDITIONS

Minimal to no government restrictions. Widespread testing, identification of new COVID-19 cases with quarantining and contact tracing, effective therapeutic(s) and/or vaccine widely available.

RESEARCH EFFORTS

PHASE 4. New Normal.

  1. All on-campus research permitted, including computational research, in-person human subjects research, and extension/outreach activities. Some physical distancing requirements remain in place. Common areas and shared offices re-open consistent with executive order guidance on gathering group sizes in effect. Should still consider performing work remotely.


Frequently Asked Questions

General
1. What face mask requirements apply?

High-quality face masks are effective in reducing the spread of the COVID-19 virus through airborne droplets, especially indoors. Masks are not required in most indoor settings on campus, except healthcare and clinical settings. Individuals may always make the personal decision to wear a mask to protect themselves and others around them. For those returning to campus for the spring semester, this is a reminder that the CDC continues to recommend wearing a mask when you travel, particularly in airports, train and bus stations and on public transportation.

Masks continue to be required for people who are exhibiting COVID-19 symptoms, have tested positive for COVID-19 within the past 10 days or have been exposed to someone with COVID-19.

Please note that KN95 masks and surgical masks are available on campus.

Individuals who are exposed to someone with COVID-19 no longer need to quarantine, based on current CDC guidance. All individuals with a COVID-19 exposure, regardless of vaccination status, must wear a mask for 10 days, have a negative test five days after their exposure, and monitor for symptoms for 10 days. 

Departments/units (not individual researchers) should use this form on the UD Environmental Health and Safety website to order COVID protection supplies, including KN95 and fire-resistant masks.

2. What additional health and safety protocols do researchers need to follow?

Testing — Individuals are strongly encouraged to get tested 24 hours before their return to campus for the spring semester. At-home testing is widely available on and near campus.

If you test positive for COVID-19 — You must isolate yourself for five days, then wear a mask for five additional days as symptoms improve. On-campus students will be asked to isolate at home, if possible. We will not have space on campus for students who live off campus to isolate.

If you are exposed to someone with COVID-19 — You must wear a mask and monitor symptoms for 10 days, and are strongly encouraged to test five days after exposure or any time symptoms may develop. 

Vaccinations — All UD students must receive a COVID-19 primary vaccine series plus one booster when eligible. The bivalent booster is highly recommended.  Faculty and staff are highly encouraged to be up to date on vaccinations, including the updated bivalent booster released last fall.

3. How do I go about getting personal protective equipment (PPE), including KN95 and fire-resistant face masks, for my research team?

Departments/units (not individual researchers) should use this form on the UD Environmental Health and Safety website to order COVID protection supplies, including KN95 and fire-resistant masks.

4. Is travel for research purposes permitted?

UD travel restrictions to level 4 countries were lifted on March 1, 2022, and a travel request form no longer needs to be completed and approved before departure. Individuals must be vaccinated for travel — with no exceptions. Traveling individuals are encouraged to book all travel via Concur and are responsible for remaining aware of the changing CDC and U.S. Department of State travel guidance.

 

Human Subjects
1. Can in-person research with human subjects be conducted at at UD?

Yes. In-person research with human subjects can be conducted following IRB-approved research protocols. Please visit the COVID-19 Human Subjects Research Checklist for up-to-date information and detailed guidance as it pertains to each ramp-up phase. 

2. Should IRB-approved protocols be modified to accommodate changes triggered by COVID-19?

Yes. COVID-19-related changes to IRB-approved research protocols (e.g., changes to request on-line data collection from subjects, etc.) need to be submitted to the IRB via amendment and must be reviewed and approved prior to implementation.

DHHS and FDA regulations require that all changes in IRB-approved research must be reviewed and approved before changes may be implemented. The only exception to this requirement is that an emergency change may be made without prior IRB review and approval if it is done to eliminate an apparent immediate hazard to a specific participant. Emergency changes must be reported promptly to the IRB for review.

 

3. Can safety checks related to COVID-19 (i.e., body temperature checks and health screening questions pertaining to COVID) prior to in-person interaction with research participants be implemented without IRB approval?

Yes. Researchers can implement the COVID-19 related health screening protocols posted at https://www.udel.edu/home/coronavirus/return/testing/ prior to in-person interaction with human subjects without requirement for those screenings to be approved by the IRB. Body temperature checks and other safety screening COVID-19 health-related questions can be collected and those modifications do not need to be submitted for IRB review and approval unless they are intended to be used as research data (e.g., co-variants, COVID-19 related studies).

Any other changes protocols may need related to COVID-19 (e.g., changes to inclusion/exclusion criteria, elimination of certain procedures previously approved and now removed from protocol, etc.) must be reviewed and approved by the IRB via the amendment process prior to implementation.

 

4. How should COVID-19 related risks as they pertain to in-person visits be communicated to research participants?

The communicable spread of COVID-19 is a risk the members of our community are encountering in daily life. Research- informed consent documents must describe research-specific risks and should not address COVID-19 related risks not specific to research procedures. While not research-specific, the impact of COVID-19 in our daily lives has drastically affected how we interact with each other and it is important for prospective and returning subjects to be informed when making decisions about participating in in-person research visits. It is recommended that researchers provide subjects with the “Important information about COVID-19 and Research Participation” sheet at the time they are contacted to schedule in-person visits and instructed on how to complete the required health screening form.

 

5. I have an ongoing study registered in Clinicaltrials.gov. Do I have to make any changes to my registration?

Any changes made for research purposes to a registered and approved trial must be updated in the ClinicalTrials.gov registration within 30 days after IRB approval of the modification.

 

6. I am a UD researcher conducting a multi-site study approved and overseen by another institution’s IRB (under single IRB review). What should I do about the study?

Contact the study’s primary PI to request guidance from the reviewing IRB and proceed accordingly. There is no need for immediate submission of amendments to the UD IRB when relying on the review and approval of another IRB.
 

7. Is the use of remote online tools acceptable to collect data from research subjects?

Yes. Online tools to enable remote meetings can be used when conducting research with human subjects. Transition from in-person to online/remote data collection must be submitted as a protocol amendment to the IRB for review and approval.

UD central IT recommends the use of Zoom for remote meetings/interviews.  Zoom can be  downloaded  from My UD. UD offers several tips to manage privacy and security of meetings The use of HIPAA-compliant Zoom account> should be considered when collecting sensitive research data.

 

8. How should informed consent be documented when in-person signature of paper documents is not possible?

If signed informed consent documents are required as per the IRB- approved protocol, a written consent (can be an electronic version) must be provided and signed by the subject of legally authorized representative and collected by the researchers some way (i.e., by mail, electronically signed, scanned/faxed, etc.). Exchange of signed documents must be done securely. The IRB suggest consultation with IT as to secured used of available resources https://www1.udel.edu/security/bestpractices/”. Please remember subjects must be given a copy of the informed consent document for their records.

If researchers propose to complete an informed consent process but cannot obtain an original signature as per normal procedure, they may request a waiver of documentation of informed consent. To qualify, the research must present no more than minimal risk of harm to the subjects and involve no procedures for which written consent is normally required. For example, a waiver of documentation of consent is sometimes appropriate for non-sensitive survey type research. These justifications for a waiver of documentation should be added to the protocol form and must be approved by the IRB.

Detailed guidance and best practices on obtaining and documenting informed consent can be found on the Human Subject webpage.

 

9. When can remote enrollment of research participants be proposed for studies?

Remote enrollment can be considered in cases in which no in-person visit with a subject is feasible prior to their study initiation. That is, study will only involve remote interactions/data collection, or study can start remotely prior to in-person visits (e.g., some initial data collection can be completed electronically or via on-line meeting tools). Studies requiring in-person interactions with subjects can propose remote conversations seeking verbal agreement to participate from the subject but should ensure signature is obtained in ink or electronically at the time of the first visit.

Changes to existing protocols related to remote enrollment of subjects must be submitted to the IRB for review and approval via the amendment process.

 

10. Who should I contact if I have additional human subjects related questions?

For additional information, please reach out by email to University of Delaware – HSRB (hsrb-research@udel.edu) or by phone at (302) 831-2137.