UD’s Return to Research Under COVID-19
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.
BEGINNING PHASE
• Essential Maintenance of Effort
• COVID-19 PPE Production
THE RESEARCH COMMUNITY
EFFECTIVE JUNE 2020
• Time-Sensitive Research
• Some Field-Based Research
10-15%
OF THE RESEARCH COMMUNITY
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
EFFECTIVE AUG 10, 2020
• Further Research Gradual Ramp-Up
• Some In-Person Human Subjects
~67%
OF THE RESEARCH COMMUNITY
EFFECTIVE MAY 21, 2021
• New Normal
• All On-Campus Research Resumes
85-100%
OF THE RESEARCH COMMUNITY
• COVID-19 PPE Production
THE RESEARCH COMMUNITY
ACTIVE PHASE
• Time-Sensitive Research
• Some Field-Based Research
10-15%
OF THE RESEARCH COMMUNITY
• All Field Based
~33%
OF THE RESEARCH COMMUNITY
• Some In-Person Human Subjects
~67%
OF THE RESEARCH COMMUNITY
• All On-Campus Research Resumes
85-100%
OF THE RESEARCH COMMUNITY
Frequently Asked Questions
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.
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?
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.
ASSISTANCE
Compliance Hotline
Phone: (302) 831-2792
UD Research Office
210 Hullihen Hall
Newark, DE 19716
Phone: (302) 831-2136
Fax: (302) 831-2828
Contact us
AGENCY ANNOUNCEMENTS
• APLU’s Input on Future Stimulus Package
• NSFs Implementation of OMB Memorandum Repurposing Existing Federal Financial Assistance Programs
• Higher Ed Research Relief Objectives
• Federal Agency Guidance Matrix from COGR
• Federal Agency Guidance: List by Council on Governmental Relations