UD’s Return to Research Under COVID-19

LAST UPDATED: 5/12/2020

Guidelines & Resources

PPE Recommendations for Research Work at UDThe University of Delaware is working to resume research operations — with the safety and wellbeing of the community our highest priority. This page provides an overview of UD’s phased-in return to research, in alignment with state and University guidance. It draws from a comprehensive plan developed with broad input from a working group including representatives from colleges, institutes, core facilities, environmental health and safety, communications, maintenance and operations.

Here, UD researchers also will find required forms that must be approved and access to training materials that must be completed prior to returning to campus, field-based or site-based research. A phased-in approach is being implemented. For additional information contact: UDResearch@udel.edu

Planning for Return to Research on Campus
Principles
  • Safety and wellbeing of the UD community is paramount.
  • Ensuring UD’s academic mission–learning, scholarly activities, public engagement–and position as a leading research university.
  • Maintaining our staffing to the greatest extent possible.
  • Follow public health and government authority guidance and recommendations.
    “…you don’t make the timeline, the virus makes the timeline.”— Dr. Anthony Fauci
  • Establish new and improved best practices and instill an enhanced culture of individual accountability and safety.
  • Overall Objective: Ramp up research activities as safely and expeditiously as public health recommendations permit.
    Expectations
    • Safety and wellbeing of the UD community is paramount.
    • Measured and phased ramping up of research activities.
    • Continue to perform research remotely as much as possible.
    • If there is a significant increase in infections, it may be necessary to return quickly to an earlier phase to protect health and safety.
    • Physical distancing will remain in place, thus, laboratory or field-based procedures requiring close proximity (i.e., < 6 ft) of researchers will not be permitted.
    • Research work conducted by trained independent researchers not requiring direct mentorship in research techniques that would require close physical proximity of individuals.
    • New standards for protective personal equipment required including training on use. Individuals within facilities must wear a mask at all times, except, for example when alone in a single person office. Masks required for outside work when in close proximity (< 6 ft.) to others. Eating within indoor common or research spaces (e.g., break rooms, desks) will not be allowed until phase 4.
    • Support and protect those individuals in vulnerable populations.
    • Implement a fair, transparent and accountable process for granting access.
    • Expect high levels of enforcement of protocols and individual accountability.
      Research Space Categories and Definitions
      Field-based research: Entirety of research work conducted outdoors on non-human subjects without dependence on indoor UD research facility. Data processing can be done off-campus (e.g., at home, remotely). Field-based research that requires access to any indoor research spaces (defined below) will be considered indoor research and will be subject to indoor research guidelines.

      Common spaces: Spaces in research facilities such as lunchrooms, break rooms, classrooms and open desk environments, e.g. carrels, shared desk/workspaces.

      Open offices: Spaces where desks are assigned within a larger room. Desks may or may not be with half walls surrounding the desk, i.e., carrels.

      Shared offices: Smaller office spaces where desks are assigned to multiple people.

      Office: Single room assigned to a single individual.

      Open research laboratories: Laboratories where two or more PI groups share a single laboratory.

      Single PI research laboratories: Laboratories assigned to a single PI group.

      Common research spaces (controlled access): Research spaces not assigned to a single PI, but used commonly by researchers who have key card or key access.

      Common research spaces (non-controlled access): Research spaces not assigned to a single PI, access potentially allowed to all UD researchers.

      Core facilities: Managed research spaces that provide instrument access and research services to UD and outside researchers. Space is managed by a core facility director.

      Human-subjects research: Work involves in-person contact between a UD researcher or an extension/outreach agent and a human research subject or outreach participant, regardless of whether contact occurs in a UD facility.

      Health Screening Protocols

      Applicable to all individuals working and visiting campus. Daily home health screening. Record and document daily

      If feeling ill or have a fever, cough, difficulty breathing and/or loss of taste or smell stay home and call your healthcare provider (faculty, staff) or Student Health Services (students).

      Wash hands frequently. Avoid touching your face. Sneeze, cough into your elbow.

      If you have not been vaccinated and come in contact with a COVID-19 positive individual, need to self-quarantine for 14 days before returning to work.

      PPE Requirements

      Cloth masks required when traveling to/from and on campus when physical distancing is not possible. Procure at least two cloth masks per person. UD provides cloth face masks for all employees. Employees are permitted to use their own cloth face masks provided they meet CDC requirements. Employees wash masks daily with hot water and soap/detergent. Continue with standard PPE use for labs following SOPs. UD procuring PPE centrally for purchase by lab groups, units, etc. Contact  UD Environmental Health and Safety and Fisher Scientific.

      Detailed Recommendations >

      Physical Distancing

      Consistently maintain physical distancing of at least 6 feet (Phase 4), and wear face coverings and lab-appropriate PPE indoors regardless of vaccination status. Also, in Phase 4, research meetings of up to 12 individuals may be held indoors, with the wearing of face coverings and physical distancing of at least 6 feet.

      Protecting Vulnerable Populations

      UD is committed to the health and wellbeing of all employees and students, including individuals from vulnerable populations. Resources to consult for guidance include your advisor/supervisor, graduate program director or Human Resources, as applicable. Questions regarding accommodations may be directed to Disability Support Services.

      Facilities

      Clean, disinfect using PPE–gloves, aprons and masks. Restrooms and common areas cleaned and supplies replenished frequently.

      Common/gathering areas remain locked, whenever possible until at least phase 3.

      Electronics. Consider putting a wipeable cover on electronics. Follow manufacturer’s instruction for cleaning and disinfecting. If no guidance, use alcohol-based wipes or sprays containing at least 70% alcohol. Dry surface thoroughly.

      Coordinate the posting of signage for cleaning, disinfecting and personal hygiene with Environmental Health and Safety. Other building signage is being handled centrally by UD Facilities, Real Estate and Auxiliary Services.

       

      Compliance

      UD is a supportive campus community that advocates for each individual’s voice to be heard. Every member of the community is accountable for themselves and others. UD endorses a “see something, say something” mindset to ensure health and safety as we return to campus. Individuals are directed to the UD compliance hotline for anonymous reporting of non-compliance with any aspects of research ramp-up guidelines, including state guidance, physical distancing protocols or pressure to perform outside of an individual’s comfort zone.

      COVID-19 Planning Group

      This working group met remotely every Monday from mid-March through mid-May 2020 to discuss concerns and plan toward a future ramp-up of UD’s research operations. Research phasing is now under the guidance of the Research and Graduate Education Campus Reopening Committee.

      Charlie Riordan, Chair
      Vice President, Research, Scholarship & Innovation

      Tracey Bryant
      Senior Director, Research Communications

      Jeffrey Caplan
      Director, Bio-Imaging Center

      Judy David
      Assoc. Director, Custodial & University Services

      Laura Desimone
      Director of Research Education & Human Development

      Paul Dickinson
      Director, Maintenance & Operations

      Doug Doren
      Interim Dean, Graduate College

      Tim Dowling
      Director, Student Health Services

      David Edwards
      Assoc. Dean, Health Sciences

      Jeff Friedland
      Assoc. Vice President, Research Administration

      Mike Gladle
      Director, Environmental Health & Safety

      Jennifer Horney
      Director, Epidemiology Program

      Sylvester Johnson
      Director, Custodial & University Services

      Murray Johnston
      Assoc. Dean, Arts & Sciences

      Sheryl Kline
      Deputy Dean, Business & Economics

      Dave Martin
      Assoc. Dean, Engineering

      Cordell Overby
      Assoc. Vice President, Regulatory Affairs & Compliance

      Gerald Poirier
      Facility Manager, Advanced Materials Characterization Lab

      Sindhuja Sunder
      Graduate Student, Geography & Spatial Sciences

      Gwen Talham
      Director, Animal Care Program

      Fabrice Veron
      Deputy Dean, Earth, Ocean & Environment

      Eric Wommack
      Deputy Dean, Agriculture & Natural Resources

      PI Return to Campus and Outreach Forms

      As of May 21, 2021, these forms are no longer required.

      Return to Research Checklists

      For access to campus facilities and human subject interaction

      Employee, Student and Visitor Training

      All employees and visitors must complete required safety training

      PI Return to Campus and Outreach Form

      As of May 21, 2021, these forms are no longer required.

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      PI Return to Campus Request and Outreach Form

      NOTE: As of May 21, 2021, these form are no longer required.

       

      Return to Research Checklist

      For access to campus facilities and human subject interaction

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      Return to Research Checklist

      The Research Office is providing two checklists to aid in returning our research community back to campus during the COVID-19 pandemic. All University of Delaware PIs and core facility directors conducting research or who are part of UD Research must complete a research ramp-up checklist. A link to this checklist can be found below.

      If a PI’s research involves human subject interaction procedure modification and adjustments must be in place to conduct in-person interactions. These procedures must be approved by the IRB when required, prior to completing the Research Office online form requesting permission to return to campus. Prior IRB review and approval is required for any proposed research protocol modifications beyond the incorporation of COVID-19 related health screening questionnaires/temperature checks, and implementation of PPE and physical distancing modifications, or phasing of different populations enrollment (e.g., not enrolling COVID-19 vulnerable populations). A link to this checklist is below.

      Employee, Student and Visitor Training

      All employees and visitors must complete required safety training

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      Employee, Student and Visitor Training

      During the COVID-19 pandemic all University of Delaware faculty, students, staff and visitors who are conducting research or who are part of the UD Research must complete training and adhere to guidelines of their respective programs. Click below to complete this training:

      Faculty Training     Student/Staff Training     Visitor Access Training

      “Visitor Access Training” is password protected. Contact us to obtain this password.

      UD Workplace Guidelines

      Return to campus guidelines for all UD employees

      Home Health Screening

      Are you at risk of COVID-19 exposure?

      Campus Reopening and Planning

      Task forces guiding UD’s phased approach to reopening

      Research Ramp-Up Phases

      Research Currently in Phase 3 Until May 21, 2021

      Click on each phase for more details.  We are now reviewing PI request forms for Phase 3. If you already have campus access and are bringing additional coworkers on-site and/or accessing additional space you must submit a new Phase 3 request.

      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

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      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

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      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

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      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

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      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 changes as UD’s research operations move from Phase 3 to Phase 4?

      • All on-campus research will be permitted — no application required — including undergraduate research, computational research, in-person human subjects research, and extension/outreach activities. Please note that shuttered buildings/facilities need to be approved for reopening before personnel can enter.
      • For research involving vulnerable populations, consider the benefits of continuing virtual engagement. Continue to follow the COVID-19 Human Subjects Research Checklist (add hyperlink). Questions should be directed to the UD Institutional Review Board (IRB).
      • Research meetings of up to 12 individuals may be held indoors, with the wearing of face coverings and physical distancing of at least 6 feet.
      • Keeping personnel records for contact tracing will no longer be required.

       

      2. What remains the same as UD’s research operations move from Phase 3 to Phase 4?

      • Wear face coverings and lab-appropriate PPE indoors regardless of vaccination status.
      • Consistently maintain a distance of >6 feet from one another.
      • Wash your hands frequently.
      • Complete the Qualtrics daily health screening survey.
      • Stay home if you have symptoms.
      • Get vaccinated!
      • Supervisors and mentors are not permitted to inquire of an employee’s or student’s vaccination status.
      • New/returning personnel and visitors need to complete UD COVID online training.
      • Travel for research, scholarship and creative/performing arts requires submission of online form and approval prior to departure. Consistent with CDC guidance, all travelers need to affirm they are fully vaccinated prior to travel.
      • Shuttered buildings/facilities need to be approved for reopening before personnel can enter and research can return.

       

      3. Do I need to apply for Phase 4 access if I already have Phase 0 - 3 access?

      No application is required for Phase 4.

       

      4. How do I go about getting personal protective equipment (PPE) for my research team?

      UD has centralized the purchase of PPE—including cloth face masks and plastic face shields—for research operations. Please contact Mike Gladle (mgladle@udel.edu) to place your order for cloth face masks, and Fisher Scientific for disposable face masks and all other types of PPE.

       

      5. How many researchers are permitted to work in the laboratory at one time?

      Phase 4 researchers should consistently maintain a distance of >6 feet from one another.

       

      6. Can human subjects research be conducted now?

      Yes, All human subjects research can commence. For research involving vulnerable populations consider the benefits of continuing virtual engagement. Continue to follow the COVID-19 Human Subjects Research Checklist. Questions should be directed to the UD Institutional Review Board (IRB).

       

      7. Will undergraduate students be permitted to return to research labs and field activities?

      Yes, undergraduate researchers are permitted to return. No application form is required.

       

      8. Can I bring a visitor to my lab?

      Research collaborators and service vendors are permitted to visit UD research facilities to perform time-sensitive work with a specific investigator who serves as their host during the visit. Please follow this procedure.

      1. All visitors must complete COVID-19 training before coming to campus.
      2. The visitor must complete and pass the daily health screening prior to arrival on campus. The host researcher must confirm the status of the daily health screening (green check) each day.
      3. The visitor must follow UD health and safety protocols: wear a face mask, maintain at least 6 feet distance and wash hands frequently.

       

      9. Is travel for research purposes permitted?

      Effective April 9, 2021, UD travel for research, scholarship and creative activities may resume provided UD travelers are fully vaccinated and their travel is fully approved, if required, via this online application process prior to departure. Other UD travel remains suspended until further notice.

      Travel approval is required when UD employees and students need to use shared/public transportation (e.g., Uber/Lyft, buses, trains, planes) and/or overnight accommodations. Day trips using one’s own vehicle are not subject to this request.

      Travelers should use this application form, which includes detailed questions, affirmation of vaccination status and an approval process that includes the traveler’s department chair and dean, with final approval by the vice president for research, scholarship and innovation, the provost and the Office of Risk Management.

      Individuals who are approved to travel 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. Do I need to complete a "Human Subjects Research Checklist” prior to conducting in-person research?

      Yes. If your research involves in-person interactions with research participants, physically in the same space, regardless of where the space is located, during the COVID-19 pandemic,then you must complete the “Human Subjects Research Checklist” prior to the return to in-person research. The checklist is not study specific. One checklist per PI starting in-person research is sufficient.

       

      2. 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.

      3. 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.

      4. 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.

      5. 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.

      6. 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.

      7. 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.

      8. 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.

       

      9. 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.

      10. 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.

      11. Is the UD IRB accepting and reviewing submissions?

      Yes, the UD IRB staff and committee members are working normal hours. Email is checked periodically and the IRB staff are triaging the urgency of requests made to the IRB.

      The volume of COVID-19 related applications to the UD IRB has increased significantly; consequently, turnaround times may be variable. Researchers are asked to plan accordingly as they prepare for return to in-person research with human subjects during UD ramp-up phases 3 and 4 and visit the COVID-19 Return to Research/ for more information.

      12. 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.

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