COVID-19 Research Planning

Research Laboratory Guidance

February 10, 2022 Update

Due to the decline in COVID in our community, we are making the following adjustments to human subjects research recommendations starting February 10th:

1. Previous requests to defer the start of new protocols and delaying visits have been lifted.
2. Investigators should continue to use remote visits, when and where feasible, and review all subjects for potential exposures or risk before any scheduled face-to-face visit.
3. Please continue to monitor and follow campus guidance that is frequently updated here.

January 21, 2022 Update

As COVID-19 cases continue to increase, all researchers should continue to assess their research personnel and subjects (or potential subjects) for symptoms and/or recent known exposures. The Office of Research and Creative Activity is asking that all investigators consider deferring the start of new protocols, delaying visits that can be delayed, and conducting activities remotely that can be remote. In addition, we encourage investigators to consider pausing all research activities for non-therapeutic research which involves face-to-face contact. We are continuing to monitor the situation so recommendations may change. Please review Chancellor Li's mask reminders and vaccine/booster clinic updates.

January 7, 2022 Update

Please review Chancellor Li’s updated guidance to the broader UNO community regarding the pandemic and this additional guidance specific to researchers. The Omicron variant is exceptionally transmissible and, therefore requires close attention to non-pharmaceutical interventions. Please follow this guidance carefully!

Safe laboratory practices:

Our laboratories can be a very safe place to work, assuming everyone is following these commonsense rules:

1. Utilize good laboratory practices including the use of appropriate PPE, reducing clutter, and regularly disinfecting surfaces such as benchtops, common equipment, computer keyboards, door handles, light switches, etc.
2. All employees and students are required to wear a mask while on campus, including while working in laboratories, unless working alone. Given the high transmissibility of the Omicron variant, cloth mask, gaiters, and bandanas are not recommended. Individuals are strongly encouraged to use approved surgical masks or N95 masks.
3. Larger labs with lots of personnel (greater than two within a single room) should devise a strategy consistent with social distancing, such as maintaining, at least 6 ft separation, working in shifts, and working from home whenever possible.
4. Minimize the number of people in your lab by prioritizing funded research, limiting the number of volunteer workers and/or internships, and encouraging work from home when not doing experimental work.
5. Most importantly, if you feel sick, stay at home and get tested as soon as you can.

As indicated before, supervisors are responsible for ensuring social distancing practices through flexible arrangements for space, schedules, and remote work. Please keep in mind that as a supervisor, you have a responsibility to your personnel to check on both their physical and mental well-being. Thus, please check-in with your team on a regular basis, either in person (if you are healthy) or by Zoom.

Human subjects research:

1. Always follow the guidance issued by the UNMC IRB: https://www.unmc.edu/irb/procedures/COVID_FAQ.html
2. Researchers are reminded students, faculty, and staff conducting human subjects research are held to a higher standard. This means taking action to prevent exposure during off-campus activities. The safety procedures are in place to prevent unnecessary exposure from and to the study subjects.
3. Please monitor the CDC recommendations for symptoms to screen for and update safety screenings accordingly. The Safety Committee requires screening via phone the day before the visit and the day of the visit.
4. If anyone who has been in contact with individuals on campus develop symptoms or test positive, it is important to notify the supervisor and PI so UNO procedures for managing COVID-19 exposures can be followed.

Thank you for your attention to these guidelines and helping us get through this current COVID wave safely and effectively.

December 21, 2021 Update

Faculty, staff, and students should follow the official guidance provided by Chancellor Li. See the Maverick COVID Response and travel guidance.

ORCA will continue to be operational during in-person learning

• As always, we encourage email communications with the ORCA team as the initial contact method.
• Lab PIs and research personnel will continue to have access to their laboratories in accordance with campus policy.
• PIs who have questions or foresee that progress will be significantly impacted are encouraged to contact their Program Officers.

Laboratory recommendations:

• Utilize good laboratory practices including the use of appropriate PPE, reducing clutter, regularly disinfecting surfaces such as benchtops, common equipment, and computer keyboards.
• In the event of an extended absence, have a plan to secure sensitive equipment, how to receive and store critical supplies, and how to access data.
• Encourage students and staff to make progress on tasks that can be completed in a remote situation.
• Stay home if you feel sick, have an underlying condition that could make you vulnerable to COVID-19, or are caring for an individual who may be vulnerable.

March 14, 2020 Update

• With the transition to a “remote teaching and learning mode”, faculty, staff, and students should follow the official guidance provided by Chancellor Gold. See updates to this guidance.
• All professional travel is suspended indefinitely.
• This is not a campus shutdown. Rather it is a strategy for “social distancing” during the COVID-19 pandemic.
• This primarily impacts classroom activities, but research activities should continue in a way that is as normal as possible.
• Remember this is a dynamic and rapidly evolving situation, so please frequently check campus updates.
• Please review our general guidance document for UNO researchers.

ORCA will be operational in the event of a campus remote working or social distancing status.

• Although the ORCA phone lines will still be open, we encourage email communications with the ORCA team as the main contact method.
• Lab PIs and individuals important for continued progress on funded research studies are deemed “essential personnel” and will be allowed access to their laboratories.
• PIs who have questions or foresee that progress will be significantly impacted are encouraged to contact their Program Officers.

Laboratory recommendations:

• Prioritize funded research and do not allow unnecessary shadowing or internships.
• Larger labs with lots of essential personnel should devise a strategy consistent with social distancing (i.e. maintain 6 ft separation, work in shifts, etc.)
• Smaller labs should work on a “buddy system” to avoid a situation where they are the only person in a building in the event that an accident occurs (e.g. biological or chemical spill, fire, flood, etc.)
• Utilize good laboratory practices including the use of appropriate PPE, reducing clutter, regularly disinfecting surfaces such as benchtops, common equipment, and computer keyboards.
• In the event of an extended absence, have a plan to secure sensitive equipment, how to receive and store critical supplies, and how to access data.
• For human subjects studies, ensure you have access to the databases with contact information in case subjects need to be contacted to cancel appointments or monitored for safety during a trial. Follow guidance from the UNMC IRB.
• Encourage students and staff to make progress on tasks that can be completed in a remote situation.
• Stay home if you feel sick, have an underlying condition that could make you vulnerable to COVID-19, or are caring for an individual who may be vulnerable.

Human Subjects Research

February 10, 2022 Update

NOTE: The Human Subjects Research Safety Review Committee has suspended the requirement of submitting a safety plan, as reviews are no longer required.

For studies involving face-to-face encounters, the research team under the responsibility of the principal investigator will agree to comply with the following safety measures on the IRB application:

1. Masking of the researcher(s) during a face-to-face encounter
2. Cleansing of any surface and/or equipment utilized before and after a subject encounter
3. The Biosafety Officer (jenna.mckenzie@unmc.edu) will be notified if obtaining saliva, nasal, sputum or stools samples to ensure safe collection, handling, and processing plan is in place
4. Suggest addressing the current health of the subject before commencing face-to-face research via questions below:
   1. Have you or anyone in your household tested positive or had a fever, chills, cough, shortness of breath, diarrhea, nausea, vomiting, recent loss of taste or smell, tiredness or fatigue, or muscle aches? If yes, the monitor will not be allowed on campus.
   2. Have you recently traveled to an area with a widespread outbreak or had close contact with a person known to have COVID-19, MERs-CoV or Ebola?
   3. Have you traveled outside of the country within the past month? If so, where did you travel and when did you return?
   4. Have you had a recent SARS-COV-2 antibody test or nasal swab and if so when and what were the results?

December 21, 2021 Update

Investigators must continue to create a Human Subjects Research Safety Plan for each protocol. This plan is reviewed and approved by the Human Subject Research Safety Review Committee prior to final approval and release of any IRB protocol.

January 14, 2021 Update

Investigators and Coordinators:

As case numbers continue their downward trend, and hospital capacity is adequate, the IRB and the Research Office have, effective Friday 1/15/2021, released the halt on approval of new human subject research projects that involve no prospect of direct subject benefit.

If research has been approved by the IRB AND all other institutional requirements have been met, PIs will shortly be receiving notification thru the RSS portal that they may proceed. YOU MUST WAIT FOR THIS NOTIFICATION BEFORE PROCEEDING

Investigators are reminded to continue to utilize appropriate mechanisms to reduce face-to-face contact with research subjects. In addition, research personnel and all research subjects undergoing face-to-face contact must be masked for all research encounters.

The Research Office and the IRB will continue to actively monitor COVID data, and investigators are advised that additional halts or other actions may be needed in the future.

November 16, 2020 Update

Masking and de-densifying laboratory research: Aerosols from asymptomatic SARS-CoV-2+ persons can travel farther and last longer in common spaces than previously thought and distance is not enough when inside common spaces. For this reason, we expect that all faculty, administrators, and leaders help monitor compliance with the following mask and de-densifying guidelines:

• All personnel in research buildings must wear a mask that covers their nose and mouth at all times, even if working 6 feet apart or alone in a lab or shared space such as a tissue culture room.
• The two exceptions are if 1) unmasked in their own single office with the door shut or 2) eating, when they should always be at least 6 feet from others.
• Even if you have already had COVID-19, masking is still our policy since reinfection is still possible.
• Labs must assure all staff is working no closer than 6 feet through scheduling or moving equipment unless required for a specific operation or technical procedure. When two or more persons must work less than 6 feet apart for a specific procedure, they need to wear a surgical/procedural mask or N-95 mask, not just a cloth mask.

Human subjects research precautions and new restrictions. First and foremost, please follow UNMC IRB Procedures for approval of COVID-19 related safety procedures to restart or begin new research studies. Activities that can be conducted remotely are highly encouraged. In-person protocols should be adjusted to decrease, as much as safely possible, the cumulative time individuals are within six feet of each other during the research session. With increasing numbers of COVID-19 cases in our community, this message includes information to clarify best research practices and procedures as well as proposed changes in research practices. Be advised that additional actions may be needed to minimize risk to research subjects and staff as COVID-19 cases continue to rise.

• Effective immediately, the IRB will halt approval of new human subject research projects that involve: (1) face-to-face contact between subject and research or clinical staff, AND (2) no prospect of direct subject benefit.
• All remaining approved research should continue to implement distance methods to reduce face-to-face contact with research subjects, whenever and wherever they can.
• Research personnel conducting face-to-face visits must be masked at all times with at least a surgical/procedural mask (unless an N-95 is required and fit tested) and if less than 6 feet from a research subject, wear eye protection.
• All research subjects must be masked for all research encounters, and if they cannot, test negative for SARS-CoV-2 within 4 days before the scheduled procedure, unless they are an inpatient that has tested negative; or on a ventilator or other type of assisted ventilation.
• Research involving children less than 2 years old or those with a developmental delay that cannot mask may proceed if they either have 1) known negative SARS-CoV-2 status (inpatients, including newborns from tested negative mothers, or outpatients within 4 days) or 2) on an outpatient protocol with direct benefit, with no known symptoms or recent exposures or as treatment for COVID-19.

Visitors and Volunteers

Visitors, volunteers, and visiting scientists must have approval from the Senior Vice Chancellor of Academic Affairs via this request form.

Managing Exposures

Despite all of these precautions, it is possible that a researcher may test positive after an interaction with a research subject. If this happens, the individual testing positive needs to follow the normal UNO reporting procedures found here.

In addition, individuals must inform the IRB protocol Principal Investigator. The PI is then responsible for 1) notifying the IRB Chair with a letter detailing the situation, including the number of subjects exposed within 48 hours prior to the COVID-19 positive test, and the dates of exposure; 2) Informing all exposed subjects and following up with questions asking whether subjects have been tested, the results of the test, and offering to provide help with testing if subjects request assistance.

Individuals can be referred to any Test Nebraska site. This information must be clearly documented with the IRB protocol records and shared with the IRB.

June 29, 2020 Update

Opening Up Human Subjects Research Safely

All remaining human subject research IRB protocols which were halted due to the pandemic can apply to restart. Investigators must first complete and submit a Research Safety Plan using this link. Once received, the plan will be reviewed. The investigator may be asked for clarification if what is written is unclear. The plan must be approved before the research will be allowed to proceed. The person completing the form will receive an email confirming the form was successfully submitted. The plans will be evaluated in the order that they were received. The number received will impact how quickly the investigators receive a response. The IRB will communicate with the team if more information is required and to confirm that the team can proceed with opening their research once reviewed, pending any requirement for submitting an IRB protocol modification for review and approval through the RSS portal. Key elements that will be requested in this Human Subjects Research Safety Plan include the following:

• Confirmation that the researchers have permission to restart by the funding sponsor, particularly if the sponsor paused the study.
• Confirmation that the researchers have permission to conduct the study in the location(s) proposed with the name of the person they spoke to obtain permission, as well as what mask, visitor, eyeglass protection, or other guidance or policies required by each site.
• What, if any, modifications have been made to enhance safety, such as distance techniques, where it is reasonable to do so, as well as the masking and cleaning protocol to be used.
• What COVID-19 screening questions will be asked of each research subject, and when they will be asked, and by whom
• Acknowledgment that the study team is prepared to provide and have their own cleaning supplies and PPE for the study.

If you have questions about the process or the form, please contact the IRB through the RSS portal. If you have questions or need assistance, please contact the Office of Regulatory Affairs at 402.559.6463 or email at IRBORA@unmc.edu.

Other Helpful Links

• UNO Campus Updates
• Funding Opportunities
• Nebraska DHHS COVID-19 Updates
• The United States Army Medical Research Acquisition Activity provided information to applicants and recipient communities in response to COVID-19
• The Council on Governmental Relations issued this webpage for Agency Guidance Specific to Federal Award Impact
• Special OLAW Webinar on March 19: Pandemic Contingency Planning and Its Impact on Animal Care (includes flexibilities provided by the PHS Policy)
• Flexibilities for Assured Institutions for Activities of Institutional Animal Care and Use Committees (IACUC) Due to COVID-19
• OMB Issued M-20-11, "Administrative Relief for Recipients and Applicants of Federal Financial Assistance Directly Impacted by the Novel Coronavirus (COVID-19) due to Loss of Operations"
• NCURA published this webinar, "RESEARCH ADMINISTRATION IN A TIME OF DISRUPTION- The Impact of COVID-19 on University Research Environment and Management"

• NSF Proposal Submission and Award Management Related to COVID-19
• NSF implementation of OMB Memo M-20-17
• NSF COVID-19 Website
• NSF Letter to Community

• Information for NIH Applicants and Recipients of Funding
• NIH Proposal Submission and Award Management Related to COVID-19
• NIH Late Application Policy Due to COVID-19
• NIH Flexibilities available to applicants and recipients of federal financial assistance affected by COVID-19
• UPDATED MAY 19 - Guidance for NIH-Funded Clinical Trials and Human Subjects Studies Affected by COVID-19

• Frequently Asked Questions for DOD Research Proposers and Awardees Impacted by the Novel Coronavirus (COVID-19)
• Frequently Asked Questions about COVID-19 for DARPA Performers