COVID-19 Research Planning
Research Laboratory Guidance During the COVID-19 Pandemic
- 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 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.
- 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 (e.g. 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 Update - January 14, 2021
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.
Human Subjects Research Update - November 16, 2020
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 are 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.
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.
Human Subjects Research Update - June 29, 2020
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
- Acknowledgement 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"
National Science Foundation Updates
- 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
National Institutes of Health Updates
- 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
Department of Defense