This information is being provided by the Office of the Vice President for Research (OVPR) for University of Iowa research PIs, staff, and administrators. Direct any questions or concerns about this page to OVPR Strategic Communication Director Steve Pradarelli at stephen-pradarelli@uiowa.edu or 319-384-1282. For more general COVID-19 information for the University of Iowa, please visit this site


***Subscribe to email updates OVPR will send periodically to help PIs and research staff navigate funding, health and safety, and other issues during the COVID-19 outbreak by clicking here***


Entries marked *UPDATE* were added or modified on May 18, 2020

ANNOUNCEMENTS

RESEARCHER RESOURCES

FAQs

GENERAL

STUDENT RESEARCHERS

HUMAN SUBJECTS

ANIMAL SUBJECTS

CONFLICTS OF INTEREST

PROJECT CHANGES, DELAYS, AND SPONSOR NOTICE REQUIREMENTS

PROPOSAL AND PROJECT REPORT DEADLINES

COSTS CHARGED TO SPONSORED PROJECTS

SUBRECIPIENTS AND OUTGOING SUBAWARDS

COVID-19 RESEARCH STUDIES

HEALTH AND SAFETY

CORE FACILITIES 


GENERAL

Who can I contact in OVPR with research questions I don’t see listed in these FAQs?

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Where can I find information and guidance from federal funding agencies?

The Council on Governmental Relations (COGR) is aggregating responses and resources from federal agencies on this site

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STUDENT RESEARCHERS

Are undergraduates allowed to work in research labs at this time?

No. Undergraduate students (even if employed with the university) and all external visitors (including minors and volunteers) are not allowed in research spaces, including those within UI Health Care.

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Can undergraduates who were assigned to labs continue working remotely?

Students should contact their supervisors to discuss this possibility. 

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HUMAN SUBJECTS

Are the Human Subjects Office and UI Institutional Review Boards operating as usual?

Yes, the staff in the Human Subjects Office and the University of Iowa IRBs are conducting business as normal.  We expect this to continue even in the event the University of Iowa requires the UI community to work remotely.  The Human Subjects Office and UI IRBs are fully capable of conducting reviews via the eResearch (HawkIRB) application from any location. 

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Is HSO still offering training this spring?

While HSO remains open and ready to assist campus, it will not be holding HawkIRB trainings, IRB Office Hours, or IRB presentations until further notice.

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What is the current guidance regarding human subjects research?

Effective March 16, the Office of the Vice President for Research requires leaders of all research involving in-person human subjects research to pause in person research study visits or conduct them remotely using Zoom, Skype, or other means until further notice unless the study visit is essential to the health and/or wellbeing of the subject. This applies to all research, including social and behavioral research, and all labs and research facilities under the University of Iowa as well as off campus locations. A memo with additional details about this policy may be found at https://research.uiowa.edu/impact/news/temporary-policy-human-subjects-research-related-visits-during-covid-19-outbreak. Researchers should prioritize the health and safety of project personnel, collaborators, students, and human subjects when deciding how to move forward with research activities.  Research involving vulnerable populations or individuals with underlying health conditions should include special precautions when possible (CDC guidelines: https://www.cdc.gov/coronavirus/2019-ncov/specific-groups/high-risk-complications.html).

Additionally, on March 18, 2020, the FDA issued “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic” to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity during the COVID-19 pandemic.  On March 27, 2020, the FDA amended the guidance to include an appendix to further explain those general considerations by providing answers to questions about conducting clinical trials that the agency has received during the COVID-19 pandemic.  If you have questions about how to implement recommendations outlined by the FDA, please contact the Human Subjects Office at 319-335-6564 or email irb@uiowa.edu.

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What should I consider in developing a contingency plan for my research study?

The Office of the Vice President for Research is strongly encouraging all investigators to develop a contingency plan and communicate it to your research teams. The plan should include possibilities for:

  • Continuing or halting data collection.
  • Regularly communicating with the following to ensure everyone is operating under the procedures recommended by the university: Your research team, study sites, participants, and their caregivers.
  • Identifying research priorities in the event University of Iowa employees are not able to come to work.
  • Managing data in the event the UI or its health campuses are closed for research purposes.
  • Arranging for the possibility of remote access to research files.

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If I change my human subjects research activities, do I have to submit a modification to the IRB?

Yes, all human subjects research regulations still apply.  If a change to research related activities does occur, a modification is required.  All modifications to research related activities require IRB for review and approval prior to implementation.  Information on how to complete a modification to your research application can be found on the HSO website.

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How do I modify study procedures to alter in person visits to virtual visits?

If a PI chooses to modify their procedures to replace in-person study visits with virtual or phone options for administering questionnaires, surveys, check-ins, screening, and consenting, these changes must be approved in advance by the IRB as a modification to the study, unless they are necessary to eliminate immediate apparent hazards to participants. If you have any questions about whether a remote option is possible or approvable (especially for consent), contact the IRB at irb@uiowa.edu.  If you do choose to submit a modification, please add “COVID” in the free text field box offer in the modification form just prior to submission.  The HSO\UI IRBs will prioritize these modifications.

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Can I allow my researchers to conduct research related work from home?

Principal Investigators\Research Teams should consider whether or not appropriate data security and confidentiality measures can be put in place for research to conduct work at an alternate location.  UI ITS recommends the study team ensure remote access to study files is set up for work at an alternate location (e.g. data entry, transcription, data or statistical analysis, coding data, etc.) Appropriate IT security and confidentiality measures consistent with UI ITS policies (e.g. encryption, use of VPN, use of OneDrive, etc.) would be required. 

PI\research teams should also consider grant or contractual obligations related to data security, storage, and confidentiality measures prior to allowing research team members to work from a location outside of the University of Iowa campus.  Check with the Division of Sponsored Programs or UI ITS if you have questions regarding if these obligations apply to your research.  Any changes must be approved in advance by the IRB as a modification to the study. If you have any questions about whether a remote option is possible or approvable (especially for consent), contact the IRB at irb@uiowa.edu.  If you do choose to submit a modification, please add “COVID” in the free text field box offer in the modification form just prior to submission.  The HSO\UI IRBs will prioritize these modifications.

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What do I do if I have a single patient emergency use scenario?

The procedures for a single patient emergency use of an investigational drug or device remains unchanged during this time.  The policy for Emergency Use of an Investigational Drug or Device is in Section 9.D.vi of the UI Investigator’s Guide.  Contact the IRB office in the event an emergency use scenario arises.  (FDA Guidelines:  https://www.fda.gov/drugs/investigational-new-drug-ind-application/physicians-how-request-single-patient-expanded-access-compassionate-use)

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How do I submit a modification to conduct my study procedures remotely?

Modifications should be submitted to the IRB of record for the project.  Instructions are available on how to submit modifications to project approved by the UI IRBs on the HSO Website.  If you do choose to submit a modification, please add “COVID” in the free text field box offer in the modification form just prior to submission.  The HSO\UI IRBs will prioritize these modifications.

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My research currently requires parents and their children to come to my lab to conduct specified research tasks.  Should I cancel those visits?

See the temporary policy on human subjects research-related visits during COVID-19 outbreak effective March 16 Researchers should prioritize the health and safety of project personnel, collaborators, students, and human subjects when deciding how to move forward with research activities.  Research involving vulnerable populations or individuals with underlying health conditions should include special precautions when possible (CDC guidelines: https://www.cdc.gov/coronavirus/2019-ncov/specific-groups/high-risk-complications.html).

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I have a large focus group scheduled, should I cancel or reschedule it?

See the temporary policy on human subjects research-related visits during COVID-19 outbreak effective March 16. Researchers should prioritize the health and safety of project personnel, collaborators, students, and human subjects when deciding how to move forward with research activities.  Research involving vulnerable populations or individuals with underlying health conditions should include special precautions when possible (CDC guidelines: https://www.cdc.gov/coronavirus/2019-ncov/specific-groups/high-risk-complications.html).

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I need to temporarily pause recruitment or enrollment activities for my research project. What do I do?

Ultimately this is a decision that should be made by the Principal Investigator, at this time the University of Iowa has not restricted research related interactions with subjects.  The UI IRB does not have specific recommendations or requirements about pausing recruitment or enrollment activities, but we believe it would be prudent for investigators to follow University and CDC recommendations.  This should be reported to the IRB of record via a reportable event form (Receipt of New Information) within their specified timeframe.  For studies under the review of the University of Iowa IRBs, this must be reported within 10 working days.  Keep in mind if a decision is made to pause research related activities, additional reporting may be necessary.  (e.g. sponsor, NIH, or FDA as applicable.)

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My research offers extra credit to students or uses a student subject pool to recruit UI students (e.g. Sona), can I continue those activities if classes are online?

Ultimately this is a decision that should be made by the Principal Investigator.  This decision should be consistent with the temporary policy guidance on human subjects research related visits during the COVID-19 outbreak effective March 16, 2020.,Researchers should prioritize the health and safety of project personnel, collaborators, students, and human subjects when deciding how to move forward with research activities.  Research involving vulnerable populations or individuals with underlying health conditions should include special precautions when possible (CDC guidelines: https://www.cdc.gov/coronavirus/2019-ncov/specific-groups/high-risk-complications.html). 

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My research is conducted in a nursing home, can that still continue?

See the temporary policy on human subjects research-related visits during COVID-19 outbreak effective March 16 Researchers are strongly encouraged to check with the specific nursing home or skilled care facility to determine whether or not they are allowing visitors.  (CDC Guidelines: https://www.cdc.gov/coronavirus/2019-ncov/healthcare-facilities/prevent-spread-in-long-term-care-facilities.html)

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My research occurs in a school district, can that still continue?

See the temporary policy on human subjects research-related visits during COVID-19 outbreak effective March 16.  Researchers are strongly encouraged to check with the school district to ensure they are still allowing visitors or remain open. (https://idph.iowa.gov/Emerging-Health-Issues/Novel-Coronavirus/Schools)

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What if my subject does not want to come in for their research related visit because of COVID-19?

This should be handled in the same manner as it has in the past.  Subjects may miss study visits for a variety of reasons.  If this occurs, identify if missing a study visit would put the subject at additional risk.  If applicable, notify the study sponsor.  If necessary, reschedule the visit as soon as possible.  Consider whether the study visit can be safely conducted in an alternate location or whether or not the schedule of study related events can be altered.  This should be reported to the IRB as a reportable event form (noncompliance-protocol deviation).   

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Should I implement COVID-19 screening?

The UI IRB strongly recommends all research studies implement for COVID-19 screening if in person study visits must occur.  Research that requires subjects to enter UI Hospitals & Clinics (UIHC) will now be required to complete screening for all subjects that enter the University of Iowa Hospitals and Clinics.  This screening is occurring upon entrance to the UIHC.  More information can be found at https://uihc.org/2019-novel-coronavirus-covid-19.  UIHC and non UIHC patients can call 1-319-384-9010 if they are experiencing symptoms.  For UIHC patients, they may also schedule a video visit via MyChart.

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Can I submit research protocols involving human subjects research at an international location?

The UI IRBs will continue to review human subjects research submissions as staffing levels permit.  IRB approval of human subjects research proposing to conduct activities at an international location should not be construed as approval to override University of Iowa or CDC\WHO guidelines on travel.  Researchers must comply with institutional requirements as documented on the University of Iowa Campus Coronavirus Updates website and the latest guidelines issued by the Centers for Disease Control and Prevention (CDC),  the World Health Organization (WHO), and the Iowa Department of Public Health (IDPH).

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My study requires a site initiation visit or a study monitor visit. Can this visit proceed?

The UIHC is currently discouraging all visitors and vendors to reduce traffic in the hospital.  The current UIHC recommendation is to reschedule the site initiation or monitoring visit to a new date\time whenever possible, especially if the visit requires direct access to the pharmacy or UIHC clinics.  If the visit is required to initiate or allow an essential treatment trial to continue, the study team must contact the sponsor\monitor to inform them if they have COVID symptoms, they must reschedule and that they will be screened at the door when entering the UIHC. 

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Can I conduct research-related activities if my participant is already coming to UI Hospitals & Clinics for a clinical visit?

UI Hospitals & Clinics has implemented slowdowns for many activities, so be sure to check The Loop for the most up to date information regarding clinical visits. If a participant is coming in for a regular clinic visit--AND there is not a need for PPE-Personal Protective Equipment (i.e. masks, gloves, swabs, gowns, etc.), AND the additional research-related activities will not detract from clinical service support--research related activities can occur if the PI deems the activity is essential to the health and wellbeing of the subject. As a note, the UI Hospitals is not allowing new enrollments to begin for non-essential research. 

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ANIMAL SUBJECTS

What is the Office of Animal Resources (OAR) doing to prepare for the potential impacts of COVID-19?

The OAR has an emergency preparedness plan intended to cover multiple emergency/disaster scenarios, including pandemics. This plan is updated on an annual basis and provided to the Department of Public Safety/Emergency Management.  OAR plans are based on maintaining critical services and preventing the spread of illness through our workforce. Topics addressed include: animal care and welfare, working conditions, succession planning if colleagues fall ill, acquiring and storing a surplus of food, bedding and supplies, among other issues.

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What are the biggest threats to animal care operations?

The major impact of a local COVID-19 outbreak would likely be a reduction of workforce in the OAR. OAR employees may become ill or be needed at home to care for dependents. Secondarily, a widespread pandemic may result in interruption of transportation throughout the community, and deliveries of feed and other supplies may be affected.

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Will I have access to my research animals as usual?

Direction from the University and local public health officials will be critical for informing our decisions concerning access to research facilities. This will be especially important when considering whether non-essential workers will be permitted to access our facilities to perform animal care or research activities in the event the university closes. 

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What is the impact of Iowa’s disaster declaration on my research activities?

The following planned research protocol-related activities are suspended and/or not allowed to begin:

  • All protocol related surgeries
  • All hazard work (chemical, biologic, radiologic)
  • All movements of animals between animal facilities/vivaria
  • New animal orders
  • New animal deliveries
  • Non-critical supplies for labs ordered through OAR

It is also the responsibility of the investigator using animals at the U of Iowa to help mitigate the potential impact on his/her research and data. Investigators are encouraged to cryopreserve unique animal strains when possible, plan, and forecast their work.  

For more information, see this March 18, 2020 message for OAR clients

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What can I do to help?

OAR is urging any labs who wish to volunteer to assist with animal husbandry activities in the event we cannot maintain adequate staffing to humanely care for all animals, to do so immediately. Interested labs will be given the opportunity to cross train their staff with OAR staff on the necessary care (cage changes, food/water refills etc.) in order for the lab to be able to maintain a greater number of animals during the staff shortage, should one develop.  PIs should speak to their lab staff and begin identifying individuals, important areas of research and coordinating which strains, lines, and animals are critically important.  Interested PIs should contact the OAR Animal Husbandry Managers.   

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Whom should I contact in an emergency?

Contact information for the Office of Animal Resources is available at https://animal.research.uiowa.edu/oar-contacts   

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Is the Institutional Animal Care and Use Committee (IACUC) operating as usual?

IACUC staff will be primarily working remotely but will continue reviewing protocols and amendments. You may call or e-mail IACUC as needed, using our regular office phone numbers unless otherwise directed. IACUC meetings will continue as normally scheduled, by teleconference if needed. 

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My area was scheduled to have an inspection by IACUC? Are those moving forward?

IACUC  is postponing those inspections until normal operations resume.  These include regulatory mandated semi-annual inspections of surgical sites, core facilities, and greater than 24 hour housing locations. The Office of Laboratory Animal Welfare and the U.S. Department of Agriculture have given position statements and/or guidance to IACUCs for this situation and we will follow those procedures.

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I have a protocol that's ready to expire. What should I do?

You will need to renew that protocol prior to its expiration. Animals on an expired protocol cannot undergo any procedures or experiments. Animals on an expired protocol are transferred to the IACUC Holding Protocol, where they can receive standard husbandry and care as well as any medically necessary treatments to support animal with phenotypic conditions.

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CONFLICT OF INTEREST IN RESEARCH

Do I still need to submit my Annual Certification in eCOI?

Yes, this is still required and your Annual Certification must be completed by April 30th  as required by University policy.

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My financial conflict of interest requires management before my research project can go forward. What happens next?

Conflict of interest in research staff will continue to conducting  usual day-to-day operations working remotely if needed. Contingency plans have been put into place to prevent research projects from stalling. Please contact Martha Hedberg, Christopher Taylor, or the coi-research@uiowa.edu inbox if you have questions or concerns.

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PROJECT CHANGES, DELAYS, AND SPONSOR NOTICE REQUIREMENTS

Do I need to notify the sponsor if there will be a COVID-19 related delay in my research? 

Refer to sponsor policies related to no-cost extension and prior approval requirements. Check the DSP website for COVID-19 related sponsor guidance or you may contact DSP (dsp@uiowa.edu) with questions. 

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My project is funded by a company. Do I need to notify the company of COVID-19 related delays in my project? 

The answer depends on your contract terms. For clinical trial studies notice is generally required. Please contact DSP (dsp-contracts@uiowa.edu) with questions regarding notification content and process. 

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My project is funded by a subaward from another organization. Do I need to notify that pass-through entity regarding COVID-19 related delays or project changes? 

The answer depends on your subaward terms and the underlying regulations (e.g., federal regulations) that may apply to your project. Please confer with DSP (dsp-contracts@uiowa.edu) for guidance and questions regarding notification content and process. 

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How will a COVID-19 related delay in my research impact my project expenditures? 

Study related activities that are not affected by the delay can be charged as usual. For prior approval requirements related to a significant change in effort for the PI or other key personnel, look to the sponsor specific requirements. Check the DSP website for sponsor notices or contact DSP (dsp@uiowa.edu) with questions.

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PROPOSAL AND PROJECT DEADLINES

I am working on a proposal or progress report, but cannot access all necessary information or study related personnel due to COVID-19 related issues. Can I submit my proposal or progress report late? 

Refer to your sponsor/agency specific guidance for updates and current policy. Check the DSP website for sponsor notices or contact DSP (dsp@uiowa.edu) with questions.

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I have a progress report due and my study is impacted by a COVID-19 related delay. Should I report this in my progress report? 

Yes. If your study is impacted refer to the sponsor’s requirements regarding where and how this should be included in your progress report. You may also confer with DSP (dsp@uiowa.edu) with questions. 

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COSTS CHARGED TO SPONSORED PROJECTS 

Project personnel are working remotely from home during self-isolation. Can their effort still be charged to the sponsored project?

In general, yes. Refer to the UI COVID-19 Campus Update issued March 27, 2020, for the UI’s paid leave policy. [See also the announcement regarding funding and documenting costs.] Sponsor agency announcements are available here.  We recommend you continue to watch for sponsor updates as they continue to issue new guidance.   You may also contact DSP (dsp@uiowa.edu) or Grant Accounting (gao@uiowa.edu) for questions regarding your specific project.

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Who will cover costs incurred during the research ramp down if our sponsored project runs out of funding before completion?

There is no guarantee that supplemental funding will be available to cover a shortage of funds to complete a project. Please refer to the guidance pertaining to grants or contracts provided by your specific funding agency to determine if supplemental funding is available.  If research funding shortfalls cannot be resolved through a sponsor agency’s supplemental funding process, it is the responsibility of the PI and department to work with the College to identify alternative unrestricted funding.  There are no central University funds identified for this purpose.

As stated in the memo dated 03/30/20, we strongly recommend that you document research personnel efforts & other project costs during the ramp down using the template provided or other means.

Federal agency guidance on charging costs to sponsored projects during the COVID-19 pandemic emergency continues to be published at https://www.cogr.edu/institutional-and-agency-responses-covid-19-and-additional-resources.

Non-federal sponsor guidance is available here https://dsp.research.uiowa.edu/coronavirus-covid-19-updates-related-sponsored-projects-0 or by contacting the Division of Sponsored Programs (dsp@uiowa.edu).

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Personnel on my project are able to work, but are in self-isolation and cannot come to their usual work location. Can I charge my project for expenditures related to remote work or telework (e.g., laptop, printer, office supplies, internet access, etc.)? 

These expenses are generally considered as facilities and administrative (F&A) costs and generally are not allowable as a direct cost to sponsored projects unless specifically approved by the sponsor. Refer to the DSP website for agency guidance and updates.

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Can travel insurance be charged to sponsored projects? 

Given the uncertainty facing travel, the University will allow travel insurance to be purchased. For more information, see the University Travel Policy. We will monitor for additional guidance federal agencies may issue related to travel costs. Check the DSP website for additional agency guidance. You may also contact DSP (dsp@uiowa.edu) to request sponsor prior approval to charge specific costs to a project. 

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If the sponsor agency program officer, grants management or contracting officer is unavailable, or if the agency is closed, due to COVID-19, can project personnel continue to work and charge salary to the project? 

At this time, we expect that project personnel would be able to continue work until their period of performance and funding is exhausted. However, monitor the DSP website for agency updates. If prior approvals are required, confer with DSP (dsp@uiowa.edu) regarding submission of approvals. The answer, and the level of risk regarding allowability of costs and project changes may vary depending on the type of request, whether the sponsor has an electronic system, etc.

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I have questions about other project costs that are not addressed here. Who can help me? 

Contact your Grant Accountant with questions.

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Is the Grant Accounting Office operating as usual?  

Yes, Grant Accounting Office staff are conducting business as usual at this time. We are taking steps to ensure that our staff have the technology necessary to work remotely if need be. We are monitoring sponsor notices and will update you if there are changes based on notices from the government, Board of Regents, or university, or changes related to staffing. Please check the GAO website for updates.

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SUBRECIPIENTS AND OUTGOING SUBAWARDS

My project sponsor has instructed me to suspend work at the University of Iowa due to COVID-19 related matters. Do I need to notify subrecipients to suspend their work also?

If a sponsor inactivates or temporarily suspends your project at the University of Iowa, you will need to notify subrecipients to inactivate or temporarily suspend their work as well.  Please confer with DSP (dsp@uiowa.edu) regarding questions for your specific project and to send the appropriate notices.

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My subrecipient has indicated they will have a delay in performance due to COVID-19 related matters.  What actions should I take?

If the subrecipient’s performance reflects a change in scope to the UI project, you will likely need to notify the sponsor regarding those changes.  Notice requirements and the mechanism for notifying sponsors depend on the type of funding and sponsor.  Please confer with DSP (dsp@uiowa.edu) for your project-specific questions and regarding the appropriate notices to share with sponsors. 

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COVID-19 Research Studies 

How do I find funding opportunities related to COVID-19 research?

Check the federal funding agency websites for funding opportunities related to COVID-19.    

The University of Iowa community can search the Pivot funding database for coronavirus here.

Select funding opportunities are also available on the UI Grant Bulletin website.

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I would like to receive or send materials related to COVID-19 (e.g., pathogens, virus, etc.) from or to another provider or entity. What documentation do I need for this? 

The Division of Sponsored Programs assists with material transfer agreements that are used to receive or send materials. Refer to the DSP Material Transfer Agreement website or contact DSP (dsp-contracts@uiowa.edu) with questions. Confer with the UI Environmental Health & Safety Office for additional considerations. ehs-contact@uiowa.edu TOP

HEALTH AND SAFETY

Is the Environmental Health and Safety Office still open?

EHS is implementing a remote workforce to the extent possible. Staff will continue to respond to phone and email questions/requests and process protocols and forms. Chemical, radioactive and biohazardous waste pick-ups will continue as well. Contact your safety advisor or other EHS staff, as needed. 

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Will EHS continue conducting compliance reviews?

EHS has temporarily suspended lab and shop reviews that are not required by regulations; any required inspections will continue. Industrial hygiene requests and exposure monitoring for immediate health hazards will continue; monitoring for any research that will be postponed during the pandemic response will be rescheduled.  In instances where reviews continue, EHS staff will limit face-to-face interactions and will practice social distancing as much as possible.

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Is EHS staff available for respirator fit testing?

All EHS staff and equipment is being used to fit test employees at the hospital.  UI employee fit tests should be scheduled through UEHC. Ph: 319-356-3631 or https://uihc.org/university-employee-health-clinic-uehc

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CORE FACILITIES 

What’s the status of OVPR’s core facilities? 

The Materials Analysis, Testing, and Fabrication (MATFab) Facility is closed until further notice to minimize the potential of spread of COVID-19 to users or staff. All instrumentation will be powered off. All instrumentation will be powered off, except for instruments with a critical need to remain on and will be powered at minimum levels. Users must not enter the facility until MATFab staff notify them that the facility is reopen.

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