The purpose of this website is to provide information on research operations guidance for the UofU research community.
Office of comparative medicine
CONFLICT OF INTEREST
corporate and foundation relations
CZAR and CBRZ Facilities
ENVIRONMENTAL HEALTH & SAFETY
HUMAN SUBJECTS RESEARCH-RELATED VISITS
INSTITUTIONAL ANIMAL CARE & USE COMMITTEE
INSTITUTIONAL REVIEW BOARD
OFFICE OF SPONSORED PROJECTS
OFFICE OF RESEARCH EDUCATION
RESEARCH PARTICIPANT ADVOCACY
Resource for Genetic and Epidemiologic Research (RGE)
TECHNOLOGY VENTURE & COMMERCIALIZATION
office of the vice president for research
The U of U OCM is responding to guidance from Federal, State, Local, and University leaders in response to the COVID-19 outbreak. This document provides key information for investigators and laboratory personnel regarding OCM operations during this time.
OCM remains operational.
Most OCM personnel perform daily onsite animal care. To the best of our ability this will continue throughout this outbreak. All administrative support continues with individuals working remotely. Administrative personnel working at home have limited access to OCM phones. They can be reached via email at:email@example.com
Our standard PPE and cleanliness practices for husbandry will support safety of OCM and laboratory staff during this time. We have added hand sanitizers near vivaria entrances and encourage their use.
At this time only essential research activities are allowed on campus. Deans are currently tasked with making this determination in consultation with the Vice President for Research. For institutes without deans directors may serve this role.
We ask that investigative staff limit visits to vivaria and not travel from one vivarium to another if possible. We remind everyone that only individuals with specific card access are allowed in vivaria. Do not bring unapproved individuals into vivaria or hold the door for individuals who have not scanned into facilities. Similarly, please limit traffic between vivaria traffic to the extent possible. OCM has instituted altered scheduling for our technicians to minimize risk of cross-traffic and cross-contamination. If campus does move to a more restrictive policy we may have to limit facility access but until then we are asking for voluntary cooperation with this request. We know of several cases of COVID-19 in offices near vivaria. We are working diligently to prevent spread within vivaria and this requires we all work together.
As this situation evolves OCM continues to provide food, water, and clean bedding to animals, until normal research operations may resume. Should our staff experience significant illness or quarantine it may be necessary to reconsider staff assignment to ensure adequate care in all locations.
Under the current campus directive, most new animal orders will not be processed. Similarly, if animal transfers require physical relocation these will likely be delayed. If you have a specific time sensitive need please contact us to discuss how we best proceed.
OCM remains committed to the highest quality animal care in support of your research. We look forward to ongoing partnership during this challenging time.
As mentioned, we have established a single point of contact email address to facilitate communication with OCM and research staff: firstname.lastname@example.org
Until further notice, the CZAR and CBRZ are closed to everyone except scheduled staff. We remain highly sensitive to your research needs and will do our best to support time-sensitive or phenotype-dependent experimental activities that cannot be postponed - by appointment only. Be aware that dates listed below may change as the COVID-19 situation develops.
In light of recent information about the corona virus longevity, the CZAR staff will suspend all face-to-face activities at this time.
To ensure the safety of our limited active staff, we are implementing the following measures immediately:
- Do NOT come to the CZAR or CBRZ on weekends - let the students work without visitors.
- Do NOT enter the nursery - let Talmage work without visitors.
- No new mating tanks may be set up before Monday, March 30th.
- Aside from the nursery plates currently in the incubator, no new fry plates will be set up before Monday, April 6th.
- Please arrange all visits to the CZAR through the director (email@example.com) - she will schedule people to be in rooms when the staff will be working elsewhere.
- Please assume all CZAR surfaces and personnel could be contaminated (and we will return the favor).
If you have an appointment to work in the CZAR or CBRZ, please follow these guidelines while here:
- Bring and wear a mask. Wash your hands when you enter.
- Clean the bench where you will work with 70% EtOH before you start.
- Use the minimum number of mating tanks/dishes as possible.
- Clean the area when you are done, and follow up with another 70% EtOH cleaning of the bench.
- Wash your hands, and exit the CZAR.
The University of Utah Conflict of Interest (COI) Office is heeding current guidelines from University leaders in response to the COVID-19 outbreak. This notice is to provide the research community with information regarding COI review and oversight of research and purchasing during this time.
The University of Utah COI Office and Committee will be fully operational. There will be no reduced review or consultation services. Currently, COI staff are working remotely to support self-isolation efforts. Though it may not be possible for COI staff to meet with researchers in person, phone and web conferencing will be fully functional for all COI staff members. The COI staff will be unable to answer direct phone calls while working remotely; however, all COI staff will receive voicemails and can return calls or respond to emails.
The COI Committee will continue its regularly scheduled meetings every three weeks.
Researchers need to prepare their studies for possible interruptions or delays regarding COI review.
Because of public and institutional self-isolation efforts, as well as possible quarantine of exposed individuals, critical communication between researchers and COI staff and committee members may be affected. Please practice patience and allow for additional time for COI review of IRB applications and sponsored projects.
If you have any questions, please contact the COI Office at 801-587-3232 or firstname.lastname@example.org.
The University of Utah Office of Corporate and Foundation Relations is heeding current guidelines from University leaders in response to the COVID-19 outbreak.
The University of Utah CFR services are fully operational. We are continuing to fully engage in letter of inquiry, proposal, funder strategy, and faculty consultation services while working remotely to support physical isolation efforts.
Though we cannot meet with faculty and funders in person, email, voicemail, phone and web conferencing are fully functional for the entire team.
Many foundation sponsors are allowing no-cost extensions, delayed progress report
submission, and budget conversions as necessitated by the COVID-19 outbreak. Extensions
and budget revisions still require institutional approval. Please work with our team
and your sponsored projects officer before you engage your sponsor in any requested project changes.
University of Utah EHS operations are heeding current guidelines from University and government leaders in response to the COVID-19 outbreak. This summary is to provide the University community with information regarding EHS support and services during this time.
As of Wednesday, March 24, 2020, EHS personnel will conduct weekly walk-throughs of all research buildings, verifying that personnel are complying with University guidance on physical distancing, confirming that on-going work is limited to essential functions, and verifying that building conditions are safe and stable. Appropriate College and Department leadership will be notified of any issues identified. Please contact EHS at 801-581-6590 if you have specific requests for these walk-throughs.
EHS will remain fully functional and operational during this time. While some EHS staff will be working remotely in support of the recommendation for self-isolation, all EHS staff will be available for consultation and support and all essential EHS on-site functions will continue. EHS will be suspending certain non-essential functions such as lab inspections and in-person trainings. Trainings and other meetings will continue but will utilize remote access technology.
EHS will maintain an on-campus presence as well as 24/7 on-call coverage should the need for incident response arise. Should you experience an emergency requiring EHS assistance please call University Police Dispatch at 801-585-5788 and request EHS On-Call. For non-urgent needs please call EHS at 801-581-6590, and leave a message detailing your need. This number will be monitored in real time during normal business hours and your call routed to the appropriate EHS staff member for response. EHS will respond to all messages as quickly as possible.
EHS fire and life safety, environmental compliance, and hazardous waste operations will continue as normal. We would ask researchers to be mindful of their operations and take steps to reduce the amount of unwanted materials generated by your operations.
Thank you for your support and patience during these rapidly changing events. If you have concerns or questions please call 801-581-6590 or email email@example.com.
Subject: Suspension of Non-Essential In-Person Clinical Research Study Activities as Part of University of Utah Clinical Research COVID-19 Response – Effective March 17, 2020
Revision Effective March 28, 2020 re. Non-COVID trials
Temporary Policy: University of Utah Temporary policy on Human Subjects Research Related Visits During COVID-19 Outbreak,
The Office of the Vice President for Research is providing guidance related to human subjects-related research visits. This policy is being implemented to protect research participants, research personnel, and the larger University community from risk of infection from COVID-19, and to ensure continued access to clinical research that may provide essential therapies to participants.
- Participant research visits must be performed remotely (i.e., by phone, Zoom, or other means) whenever possible.
- If a research visit cannot be performed remotely, the principal investigator, in consultation
with the participant’s clinical care provider, should determine if the visit is essential
or not essential to the participant’s health and/or well-being.
- Study teams should contact participants prior to any in-person visit to determine whether the subject has fever or respiratory symptoms. If this is the case, they should be directed to schedule screening for COVID testing and the research visit should be postponed.
- Research visits that cannot be performed remotely or in conjunction with a clinical visit and are essential to a participant's health and/or well-being may be performed in person. The visit should be accomplished outside University Hospital and Clinics in research compliant facilities if possible. Otherwise, participants should be made aware of how to access the University Hospital and Clinics facility for the visit, and provided with information about the current COVID-19 pandemic and how to reduce their risk of infection.
- Research visits that cannot be performed remotely and are not essential to a participant’s health and/or well-being should be postponed until further guidance.
- Enrollment of new patients on a clinical trial or other human subjects-related research should occur only if: 1) participation in the research is essential to a participant's health and/or well-being, as determined above; or 2) the enrollment and participant interactions (can be conducted remotely until further guidance.
- There may be studies that are not essential to a participant’s health and/or well-being, but have research-only procedures that can be performed at a participant’s clinical or surgical visits at usual care (i.e., extra blood draws, sample collection, data collection, etc.). Research-only procedures at usual care visits may be performed during the outbreak at the discretion of the treating physician and care team. If the research-only procedures will impede or weaken protection of the participant, other patients, or the care team from COVID-19 exposure, the research-only procedures should not be performed.
- For necessary in-person visits we encourage visits to be relocated from University Hospitals and Clinics to research compliant space on campus. Please contact Nurse Manager Michelle Adams if you need assistance relocating your study activities from a clinical area of the UU Hospitals and Clinics to the Clinical Services Core of the CCTS, 421 Wakara. If you have questions about clinical research, please contact the CCTS at Dixie.Thompson@hsc.utah.edu.
The Institutional Animal Care & Use Committee is telecommuting, but remains fully functional.
Protocols and amendments under current review will be processed by a Designated Member Review (DMR). In lieu of an official gathering, the review process will be conducted by IACUC committee members electronically.
All other animal welfare items (protocols, amendments, transfers, personnel) be processed electronically by the IACUC DMR. No delays are expected.
IACUC committee business items will be prioritized and reviewed virtually – as needed.
All IACUC office staff are telecommuting but can answer phone calls and email and have access to all IACUC documents.
Forms - As it has been routine procedure the IACUC website will not be available to researchers off campus. Please refer to the website for forms (i.e., protocol application, amendments, change in personnel, etc.), training, instructions regarding occupational health, and policies & guidelines. You can also email the IACUC office IACUC@ocm.utah.edu to directly request information/forms.
Reporting Adverse Events – Please be aware that if your research with animals is interrupted or “put on hold” where study data is lost or if a started procedures is unable to be completed, these events must be reported in writing to the IACUC office (IACUC@ocm.utah.edu) on the “adverse event form”. The “adverse event form” is found on our website and/or it will be sent to you by an email request. Please call our office (801-581-5950) if you would like to first discuss the potential adverse event.
IACUC Notice – Please be aware that early termination of studies due to Covid-19 and/or earthquake disruptions need to be discussed and approved by the Attending Veterinarian consistent with the U of U Animal Disaster Plan. Contact the veterinarian at firstname.lastname@example.org.
The University of Utah IBC and the Biosafety Office within Environmental Health and Safety (EHS) will be fully operational. We anticipate that there will be no reduced protocol review or risk assessment services, although we will defer annual laboratory inspections to a later date. There may be periods of time that the IBC and EHS staff are expected to work remotely to support social isolation efforts. In addition, we are working with Emergency Management to develop protocols for the campus COVID-19 response. Therefore, while we will be able to answer phone calls and we will have access to Voicemails, there may be a delay in response. We would encourage you to contact us through e mail. Although it may not be possible for the IBC and EHS staff to meet with research groups in person, we are happy to utilize phone and web conferencing (such as Skype for Business, Zoom or WebEx) to assist you.
Researchers need to prepare their research protocols for possible interruptions or complications in conducting procedures and trainings.
Please take into account the following:
- IBC registration require periodic renewal and re-review. Three months prior to the expiration of your current protocol, you will receive notification of this date. If you are unable to resubmit an updated protocol at least one month prior to the expiration date, contact the Biosafety Office to request an extension.
- New IBC registrations will continue to be submitted through BioRAFT (laboratory-based research) or ERICA (research involving human subjects) https://ibc.utah.edu/ibc-registration.php.
- IBC protocols will be reviewed according to the normal schedule: https://ibc.utah.edu/ibc-registration-review.php. However, convened IBC meetings will take place remotely through web conferencing.
- Protocols involving research samples collected from patients with COVID-19 or research involving coronaviruses will be reviewed as received.
- It is likely that research studies involving samples collected from patients with
confirmed or suspected COVID-19 will be developed, as well as studies with coronaviruses.
Before these studies begin, this work must be registered with, and approved by, the
IBC. The CDC requires work with clinical samples from these patients be conducted
with at least Biosafety Level-2 containment and practices: all manipulations that
could generate aerosols occur in a biological safety cabinet. Studies involving the
propagation and manipulation of SARS-CoV-2 requires at least Biosafety Level-3 containment
and practices: other coronaviruses may have lower containment requirements.
- The American Biosafety Association (ABSA International) have developed an information sheet for identifying appropriate containment requirements for working with samples from COVID-19 patients or the SARS-CoV-2. However, the IBC sets the required containment level based on the risk assessment.
- If you are submitting a registration for work with SARS-CoV-2, coronaviruses requiring
BSL-2 containment, or samples from COVID-19 patients, ensure that the registration
is complete as possible in order to facilitate rapid review and approval. This must
include Project and Pathogen Forms in BioRAFT, as well as detailed SOPs/Biosafety
Manuals that include:
- A risk assessment for the work
- Experimental procedures and SOPs
- Descriptions of engineering and administrative controls and PPE
- Spill Procedures using disinfectants included on the EPA list N
- Post Exposure Procedures
- Documentation of training on the aforementioned procedures
- Documentation of BSL-2 training within the past year or confirmation that all personnel have signed up for the next available class (see #6)
- We will defer annual laboratory biosafety inspections. However, if you need a letter
of support for a grant application or purchase of biological materials we may need
to inspect your facility.
- Laboratories that have not previously been approved for work at BSL-2 will require an inspection. These will be conducted in a manner to facilitate social distancing.
- Biosafety trainings will be conducted through web conferencing. Continue to register for classes as currently: https://ibc.utah.edu/training.php. However, prior to the class you will be provided a link to access the class online.
Templates for SOPS and Biosafety Manuals can be found on the IBC website; https://ibc.utah.edu/biosafety-policies.php
The University of Utah IRB is heeding current guidelines from University leaders in response to the COVID-19 outbreak. This email is to provide the research community with information regarding the review and conduct of human subject research during this time.
The University of Utah IRB will be fully operational. There will be no reduced IRB review or consultation services. There may be periods
of time that the IRB staff are expected to work remotely to support self-isolation
efforts. Though it may not be possible for the IRB staff to meet with study teams
in person, phone and web conferencing will be functional for all IRB staff members.
The IRB staff will be unable to answer direct phone calls while working remotely;
however, all IRB staff will receive voicemails and can return calls or respond to
Researchers need to prepare their studies for possible interruptions or complications in conducting procedures.
Because of public and institutional self isolation efforts, as well as possible quarantine of exposed individuals, it may be necessary to alter your research plans in order to keep study team members and research participants safe. Please make the following considerations for each active study.
- Additional clinical services, testing, and screening related to COVID-19 that need to be performed for research participants do not need IRB approval prior to initiation. Such procedures would be considered usual care outside of the research context.
- Consider whether your study or parts of your study should be placed on hold during this time. This hold may be for all research procedures. Perhaps placing a hold on enrollment, study visits, data collection, or data analysis separately is reasonable. It is recognized that discontinuing a participant’s care during this time may not be safe or may dramatically jeopardize the results of the project. The decision to place a hold on your study needs to be made on a study by study basis, likely in consultation with your department leadership to ensure department and participant needs are met. You are not required to report study holds to the IRB; however, you must document them in your research records and report them to sponsors as necessary.
- Any changes to your protocol or the conduct of your research procedures still requires an amendment with the IRB. The IRB does not pre-approve deviations from protocol outside of the amendment process.
- There may be an urgency to deviate from the protocol or the conduct of research procedures before an amendment can be approved by the IRB. Some deviations will be minor. Some may have major effects on the welfare of participants and/or study validity. All deviations must be reported according to the IRB’s reporting policy. The IRB acknowledges that the COVID-19 outbreak and isolation/quarantine requirements may result in deviations that are intended to eliminate apparent immediate hazard to a research participant. The IRB recognizes that some deviations pose little to no threat to participant safety or scientific integrity. For example, when the subject misses a clinic visit and the only available re-schedule date is outside the study visit window, though no study procedures or medication doses are missed. In this case, the subject may not incur possible harm from a missed dose or missed procedures meant to maintain or evaluate the subject's safety and welfare. As such, reporting is left to the discretion of the investigator within the context of the IRB’s reporting policy. Though a deviation may not pose a conceivable threat or possible harm, it may represent possible continuing non-compliance if an amendment is not pursued with the IRB. All deviations must be documented in the research record, regardless of whether they meet the IRB’s reporting criteria
- The IRB supports the use of home visits and phone calls for participant data collection and monitoring, so long as no procedures would be performed that are unsafe in this setting. Home visits and phone calls need to be conducted by a member of the study team that is approved in the IRB application. Your IRB application should be amended to include these methods if you choose to use them.
- Do not store electronic research data on unsecure devices in order to work remotely.
The IRB encourages the use of University-approved cloud services and VPN access while
working at home instead of storing data directly on your devices. Do not take home
physical research records or data (paper consent forms, case report forms, questionnaires/surveys,
etc.). All physical records must continue to be stored in IRB-approved, secure locations.
Updates on March 18, 2020
- The amendment and deviation instructions above are still in place in tandem with the University’s Temporary Policy on Human Subjects Research Related Visits During COVID-19.
- The FDA has released new guidance on the Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic.
Updates on March 20, 2020
- For studies at the VA, per the VA Office of Research Development: If you initiate a temporary hold on VA research, it must be reported to the IRB within 10 business days and a note to file should be placed in the Investigator’s study records. Please submit notice of these holds to the University of Utah IRB via a Report of Information in ERICA.
Updates on March 30, 2020
The FDA has updated its guidance on informed consent during the COVID-19 Pandemic. In summary, the following consent processes and documentation is described:
- Use electronic methods of obtaining consent where technology is available.
- If in-person communication with a patient in isolation is not feasible or safe, the investigator/designee arranges for a copy of the consent form to be provided to the patient and also arranges a three-way call or video conference with the patient and an impartial witness (not a member of the study team). The consent process should then be conducted in standard fashion, with verbal confirmation that the patient would like to participate in the trial. The patient must still sign and date the consent document in their possession.
- If the signed informed consent document cannot be collected from the patient’s location
and included in the study records because of COVID-19 transmission concerns, the FDA
considers the following two options acceptable:
- A written attestation by the impartial witness and the investigator/designee that
the patient verbally agreed to participate. The witness and investigator ALSO sign
a separate copy of the consent form. These documents are kept in the research record
as documentation of consent.
- A photograph of the signed informed consent document, accompanied by a written attestation by the investigator/designee that states how that photograph was obtained. The witness and investigator ALSO sign a copy of the consent form. These documents are kept in the research record as documentation of consent.
- A written attestation by the impartial witness and the investigator/designee that the patient verbally agreed to participate. The witness and investigator ALSO sign a separate copy of the consent form. These documents are kept in the research record as documentation of consent.
- If a Legally Authorized Representative is providing consent on behalf of a patient, the usual regulatory methods for obtaining a signed consent document remain in place.
In order for a witness to sign the consent document and make their written attestation, use the COVID-19 Witness Signature & Attestation Page available on the IRB website (no IRB amendment required).
In order for the investigator/designee to make their written attestation, use the COVID-19 Person Obtaining Consent AttestationPage available on the IRB website (no IRB amendment required).
The IRB now provides a Research Consent Process Worksheet – Obtaining Signed Consent During the COVID-19 Pandemic, which can be used by study teams to document that appropriate processes and documentation have occurred.
If you have any questions, please contact the IRB at 801-581-3655 or email@example.com.
Starting immediately, the University is requiring that all COVID related proposals and awards be flagged. We are defining “COVID related” broadly as any COVID specific solicitation or project activities directed to COVID.
To support this effort, OSP is requesting that you add the term “COVID:” to the beginning of both the short and long titles in the Document Summary Sheet (DSS) prepared in eProposal. This naming convention would then carry forward into eAward and Peoplesoft automatically.
For tracking purposes, please also create a new DSS for COVID related pre-proposals (including white papers) and supplements. OSP's procedure on DSS Creation has been updated to reflect this change.
The Office of Sponsored Projects is working to address and respond to the evolving nature and implications of COVID-19.
We want to reassure the University community that the Office of Sponsored Projects is open for business.
We are also taking actions to limit exposure and the spread of the virus. OSP has adopted best practices to protect the safety of staff and has the telecommuting protocols and infrastructure necessary to remain operational in the case of a community-wide spread of the virus. As of March 16th, OSP staff will be working remotely.
While working remotely, OSP staff will be able to receive voicemail messages, return calls, and respond to email. Understandably, face-to-face meetings may be limited.
At this time, all OSP services are currently unaffected, including proposal review, submission, and post-award processing. In the event OSP experiences staffing shortages, OSP will prioritize proposal review and submission. If staffing shortages continue, OSP may not be able to provide a full review of proposals but will instead perform limited compliance reviews for University institutional standards. It is very important that you communicate with your assigned Sponsored Projects Officer as soon as you know you will be applying for a grant and throughout to ensure the successful submission of an application. OSP will not be able to review proposal drafts during this period. Please provide OSP with your proposal applications in final form (ready to send to the sponsor) at least 5 business days prior to the submission deadline.
In order to keep everyone up to date, we have launched a COVID-19 site that will include the latest guidance and information, answers to frequent concerns, and ongoing updates. We will also publish agency specific guidelines as they are released.
OSP will continue to closely monitor the outbreak and plan for its potential impact on our operations. If you have any questions, please do not hesitate to contact the Director of OSP at firstname.lastname@example.org or 801-581-3003.
The University of Utah Office of Research Education (REd) is heeding current guidelines from University leaders in response to the COVID-19 outbreak. This email is to provide the research community with information regarding the review and conduct of human subject research during this time. For more information, please see the University of Utah's Vice President for Research website: https://research.utah.edu/
The University of Utah REd will be fully operational. There will be no reduced course offerings through REd. We are moving all of the REd courses online at this time, and these will be offered for the months of March and April 2020. As we move to work remotely, we can answer questions that you may have aboutREd courses via e-mail and/or phone. Our contact information is provided below.
The ORPA (which includes Research Translation and Interpretation Services) is following current guidelines from University leaders in response to the COVID-19 outbreak.
Maintaining open communication with study participants during this time is crucial. Participants need to know how to reach study team members with questions and concerns they may have during this time. The Office of Research Participant Advocacy is available to assist you if you would like support in communicating with your participants about the changing environment and how it impacts their participation. Please contact the office at: (801) 581-3803, email@example.com or firstname.lastname@example.org
The OPRA will continue to be fully operational during this time.
All OPRA staff members will be working remotely until further notice. All in-house Spanish interpretation services will be available during business hours, M-F 8 am – 5 pm. Spanish interpretation services will be conducted over the phone or through video chat, depending on the availability of resources at that time. No in-person Spanish interpretation services will be available until further notice. Interpretation services for ALL other languages will continue to be available and will follow the UUHSC’s Interpreter Services COVID-19 guidelines at the time of the interaction. Please note that some individual interpreters from our vendor have selected to self-quarantine at this time. In those instances, these interactions will be carried out over the phone or through video chat.
Any human subjects research on COVID-19 should be translated into Spanish, at minimum, to serve our LEP patient population. Our in-house team is prepared to turn these around quickly to help facilitate recruitment into these critical studies.
Research teams needing interpretation assistance for study encounters need to plan
Due to the rapidly changing conditions, please plan to schedule the use of an interpreter ahead of time, if possible, to ensure an interpreter is available.
Please contact us at (801) 585-6745 to schedule an interpreter. Please be aware that some languages may be more difficult to obtain during this critical time.
Participant concerns regarding study participation and the impact COVID-19 may have
on their participation can be directed to the ORPA for additional support.
Please direct participant concerns to the ORPA at email@example.com or (801) 581 -3803. We will help mitigate issues that arise due to study interruptions or continued participation amid the changing landscape due to COVID-19.
If you have any questions, please contact the ORPA at: firstname.lastname@example.org or (801) 581-3803.
The Utah Resource for Genetic and Epidemiologic Research (RGE) and the Utah Population Database Shared Resource at Huntsman Cancer Institute are currently operating remotely in response to the COVID-19 pandemic.
We are working with the UHealth and Intermountain Healthcare EDW teams to help researchers gain access to COVID-19 testing data linked to other health, geographic and family history data available in the UPDB. RGE is committed to balancing the need to move quickly to approve these studies with the protection of the data contributors and patient privacy. We will be scheduling RGE meetings as needed to respond rapidly to applications for COVID-19 studies. If you are interested in using UPDB to study COVID-19, please contact Ken Smith at email@example.com. If you are planning to submit an application to RGE for a study using COVID-19 test results, please contact Jennifer West at firstname.lastname@example.org before you submit your application.
Additionally, all of our standard services are available, including:
Discussions on Research and Scientific Design
To review your research ideas, feasibility and study design, please contact one of our faculty: Ken Smith at email@example.com, Karen Curtin at Karen.firstname.lastname@example.org, Heidi Hanson at Heidi.email@example.com or Nicki Camp at firstname.lastname@example.org.
Consultations via video teleconferencing and ERICA application development
To set up an online consultation or for assistance with your ERICA application, please contact the Jennifer West at email@example.com for UPDB, or Marjorie Carter at firstname.lastname@example.org for the Utah Cancer Registry.
RGE review of preliminary data requests, new study applications, amendments and renewals
The RGE Committee will continue regular monthly meetings online for as long as necessary.
For assistance with questions about the status of your RGE applications, please contact Jahn Barlow at email@example.com.
Please be respectful of our meeting deadlines. We will only be able to accommodate requests to extend the deadlines under extraordinary circumstances.
UPDB Data Requests for approved projects
For assistance submitting a data request for an approved project, please contact Jennifer West at firstname.lastname@example.org or Ankita Date at email@example.com.
If your UPDB data request has been assigned to a programmer, please contact the programmer directly.
If you have questions about billing for your data request, please contact Diana Lane Reed at firstname.lastname@example.org.
Services for HCI virtual machines
For assistance with HCI virtual machines, please contact Stevie Kinnear at email@example.com
The University of Utah Center for Technology & Commercialization (TVC) is heeding current guidelines from University leaders in response to the COVID-19 outbreak. This email is to provide the research community with information regarding the management of intellectual property, invention disclosures and agreements during this time.
The University of Utah TVC will be fully operational. The TVC staff is currently working remotely. Though it may not be possible for the TVC staff to meet in person, phone and web conferencing is fully functional for all TVC staff members. The TVC staff will be unable to answer direct phone calls while working remotely; however, all TVC staff will receive voicemails and can return calls or respond to emails.
Researchers need to prepare for possible interruptions or complications in managing
confidential information, intellectual property, invention disclosures and agreements.
Because of public and institutional self-isolation efforts, as well as possible quarantine of exposed individuals, it may be necessary to alter your plans. Please consider the following:
- Please submit your invention disclosure at least thirty days prior to any public disclosure in order for TVC to consider intellectual property protection.
- Please provide TVC essential contact information (i.e. mobile phone number) if you will not be available at the contact information previously provided.
- TVC works closely with other universities and companies for the management of intellectual property and agreements. The COVID-19 management protocols of these outside entities may impact the time and access necessary to manage certain responsibilities. Therefore, please make TVC aware of any pending deadlines so we can communicate them to other parties.
- Do not store proprietary electronic data on unsecure devices in order to work remotely. TVC encourages the use of University-approved cloud services and VPN access while working at home instead of storing data directly on your devices.
If you have any questions, please contact TVC at 801-581-7792 or firstname.lastname@example.org.
Information regarding patents
The United States Patent and Trademark Office (PTO) released a notice about the effects of coronavirus. The coronavirus is considered to be an "extraordinary situation" within the meaning of 37 CFR 1.183 and 37 CFR 2.146 for affected patent and trademark applicants, patentees, reexamination parties, and trademark owners.
However, the USPTO cannot grant waivers or extensions of dates or requirements set by statute. Such requirements include:
- 12-month deadline to file a utility patent based on a provisional or foreign application.
- The issue date / co-pendency deadline for filing continuation, continuation in part or divisional applications.
- The three-month deadline to pay an issue fee in response to a notice of allowance.
- The two-year deadline to file reexamination proceedings.
- Post registration renewals and deadlines.
- Statement of use or extension requests for pending intent to use applications.
- Deadline to file opposition or cancellation proceedings.
TVC remains fully operational and will continue to manage patent prosecution as a matter of its normal course of business. Timely communication with inventors is an important part of this process. Please continue to respond in a timely manner to all emails and calls from TVC and IP counsel regarding patent prosecution.
The University of Utah has adopted a “for the greater good” approach to commercialization of any technology which is owned by the U and has the potential to be commercialized. This means we are working, where possible, to make technologies available for free when possible. If you have a technology you think may have the potential to treat, diagnose, prevent, monitor or otherwise impact the COVID-19 pandemic, please contact TVC.
TVC continues to receive inquiries regarding resources for research related to COVID-19. While we continue to work across a global network to make individual connections, below are several resources which may be of interest:
- Partners Health COVID-19 working groups: https://covidinnovation.partners.org/wg-info/
- Relecura “Tech Explorer” database for coronavirus researchers (free thru May 31st): https://lnkd.in/gCHDUKP
- Milken Institute COVID-19 treatment and vaccine tracker.
- BioUtah list of local providers [various resources] – contact TVC for specific inquiries
The Office of the Vice President for Research (VPR) remains open and fully operational as we closely monitor the ongoing coronavirus (COVID-19) outbreak, and continuance of research operation plans are in place.
The VPR office is also encouraging research laboratories to develop and/or review established local continuance plans. Due to the COVID-19 outbreak, or other infectious agents in the future, it is possible that a significant number of laboratory personnel will be absent. We recommend that each facility/laboratory develop a written continuity plan.
Examples of elements to consider include:
Identify the minimum essential personnel and ensure they know what to do in the event of suspended operations.
- Encourage employees to telecommute, especially job duties that do not require them to be on campus. Note that telecommuting is not appropriate for all jobs. All employees who telecommute are required to follow the University’s Telecommuting Policy for Staff Employees (Policy 5-140) and Telecommuting Guides (Guideline 5-140) and complete the University of Utah Telecommuting Form.
- Review important operational questions, such as: Are there sufficient back-up personnel if these personnel become unavailable? How will employees be trained to ensure their safety while they are at work?
Create a communication plan. All emergency contact information should be shared between personnel and departmental leadership (e.g., cell phone numbers).
Identify critical processes that will need to be maintained if the campus is shut down and review samples/facilities that are at risk of harm in the laboratory or facility. For example, do you have live animals that will need feeding? Do you have equipment that cannot be shut down and will need regular maintenance? Are all critical equipment on emergency power and are all refrigerator/freezers connected to alarms with remote monitoring?
Review telecommuting needs. Ensure that you and your key personnel have remote access to files, data, servers, IT devices, etc.
Keep amounts of hazardous materials waste to a minimum. Be mindful that the Environmental Health & Safety (EHS) waste disposal group may also be affected by illness, increasing pick up wait times.
Start prioritizing experiments. If you are carrying out a long-term experiment, and if it is feasible to freeze samples at specific steps, you might consider doing this more often. Ensure that critical materials are secured.
Prepare for delays in ordering. Ensure that you have sufficient materials/supplies for critical functions, e.g., PPE, CO2 tanks, liquid nitrogen tanks. Contact vendors/collaborators to discuss plans to suspend regular shipments (receiving and outgoing).
Be cognizant of upcoming deadlines. Although central research administration remains open, reviews by the Office of Sponsored Projects (OSP), Institutional Review Board (IRB), Institutional Animal Care & Use Committee (IACUC), Institutional Biosafety Committee (IRB), etc., may be prolonged or delayed.
Keep personnel up-to-date on wellness training. All personnel should be trained on what to do if they are concerned that they have been exposed to an illness. This also includes training on prevention methods to keep a healthy and safe work environment. Please print and post the Safe Laboratory Guidance document in your laboratories/facilities. The Center for Disease Control and Prevention (CDC) also has helpful tips on what to do if you are exposed to the coronavirus.
Create a Rapid Laboratory Shutdown Plan. Please create a contingency plan in the event the University needs to suspend and/or significantly reduce laboratory research operations on short notice (i.e., 24-72 hours).
The VPR office has created an example template regarding instructional laboratory guidance. Your written plan should be shared with your Department Chair or Division Chief. We hope that advance planning will allow everyone in your group to focus on their own efforts and work together as a team. Be prepared and stay safe!