Research Reactivation Updates

May 28, 2020 3:45 PM

Renee Beardslee is a Research Lab Specialist who has been designated to participate in the phased return to work at BSRB. She offered these comments on what it's like to work in the building, in these early days of research reactivation. We thought her thoughtful observations, as well as the photos she took, would be helpful for others, as they plan to return to the labs in the next waves of reactivation.

Entry

  • BSRB entry I had to scan my badge to enter like I would during normal after-hours entry; the doors were locked.  There was a person immediately present that gave me a sticker with date that you have to wear all day.  The lobby is all set up with lanes for entry and departure and there was a second person that screened the questions.  There is a website set up now where you can answer the questions online and just show them the date-time-stamped result.  Then there was a third screening spot with a police officer in a booth with plexiglass and they took my temperature.  If you have bangs, you have to push them aside for it to work!
  • You also have to leave through this door.  Couldn’t just enter here and then leave anywhere.

General building environment

  • BSRB Atrium All furniture has been rearranged, marked off or removed to allow for 6 feet distancing.  There are signs specifically instructing people that they are not allowed to move furniture.
  • Speaking of signs, they are EVERYWHERE!  Signs telling you: how many people are allowed in an elevator, the number of people allowed in a bathroom, occupancy of 1 at tables, occupancy allowed in kitchen areas.  They clearly put A LOT of thought into this part of things and it makes it very easy to know what is allowed.
  • Bathroom sinks and stalls are closed off or closed entirely for social distancing.  Lots of signs in the bathrooms.  Signs at drinking fountains; obviously can’t use those.
  • Atrium space dedicated to eating lunch, so you don’t have to go outside or go to your car!

Labs

  • BSRB labThere were ‘welcome back packs’ for each PI with blue painter’s tape, a few disinfecting wipes, hand sanitizer and a few masks.
  • The first two days were split by floors; half came in on Thursday and the other half on Friday.  These two days were for marking the lab, plugging everything back in, cleaning and readying other things (e.g., running sink water if it hadn’t been used) only.
  • Everyone marked their workstations and six foot reminders as they feel are appropriate for their individual needs.  We also posted signage on ante rooms saying “Only one person occupancy” or at equipment saying “One person at shared equipment at a time”, etc.  Lots of signs went up!
  • We also marked off in red lab tape any bench space that can’t be used. e.g., anything in an entry hall that is needed for traffic flow, anything that is opposite a working bench etc. and posted a sign indicating “No work allowed here” or whatever is appropriate for the situation.  Posted cleaning logs and instructions for everything.
  • Cleaning everything was somewhat time-consuming.

Managing distancing

  • BSRB signs We were probably at only 50% of our “allowed” people (that is, 50% of the 30%) present in our greater shared lab space, and even with that and minimal movement because no one was actually doing lab work, we were definitely already running into each other in the walkways.  It’s tricky and there was a lot of dancing and stopping and getting out of the way.  Other labs reported that they plan to not even allow their max allocated because the distancing is somewhat difficult.
  • We identified that the shared equipment and other equipment may turn out to be a pain point because if it is near a workspace where someone is present, then someone has to move away or wait.  If both are working on time-sensitive items, this can possibly become problematic.
  • I generally felt safe, although it was actually pretty quiet and I speculate that the density will increase next week, so we’ll see.  Managing touching door handles and whatnot is always going to be tricky, but the CDC just indicated that their position is that touching surfaces “isn’t thought to be the main way the virus spreads,” so there’s that.

Many thanks to Renee for sharing these comments. CLICK HERE to learn more about the research reactivation process at BSRB. Questions? Contact ummsresearch@umich.edu.

 

May 27, 2020 9:15 AM

All U-M research faculty and staff are invited to join Dr. Rebecca Cunningham, U-M VP for Research, Dr. Steven Kunkel, Executive Vice Dean for Research of the Medical School and Chief Scientific Officer for Michigan Medicine, and other research leadership for a Research Town Hall on Tuesday, June 2, 3:30PM-4:30PM.

Members of the research community are encouraged to CLICK HERE to submit questions prior to the event.

CLICK HERE for login details (level 1 authentication required).


 

May 16, 2020 3:30 PM
Button leading to UMMS Office of Research FAQs
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CLICK HERE for BSRB Research Reactivation Info

Governor Whitmer’s announcement on May 15 that research and development activities can resume, Dr. Kunkel and the Medical School Office of Research (OoR) have developed a re-activation process for research at the Medical School. This process conforms with the U-M Research Re-Engagement Guidelines developed by central campus, while at the same time recognizing the unique needs and circumstances of research at the Medical School.

Medical School research will return to full capacity over several phases, with restrictions lifted in each subsequent phase, as informed by outcomes and public health guidelines. Once approved to do so by the governor and U-M leadership, we will commence with Phase 1, which is expected to occur in waves over a period of several weeks.

The Medical School reactivation is part of the larger university plan. The first wave of this plan is limited to a “pilot,” with one building participating from each of only a few of the U-M schools and colleges. The intent of the pilot is to learn what is working and what is not working as we bring back scientists into our wet laboratories.  

The second and subsequent waves will include several Medical School buildings, as well as additional buildings in other schools and colleges, as we reach our final goal of putting all the research buildings on-line. Keep in mind that while there is a plan to bring back all of our research buildings, this will be at a reduced capacity from pre-COVID-19 occupancy.

Full research work force numbers will occur over time. The Medical School is privileged to bring a building on-line during the first-wave pilot. Progression through the Phase 1 waves are informed by safety, supply chain, and operational logistics. The goal is to ramp up slowly, safely, and successfully as opposed to having to pull back and revert to our current state if done inappropriately and too fast.

Phase 1

Proposed waves (subject to change depending on the governor’s orders and U-M metrics):

  • Wave 1: Pilot one Medical School building
    • Staggered start times to avoid long lines
    • 2 weeks of operations before next wave initiated
  • Waves 2-4: Medical Campus and North Campus Research Complex buildings
    • Buildings opened in “groups”
    • 1-2 weeks between each wave
  • Implement shift work once permissible by U-M leadership.

Metrics to determine progression through waves will be provided as soon as approved and authorized for distribution by the Office for the Vice President for Research.

Buildings, or groups of buildings, once activated will have a single-entry point that will have limited access to approved personnel and a health screen before being granted access.  All critical and essential laboratory maintenance and COVID-19 approved research may continue consistent with the “ramped-down” level of activity and following all safety precautions until the laboratory building is included as part of a reactivation wave. At that time, laboratories will have to follow all U-M guidance related to the safe reactivation of U-M laboratories and building access protocols.

Process for Reactivation

As of Thursday, March 14, the OoR has communicated with all Department Chairs regarding the very specific process required to begin re-activating labs according to the phased plan described above. PIs, please communicate directly with your Department Chair to learn if your lab and the building it occupies will be a part of this first pilot Wave 1. As part of this process, PIs with labs will be required to do the following:

The total headcount returning to the lab in the initial part of Phase 1 will be reduced. Faculty will need to prioritize their research and only request access for personnel who are needed immediately to reactivate the laboratory and begin high-priority experiments.

It is expected that approximately 30-40% of laboratory personnel for each lab will be returning in the first few weeks of reactivation. The PI does not need to be included in the 30-40%. The PI will be added automatically to the building access list. For small laboratories with modest staffing (i.e., 30-40% would be less than 1 FTE) at least 1 person may be listed.

The school will take into consideration, working with department leadership, the number of staff listed along with the laboratory square footage and social distancing directives, building density, supply chain, and operational logistics to determine the approved maximum occupancy per laboratory room. Final decisions must be consistent with all State of Michigan orders and U-M guidelines.

The new list of personnel submitted via the Medical School Laboratory Space Usage Form will replace the critical personnel list used during ramp down ONLY once the building in which the PI’s laboratory is housed is reactivated as part of the ramp up.

Additional personnel may be added once all laboratories are reactivated or when indicated to do so by U-M executive leadership.

Once the OoR has confirmed that a PI/lab has complied with the steps described above, the PI will receive an email with:

  • location of the building’s screening entrance;
  • assigned building entrance time for their laboratory;
  • approved occupancy signs to post on their laboratory doors or in a public, visible location for large, open-bay lab designs;
  • Environment, Health & Safety (EHS) Checklist for Restarting Research Activities.

The OoR will also submit the lab personnel list to facilities for programming building access.

Additionally, the OoR and Facilities staff will host a virtual meeting for building occupants prior to activating a building/building group to orient individuals to the building entrance process, to share expectations, and to answer questions.

Compliance & Continuous Improvement

The importance of doing this well and right cannot be overstated. Each subsequent wave is dependent on the success of the prior wave(s), and returning the remaining research workforce via shifts is dependent on successfully activating Medical School and campus research buildings.

The PI and research team will self-monitor adherence to U-M guidelines and compliance with their safety and hygiene plan.

If needed, Department leadership will prioritize competing departmental research priorities and aid in the enforcement of U-M guidelines and individual safety and hygiene plans.

The OoR will enforce U-M guidelines and mediate reports of noncompliance, which may result in sanctions leading up to and including termination of access to buildings and research laboratories.

Questions? Contact ummsresearch@umich.edu.

 

May 16, 2020 2:15 PM

A message from Dr. Kunkel

Dear Colleagues,

Messages were sent out earlier today from both President Schlissel and U-M VP of Research Rebecca Cunningham indicating that the university can begin to cautiously reactivate research activities. We anticipate the first wave of lab buildings—a pilot wave—to begin toward the end of next week. In subsequent waves, we will activate the remaining research buildings using a shift strategy to bring back additional personnel. We have been planning for this milestone literally since ramp-down was announced back in March. The Medical School Office of Research (OoR) has been working in close collaboration with Facilities, DPSS, EHS, and other units to develop a re-activation process for research at the Medical School. This process conforms with the U-M Research Re-Engagement Guidelines developed by central campus, while at the same time recognizing the unique needs and circumstances of research at the Medical School.

Medical School research will reactivate over several phases, with restrictions lifted in each subsequent phase, as informed by outcomes and public health guidelines. The Medical School reactivation is part of the larger university plan. The first wave of this plan is limited to a “pilot,” with one building participating from each of only a few of the U-M schools and colleges. The intent of the pilot is to learn what is working and what is not working as we bring back scientists into our wet laboratories.

BSRB has been selected as the Medical School’s pilot building for Phase 1. The selection of BSRB and subsequent progression through Phase 1 waves has been informed by safety, supply chain, and operational logistics. In compliance with the university’s Research Re-engagement Guidelines, 30%-40% of personnel will be allowed access to the building in this first phase. In preparation, last week we communicated the reactivation process to the Department Chairs. CLICK HERE to view the webpage outlining that process, as well as links to reactivation FAQs from OoR, Facilities, and EHS.

The second and subsequent waves will include several Medical School buildings, as well as additional buildings in other schools and colleges, as we reach our final goal of putting all the research buildings on-line. Keep in mind that while there is a plan to bring back all of our research buildings, this will be at an initial reduced capacity from pre-COVID-19 occupancy.

“Patience” is going to be the word we employ the most in the coming days, both for those of you allowed to return to BSRB, and for those waiting for their buildings to reactivate. There will be bumps in the road. But our ultimate goal is to ramp up safely and successfully, as opposed to having to pull back and revert if done inappropriately and too fast. I encourage you to connect with your Department Chair to discuss how you and your team can plan for your role in this important reactivation process.

I hope and believe the worst is behind us, and am excited at the prospect of returning to our laboratories and seeing our colleagues in person – albeit from a socially distant perspective. Thank you in advance for your patience and conscientiousness.

Best regards,
Steve

Steven L. Kunkel, Ph.D.
Executive Vice Dean for Research, Medical School
Chief Scientific Officer, Michigan Medicine
Peter A. Ward Distinguished University Professor
Endowed Professor of Pathology Research

 

May 13, 2020 7:30 PM

During this time of restricted financial resources, describing the wide range of institutional resources available at the University of Michigan will help demonstrate to your sponsor the ready-for-success environment for your study.  Financial cost sharing is not typically an option, but conveying the depth of support already available to you can equally convince peer reviewers that your study has all the integral components to be a complete success.

When composing sections of your grant proposal, be sure to highlight the scientific environment and institutional investment at U-M that will contribute to the success of your research. Your sponsor will consider environment as part of their evaluation of your grant proposal, so be sure to give as much detail as possible about the available institutional resources that are relevant to your research.

See what criteria NIH reviewers are asked to consider here.

In your proposals, address specific concepts here.

Questions? Email the team at msgrants@umich.edu.

 

May 11, 2020 8:30 AM

Data Access

The Data Office for Clinical and Translational Research (Data Office) is committed to continuing to facilitate your research despite the challenging climate. 

Here is what the Data Office can help with:

  • Feasibility: DataDirect starting population of COVID-19 positive patients.
  • Data Access: Self-serve (DataDirect) or custom data extract with appropriate IRB approval.
  • Consultations: E-Mail the Data Office for an in-depth consultation here.
  • Biospecimens: Search DataDirect for available serum and plasma on COVID-19-positive patients.

With the self-serve tool, DataDirect (DD), researchers can answer these questions:

DataDirect COVID table

_________________________________________________________________________________________

COVID-19 Research and the Data Sharing Policy

Does your COVID-19-related study fall in scope of the University of Michigan Medical School Policy Governing Human Data and Biospecimen Transfers to Industry or Non-Academic and Non-Governmental Entities?
 
NOT IN SCOPE if the study involves:

  • Transfer of patient level data and/or biospecimens to governmental agencies, other academic medical centers or universities
  • Transfer of aggregate counts or summary level data to commercial entities
  • Sharing of data for purposes of patient care
  • Transfer of data for purposes of clinical trial* site activity.

*to be considered a clinical trial, the study must meet the NIH definition of a clinical trial
 
IN SCOPE and requires review by the Medical School Human Data and Biospecimen Release Committee if the study involves the transfer of patient level data (including de-identified) and/or biospecimens to a for profit or commercial entity, non-academic foundation, or professional society.
 
How to have the study reviewed:

  • Complete the checklist form, and:
    • It isn’t necessary to have IRB approval before having your study reviewed by the Data Release Committee. 
    • You may not be able to complete all sections of the checklist if in early stages of study planning. Provide as much detail as you can, including a detailed description of the project in the Transfer Overview section, a clear description of the data to be sent (is it coded? limited data set?), and the draft budget.    
  • The Data Office will facilitate review. Contact Sheryl Flanagan or Erin Kaleba by sending the checklist to OoR-DataRelease-All@med.umich.edu
  • Questions? Call 734-764-9318 and leave a voice message or send an email to OoR-DataRelease-All@med.umich.edu 

What will an approval include?

  • Patient Consent Required - The main goal of the policy is to ensure that data and biospecimens shared with industry are collected under transparent informed consent. The Committee will provide instruction on what must be included in the patient consent.
  • Agreement Terms - specific contract terms to be included in the final agreement. These can be found in the policy. You can view the policy here. You must login.
  • Budget – Committee will review the proposed budget to ensure cost recovery is satisfied
  • Medical School fees – a one- time $5,000 Medical School transfer fee applies to all projects in scope of the policy.
  • Requirement to disclose COI - if the PI has a COI with the sponsor, it must be disclosed and an appropriate management plan prepared.

__________________________________________________________________________________________

Available Data for Access

In anticipation of COVID-19 data need for research, the Data Office built COVID-19 Research Cohorts to serve as a starting point for COVID-19-related custom data requests. It is updated daily and intended to be used for retrospective studies. Currently, it has the following cohorts and data (and we can pull additional data elements based on your custom request):
 

COVID Research Cohorts chart

Stay up-to-date on the latest COVID-19 research and updates from the Office of Research here.

Contact us for more information or questions.

May 7, 2020 3:00 PM

A message from Dr. Kunkel

Dear Colleagues,

Earlier today, Rebecca Cunningham, U-M Vice President for Research, announced how the university has initiated planning for the safe ramp-up of on-campus laboratory research, in a public health-informed manner, when granted permission by the State of Michigan and U-M executive leadership.

Dr. Cunningham shared a new Research Re-engagement webpage maintained by UMOR. This page includes guidelines developed by the Research Ramp-up Committee and informed by public health authorities and the State of Michigan. I ask you to review them carefully – they have been developed after much consideration and with your health and safety as the highest priorities.

As the largest research enterprise at the university, I am working closely with the Department Chairs and Associate Chairs for Research to develop a staged plan for the Medical School’s research lab reactivation. Opening will take place over a number of phases, starting slowly at first to ensure that our processes are working and that our operations remain safe.

The conditions for opening are multi-faceted, and upon permission from the state and U-M executive leadership to activate, will require:

  • opening buildings in a phased approach,
  • establishing that safe operations can be conducted under public health requirements for social distancing,
  • planning to return at a reduced capacity with some research activities limited,
  • keeping many community spaces closed, and
  • requiring remote work to continue for office-based and dry research and administrative activities.

Also, access to our buildings will be quite different. There will be single points of entry for groups of buildings. Those who enter will need to meet requirements for daily health attestations and temperature monitoring. Building access will be restricted to approved personnel only.

You will hear more from your department soon with further instructions on the process, and we’ll also be sharing the latest updates in the weekly e-newsletter Research News. Questions can be directed to the Medical School Office of Research at ummsresearch@umich.edu.

When we were forced to ramp down back in March, I was amazed with how our entire research community addressed the crisis with speed, thoroughness, and composure. This course of action, joined with the efforts of citizens across Michigan, collectively caused the COVID-19 curve to flatten. Hundreds of lives were possibly saved.

Looking forward, our ramping up will proceed gradually and carefully, to promote the safety of not only our colleagues, but our community members here in Ann Arbor, Flint, Dearborn, and beyond. Our success in this early stage may enable further openings sooner and inform instruction in the fall. However, breakdowns in our processes could result in a reversal of the activation. As with the ramp down, I know you will ramp up with the utmost care and professionalism.

There is no doubt that even once we are back in the labs, the way we conduct our research will look very different from the way it has in the past. Thank you in advance for your adaptability and dedication as we proceed into this next phase of our very important work here at the University of Michigan.

Best regards,
Steve

Steven L. Kunkel, Ph.D.
Executive Vice Dean for Research, Medical School
Chief Scientific Officer, Michigan Medicine
Peter A. Ward Distinguished University Professor
Endowed Professor of Pathology Research

 

April 29, 2020 3:30 PM

The University of Michigan has been selected to participate in the first study to use the new national Healthcare Worker Exposure Response & Outcomes (HERO) registry. Supported by the CTSO’s Ambulatory & Chronic Disease (ACD) Clinical Trials Support Unit (CTSU), in collaboration with Michigan Institute for Clinical & Health Research (MICHR), this study focuses on how effective Hydroxychloroquine (HCQ) may be in protecting healthcare providers. 

Led by Marisa Miceli, MD, Associate Professor, Infectious Diseases, Internal Medicine, and Peter Higgins, MD, PhD, MSc, Professor, Division of Gastroenterology; Director, IBD Program; and Medical Director, ACD CTSU, the study aims to determine if HCQ can prevent COVID infections or reduce the severity of COVID infections in providers.

“This provider prevention study, with 15,000 healthcare providers nationwide, randomizes health care providers to HCQ vs placebo,” said Peter Higgins, MD, PhD, MSc (CRDSA), “We intend to identify whether HCQ can reduce infections in healthcare providers at high risk and reduce the severity of COVID-19 infections.”

Marisa Miceli, MD, will be leading the collection of 1,000+ nasal swabs when she is doing clinical service, as part of the study. 

The HERO registry collects information from healthcare workers to better understand the impact that the COVID-19 pandemic has on them, their colleagues, family, and friends. The registry is open to all healthcare workers, including nurses, therapists, physicians, emergency responders, food service workers, environmental service workers, interpreters, and transporters.

Michigan Medicine healthcare workers who want to help others understand the impact COVID-19 can learn more and sign up here.

 

April 29, 2020 10:15 AM

Monitoring Financial Risk of External Awards

In order to minimize potential U-M financial liabilities, monitoring the financial health of sponsored research, including reviewing all project activity in a timely manner and ensuring investigators are kept up-to-date on the overall financial health of their projects, are essential fiscal responsibilities.

Projects with expenses that significantly exceed the amount of revenue received, delinquent payments, or outstanding invoices, pose a higher risk for uncompensated work.  Key factors to consider when evaluating the financial health of a project, and the risks associated in fulfilling the aims and scope of a project, include the following simple questions:

  • Are you monitoring revenue received against expenses to ensure correct pacing of expenses?
  • Do project expenditures, to-date, significantly exceed revenue received?
  • Are invoices current and paid in full?

On a monthly basis, faculty and administrators can minimize risk by consistently reviewing and monitoring the following:

Project revenue status (‘actuals’ balance)

  • Projects with expenses that significantly exceed revenue received pose a higher risk for uncompensated work.
  • Monitor by reviewing the ‘actual’ balance reported for the project which reflects payments received less expenses charged, or amount of funding received or invoiced for to-date for the work that has transpired.
  • Use:
    •  M-Reports [FIN. MGMT or RESEARCH tab]: Budget Status (Project/Grant or Parent Summary) Reports review the Revenue/Expense Balance as of last month closed column
    •  MPathways Financials & Physical Resources System  [GL Reports]: Budget Status (Project/Grant or Parent Summary) Reports review the P/G Actuals Balance on the report   
  • Important note: Sponsored project revenue reported reflects both payments received as well as outstanding invoices submitted for payment. Although both reports provide revenue information M-Reports includes additional information regarding the amount of revenue that is billed (Outstanding Invoices Receivable, see below). Selecting the Outstanding Invoices Receivables dollar amount hyperlink displays the Outstanding Invoices Receivable – Aging Summary & Statement of Receivables Report for the project.

The project invoice status (outstanding receivables amount)

  • The project invoice status (outstanding receivables amount)
  • Projects with unpaid aging invoices pose a higher risk for uncompensated work.
  • Monitor revenue for sponsored projects, which reflects both payments received to-date as well as invoices submitted for payment to the sponsor. It is important to monitor the status of outstanding invoices to ensure all project revenue is received.
  • Use:
    • M-Reports [FIN. MGMT or RESEARCH tab]: Outstanding Receivables Report  This report displays Outstanding Invoices Receivable – Aging Summary & Statement of Receivables Information and can be run at the department ID or individual project grant level (individual project grant information is the same information accessed by selecting the Outstanding Invoices Receivables dollar amount hyperlink in the Project Grant Summary Reports)
    • UM Data Warehouse  (Business Objects) [Public Folders / U-M Maintained / Financials]: AR01 AcctsRec Aging Detail by Project Grant This report is run at the individual project grant level
  • Important note: inactivated project grants may have outstanding receivables due. It is important to continue to monitor invoice status for projects until ALL revenue is received.

Adherence to Payment Terms

  • Projects with delinquent payments or partial payments pose a higher risk for uncompensated work.  
  • For sponsored projects receiving automatic payments according to a predetermined payment rate and schedule specified in the award document make sure the sponsor is current with all payment terms.
  • Use:
    • eRPM:  Review the terms and conditions of each agreement
      • Best Practice: Use the Award Record Manage-Unit Defined Terms and Conditions Activity to document payment terms and other important information related to the award. Information added is easily accessible on the Unit Info tab of the Award Workspace.

The important take away is to actively monitor revenue, billing and payments to allow early identification of potential financial distress that may pose a liability to UM. It is equally important to evaluate the financial health of each project in relation to the work remaining, paying particular attention to those agreements that have specific required deliverables. For projects that are higher risk, proactively engage department leadership – especially if the sponsor becomes delinquent in payments, issues only partial payments, or becomes non-responsive

Upon review, if the PI or department determines the best course of action may be discontinuing project activity contact the ORSP Project Representative for guidance to ensure all contractual obligations are handled appropriately.  In most agreements discontinuation of work requires notification to the sponsor. Likewise, if a sponsor issues a stop work order or study suspension notification this information should be communicated to ORSP immediately.

Additional information on these topics and expectations related to post-award management can be found in the Post-Award Procedures Manual.

Questions? Contact msgrants@umich.edu.

 

 

April 22, 2020 2:00 PM

A Message from Dr. Kunkel

Dear Colleagues,

We are all anxious to get the laboratories opened; however, we don’t have a clear idea of when that will be yet. U-M is working closely with the Governor’s office, and our actions are dependent on the shelter-in-place order and other statewide requirements that may be issued related to a return to work. I am working with the U-M Vice President for Research, Dr. Cunningham, and research deans from the other schools and colleges on developing a research ramp-up framework. Every indication is that the ramp-up of research will be a phased return to the labs with social distancing, density considerations, and other safety measures put into place, so the research enterprise is likely to look and feel different for some time upon our return.

Like you, I am eager to return to my lab. I promise to keep you apprised as planning continues to progress. Keep in mind that the safety and well-being of our research community continues to be our top priority, so that will be at the forefront of any planning for future ramp-up in operations.
 
Be well and stay safe,
Steve

Steven L. Kunkel, Ph.D.
Executive Vice Dean for Research, Medical School
Chief Scientific Officer, Michigan Medicine
Peter A. Ward Distinguished University Professor
Endowed Professor of Pathology Research

 

April 22, 2020 11:00 AM

In response to President's Schlissel's message on April 20 regarding the university's financial challenges in the face of the COVID-19 pandemic, UMOR has posted a number of new FAQs that address questions around funding from external sponsors, internal funding, cost shares, pilot funds, and more. As leadership and our research community continues to understand the ramifications of the President's directive on research, updates will continue to be shared by UMOR and the Medical School Office of Research.

Questions? Contact umor.news@umich.edu.

 

April 22, 2020 10:30 AM

Research studies that are funded by NIH are automatically deemed issued a Certificate under the NIH Policy on Certificates of Confidentiality (CoC). The CoC automatically extends as long as the NIH funding continues, including any no-cost extensions. Under normal circumstances institutions with CoCs for non-NIH funded studies are required to apply for a new CoC upon the expiration of the current one in order to extend the CoC protection past the stated expiration date.

To decrease the burden for the research community, during the public health emergency for COVID-19, NIH is automatically extending the expiration dates for NIH issued CoCs that were current (i.e., not expired) as of April 15, 2020. NIH therefore deems all CoCs current (i.e., not expired) on April 15, 2020 for non-NIH funded studies to have a 12-month extension of their expiration date.

CLICK HERE to learn more.

 

April 15, 2020 3:30 PM

On Tuesday, April 14, UMOR hosted a virtual Research Town Hall, which featured updates on the entire U-M research enterprise from Dr. Rebecca Cunningham, Dr. Steven Kunkel, and other U-M research leadership.

CLICK HERE to view the video recording of the virtual event in Mbox (download if your connection is to slow to preview).

Questions? Contact umor.news@umich.edu.

 

 

April 14, 2020 11:30 AM

Michigan Medicine has many brilliant physicians and scientists with creative ideas on how to better treat or prevent COVID-19. Fortunately, there are fewer COVID-19 patients in our hospital than originally expected. We also have a limited number of study coordinators and trained personnel experienced with clinical trials in the ICU setting. With an average of one new trial coming in each week, the Clinical Trials Support Office Leadership has determined that it is necessary to prioritize trials that have the greatest likelihood of providing benefit to patients or the scientific community and that are the most feasible to implement from a logistics standpoint.

With the support of Dr. Rebecca Cunningham, Vice President for Research and Dr. Steven Kunkel, Executive Vice Dean for Research of the Medical School and Chief Scientific Officer for Michigan Medicine, we established the COVID-19 Trials Feasibility Review Committee (TRIFREC) to review and prioritize COVID-19 trials.

All COVID-19 clinical trials must be submitted to the UMOR COVID-19 Research Prioritization Committee. Once the review has been completed, PIs will receive a notification to:

  1. Submit a CTSU Intake Form
  2. Submit protocol and other documents to COVID-19 TRIFREC.

TRIFREC is expected to be able to generate priority scores, priority level (High/Medium/Low), and decisions to Proceed/Not Proceed within 5 business days from the receipt of a complete application.

Disclaimer: Approval from this panel does not mean a trial can start enrolling; rather, trials with feasibility approval will receive high priority support for activation.

Support for COVID-19 trials is provided through collaboration across CTSUs and MCRU, with patient consent coordination by the ACCST CTSU, sample collection and processing by MCRU, and financial and portfolio management remaining within a study team’s current CTSU.

To learn more about current and upcoming COVID-19 clinical trials at the University of Michigan, view the COVID-19 Research Index.

We are deeply appreciative of the hard work of many teams, and in particular, ACCST CTSU PIs and staff for implementing clinical trials at record speed at Michigan Medicine. As of April 14, 2020, we have enrolled a remarkable total of 50 patients in COVID-19 trials. We also want to thank our partners including ORSP, IRB, CRAO, and IDS for moving the process along expeditiously, as well as our clinical colleagues for fantastic collaboration and their outstanding care of COVID patients.

Questions or concerns about the Feasibility Review may be directed to Debra Tanton (debratan@med.umich.edu) or Peter Higgins (phiggins@med.umich.edu).

 

April 9, 2020 11:45 AM

SignNow Software is now HIPAA and FDA 21 CFR Part 11 compliant for patient signatures. Study Coordinators are no longer required to have patients sign the HIPAA Permission to Use SignNow form before signing informed consent documents. See IRBMED updated guidance for ‘Informed Consent Procedures Using Electronic Systems and Remote Use of Paper Documents’ and guidance for the use of ‘SignNow for Electronic Informed Consent Procedures’.

Questions? Contact irbmed@umich.edu

 

April 8, 2020 2:30 PM

The Medical School has opened a Biosafety Level 3 Lab (BSL3) in Med Sci II, equipped for invitro research. BSL3 is a lab where work can occur involving microbes that can cause serious or potentially lethal disease through inhalation.

Access to the lab is currently limited to projects related to COVID-19, and must be channeled through the COVID-19 Research Prioritization Committee

Questions? Contact Beth Moore, Ph.D., at bmoore@umich.edu.

 

April 6, 2020 4:00 PM

A message from Dr. Kunkel:

Dear Colleagues,

As we enter week three of the “ramp down” of on-campus Medical School research operations, I wanted to share with you that there is a significant amount of research activity going on, albeit in ways we may not have experienced before.

Let me offer a snapshot of what I’ve been seeing in the last couple weeks. Our research teams have routed 225 projects to the Grants Services & Analysis team for submission to extramural sponsors, and more than 200 investigators have been using DataDirect to continue their research remotely. 17 faculty teams performed the final “pitch” for their commercialization projects in Fast Forward Medical Innovation’s “fastPACE” program, remotely using BlueJeans.

All across what has basically become a virtual campus, researchers and staff are finding new ways to collaborate and continue forward progress on our very important work.

Not surprisingly, there has been an amazing – and inspiring – uptick in research activity related to COVID-19. To date, over 500 residual biospecimens from COVID-19 patients have been collected and will soon be available for collaborative research. The U-M COVID-19 Research Prioritization Committee is evaluating new projects every day, and highly ranked clinical trials are being fast-tracked by our Clinical Trials Support Office and their partners for launch and patient enrollment. For instance, Kevin Gregg, M.D., is already enrolling participants in a trial to determine whether Sarilumab, an Interleukin-6 inhibitor, is efficacious in reducing inflammation in COVID-19 patients.  Daniel Kaul, M.D., has launched two different trials examining the potential of Remdesivir to act as an effective antiviral therapy for COVID-19 patients. And our College of Engineering colleagues are collaborating with Michigan Medicine on projects like testing new methods for recycling N95 masks and understanding risks associated with using nasal cannula with COVID-19 patients.

I encourage you to learn more about these and other projects from the COVID-19 Research Index, a new webpage maintained by UMOR. Moving forward, this webpage will be a great resource for collaboration, as our entire research community looks for ways to contribute to the battle against COVID-19.

Each day brings important new information and strategies as we all continue to adapt to our new normal. On Tuesday, April 14 at 3:30pm, Dr. Rebecca Cunningham, myself, and other U-M research leadership will host a virtual Research Town Hall, where we’ll provide an update on the entire university research enterprise. CLICK HERE for login details. I encourage you to continue to monitor the COVID-19 websites maintained by the Medical School Office of Research and UMOR, as well as keep an eye out for our e-newsletter, Research News, which is now publishing every Wednesday. Please don’t hesitate to reach out to ummsresearch@umich.edu if you have any questions.

In ways large and small, we are ALL engaged in what some are calling the battle of our lifetimes. Our clinical colleagues are making herculean efforts on the front lines of that battle. But never forget - biomedical research has a huge role to play, as our faculty will be among many around the world who will identify, develop, and test treatments for this disease. The work we do here will lay the groundwork for the weapons required for future health crises and pandemics. Thank you for your hard work, your creativity, and your dedication.

Be well and stay safe,
Steve

Steven L. Kunkel, Ph.D.
Executive Vice Dean for Research, Medical School
Chief Scientific Officer, Michigan Medicine
Peter A. Ward Distinguished University Professor
Endowed Professor of Pathology Research

 

April 6, 2020 2:45 PM

All COVID-19 clinical trials must to be submitted to the COVID-19 Research Prioritization Committee and will be assigned as a high priority. Once the designation has been made, Anna Lok, M.D., Assistant Dean for Clinical Research will reach out to the Principal Investigator to offer logistical assistance. COVID-19 trials have now been fast-tracked to open in as little as two weeks from receiving the protocol.

Consent and sample collection is currently being managed by the ACCST CTSU and MCRU Lab. Some upcoming trials may be co-managed by staff from other CTSUs as appropriate. A committee including bioethicists and IRB is developing guiding principles for when a patient is eligible for more than one trial.

To date, we have opened three clinical trials, with four more opening within days. Current and upcoming trials are for patients with severe illness in the ICU, as well as those with mild to moderate illness looking to prevent progression. The CTSO is also supporting trials aimed at preventing infection in those at risk of exposure, such as healthcare workers. To learn more about current and upcoming COVID-19 clinical trials at the University of Michigan, view the COVID-19 Research Index

At this time, we would like to acknowledge all of the hard work that ACCST CTSU PIs and Staff have done to implement clinical trials at record speed at Michigan Medicine. Their diligence has laid the groundwork to offer the best care possible to our patients.

 

April 6, 2020 10:15 AM

All U-M research faculty and staff are invited to join Dr. Rebecca Cunningham, U-M VP for Research, Dr. Steven Kunkel, Executive Vice Dean for Research of the Medical School and Chief Scientific Officer for Michigan Medicine, and other research leadership for a Research Town Hall on Tuesday, April 14, 3:30PM-4:30PM.

Members of the research community are encouraged to CLICK HERE to submit questions prior to the event.

CLICK HERE for login details (level 1 authentication required).


 

April 1, 2020 2:00 PM

UMOR has launched the COVID-19 Research Index, a new web tool that catalogues COVID-related research projects led by U-M that are in various stages of development, from planning to fully launched. UMOR is actively managing the site, continuing to enter new research projects every day.

The webpage will be a great tool for researchers seeking collaborators on campus - at last count, there are currently over 30 projects related to COVID-19, in categories like "Clinical Trials" and "Medical Device Development."

Questions? Contact research-news@umich.edu.