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COVID-19 Research Operations

COVID-19 Research

The Office of the Vice President for Research has organized a committee to review and prioritize (within two days) new or modified research projects related to COVID-19 that involve university resources, including human subjects, basic laboratory and animal research, or require significant university resources to stand up. U-M researchers that are interested in leading COVID-19 research projects should complete the following form:

COVID-related Research Prioritization Form

Last Updated: 12:20 p.m. on May 29, 2020

The Office of the Vice President for Research partnered with schools, colleges and units across the University of Michigan to develop important FAQs about research operations amid the COVID-19 pandemic.

The novel coronavirus has impacted nearly every facet of the U-M research enterprise, including the ramp down of noncritical laboratory research activities on March 20. Research leadership from across U-M have developed guidelines for how to safely re-engage limited research activity, in accordance with state regulations, so please refer back to this webpage for frequently updated FAQs.


Symptomatic employees should contact U-M Occupational Health Services' COVID-19 Hotline at 734-764-8021 (Option 1). The health and safety of our workplace is critical. If you see or feel someone is not following appropriate guidance for maintaining a lab space, we encourage constructive feedback in the labs between personnel. Anonymous concerns can be directed to your associate dean for research, or refer to the U-M compliance hotline.


For information about research re-engagement efforts amid COVID-19, please refer to the university's Research Re-engagement webpage.


 

Research and Sponsored Projects’ Spending and Hiring Amid COVID-related Financial Challenges

  1. How does President Schlissel’s message on April 20, 2020 regarding U-M’s response to the financial challenges we face impact research and sponsored projects that are funded by external sponsors?

    1. Federal, State and Nonprofit Sponsors: Grants and contracts from these external sponsors should continue operations to fulfill the aims and scope of the grant or contract. This includes hiring, if needed (with attention to RIF candidates), along with ongoing salary and purchases utilizing external funding needed for the completion of the committed project. Note, however, that U-M’s policies and procedures regarding employee compensation shall be consistently applied to all employees regardless of whether they are supported by external funds or U-M funds (e.g., grant-funded employees will not be entitled to merit increases if their U-M funded colleagues are not).

    2. Industry Sponsors: Grants and contracts from industry sponsors may continue operations to fulfill the aims and scope of the grant or contract if:

      1. The terms and conditions of the award require the sponsor to pay for the research prior to the commencement of the work; OR

      2. The terms and conditions of the award require the sponsor to (a) provide no less than 30 days advance notice in the event of termination and (b) cover the cost of non-cancellable obligations in effect at the time notice is given; OR

      3. Expenditures on the project through the most recently closed accounting period (month) do not exceed revenues received through the same accounting period; OR

      4. The unexpended balance on the total of committed budget periods does not exceed $100K;  OR

      5. The performance of the award does not require the hiring of additional personnel or external purchases totaling over $100K; OR

      6. The contract is for an ongoing clinical trial.

        In order for an industry-sponsored grant or contract that does not meet one of the above criteria to move forward, the administrative home department or school/college must have identified a contingency reserve equivalent to no less than one month of the average expenditures on the grant or contract.

        The administrative homes of these allowable industry-sponsored projects must immediately halt or pause all sponsored activity if the sponsor (a) becomes delinquent or makes partial payment on an undisputed invoice, or (b) issues a stop work order. ORSP must also be contacted as soon as possible.

        If after reviewing the terms of your grant/contract you have additional questions, please contact your Project Representative in the Office of Research and Sponsored ProjectsApril 27, 9 p.m.

  2. I have a research project that is ongoing and funded from my internal startup or internal U-M pilot program funds. Can I continue to do work on this project, including spending for existing salaries and supplies?

    1. Yes, research projects in progress can continue. New hiring requires department approval and should first account for other research staff that may be idle. April 20, 12:45 p.m.

  3. I have a research project that is ongoing from internal pilot funds. Can I continue my work on this project, including spending for existing salaries and supplies?

    1. Yes, research projects in progress can continue, however new hiring may not be permitted and is subject to approval by your school/college/unit. April 20, 12:45 p.m.

  4. I was planning to start a project with my internal research funds. Can I still begin this?

    1. Faculty can continue to use their existing research discretionary and startup accounts to pursue their program of research. Non-research expenditures are limited as directed in the president's guidance.

      1. Note research travel, conferences, hosting, professional development are not allowable research expenses on internal U-M accounts currently.

      2. Events, marketing and advertising, outside printing, subscriptions, prizes, gifts and awards, and supplies (all categories, including office, computer) require justification that they are needed and urgent to complete the current aims of the project.

      3. Furniture, remodeling, etc. are not allowable under internal faculty research accounts at this time. April 20, 12:45 p.m.​​

  5. Can I purchase new supplies using funding from an internally sponsored research project?

    1. Yes, if the research project is in progress, new supplies can be ordered to fulfill the aims and scope of the research project. Please note that Procurement may require justification from PIs that outlines why new supplies are essential. And where possible, please consider delaying purchases. April 20, 12:45 p.m.​​

  6. Can I hire a postdoctoral researcher as part of my externally funded training grant?

    1. ​Yes, if needed to fulfill the aims and scope of the grant or contract. April 20, 12:45 p.m.​​

  7. Can I hire a postdoctoral researcher as part of my internally funded account?

    1. New hiring is paused currently and would require an exception approval. April 20, 12:45 p.m.​​

  8. Can I buy research equipment?

    1. If it is externally funded and is necessary to fulfill the aims and scope of the grant or contract, then yes, you can proceed with purchase. If it is a replacement needed for an internally funded ongoing program, this may or may not be allowable and would need to be approved. Please check with your unit. April 20, 12:45 p.m.​​

  9. ​How does this impact university cost-share commitments on my sponsored project?

    1. Prior cost-share commitments for externally sponsored grants and contracts will be honored by the university. April 20, 12:45 p.m.​​

  10. Will UMOR still provide cost-share on research for sponsored funding?

    1. Cost-share requests will be considered in light of the COVID-19 financial environment during the remainder of FY20 and FY21. Please work with your unit research leadership on cost-share requests. April 20, 12:45 p.m.​​

  11. ​Is the voluntary furlough available to staff whose salary is paid by federally funded grants?

    1. Yes. April 29, 7:45 a.m.

  12. Is traveling to attend a conference in-person, or attending a conference virtually, allowed if it is budgeted in an externally-funded grant?

    1. Assuming it is not otherwise prohibited by a governmental entity, the allowability of in-person or virtual conference attendance depends on the policy of your school/college/institute/unit. May 4, 12:45 p.m.

  13. If a project is sponsored by an industry partner, but the source of funding is federal and the university is receiving a subcontract, should the project be treated like it is sponsored by industry or the federal government?

    1. The project should be treated as an industry-sponsored project, as the industry partner is the legal entity with whom U-M has a written agreement and who can ultimately make decisions about whether payment is made. April 29, 7:45 a.m.

  14. The President's message stated, “Research projects that are fully funded by federal sponsors can continue operations.” Can my federal grant continue if it is incrementally funded?

    1. Yes. April 29, 7:45 a.m.

  15. My project is sponsored by an industry partner who has paid for all project-related costs up front. Can my industry-sponsored project continue?

    1. Yes. April 29, 7:50 a.m.

  16. My project is a consortium that is co-funded by the federal government and a number of industry partners who pay their membership fees up front. Can work in my consortium continue?

    1. Yes, as long as consortium expenses do not exceed revenues. April 29, 7:50 a.m.

  17. I have a U-year appointment and planned to charge summer salary to my externally funded sponsored project, but my project is on hold due to COVID-19. Can I still charge summer salary to my project while I am unable to work on it?

    1. No. In the case of summer salary for U-year faculty, you are only allowed to charge an externally funded sponsored project for time actually worked on the project. May 12, 10:05 p.m.

Research Facilities/Laboratory Safety

  1. What is the current timeline for opening up buildings and labs to resume research?

    1. The pilot wave to ramp up on-campus activities began on May 21, 2020. Please see the Research Re-engagment webpage for further information. May 25, 10:25 a.m.

  2. What is the current policy for field-based research?

    1. Limited field research conducted in the State of Michigan can be approved with appropriate safety plans in place. Please refer to our field research re-engagement guidelines for more information. Out-of-state travel remains restricted, with the possibility for approval in only rare circumstances. We are actively examining the changing State guidance as to whether field work can be expanded, and we will have updated guidance as soon as possible. May 27, 1:45 p.m.

  3. What should I do if I suspect some researchers are performing laboratory work without following appropriate guidance for operating a safe lab?

    1. The health and safety of our workplace is critical. If you see or feel someone is not following appropriate guidance for maintaining a lab space, we encourage constructive feedback in the labs between personnel. Anonymous concerns can be directed to your associate dean for research, or refer to the U-M compliance hotlineMay 16, 10:35 a.m.

  4. What is the procedure to get biorepository samples?

    1. Researchers should submit a COVID-19 research prioritization request and contact the UMMS Biorepository for questions. May 6, 4:30 p.m.​

  5. Will anyone be coming into the laboratory facilities to check on equipment during closures or eventual re-engagement?

    1. EHS will continue to conduct walkthroughs on a regular basis to ensure all safety aspects of the spaces are assessed and addressed as needed. May 6, 4:40 p.m.

  6. I want to initiate a research project on SARS-CoV-2 that would require BSL3 containment. What should I do?

    1. The U-M Institutional Biosafety Committee has a special BSL3 Subcommittee that will expedite review of applications for research on SARS-CoV-2. Please send a message to IBCcovid19@umich.edu to inform us of your proposal. We will send you the special application to complete and will expedite review. If you are new to BSL3 work, or seek advice/information as to what is involved with BSL3 work at U-M, we can assist. May 6, 4:45 p.m.

  7. Are there facilities available at U-M for research on SARS-CoV-2?

    1. Facilities dedicated to SARS-CoV-2 are limited. Labs planning in vitro/in vivo research on the virus should prepare research specific protocols outlining the details of their work, send a message to research.covid19@umich.edu. The type and location of the facility will be determined by the research needs. May 6, 4:45 p.m.

  8. What should I do if I have waste that needs to be collected while some buildings are closed and others are reopening?

    1. Please complete the online request form or call the EHS office at 734-763-4568 as soon as possible to request a waste pick up, regardless of whether your building is open or not. Please identify the exact location of the waste and, if possible, the cell phone number of someone familiar with the location of the waste. If no one is present when pickup occurs, they can ensure their waste is collected by isolating it in one area of the lab and specifically identifying it with a sign or label indicating what containers need to be collected. If you have questions about how to label and/or manifest waste, please visit http://ehs.umich.edu/haz-waste/ for more information. May 25, 10:30 a.m.

  9. What precautions should be taken by a person going into the lab alone or after hours to conduct research?

    1. The MIOSHA Hazardous Work in Laboratories Standard states: “Avoid working alone in a building; do not work alone in a laboratory if the procedures being conducted are hazardous.” Accidents are unexpected by definition, and if a person is working alone when one occurs, his or her ability to respond appropriately could be severely impaired, which could result in personal injury or death. Thus it is imperative that, whenever working in the laboratory, others are actively aware of your activities.

    2. You should establish a designated back up “buddy,” in coordination with your PI, that you can check in with periodically and is aware of the work you are doing and when you will be done. This individual is responsible for contacting UMPD at 734-763-1131 in the event there is a breakdown in your communication. May 6, 4:45 p.m.

  10. Can I continue my research remotely?

    1. Many aspects of research (analysis, computational work, etc.) can be done remotely; however, hazardous materials (chemical, biological or radiological) or laboratory equipment are prohibited from being removed from campus. May 6, 4:45 a.m.

  11. Who should I contact if I have questions about closures or ramp up of lab/shop activities in my lab or building?

    1. Your primary contact should be the Research Associate Dean (or equivalent) within your school, college or unit. For UMOR units, please contact your designated Associate Vice President for Research. May 6, 4:50 p.m.

  12. What can I do to prepare my laboratory research area for reduced operations?

    1. Ensure your Continuity of Operations Plan considers the following:

      1. Identify procedures and processes that require regular personnel attention (e.g. cell culture maintenance, animal studies, human subjects contacts).

      2. Assess and prioritize critical laboratory research activities.

      3. Identify personnel able to safely perform essential activities.

      4. Ensure you have access to contact information for your critical staff.

      5. Cross-train research staff to fill in for others who may be out sick or unable to come to work.

      6. Ensure staff have the appropriate training.

      7. Consider documenting critical step-by-step instructions.

      8. Coordinate with colleagues who have similar research activities to identify ways to ensure coverage of critical activities.

      9. Review emergency procedures with researchers and staff. Ensure your door signage is up to date.

      10. Maintain a sufficient inventory of critical supplies that may be impacted by global shipping delays.

      11. Consider installing remote-control monitoring devices for critical equipment (e.g., -80C freezers, liquid nitrogen storage dewars, incubators).

      12. Communicate the need to avoid performing high-risk procedures alone. If working alone is permitted, ensure a notification procedure is in place.

      13. Ensure that high-risk materials (radioactive, biohazards, chemicals) are secured and freezers are labeled with emergency contact information.

      14. All waste should be secured. May 25, 10:35 a.m.

  13. Are there any restrictions regarding how many individuals can be in a research laboratory space?

    1. Each lab/studio room can only accommodate a maximum of 1 person per 144 square feet. Once you have determined the number of persons allowable, then determine if they would be able to work and maintain social distancing of >6ft. If not, reduce the number allowed in the lab. In buildings that have not yet re-opened, only essential laboratory personnel performing critical procedures are allowed in the laboratory facilities during this ramp down. May 6, 4:50 p.m.

  14. Should researchers expect shortages of laboratory Personal Protective Equipment (PPE) and disinfectants?

    1. Supplies of certain PPE including N95 masks and some common laboratory disinfectant continue to be in short supply. Labs must ensure PPE and disinfectants are available prior to resuming research. Please contact EHS to discuss PPE options available if shortages do occur. May 6, 4:55 p.m.

  15. Can we leave our lab doors unsecured when we are not present?

    1. No, labs should be locked when there is no one present. If key access is an issue, staff should be equipped with key access. May 6, 4:55 p.m.

  16. Will the U-M Department of Environment, Health & Safety be available if needed?

    1. EHS is available for lab safety consults, emergency spill and fire response, hazardous waste collection and supplies, radioactive package delivery, and public health activities. May 6, 4:55 p.m.

Costs During the COVID-19 Health Crisis

  1. Who is eligible to use the paid time off options who need to be absent from work due to the COVID-19 (coronavirus) pandemic?

    1. U-M Human Resources maintains a webpage with the authoritative information on who is eligible to participate in the Federal Emergency Paid Sick Leave Act (EPSLA), the U-M COVID-19 Paid Time Off bank, the U-M COVID Paid Time Off Supplement (through April 30, 2020) and the Expanded Family Medical Leave Act (EFMLA) supplement.

    2. To clarify what this means for the U-M research community, a nonexhaustive list of employee groups who may draw on these time off options includes tenured, tenure-track, research and clinical faculty, research scientists, postdoctoral fellows, GSRAs, and regular and temporary full- and part-time staff, including student employees. 

    3. It is also important to understand that these time off options are benefit programs, not additional sources of funding. The cost associated with these benefits are borne by school/college, department or grant. April 1, 8:20 p.m.

  2. I am a principal investigator and am wondering who approves the use of the new paid time off benefit programs on my grant? Are there any guidelines to follow?

    1. Whoever usually approves the timesheets of the individuals working on your grant (normally the PI) also approves the use of the EPSLA, COVID-19 and/or E-FMLA as part of the standard timesheet approval process. 

    2. If a faculty member needs to use one or more of these time-off options, PIs should follow their academic unit's process for approving exception time; if uncertain about the process, PIs should consult with their department chair or associate dean. April 1, 8:20 p.m.

  3. Do U-M’s sponsors (e.g., federal funding agencies and corporations) allow COVID-19 paid time off charges to the grants and contracts they have funded?

    1. All of the COVID-19 related paid time off options (EPSLA, COVID-19, E-FMLA) are university benefits, like dental insurance or accrued vacation time, and should be treated as an allowable cost on all university grants and contracts.

    2. The following federal agencies among others have gone on record as stating that these costs are allowable, as long as U-M’s employees are eligible to participate in the program regardless of the source of their salary support (i.e.,whether they are funded by the federal government or some other non-federal entity):

      1. Centers for Disease Control and Prevention (CDC)

      2. Department of Defense (DOD)

      3. Department of Energy (DOE)

      4. Department of Justice Office of Justice Programs (DOJ/OJP)

      5. Environmental Protection Agency (EPA)

      6. Food and Drug Administration (FDA)

      7. Health Resources and Services Administration (HRSA)

      8. National Institutes of Health (NIH)

      9. National Science Foundation (NSF)

      10. National Aeronautics and Space Administration (NASA)

      11. Substance Abuse and Mental Health Services Administration (SAMHSA)

    3. The numerous time off options provide coverage for employees who are sick or lack work to continue to charge their effort or hours to a grant or contract, if allowable by the sponsor. We encourage you to consider the many grant-related activities that research personnel can do remotely, such as data cleaning and analysis, manuscript preparation, training videos, etc. Click here for a list of such activities.

    4. PIs who are funded by corporate or foundation sponsors that raise objections to U-M’s time off benefits should listen respectfully to the sponsor’s concerns and engage in some gentle education about how the university is protecting its employees during this unprecedented public health emergency. PIs should note how these paid time off programs -- some of which are mandated -- are university benefits, like dental insurance or accrued vacation time. PIs should be prepared to have an open dialogue with the sponsor about how progress toward achieving the contracted deliverables is going (or not going) and whether adjustments to the scope of work or budget may be needed. Please be mindful of the fact that dwelling on the negative impacts of the research ramp down will advance neither your science nor the university’s relationship with your research sponsor. April 29, 8 a.m.

  4. I am a PI, and although I want to support my staff, I am worried that my grant cannot afford to continue to pay salaries that the new paid time off benefits will incur on my grant. Can I choose not to pay staff on my grant?

    1. Grants will incur costs for personnel who are utilizing any paid time off benefits (EPSLA, U-M COVID-19, E-FMLA) the same way grants pay for sick or vacation time. In this time of uncertainty it is not known if these costs must be absorbed by the university, and hence our PIs, or if our sponsors may make supplements available later. While our research mission is critically important, our personnel are even more important, and these costs to grants will need to be absorbed if the grants are not supplemented later. If supplements do not materialize, then grants may not be able to deliver on all the specific aims as originally planned -- and this is the same position that PIs across the country are in. April 1, 8:30 p.m.

  5. As we plan to scale back research activities and work hours, can you clarify for us what we need to be doing as PIs to ensure that our employees continue to be paid?

    1. In order to ensure a regular employee’s salary continues to be paid during a period of scaled back research, PIs should first attempt to rearrange their lab operations so that the employees continue to expend effort on the funded research (e.g., by working remotely). If no work exists for their employees, or if research is halted altogether, PIs should ensure that their employees record their time using the new paid time off codes as detailed in the U-M Human Resources’ COVID-19 FAQApril 1, 8:30 p.m.

  6. What documentation should we be keeping in regard to the impact of COVID-19 and how should we be tracking expenses related to COVID-19?

    1. U-M central offices are keeping a record of institutional communications that memorialize decisions or guidance to campus regarding research activity. PIs are similarly advised to document their key decisions and actions taken in response to U-M’s guidance, and to track as best they can the costs their grants incurred to implement U-M’s guidance.

    2. U-M also has created a new program code, COVID, within M-Pathways to identify incremental costs (i.e., additional costs above and beyond those expected to be incurred under normal operations) associated with the outbreak. Units may open chartfields/shortcodes mapped to the new COVID program code.  If your unit has already opened a set of chartfields to track this activity, such as a new program code or dept id, contact the Shared Services Center (SSC) for assistance in remapping previously recorded transactions as appropriate. March 20, 7:45 a.m.

  7. How should I charge my employee on a grant during the COVID-19 crisis?

    1. If an employee is currently paid on a grant and continues to be able to productively work on the grant remotely at the same level of effort, no change is needed.

    2. If an employee does not have enough work for the allocated time to the project, other work may be identified to fulfill the appointment hours. Depending on the type of work being done, these hours may require a change in effort distribution/funding source in the HR system. Activity should be reflected and may need to be charged to another grant, discretionary funds or other funds within the unit, dependent on the activity performed.

    3. If other work is not identified to fill the employee’s appointed hours, the hours for which “no work” is assigned can be paid using the new paid time off benefits as described in this table on the Human Resources site.  As a university benefit, these hours may be charged against the sponsored project at the same effort distribution work was assigned. 

    4. When all of the paid time off benefits and eligible exception time are depleted, the employee's position will need to be handled consistent with university policy in place at the time. Further information will be provided as it becomes available. April 1, 8:35 p.m.

  8. What are some activities that I can have my research staff do remotely that can be charged to a grant?

    1. The Medical School Office of Research compiled a comprehensive list of activities that research staff can do remotely.

    2. Click here for additional activities that U-M research staff can do remotely. April 13, 2:10 p.m.

  9. Is there a way to get reimbursed for the costs my lab incurred during the pause on my NIH-funded human subjects research?

    1. NIH issued a notice on March 16, 2020 stating that If unanticipated costs related to clinical trials or human subject research are identified due to impacts of COVID-19, and unobligated balances are not available to rebudget, recipients may request administrative supplements from NIH. March 17, 8:45 p.m.

  10. Interviewers for human subjects research who will not be working may find other jobs if the pause lasts several weeks and not be available when research resumes, so additional training costs will be incurred as new research personnel are hired.  Will those costs be allowable charges on grants? This question applies not just to interviewers but research personnel more generally once the 80 hours are exhausted and personnel seek other positions.

    1. Yes, training costs for new interviewers and other research personnel are allowable. March 17, 8:45 p.m.

  11. Will my grant have to pay for project-related costs incurred during the university’s ramp down in research operations if we aren’t able to work on the project (e.g., animal per diem, idle lab staff, etc.?)

    1. ​​​​In general, the answer is “Yes,” your grant will likely be required to cover the costs incurred during the ramp down in research operations -- provided U-M would likewise require a nonsponsored fund to pay for the same cost in similar circumstances. Put the other way around, if the university would not allow a certain cost to be incurred on a nonsponsored fund during the ramp down, the university will not allow the same cost to be charged to a sponsored project. This practice adheres to the federal government’s Uniform Guidance (2 CFR §200.403) requirement that costs be incurred “consistent with policies and procedures that apply uniformly to both federally financed and other activities of the non-Federal entity.” March 20, 7:50 a.m.

  12. I am a principal investigator working remotely from home during self-isolation. Can my effort still be charged to my federal grant?

    1. In general, yes, provided you remain engaged in your project. Current NIH and NSF prior approval requirements regarding disengagement from the project for three (3) months or more, and effort reductions of 25 percent or more, remain in effect.

  13. I am a principal investigator and am required to work from home as a result of COVID-19. Can I charge supplies relating to telework (i.e., such as a laptop, printer, office supplies, etc.) to my grant?

    1. No. These types of expenses are considered indirect (Facilities & Administrative) costs, and generally are not appropriate as a direct cost unless specifically approved by the sponsor. The ramp down in research operations at U-M does not change this fact. If you need to work remotely from home, please consult with your department or school to identify whether computing resources are available. March 20, 7:50 a.m.

  14. I had planned to travel to a conference to present my federally funded results, but the conference was cancelled due to precautions regarding COVID-19. Can I charge trip cancellation fees to my federal grant?

    1. ​​​​​​​​Yes, provided the federal sponsor has issued a policy statement allowing trip cancellation fees.​​​​​​​​ April 29, 8 a.m.

  15. I have a temporary employee/student worker who is no longer able to work on my grant as a consequence of the COVID-19 situation. What are my options for keeping this individual on the university payroll?

    1. If a temporary employee is no longer able, for whatever reason, to work on a sponsored project, the principal investigator (PI) should first determine if the individual can be legitimately reassigned to other grant-funded activities. If yes, the individual’s appointment should be moved to the appropriate award. If the PI does not have work for the individual to perform, then the PI should check with his/her unit to see about reassignment to other nonsponsored projects or activities. If reassignment is not feasible, then the temporary employee may be eligible for a prorated amount of paid time off through the new paid time off banks (EPSLA, COVID-19, E-FMLA). Units are responsible for determining the appropriate appointment effort and number of hours of paid time off for their part-time and temporary staff. For more information, see U-M Human Resources’ COVID-19 FAQApril 1, 8:35 p.m.

  16. I understand there are new paid time off benefits that my lab personnel can access for a variety of COVID-19 related reasons (e.g., they have contracted the virus, there isn’t sufficient work in the lab to keep them busy due to a pause in research activity, etc.), but who pays for it? Is the paid time off charged to my grant or will U-M cover the cost?

    1. Please continue to pay lab staff as you normally would, asking staff to use the appropriate time reporting code as described in this table on the Human Resources COVID-19 FAQ page. Specifically, if your lab personnel are currently supported by your grant(s), their paid time off would also be charged to your grant. April 1, 8:35 p.m.

  17. Will the EPSLA, COVID-19, and E-FMLA paid time off benefits be available for research personnel who are full-time temps and therefore not currently eligible for U-M benefits?

    1. Temporary employees are eligible for a prorated amount based on effort. Please see the Human Resources COVID-19 FAQ page for additional information. April 1, 8:40 p.m.

  18. What percent effort should I or my exempt laboratory staff charge to my grant during a pause in research activity?

    1. Employees’ effort should initially be charged at the rate in effect at the time that the pause in research activity was announced. During the COVID-19 pandemic, as before, changes in one’s appointment are allowable (indeed required) to the extent they correspond to changes in one’s effort. April 8, 8:55 p.m.

  19. As it relates to core services and other research-related recharge operations, should I continue to charge budgeted salary and other expenses to the recharge rate even though service requests have temporarily decreased or ceased due to the research ramp-down?

    1. For the time being, continue to charge budgeted salary and actual expenses to recharge rates as you normally would.  Do not shift effort off of the recharge to other internal funds. This includes staff who are using the COVID time bank. March 30, 2:30 p.m.

  20. I am the PI on a non-federal grant, and I received a letter from the sponsor indicating they will allow charges for idled employees in excess of the benefits provided by the university. Can my lab staff take advantage of the more generous benefits allowed by this sponsor?

    1. No. Similar to other grant management issues, the university's policies prevail when they are more restrictive than what a sponsor will allow. For example, if a sponsor allows charges of up to 60 days for idled personnel, but an employee only has 50 days available of benefits for COVID-19 related idle time, the employee is not entitled to an additional 10 days by virtue of the fact that the employee is supported by this particular sponsor. April 6, 3:50 p.m.

  21. I am the PI on an award from a non-governmental sponsor (in this case a contract from a corporate sponsor), and the sponsor has been silent with regard to how the COVID-19 pandemic has impacted U-M and my research  Is it okay to charge the time and effort of idled research personnel to this project in the absence of an explicit sponsor policy? 

    1. Yes. U-M will consistently provide COVID-19 related benefits to idled research personnel, regardless of funding source, unless the sponsor states the practice is not allowed. April 6, 3:50 p.m.

  22. My sponsor has indicated that it will not allow the salaries of research personnel to be charged to my grant if they are unable to work remotely and have exhausted the various banks of COVID-19 exception time. The sponsor has even suggested issuing a Stop Work order. What does this mean for my lab staff?

    1. The answer depends on the terms and conditions of the award, particularly the termination and force majeure clauses. But generally speaking, how these matters get resolved has not materially changed since the COVID-19 crisis. If an employee exhausts their COVID-19 benefit and exception time, or if the sponsor issues a stop work order, the situation should be handled the same way it would have been handled two months ago in similar circumstances, starting with moving that impacted employees’ effort off of the grant. See also Question 7 of this section, “How should I charge my employee on a grant during the COVID-19 crisis?” April 6, 3:50 p.m.

  23. ​Can you please explain the university's COVID-19 paid time-off bank, and how does it impact my research support?

    1. The COVID-19 paid time-off bank is a benefit to U-M faculty and staff, similar to vacation/sick leave. The time-off bank is not, however, a new or existing source of funding. To be clear, grants will be charged for the cost of COVID-19 related benefits.

    2. Given that U-M employees are entitled to the COVID-19 PTO, EPSLA and/or EFMLA benefits, if a grant has insufficient funds to cover the cost of these benefits, the PI/department/school will be responsible for finding an alternative source of funding.

    3. PIs should understand that, in the absence of being allowed a time extension and/or supplemental funds from the sponsor, it is possible that they might not be able to achieve their stated grant aims/deliverables under the original time schedule. April 16, 10:05 a.m.

  24. Are principal investigators eligible to apply for paycheck protection program grants?

    1. No. April 21, 4:25 p.m.

Proposal Submission and Award Management

  1. Will my proposal still be submitted to the sponsor on time amid a COVID-19 outbreak?

    1. At present, proposals are being submitted by the Office of Research and Sponsored Projects (ORSP)/Medical School’s Grant Services & Analysis (GS&A) according to U-M’s new internal proposal submission deadline policy. In the event of a COVID-19 outbreak at U-M, proposals will still be submitted timely. ORSP and GS&A have Continuity of Operations Plans (CoOPs) to ensure proposals will be submitted amid the COVID-19 situation by having staff work remotely.

  2. Will my proposal still be submitted to the federal government on time if the federal agency to which I intend to apply is closed due to a COVID-19 outbreak?

    1. At present, all federal agencies are accepting proposal submissions as usual. In the event a COVID-19 outbreak closes a federal agency that is currently accepting proposals, we expect the agency will continue to accept proposals; however, the proposals will most likely remain in a queue (e.g., within the Grants.gov system), pending resumption of agency operations – as has been the case during recent federal budget-related shutdowns.

    2. The Council On Governmental Relations developed a webpage that features comprehensive links to key federal agencies' COVID-19 operations.

  3. Amid a COVID-19 outbreak, what level of review will my proposal receive under U-M’s new internal proposal submission deadline policy?

    1. At present, proposals are being reviewed by ORSP/GS&A according to the standards identified in U-M’s new internal proposal submission deadline policy. In the event of a COVID-19 outbreak at U-M, the standards and timelines for full and limited reviews will still be enforced, assuming ORSP/GS&A are adequately staffed. In the event that the number of available ORSP/GS&A staff is severely compromised (e.g., a COVID-19 outbreak within one of the offices), the service level standards for proposal review in the deadline policy may be temporarily suspended in favor of the timely submission of proposals.  Project Teams will be advised of any changes in level of service provided by ORSP.

  4. How can I reach ORSP or GS&A amid a COVID-19 outbreak?

    1. In the event of a COVID-19 outbreak, ORSP and GS&A employees who are working remotely will respond to emails and monitor phone calls  as normal. For ORSP staff, you should check their MCommunity profile to see their preferred method of communication. For GS&A staff, you may reach out to the individual and include msgrants@umich.edu with any questions.  Since the vast majority of the work done by the two offices will continue to be facilitated by the eResearch Proposal Management System (eRPM), staff also can be reached easily by “posting a comment” to the relevant Proposal Approval Form (PAF), Unfunded Agreement (UFA) or Award (AWD) record in eRPM.

  5. Will I be able to get an extension on a proposal deadline in the event of a COVID-19 outbreak?

    1. Most of U-M’s sponsors do not accept late proposals, and if they grant extensions, they do so on a case-by-case basis. Given that ORSP/GS&A may be working remotely, and thus operational, it may prove difficult to convince a sponsor that your circumstances warrant granting an extension. Faculty who are working on a proposal now should therefore plan on submitting by the sponsor’s stated deadline regardless of whether there is an active COVID-19 outbreak at U-M.  If you personally experience impacts from COVID-19, reviewing the sponsor's standard exception policies may be warranted.

  6. As it relates to research grants, how does the National Institutes of Health respond to natural disasters and other emergencies?

    1. With respect to proposal submissions, on March 26, 2020, NIH published the following notice:

      1. UPDATE: NIH Late Application Policy Due to Public Health Emergency for United States for 2019 Novel Coronavirus (COVID-19)

        1. ​​All grant applications submitted late for due dates between March 9, 2020 and May 1, 2020, will be accepted through May 1, 2020.  

        2. This notice applies to all relevant funding opportunity announcements, including those that indicate no late applications will be accepted. 

        3. Institutions need not request advance permission to submit late due to this declared emergency and a cover letter providing a justification is not required.

        4. For Funding Opportunity Announcements that expire prior to May 1, 2020, NIH will extend the expiration date for 90 days to accommodate the submission of late applications and Grants.gov will be adjusted to allow NIH to receive applications.

        5. Applicants should assume that late applications submitted after May 1 may not be reviewed until meetings for the January 2021 council round (e.g., October-November 2020).

    2. On March 10, 2020, NIH also published the following notice related to COVID-19:

      1. General Frequently Asked Questions (FAQs) - Proposal Submission and Award Management Related to COVID-19

        1. “This Guide Notice intends to address general questions associated with proposal submission and award management that may arise in relation to COVID-19. NIH is providing this information as a service to our applicant and recipient communities in the hopes it will address high-level questions that may arise in this regard. Please note that given the fact that COVID-19 and associated impacts continue to evolve, applicants and recipients are strongly encouraged to monitor this website for updates. NIH intends to publish detailed guidance related to administrative flexibilities and associated FAQs.”

    3. On March 12-13, 2020, NIH published the following notice and FAQ related to COVID-19:

      1. Flexibilities Available to Applicants and Recipients of Federal Financial Assistance Affected by COVID-19​​

        1. The NIH-funded U-M research community is strongly encouraged to read this NIH notice, which provides a number of important flexibilities for managing NIH awards during this public health emergency. Highlights include:
          1. Expanded use of allowable pre-award costs

          2. Extended due dates for Financial and Other Reporting (e.g. RPPRs)

          3. Waiver of certain prior approval requirements

          4. Allowance of certain costs that would normally not be allowable (e.g., stipends, salaries and benefits when no work is being performed on the project, cancelled travel costs, etc.)

      2. Frequently Asked Questions (FAQs): COVID-19 Flexibilities for Applicants and Recipients

        1. This document provides clarifying answers surrounding the newly authorized flexibilities, particularly with respect to:

          1. Application Submission

          2. Delays in Research Progress

          3. Financial and Performance Reporting (RPPR)

          4. Costs March 27, 4:10 a.m.

  7. What if a NIH-funded project requires an immediate change that affects the outcomes or trajectory of a clinical trial or human subjects research protocol? Do the changes need to be approved by the program officer?

    1. ​If you need to make changes because of safety, that’s top priority. The first administrative authority would be IRB. Do what you need to do. Then please get in contact with your program officer. Please don’t let administrative concerns with the agency get in the way of public health or patient safety. March 17, 8:20 a.m.

  8. As it relates to research grants, how does the National Science Foundation respond to natural disasters and other emergencies?

    1. ​​​Per NSF’s Proposal and Awards Policies and Procedures Guide:

      1. “In the event of a natural or anthropogenic disaster, or when NSF is closed due to inclement weather or other reason that interferes with an organization’s ability to meet a proposal submission deadline, NSF has developed the following guidelines for use by impacted organizations.”

        1. Natural or Anthropogenic Disasters: Flexibility in meeting announced deadline dates because of a natural or anthropogenic disaster that impacts a proposer’s ability to submit a proposal to NSF may be granted with the approval of the cognizant NSF Program Officer. Where possible, such requests should be submitted in advance of the proposal deadline. Proposers should contact the cognizant NSF Program Officer in the Division/Office to which they intend to submit their proposal and request authorization to submit a proposal after the deadline date. Proposers should then follow the written or verbal guidance provided by the cognizant NSF Program Officer. The Foundation will work with each impacted organization on a case-by-case basis to address its specific issue(s). Generally, NSF permits extension of the deadline by up to five business days.

        2. To submit the proposal after the deadline date, proposers must check the “Special Exception to the Deadline Date Policy” box on the NSF Cover Sheet, indicating NSF approval has been obtained. A statement identifying the nature of the event that impacted the ability to submit the proposal on time should be uploaded under Nature of Natural or Anthropogenic event in the Single Copy Document section in FastLane. If available, written approval from the cognizant NSF Program Officer also should be uploaded under the Additional Single Copy Documents in the Single Copy Document section in FastLane.

        3. Closure of NSF: When NSF is closed due to inclement weather or other reason, deadline(s) that occurred during the closure automatically will be extended to the following business day after the closure ends.

    2. NSF recently developed a webpage for the research community with detailed guidance regarding COVID-19. This includes guidance for awardee organizations, researchers and reviewers of NSF proposals. Learn more

  9. As it relates to research proposals, how is the U.S. Department of Energy responding to COVID-19 public health emergency?

    1. ​With respect to proposal submissions, on March 16, 2020, the DOE Office of Science stated in a notice related to COVID-19 that: “If the lead principal investigator (PI) or the applicant institution are subject to a quarantine or a closure, deadlines for submitting pre-applications, letters of intent, or applications may be extended by no more than fourteen (14) days from the applicable due date.” March 17, 7:55 a.m.

  10. What should I do if I am conducting a U-M Office of Research-sponsored project for which the COVID-19 conditions will likely halt or slow progress to completion within the funding period?

    1. Please direct your questions to the contact for the specific UMOR funding program. Each case will be assessed and addressed based on the project circumstances and needs.

      1. Faculty Grants and Awards (UMOR-FGA-Submissions@umich.edu)

  11. Is there a formal process for notifying sponsors about the pause in human subjects interactions if it applies to us?

    1. The determination of whether a sponsor must be notified about the pause in human subjects interactions, and the process for providing said notice, will vary by sponsor and the terms and conditions specific to the award document in question. Please familiarize yourself with the requirements of your award agreements and, if after having done so you still have questions, contact your ORSP Project Representative. March 18, 7:55 p.m.

  12. Will requests for no-cost extensions on projects need to be run through ORSP?

    1. Yes. March 18, 7:55 p.m.

  13. How might we have to proceed with grants and contracts from industry, foundations and other nonfederal entities in regard to changes in costs or expected outcomes? 

    1. Due to the heterogeneity of nonfederal sponsors, it is not easy to make a blanket statement. We advise following the general principles from federal grants (e.g., if a cost wasn't allowable on the grant in regular times, it likely won't be allowable now), but more specific issues around effects of timelines on nonfederal projects will likely have to be discussed with the sponsor. If the terms of the award need to be amended, ORSP personnel are available to help through this process and discussions. March 18, 8 p.m.

  14. Michigan Medicine has put out an urgent request for personal protective equipment and other medical supplies, and I would like to donate some lab masks that I purchased from my grant funds. May I, and is there anything special I need to do to make this donation?

    1. Yes, you may donate grant-funded supplies during this public health emergency, but please note you may need to transfer the charges to a nonsponsored fund. Before making the donation, you need to make a record of what was donated, the value of the donation and the source of funding (e.g. PGN or AWD number) used to originally purchase the donated items. March 20, 7:55 a.m.

  15. Is ORSP changing any of its business processes given the fact that many sponsors are reaching out to support U-M research related to COVID-19 or are publishing relevant funding opportunities with very short turnaround times?
    1. ORSP will prioritize the submission of any proposal related to COVID-19. As long as ORSP is given a day’s advance notice, staff will review and submit COVID-19 related proposals by the deadline, regardless of when the proposal is finalized.

    2. To ensure your document is prioritized accordingly, put “COVID-19” in the title of your Clinical Trial Routing Form (CTRF), Proposal Approval Form (PAF) or Unfunded Agreement (UFA), and alert your ORSP Project Representative by phone. See ORSP’s webpage for details on what additional information may be needed.

    3. ORSP also will prioritize the negotiation of any contract, agreement or clinical trial related to COVID-19. This commitment applies to agreements for Expanded Access/Emergency IND authorization as well.

    4. Note, as well, that all investigators who wish to carry out new or modified research projects related to COVID-19 that involve human subjects, basic laboratory or animal research, or require significant university resources to stand up, must submit a COVID-related Research Prioritization Form to UMOR’s COVID-19 committee. Please direct questions regarding this process to research.covid19@umich.edu. March 21, 9:50 p.m.

  16. The NIH FAQs indicate that research time can be used for clinical services during the public health crisis as long as it is consistent with university policy and clinical revenue is returned to the project to offset research salaries. How do I do this?

    1. The U-M institutional effort reporting policy requires that changes in functions that are >5% (or more restrictive, >3% in the Medical School) be handled by reallocating the effort in the HR system. By continuing to use this guidance, you will: be following university policy; reduce immediate cost to the project by redirecting effort to clinical activities and free up those dollars for later use on the sponsored project; and, remove the need to track clinical revenue from any services provided - which is difficult in our decentralized environment.  We do encourage you to reallocate your time as needed in discussion with your unit, note the changes, and process through the HR system as soon as it is practical to reflect the time. Depending on the final time allocation, notification may need to be made to NIH (retrospectively) if you are key personnel on the project where effort was reduced. Of note, all sponsored project effort that needs to be redirected into a clinical activity may follow the same approach above and remain compliant. March 31, 8:10 a.m.

  17. Can you summarize which federal agencies have made major changes in proposal submission and award management policies in response to the COVID-19 outbreak?

    1. The Council on Governmental Relations (COGR) maintains a matrix of agency guidance that describes how various federal agencies’ have implemented policies that are consistent with the authorities granted to them under OMB Memorandum M-20-17.

    2. Please note that, at this time, the only salary and benefit charges of idled employees that are allowable are those that use EPSLA, U-M’s COVID-19 PTO bank or Supplement, E-FMLA, or other exception time that the staff member has accrued, e.g. vacation.

    3. The federal agencies that have adopted the OMB memo (e.g., NIH, NSF, DOE, DOD) will only allow the salary and benefit costs of idled employees who have exhausted their accrued EPSLA, COVID-19 bank, personal time off, etc. if U-M has a "policy of paying salaries (under unexpected or extraordinary circumstances) from all funding sources, Federal and non-Federal.” U-M does not at this time have a policy that allows these salary charges to be incurred for all idled employees of the university. April 6, 4 p.m.

  18. I am the PI on a new NSF grant that was awarded after U-M ramped down its research operations, and I will not be able to work on the project until campus reopens and research operations resume. Since the grant includes funding for 20 percent of my effort, can I allocate my effort to the project as planned, but draw down from one of the COVID-19 related benefits that the university provides?

    1. No. The OMB memo that authorizes allocating effort to a Federal grant when an employee cannot work on the project is limited to grants that were “currently active” on the date that the memo was issued, i.e., March 19, 2020. April 8, 8:55 p.m.

  19. Are you requiring all COVID-19 proposals to be preapproved by the COVID-19 research committee before being submitted to the sponsor?

    1. No, proposals do not have to be pre-approved by the committee or the IRB before you submit to a sponsor. April 21, 4:30 p.m.

Research Involving Animals

  1. What plans are in place to ensure that the animals housed on campus will continue to receive care?

    1. The Unit for Laboratory Animal Medicine (ULAM) will maintain mechanisms for providing continued daily care to all animals housed on campus in the event of a natural disaster or other events that may interrupt normal business, including the COVID-19 situation. This includes continued veterinary medical care; assessment of animal health and well-being; provision of food, water, and clean cages; and maintenance of appropriate environmental conditions. Our top priority is to continue the provision of critical life support services that ensure animal welfare. May 1, 10:15 a.m.

  2. Can I access the animals in my facility during the ramp down in research operations?

    1. Since March 18, 2020, only COVID-19-related or other experiments deemed critical during ramp-down, as approved by the Research Associate Dean (RAD), and essential maintenance activities are currently permitted. 

    2. Once research re-engagement commences, other studies may be permitted as approved by the RAD; however, the resumption of laboratory work during this phase will be building-specific. Except for animal activities currently permitted, research staff may only enter the building(s) covered by their laboratory’s specific  re-engagement plan; vivaria in other buildings cannot be entered. 

    3. Visitor access to all animal facilities remains prohibited. May 6, 5 p.m.

  3. Since my animal research solely involves activities that are conducted in isolated areas (e.g., forests and streams), can I still perform these activities if I’m alone?

    1. U-M’s ramp down of all non-critical laboratory research activities, which went into effect on March 20, is also currently applicable to field research, which is not considered critical at this time.

    2. The Michigan Department of Natural Resources (DNR) has set a precedent by closing state fishery research facilities and limiting public access to many of their facilities in order to adhere to the recommendations provided by both Governor Whitmer and the Michigan Department of Health and Human Services. May 6, 5 p.m.
  4. How do I request veterinary care?

    1. If you have an animal in need of immediate attention, the quickest means to get in touch with on-call veterinary faculty and staff is to locate a ULAM staff member in your facility. If you are unable to locate someone in your facility:

      1. During business hours​ (Monday – Friday, 6 a.m. – 2:30 p.m.), call the ULAM Veterinary Technician Office at 734-936-1037.

      2. Outside of business hours, call the U-M Division of Public Safety & Security (DPSS) at 734-763-1131 to get in touch with the on-call veterinarian. March 18, 2:40 p.m.

  5. How will I be notified of any animal health issues during a ramp down in research operations?

    1. ULAM team members (e.g., husbandry personnel, veterinarians, veterinary technicians) will reach out to the individual designated as the Animal Health Contact in your IACUC approved protocol with any animal health issues requiring attention. Notifications will be sent using the contact information (i.e., email address, phone number) provided in the protocol. March 18, 2:40 p.m.

  6. What can I do now that COVID-19 is disrupting my animal experiments?

    1. With the exception of research related to COVID-19 that has been approved by either the COVID Research Prioritization Committee and/or Research Associate Deans (RAD), no additional studies/experiments may begin at this time. That is, no procedures may be performed on naïve animals so that we may minimize the number of animals requiring daily care.

    2. Note that IACUC approval processes remain intact for protocol changes and reviews.

    3. Once research re-engagement commences, limited additional animal work may be approved by the RAD. During initial phases of ramp-up, the following will remain in effect:

      1. ULAM will not process animal orders except for COVID-19-related studies.

      2. Breeding must remain in maintenance mode only. May 6, 5 p.m.

  7. How do I Identify My Critical/High-Priority (20%) Preserve Animals at the Cage Level?

    1. Please note that this guidance only refers to 20% of your active animal census (animals on campus) as of March 9, 2020. Any requests beyond that threshold must be approved by the ULAM Executive Director/U-M Attending Veterinarian, in consultation with an IACUC Subcommittee.

    2. To identify critical/high-priority animals at the cage level, use a sharpie marker and draw a large “S” on the cage card. The “S” should be 1-2” in height so that it’s clear to staff that it should be saved. ULAM Husbandry Supervisors are prepared to assist you in clearly identifying cages with a large “S” (save). Please contact your facility’s supervisor for additional assistance.

    3. This should have been completed no later than Friday, March 20, 2020. May 1, 10:25 a.m.

  8. Can I donate any of the animals I no longer need to the ULAM Rodent Recycling Program?

    1. ULAM is not accepting any animals into the Rodent Recycling Program at this time. March 18, 2:40 p.m.

  9. Can I still rent anesthesia machines from ULAM?

    1. Until further notice, ULAM is unable to rent anesthesia units for use on naïve animals unless the procedure is terminal. We will be providing rentals on a case-by-case basis to assist in finishing up any existing experiments. March 18, 2:40 p.m.

  10. What are the best methods for us to reduce our animal breeding colonies in response to the directives issued by UMOR and ULAM?

    1. If you are suspending breeding of commercially-available animals, try to conserve the fewest number of animals needed to maintain the strain or line. Specifically:

      1. Remove male breeders from breeding cages and identify the male

      2. Ideally, save the youngest weanlings of a strain (~3-5 weanlings, male and female in separate cages)

      3. Save one cage of female weanlings (3-5 weanlings, ideally 6-8 weeks old or youngest available) and label the cages with a “Save for Breeding” note

      4. Save one cage of male weanlings (2-3 weanlings, ideally 6-8 weeks old or youngest available) and label the cages with a “Save for Breeding” note

      5. If possible, recombine females into socially-housed cages (up to 5 per cage); females from different strains may be combined if socially compatible. Consider euthanatizing males if there are several of the same strain to reduce the number of singly-housed animals

    2. For strains that need to be maintained by breeding:

      1. It is recommended that you reduce the number of breeding cages to 2-3 cages and allow mice to continue to breed

      2. Pups should be euthanized prior to weaning except in cases in which breeder cages are being replaced due to age or poor breeding

      3. The U-M Transgenic Animal Model Core does have the capacity to provide sperm cryopreservation for valuable strains at this time. To request this service, login to MiCores (umich.corefacilities.org) and navigate to the Transgenic Animal Model Core.

        1. Click on the Request Services tab to “Mouse Cryopreservation Services” to fill out a submission form. Please contact Thom Saunders (tsaunder@umich.edu) with any additional questions. March 18, 2:40 p.m.

  11. What is an example of maintenance activities that may be performed with animals?

    1. ​Maintaining the viability of a breeding colony that includes irreplaceable lines or strains involves actions by critical personnel. This may include establishing breeder pairs, weaning of offspring, animal identification, and genotyping. All of these can be performed by a single member of the laboratory in a relatively short amount of time and are considered “critical maintenance activities.” March 24, 8:27 a.m.

  12. Can ULAM continue to feed my special diet during a ramp down in research operations?

    1. ​ULAM will continue to provide special diets if appropriate arrangements have been made with ULAM staff. We will continue to do our best to provide special diets for which we have ready access.

    2. If the diets are for clinical care (e.g., required to maintain animal welfare) ULAM will continue to provide these as a priority. March 18, 2:40 p.m.​

  13. Can I still place orders for animals through the ULAM Business Office?

    1. Effective Friday, March 13, 2020, orders for acquiring additional animals were no longer being accepted. ULAM has canceled all pending animal orders until further notice.

    2. If you have specific questions about ULAM business operations or billing, please contact ulam-questions@umich.eduMay 1, 10:29 a.m.

  14. Can I still order supplies and medications from the ULAM Business Office (e.g., isoflurane, Puralube® eye ointment, suture material)?

    1. The ULAM Business Office will continue placing orders for the critical supplies needed to ensure animal health and well-being (e.g., feed, bedding, critical care veterinary supplies), but procurement of all non-critical supplies has been temporarily placed on hold. Customers will be notified once normal purchasing operations resume. May 1, 10:30 a.m.

  15. Am I still able to take training classes through the ULAM Training Core?

    1. In accordance with U-M guidance, all in-person training classes and workshops offered through the ULAM Training Core have been canceled until further notice. Classes will be rescheduled at a later date and registrants will be notified once these changes have been finalized.

    2. Institutional Animal Care & Use Committee (IACUC) deadlines for in-person class and workshop completion will be given a grace period due to the unavailability of classes during this time.

    3. Online training classes offered through MLearning are still available during this time, and administrative staff from the ULAM Training Core are available to answer questions remotely via email or phone. May 1, 10:30 a.m.

  16. Can COVID-19 directly infect or impact research animals and/or present an exposure risk to personnel working with them?​

    1. While dogs and cats living with people diagnosed with COVID-19 in several countries have been reported to have been infected with SARS-CoV-2, infectious disease experts and multiple international and domestic human and animal health organizations continue to agree that there is no evidence at this point to indicate that, under natural conditions, pets spread COVID-19 to people.  – Source: American Veterinary Medical Association (AVMA)

    2. It is recommended that those ill with COVID-19 limit contact with animals until more information is known about the virus.

    3. Although several new research articles have been disseminated showing that some domestic animals can be experimentally infected with SARS-CoV-2 and may transmit the virus to other animals in an experimental setting, it is important to note that:

      1. Studies include a very small number of animals in an experimental setting and, therefore,

      2. Results from these studies should not be extrapolated to the potential for SARS-CoV-2 to be transmitted by companion animals kept as pets.
        – Source: AVMA

    4. ULAM veterinary personnel will continue to monitor reports on risks related to research animals and communicate those with the research community. April 23, 4:35 p.m.

  17. Will there be any disruption to the Institutional Animal Care & Use Committee (IACUC) and the review of protocols during the COVID-19 situation?

    1. The IACUC, through the Animal Care & Use Office (ACUO), is continuing to review submissions (i.e., protocols and protocol amendments) to the Committee at this time. PIs can submit and committee members can review submissions to the IACUC using eRAM.

    2. Members (e.g., the Research Compliance Associates – RCAs) of the ACUO continue to provide service to researchers remotely. Please contact the ACUO for assistance at acuoffice@umich.eduMay 1, 10:34 a.m.

  18. What will happen if my authorization (i.e., protocol approval) to use animals expires during the ramp down in research operations?

    1. The IACUC, through the Animal Care & Use Office (ACUO), is still reviewing animal use protocols from remote locations. Consequently, PIs and research teams should continue to submit protocol renewals to the IACUC in a timely manner to ensure that the Committee has adequate time to conduct reviews.

    2. If you are unable to access eRAM, you should contact the ACUO before your protocol is set to expire. A member of the ACUO (e.g., your RCA) will help with the preparation of your “new” submission. However, please note that no experimental procedures may be performed during this time. May 1, 10:35 a.m.

  19. Who do I contact with animal-related compliance questions?

    1. The Animal Care & Use Office (ACUO) continues to provide services remotely. Should you have any questions, please use the same processes you have normally used to contact the office (e.g., send an email to acuoffice@umich.edu, contact your Research Compliance Associate directly, or call the main office line at 734-763-8028. May 1, 10:35 a.m.

  20. If my protocol involves the use of USDA-covered species and/or Department of Defense (DoD) funding, will the IACUC still conduct annual reviews?

    1. Yes, all federally-mandated annual reviews will continue to be processed and reviewed through eRAM. Animal Care & Use Office (ACUO) staff and Institutional Animal Care & Use Committee (IACUC) members will facilitate and conduct these reviews remotely.

    2. If you are unable to access eRAM and cannot complete your annual renewal online, the review can be conducted via email or phone. In the event that we need to contact you, please ensure that the contact information you have provided in eRAM is up-to-date. If you need to provide an alternate means of communication and are unable to update your information in the eRAM system, please send an email to the ACUO at acuoffice@umich.edu with the relevant updates. March 18, 3:00 p.m.​

  21. Will the AAALAC Site Visit still take place as planned?

    1. AAALAC is scheduled to conduct an accreditation visit at U-M during the summer of 2020. The original plan was for the site visit to occur in either May, June, or July. Unfortunately, the disruption from COVID-19 has also affected the timing of our anticipated AAALAC Site Visit.

    2. We are currently planning for the AAALAC Site Visit to occur in either July or August. This timeframe will depend entirely on the feedback and guidance provided by local and state health officials, and AAALAC’s ability to identify site team members that are able to travel to conduct the visit.

    3. Visit the AAALAC webpage (Level-1 login required) on the Animal Care & Use Program website for the latest news, updates, and information about the Site Visit. May 1, 10:37 a.m.

  22. Knowing that animals take two weeks to arrive, will we be allowed to order animals two weeks prior to an estimated research restart date?

    1. Currently, ULAM’s animal ordering process is focused on ongoing experiments that have been approved by Research Associate Deans and new studies approved by the COVID-19 Research Prioritization Committee. Initial phases of the research re-engagement must only involve animals already in-house.

    2. Timing for the receipt of animals for future purposes has not been determined; as those plans crystallize, ULAM will notify the research community when ordering may re-commence so that animals will arrive in a timely manner.

    3. Note that ULAM will continue to carefully monitor staffing levels to ensure appropriate animal care; unexpected reduction may impact animal orders in process.

    4. For any animal orders that are expected to require additional lead-time, laboratories are encouraged to contact the ULAM procurement team (ULAM-Procurement@umich.edu). Visit the Animal Ordering & Acquisition webpage for more information. May 6, 5 p.m.

Research Involving Human Subjects

  1. Why must some human participant research studies or specific activities be paused?

    1. Given the current COVID-19 coronavirus outbreak, the need to prioritize personal protective equipment (PPE) for clinical operations, and the real or perceived risk of viral transmission, the risk/benefit ratio for in-person contact associated with research activities must be assessed for each protocol. Ethical principles of research and federal regulations for the protection of human research participants require an acceptable risk/benefit ratio. March 14, 6:45 p.m.

  2. Which studies or study procedures must be paused?

    1. Studies or study procedures involving person-to-person interaction with participants that have no direct significant ‘positive outcome’ and studies or study procedures that do not involve a drug, device or stabilization of a high-risk psychological condition (e.g., psychosis), as a therapeutic benefit, must be paused or modified.

      1. Study procedures involving in-person contact with participants or participant travel for research purposes must be paused, effective immediately (but not later than Saturday, March 14), if they do not meet the above criteria. Research interactions with participants such as telephone contact, remote monitoring or remote data collection may continue.

      2. For purposes of this pause, therapeutic benefit is defined as one in which the treatment under investigation is believed to provide direct benefit to the individual research participant such that the research activity will offer a significant ‘positive outcome’ to an individual participant (e.g., cure/reduction of disease burden or stabilization of high-risk psychological conditions such as psychosis). Refer to question 6.5 in your eResearch application to determine whether your study offers direct benefit to research participants. For studies with multiple intervention ‘arms,’ not all arms will indicate a direct benefit. Study arms with no direct benefit that include person-to-person interactions should stop. All other study arms, even those with direct benefit, may continue, but should shift all possible interactions to remote contacts, or pause study interactions until a later point in time (e.g., control groups). The goal is to eliminate unnecessary viral transmission opportunities and use of PPE. March 18, 2:50 p.m.

  3. ​​Are these simply guidelines or true restrictions?

    1. The temporary restrictions involving human subjects research are required. Please refer to the IRBMED and IRB-HSBS webpages for additional information. March 18, 2:50 p.m.

  4. Which studies may continue?

    1. Studies which offer significant direct therapeutic benefit to participants

      1. For the purpose of the pause, it is assumed that studies with investigational treatments, such as drugs and devices or stabilization of high-risk psychological conditions (e.g., psychosis), provide the potential for significant direct therapeutic benefit and should continue. Even so, to the extent possible within these studies, activities with participants (e.g., screening, follow-up) should be done remotely by telephone or other electronic interface. Submit an amendment to the IRB to indicate the temporary modifications. Or, if the change is necessary to prevent an imminent harm to the participants, the change may be instituted immediately and reported promptly to the IRB (within 5 days). Refer to the IRBMED and IRB-HSBS webpages for important guidance and additional information.

    2. Studies that do not involve person-to-person interactions with participants

      1. Studies conducted electronically or via telephone or involving secondary data analysis may continue. March 20 11 a.m.

  5. I have research staff on the study, whose work is disrupted by this pause, will they be paid?

    1. Yes, permanent staff and GSRA salaries will continue to be charged to the grant during this pause. Funding agencies are considering mechanisms to relieve this burden.

  6. My study may be impacted by the pause, which could lead to delays in completing my study by the end of the project period. What should I do?

    1. Most federal sponsors allow for a one-time no cost extension for 12 months at the end of the project. Sponsors are considering the impact of COVID-19 on project timelines.

  7. How will the pause in research impact studies conducted outside of a U-M setting, both domestic and international?

    1. If a study is deemed to have potential direct therapeutic benefit (i.e., use of investigational treatments, such as drugs and devices or stabilization of high-risk psychological conditions (e.g., psychosis)) for individual participants, the study may continue, unless there is concern that the risks from COVID-19 outweigh the potential benefits to participants. Evaluate each study for opportunities to reduce person-person contact. Submit an amendment to the IRB to indicate the temporary modifications. Or, if the change is necessary to prevent an imminent harm to the participants, the change may be instituted immediately and reported promptly to the IRB (within 5 days).  Refer to the IRBMED and IRB-HSBS webpages for important guidance and additional information.

    2. All other domestic studies involving person-to-person interactions must be paused, unless research procedures are modified to eliminate direct interactions with participants.

    3. All other research in international settings (social/behavioral/biomedical research with no direct therapeutic benefit) must be paused or modified as described below:

      1. For projects where an international collaborator is responsible for the direct interaction/intervention with participants, or where U-M and international researchers are conducting such interactions together, the local COVID-19 situation must be considered. The study team should seek guidance from the local IRB or research ethics review board regarding the continuation of the research and share this information with the U-M IRB. In areas with high-risk for COVID-19, projects involving person-to-person contact should be paused or use modified procedures to eliminate the need for person-to-person contact. Investigators must monitor the changing COVID-19 situation.

      2. For projects where independent U-M researchers, such as anthropologists, are already in country and actively involved in person-to-person subject interactions independently, the research must be paused and procedures modified to eliminate person-to-person interactions, unless the investigator can demonstrate that the research is being conducted in an area of low risk for COVID-19. Investigators must monitor the changing COVID-19 situation. March 20, 11:05 a.m.

  8. What if my study doesn't clearly fall into any of these categories?

    1. Contact the IRB to discuss the ethical basis/demonstrated need for continuing the study and a plan for minimizing person-to-person contact. March 18, 2:50 p.m.

  9. Should social-behavioral and observational studies be paused?

    1. Yes, if they have person-to-person contact. March 18, 2:50 p.m.

  10. May we continue to collect data and follow up with subjects by telephone when in-person data collection has been paused?

    1. Yes

  11. May we continue conducting telephone screening of potential subjects?

    1. Yes

  12. May we conduct home visits to collect data in studies with no potential therapeutic direct benefit (drug or device)​ to participants?

    1. No

  13. May we enroll new subjects on existing studies not subject to the pause?

    1. This should be decided on a study-by-study basis. The risk/benefit ratio for subjects may have changed from the time at which the protocol was reviewed and approved.

  14. May we submit a new study for IRB review that involves direct therapeutic benefit and utilizes a drug, device or stabilization of a high-risk psychological condition, but is not intended to study or treat COVID-19?
    1. New studies may be submitted for IRB review that are not COVID-19 related. However, the IRB will prioritize their review based on available resources and any current restrictions. New studies approved by the IRB may not begin enrolling if they are prohibited to do so under the current research restrictions. New IRB-approved studies intended to provide direct therapeutic benefit per the research restriction policy may initiate enrollment within the boundaries of any current restrictions – however, PIs must evaluate the risk/benefit circumstances for research participants and U-M staff while PPE and personnel resources are limited and the risk of viral transmissibility is high. March 20, 11:10 a.m.

  15. Must the IRB approve amendments to the study protocol before implementing changes?
    1. Submit an amendment to the IRB to indicate the temporary modifications. Or, if the change is necessary to prevent an imminent harm to the participants, the change may be instituted immediately and reported promptly to the IRB (within 5 days). Refer to the IRBMED and IRB-HSBS webpages for important guidance and additional information. March 20, 11:10 a.m.

  16. Is an amendment necessary if I wish to change the mode of data collection for my exempt study?

    1. No, amendments to change from person-to-person to phone or electronic data collection are not required. Do not submit amendments for these studies. March 18, 2:55 p.m.

  17. Do we need approval from the IRB for communications to study subjects explaining the pause in activities?

    1. No. It is not necessary to submit a modification.

  18. If I am pausing study procedures on a project reviewed by an external IRB of Record, must I notify that IRB?

    1. Yes, as soon as feasible, for their awareness. The IRB of Record may require review/approval prior to resumption of study procedures.

  19. Where can I find more information about FDA-regulated research regarding the COVID-19 situation?

    1. ​Please refer to the FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic webpage. March 19, 1:55 p.m.

  20. I am conducting FDA-regulated research for which I am the sponsor of an IND or IDE. Do I need to notify the FDA if I pause my study?

    1. Yes. The FDA will need to be notified as soon as feasible. Contact the MICHR IND/IDE Investigator Assistance Program (MICHRMIAP@med.umich.edu) for specific guidance and information on the notification process.

  21. Should I notify the industry sponsor if my research activities are paused on my clinical trial?

    1. If the study needs to be paused, the sponsor will need to be notified as soon as feasible. Utilize the standard process for informing sponsors of changes to the research.

  22. Will the pause or change to the method of data collection be considered a protocol violation?

    1. You should inform the study sponsor and/or the overall PI of the study of the modified procedures and what documentation requirements will need to be modified (e.g., changes to CRFs, etc.).  IRB approval should be sought for the modifications and any deviations that occurred prior to IRB approval should be reported per standard IRB guidance based on the significance of the deviation (major or minor). 

  23. What are some considerations for communicating with study sponsors?

    1. Contact study sponsors/industry for study-specific information on how to continue the study or pause the research

    2. Obtain sponsor guidance for study conduct, including:

      1. Changes in reporting requirements

      2. Sample storage and shipping

      3. Drug shortages or delays in shipping

      4. Alternative safety assessments due to delays

      5. Delayed or missed participant contacts/visits

      6. Changing the study procedures with appropriate IRB approval

  24. If a research study involving human subjects is not providing medical treatment for a disease, should it be paused? If so, does this include studies with pharmacologic and nonpharmacologic self-management for diabetes or cancer symptoms?

    1. Yes, the study would be required to pause if it offers no direct therapeutic benefit and the interventions with the participants cannot be transitioned to procedures that avoid person-person contact. If data collection can continue through remote interactions with the participants, the study may continue (submit an amendment to the IRB for review and approval of the modifications).

  25. I am involved in research projects that focus on influenza and other viruses, and am actively working directly with the CDC and/or NIH to utilize their study infrastructure/participant contact to also measure and study coronavirus. Can these projects proceed under the new restrictions for human subjects research?
    1. ​Yes, studies actively involved in studying influenza and COVID-19 are permitted to proceed and are an exception to the new restrictions for human subjects research. Investigators should work with the reviewing IRB to amend the studies as appropriate. March 20, 11:15 a.m.

  26. Given the new restrictions on human subjects research, does this also impact U-M research sites that have subawards through the university? Each site has their own/local IRB approval and we only send money.

    1. As these sites are under the oversight of their local institutions/IRBs, they should be informed of the university's pause, but they would make an independent decision as to whether to proceed with research activities at their site. March 14, 6:45 p.m.

  27. My laboratory requires blood draws for our research studies. Do we need to halt all blood draws?

    1. This research activity would need to stop as there is no direct therapeutic benefit to the research participant and it includes person-to-person contact and the use of PPE. March 15, 1:05 p.m.

  28. ​I am interested in conducting research related to COVID-19. What is required?

    1. The COVID Research Prioritization Committee was established to review and prioritize new or modified research projects related to COVID-19 that involve human subjects, basic laboratory or animal research, or require significant university resources to initiate. To receive committee review, please complete the following form.

      1. In addition to the Prioritization Committee approval, all appropriate regulatory approvals are required prior to initiating any studies related to COVID-19 (e.g., IRB, IBC, IACUC). Contact the relevant office for additional guidance.

      2. Working with the live infectious SARS-CoV-2 virus (causative agent of COVID-19) in culture is considered permissible only at BSL3. Contact the EHS Biosafety Officer at 734-647-1143 for information regarding the use of the U-M BSL3 facility, anticipated activation date and operational capacity for these facilities.

      3. Other manipulations that do not involve virus propagation, such as inactivation, extractions and PCR, are considered BSL2 and require the use of a biosafety cabinet for the inactivation step. Learn more about CDC guidance.

      4. If the proposed research involves a clinical trial, it must also undergo review by the COVID-19 Clinical Trial Feasibility Review Committee to evaluate the ability of the PI to conduct the trial in the current circumstances.  Factors considered include scientific evidence to support the research, PI experience with clinical trials, sufficiency of funding, FDA requirements, study logistics, and overlap with other IRB approved COVID-19 studies. May 6, 5:05 p.m.

  29. ​​If a research study is testing a drug or device in a blinded, randomized controlled trial (RCT), but one group is receiving placebo or standard of care (SOC) therapy, may the trial continue if there is direct benefit in the intervention group?

    1. For clinical trials involving an investigational agent with a SOC or placebo arm, there is direct benefit and a pause is not recommended. The study team should consider all research interactions and interventions, and consider eliminating any visits or specimen collections that are not strictly necessary for safety or endpoint determination.

    2. For ‘no more than minimal risk’ comparative efficacy research, without direct benefit, involving two or more standard of care procedures, the potential risks to study team members in research interaction or specimen collection may outweigh the potential benefits. The study should pause. March 16, 5 p.m.

  30. Can biospecimen collection for research continue under this pause?

    1. No, if the collection is only for a biorepository and the specimen collection is performed by U-M personnel, even if the research is indicated as minimal risk.

      1. There is no direct therapeutic benefit and

      2. Requires additional person-to-person contact between research participants/research personnel and

      3. Utilizes additional PPE that may be in short supply.

    2. Yes, if biospecimen collection is conducted remotely by the participant and sent to the research laboratory. For example, a cheek swab mailed from the participant (at home), to the research laboratory.

      1. There is no direct therapeutic benefit, but

      2. There is no person-to-person contact between research participants/research personnel and

      3. There is no additional use of PPE

    3. Yes, if the collection is completed as part of an IRB-approved clinical research protocol at the time of clinical care. For example, collecting an extra tube of blood at the time of a necessary clinical blood draw.

      1. There may or may not be direct therapeutic benefit, but

      2. The collection does not involve additional person-to-person contact between the research participant and research/clinical personnel and

      3. There is no additional PPE required beyond what is utilized at the clinic visit when the specimen is collected

    4. Yes, if the biospecimen collection is already occurring as part of clinical care and a portion is secondarily allocated for research. For example, to-be discarded blood or cerebrospinal fluid (CSF).

      1. There is no direct therapeutic benefit, but

      2. The collection does not require additional person-to-person contact with the patient and clinical personnel and

      3. There is no additional use of PPE beyond what is utilized for clinical care when the specimen is collected

    5. If a patient has suspected or confirmed COVID-19 infection, direct collection or secondary use of research biospecimens may be permissible per information in FAQ No. 27 (which includes IRB approval and other biosafety requirements). March 18, 4 p.m.

  31. What is our responsibility related to people who may have been exposed to COVID-19 by research personnel? What should our process be if we hear, for example, that a significant other of our research assistant tested positive and, in the interim, had been working with study participants? Who is responsible for notifying the study participants or all other people that have been exposed?

    1. If a patient tested positive for COVID-19, the health department will take the lead in determining who else requires notification. EHS can assist to discuss with the county, if necessary. March 17, 12:50 p.m.

  32. Where can I find answers about how to manage my human subjects research protocols and changes amid the COVID-19 situation?

    1. Please refer to the IRBMED and IRB-HSBS webpages, which include information regarding changes in workflows and additional guidance involving U-M human subjects research amid the COVID-19 situation.

  33. The University of Michigan is the IRB of Record in a multi-site research study. Do I need to inform the external sites and must they pause under the U-M research restriction?

    1. U-M IRBs are providing notice of the research pause where we are the IRB of Record. These external sites are encouraged to undertake similar restrictions. Sites are to asked to submit information to the U-M IRB as to the current status of research at their institution. March 20, 11:15 a.m.

  34. ​Who can I contact if I need help in arranging for incentive payments to subjects?

    1. The Human Subjects Incentive Program (HSIP) is operating remotely and can be contacted at subject-incentives@umich.edu.

  35. I have a study that is registered in ClinicalTrials.gov and is undergoing a long-term pause due to COVID-19. What should I report in ClinicalTrials.gov?

    1. Please refer to the institutional guidance on suggested updates to ClinicalTrials.gov status information based on study situationApril 9, 1:15 p.m.

  36. ​My proposed COVID-19 research project will likely qualify for an IRB exemption or involves an amendment to an existing exempt project. Must I submit my project to the COVID-related Research Prioritization Committee?

    1. Yes, COVID-related exempt research must be registered with the COVID Committee using the COVID-related Research Prioritization Form, but may be submitted to the IRB concurrently. The IRB may issue the exemption determination before the prioritization decision is returned by the Committee and researchers may begin work on projects that do not involve face-to-face interactions with participants. April 6, 1:40 p.m.

  37. ​What are the considerations with respect to study monitoring and/or auditing activities?

    1. All internal and external monitoring and auditing activities must be converted to remote-only procedures. Communications may occur via secure email and video conferencing and record review may be completed via access to existing electronic records or by a secure exchange of files and data. Exceptions may be allowed in circumstances of significant concern and only in areas where it would not violate institutional or state mandates.

    2. Additional information about monitoring may be found on the Clinical Trials Support Office website. April 16, 5:20 p.m.

  38. How will the IRBs keep up with the number of new applications and amendments as a result of the COVID-19 pandemic?

    1. The IRBs are functioning remotely and have implemented a number of processes to facilitate the review process for COVID-related submissions. Consult the IRB websites for specific COVID-related amendment procedures. April 21, 4:30 p.m.

  39. For survey research that is allowed to continue, which would normally involve phone consent preceded or followed by a mailed consent form, we considered amending to email consents to people. Is the expectation that we should use Sign Now for this research?

    1. Contact your IRB to discuss the appropriate consent process for your study. Many surveys and other minimal risk projects qualify for a waiver of documentation of informed consent, meaning that obtaining a copy of a signed informed consent document is not required. The consent information can be emailed to the participant without the requirement that a signed document be returned. If signed consent is necessary, SignNow is a HIPAA and FDA compliant option to route the informed consent to participants for their signature. April 21, 4:30 p.m.

  40. I have submitted an IRB application already because I plan to interview subjects this fall, so do I need to do anything differently? Will approval for this just be delayed?

    1. The IRBs are functioning remotely and are accepting applications for new research. The IRBs are prioritizing the review of new COVID-related research and amendments related to COVID-19, but are processing all submissions. April 21, 4:30 p.m.

  41. As a psychologist conducting human subjects research unrelated to COVID-19, under the new prioritization guidelines: A) can old studies be amended to be online/remote (if so, how?) and B)will new online/remote studies unrelated to COVID-19 be approved in the current climate?

    1. A) Existing studies unrelated to COVID-19 can be amended to change the mode of data collection to remote/online methods. Amendments are not required to change the mode of data collection for some exempt studies. Consult the IRB websites for specific amendment procedures for changes to research because of the face-to-face research restrictions. B) The IRBs are functioning remotely and are accepting applications for new research. The IRBs are prioritizing the review of new COVID-related research and amendments related to COVID-19, but are processing all submissions. April 21, 4:35 p.m.

Research Commercialization/Technology Transfer

  1. Can I still submit invention disclosures to the Office of Technology Transfer (OTT)?

    1. Yes, Invention Disclosures will be accepted through OTT’s online portal. There is currently no disruption to this process.

  2. Is OTT able to file rush patent applications in advance of a pending publication or other public disclosure?

    1. Yes. However, to ensure good communication, requests for rush patent filing should be sent to both your OTT Case Manager and to techtransfer@umich.edu. With the rapidly changing COVID-19 situation and the potential for U-M’s external law firms potentially having disrupted operations, it is more important than ever to provide as much lead time as possible prior to public disclosures.

  3. If a U-M innovator has an urgent question about a patent application, can I contact OTT’s outside patent attorney directly?

    1. Please forward these questions to your OTT Case Manager and to techtransfer@umich.edu. We will do our best to respond in a timely fashion and to connect you with the outside patent attorney in a coordinated fashion.

  4. Will licensing activities relating to my invention continue during the COVID-19 research ramp-down?

    1. Yes, OTT is functioning at full capacity as a distributed team during the COVID-19 shutdown. May 6, 5:05 p.m.

  5. Will deadlines imposed by governmental patent offices be extended during this time?

    1. You should always assume that a deadline previously described to you still applies. OTT, U-M General Counsel and outside patent counsel continually monitor for patent office closures or changes in applicable deadlines, and there will be cases in which we are able to extend deadlines if necessary, but it still will be best to respond by the original deadline. 

    2. Importantly, while there are sometimes ways for us to receive additional time to take action with respect to a pending application (e.g., under existing or emergency rules), we must assume this does not apply to the filing of new patent applications in advance of publications or new prior art. So, everyone involved should work with our patent counsel to secure timely filing of new applications during this period. May 6, 5:05 p.m.

  6. Will OTT still negotiate a Material Transfer Agreement so that I may share or receive materials during this time?

    1. If you are conducting University-approved research, then OTT will negotiate and execute a Material Transfer Agreement for you to send or receive materials.  Investigators are responsible for ensuring that research is permitted during the COVID-19 research ramp-down period. May 6, 5:05 p.m.

Undergraduate Student Research

  1. Are undergraduates allowed to conduct research on campus?

    1. No, undergraduates are not permitted to perform laboratory research at this time. May 6, 5:10 p.m.

  2. I was wondering if it might be possible to hire a student (who does not have a I-9 on file) without requiring them to physically go to HR and sign the paperwork at this time? In my case, the student and I can work fine remotely, she is set to graduate in a year and we have work that we would like to finish.

    1. Information about the university's Remote I-9 Process can be found here. If, after reviewing this information you need additional assistance, please contact the Shared Service Center. April 21, 4:35 p.m.

Graduate Student and Postdoctoral Research

Whenever possible, faculty are expected to serve as primary critical personnel during this ramp down phase, and tasks at this time should not be delegated to graduate students and/or trainees. Graduate students and/or trainees can serve in backup roles in the event faculty become ill. The exception involves instances in which graduate students have certain technical expertise that cannot reasonably be transferred to faculty.

  1. I am a graduate student and am uncertain as to what is happening in my research lab. When will it reopen?

    1. Please communicate with your faculty mentor/PI about the status of your research lab. Graduate students and faculty mentors/PIs should work together to develop a mutually agreeable plan that allows for the student to return to on-campus research. The student’s graduate program or department can help by providing specific guidance for the development of work plans describing the ramp up and ensure that the ramp up in activity is accomplished in a safe and equitable manner with the exception of critical activities. May 6, 5:35 p.m.

  2. The COVID-19 situation will impact my graduate research and/or dissertation. What should I do?

    1. We will work to mitigate any challenges that the COVID-19 situation creates in completing research projects and/or dissertations on time. Labs and other employers that are expecting you to arrive after you defend your dissertation should be understanding of the delays due to the pandemic. We encourage open communication to ensure agreement about procedures for graduate student researchers. We ask all faculty to work with students to accommodate their particular situations, while helping each student continue their research path under the current circumstances.

    2. Remember that research and scholarship involves many activities that can occur remotely, including literature reviews, experimental design, data analysis, reading the literature use of digitized archives and other online research and data collections, video and phone interviews, and writing (this is a great time to be thinking about the introductory chapter of your dissertation). We ask all faculty to work with graduate students to allow flexibility with regard to where research is performed.

    3. More information of specific interest to graduate students is available on the Rackham Graduate School websiteMarch 18, 3:40 p.m.

  3. I am a graduate student research assistant and am participating in a research project that has been paused. Will I continue to receive pay?

    1. ​​​​In general, the answer is “Yes,” your grant will likely be required to cover the costs incurred during a reduction in operations -- provided U-M would likewise require a nonsponsored fund to pay for the same cost in similar circumstances. May 6, 5:35 p.m.

  4. My study may be impacted by the pause, which could lead to delays in completing my U-M graduate degree or professional certification. What resources are available to me?

    1. Rackham Graduate School has posted guidance on its website. Please consult with your faculty adviser or the administrator of your certification program for available options.

  5. I understand that postdocs are to be entitled to the same benefits as other university employees. Where can I find this information?

    1. Per U-M HR's COVID-19 webpage (see the section entitled "Paid Time Off Programs for COVID-19"), postdoctoral fellows are eligible for EPSLA, U-M COVID-19 PTO, U-M COVID-19 PTO Supplement and E-FMLA. April 21, 4:40 p.m.

  6. I have postdocs and graduate students who are currently supported by NIH grants, but they cannot do their experiments. They do not have sufficient computational work to do. Can they be on NIH grants while not working for NIH projects? Will NIH provide supplemental funds because now we have to pay NIH-supported people who are not working for the NIH projects?

    1. Generally, postdocs and graduate students who cannot do their lab experiments should be directed to work remotely on grant-related activities which can also include things like training, literature reviews, paper and proposal writing. If it is not possible for them to work remotely, it is allowable for them to be supported by the grant, as long as they have not exhausted their various COVID-19 benefits.

    2. Unless expressly disallowed by the sponsor, federal and non-federal grants will continue to assume the costs of postdoc and grad student salaries and benefits, including benefits related to COVID-19. If the sponsor doesn’t allow, postdoc and graduate student salaries and benefits should be handled the same way they were prior to the pandemic when a sponsor won’t allow a cost or refuses payment -- by moving their appointments to another source of funding. If the new source of funding is another sponsored project, however, the trainee must perform work directly related to that project and not the original grant. April 21, 4:40 p.m.

  7. Recognizing the challenge in keeping up with rapidly changing policies, the U-M Medical School's Office of Graduate & Postdoctoral Studies developed an online resource that includes information that directly impacts its postdoctoral research fellows.

    1. COVID-19 Postdoc Policy Updates - FAQs

Controlled Substances

  1. What should I do with my controlled substances during a ramp down in research operations?

    1. Just as at any time when authorized personnel are not present, all of your controlled substances must be securely stored in a locked, substantially constructed safe, drawer, or cabinet (or as previously approved by your Controlled Substance Monitor). March 18, 5:50 p.m.​

  2. I am concerned about a possible theft of controlled substances from my lab. What should I do if controlled substances are lost during this time?

    1.  Do all of the following in this order:

      1. Notify the U-M Division of Public Safety & Security (DPSS) at 734-763-1131. DPSS will take a report and conduct an investigation

      2. Obtain the following information from DPSS:

        1. UMDPS report number

        2. Investigating officer's name

        3. Officer's phone number

      3. Notify the UMOR Controlled Substance Monitors via pager at 734-936-6266

        1. Enter 31685, then enter your return phone number

        2. The Controlled Substance Monitors will assist in reporting the incident to the DEA, if applicable.  March 18, 5:50 p.m.​

  3. I have been contacted by the State of Michigan or DEA to inspect my storage location and records. What should I do?

    1. Contact the UMOR Controlled Substance Monitors immediately via pager at 734-936-6266

      1. Enter 31685, then enter your return phone number

      2. They will assist you through the inspection process. March 18, 5:50 p.m.​ 

  4. I have a controlled substance monitoring visit scheduled during the ramp down in research operations. What should I do?

    1. Routine monitoring visits will not occur at this time. Please email cs-monitors@med.umich.edu to reschedule. March 18, 5:50 p.m.​

  5. I have a controlled substance pickup scheduled during the ramp down in research operations. What should I do?

    1. ​Continue to securely store your controlled substances and email EHSControlledSubstanceDisposal@umich.edu to reschedule your pickup date. 

    2. If a controlled substance pickup is required (i.e., the registrant is leaving U-M or will retire the license and registration), email cs-monitors@med.umich.edu. May 1, 10:46 a.m.

  6. I have a question about using controlled substances in research. Who should I contact?

    1. The UMOR Controlled Substance Monitors are working remotely during the ramp down in research operations. To reach them, please email cs-monitors@med.umich.edu.

    2. Additional information can also be found on the UMOR Controlled Substances Monitoring Program webpageMay 1, 10:47 a.m.

  7. The State of Michigan Annual Controlled Substance Inventory is due to be completed between April 1-June 30, but my lab is working remotely. What should I do?

    1. You do not need to complete the State of Michigan Annual Inventory at this time. As communicated to U-M by the Michigan Department of Licensing and Regulatory Affairs, under an Executive Order issued by Governor Whitmer, in-person activities that are not necessary to protect or sustain life must be suspended. This includes coming to work solely to complete the State of Michigan Annual Inventory.

    2. You will have two months after the Executive Order has expired or is rescinded to complete the inventory. You will receive a reminder from the CS Monitoring Program at that time.

    3. Please contact the Controlled Substance Monitors at cs-monitors@med.umich.edu if you have questions. May 1, 10:50 a.m.

Questions?

  1. If there are additional FAQs that you have and which may be applicable to others as part of the research guidance document, please send them to research-news@umich.edu.

  2. If you receive a media inquiry about your COVID-19 research, or about how your research is being impacted by the ongoing COVID-19 situation, please reach out to our communications offices for guidance and support prior to responding.

    • ​​​If you are part of Michigan Medicine, please contact the Michigan Medicine Department of Communication at (734) 764-2220 or DeptComm-PR-Team@med.umich.edu.

    • If you are not part of Michigan Medicine (e.g., any central campus school/college/unit), please contact the U-M Office of Public Affairs at (734) 936-5190 or public.affairs@umich.edu.