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COVID-19 Research Operations

Last Updated: 7 p.m. on September 23, 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. 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. Can PPE be charged to NIH grants?

    1. Personal Protective Equipment (PPE) and related supplies are normally indirect costs, especially when donning PPE is at the discretion of the employee or is not integral to the conduct of the sponsored project. However, these items may be allowable as direct costs on a sponsored project if they are necessary to achieve the project's objectives. As with all other U-M expenses, if PPE and related supplies are used for multiple projects, then they must be allocated to each project in proportion to the "relative benefit" each project receives using a defensible and documented allocation methodology.

      Notwithstanding the above, project teams should be aware that sponsors may have policies that put additional restrictions on direct charging of PPE. For example, the National Institutes of Health recently published NOT-OD-20-164 that allows for necessary PPE to be treated as a direct cost, but only if the expense of acquiring the PPE is below $500K and if the funded project is a clinical trial or clinical research. Certain NIH institutes are even more restrictive. The National Institute of Allergy and Infectious Diseases' position on PPE has led them to return non-clinical proposals that request funding for PPE on the grounds that they do not comply with NOT-OD-20-164. Applicants to NIAID may therefore wish to consult with the sponsor prior to proposal submission. September 23, 7 p.m.

  3. 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.

  4. 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.

  5. 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.​​

  6. 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.​​

  7. 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.​​

  8. 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.​​

  9. 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.​​

  10. ​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.​​

  11. 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.​​

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

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

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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. Please refer to the U-M Environment, Health and Safety website for more details about research facilities and laboratory safety amid COVID-19.

  2. What types of research activities are allowed to take place on campus?

    1. Most types of research and scholarship that require activities to take place on site have started a phased re-engagement process, including research in laboratories and studios, field research and human research. Please refer to the university's research re-engagement webpage for specific guidance by type of activity, as well as FAQs. June 18, 1:20 p.m.

  3. ​Will service personnel from vendors be allowed into buildings to perform maintenance or service of instruments?

    1. Yes, maintenance and service workers will be allowed in buildings. Please ensure any such workers needing access to buildings are approved by your chair or research associate dean, and they will have to follow all U-M screening procedures per state regulations. June 18, 1:20 p.m.

  4. Can researchers enter buildings after hours in cases of emergencies, such as when an alarm for an instrument is received remotely?

    1. In the case of an emergency with equipment, researchers may enter buildings using their Mcard after hours, assuming social distancing protocols are followed. June 18, 1:20 p.m.

  5. Can I continue my research remotely?

    1. ​All work that does not need to be done on site (on campus or at a remote location) must continue to be performed from home. This includes many aspects of research (analysis, computational work, etc.) and scholarship. Hazardous materials (chemical, biological or radiological) or laboratory equipment are prohibited from being removed from campus. June 18, 1:20 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 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 the school/college, department or grant. July 14, 2:45 p.m.

  2. I am a principal investigator and am wondering who approves the use of the 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. July 14, 2:45 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. Most (in general) COVID-19 related paid time off options (EPSLA, COVID-19, E-FMLA) are university benefits that can be treated as an allowable cost on university grants and contracts. The one exception to this rule is paid time off because there is no work for an employee to do (i.e., an “idled employee”).

      Effective June 7, the timecode for the Federal Emergency Paid Sick Leave Act (PEL) cannot be used for idled employees.

      Effective June 17, the timecode for Regular Pay Not Worked (RPN) cannot be used for idled employees appointed to a federal award. RPN can, however, still be used on federal funds for other authorized purposes.

    2. 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 (e.g., Federal agencies no longer allow idled employees to be charged to the grants they award). 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.

    3. 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. July 14, 2:45 p.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. 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 an employee and the employee is appointed to a federal award, PIs should know that another source of funding will be required to cover the cost of the employee’s idle time. July 14, 3 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 -- if not from federal funds -- using the 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. July 14, 3:35 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. 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.

  11. 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.

  12. 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.

  13. 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.

  14. I have a temporary employee/student worker who no longer has available work 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 no longer has available  work on a sponsored project, the principal investigator (PI) should first determine if the individual can be legitimately reassigned to non-federal sponsored 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’s appointment may need to be terminated . 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 FAQJuly 14, 3:35 p.m.

  15. I understand there are 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. With the exception of RPN time on federal funds for idled employees, if your lab personnel are currently supported by your grant(s), their paid time off would also be charged to your grant. July 14, 3:35 p.m.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. I am the PI on an award from a non-federal 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.

  21. 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.

  22. ​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.

  23. 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 June 16, 2020, NIH published the following:

      1. “NIH has announced an updated late policy for the parent institutional training grants which have just a single due date each year. In addition, some NIH ICs have issued late notices for specific funding opportunities, which are posted on the Coronavirus Disease 2019 (COVID-19): Information for NIH Applicants and Recipients of NIH Funding website. For all other Funding Opportunity Announcements NIH is taking a very flexible stance for applications submitted within the standard two week late policy. Applicants should include a cover letter with an explanation for the late submission.” July 14, 3:50 p.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)

      2. Mcubed (MCubedinfo@umich.edu) June 18, 1:30 p.m.

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

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

  12. 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.

  13. 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. Until August 17, 2020, per this announcement, 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. Proposals received on or after August 17, 2020, will be handled in accordance with our standard deadline policy.

    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. August 5, 3:20 p.m.

  14. If my COVID-related proposal was in ORSP review prior to August 17, 2020, will it then be subject to the standard deadline policy that resumes on that day?

    1. No. Items submitted to ORSP before the 17th are exempt from the standard deadline policy. This will apply to proposals submitted to ORSP for review on or after Monday, August 17. August 5, 3:20 p.m.

  15. 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.

  16. 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.

Research Involving Animals

  1. Please refer to the U-M Animal Care website for important FAQs about animal-related research amid COVID-19.

Research Involving Human Subjects

Please refer to the university's research re-engagement webpage for important FAQs about human research reactivation efforts.

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

    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 pandemic. Please also see the Human Research Reactivation guidance here for information on restarting studies that were paused due to COVID-19. June 18, 5:20 p.m.

  2. Can biospecimen collection for research continue if my human research study is not yet reactivated?

    1. Not 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. Biospecimens collected remotely by the participant (e.g., cheek swabs) can be sent to the research laboratory. Biospecimens can also be collected as part of an IRB-approved clinical research protocol at the time of clinical care (e.g., an extra tube of blood at the time of a necessary clinical blood draw) or other if the biospecimen collection is already occurring as part of clinical care and a portion is secondarily allocated for research (e.g., to-be discarded blood or cerebrospinal fluid). June 18, 5:20 p.m.

  3. May we continue to conduct telephone screening of potential participants, collect data, and follow-up with participants by telephone instead of in-person data collection after the study is permitted to activate?
    1. Yes.

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

    1. Yes.

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

    1. Not until the study is reactivated under the formal reactivation process.

  6. May we submit a new study for IRB review 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 in association with the Tier structure of the reactivation process and available resources. New studies approved by the IRB may not begin enrolling until they are permitted to do so under the reactivation process.  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. June 18, 5:20 p.m.

  7. Must the IRB approve amendments to the study protocol before implementing changes?

    1. Submit an amendment to the IRB to indicate the modifications and obtain approval. 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.

  8. 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.

  9. If I am reactivating 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.

  10. 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 webpageJune 18, 5:20 p.m.

  11. I am conducting FDA-regulated research for which I am the sponsor of an IND or IDE. Do I need to notify the FDA when I reactivate 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.

  12. Should I notify the industry sponsor that I plan to resume research activities on my clinical trial?

    1. The sponsor will need to be notified as soon as feasible. Utilize the standard process for informing sponsors of changes to the research.

  13. Will a 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). 

  14. 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. Study start-up after the pause

      2. Changes in reporting requirements

      3. Sample storage and shipping

      4. Drug shortages or delays in shipping

      5. Alternative safety assessments due to delays

      6. Delayed or missed participant contacts/visits

      7. Changing the study procedures with appropriate IRB approval

  15. Given the reactivation plan for 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 reactivation of the research, but they would make an independent decision as to whether to proceed with research activities at their site. June 18, 5:20 p.m.

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

    1. Complete all of the necessary regulatory applications for human participants, basic laboratory, or animal research and complete the Reactivation application process if working with human participants.

    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.

      1. 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. March 30, 7:30 a.m.

  17. ​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 will provide contact tracing for U-M employees aiding the county. June 18, 5:20 p.m.

  18. The University of Michigan is the IRB of Record in a multi-site research study. Do I need to inform the external sites of the research reactivation?

    1. Yes, provide notice of the research reactivation where we are the IRB of Record. Sites should  submit information updates to the U-M IRB as to the current status of research at their institution. June 18, 5:20 p.m.

  19. ​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.

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

    1. All internal and external monitoring and auditing activities should be conducted in the safest manner possible which may mean remaining as a remote-only procedure. 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. Contact sponsors to determine their plans for monitoring. Additional information about monitoring may be found on the Clinical Trials Support Office website. April 16, 5:20 p.m.

  21. ​How will the IRBs keep up with the amendments for reactivation as a result of the COVID-19 pandemic?

    1. The IRBs are functioning remotely and have implemented a number of processes to facilitate an efficient review process for these circumstances. Consult the IRB websites for specific reactivation amendment procedures. April 21, 4:30 p.m.

  22. 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.

  23. 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.

Research Commercialization/Technology Transfer

  1. Please refer to the U-M Technology Transfer website for important FAQs about research commercialization efforts amid COVID-19.

Graduate Student and Postdoctoral Research

Graduate students and faculty advisers should refer to guidance and resources from Rackham Graduate School, including guidance for research and scholarship during COVID-19 and frequently asked questions.

Postdoctoral researchers are considered staff and must therefore work first through their immediate supervisor to discuss plans for re-engaging in research activities. For postdocs in the Medical School, please see the Office of Postdoctoral Studies' COVID-19 Postdoc Policy FAQs. For postdocs in other schools or colleges, please see your individual unit for guidance and Rackham Graduate School’s resources of postdoctoral fellows.

  1. ​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. 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 website. March 18, 3:40 p.m.

  2. My study was 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. June 18, 5:05 p.m.

  3. 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.

  4. ​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.

References and Resources

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.