The situation involving coronavirus is rapidly changing, so the Office of the Vice President for Research has developed this web page to help Indiana University faculty, staff, and students manage their ongoing research activities. This page is being updated regularly as new information emerges.
Essential Research Activities may be continued, provided that they can otherwise comply with university policies, including IACUC, IRB, and IBC protocols and lab safety policies; state law; and CDC guidelines.
IMPORTANT: To qualify for the Essential Research Activities exemption, the PI or his or her designee must complete a brief Essential Research Activities online form. This will allow us to maintain an ongoing record of essential research activities.
Researchers should comply with this guidance as soon as they have research to submit.
“Essential Research Activities” are defined for this purpose as comprising two categories:
1. Essential Research
Work that directly relates to preventing, containing, or treating the COVID-19 pandemic
Clinical trials and other research that if discontinued would have a significant negative impact on human health or patient care
Work that directly relates to national security
Agricultural research with critical implications for human and animal health or food security
Activity that if discontinued would pose a safety hazard
Laboratory or field work where discontinuation would result in loss of significant data and samples
Longitudinal or seasonal work where discontinuation would result in loss of significant data or samples
2. Essential Support Activities for Research
Work to maintain critical equipment, whether in stand-by mode or operational
Work to maintain critical plant populations, tissue cultures, bacteria, archaea, animal populations, and other living organisms
Research administration, compliance, and other support functions required by law
Research labs and other research facilities should begin immediately the orderly hibernation of non-essential research activities that require labs and other campus facilities. This wind-down must be completed by March 27, 2020.
Research activities that can be continued entirely remotely are not affected by this guidance and are strongly encouraged. Many research and scholarly activities can be continued remotely and supported by regular electronic and virtual contact with research groups. Alternate approaches for research personnel working remotely might include data analysis, manuscript preparation and review, presentation preparation, proposal development, grant report preparation, and online discussions with students and lab staff.
Do not remove university chemicals, equipment, or animals in an attempt to recreate your labs at off-site locations.
Veterinary and other lab animal care staff have prepared guidance concerning the orderly hibernation of research involving animals; researchers are encouraged to reach out to these colleagues directly for further guidance and help. Care of research animals will continue and researchers are reminded that they remain subject to their IACUC-approved (and, where applicable, IRB-approved) protocols.
Research administration staff have prepared guidance on grant-related issues raised by the hibernation of non-essential research activities that may be funded by federal or other grants. Researchers are also encouraged to reach out to these colleagues directly for further guidance and help.
Campuses and schools may have additional guidance that you are encouraged to consult.
Exceptions to this guidance require the written approval of the Vice President for Research. Requests for exceptions should be directed to email@example.com.
This guidance will be reviewed regularly and will be lifted or amended as soon as possible. It will remain in effect until then. While no one knows how long it will be required, it will likely be months, rather than weeks.
Additional guidance, including information from federal funders, is listed below, as are sources for getting your questions answered. For more information on IU policies during the pandemic, including campus procedures and travel information, visit coronavirus.iu.edu.
What IU is doing to help the community respond to the coronavirus
Per OMB: OMB is allowing Federal agencies to grant class exceptions in instances where the agency has determined that the purpose of the Federal awards is to support the continued research and services necessary to carry out the emergency response related to COVID-19. Further, agencies are reminded of their existing flexibility to issue exceptions on a case-by-case basis in accordance with 2 CFR § 200.102, Exceptions. The Administration will evaluate if these flexibilities should be extended to recipients whose operations have been adversely impacted in the emergency response related to COVID-19 at a later date.
Research Administration Guidance
Frequently Asked Questions related to research administration and COVID-19
(Answer updated 4/2/20) Yes. Several funding agencies, both federal and non-federal, have expressed their willingness to provide much greater flexibilities for projects that have been adversely impacted due to COVID-19. Keeping your funder informed will help them provide flexibility to you where possible, including the future awarding of supplemental funding in some cases. Research administration staff are available to look at your specific award conditions to determine if such a notification is required. In many cases, it will be required, so please err on the side of caution. You can request assistance from ORA by sending a request to firstname.lastname@example.org.
All federally funded projects (including pass-through) require notification to the federal agency. Uniform Guidance §200.328 provides the following:
(d) Significant developments. Events may occur between the scheduled performance reporting dates that have significant impact upon the supported activity. In such cases, the non-Federal entity must inform the Federal awarding agency or pass-through entity as soon as the following types of conditions become known: (1) Problems, delays, or adverse conditions which will materially impair the ability to meet the objective of the Federal award. This disclosure must include a statement of the action taken, or contemplated, and any assistance needed to resolve the situation.
While you may not be able to address all of these points in your communication to your program officer due to the many unknowns and evolving nature of the impacts of COVID-19, you should address what you can. Unfortunately, agencies are currently requiring a project by project notification. An email directly to your program officer (please Cc ORA at email@example.com) to notify them that your project is currently impeded and any known impacts will suffice in most cases.
A generalized Sponsor notification template has been developed to simplify your communication to your program officer. It is available for you to use if you prefer.
Most funding agencies are providing significant flexibilities in providing no cost extensions given the present circumstances. ORA staff will help you in submitting a request. Please email firstname.lastname@example.org with “NCE Request” in the subject line and include the account number, PI, and agency name in the body of the email. An ORA Grant Services Administrator will be assigned to assist you with the request.
IU Policy does not require a new Proposal Development document for a no-cost extension. However, most funding agencies require that an authorized official (ORA) submit the request for the no-cost extension.
In most cases, yes, they may continue to be paid from sponsored projects.
Please note that the IU campuses are not currently closed. However, IU President McRobbie has directed that supervisors allow employees to work from home if at all possible. The IU Vice President for Research has determined that as of March 27,2020, in-person research activities are limited to essential research. Other research activities may only continue to the extent that they may be accomplished remotely (telecommuting).
Essential Research & Telecommuting Project Staff: Employees paid from grants supporting essential research (meaning that it continues to proceed on campus) or project activities that are being accomplished via telecommuting, you should continue to allocate compensation expenses as you would normally in terms of allocating salary to the grant proportionate to their other assigned activities. Many research and scholarly activities can be continued remotely and supported by regular electronic and virtual contact with research groups. Alternate approaches for research personnel working remotely might include data analysis, manuscript preparation and review, presentation preparation, grant report preparation, and online discussions with students and lab staff.
Project Staff Unable to Telecommute or Not Involved with Essential Research: In cases where the project work does not meet the criteria for essential research and telecommuting is not an option, you may continue to allocate compensation costs to sponsored projects subject to the following:
For all grants, cooperative agreements, and fixed price contracts, compensation paid to those that cannot work may be allocated to active awards so long as it is done so consistent with the announcement from the IU President and in accordance with IU policies. The effective date for this is March 23, 2020, and will extend through a period as defined by the IU President. Compensation costs for those not able to work should be allocated to sponsored awards at the current or planned levels. Departments should retain documentation citing the circumstances (e.g. reasons why work cannot be completed remotely) and the number of days paid while not working. PIs should notify their program officers of any delays caused by the inability to continue work as outlined in FAQ #1 above.
For cost reimbursable contracts (including federal and State of Indiana), the funder should be contacted to notify them of potential delays to the project and guidance sought as to the allowability of charging costs for employees that are unable to work and are being paid by the university outside of their normal paid time off accruals. Please note that normal paid time off accruals provided under IU Policy (sick, vacation, family leave) remain an allowable cost to cost reimbursable contracts.
Additional guidance for several federal agencies is available on elsewhere this web page.
Any type of appointments that are eligible for continued pay by IU if they are not able to work may continue to be charged to sponsored programs consistent with FAQ #3. The announcement from the IU President indicated that “faculty, staff, academic appointees including graduate students, and temporary workers” would be eligible for continued pay. Please consult HR policies and guidance for specifics on who may continue to be paid when not able to work.
Yes, premium pay (aka overtime or extra service pay) is allowable on all sponsored projects, including federally funded, as long as it is paid consistently with IU institutional policy, regardless of the source of funds.
If the travel cost was originally incurred to benefit the project and the trip was cancelled, you may allocate the unrecoverable travel costs to the sponsored project award. In all such cases, a refund or credit for the travel should be requested. Refunds should be recorded in the sponsored project account that incurred the original travel costs. If you receive a credit for future travel (hotel, airfare, etc), the portion of expense related to the value of the credit should be transferred off of the sponsored project account. This expense may be reallocated to the grant if the travel credit is used to benefit the sponsored project in the future.
(Answer updated 4/2/20) For NIH, yes, recipients may donate PPE and other lab supplies in support of efforts related to COVID-19. Recipients may re-budget grant funds to repurchase supplies at a later date, use large unobligated balances, or submit an administrative supplement request to the funding IC for consideration. This is further outlined in the NIH FAQ’s.
For other agencies, if the donated PPE was purchased from an active grant award, the proportional cost should be removed from that grant – which would then allow you to charge the grant in the future if that project needed more PPE. If it was purchased from an expired grant, it may be donated without offsetting the original grant award.
Yes, essential research activities may begin on new projects that meet the detailed VPR criteria Please review the criteria under “What are Essential Research Activities” higher up on this page, and complete and submit the essential research activities form.
Faculty should review the criteria under “What are Essential Research Activities” (see top of this web page) and make a determination to the best of their ability. If further guidance is needed, your department chair or dean should be consulted.
NIH’s decision to postpone submission due dates to May 1 may result in a large backlog of proposals being submitted on or shortly before that deadline. If possible, it is best to complete your proposal submission prior to the deadline. ORA staff (and likely you and your departmental staff) are working from home with varying levels of internet access. Submitting earlier than May 1 provides added flexibility to ensure these proposals are submitted smoothly.
Research Compliance Guidance
The IU Research Compliance Office continues to be fully operational. Operations will continue without interruption even in the event of additional campus restrictions and/or closure. Many staff are already working remotely, and we are prepared to conduct IRB, IACUC, IBC, and COI meetings remotely.
Human subjects research activities requiring in-person contact must be put on hold unless such activities are defined as Essential Research Activities. Such Essential Research Activities must be registered via completion of the online form linked on this page to be eligible for continuation.
Human subjects research activities that can be conducted without in-person contact may continue. Continuation of activities that do not require in-person contact does not require notification to the university or the Human Subjects Office.
If your research was originally designed to be completed via in-person contact but can be completed remotely, we encourage you to revise your research plan to allow for conduct of research procedures remotely. If remote conduct of research procedures is not possible and the activities are not Essential Research Activities, research activities cannot continue until these restrictions are lifted.
Following research guidance issued on March 23, 2020 and to comply fully with Gov. Holcomb's executive order, all in-person research activities on IU campuses will be limited to Essential Research Activities.
Laboratory and animal research that are Essential Research Activities may be continued, provided that they can otherwise comply with university policies (including IACUC, IRB, and IBC protocols and laboratory safety policies) state law, and CDC guidelines.
Please see the top of this page for the definition of Essential Research Activities and steps required to confirm this status.
Temporarily ceasing research procedures as a result of the COVID-related restrictions does not require reporting to the IRB unless subjects may be placed at risk.
For other changes, if there is sufficient time to obtain prospective IRB approval of planned changes to your research, an Amendment should be submitted. Generally, IRB approval can be obtained for COVID-19-related changes within a few hours to one day after submission. Notify IRB staff when such an Amendment is submitted so we can ensure it is prioritized for review.
If prior IRB approval is not possible, you should still proceed with changes to your research to ensure it is conducted in compliance with the current restrictions. Most COVID-19-related changes to your research plan, including delay of research visits and conduct of data collection and study procedures remotely rather than in-person, can be considered minor protocol deviations that can be reported at Renewal or study closure if you are unable to obtain prior IRB approval prior to implementation of the change.
If prior IRB approval is not obtained and the deviation may adversely impact subject safety or integrity of study data, e.g., delaying visits at which safety data or primary outcome data are collected, the deviation is considered major and must be promptly reported to the IRB, within five business days, via KC IRB.
Contact HSO staff if additional guidance is needed regarding amendments and reporting of changes to the IRB.
The Office of the Vice President for Research, the Office of the Vice Chancellor for Research at IUPUI, and the Office of the Vice Provost for Research at IU Bloomington have temporarily delayed all internal funding competitions and funding decisions unrelated to COVID-19 until such time that social distance and travel restrictions are eased, if not lifted entirely. If you have questions about an internal grant program funded by VPR, OVPR, or OVCR, please contact the following:
Centers for Disease Control and Prevention (Awarding over $560 million to states, localities, territories, and tribes. CDC will use existing networks to reach out to state and local jurisdictions to access this initial funding.)
Research Innovation, Commercialization, Technology Transfer
IU’s Innovation and Commercialization Office (ICO) is available to provide support for any new SBIR/STTR opportunities related to COVID-19. Also, ICO can provide support for specific sections of other federal grants (e.g. commercialization plans) that require input from our office. Please contact Amie Frame (email@example.com) for assistance. Please provide the RFA number or a link to the RFA in your email as well as contact information for the lead PI and all other investigators involved in the research.
ICO looks forward to working with all faculty and staff to ensure the development of competitive grants for the $2.5B federal SBIR/STTR grants and contracts programs along with all other federal grants requiring Intellectual Property Management and Commercialization plans. The deadline for the SBIR/STTR grants that were to be submitted by the April round has been delayed to May 1, 2020.
Yes, although there may be some delays in negotiations.
You should always assume that a deadline previously described to you still applies. These deadlines are typically identified in correspondence from IU’s patent counsel describing the action that needs to be taken. Typically, governmental patent offices do not either close or extend deadlines, even for events that could cause broad disruptions in communication. However, the same situations that result in a reduction in ICO operations could possibly cause such closures or extensions. As a result, ICO and outside patent counsel continually monitor for patent office closures or changes in applicable deadlines. We will take such closures or extensions into account, but we will instruct our patent counsel to take action during this period to preserve all substantive rights possible.
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.
If you have emailed and telephoned an ICO team member about an urgent issue, but have not received a response, please email firstname.lastname@example.org.