Coronavirus

COVID-19: Guidance for Research Operations at IU

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.

UPDATE March 23, 2020: To protect the health and safety of the university community and our state, 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

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.

Access the Essential Research Activities form

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 baumannj@iu.edu.

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

Federal Agency Guidance Concerning Existing Grants

  • Administrative Relief for Recipients and Applicants of Federal Financial Assistance Directly Impacted by the Novel Coronavirus (COVID-19)
  • 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 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.

Other Guidance for Research Universities

IU Internal Funding Guidance

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:

VPR and OVPR internal grants: ovprgrnt@indiana.edu

OVCR internal grants: Alicia Gahimer, algahime@iupui.edu

Please note, the temporary delay on research internal funding competitions will not affect internal competitions related to Limited Submissions opportunities.

Funding for Research on COVID-19

Various agencies, foundations, and organizations are making funding available for research related to COVID-19:

Foundations and Non-Profits

Medical CBRN Defense Consortium (MCDC)

Request for Information -- CoV Pandemic Response (call for White Papers from both MCDC members and other interested industry/academia partners in response to  pandemic in the United States)

Medical Technology Enterprise Consortium (MTEC)

Pre-announcement for potential Request for Project Proposals focused on the development of prototypes aimed to combat COVID-19
Please contact IU Federal Research Relations Diretor Laura Kolton for more information on this opportunity.

U.S. Department of Energy

Dear Colleague Letter: Contributing DOE and National Labs resources to help address COVID-19

DOE Resources Supporting Coronavirus Research

U.S. Department of Health and Human Services

Office of Biomedical Advanced Research and Development Authority (BARDA) Broad Agency Announcement (BAA)

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.)

NIH

NSF RAPID Research on COVID-19

Universities

MIT Solve: How can communities around the world prepare for, detect, and respond to emerging pandemics and health security threats?

White House Office of Science and Technology Policy

Call to action to develop new text and data mining techniques to help the science community answer high-priority scientific questions related to COVID-19 using newly released COVID-19 Open Research Dataset (CORD-19) of scholarly literature about COVID-19, SARS-CoV-2, and the coronavirus group

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 (amiframe@iu.edu) 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, Invention Disclosures will be accepted through IU's ICO Sophia database by Wellspring. There is currently no disruption to this process.

​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 ico@iu.edu.

Contact Information