The Office of the Vice President and Associate Provost for Research and Graduate Studies is committed to the ongoing support of the research enterprise as the coronavirus disease (COVID-19) impacts our campus. Given the evolving nature of the situation, this page will be updated regularly.
Lehigh is currently following a phased approach to reopening on campus research activities. For more details see the central site and contact your Department Chair.
Please visit the Lehigh central site for updated information from the university, including more detail on graduate students.
Please don't hesitate to contact us with any questions.
Lehigh’s Office of Research and Sponsored Programs is positioned to continue to support research administrative efforts at the university at this time. Proposals should be submitted as normal, allowing ample time (e.g. five business days) for budget development, review and submission. New and continuing awards will continue to be processed, and your Contract and Grant Specialist (CGS) will be available to you for prior approvals, sponsor related issues and other guidance you would normally be seeking.
Federal agencies have historically been flexible about deadlines under circumstances beyond our control. Should the situation at Lehigh change such that we are unable to meet stated deadlines, your CGS will work with you to contact the cognizant program officer at the sponsoring agency to discuss the situation.
See also: Agency-Specific Guidance
The Lehigh University office of Research Integrity continues to function across its areas. The preparation, review, and submission of applications to the IRB and IACUC occurs entirely electronically. The IRB, IACUC, and CIRC have the capability to meet by video and teleconference. These activities occur on time and without interruption.
Research Integrity staff are available for all compliance-related guidance and other guidance researchers would normally seek. Please contact us with questions or concerns.
Modifying IRB-approved research protocols to convert in-person procedures to remote procedures:
As of March 17, 2020, the University has required that all studies involving in-person interactions with study participants or travel to participants’ homes are converted to remote procedures, or that active data collection is suspended. Remote procedures include online surveys, phone calls, video conferencing, and email.
Modifying In-person Research Protocols:
- Rather than indefinitely pausing all human subjects research, researchers may convert in-person procedures to remote procedures by submitting an Amendment in IRBNet for review and approval by the IRB. An Amendment/Modification Form for Adding Remote Study Procedures has been created to address the unique challenges the COVID-19 pandemic has posed to Human Subjects Research. This form can be found under “Forms and Templates” in IRBNet. Amendments must be reviewed and approved by the IRB before the proposed changes can be implemented.
- Any changes necessary to remove immediate apparent hazards to research participants or study personnel, including any changes necessary to reduce potential direct exposure to COVID-19, should be carried out immediately without advance IRB approval, especially in situations where there is not sufficient time to obtain IRB approval of an Amendment, per item 1 above.
- The IRB must be notified of all changes made to eliminate immediate hazards as soon as possible. To notify the IRB, you must report an Unanticipated Problem in IRBNet within 5 days of implementation. You can find instructions for how to do so here. In the Unanticipated Problem form, please indicate that this new information falls under category 8, “Change to the protocol taken without prior IRB review to eliminate an apparent immediate hazard to the subject.”
- If you will maintain these changes to your protocol, you must describe these changes in an amendment to your IRB protocol in IRBNet. Please submit an amendment within 10 days of implementing the change. Please use the Amendment/Modification Form for Adding Remote Study Procedures that has been created for amendments to conduct human subjects research remotely. This form can be found under “Forms and Templates” in IRBNet.
- If you are pausing an in-person research study and you are not modifying study procedures to enable remote data collection, you do not need IRB approval to communicate with participants regarding the pause in research.
Faculty Principal Investigators are responsible for ensuring that all study personnel, including undergraduate and graduate students, are aware that all in-person research must be converted to remote interactions or suspended.
Existing IRB-approved research protocols that already involve only remote procedures may proceed as originally planned.
Collaborative Research and Authorization Agreements:
Collaborative research in which Lehigh is the IRB of record (the reviewing IRB):
If you are amending study procedures in order to conduct your study remotely, you must ensure that all changes have been clearly communicated to collaborators and that they are adhering to these changes. Please be sure that the amendment approval letter is shared with the IRB(s) of the collaborating institution(s). If you are pausing all human subjects researchers, you must ensure that all collaborators do so as well.
Collaborative research in which another institution’s IRB is the IRB of record:
If you are 1). amending study procedures in order to conduct the study remotely, or 2.) pausing all data collection, please work with your collaborators to notify the IRB of record immediately. All changes should be submitted to the reviewing IRB, according to their instructions.
Handling Human Specimens:
Researchers are reminded to follow proper safety procedures for handling human specimens that may contain COVID-19. Human specimens are handled at Biosafety Level 2 (BSL-2). Researchers are reminded that appropriate PPE (lab coats, gloves, eye protection and face shields) should be worn in BSL-2 laboratories and procedures should be performed within a biological safety cabinet if there is a risk of infection. The CDC offers additional guidance: https://www.cdc.gov/coronavirus/2019-ncov/lab/lab-biosafety-guidelines.html.
IACUC Updates Related to COVID-19:
As of June 5, 2020, faculty, staff, and graduate students may return to campus to complete work that can only be completed on campus. Per the University-wide requirements, all faculty, staff, and graduate students who wish to return to campus must receive approval from their chair or supervisor and the office of Environmental Health and Safety. All personnel must also complete COVID-19 safety training. Please see email communications from The Task Force to Safely Reopen the Lehigh Campus, sent by firstname.lastname@example.org, for more detailed information.
Additionally, all researchers who wish to resume a teaching or research protocol involving live vertebrate animals must contact the IACUC to confirm that the research will be conducted as described in an active IACUC protocol.
Whether or not research activity resumes, PIs remain responsible for that animals in their individual laboratories receive basic care. Basic care includes provision of food and water, and checking for any animals who appear to be ill or in distress. Despite the circumstances presented by the pandemic, departures from standards of care, other than as allowed in a previously approved IACUC protocol, must still be reported to the IACUC.
Laboratory Contingency Plans:
The Lehigh University IACUC has a formal contingency plan that provides an overall plan of action for responding to emergencies, including restricted access to facilities, that may affect the care and use of laboratory animals.
Principal Investigators have each been required to develop their own laboratory contingency plans, should there be an insufficient number of qualified people available for provision of animal care. Each PI must send an up-to-date copy of their lab’s contingency plan to email@example.com. Individuals who require additional assistance implementing contingency plans should contact:
The Taskforce to Safetly Reopen the Lehigh Campus has a phased reopening plan in place with details here. Laboratory reopening is handled through the departments and colleges in conjunction with Environmental Health and Safety. Please contact your department chair with questions.