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.
July 30, 2021: Resuming In-Person Human Subjects Research
Consistent with Lehigh University’s current campus status, the IRB now permits the conduct of in-person human subjects’ research. Information about the risks of COVID-19 and COVID-19 mitigation must be conveyed to research participants who take part in research off-campus or who are not Lehigh students, faculty, and staff. Researchers who invite participants to campus must also maintain compliance with the campus-wide Visitor Policy.
- No supplemental COVID-19 requirements/materials required:
In-person research that both:
a. takes place on Lehigh’s campus, and
b. involves only Lehigh students, faculty, or staff,
may resume without physical distancing, cleaning, or screening requirements in accordance with the current campus status. Masks are required in all indoor spaces, including labs, regardless of vaccination status. No supplemental materials must be submitted to the IRB or shared with research participants.
- Limited supplemental COVID-19 materials required:
All research involving:
a. in-person human subjects research that will take place outside of Lehigh’s campus, or
b. in-person human subjects research that involves visitors to Lehigh’s campus,
may resume without physical distancing or cleaning requirements in accordance with the current campus status. All research participants and research personnel must wear masks in any indoor setting, regardless of vaccination status
When research takes place off-campus or involves visitors to campus, researchers must distribute the IRB’s “COVID-19 Information Sheet for Research Participants” during the consent procedure, before the study session begins. This form describes the risks of COVID-19 and the current federal and state masking requirements. Participants should elect to adhere to this guidance. However, researchers are not required to ask participants about their vaccination status or to enforce masking or physical distancing.
Researchers must describe their procedures for distributing the “COVID-19 Information Sheet for Research Participants” when describing the consent process in their Human Subjects Application. (In the New Studies Application, see question 6 for studies that receive expedited or full board review. See question 7 for studies that receive exempt review.
- Campus-wide requirements for visitors:
All visitors to Lehigh’s campus, including those who will take part in in-person research, must complete and sign a “Mandatory Requirements for Visiting Lehigh University” form. This form includes a required Self-Assessment. Researchers must email all completed copies of this form to firstname.lastname@example.org.
- Required for all research protocols:
Researchers may remove physical distancing requirements and cleaning requirements without submitting an amendment to the IRB. All research participants and research personnel must wear masks in any indoor setting, regardless of vaccination status, and researchers may add this requirement to their protocols without submitting an IRB amendment.
However, if researchers are making other changes to the study procedures, these changes must be submitted to the IRB. All changes to study procedures must receive IRB review and approval before they are initiated. For example, if a study that previously involved remote components will now be conducted fully in-person, or if a researcher would like to add new measures to a protocol that were not possible with physical distancing, these changes must be submitted to the IRB and must receive IRB approval before the changes are initiated. Please see the instructions for submitting IRB amendments for a step-by-step guide to submitting amendments.
August 28, 2020 - Resuming In-Person Human Subjects Research:
The IRB will determine on a case by case basis, for each individual research project, if it is appropriate for in-person human subjects research to take place. Requests must be submitted via IRBNet, and in-person human subjects research may not be conducted without prior approval by the IRB.
While the University continues to operate in the Open IV phase, only in-person research that cannot be conducted using remote procedures and research that allows for adequate health and safety measures will be considered for resumption. The health and safety of participants, researchers, and those in the community are the first priority of the IRB when reviewing individual requests to conduct in-person human subjects research.
- The following guidance describes the steps for submitting a request to conduct in-person human subjects research, Guidance: Resuming or Beginning In-Person Human Subjects Research During the Open IV Phase.
- The In-Person Human Subjects Research Guidance Table summarizes the requirements and procedures for submitting requests to conduct in-person human subjects research.
- All requests to conduct in-person research must include a completed Request to Conduct In-Person Research form. This form must be completed and submitted as a supplement to a Human Subjects Application or an Amendment/Modification Form. See Guidance for more detailed information.
- All participants who are considering taking part in in-person human subjects research must be sent the following information before they agree to take part in human subjects research: COVID-19 Information Sheet for Research Participants. This form outlines the potential COVID-19 related risks participants face if they are to take part in human subjects research.
To amend an existing study to use remote procedures, please continue to use the Remote Modifications Form (described below). Please also be aware that the IRB has issued guidance for the use of Audio and Video Conferencing in Human Subjects Research.
March 17, 2020 - Modifying IRB-approved research protocols to convert in-person procedures to remote procedures:
- 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.
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 or to conduct in-person research, 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 researcher, 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 in person, 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.
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 email@example.com, 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 firstname.lastname@example.org. 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.