June 5, 2020: IRB information realted to COVID-19
Given the continued risk of COVID-19 transmission, all studies involving in-person interactions with study participants continue to to be suspended. This includes all studies involving lab visits, travel to participants’ homes, and travel to schools or daycares. IRB-approved/exempted research may be conducted using remote procedures, including online surveys, phone calls, video conferencing, and email.
To amend an existing study to use remote procedures, please use the Remote Modifications Form. Please also be aware that the IRB has issued guidance for the use of Audio and Video Conferencing in Human Subjects Research.
April 14, 2020: IRB and IACUC Review of New Research
The IRB and IACUC continue to review new protocol submissions. Approvals for new IRB protocols involving in-person procedures or new IACUC protocols will not be issued until normal research activity is permitted to resume, in accordance with institutional guidelines and local/national public health guidance. In the event that new sponsored research requires documentation of IRB / IACUC approval, conditional approval will be issued, with specific instructions indicating that research activity may not commence until full approval is obtained.
March 20th, 2020: IACUC updates related to COVID-19
Laboratory Shut-Down Procedures:
All on-campus research operations have been shut-down as of March 20, 2020. Experiments may not commence or continue at this time. Faculty investigators must implement individual laboratory shutdown plans.
Access to campus facilities is strictly limited, with ongoing care of laboratory animals being one of the few approved purposes for entering campus buildings. PIs must ensure that animals in their individual laboratories will continue to 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, departures from standards of care, other than as allowed in a previously approved IACUC protocol, must still be reported to the IACUC.
As PIs proceed with shutdown plans, please keep in mind that we cannot predict the duration of the current public health crisis. Therefore, PIs must plan in anticipation of a lengthy shutdown period.
Please see the email sent on March 20, 2020, by Alan Snyder, VP of Research and Graduate studies, for more detailed information.
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. Individuals who require additional assistance implementing contingency plans should contact:
March 17th, 2020: IRB updates related to COVID-19
The Office or Research Integrity will remain operational:
The Lehigh University Office of Research Integrity will continue to function across its areas. Staff are working remotely, and the preparation, review, and submission of applications to the IRB occurs entirely electronically. The IRB has the capability to meet by video and teleconference. Provided that Research Integrity staff are not severely impacted by COVID-19, these activities should occur on time and without interruption.
Modifying IRB-approved research protocols to convert in-person procedures to remote procedures:
Effective March 17, 2020, the University requires that all studies involving in-person interactions with study participants or travel to participants’ homes are immediately converted to remote procedures or suspend active data collection. 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.
March 10th, 2020: The Lehigh University Office of Research Integrity is positioned to continue to function across its areas. The preparation, review, and submission of applications to the IRB and IACUC can happen entirely electronically. The IRB, IACUC, and CIRC have the capability to meet by video and teleconference. Provided that Research Integrity staff are not severely impacted by COVID-19, these activities should occur on time and without interruption.
Research Integrity staff will be available for all compliance-related guidance and other guidance researchers would normally seek. Please contact us with questions or concerns.
The Office of the Vice President and Associate Provost for Research and Graduate Studies maintains a website with COVID-19-related guidance for researchers that will be updated as circumstances evolve. This site includes information about support on sponsored programs and information on laboratory shut down policies and procedures.