Research Integrity: COVID-19 Information

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July 30, 2021: Resuming In-Person Human Subjects Research

Overview

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.

Procedures

  1. 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. As per Lehigh policy, 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.

  2. 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. In accordance with Lehigh's mask policy, 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.)

  3. 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 inreopen@lehigh.edu.

  4. 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 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.