Research Integrity: COVID-19 Information

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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.

  1. 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.
     
  2. The In-Person Human Subjects Research Guidance Table summarizes the requirements and procedures for submitting requests to conduct in-person human subjects research.
     
  3. 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.
     
  4. 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. Please also be aware that the IRB has issued guidance for the use of Audio and Video Conferencing in Human Subjects Research.

Modifying IRB-approved research protocols to convert in-person procedures to remote procedures (published March 17, 2020):

  1. 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.
     
  2. 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.
    1. 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.”
       
    2. 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.
       
  3. 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.