COVID-19 FAQs

Frequently Asked Questions (FAQs) specific to COVID-19 are available below.

Please note that all in-person interactions with research participants by MSU employees, MSU students, or agents of MSU must follow current COVID-19 university requirements and as applicable, any local site requirements including facility (e.g., school, hospital) and city, state, or country requirements. Please visit the MSU COVID-19 webpage for current requirements. 

  • Human Research Reactivation

    When can I restart in-person interactions?

    All in-person interactions with research participants by MSU employees, MSU students, or agents of MSU must follow current COVID-19 university requirements and as applicable, any local site requirements including facility (e.g., school, hospital) and city, state, or country requirements.

    Currently, Human Research Plans and the Tier approach are not in use. The MSU Returning to On-Site Work framework plans are also no longer required; however, please follow any applicable Department, College, or Major Administrative Unit requirements.

    Please visit the main HRPP COVID-19 webpage for more information about COVID-19 considerations in human research.

    Last updated: 7/21/2021

    My thesis or dissertation project required in-person participant interaction. What can I do? 

    • Please visit the main HRPP COVID-19 webpage for information about COVID-19 considerations in human research.

    • Please work with your advisor to determine if there are any Department, College, or Major Administrative Unit that need to be met before in-person interactions with participants can begin. All in-person interactions with research participants by MSU employees, MSU students, or agents of MSU must follow current COVID-19 university requirements and as applicable, any local site requirements including facility (e.g., school, hospital) and city, state, or country requirements.

    Last updated: 7/21/2021

  • Health Screening

    A research participant will be coming to my lab (not a health care setting) on campus to participate in the research. Do they have to complete a health screening?

    Except for health care settings or other settings with local site requirements, health screening forms no longer need to be completed by MSU employees, MSU students, or research participants or those accompanying research participants.

    Last updated: 7/21/2021

    What if the research takes place at a site owned by another organization, like a school or hospital. What health screening needs to be completed?

    Individuals would complete the local site requirement.

    Last updated: 7/21/2021

    What if the research takes place at a site that isn’t owned by another institution, like a participant’s home?

    Individuals would complete any local site requirement (e.g. city, county, state, country  requirements or orders).

    Last updated: 7/21/2021

  • Face Mask and Social Distancing

    When do research participants need to wear a face mask and social distance?

    Face masks may be required depending upon where the research is taking place.

    • If your research takes place in MSU campus buildings and other MSU facilities in East Lansing and throughout the state, please visit the MSU COVID-19 website for the latest requirements.

    • If your research takes place at a health care setting, another facility (e.g., school, office), or within a city, county, state, or country with local COVID-19 site requirements, any requirements for face masks must be followed.

    • Even if face masks are not required, any individual who chooses to wear a mask should be allowed to do so.

    Please also consider whether additional COVID-19 safety precautions (e.g., use of additional PPE, location designed to reduce risk of COVID-19 transmission, social distancing, reduced wait time, limits to the number of individuals who accompany a participant) are necessary based on the local site and your specific research study to reduce the risk of COVID-19 transmission. Consult with Jamie Willard, MSU Biological Safety Officer (cherryme@msu.edu) when needed.

    Last Updated: 8/5/2021

  • Collaborative Research

    How does the human research reactivation impact collaborative research?

    Sites under the oversight of their local organizations should be informed of the status of in-person interactions by the MSU PI or research team, but the organization would make an independent decision as to whether to proceed with research activities at their organization. 

    MSU researchers should communicate and work with their collaborators to ensure COVID-19 risks have been addressed through COVID-19 mitigation strategies appropriate to the research and location. The expectation is that collaborating organizations have COVID-19 safety protocols in place appropriate to the location and procedures being conducted.

    If there are any concerns about the collaborator’s procedures, Principal Investigators should address these with the collaborators and consult with their Department Chairs and Associate Deans for Research as needed

    Last updated: 6/18/2021

    What if MSU is the Single IRB for multiple institutions?

    The relying institutions should be informed of the status of in-person interactions with research participants by the local collaborating PIs through communication with the MSU PI or research team and should be asked to consider the status with their institution. Researchers should consider how modifications to in-person participant interactions at MSU impact the overall study.

    Last updated: 6/18/2021

    What if an External IRB is the IRB record for my study?

    Any MSU requirements related to in-person interactions would apply to all research conducted by MSU employees or agents, even if the study is under review by an External IRB. The research team should notify the External IRB and follow all External IRB requirements for any modifications or reporting that occurs from the restrictions, as well as any reporting requirements if approved to resume in-person interactions with participants.

    Last updated: 7/21/2021

  • Sponsored Research

    What are some considerations for communicating with study sponsors?

    • Contact study sponsors/industry for study-specific information on how to continue the study or pause the research, or to discuss changes to MSU requirements.

    • Obtain sponsor guidance for study conduct, including:

      • Changes in reporting requirements

      • Sample storage and shipping

      • Drug shortages or delays in shipping

      • Facility restrictions or requirements

      • Alternative safety assessments due to delays

      • Delayed or missed participant contacts/visits

      • Changing the study procedures with appropriate IRB approval

    Last updated: 6/18/2021

  • Remote Procedures

    May we continue already approved data collection that occurs by telephone or online?

    Yes.

    Last updated: 3/16/2020

    What should I do if I want to use telehealth as part of my clinical trial because of COVID-19? 

    The Office for Civil Rights at the U.S. Department of Health and Human Services has issued a notification of enforcement discretion for telehealth remote communications during COVID-19 nationwide public health emergency. Researchers who are covered health care providers should work with the covered entity if telehealth is necessary to provide both standard of care and research to patients.

    Last updated: 3/31/2020

  • Home Visits

    May we conduct home visits to collect data for studies conducted in Michigan?

    All in-person interactions with research participants by MSU employees, MSU students, or agents of MSU must follow current COVID-19 university requirements and as applicable, any local site requirements including facility (e.g., school, hospital) and city, state, or country requirements.

    Currently, Human Research Plans and the Tier approach are not in use. The MSU Returning to On-Site Work framework plans are also no longer required; however, please follow any applicable Department, College, or Major Administrative Unit requirements.

    Please visit the main HRPP COVID-19 webpage for more information about COVID-19 considerations in human research.
    Consider whether additional COVID-19 safety precautions (e.g., use of additional PPE, location designed to reduce risk of COVID-19 transmission, social distancing, reduced wait time, limits to the number of individuals who accompany a participant) are necessary based on the local site and your specific research study to reduce the risk of COVID-19 transmission. Consult with Jamie Willard, MSU Biological Safety Officer (cherryme@msu.edu) when needed.

    Last updated: 7/21/2021

    Can I go to a participant’s home in Michigan and pick up something for research from their porch, there will be no interaction? 

    All in-person interactions with research participants by MSU employees, MSU students, or agents of MSU must follow current COVID-19 university requirements and as applicable, any local site requirements including facility (e.g., school, hospital) and city, state, or country requirements.

    Currently, Human Research Plans and the Tier approach are not in use. The MSU Returning to On-Site Work framework plans are also no longer required; however, please follow any applicable Department, College, or Major Administrative Unit requirements.

    Please visit the main HRPP COVID-19 webpage for more information about COVID-19 considerations in human research.
    Consider whether additional COVID-19 safety precautions (e.g., use of additional PPE, location designed to reduce risk of COVID-19 transmission, social distancing, reduced wait time, limits to the number of individuals who accompany a participant) are necessary based on the local site and your specific research study to reduce the risk of COVID-19 transmission. Consult with Jamie Willard, MSU Biological Safety Officer (cherryme@msu.edu) when needed.
    Last updated: 7/21/2021
  • IRB Modifications

    Must the IRB approve modifications to the study protocol before implementing changes?

    It depends on whether the study is exempt or non-exempt, and whether MSU is the IRB of record. Please view the Guidance on IRB Modifications Related to COVID-19 for information and examples of when modifications are required.

    Last updated: 7/28/2020

    Does COVID-19 screening require a modification to my protocol? 

    For research approved by the MSU IRB, no, COVID-19 screening procedures do not need to be reported as a modification to the protocol even if done during clinical study visits unless the sponsor or researcher is incorporating the data collected as part of a new research objective or will be using or analyzing the data for research. Actions taken for public health or clinical purposes, and not for research purposes, are not research procedures and therefore do not require institutional review board IRB approval before being implemented.

    For research relying on an External IRB (MSU IRB is not the IRB of record), please check and follow the External IRB’s requirements.

    Last updated: 7/28/2020

    I am modifying my study to collect data remotely, and I can’t obtain a signed consent. What do I need to do for non-exempt studies? 

    Investigators would need to submit the informed consent script with their modification or new application submission for IRB review. The IRB may waive the requirement for the investigator to obtain a signed informed consent for some or all subjects in several circumstances. One of those circumstances relevant to COVID-19 and conducting research remotely is a waiver may be granted when the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

    Investigators should also keep a log documenting the oral consent process throughout the duration of the study and maintain such records. The IRB may require the investigator to provide subjects with a written statement regarding the research.

    What do I do if a change is necessary to eliminate an apparent immediate hazard to participants for a non-exempt study?

    For research approved by the MSU IRB, if a change in protocol is made to eliminate an apparent immediate hazard to participants, it must be reported immediately thereafter. Please submit a “Report of New Information” through Click, explaining why the change was necessary to ensure the participant’s welfare and please include COVID-19 in the RNI title. Please contact the HRPP with any questions.

    For research relying on an External IRB (MSU IRB is not the IRB of record), please check and follow the External IRB’s requirements for changes necessary to eliminate an apparent immediate hazard.

    Last updated: 3/16/2020

    Changes in non-exempt studies may be made without IRB approval when the change is necessary to eliminate an apparent immediate hazard to subjects. What is an apparent immediate hazard? 

    An apparent immediate hazard is a hazard that could place the subject’s life or well-being at risk, and the change must be made immediately to prevent the subject from being exposed to the hazard (e.g. there is not time to obtain IRB approval for the change). In such situations, however, investigators must report the change in protocol to the IRB immediately thereafter through a Report of New Information in the Click system. Within the report, the investigator should document why the change was necessary to ensure the subject’s welfare.

    If your study is reviewed by an External IRB, contact the External IRB for any questions on what is considered to be an apparent immediate hazard.

    Last updated: 3/31/2020

    How do I let the IRB know that the modification is related to COVID-19?

    The HRPP staff and the MSU IRB will be prioritizing modifications related to COVID-19. To help with this process, when summarizing the modification in the Click Modification submission, please indicate that the change is related to COVID-19. You may also email (irb@msu.edu) to let us know so we can prioritize the submission.

    Last updated: 3/16/2020

    Do we need approval from the IRB for communications to study subjects explaining the restriction in activities?

    For research approved by the MSU IRB or determined exempt by MSU, no, it is not necessary to submit a modification. However, if the study is sponsored, please check with the study sponsor for any requirements.

    For research relying on an External IRB (MSU IRB is not the IRB of record), check with the External IRB.

    Last updated: 3/26/2020

  • Protocol Deviations

    Will the restrictions or change to the method of data collection be considered a protocol violation?

    A protocol deviation/violation (deviation) is any change, divergence, or departure from the study design or procedures of a research protocol that has not been approved by the IRB, such as failure to perform a required lab test, or the study visit is conducted outside the required time frame. Deviations need to be reported even if it was outside of the researchers’ control (e.g. participant is in self-isolation or sick, hospital does not have resources to perform the test). Report the deviation to the IRB through a “Report of New Information” through Click and please include COVID-19 in the RNI title. Deviations that may affect participant’s rights, safety, or well-being and/or affect the participant’s willingness to participate in the study should be reported within 72 hours. See HRPP Manual Section 9-8, Protocol Deviations or Violations for more information.

    Last updated: 3/26/2020

  • IRB Continuing Review

    Are continuing review submissions still being reviewed?

    Yes. The continuing review (renewal) submissions are still undergoing review. If you have difficulty completing the continuing review submission because you are unable to access subject information in your office or lab, for example, please provide a detailed explanation within the continuing review submission.

    Last updated: 7/21/2021

  • IRB and Compliance Office Operations

    How is the IRB and the IRB office impacted by COVID-19?

    Convened IRB meetings will continue but will be conducted remotely. Expedited reviews will continue remotely as well. The IRB staff plan to work their standard hours but will be working offsite. However, they will be responding to all phone calls and emails. If you have a question do not hesitate to call or email the HRPP office or the IRB Coordinator.

    Last updated: 3/16/2020

    How is the Compliance office impacted by COVID-19?

    The HRPP office is working remotely. During this time the Compliance office will only conduct site visits in-person when there is a risk to subjects.  The Compliance Office has been conducting remote monitoring. TEACH visits will not be conducted in-person. Compliance reviews will continue, and any submissions related to COVID-19 will be prioritized.

    Last updated: 6/18/2021

COVID-19