COVID-19

The MSU Human Research Protection Program (HRPP) has established this webpage with information about the impact of the novel coronavirus (COVID-19) on the HRPP and to address questions from researchers, which will be updated as the situation evolves.  

Human Research Reactivation Update (8/5/2021)

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.

Because requirements can change quickly, please visit the MSU COVID-19 webpage for current requirements. 

Please consider the following when conducting human research:

  • 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.
  • Health screening forms no longer need to be completed by MSU employees, MSU students, or research participants or those accompanying research participants.
  • Check with the local site on whether there is a limitation on gathering size for in-person research interactions.
  • The MSU COVID-19 Information Sheet for Research Participants no longer needs to be provided to research participants.
  • The MSU Returning to On-Site Work framework plans are no longer required; however, please follow any applicable Department, College, or Major Administrative Unit requirements.

The Principal Investigator (PI) remains responsible for implementing and monitoring changes to COVID-19 control strategies and assuring that the research team has appropriate staffing, resources, and training to support in-person interactions with research participants.

Last updated: 8/5/2021

Follow All Local Site 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, all local COVID-19 site requirements must be followed (e.g., wearing a mask, health screening, any other COVID-19 safety precautions). If there are local COVID-19 site requirements:

  • If a face mask is required, removal of the face mask for research procedures can only occur if permitted by local requirements. Consider having face masks available for research participants.
  • 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.
  • The PI is responsible for assuring that all members of the research team are trained and knowledgeable on the COVID-19 safety precautions needed to conduct in-person human research, including any study specific requirements.
  • Concerns about COVID-19 safety precautions should be reported to the PI, who is then responsible for either addressing reported concerns or working with other MSU individuals to address the concerns when needed. Concerns about COVID-19 safety precautions may also be reported to the MSU Misconduct Hotline (1-800-763-0764 or https://misconduct.msu.edu)

Collaborators Must Follow Their Organization’s Requirements

If your research involves collaborators under the oversight of their own organization (employees or agents of a non-MSU organization), they must comply with their own organizational requirements and the collaborators need to obtain the appropriate approvals at their organization.

Continue to Incorporate Key Prevention Measures

Key prevention measures should still be followed, including:

  • Maintaining proper hygiene and health practices (frequent hand washing, routinely cleaning your research space).
  • Adhering to all signage and instructions posted by MSU, public health authorities, or facilities where research is conducted.
  • Self-monitoring, staying at your place of residence and contacting a health care provider if you experience COVID 19 or flu like symptoms.
  • Communicate to participants or others that they should not come to participate in any in-person interactions if they have COVID-19 or flu-like symptoms.
  • Delay in-person interactions if a participant or an individual accompanying the participant has indicated that they have or display COVID-19 or flu-like symptoms.
  • Contacting a health care provider and following all public health recommendations if you have been exposed to someone who is ill or tested positive for COVID 19.
  • Following all applicable state and public health guidance, as well as cooperating with public health authorities (including contact tracing).
  • Should someone in your research group test positive for COVID-19 or if you are notified that a participant or any other individual present for the in-person interaction tested positive for COVID-19, contact the University Physician (Tel: 517-353-8933; email: uphys@msu.edu). Also, contact Jamie Willard, MSU Biological Safety Officer (cherryme@msu.edu) for guidance regarding cleaning and disinfection.

Please visit the MSU COVID-19 webpage for information about vaccination requirements for MSU faculty, staff, and students. 

COVID-19 Training

COVID-19 training is offered by MSU Environmental Health and Safety. Links to the training is available on the EHS COVID-19 Resources webpage. 

Last Updated: 7/14/2021

Collaborative Research

If the interaction is being performed by an external collaborator who is acting under the oversight of the external organization, that organization’s requirements would be followed, including COVID-19 safety precautions, and they would make their own decision about conducting the research, following the organization's processes to restart in-person research.

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: 7/28/2020

International Research

Please note that all MSU requirements related to travel must also be followed. See the Office of International Health and Safety website for requirements. 

Last updated: 6/16/2021

Changes Necessary to Eliminate an Apparent Immediate Hazard

For non-exempt research, changes must be approved in advance by the IRB as a modification to the study, unless they are necessary to eliminate an apparent immediate hazard to participants. See HRPP Manual Section 9-5, Unapproved Change in Protocol

For research approved by the MSU IRB, if a change in protocol is made to eliminate an apparent 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

Modifications

Information is included below on what is needed if you have determined that you need to modify your study. Please also view the HRPP Flow Chart Guidance on IRB Modifications Related to COVID-19 to help determine whether a change needs to be submitted.

Non-Exempt Research

For research approved by the MSU IRB:

All modifications are submitted through Click. Please note that for modifications to study staff, only changes to key project personnel must be submitted. See HRPP Manual Section 4-10, Designation as Key Project Personnel on Non-Exempt IRB Projects for who is key project personnel. The HRPP staff and the MSU IRB will be prioritizing modifications related to COVID-19. To help with this process, when summarizing the modification, 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. If you have any questions, please contact the MSU HRPP. Please see HRPP Manual Section 8-6, Modifications to an Approved Research Study for more information about the modification process.

Please note that 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. Please view the HRPP Guidance on IRB Modifications Related to COVID-19 to help determine whether a change needs to be submitted.

For studies restarting in-person interactions, please obtain approval for the Human Research Plan for s Safe Return prior to submitting any required IRB modifications. 

For research relying on an External IRB, if a modification is needed, please work with the External IRB and/or any collaborating PI to submit the changes as required by the External IRB.

Exempt Research

In general, investigators are not required to submit changes to the IRB office once a research study is designated as exempt as long as those changes do not affect the exempt category or criteria for exempt determination (changing from exempt status to expedited or full review, changing exempt category) or that may substantially change the focus of the research study such as a change in hypothesis or study design. Modifying an in-person visit to a remote option would not typically require submission to the IRB office. However, if the change impacts the exempt category or criteria (e.g. before the participant identity could not readily be ascertained, and now it can), it may require submission to the IRB. Please contact the MSU HRPP with questions. Please see HRPP Manual Section 8-1, Exemptions, for more information.

Last updated: 7/28/2020

Protocol Deviation/Violations for Non-Exempt Research

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 in 72 hours. See HRPP Manual Section 9-8, Protocol Deviations or Violations for more information.

Last updated: 3/16/2020 

Research Continuity

Research teams should consider how COVID-19 may affect the ability of the research team to conduct their study, the impact to participants, and whether that impact may present a risk to participants. Please consider what steps or plans can be made to reduce the risk to participants. Please discuss with your study’s sponsor, when appropriate.

Considerations may include:

  • Business continuity plans for the MSU research site(s) and the impacts to the study
  • Consider how the research location (e.g. school, hospital, clinic, lab) may be impacted by COVID-19, any restrictions the sites may put in place, and what provisions could be made
  • Consider the impact if members of your research team become unavailable
  • For studies that involve investigational drugs or devices, discuss how access to drugs or devices that are provided to participants as part of the study will be maintained, the risk to participants if the drugs or devices cannot be obtained, and what provisions could be made (e.g. alternative treatments, dose tapering)
  • Consider alternatives for any monitoring procedures that are necessary for participant safety
  • Consider whether modifications to the study may be necessary to protect participants

If a modification may be necessary, please see the modification section for more information. Changes may also require study sponsor approval, for externally funded research.

Last updated: 3/16/2020

Risk to Participants

If you believe that potential disruptions to your study from COVID-19 could place participants at risk (e.g. inability of participants to obtain study drug or inability of subjects to come in for a study visit which would result in a risk), please submit a “Report of New Information” in Click. This will help the IRB to identify these projects with researchers’ input and to work with the researchers.

Last updated: 3/16/2020

HRPP and IRB Operations

The HRPP office is fully functional and we expect this to continue as we work remotely. All HRPP staff can work remotely and the Institutional Review Boards (IRBs) will continue to perform reviews. Updates will be provided if there are changes that impacts HRPP operations.

Last updated: 6/16/2021

Questions?

If you have questions about MSU requirements for face masks or vaccination, please contact the University Physician (Tel: 517-353-8933; email: uphys@msu.edu).

If you have other COVID-19 questions related to MSU human research, please contact Judy McMillan (mcmill12@msu.edu).

Last updated: 8/5/2021