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 (6/16/2021)

Over the past year, human research that has the potential for in-person interactions with participants has been phased in using a Tiered approach. In-person interactions with human participants by MSU employees, MSU students, or agents of MSU were paused unless the activity was permitted under a Tier and a Human Research Plan for a Safe Return was approved.

The university continues to adapt to changes in COVID-19 requirements and continues to move forward with processes to return to on-site work. Dr. Gage recently provided expectations for active research teams regarding research under new on-site work framework (Research Reactivation Update).

This information is in follow-up to these changes.

Effective June 16, 2021:

  • The MSU Returning to On-Site Work framework plans completed by the major administrative unit (MAU) replace the MSU Human Research Plan and use of the Tiers.

  • Because the MSU Returning to On-Site Work framework replace the Human Research Plans and use of the Tiers, in-person interactions with research participants by MSU employees, MSU students, or agents of MSU are now permitted so long as the research team’s MAU has obtained approval for their MSU Return to On-Site Work framework.

  • However, because there are unique considerations specific to human research, the MSU COVID-19 Considerations for In-Person Interactions with Research Participants document has been developed and research teams are expected to incorporate these considerations into their interactions with research participants. The guiding principle has been and continues to be the safety of our students, staff, faculty, and the community.

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 be prepared to pause in-person interactions again if a spike in COVID-19 infections occurs.

We are in the process of updating the resources on the MSU HRPP COVID-19 website to reflect these changes. If you have any questions, please contact Judy McMillan (mcmill12@msu.edu).

Again, we thank you for your patience and understanding. It has been a difficult period for everyone. Now we want to get human research reactivated, but it must be done in a manner that will ensure the safety of research participants and research teams.

View the MSU COVID-19 Considerations for In-Person Interactions with Research Participants.

Last Updated: 6/16/2021

MDHHS Epidemic Order

Please note that the Michigan Department of Health and Human Services (MDHHS) June 1, 2021 Gatherings and Face Mask Epidemic Order is still in effect until June 22, 2021 at 12:01AM.

This order states that indoor gatherings are permitted at establishments only if occupancy does not exceed the greater of:

  • (1) 50% of the limits established by the State Fire Marshal or a local fire marshal (or 30 persons per 1,000 square feet if no applicable fire marshal limit exists); or
  • (2) 25 persons.

This requirement does not apply to certain designated gatherings such as gatherings that occur for the purpose of medical treatment (as defined in the order). 

If your in-person research takes place in Michigan and you are unsure whether the in-person interaction is permitted under the current MDHHS requirements, please contact Judy McMillan at mcmill12@msu.edu.

Last updated: 6/18/2021

Frequently Asked Questions

For FAQs, please visit the COVID-19 Frequently Asked Questions webpage

COVID-19 Training

All researchers must complete the COVID-19 training offered by MSU Environmental Health and Safety. Researchers should take the training appropriate to the study (for lab workers, healthcare workers, or other workers). Links to the training is available on the EHS COVID-19 Resources webpage

Last Updated: 7/28/2020

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

Questions about Human Research Reactivation

If you have questions about the human research reactivation, please contact Judy McMillan at mcmill12@msu.edu.

Last Updated: 6/16/2021

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

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

Main HRPP Office Contact Information

Phone: 517-355-2180
Email: irb@msu.edu
Website: hrpp.msu.edu