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 we learn more and as the situation evolves. 

Frequently Asked Questions

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

"Stay Safe, Stay Home" Executive Order

On March 23, 2020, Governor Whitmer issued Executive Order No. 2020-21, “Temporary requirement to suspend activities that are not necessary to sustain or protect life” which takes effect on March 24, 2020 at 12:01 am and continues through April 13, 2020 at 11:59 pm. The order requires individuals in Michigan to stay at home or their place of residence, unless an exception is met such as maintaining basic minimum operations or traveling to receive necessary medical care. For the full text of the order, please visit the Executive Order webpage of the Office of Governor Gretchen Whitmer.

Dr. Stephen Hsu, Michigan State University Senior Vice President for Research and Innovation, sent a communication on March 23, 2020 regarding research-related minimum basic operations. 

Last Updated: 3/26/2020

Impact to MSU Human Research Conducted in Michigan from the Executive Order

All MSU human research activities conducted by MSU employees or agents that take place in Michigan and that cannot be done remotely at home or place of residence with no inter-personal interaction with participants or others like research staff must stop unless the project is:

  • A clinical trial activity, which if discontinued, would negatively impact the patient’s care, or
  • Related to COVID-19, particularly if they have a timeline for deployment that could address the crisis.

Ongoing Clinical Trials

Ongoing clinical trial activity, which if discontinued, would negatively impact the patient’s care may continue with already enrolled participants. To the extent possible under the circumstances, researchers and participants must adhere to social distancing measures recommended by the Centers for Disease Control and Prevention, including remaining at least six feet from one another. Researchers should follow the clinic or facility’s policies related to COVID-19, including screening prior to the study visits for COVID-19. Researchers with their unit’s leadership (e.g. Chair  and Dean’s Office) will need to evaluate whether clinical trial activities are essential or whether any could be delayed without negatively impacting the patient’s care. Please see the information below related to modifications, protocol deviations, and reporting to sponsors and others.

New Participant Enrollment

New enrollment in clinical trials conducted in Michigan is not permitted without additional institutional approval. If you would like to enroll participants in a new or ongoing clinical trial that is not related to COVID-19, please send a request to hrpp@ora.msu.edu, and we will help coordinate the review process. Please also inform your Chair (e.g., by email), so that these activities can be reviewed and documented.

Research Continuity

Please continue to plan for facility restrictions or closures, illness or absence of research team, drug or device shortage, or lack of required personal protective equipment.

Remote Research Procedures

Research procedures involving no direct in-person interactions with participants conducted in Michigan may continue (e.g. data analysis, online surveys, telephone interviews) so long as those procedures are done at home or place of residence and follow the restrictions set forth in Executive Order No, 2020-21.

Exceptions

As this is an Executive Order from the Governor of Michigan, no institutional exceptions can be provided for activities not permitted under the Executive Order. If you believe you need to undertake human research activities that should be considered essential to “minimum basic operations”, but that are not explicitly described above, please send a request to hrpp@ora.msu.edu, and we will help coordinate the review process. Please also inform your chair (e.g., by email), so that these activities can be reviewed and documented.

Last Updated: 3/26/2020

MSU Human Research Conducted Outside of Michigan

Temporary Pause Continues

Regardless of location, all in-person participant interactions in MSU human research conducted by MSU employees or agents, whether domestic or international, must pause unless there is the potential for direct therapeutic benefit to the participant (drug or device) and local requirements are followed.

Remote Research Procedures

Research procedures involving no direct in-person interactions with participants may continue (e.g. data analysis, online surveys, telephone interviews), so long as local requirements are met.

Local Requirements

While the Executive Order restricts activities in Michigan, other states and countries have also enacted similar restrictions. Researchers should keep up to date on any local requirements or context and communicate with collaborators as appropriate. If restrictions put in place at the location of where the research is being conducted are more stringent, the more stringent requirement would apply.

Last Updated: 3/26/2020

Collaborative Research

For collaborative research that involves an external institution, those external collaborators should be informed by the MSU Principal Investigator of these restrictions, and the collaborating institution would make an independent decision as to whether to allow the collaborating investigators to proceed with research activities at their site.

Last Updated: 3/26/2020

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 from home 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: 3/16/2020

In-Person Interactions with Research Participants

If in-person research interactions are permitted under the restrictions, researchers must consider how in-person participant interactions can be modified to reduce the potential impact and risk of COVID-19 on participants and the research team. For in-person participant interactions that must occur, researchers should follow the recommendations of the Ingham County Health Department, the State of Michigan, and the Centers for Disease Control.

Researchers should also:

  • Follow MSU requirements related to COVID-19 such as travel
  • Follow any guidelines or instructions from the specific facility (e.g. school, hospital, clinic) where the participant interaction would occur (e.g. screening)
  • Consult with the study sponsor, when appropriate
  • Consider the participant population (e.g. are they considered “high risk” for COVID-19?)
  • Consider alternatives to in-person interactions or participant monitoring
  • Consider whether the in-person interaction is essential to the participant’s safety

Last updated: 3/26/2020

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.

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.

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: 3/16/2020

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

Communication Related to COVID-19

Visit the HRPP COVID-19 Communications webpage for HRPP communications regarding COVID-19.

Main HRPP Office Contact Information

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