MSU Human Research Restrictions and the Stay Safe, Stay Home Executive Order

March 27, 2020

"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. 

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.

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.

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.

More Information

For information related to human research protection, visit the HRPP COVID-19 webpage for the latest information and updates, including the restrictions and their duration as the situation evolves.