Human Subjects and COVID-19
Last Update: July 28, 2020
The guiding principle for reactivating research at Michigan State University has been the safety of our students, staff and faculty, and the community (https://msu.edu/coronavirus/reopening-campus/recap-task-force-work.html). Any work that can be conducted remotely should still be done so, including human research. We have taken a measured approach to our return to ensure safety in our buildings by requiring safety plans for buildings and laboratories. In expanding the in-person participant interactions, we will continue to focus on the safety of the research team as well as the safety of research participants. The University has not opened widely as we are still in a pandemic and working under the Governor’s Executive Orders (EO).
As a result, we are phasing in human research that has the potential for in-person interactions with participants over several months using different tiers of criteria as our guide, focusing on study location, participant benefit, and COVID-19 risks. The initial tiers of reopening will focus on research conducted in health care clinics, campus research laboratories, and outdoor activities. A matrix of the tiers of research and the order in which they will start is available at http://hrpp.msu.edu/COVID-19/index.html.
Effective July 28, 2020, we will only accept the Human Research Plans for a Safe Return applications for Tiers 0, 1 and 2. We will look at expanding beyond these tiers as experience is gained and as we acquire an understanding of the complexities associated with each tier. A major factor for expansion will be the prevailing rate of infection in Michigan and around the country.
Community, national, and international research will necessarily be delayed. Even to open research locally, investigators need to make sure that the necessary staffing, training, and resources such as personal protective equipment (PPE) are available to conduct their studies. In-person research interactions should not start until the appropriate resources and approvals are in place.
Process to Reactivate In-Person Interactions with Research Participants
The process of reactivation of in-person human participant research will be similar to that of the wet bench research.
· Completion of a “Human Research Plan for a Safe Return” form will be required to start in-person interactions with research participants conducted by MSU individuals (e.g. faculty, staff, students, agents).
· If the research is to be conducted by collaborators at other organizations, that organization’s requirements would be followed and they would make their own decision about conducting the research.
· If in-person interactions were permitted during minimum basic operations, a "Human Research Plan for a Safe Return” form will still need to be completed.
· Principal Investigators should work through Department Chairs and Research Associate Deans to review and submit the Plan to the Office of Regulatory Affairs for review.
· Forms and more detailed information can be found at http://hrpp.msu.edu/COVID-19/index.html.
Some buildings on campus have been opened; for others, researchers will need to work with Associate Deans for Research to ensure their building is ready. Both building preparation and Human Research Plans need to be approved before in-person research can begin. Research in health care clinics (including MSU Health Care clinics) will need approval from those partners along with the approval of the Human Research Plan. The Human Research Plan is separate from the IRB review process and study changes resulting from the Human Research Plan may require IRB approval of a modification before the in-person interaction begins. Finally, resources are available to investigators to help facilitate the safety of their research and provide guidance (e.g. when an IRB modification is needed) at the HRPP COVID-19 webpage (http://hrpp.msu.edu/COVID-19/index.html) and EHS COVID-19 Resources webpage (https://ehs.msu.edu/).
Importantly, you should be prepared to pause in-person interactions again if a spike in COVID-19 infections occurs. We are better prepared now for such an event and will do all that we can to keep research open. However, if another Stay at Home EO is released, we may not have a choice. Please continue to monitor the situation.
Restrictions: In-Person Participant Interactions
Restrictions to in-person interactions with human research participants by MSU employees, MSU students, or agents of MSU are in place until the activity is permitted under a Tier and a Human Research Plan for a Safe Return is approved.
All MSU human research activities conducted by MSU employees, students, or agents that take place in Michigan and that cannot be done remotely with no inter-personal interaction with participants must stop unless the study 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
At this time, new enrollment in clinical trials is not permitted without additional institutional approval
Regardless of location, all in-person participant interactions in MSU human research conducted by MSU employees, students, 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
If you believe you need to undertake human research activities that should be considered essential but does not fall within a Tier of research permitted to restart with an approved Human Research Plan for a Safe Return, please send a request to email@example.com, and we will help coordinate the review process.
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 will continue to perform reviews.