Human Subjects and COVID-19
Last Update: May 1, 2020
For research involving human subjects, restrictions are expected to continue until further notice.
MSU Human Research Conducted in Michigan
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
- Urgently related to the COVID-19 pandemic.
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 firstname.lastname@example.org, 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.
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 in otherwise permissible venues, so long as State and local requirements are met.
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.
Please note that 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.
All MSU Human Research
If you believe you need to undertake human research activities that should be considered essential or are otherwise restricted at this time, please send a request to email@example.com, 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.
Researchers should also consider the rapidly evolving environment and plan for research continuity, such as planning for facility restrictions or closures, illness or absence of research team, drug or device shortage, or lack of required personal protective equipment.
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.