Since March 2020, there has been increased use of remote study procedures in human subject research activities due to the restrictions on in-person research activities. While the in-person restrictions have been relaxed, IRBMED has noted continued use of remote study procedures. The following are some of the most common remote study procedures:
- Remote recruitment activities
- Electronic informed consent process
- Remote data collection activities through surveys or phone calls/telehealth visits
- Performing study assessments (labs, imaging, etc.) at external (non-UM) facilities
- Shipping investigational products directly to subjects' home
IRBMED issued several guidance documents to address these scenarios (linked in the resources below). In addition, the FDA’s guidance on this topic, Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency, was also extensively utilized by UM researchers. According to the FDA, this guidance is intended to remain in effect until November 7, 2023, unless superseded by a revised final guidance before that date. Through this document, IRBMED intends to update the research community on this information and clarify the IRB submission procedures for remote study activities.
Click for a .pdf version of this Statement of Practice.