COVID-19 and Human Subject Research Studies

Beginning Monday March 16th, the Vice President for Research office requires the following:

For all human subject research studies that involve direct subject contact, and that provide little or no potential benefit to subjects - human subject direct contact (face to face) must be paused until further notice in recognition of the COVID-19 pandemic. This directive is being made to decrease exposure for our staff, faculty and learners as well as research subjects. All other aspects of the research that do not involve direct human subject contact may be continued.

It is anticipated that certain types of human subject research will be allowed to continue. These include (but are not limited to):

  • FDA regulated clinical research that has the potential for direct health benefit to subjects.
  • Interventional/treatment trials that have the potential for direct health benefit to subjects.
  • Studies that do not meet the criteria of # 1 and # 2 above and that have no physical or direct subject contact.  These are studies done via mail, phone, online, etc. or could be those involving things like review of medical records/ archival data/ public data sets or studies that are in the status of data analysis.

We recognize that this request will significantly impact your research on multiple levels. Guidance as to how to manage research delays and sponsor requirements as well as other research questions can be found at the website: https://research.virginia.edu/ResearchContinuity. Please visit the website frequently as we will be making daily updates. It is the responsibility of the Principal Investigator/Project leader to notify subjects as needed.

If you have questions about your particular study (including assessing health benefit), please direct these questions to the Research Deans or to the SOM Clinical Research site: https://research.med.virginia.edu/clinicalresearch/

For other questions about SOM-specific research needs, facilities and grants and contracts, please see this site, which will be updated as needed: https://med.virginia.edu/office-for-research/covid-19/