Research Projects Involving Human Subjects Contingency Planning

Research projects involving human subjects are an important aspect of the University’s research enterprise. These projects come with considerable ethical responsibilities and regulatory oversight. Due to the COVID-19 outbreak, there are particularly pressing regulatory and operational questions facing researchers involved in human subjects research. Below we provide guidance on these questions. Please check this site often for updated guidance.

Our guiding principle in addressing these questions is maintaining the safety of the research subjects and the research team members.

Human Subjects Research Update

In follow-up to the action of limiting on-campus activities to only critical research activities, we are providing an update as it relates to our research activities involving human subjects.

To ensure safety of our researchers, staff, and research participants and to be aligned with the most recent NIH guidance, the Office of Research & Innovation is requesting that research involving person-to-person contact or gatherings of human research participants be paused as soon as possible unless needed for participant safety.

The duration of the pause is unknown, but to reduce disruption to the extent possible, we will be reassessing daily. Please visit this page for updates.

It is our responsibility to ensure the safety of all human participants and research staff involved in clinical trials and human subjects studies. We strongly recommend implementing the following measures:

  • Limiting study visits to those needed for participant safety or coincident with clinical care. If a visit is necessary, please refer to our earlier guidance on Human Subject Recruitment and Data Collection section below.
  • Conducting virtual study visits
  • Arranging flexibilities for required laboratory tests or imaging needed for safety monitoring to occur at local laboratories or clinics
  • Canceling gatherings of 10 or more people
  • Limiting or suspending unnecessary travel
  • Continue to maintain social distancing and personal hygiene during all research activity

If human participants in a study are at risk of harm from the research suspension, please document a plan to safely discontinue protocol activities and submit the plan via a Reportable New Information (RNI) to the IRB. This is recommended to ensure the safety of subjects and the IRB may not have the time to review and approve before the necessary steps need to be taken.

If pausing your activities requires a permanent change in your protocol, please submit an amendment to the IRB and notify your sponsor. Otherwise, see instructions above for submitting as RNI. If you have questions, please contact program staff at hrpp@drexel.edu.

Our federal sponsors recognize the significant effects this emergency is having on funded clinical trials and other human subjects studies. The NIH has published guidance to assist researchers during these times.

Additional Resources

Additional Resources can be found on the ORI Research Preparedness for COVID-19 Pandemic website.