Limited clinical human subjects research may resume May 11

Monday, May 11, 2020

IMPORTANT: The following message from Vice President for Research Marty Scholtz applies only to research study visits occurring in UI Hospitals & Clinics and other clinical settings during scheduled patient visits. Guidance for other human subjects and broader research on campus is forthcoming. We're working closely with the campus Critical Incident Management Team, collegiate leaders, and the Board of Regents to ensure our research ramp-up is methodical, strategic, and safe.

As some COVID-19 related restrictions are lifted across the state, the Office of the Vice President for Research and the Human Subjects Office are providing updated guidance related to human subjects-related research visits.  While we prepare for research efforts to gradually resume on campus, the health and safety of research participants, study teams, faculty and staff must remain a priority. Please be aware that the situation is fluid and we may encounter setbacks as we endeavor to slowly move toward more normal research operation

Currently, most guidance for research-related visits issued on March 15 and applicable FAQs remain in effect. See the COIVD-19 Information for Researchers webpage for complete information. However, some research in a clinical setting will be allowed to resume with limitations as University of Iowa Hospitals & Clinics and other health care systems across the state are allowed to resume some non-essential health care activities.

Effective May 11, research study visits coincident with clinical care may resume with the following conditions:

  • Participation in study must not increase the risk that the participant may be exposed to COVID-19.
  • Study teams must work with the health care system or clinic on appropriate scheduling of the research component of the visit; study activities must not overburden clinics.
  • Patients may be uncomfortable returning to the health care setting.  If that occurs, study team members must be respectful and should be prepared to modify study visit activities with input from the subject, sponsor, and Institutional Review Board.

All the UI, UI Hospitals & Clinics and state/local public health guidelines must be followed during conduct of the research. Appropriate PPE must be available for study teams before the work begins, following the guidance in place at the location where the research is performed. Study teams may be required to supply their own PPE. In addition, virtual consenting and monitoring processes should be followed whenever possible.

This policy will be updated when appropriate based on new information and circulated to the UI research community.

Please address questions to the Office of the Vice President for Research at 319-335-2119 or jennifer-lassner@uiowa.edu, the Human Subjects Office irb@uiowa.edu or 319-335-6564, or visit the HSO website at hso.research.uiowa.edu.  

Tags: COVID-19research ramp-upclinical researchUI Hospitals & Clinics