Human Subjects research begins Stage 3 of ramp-up

Tuesday, June 16, 2020

The Office of the Vice President for Research and the Human Subjects Office are providing updated guidance related to human subjects-related research visits. As research activities 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.

Effective immediately, in-person research study visits may resume outside of clinical care settings under the following conditions:

Research may resume in university buildings and off-campus locations and facilities (schools, nursing homes, etc.) as they are brought online, following the health and safety guidelines in place at each location.

Situation-specific research ramp-up plans for activities involving human subjects must be approved by the respective associate dean for research or their designee.

  • Associate deans for research will have specific instructions for research ramp up plans and implementation schedule.
  •  A sample Research Ramp-up checklist and Research Ramp-up plan can be found on the VPR COVID Ramp Up Website, under the top-center box called Resources.

Study teams should consider Potential Sources of COVID-19 Related Risks for Research Participants while preparing ramp-up plans.

Researchers will follow the Guidelines for All Research Study TeamsGuidelines for In Person Research Study Visits and the Guidelines for Maintaining Healthy Research Environments as well as additional direction provided by their department, college or study location.

Care must be taken not to overburden newly opened facilities.

Study teams must work with each participating facility/agency to develop a study plan that incorporates updated safety and operational requirements. For previously approved studies, the teams may be required to update operational plans.

Appropriate PPE must be available before for both researchers and research participants prior to when the research work begins, following the guidance in place at the location where the research is performed.

UI and state/local public health guidelines must be followed when interacting with research participants. Research study visits as should continue to be conducted remotely as much as possible. In addition, virtual consenting and monitoring processes, if available, should be followed.

Additional information such as keeping research data secure while working remotely, conducting virtual research visits, FDA regulatory guidance, and many other topics related to conducting research during the COVID pandemic can be found on the HSO website at COVID-19 Information and Human Subjects Research.

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.