Removing restrictions on in-person human research

From: Simon Atkinson, Vice Chancellor for Research; Kathleen Lynne Lane, Associate Vice Chancellor & Institutional Official for Human Research; Monica Biernat, Distinguished Professor & IRB Chair
Sent: Tuesday, April 5, 2022, 10 a.m.
To: KU Lawrence human subjects PIs, deans, and associate deans for research

Human subjects research community,
Effective immediately, the Human Research Protection Program is moving to Phase 4, the final phase of reactivation, which removes COVID-related restrictions on in-person human subjects research. The move to Phase 4 is prompted by current low COVID-19 risk levels, public health guidance, and easing of KU safety precautions as of March 3 and March 28.
New study submissions proposing in-person human research will no longer require documentation related to COVID safety, including:

  • Reactivation safety plan or checklist
  • Re-consent of participants with COVID language in the consent form
  • Tracking safety compliance with a procedural integrity checklist

Studies approved for in-person research with additional COVID-related safety procedures in Phase 1, 2 or 3 may eliminate those safety procedures. The PI or faculty supervisor of the study must record the specific reduction in procedures and the effective date of the changes in their internal records. A modification to the study is not required. Contact if you have questions about reducing COVID-specific safety measures and documenting the changes.
Studies that were halted due to the COVID-19 pandemic and were not reactivated in Phase 1, 2 or 3 may resume in-person procedures as they were previously approved for the study.
Out of consideration for research participants and the study team, the research team may choose to wear masks or take other protective measures, and are encouraged to have masks available for participants and to continue screening for COVID symptoms with the study team and participants.
Conditions of the research context may still require researchers to consider COVID-related precautions and safety protocols according to local conditions and guidelines. If conducting research in locations other than the KU campus, researchers are expected to monitor local public health guidance and follow the safety protocols in place for the specific institution or location.
Thank you for your continued commitment to protecting human participants in research. If there is an increase in KU or Lawrence COVID risk or shifts in KU safety requirements, the HRPP will notify researchers of any changes in procedures.
Simon, Kathleen & Monica
Simon Atkinson
Vice Chancellor for Research
Kathleen Lynne Lane
Associate Vice Chancellor & Institutional Official for Human Research
Monica Biernat
Distinguished Professor & IRB Chair