Moving to Phase 3 of in-person human research reactivation

From: Kathleen Lynne Lane, Associate Vice Chancellor & Institutional Official for Human Research; Monica Biernat, Distinguished Professor & IRB Chair
Sent: Monday, Nov. 22, 2021, 12:59 p.m.
To: KU Lawrence human subjects PIs, deans, and associate deans for research

Human subjects research community,
  
Given the current COVID-19 risk levels and public health guidance, we will be simplifying the process to request approval for certain minimal risk in-person research. Effective Dec. 8, 2021, the Human Research Protection Program is moving to Phase 3 reactivation of in-person human subjects research.
 
Our goals are to prevent transmission from study team personnel to participants and to prevent transmission among participants.

  • Studies with low to moderate risk of COVID: New studies and modifications to currently approved studies may be approved through a streamlined reactivation process: 
     
    1. Simply complete the Phase 3 HRPP Reactivation Checklist (.docx) and attach it to a modification or new study in eCompliance.
       
    2. There is no need to submit an RNI. The Phase 3 Reactivation Checklist replaces the HRPP Reactivation Safety Plan.
       
  • Studies with populations at high risk of COVID complications will be considered on a case-by-case basis, and may be approved with additional safety details that effectively mitigate risks inherent in the environment or by the activity. HRPP will monitor these studies periodically for safety plan fidelity.
     
  • Reactivated studies: Researchers are expected to continue use the procedural integrity checklist to document compliance. Post-approval monitoring (PAM) check-ins will be conducted intermittently on low- to moderate-risk reactivated studies.

Thank you for your continued commitment to protecting human subjects. In case of an increase in community risk or change in KU safety requirements, the HRPP will notify researchers of any changes in procedures.

Respectfully,

Kathleen & Monica

Kathleen Lynne Lane
Associate Vice Chancellor & Institutional Official for Human Research

Monica Biernat
Distinguished Professor & IRB Chair