Expanding Phase 2 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: Friday, June 4, 2021, 9:01 a.m.
To: KU Lawrence human subjects PIs, deans, and associate deans for research

Human Subjects Research Community,

In response to the recent KU, Douglas County and state of Kansas decisions to adopt new CDC recommendations regarding mask-wearing for vaccinated individuals, we are expanding Phase 2 of reactivation for in-person human subjects research:

  • Certain on-campus, in-person research proposed without masks or social distancing may be approved depending on contextual factors.  
     
  • All requests for reactivation will continue to follow the RNI process for Phase 2; namely, submit an RNI and a modification.  
     
  • Each request for reactivation will continue to be assessed on all risk factors within our COVID-19 risk matrix (.pdf).
     
  • Researchers working with populations of greater vulnerability to COVID-19 may be required to take additional precautions, such as having a negative COVID saliva test shortly before an in-person session.
     

Consistent with ethical tenets of human subjects research, researchers will still need to consider safety procedures when interacting with human subjects. Trust between researchers and participants is important, including demonstrating respect for each subject's voluntary participation and that the research team has taken precautions against potential transmission of COVID-19 or other disease.  

  • In accordance with current university guidance, unvaccinated researchers are strongly encouraged to continue mask-wearing and social distancing when conducting in-person research. Likewise, vaccinated researchers may opt to wear a mask and maintain social distancing out of consideration for subjects.
     
  • Principal investigators who would like to demonstrate a low risk of transmission by study team members may require study team members to have a negative COVID-19 saliva test within 48 hours of an in-person session.
     
  • Principal investigators who think it would be prudent to require study team members to wear masks should contact HRPP. A justification for protection of vulnerable subjects may be required.
     

The recent lifting of COVID-related restrictions is liberating and exciting. We also know, given current vaccination rates in the local population, that some risk of COVID transmission still exists. It is up to all individuals to take responsibility for themselves and to consider others in the community with whom they interact. The HRPP looks forward to carefully broadening support of in-person human research, on a case-by-case basis, in keeping with university and local COVID policies, and where risk of virus transmission to participants can be mitigated.

Respectfully,

Kathleen & Monica

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

Monica Biernat
Distinguished Professor & IRB Chair