Moving carefully beyond Phase 1 approval of in-person human subjects research

From: Simon Atkinson, Vice Chancellor for Research; Kathleen Lynne Lane, Associate Vice Chancellor & Institutional Official for Human Research
Sent: Wednesday, July 1 2020, 3:45 p.m.
To: KU Lawrence human subjects PIs, research center directors, and research associate deans

Dear Human Subjects Researchers,

The COVID-19 Safety Review Panel and IRB will begin carefully considering proposals that move beyond the original parameters for Phase 1 approval. Due to current spikes in COVID-19 throughout the country and in Douglas County, this is not an advancement to Phase 2, but an expansion of Phase 1.

As Dr. Robert Redfield, director of the Centers for Disease Control & Prevention, said in the June 25 CDC Telebriefing Update on COVID-19, "when you must go out into the community, being in contact with few people is better than many, shorter periods are better than longer, and contact at greater distance, ideally, at least six feet, is better than closer."

Please note that the CDC is updating its information about people who are at higher risk of severe outcomes from COVID-19. It is important to stay current with CDC guidelines because recommendations are shifting as new data emerges.

Requests for reactivation will be reviewed on a case-by-case basis, and approvals will be focused on:

  1. Projects studying COVID-19, with the goal of addressing public health issues where risks can be managed.

  2. Certain longitudinal studies, where risks can be managed.

  3. Certain studies that have direct benefit to participants and low risks that can be managed.

  4. Certain studies that do not have direct benefit to participants and do not present additional risks to participants.

  5. Certain studies involving vulnerable populations (e.g., children, individuals with exceptionalities) where risks can be managed.

  6. Certain studies outside of the KU campus, where risks are low or can be managed.

We appreciate investigators’ commitment to continuing their important lines of inquiry in the safest manner possible, and we stand ready to answer your questions as you apply for reactivation and to facilitate moving research forward with the best interests of all parties in mind.

Respectfully,

Simon and Kathleen

Simon Atkinson
Vice Chancellor for Research

Kathleen Lane
Associate Vice Chancellor & Institutional Official for Human Research