Reactivating in-person human subjects research

Reactivation will occur in phases that are safety-bound rather than time-bound, and may progress or revert based on CDC, institutional, state and local guidelines. Investigators will apply for reactivation approval from the Human Research Protection Program (HRPP), which will weigh study benefits against the best current understanding of disease transmission risk. Some requests may require review by KU's full Institutional Review Board (IRB).

Phase 4: Full activation

Effective April 5, 2022

New study submissions proposing in-person human research will no longer require the following documentation related to COVID safety:

• 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 irb@ku.edu 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.

Phase 3: Tertiary activation

Dec. 8, 2021 – April 3, 2022

1. Studies with low-moderate risk of COVID: New studies and modifications to currently approved studies may be approved through a streamlined reactivation process. 
   • Simply complete the Phase 3 HRPP Reactivation Checklist (.docx) and attach it to a modification or new study in eCompliance.
   • There is no need to submit an RNI or HRPP Reactivation Safety Plan.
      
2. 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.
    
3. Reactivated studies: Researchers are expected to continue use the procedural integrity checklist to document compliance. PAM (post-approval monitoring) check-ins will be conducted intermittently on low-moderate risk reactivated studies.

Phase 2: Secondary activation

May 11 – Dec. 7, 2021

The HRPP team is pleased to announce the following moves to simplify the reactivation request process and consider additional proposals for in-person research:

1. The following factors will no longer prevent approval of in-person research:
   • Benefit to participant: Study proposals for in-person research will now be considered regardless of whether participants benefit directly. In Phase 2, reactivation review will focus on risk to participants.
   • Non-contact transfer of materials or equipment is now permitted without COVID Reactivation Panel review. Simply submit a modification describing the change or a new study describing the no-contact processes.
      
2. Additional characteristics of in-person studies that may be considered for approval:
   • Studies with moderate, adequately mitigated risk may be approved on a case-by-case basis. See the risk matrix (.pdf) for assessing overall risk of a study. For instance, studies that involve populations not considered highly vulnerable or activities that are short or moderate in duration — or in which group densities permit reasonable health protections — may be approved in Phase 2.
   • Research in schools and day care centers that are operating in person may be approved if the research does not introduce significant additional risk of virus transmission for participants. 
   • If a study site requires researchers to be vaccinated by policy, the requirement can be passed to study team members who have been approved to conduct in-person research at the site. This accommodation of a study site’s policy does not change KU’s policy not to require vaccination or ask employees about their vaccination status.

Phase 1 expansion

July 1, 2020 – May 10, 2021

Expanding beyond lowest risk possible: on-campus; non-vulnerable populations; controlled environment; meet standards for social distancing; space safety considerations; clear, direct benefit for participants

During the Phase 1 expansion, proposals will be reviewed on a case-by-case basis and approvals will focus 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.

Phase 1: Preliminary activation

June 3 – 30, 2020

Lowest risk possible: on-campus; non-vulnerable populations; controlled environment; meet standards for social distancing; space safety considerations; clear, direct benefit for participants

In Phase 1, proposals will be reviewed on a case-by-case basis and approvals will be limited to:

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 have low risks that can be managed.