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).

Preliminary Activation

Starting June 3, 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.

Phase 1 Expansion

Starting July 1, 2020

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.

Secondary Activation

Conditions + timing to be determined.

Tertiary Activation

Conditions + timing to be determined.

Full Activation

Conditions + timing to be determined.

If you are unable to conduct activities remotely AND you believe your study may meet Phase 1 expansion dimensions, you may submit a request to HRPP to have your project assessed for possible reactivation. PIs have responsibility for ensuring adequate safety practices are in place for all constituents in the conduct of in-person research. Risks associated with the proposed human research activity, in light of COVID-19, must be eliminated or sufficiently mitigated.

Step 1

Read the following documents:

• Requirements for Reactivation of In-Person Research - Phase 1 (PDF)
• COVID-19 Safety Training and Information Resources (PDF)

Step 2

Complete Environment, Health & Safety (EHS) "COVID-19 Return to Work Safety 101" training.

• Refer to COVID-19 Safety Training and Information Resources (PDF) for instructions to complete the training.

Step 3

Complete required documents:

1. HRPP Reactivation Safety Plan (DOC)
2. Procedural Integrity Checklist (XLXS) to monitor implementation of safety plan
3. Revised HRPP protocol with appropriate revisions as defined in HRPP Reactivation Safety Plan:
   • Procedures for promoting safety of physical environments (e.g., physical space, cleaning/decontamination between subjects etc.)
   • Procedures for promoting safety of interactions between individuals (e.g., limiting number of people, social distancing requirements)
   • Procedures for promoting safety of activities (e.g., interacting with keyboards, manipulatives)
   • Procedures for re-consenting participants
   • Requirements for collaborations (e.g., IAA, IIA, district partners, agencies letter: “I have read and approve of the full set of procedures, taking into account potential risks related to COVID-19)
   • Procedural Integrity Checklist (XLXS) to monitor adherence to items above (e.g., progress monitoring logs)
4. Updated consent forms to include COVID-19-specific safety procedures. See COVID-19 Consent Template (DOC) for guidance.

Step 4

Submit a Report of New Information (RNI) in eCompliance indicating REACTIVATION REQUEST in question 4.

1. On the main study page, click the button titled "Report New Information."
   
2. Complete the questions on the RNI smartform,
   *Note: On question 4, indicate this is a reactivation request.
3. Upload completed HRPP Reactivation Safety Plan.
4. Upload Procedural Integrity Checklist.
5. Upload verification of completed EHS training for all KU study team members and equivalent training for all external study team members.
6. Upload revised protocol, revised consent form(s) and related study materials as appropriate per phase.
7. Click “Submit” to send the completed RNI to the HRPP.

Download the application steps in PDF format

A panel comprised of IRB members will review requests for reactivation on a regular basis. Applications will be reviewed in the order in which they are received, as swiftly as possible. Depending on the risk-benefit analysis, the application may be referred to the full IRB for review. If full board approval is required, the application will be reviewed at the next scheduled monthly meeting.

The Risk Matrix for Assessing In-Person Human Subjects Research (PDF) was developed at KU to facilitate HRPP review of reactivation applications. The matrix incorporates three dimensions of risk: 1) population, 2) location and 3) activity. Reviewers will carefully consider potential benefits for participants in the context of these risks.

Approved protocols will be reviewed regularly by the HRPP as part of a Post-Approval Monitoring (PAM) process. A Procedural Integrity Checklist is required for PIs to track implementation of safety procedures as well as health screenings. The procedural integrity checklists may be reviewed by the HRPP to assure compliance.

The framework for safely reactivating in-person human subjects research was thoughtfully developed by KU's Human Subjects Research Reactivation Subcommittee and reviewed and approved by KU's Research Design Team, led by Vice Chancellor for Research Simon Atkinson:

Human Subjects Research Reactivation Subcommittee

Research Design Team

To achieve the objective of safely re-engaging KU human subjects research involving interpersonal, face-to-face interactions, the subcommittee took the following actions:

1. Developed key reactivation resources to be approved by the Vice Chancellor for Research.
   • A risk matrix to facilitate the review process of IRB applications, with careful consideration of potential benefits for participants during each phase.
   • Forms for reactivation requests.
   • Reliability checks to monitor procedural integrity.
2. Developed and provided training opportunities (including review of specific procedures for consideration) for investigators (e.g., accessing established training resources as well as developing new resources).
3. Developed an application and review/approval process for reactivation of in-person human subjects research.
4. Distributed to primary investigators an opportunity to re-engage with in-person human subjects research by completing required documents and submitting a Request for New Information (RNI) to HRPP.