Reactivating in-person human subjects research


Updated Nov. 22, 2021

With an increasing proportion of the population achieving full vaccination and general easing of public health restrictions implemented during the pandemic, KU’s Human Research Protection Program is moving to Phase 3 of reactivation for in-person research, effective Dec. 8, 2021. Please keep in mind that an upswing in local virus risk may cause a return to in-person human research restrictions, depending on public health guidance and actions.

The HRPP still encourages using remote procedures when possible.

Please note: As we progress through each phase of reactivation, we anticipate making adjustments to documents and procedures based on current guidance from the CDC and feedback from researchers.

Apply for reactivation

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 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.

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 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 3: Tertiary activation

Effective Dec. 8, 2021

  1. Studies with low-moderate risk of COVID: New studies and modifications to currently approved studies may be approved through a streamlined reactivation process. 
  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 4: Full activation

Conditions + timing to be determined.

Effective Dec. 8, 2021: If you are unable to conduct activities remotely AND you believe your study may meet Phase 3 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.

Instructions have been modified to streamline approval while prioritizing in-person requests and tracking in-person research:

Step 1

Read the following document and resources:

Step 2

Complete required documents and submit with your new study or modification (MOD) to an existing study:

  1. HRPP Phase 3 Reactivation Checklist (.docx)
  2. Procedural Integrity Checklist (.xlsx) to monitor implementation of safety plan. Researchers are expected to continue to use the procedural integrity checklist to document compliance. Post-approval monitoring (PAM) check-ins will be conducted intermittently.
  3. New HRPP protocol or, if applicable, revised HRPP protocol with amendments to reflect the HRPP Phase 3 Reactivation Checklist.
  4. Updated consent forms to include COVID-19-specific safety procedures. See COVID-19 Consent Template (.docx) for guidance.

Step 3

Submit a MOD in eCompliance indicating REACTIVATION REQUEST in the summary.

Upload completed documents:

  1. HRPP Phase 3 Reactivation Checklist (.docx)
  2. New or modified protocol form
  3. Revised consent form(s)
  4. Related study materials as appropriate for Phase 3.

Click “Submit” to send the completed modification to the HRPP.

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 (.xlsx) 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

  • Kathleen Lynne Lane, Associate Vice Chancellor for Research and Professor of Special Education
  • Monica Biernat, IRB Chair and University Distinguished Professor, Psychology
  • Jonathan Brumberg, Associate Professor and Director of Undergraduate Studies, Speech-Language-Hearing
  • Alyssa Haase, HRPP Administrator
  • Susan MacNally, Director of Research Integrity

Research Design Team

  • Simon Atkinson, Vice Chancellor for Research
  • Sara Baer, Director, Kansas Biological Survey
  • Chris Beard, Distinguished Professor, Ecology & Evolutionary Biology, and Senior Curator, Biodiversity Institute & Natural History Museum
  • John Colombo, Interim Dean, College of Liberal Arts & Sciences, and Director, Life Span Institute
  • Tammara Falicov, Associate Dean for Research, College of Liberal Arts & Sciences
  • Scott Hanrath, Associate Dean for Research, KU Libraries
  • Ron Ragan, Dean, School of Pharmacy
  • Jen Roberts, Vice Provost for Graduate Studies
  • Robin Lehman, Director of Special Projects, Office of the Provost 
  • Julie Popiel, Executive Associate, Office of Research

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.

COVID-19 safety information resources

These resources may be used by your study team to inform your HRPP Reactivation Safety Plan. Please bookmark the most relevant URLs for your study and evaluate these sites regularly to keep current. If you find you need to revise your safety plan, it must be reviewed and approved.

University of Kansas

  • Protect KU: Up-to-date information on KU's response to COVID-19

Centers for Disease Control 

Kansas Department of Health & Environment 

Occupational Safety & Health Administration (OSHA) 

Environmental Protection Agency