Moving carefully to Phase 2 human subjects research reactivation
From: Kathleen Lynne Lane, Associate Vice Chancellor & Institutional Official for Human Research; Monica Biernat, Distinguished Professor & IRB Chair
Sent: Tuesday, May 11, 2021, 2 p.m.
To: KU Lawrence human subjects PIs, deans, and associate deans for research
Human Subjects Research Community,
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 2 of reactivation for in-person research. 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.
The HRPP team is pleased to announce the following moves to simplify the reactivation request process and consider additional proposals for in-person research:
- The following factors no longer will 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.
- 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.
- 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.
- 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.
- Streamlined process to submit requests for in-person research. Instructions have been modified to streamline approval while prioritizing in-person requests and tracking in-person research.
- Both an RNI and a modification or new study submission are still required.
- Submit both at the same time.
- For the RNI, no attachments are necessary. Simply submit a brief explanation of the request in the RNI, being sure to identify the parent study number. The RNI helps HRPP staff identify and prioritize in-person research requests.
- “Return to Work” training certification is no longer required for study personnel on either the RNI or modification/new study submissions.
- Submit both at the same time.
- Components of modification or new study submissions for in-person research:
- Consent form with COVID language.
- COVID safety plan.
- COVID procedural integrity checklist.
- Both an RNI and a modification or new study submission are still required.
We appreciate the care you continue to demonstrate for your study participants and the broader community as we navigate human subjects inquiry during evolving pandemic conditions.
Respectfully,
Kathleen & Monica
Kathleen Lynne Lane
Associate Vice Chancellor & Institutional Official for Human Research
Monica Biernat
Distinguished Professor & IRB Chair