University of Hawai‘i
Research Compliance

Impact Level Elevated to RED

September 2020 Announcement and Instructions

Aloha UH Researchers and Research Team Members,

We hope that you and your loved ones have continued to be safe and well during this challenging and difficult time. We are appreciative of the efforts you have made to keep your participants and research teams safe during this pandemic.

As you know, it is the responsibility of the IRB to protect participants. Sadly, the rate of infections and deaths in Hawai‘i has increased. Our hearts go out to those who have suffered or lost loved ones. To protect participants, research teams, and our community, the UH IRBs and the Human Studies Program (HSP) have made the decision to once again restrict in-person interaction as much as possible and move to impact level “red.”

What does this mean?

As explained in our last notice to researchers in July 2020, the HSP developed Safety Guidelines based on the impact level of COVID-19. Upon release of this guidance, HSP was at impact level “orange.” Researchers were required to submit a Safety Plan for the IRB’s review in order to conduct in-person research. The Safety Plan required researchers to describe the safety measures they would implement at each impact level. Effective September 8, 2020, HSP is moving to impact level “red.”

  • If the UH IRB has approved your Safety Plan, implement the measures you described for impact level “red.” Depending on the specifics of your Safety Plan, this may mean that in-person interaction with participants is restricted or halted.
  • If you must conduct in-person research and your approved Safety Plan does not allow for interaction or if your research is taking place outside of Hawai‘i in a location where the virus rates are lower, please submit a revised Safety Plan form via a Modification application in eProtocol for review by the HSP.
  • If you do not have an approved Safety Plan, until the HSP approves your plan, in-person interaction for research purposes must stop.

Please do not proceed with in-person research until your Safety Plan has been approved by the IRB.

Most clinical and/or therapeutic studies involving interaction with participants, as well as studies researching some aspect of COVID-19, already have an approved Safety Plan in place, therefore, this notice would only require researchers to implement the measures already approved for the “red’ impact level. If a researcher wishes to revise these measures, the Safety Plan should be resubmitted to the UH IRB through a Modification application as explained above.

The requirement for a Safety Plan applies to studies in which one of the UH IRBs provided initial review and approval. Studies in which the UH IRB ceded review to a non-UH IRB would first need to follow the lead IRB’s guidance and also take into account any performance site requirements (such as hospitals or clinics).

We truly appreciate your commitment to keeping participants, research teams, and the community protected during this unpredictable and difficult time. Please contact our office at UHIRB@hawaii.edu for assistance.

UH Human Studies Program
Office of Research Compliance

Human Studies Program Reponse to COVID-19

In response to the rapidly evolving situation with COVID-19, the University of Hawai‘i, Human Studies Program (HSP) is requiring all UH researchers to regularly review their active human research protocols to help ensure the ongoing protection of research participants during this challenging time.

In-person interaction with participants in human research projects now poses additional risk, both to study participants and researchers. Guideline documents for researchers who wish to resume human research involving in-person interaction with participants have been developed. These documents have been developed with your feedback, the guidance of the UH Institutional Review Boards (IRBs), the contributions of key research teams across the UH System, and inspiration from fellow institutions and IRBs nationally.

Researchers are asked to follow the (color-coded) COVID-19 Impact Level chart. Restrictions on in-person research change based on impact level. Please use the Impact Level Safety guidelines to plan your research protocol. All new research protocols involving in-person interaction, and all requests to re-open in-person interaction for already ongoing research will need to include a safety plan addressing COVID-19. This safety plan should include proposed responses for all five impact levels. You may submit the safety plan using the Safety Plan form. All requests for resuming in-person interaction for existing approved research should be submitted using the HSP modification form in eprotocol (or the paper form, if the project is pre-eprotocol). If submitting your application using eProtocol, attach the Safety Plan Form on the attachment page. If submitting for a pre-eptorotocol application, submit the Safety Plan Form as an email attachment.

Impact Level Safety Guidelines
Safety Plan Form

The Human Studies Program Impact Level chart is based on the State of Hawai‘i Impact level guidance. Please note, however, as a policy and as an additional safety measure, the UH HSP status will be carefully delayed behind the state level status by at least two weeks for opening or releasing restrictions. Researchers are to use the Impact Level chart to determine which provisions of their safety plan they may implement. It is quite possible, the impact level may become less restrictive or more restrictive. Please be sure to monitor the HSP website regularly, even after your protocol has been approved, to stay abreast of current guidance. The Human Studies Program will also notify researchers by email when Impact Level status changes.

The HSP in coordination with the IRB will review each submitted application for studies requiring face-to-face interaction and may have additional requirements or modifications to the study to ensure participant and researcher safety. The IRB will consider both the risk involved with COVID-19 and any potential benefit to participants.

UH researchers interested in resuming in-person human research are required to receive IRB approval before doing so by:

New Applications
  • Review the updated COVID-19 guidance on our website.
  • Review the Impact Level Safety Guidelines found on the COVID-19 page of our website.
  • Fill out a Safety Plan Form found on the COVID-19 page of our website.
  • Submit the Safety Plan Form via a New Application in eProtocol.
  • You may also wish to include the COVID-19 safety information sheet for participants. The link for this document is on the COVID-19 page of our website.
Existing Approved Applications
  • Review the updated COVID-19 guidance on our website.
  • Review the Impact Level Safety Guidelines found on the COVID-19 page of our website.
  • Fill out a Safety Plan Form found on the COVID-19 page of our website.
  • Submit the Safety Plan Form via a Modification Application either via eProtocol, or an email to uhirb@hawaii.edu with a modification form for pre-eProtocol applications.
  • You may also wish to include the COVID-19 safety information sheet for participants. The link for this document is on the COVID-19 page of our website.

Please do not proceed with in-person research until you have received IRB approval. Mahalo.

Informed consent considerations

In appropriate situations, the consent process can be conducted over the phone or by using other technology. Use of audio recording to document informed consent may be acceptable. Unless your protocol specifically states that consent will be done in person or otherwise prohibits the change, you do not need to modify your protocol. Consider whether changes to the consent process, and/or conduct of the protocol could mitigate risk of exposure to COVID-19. In certain minimal risk situations, it may be appropriate to request a waiver of documentation of informed consent (no signature needed) and include a statement in the consent form that participation implies consent. Requesting a waiver of documentation of consent can be done on the consent form page of the eProtocol application. If the application is “pre-eProtocol”, a waiver of documentation of consent can be requested via email to uhirb@hawaii.edu. In order to make changes, such as implementing a verbal consent process, or revising the consent process and form, you must submit a Modification of your protocol (attach updated consent documents).

Study participants should be provided information on the efforts that UH and the research community are making to protect both participants and researchers. The COVID-19 safety information sheet may be attached as an addendum to consent form documentation, for study participants.

Protocol Violations

It is recognized that there may be unavoidable protocol violations due to COVID-19 illness or control measures. Protocol violations do not need to be reported to the IRB unless they impose an increase in the risk of harm to participants, adversely affect the integrity of the data, or affect a participants’ willingness to participate in the study (see SOP 108 for details). Report protocol violations through eProtocol or by email for “pre-eProtocol” studies.

Original Guidance Limiting Face-to-Face Interaction

OLD PDF VERSION (FEB 2020)