Human Studies Program COVID-19 Response

Current Impact Level:  ORANGE

 

The current IRB impact level for in-person research is ORANGE however, the UH IRB will now consider all types of human research projects under this category. Prior to this announcement, in-person interaction for research was generally limited to certain types of research studies, like therapeutic studies where there was a potential for direct benefit to the participant. Now, with an approved Safety Plan in place which describes precautions at the Orange level, interaction for research purposes is permitted.
What does this mean for my studies?
  1. The IRB welcomes modified safety plans to expand in-person research via the modification application. For example, if you wish to conduct Observation research, the IRB welcomes safety plan submission at this time. Evaluations occur on a case by case basis.
  2. As of March 25th, 2022 the UH System no longer requires the use of the LumiSight UH health app for daily COVID-19 health screenings. If your Safety Plan was tied to the use of the LumiSight health screening, please submit a modification application with a revised Safety Plan to replace LumiSight with a health screening process. The Safety Guidelines offer a screener, or you can use the same questions that LumiSight asked.
  3. There is a new Information Sheet Consent Form Addendum to aid in the consent process that can be provided to your participants. The addendum describes safety measures to keep participants safe during in-person research participation. Use of this addendum is encouraged but not required.
  4. In the case of COVID-19 infection traced to in-person research interaction, please send us an email at uhirb@hawaii.edu as soon as possible. Reporting instructions will be provided.
The following documents were updated in April 2022:
  1. Impact Level Safety Guidelines
  2. Safety Plan Form
  3. Consent Form Addendum

Human Studies Program Response 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 study approved before eProtocol, submit the Safety Plan Form as an email attachment.

Researchers are to use the Impact Level chart to determine which provisions of their safety plan they may implement. It is possible that 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. Do not proceed with in-person research until you have received IRB approval.  Please refer to the guidance below by type of application:

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.

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.