Introduction

When the University of Utah defers to an external single IRB (SIRB) for the review and approval of research taking place at our institution or in our community, we provide the SIRB with detailed information about our local population, laws, and policies. This information is referred to as our “Institutional Profile” or “local context”. This information takes on a new dimension when the study plans to utilize an Exception from Informed Consent or “EFIC” waiver from the FDA.

The regulations at 21 CFR 50.24 and the conforming amendments contained in 21 CFR Parts 56, 312, 314, 601, 812, and 814 provide a narrow exception to the requirement that the investigator obtain informed consent from each subject, or the subject’s legally authorized representative, prior to enrollment in emergency research. The regulations also provide additional protections for subjects enrolled in these studies. For example, the regulations require consultation with representatives of and public disclosure to the communities in which the clinical investigation will be conducted and from which the subjects will be drawn, prior to initiation of the clinical investigation. They also require public disclosure of sufficient information following completion of the clinical investigation to apprise the community and researchers of the study. As well, the regulations require that an independent data monitoring committee exercises oversight of the clinical investigation.

The University of Utah HRPP employs a multi-step process for reviewing and accepting a Community Consultation Plan (CCP) for EFIC studies where an external SIRB is utilized.

1. A pre-review is conducted by a member of the IRB staff, where the basic requirements for conducting community consultation and public disclosure according to FDA guidance are verified. The pre-reviewer conducts a similar review to the board reviewers, and consults with an IRB manager as need to request revisions to ensure the CCP is as complete as possible.
2. The CCP is then forwarded to two board members – one whose primary expertise is scientific, and one community representative whose expertise is primarily non-scientific. These reviewers are primarily concerned with ensuring that the CCP proposed by the study team is adequate and appropriately customized to reach the proposed Utah community.
3. Recommendations for revisions or enhancements to the CCP are compiled by the IRB staff and forwarded to the SIRB for consideration.

The Reviewer Description, or review summary, acts as a written summary of your review and should include relevant, study-specific statements regarding the topics outlined below.

Guidance

This document describes the information that should be included in a review summary. At the end of each review summary, the board reviewer must make a recommendation regarding approval or other determination for the CCP.

What is the purpose of a Community Consultation Plan?

IRBs must review plans for community consultation and public disclosure (21 CFR 50.24(a)(7)(i), (ii), (iii)). Community consultation activities should be designed to help ensure that the communities in which the emergency research will be conducted and from which subjects will be drawn are adequately informed about the risks and expected benefits of the research and are given the opportunity to ask questions about it, and express their views prior to the IRB making a determination about the research.30 In reviewing community consultation activities, IRBs will need to exercise judgment in determining whether these activities are adequately designed to reach the broader communities identified in the investigational plan.

What does an adequate Community Consultation Plan include?

Community consultation means providing the opportunity for discussions with, and soliciting opinions from, the community in which the study will take place and the community from which the study subjects will be drawn. These communities may not always be the same; when they are not the same, both communities should be consulted. The goals of community consultation are to:

• show respect for persons by informing the community about the study in advance;
• inform community members about the trial in advance and provide a means for affected communities to provide meaningful input to the IRB before its decision to approve, require modifications to, or disapprove the study;
• show respect for the community by allowing representatives of the community to identify potential community-level concerns and effects of the research; and
• show respect for subjects’ autonomy. Respect may be shown by including in community consultation activities individuals who may have, or be at risk for, the condition under study (and thereby obtain input from a group that is expected to be similar to the eventual study subjects).

During community consultation, the sponsor and clinical investigator(s) should

1. inform the communities that it is proposed that informed consent will not be obtained for most (or all) research subjects, including an explanation as to why consent is not feasible (i.e., why the research is being conducted using the exception provided under 21 CFR 50.24);
2. inform the communities about all relevant aspects of the proposed study, including its risks and expected benefits;
3. hear and respond to the perspective of the communities on the proposed research; and
4. provide information about ways, if any, in which individuals wishing to be excluded may indicate this preference.

There is no single acceptable way to accomplish or fulfill the community consultation requirements, nor will all studies require the same amount, type, or extent of community consultation activities. It is up to the IRB to review community consultation plans and assess their adequacy, in the context of local issues that may need to be considered. Different IRBs may consider more or less community consultation necessary, depending on the unique circumstances of a particular study and the community.

Reviewing a Community Consultation Plan

You will be given access to the study application which will include the proposed CCP for a study that would like an Exception from Informed Consent (EFIC) for emergency research. As you write your review summary, please address the following points:

Subject Selection:

1. Are there populations being targeted by this study that may be more likely to be enrolled than others?
2. Are recruitment procedures designed to ensure a representative sample of participants?
3. Will certain disadvantaged or vulnerable groups be over or under represented?
4. Will potential risks and benefits be reasonably distributed across the community as a whole?

Community Consultation Plan Criteria:

1. Please provide a brief description of your site’s community consultation plan, as well as any thoughts, questions, or concerns you may have relating to the proposed plan.
2. Are the proposed community consultation methods based on appropriate factors such as the size of the communities, the languages spoken within those communities, and the targeted research population and the heterogeneity of the population?
3. Do the type and frequency of consultation activities facilitate broad community discussion with representative samples of the community?
4. Do the proposed Community Consultation materials include an accurate representation of the risks and benefits of the project, as well as a clear indication that study procedures will take place without informed consent from individual participants and/or Legally Authorized Representatives?
5. Does the proposed Community Consultation Plan include adequate methods for participants to exclude themselves from participation?
6. Does the proposed Community Consultation Plan include methods for receiving and incorporating feedback from the community into the research protocol?
7. Does the proposed Public Disclosure plan include adequate methods for dissemination of information after the investigation is completed so that communities and scientific researchers are aware of the study’s results?
8. Overall, is this research appropriate for your community?
9. Do you have any additional information to provide the IRB?

Helpful Tips for Writing Your Review

Review summaries should be written in a way that is understandable. Some things to consider include:

• Summaries should provide a layperson explanation of difficult procedures and/or scientific terms.
• Spell out acronyms at least once in your written review to ensure the clarity of the written reviews.
• Try to use complete sentences when drafting your review summary.
• Write any revisions requests clearly and with as much specificity as possible.

Documents and References

“How to Write a Review” Board Member Training Video: https://irb.utah.edu/board-members/new-members/

Guidance for Institutional Review Board, Clinical Investigators, and Sponsors, Exception from Informed Consent Requirements for Emergency Research: https://www.fda.gov/media/80554/download