Skip to content

Institutional Review Board

Main Navigation

Exception from Informed Consent Research

Planned Emergency Research

Planned emergency research involves the systematic investigation of a condition experienced by individuals "in a setting where the emergency circumstances require prompt action and generally provide insufficient time and opportunity to locate and obtain consent from each subject's legally authorized representative" (FDA 2013). Because informed consent cannot be obtained prior to initiating research procedures, there are many additional participant protections that must be in place before the IRB can approve planned emergency research. 

Planned emergency research is different than the emergency use of an investigational drug or device in a single patient. Planned emergency research involves the prospective identification and enrollment of participants into a study.  Emergency use of an investigational drug or device involves the treatment of a patient using an investigational drug or device outside of the research setting.  For more information about emergency use of an investigational drug or device, visit Emergency Use of a Test Article.

In order for a planned emergency research study to proceed, the IRB must grant an "Exception from Informed Consent" ( see definition) or "EFIC" waiver.

The Exception from Informed Consent (EFIC) Process

Significant preparation is required when an investigator undertakes a study that will take place in an emergency setting.  Research that will use an EFIC consent model undergoes a two-stage IRB process where each stage ends with an IRB approval. Where most research studies can be considered "approved to enroll participants" when initial IRB approval is granted, EFIC studies cannot open for enrollment until after the Community Consultation & Public Disclosure Plan has been reviewed and approved by the IRB, the plan has been implemented in the local community, and the results submitted to the IRB for review and approval. 

1

  Main Protocol Preparation

Begin by writing out and organizing your research plan. You will need to have a clear design outlined before you will be ready to submit your application to the IRB. 

If your study is subject to FDA regulations, you should submit an IND or IDE application to the FDA with a request for an Exception from Informed Consent (EFIC) included. 

It is very important that investigators who wish to design planned emergency research review all of the regulatory requirements for such a design.  You can find important FDA guidance at the bottom of this page. In your protocol, be prepared to provide detailed information about each of the additional regulatory requirements associated with an EFIC design, including:

  • A Community Consultation Plan
  • A Public Disclosure Plan
  • A plan for participants to opt-out of the research, if appropriate

 

Justification for Planned Emergency Research Design

The IRB considers the following criteria for justifying a planned emergency research design.  Researchers must provide justification in the IRB application to address these criteria:

  • The human subjects are in a life-threatening situation, available treatments are unproven or unsatisfactory, and the collection of valid scientific evidence, which may include evidence obtained through randomized placebo-controlled investigations, is necessary to determine the safety and effectiveness of particular interventions.
  • Obtaining informed consent is not feasible because:
    • the subjects will not be able to give their informed consent as a result of their medical condition;
    • the intervention involved in the research must be administered before consent from the subjects' legally authorized representatives is feasible; and
    • there is no reasonable way to identify prospectively the individuals likely to become eligible for participation in the research.
  • Participation in the research holds out the prospect of direct benefit to the subjects because:
    • Subjects are facing a life-threatening situation that necessitates intervention;
    • Appropriate animal and other preclinical studies have been conducted, and the information derived from those studies and related evidence support the potential for the intervention to provide a direct benefit to the individual subjects; and
    • Risks associated with the research are reasonable in relation to what is known about the medical condition of the potential class of subjects, the risks and benefits of standard therapy, if any, and what is known about the risks and benefits of the proposed intervention or activity.

 

Informed Consent Process for Planned Emergency Research

Though informed consent is not feasible prior to inclusion in planned emergency research, a consent process must be conducted as soon as reasonably possible, based on the ability to locate a patient's legally authorized representative (LAR) or the participant's regained capacity to provide informed consent. The consent document and process used must be in compliance with normal informed consent requirements described in 21 CFR 50.25 (for FDA regulated research) or 45 CFR 46.116-117 (for non-FDA regulated research). 

The consent process must include the following elements:

  • The proposed research protocol defines the length of the potential therapeutic window based on scientific evidence, and the investigator has committed to attempting to contact a legally authorized representative for each participant within that window of time and, if feasible, asking the legally authorized representative contacted for consent within that window rather than proceeding without consent.
  • The investigator has summarized efforts that will be made to contact and obtain consent from legally authorized representatives as soon as possible upon identification of an eligible participant and make this information available to the IRB at the time of continuing review.
  • If obtaining consent is not feasible and a legally authorized representative is not reasonably available, the investigator has committed, if feasible, to attempting to contact within the therapeutic window the participant’s family member who is not a legally authorized representative, and asking whether he or she objects to the participant’s participation in the clinical investigation. The investigator will summarize efforts made to contact family members and make this information available to the IRB at the time of continuing review.
    • “Family member” means any one of the following legally competent persons: spouses; parents; children (including adopted children); brothers, sisters, and spouses of brothers and sisters; and any individual related by blood or affinity whose close association with the participant is the equivalent of a family relationship.
  • If a legally authorized representative or family member is told about the clinical investigation and the participant’s condition improves, the participant is also to be informed as soon as feasible.
  • If a participant is entered into a clinical investigation with waived consent and the participant dies before a legally authorized representative or family member can be contacted, information about the clinical investigation is to be provided to the participant’s legally authorized representative or family member, if feasible.

 

Establish an Independent DSMB

An independent DSMB must be established for the study. For more information about establishing a DSMB and designing a data and safety monitoring plan, consult the IRB guidance on Data and Safety Monitoring.

 

Obtain an IND or IDE for Planned Emergency Research from the FDA

For FDA regulated studies, an IND or IDE must be in place for the study, even if the drug or device is already FDA approved for a specific indication.  

 

Design a Community Consultation Plan

Design a plan for conducting community consultation and public disclosure. We have provided several tools below to help you.

 

Tools to Help You Prepare:

 

If you are conducting a multi-site trial and will use the UU IRB as your single IRB (SIRB), some additional preparation will be needed to ensure your sites are adequately prepared to conduct EFIC research.

The ERICA system allows for flexibility and multiple methods for submitting an EFIC protocol for UU IRB review. This guidance will walk you through the recommended model for application submission.

Reliance Consultation

Communication between investigators, site Human Research Protection Programs (HRPPs), and the SIRB is extremely important throughout the EFIC review and approval process. Submit a Reliance Consultation Request Form to begin this process with the University of Utah IRB. 

Tools to Help You Prepare:

  • Consultation and Disclosure Plan Menu: Each site will be required to design a Community Consultation & Public Disclosure Plan that is appropriate for their local community. To assist your sites with this task, begin by providing them with a "menu" of activities to choose from. Use the IRB's guidance on Designing a Plan for Community Consultation & Public Disclosure in EFIC Studies to prepare this section of your protocol.
  • Participating Site Community Profile Worksheet: Each relying site should be prepared to provide a detailed community profile that describes the characteristics of their community in the context of the EFIC protocol under review.  

The lead site for a multi-site study is generally responsible for protocol preparation. When you submit your ERICA application for Human Research Protection Program (HRPP) review at the University of Utah, make sure to include a copy of the full protocol in your ERICA application.

 

2

  IRB/HRPP Review: Community Consultation & Public Disclosure

What is "Community Consultation"?

"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."

Researchers are required to complete community consultation and public disclosure activities prior to beginning the study.  Full information about community consultation and public disclosure can be found in the FDA guidance at the bottom of this page, including a list of examples for each activity.

The ethical principle of Respect for Persons should be the foundation when a Community Consultation Plan (CCP) is designed. Keep the following goals in mind:

  • Inform the community in advance that the research will take place 
  • Provide a way for the community that will be impacted by the research to provide meaningful input and express questions and concerns to the researchers and the IRB
  • The goal of public disclosure prior to initiation of the study is to provide information to the broader community so they are aware of the plans for the investigation, its risks and expected benefits, and the fact that the study will be conducted without obtaining informed consent from most study participants.
  • The goal of public disclosure after the study is completed is to ensure that the communities, the public, and scientific researchers are aware of the study’s results. 

 

Researchers describe the following in the IRB application:

  • An appropriate plan for consultation with representatives of the communities in which the clinical investigation will be conducted and from which the participants will be drawn.  
  • An appropriate plan for public disclosure to the communities in which the clinical investigation will be conducted and from which the participants will be drawn, prior to initiation of the clinical investigation, of plans for the investigation and its risks and expected benefits.
  • An appropriate plan for public disclosure of sufficient information following completion of the clinical investigation to apprise the community and researchers of the study, including the demographic characteristics of the research population, and its results. 

 

What Does an Acceptable Community Consultation Plan (CCP) Look Like?

  1. WHO?  Begin by identifying your audience. Will your participants be drawn from the general public, or are you seeking individuals with a specific condition? Will you be recruiting any vulnerable populations, such as children or individuals with decisional impairment? 

  2. WHAT?  Plan several activities that you'd like complete to consult and elicit feedback from the community. The activities should be a mix of interactive activities that will result in mostly qualitiative responses (e.g. focus groups, in-person interviews with community leaders, a booth or table at a community event, etc.) and more passive activities that may generate quantitative responses, or in the case of public disclosure activities, no responses from the public at all (e.g. online or telephone surveys, social media messaging, press releases, news articles, radio or television ads, etc.).

  3. WHERE? It is not recommended that you book venues or make firm plans for your community consultation events until after the IRB has reviewed and approved your plan in case modifications are required, but the details of events should be passed on to the IRB when plans are solidified so IRB members can attend events whenever appropriate.

  4. HOW? How do you plan to advertise your event or activity? How will you reach the members of the community you would like to and ensure they are given the opportunity to attend and provide feedback


When determining whether the community consultation and disclosure process is adequate for an EFIC study, the IRB must consider the community's opinions and concerns, assess the adequacy of the consultation and disclosure process, and incorporate the results of community consultation and discussion into its decision making.

The IRB uses a Reviewer Checklist to ensure that all requirements are met.  At initial review, the board will review and consider the Community Consultation Plan.  For sites outside of the University of Utah, the IRB may request information related to local context to assist with this review.

 

IRB Approval of Community Consultation & Public Disclosure Plan

If the IRB determines that the proposed Community Consultation plan is sufficient, approval will be granted for a specified amount of time so consultation and disclosure activities can proceed.  This initial approval does NOT grant approval to begin enrolling participants in the study.  

Tools to Help You Prepare:

If you are conducting a multi-site trial and will use the UU IRB as your single IRB (SIRB), you will need to create a plan that can be adapted to meet the needs of each of your participating sites. The UU SIRB will begin by approving your general plan, and then will review and approve each individual site's customized plan. 

  • General Plan with "Menu" Options: Each participating site will need to create a plan that is appropriate for their individual community, so begin by creating a general Community Consultation & Public Disclosure plan for your overall protocol. Include several options for consultation and disclosure activities that each site may choose from as they craft their site-specific consultation plan. 

 

Site-Specific HRP Review 

Effective community consultation and public disclosure plans used in EFIC trials require knowledge of a community’s communication style, geography, politics, socioeconomics, and cultural and social norms. Comprehensive understanding of the local context at each site is necessary for ensuring ethical principles are met when conducting the trial. As such, obtaining quality community information from multiple sources that are intimately familiar with the site is critical to the SIRB’s evaluation of community consultation and public disclosure plans. 

The UU SIRB requires each site’s human research protection program (HRPP) to formally assess the information provided in the community profile worksheet and the site-specific consultation and disclosure plan.

HRPP Community Consultation Review Process:

  1. HRPP Contact: The UU SIRB will contact each relying HRPP and request that they review their site's Community Consultation Plan and provide the SIRB with feedback.

  2. Identify Your HRPP Reviewer: The UU SIRB provides each HRPP with guidance on how to identify an HRPP representative with appropriate local knowledge and expertise to perform the assessment.

  3. Complete the HRP Review Worksheet: The designated HRP reviewer should use our review worksheet to complete the assessment. The completed review worksheets are provided to the SIRB board members as part of the convened meeting materials.


NOTE: The UU SIRB does not require all site-specific consultation and disclosure plans to be reviewed together. Our electronic system and review processes allow for each site to be reviewed on their own timeline as each sites submission is received.

Tools to Help You Prepare:

  • Who Can Be an HRP Reviewer?: This guidance is designed to help a participating site's HRPP select a reviewer that can best complete the local review of the proposed Community Consultation Plan and submit recommendations to the UU SIRB as needed. 
  • HRP Review Worksheet: This worksheet is completed by each participating site's designated HRP reviewer and should provide the UU IRB with insights into the site's local community. 

The lead site should provide a general plan for their study-wide Community Consultation & Public Disclosure plan. Once the single IRB (SIRB) has determined that the overall plan is acceptable, sites can begin customizing the plan for their particular site. 

Because community consultation is so heavily weighted in the local context for a research site, it is expected that the Community Consultation plan for Utah will be submitted to the University of Utah IRB/HRPP for review prior to implementation.

University of Utah investigators should not begin their community consultation activities for an EFIC study until they have received approval from 1) the SIRB, and  2) the University of Utah Human Research Protection Program (HRPP).

3

  Community Consultation & Public Disclosure Period 

After you receive IRB approval to conduct your Community Consultation and Public Disclosure activities, make sure you keep good records and collect robust data from each activity so you can report the results of your consultation activities back to the IRB. 

Also, keep the IRB informed as events and activities are scheduled. The FDA recommends that "IRB members attend community consultation activities to hear the views" of the communities. IRB members should be invited to attend events and activities throughout the consultation process. Please send an email to your IRB staff contact with as much notice as possible when your activities are scheduled. 

Tools to Help You Prepare:

If you are conducting a multi-site trial and will use the UU IRB as your single IRB (SIRB), make sure you have a clear plan for your site investigators to report the results of their Community Consultation Plans to the lead study team so a clear and organized report can be provided to the SIRB. 

The lead study team will be responsible for compiling the results of consultation activities at each site and submitting them to the SIRB by way of a Continuing Review Application. 

Follow the requirements of your SIRB and the lead study team. Make sure you record the results of each of your consultation activities carefully so you can report the results of your activities back to the lead study team/SIRB, and the University of Utah HRPP. 

 

4

  IRB & HRPP Review of Community Consultation Results

After Community Consultation activities have been completed and you have collected the data resulting from the activities, submit a Continuing Review application to the IRB to report the results of your consultation and disclosure period.  The IRB will review the results of your activities and determine whether sufficient consultation has occurred, or if additional activities are needed.  

As each site completes their consultation activities, compile and organize the results and submit them to the UU SIRB via a site-specific application. The UU SIRB will review each site's results and determine whether sufficient consultation has occurred, or if additional activities are needed.  This review process may include additional consultation with the site's HRPP as needed.

The SIRB should review the results of your consultation activities and determine whether the consultation process was completed adequately. Submit the results of your activities along with the SIRB's assessment to the University of Utah HRPP via a Continuing Review application. 

 

5

  IRB Approval to Open for Enrollment of Participants

When the IRB determines that adequate community consultation has occurred, the study will be approved to open for enrollment.

If you are conducting a multi-site trial and will use the UU IRB as your single IRB (SIRB), you have the following before you may open enrollment at a participating site:

  1. Approval from the University of Utah SIRB to open enrollment, and
  2. An activation notice from the participating site HRPP to allow the study to initiate locally. Please note that each site may have different processes for ensuring all HRPP requirements have been met.

 

If you are a participating investigator in a multi-site trial and will use an external IRB as your single IRB (SIRB), you have the following before you may open enrollment at the University of Utah:

  1. Approval from the SIRB to open enrollment, and
  2. An activation notice from the University of Utah HRPP to allow the study to initiate locally. This letter will come automatically via the ERICA system once all local requirements have been completed.

 

6

  IRB Review of Public Disclosure Efforts

After the study is completed, additional public disclosure activities must be conducted.

"The goal of public disclosure after the study is completed is to ensure that the communities, the public, and scientific researchers are aware of the study’s results. Disclosure to researchers of the results, both positive and negative, of studies conducted under 21 CFR 50.24 is particularly important because such disclosure may help FDA and researchers learn from these studies involving vulnerable subjects who are unable to consent. "

Please note that the IRB may also determine that additional disclosure activities are needed if new information becomes available during the study.

"FDA recommends that all such disclosures occur promptly and that public disclosure after a study is completed or terminated occur within 1 year of the completion or termination date."

 After you have completed your post-clinical trial public disclosure efforts, submit a Report Form to the IRB with a summary of the results. 

Tools to Help You Prepare:

Submit the results of your post-study public disclosure efforts to the SIRB via a Report Form. You may include the results of multiple sites, or you may submit each site's results as they are available.  

Follow the requirements of the SIRB and lead study team to conduct your post-study public disclosure activities. Submit the results of your disclosure activities to the lead study team/SIRB, and also to the University of Utah HRPP via an ERICA Report Form. 

EFIC Tools

All of the tools and guidance documents linked on this page can also be found here:

Regulatory References for Planned Emergency Research

It is very important that investigators who wish to design planned emergency research review all of the regulatory requirements for such a design.  These documents explain the additional protections and requirements necessary for approval of planned emergency research.

For research subject to FDA regulations, you should submit an IND or IDE submission to the FDA and request an exception from informed consent per the FDA's requirements. If the FDA will allow for the EFIC waiver, an IRB must then determine that the "research involves subjects unable to consent and that the research...will be carried out under an FDA IND.

For research not subject to FDA regulations, the IRB is responsible for the review and approval of research requiring an exception from informed consent. 

Not Finding What You're Looking For?

Check our our A-Z Index or Contact Us and we'll help you!   Email the IRB

Last Updated: 5/19/21