Beyond the Regulations: More Considerations for Emergency Research

Our recent webinar on conducting planned emergency research had nearly 1,000 registrants, demonstrating the importance of this topic and the increasing number of trials using the exception from informed consent (EFIC) consent method outlined in FDA regulation 21 CFR 50.24. If you are not familiar with the regulatory requirements, we encourage you to listen to the webinar, which is now available on demand.

In this blog post we go beyond the regulatory requirements and examine three other key actions that research organizations may want to consider before conducting planned emergency research at their facilities.

A Quick Refresher on Planned Emergency Research

How do you conduct research on potentially life-saving treatments in trauma or emergency situations like a car crash, unexpected stroke, or similar catastrophic and unforeseen events? These patients are most likely incapacitated and either in emergency transport or presenting at the ER without their family or others who can make medical decisions, and time is of the essence to deliver life-saving care. The traditional prospective informed consent process, with time for the patient to carefully consider and discuss their options, doesn’t fit emergency situations where it is impossible to predict who will need treatment and be eligible for the research. Yet we must conduct this research to determine if innovative treatments for stroke, trauma, and other acute conditions are effective.

Found at 21 CFR 50.24, the FDA provides a regulatory pathway for conducting planned emergency research, including an EFIC. In a nutshell, FDA allows planned emergency research to occur only after first conducting community consultations and public disclosure to alert the local community that the research is occurring. The principal investigator (PI) must have a plan to get consent from family members or another authorized representative if possible, and to have the whole plan approved by the IRB. In the end, if there is no opportunity to get consent from family, and the patient is eligible for the experimental treatment, then under the EFIC regulations investigators may administer the experimental treatment without getting explicit prospective informed consent from the participant. Experimental treatments can be administered in the field, during transport, or at the ER even if the patient cannot consent.

This seems to go against all the tenets about research consent being voluntary. But without this exception to traditional informed consent processes, it would be nearly impossible to develop new treatments for use in emergency situations.

Before conducting this type of research, you should thoroughly understand the regulatory requirements, and any organization conducting planned emergency research should consider additional actions beyond simple compliance with 21 CFR 50.24. We focus here on three specific areas that should be carefully evaluated by an organization considering participating in planned emergency research.

1. Front-line Staff Communication Plan

Regulations require the IRB to approve plans for communicating with the community in advance of the research, as well as plans for telling the participant or their family about the research after the fact. The PI and study team are also trained in advance and know what is involved in the research. However, what about the front-line hospital staff or intensive care clinical staff who may not be part of the study directly, but will likely be the first folks confronted with questions from the participant or their family? Hearing “I don’t know, you need to talk with the investigator” is likely not what the participant or their family want to hear in the moment.

Facilities should have an education and communication plan that goes well beyond the study staff. A good internal communication plan should include:

• A summary of the research, what type of participants might be involved, and a statement of why the hospital/organization feels it important to be involved.
• A summary of how to provide basic responses to question so that at a minimum front-line staff have an idea about how to guide participants and family through initial questions such as, “What do you mean, what is this experiment you are talking about?”
• Clear instructions on who staff should direct family or participants to for additional information.
• Instructions to staff on how to identify in the medical record if a patient is part of a planned emergency research study.

Internal staff communication plans do not need to be elaborate, take a lot of time, or even be approved by the IRB (since they are not technically required). However, mapping out a plan prior to starting the research is a good idea and should be a requirement of the facility’s research administration.

2. Clinical Operations/Feasibility Evaluation

While the study protocol will likely outline many details on investigational treatment administration, during the feasibility review process it is imperative for research organizations to thoroughly and thoughtfully consider if their clinical operations units can really deliver quality research execution. Those considering conducting planned emergency research for the first time should take an extra look at their operations to ensure they are ready.

Some common areas to consider:

• Investigational drug pharmacy – Does the pharmacy have capacity and training to respond with experimental drugs in the time frame needed with planned emergency research? Can research drug accountability be maintained?
• Record keeping – Do your CTMS, EMR, and other systems have the operational capacity to rapidly identify patients in the ER and enroll them in an EFIC clinical trial? Since there is no “consent” event to trigger certain operations such as research billing codes, enrollment tracking, flags in the EMR, etc., will all these events work properly?

This of course is not an all-inclusive list; your organization may have other issues to consider. The key is to consider the operational issues in advance of starting the research, and perhaps even run simulations to demonstrate operational readiness. Remember, just because the IRB determines the research is approvable at your facility does not necessarily mean your facility has the operational capacity or integrated clinical operation organization necessary to successfully execute an EFIC study.

3. Plan for Media Inquiries

Perhaps it goes without saying, but when something goes wrong in an EFIC study, the potential for media attention is higher than in typical clinical trials. Most research organizations have some type of media policy or central group who handles media inquiries. Before conducting planned emergency research consider, two important points:

1. Has your media department been briefed (or are they even aware) that EFIC research studies are being conducted at your organization (see “Front-line Staff Communication Plan” above)?
2. Are you confident your media team is ready to respond to questions about EFIC research?
   • If there is a problem, how will you respond to potential questions about conducting research on patients without their consent?
   • Do you have a planned response to possible negative press?
   • Are you being proactive in anticipating issues and controlling the message?

Research is beneficial and necessary. Without it we would have no new treatments, advancements, or cures; however, that does not mean it always goes perfectly. It’s good to be prepared.

Summary

Planned emergency research with an EFIC is a vital and necessary avenue for testing potential new treatments in the challenging setting of emergency medicine. As with many aspects of clinical research, the regulations set a minimum floor that must be adhered to; but they are just the floor. To do this type of research well, organizations should look beyond the regulations. We’ve explored just three specific areas not covered in the regulation above; we are certain you can think of more!

Need help in determining if your organization is ready to conduct planned emergency research studies? Advarra’s IRB has a long history of reviewing EFIC studies, and the team at Advarra Consulting can support you with operating procedures, training, and other tools to ensure you are ready. Contact us to get started.

Forte, now a part of Advarra, provides the industry-renowned CMTS software OnCore. Read this case study to learn how OnCore can enroll and track a patient throughout an emergency research study.

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