Research in Emergency Settings

Exceptions to Informed Consent

Clinical research studies only work when people volunteer and give their permission to participate. This process, called informed consent, begins when researchers explain to you:

The purpose of the study
Extent of your involvement, including experimental procedures or tests
Risks, benefits, and other options
Length of the study
How your privacy will be protected
Your right not to participate

The purpose of informed consent is to ensure you understand what will happen throughout the study. It will include updates that may affect your decision to continue to participate. In most cases, researchers cannot start any research study activities until you provide informed consent.

Exception from Informed Consent (EFIC) in Emergency Research

During life-threatening emergencies, it may not be possible for you to provide consent to participate in research. Given the nature of emergencies, some treatments must begin very quickly, and there may not be time to contact a family member to ask for permission. The Food and Drug Administration has special rules for these situations that allow patients to be treated in research studies using a process called Exception From Informed Consent for Emergency Research (EFIC).

EFIC studies are special and rare. An extensive vetting and community consultation process takes place before any study is approved to enroll patients without their consent. EFIC can only be used when all of the following criteria are met:

There is the possibility of direct patient benefit
There is a life-threatening emergency when treatment decisions cannot be delayed
There is no reasonable way to identify the people who are likely to become eligible for participation in a study (for example: accident victims)
Getting consent is not possible from you or a family member
When doctors don’t know if existing treatments work or when they know they won’t work well enough
The risks are reasonable in relation to what is known about your medical condition, any risks and benefits of standard therapy, and risks and benefits of study treatment

You and/or your family members will always be told about participation and given information about a study as soon as possible. You’ll also be asked if you want to continue participating in a study.

Informing the Community about an EFIC Study

Institutional review boards (IRBs) require several steps before an EFIC-approved study begins.

A research team must design and submit a “community consultation plan” that describes how the community will be informed about the study. This allows time for community members to ask questions and share views and opinions. It also offers a way to opt-out of participation.

Community consultation and public disclosure may be done in one or more of the following ways:

Meetings with community leadership, targeted groups, or the general public
Focus groups
Attending town halls, health fairs, farmers’ markets, or other local meetings
Ads on television, radio, newspapers, bulletin boards, billboards, bus displays, websites, social media, and email
Brochures, flyers, handouts, or newsletters
Household mailings
Newspaper, magazine, and local news stories
Telephone surveys for feedback
A toll-free number where community members can share thoughts and concerns

During the public disclosure and community consultation processes, residents learn how they can alert researchers if they do not want to participate in a study. This is also called “opt-out.”

Duke EFIC Study

Duke participates in an EFIC study called the Boost 3 Trial. It will compare two routine treatments for children and adults with severe traumatic brain injury in the intensive care unit to determine which treatment is more likely to help people get better.

Complete This Form to Opt-out of This Trial

EFIC Study Participant Protection

There are many protections and rules in place to ensure research studies are done in a safe and proper manner.

Local Institutional Review Board (IRB)
The Duke University Health System IRB includes doctors, nurses, researchers, ethicists, lawyers, and members of the general public committed to protecting your safety. IRB members make sure studies are appropriate and comply with research rules and regulations before volunteers are enrolled. Duke’s IRB also monitors studies while patients are treated, looks for unexpected side effects, and guarantees patients are treated correctly and safely. The IRB conducts an annual review of every study to confirm if it should continue.

Federal Agencies
Federal oversight of large research studies may involve several government agencies, including the National Institutes of Health (NIH), FDA, and Office of Human Research Protections (OHRP).

Data Safety and Monitoring Boards (DSMBs)
Data Safety and Monitoring Boards (also known as Data Monitoring Committees) are independent groups of researchers and doctors. They meet regularly to look at information about every patient in a study, the treatment each patient received, how they received it, and any side effects or outcomes of that treatment. Board members review data and make decisions about stopping a study early if patients getting one treatment are doing better than those getting a different treatment, or if there are unexpected side effects.

Examples of Past EFIC Studies

RAMPART (Rapid Anticonvulsant Medication Prior to Arrival Trial)
Non-stop seizures (status epilepticus) are a medical emergency associated with a significant risk of death and disability. Anti-seizure medicine is the treatment of choice, but it is difficult for paramedics to give this medication by vein when someone is having a seizure. This trial determined that a shot in a muscle of the anti-seizure drug midazolam was an effective option. The outcome changed the way people with this condition are treated.

ProTECT III (Progesterone for Traumatic Brain Injury)
This study set out to determine if early treatment of people with moderate-to-severe traumatic brain injury was more effective with an IV of progesterone or a placebo. The study was stopped early when the data safety and monitoring board determined progesterone showed no benefit in improving these outcomes.

PolyHeme Study: Safety and Efficacy of PolyHeme® in Hemorrhagic Shock Following Traumatic Injuries in the Pre-Hospital Setting
This study determined that a blood substitute (PolyHeme®) was less effective than saline when treating severely injured trauma patients in a pre-hospital setting when blood products were not available. PolyHeme® was also found to produce a higher likelihood of bad side effects.

Contact the Duke Recruitment Innovation Center

myresearchpartners@duke.edu

919-681-5698