Planned Emergency Research
Importance of emergency research
According to the Centers for Disease Control (CDC), there were 130.4 million visits to the emergency department in 2013 of which 32.2 million were injury-related visits. In 2014, injuries accounted for more than half the deaths in people younger than 45 years of age. In the United States, there were more than 192,900 deaths from injury, approximately one death every 3 minutes, was due to injury.1,2. There has been a focused effort to decrease the number of immediate deaths due to injury (speed limits, helmet laws, seat belts, to name a few). However, many people die after reaching the hospital due to hemorrhage or traumatic brain injury. There have not been enough rigorous research to study interventions to reduce the number of these kinds of death.
According to the CDC, heart disease is the leading cause of death in the United States. Each year in the United States, approximately 735,000 people have a heart attack. On average, every 42 seconds, someone in the United States has a heart attack.3 Stroke is the fourth leading cause of death in developed nations. Each year in the US, approximately 795,000 people experience a new or recurrent stroke. On average, every 40 seconds, someone in the United States has a stroke.4
One of the main difficulties in doing research in these emergency situations is that
The United States Food and Drug Administration (FDA) has issued special regulations for doing research in
- Provide individuals in life-threatening situations access to potentially life-saving therapies;
- Advance knowledge through
collectionof information about effectiveness and safety; and
- Improve therapies used in emergency medical situations that currently have poor clinical outcomes.
Importance of informed consent
Respect for persons is a basic ethical principle for conducting research in human beings. One of the main aspects of respect for persons is to make sure that researchers provide information about the research study and ask for people to volunteer to join the research study. This is called informed consent.
Informed consent is the process of learning the key facts about a research study before deciding whether or not to take part. It is also a continuing process throughout the study to give new information about the research to participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study such as risks, benefits and what would happen to them when they are in the research study.
In many emergency situations, the people who are taking part in the research study are not able to give their informed consent due to their condition, for example, they could be in
Many of the treatments given in an emergency situation have to be given very quickly. For example, a patient with a large acute ischemic stroke might be losing up to 2 million brain cells every minute. So any delay in treatment could result in poorer outcomes. It would not be in the patient’s best interest to delay treatment while trying to identify family members to provide informed consent for taking part in the research study.
Description of community consultation efforts.
Before a planned emergency research study is done at UTHealth, the researcher must inform the Houston community about the proposed study. This will include details including:
- Clarify that informed consent will not be obtained for most (or all) research participants,
- Explain why consent is not possible,
- Inform the communities about all relevant aspects of the proposed research:
- Risks of the intervention being studied,
- Benefits of the intervention being studied,
- Invite members of the community to reach out to the researchers for more information,
- Invite members of the community to give feedback about the research,
- Provide information about ways in which who do not wish to be part of these studies can make their preference known to the emergency departments where the research will be done.
For each proposed study, researchers will meet with community members at various meetings in community centers, churches, patient support groups etc. When the study has been completed, the researchers will share the results of the research with the community.
If you would like UTHealth researchers to
Description of additional protections for planned emergency research.
All research studies done at UTHealth in which people participate are reviewed by a group of people called the Committee for the Protection of Human Subjects. For planned emergency research studies, this Committee will review the
Planned emergency research studies must also have an independent group of experts called the data and safety monitoring board to review the data that is collected during the study to make sure that the
Opting out of emergency research that is done without informed consent.
If you do not wish to take part in a planned emergency research study done under ‘exception from informed consent’ at UTHealth, please contact email@example.com to obtain a bracelet and a card which you must carry at all times when the study is being conducted. We will keep you informed of all ongoing and upcoming studies done under ‘emergency exception from informed consent’ on this website.
ONGOING TRIALS AT UTHEALTH INVOLVING EXCEPTION FROM INFORMED CONSENT
UPCOMING NEW TRIALS AT UTHEALTH INVOLVING EXCEPTION FROM INFORMED CONSENT
More information on planned emergency research:
- SIREN-NETT Video Introduction to Emergency Research
- SIREN-NETT Video Q and A for Emergency Research
- NIH - Planned Emergency Research
More information on randomization:
- Cancer Research UK - Randomized Trials
- RoMP Research on Medical Practice
- RoMP Which Medication is Best
More information on informed consent: