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When it comes to doing research in emergency medicine situations, it is often difficult or impossible to receive informed consent from a patient to be a part of a research study. This is especially true for situations when the patient is unconscious or in critical condition.
When medical researchers want to conduct a study in an emergency medicine situation such as this, the most popular method of obtaining informed consent from potential research subjects is through an “opt-out” community consent model. In this model, communications to the community in which the hospital is located provide information about the study being conducted at the hospital and explain that everyone in the community will be considered for participation unless they opt out of the study and wear a wristband indicating that they do not. Without the bracelet and other opt-out indicators, provision of informed consent to be a part of this study is assumed.
Successfully informing an entire community is challenging, and there is potential for abuse if all research projects are allowed to use this informed consent model. The FDA has laid out its requirements for a study to be allowed to use this opt-out community consent model. Despite the FDA requirements, the opt-out community consent model is not without controversy. Issues tend to focus on properly informing the community and ensuring that proven and satisfactory treatments are not withheld from these patients.
Exception from Informed Consent(EFIC) in Emergency Research (Opt-Out)
Information on the FDA exception from informed consent requirements for emergency research is available. At Indiana University School of Medicine, the Department of Emergency Medicine ACCESS Trial is employing Exception from Informed Consent (EFIC).
All of the following conditions must be present to qualify for Exception from Informed Consent (EFIC):
- The human subjects are in a life-threatening situation that necessitates urgent intervention.
- Available treatments are unproven or unsatisfactory.
- Collection of valid scientific evidence is necessary to determine the safety and effectiveness of the intervention.
- Obtaining informed consent is not feasible because the subjects are not able to give their informed consent as a result of their medical condition.
- The intervention must be administered before consent can be obtained from the subject’s legally authorized representative.
- There is no reasonable way to identify prospectively individuals likely to become eligible for participation.
- Participation in the research holds out the prospect of direct benefit to the subjects.
- The clinical investigation could not practicably be carried out without the waiver.
Additionally, the FDA requires that for exception from informed consent to be used to enroll an entire community, there needs to be significant community consultation and public disclosure of the details of the study. In the event that the patient is unconscious or unable to give their informed consent during the course of the treatment, researchers need to make a reasonable effort to track down the legally authorized representative for the patient and obtain a written consent if possible.
Holsti, M., Zemek, R., Baren, J., Stanley, R. M., Mahajan, P., Vance, C., … & Shreve, K. (2015). Variation of community consultation and public disclosure for a pediatric multi-centered “Exception from Informed Consent” trial. Clinical Trials, 12(1), 67-76.
An examination of the methods of the different hospitals in a multi-centered emergency research study found that a great deal of variation of interpretations of the requirements for community consultation and public disclosure by the Internal Review Board at each institution, which led to different presentations to the different communities. This study also found that only five percent of the patients enrolled through the exception from informed consent had heard about the study from the community consultation and public disclosures activities.
Kutcher, M. E., Forsythe, R. M., & Tisherman, S. A. (2016). Emergency preservation and resuscitation for cardiac arrest from trauma. International Journal of Surgery, 33, 209-212.
Griggs, B. (2014, June 23). Cheating death through “suspended animation.”
Another exception from informed consent study was conducted in an emergency medicine setting where patients with severe trauma could have hypothermia induced to give the surgeons extra time to operate before the patient dies. The community was informed they would be enrolled in the study if they did not opt out and wear a wristband. The community and lawmakers did not seem to be upset about this study perhaps because the study sponsors were forthcoming with notifications and information.
Additionally, the procedure would be performed only on patients with such severe trauma that the patient had a minimal chance (5-10 percent) of surviving if the normal techniques were used. Also, the study sponsors realized that the study protocol was too narrow and they were unable to receive a single patient in four years that met the requirements, so the sponsors are reapplying to do the study with broader requirements.
In 2003, an FDA approved clinical trial for PolyHeme, a blood substitute and an oxygen-carrying resuscitative fluid made by Northfield Laboratories Inc., began. The study drew heavy criticism due to design and implementation issues