Informed consent in emergency research: what every emergency nurse should know.
Although they are not totally without controversy, proxy consent and prospective consent are generally condoned as being legally and ethically acceptable alternatives to traditional informed consent by the majority of IRBs and researchers. Deferred consent, on the other hand, continues to fuel a heated debate in the emergency research community. Detractors believe that deferred consent is nothing more than unauthorized experimentation on a vulnerable population. They argue that since the subject has no means to prevent the action that it can in no way be construed as consent. Advocates assert that deferred consent allows subjects who are unable to speak for themselves access to potentially lifesaving treatments that they otherwise would be denied if they were forced to wait for proxy consent. In addition, they believe that as long as the study is carefully screened by an IRB, that the rights of the individual have been adequately protected, research that may offer benefits beyond the individual patient to society as a whole is allowed to continue. Because of this controversy, in recent years it had become almost impossible to obtain IRB approval for emergency research because of conflicting and restrictive federal regulations. However, a recent rule change by the Department of Health and Human Services has brought diverse regulations into accord and made deferred consent once more a more viable alternative to researchers. Yet acquiring IRB approval for a waiver of informed consent is by no means a simple process. The requirements are listed in Table 2, and they represent a compromise between the two views. Although researchers are allowed to use deferred consent, it is only in the most life-threatening situations in which current treatments are unsatisfactory or unproven and when the research intervention may offer direct benefit to the patient. The new regulations place a very strong emphasis on protection of the rights of the human subject. In addition, they mandate community consultation by the researcher and advance public disclosure of the nature of the study to the community in which it is to be conducted. In this way it is hoped that both the public good and the individual rights will be equally respected. Informed consent to research in the emergency setting is a difficult issue, and its complexities continue to be debated. Nurses in emergency settings, whether researchers or associates, must understand the informed consent process to ensure that adequate steps have been taken to safeguard the patient and his or her rights. Yet they must also appreciate the precautions that have been taken, and the difficult decisions that have been made, by an IRB before an emergency research study is approved. By understanding the consent process, emergency nurses can become more fully informed research participants, ensuring that the rights of the patients have been protected, while working to advance medical science through legally sound, ethically proper, clinical investigation.
Watts
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Department of Trauma Services, Fairfax Regional Trauma Center, Falls Church, Virginia, USA.
D016529:Emergency Nursing; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D016743:Mental Competency; D012106:Research / Q000331:legislation & jurisprudence*; D014481:United States