Acting Without Asking: An Ethical Analysis of the Food and Drug Administration Waiver of Informed Consent for Emergency Research☆,☆☆
Section snippets
INTRODUCTION
This article attempts to provide a concise summary and ethical analysis of the current Food and Drug Administration (FDA) and Department of Health and Human Services (DHHS) guidelines for emergency research involving a waiver of informed consent. This article is intended to provide an ethical context for the application of the rules. This summary should not be used as a substitute for a careful reading of the actual guidelines, but can provide an operational and ethical perspective to those who
INFORMED CONSENT IN EMERGENCY RESEARCH
Informed consent has been required for all research involving human subjects since the latter half of the 20th century.2, 3, 4, 5 To provide an informed consent, the patient must possess decisionmaking capacity, which is the ability to make a reasoned decision on the basis of the individual’s goals, wishes, and values. An informed subject is one who understands the basic nature of the research and can make a realistic assessment of potential risks, benefits, and alternatives. It is presumed
SUMMARY: WAIVER OF INFORMED CONSENT FOR EMERGENCY RESEARCH
The FDA determined that a waiver of informed consent can be granted if an institutional review board (IRB) finds and documents each of the following13:
ANALYSIS
Use of the term “waiver” of informed consent might lead an inexperienced investigator to believe that there is less responsibility to expend effort to obtain consent. In reality, the responsibilities increase in a variety of ways. There are additional requirements for patient protection when research subjects are unable to give consent. These responsibilities include advance community disclosure, immediate attempts to notify family of the patient, maximal communication with the patient, if
ETHICS OF RESEARCH
Underlying all research are 3 ethical requirements: respect for autonomy, beneficence, and justice.3, 4, 18 In an effort to maintain patient autonomy during research, investigators rely primarily on the informed consent of the research subject. Partly because of ethical failures such as the Tuskegee syphilis study and other federally sponsored research, as well as atrocities during World War II, informed consent has become an essential component of human research.19, 20 When informed consent is
COMMUNITY NOTIFICATION
An informed community helps prevent real or imagined abuses by researchers. It is possible that community opposition would have to be overcome. It might be thought that such disclosure inevitably enhances trust. Paradoxically, the complexities of clinical research could cause confusion and, therefore, mistrust. It is the responsibility of the potential researcher to overcome this through a sincere sharing of information. Public relations strategies to generate support are not intended, but
FAMILY NOTIFICATION
Even if a legal representative is not available, the investigator should make an effort to contact any of the subject’s family members who are not legally authorized representatives and ask if they object to the subject’s participation in the investigation.21 Family members may disagree about the course of treatment, or be unable to make decisions in a confusing and stressful emergency situation. To complicate matters, the definition of family member is broad. A family member is defined by the
INDEPENDENT PHYSICIAN AND DATA MONITORING COMMITTEE
When a waiver of informed consent is granted, an independent data monitoring committee must be established. This data monitoring committee may help to continually assess the necessity and value of the research.23 A data monitoring committee should be composed of individuals with no investment in, or connection to the research. This helps ensure that the needs of the patient are always put above research concerns. Such a committee cannot speak for the interests of an individual research subject,
MINIMAL RISK
An IRB may permit an investigator to waive the requirement for informed consent if the research presents no more than minimal risk to the subject.24 A threshold exists where no meaningful risk is presented to the patient, such as that posed by extra vital sign measurements, so the protections as outlined above may not be required. There is no clear definition of what constitutes such minimal risk. Research may be considered to pose no more than minimal risk if it involves no interventions for
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Address for reprints:James G Adams, MD, Department of Emergency Medicine, 75 Francis Street, Boston, MA 02115; 617-732-5640, fax 617-264-6848; E-mail [email protected].
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