Research and Training Issues

The use of newly dead patients for training raises important ethical and legal issues. The consent of family members is both ideal and respectful of the newly dead but not always possible or practical at the time of cardiac arrest. Research advocates argue that presuming consent in these situations serves a "greater good" that will benefit the living. Others claim that consent is unnecessary because the body is "non persona" and without autonomy or interests. These arguments, however, do not consider the potential for harm to surviving family members who may oppose using a recently deceased loved one for the purpose of training or research. This view also ignores significant cultural differences in the acceptance or nonacceptance of the use of cadavers.

Clinical research in patients with cardiorespiratory arrest is challenging. In general, research involving human subjects requires the consent of the subject or, in some cases, a legally authorized surrogate. This has proved to be a challenge for research involving patients in cardiac arrest because research interventions must frequently be implemented at a time when obtaining consent may be impossible. After much public discussion and in recognition of the value of this type of human research, the government, through the Food and Drug Administration and the National Institutes of Health, adopted regulations that allow an exception for the need to obtain informed consent in certain limited circumstances. Stringent preresearch directives require that researchers consult with experts plus representative laypersons who might be study patients and to make full public disclosure of the details of the study methodology. Investigators must engage in candid public discussion of the need for resuscitation research, acknowledge the lack of an evidence-based foundation for many current practices, and describe the many potential benefits of the research.

In 1996 Congress passed the Health Insurance Portability and Accountability Act, commonly referred to as HIPAA. As its name suggests, one of the primary goals of the HIPAA legislation was to ensure the availability and continuity of health insurance coverage, but it has been amended over the past few years to include provisions that protect the privacy of patients' health information and their medical records. For details see http://www.hhs.gov/ocr/hipaa/finalreg. html. Healthcare providers involved in training and research must be careful to protect patient privacy and the confidentiality of patient data.

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