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Informed consent.

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Consent Forms↗

Consent and privacy in telemedicine.

The electronic broadcast of a medical interview, or a video tele-consultation (VTC), challenges many of our traditional concepts of privacy and confidentiality. The nature of a doctor-patient relationship changes dramatically when the open airwaves carry the personal histories, images, and concerns of a patient. Discussions of telemedicine often allude to inherent ethical concerns yet there are no established guidelines for the ethical conduct of a VTC.

Confidentiality↗

[Telemedicine--legal aspects].

Due to the complexity of its scope of use, telemedicine involves new risks of legal liability against which often neither physicians nor clinics are insured; for example, division of responsibility which is not legally defined between the consultant and the attending physician, or demands for compensation from abroad. Special information sheets and forms of consent for telemedicine must be introduced, and particularly the risks of this type of diagnostics and therapy must also be pointed out. On these forms patients must give their consent to their physician consulting a specialist via data line. Furthermore, the court of jurisdiction and the law under which a court must judge in a liability case must be defined on these forms. Insurers must be informed about the type and scope of telemetric activities without delay.

Germany↗

Is signed consent for influenza or pneumococcal polysaccharide vaccination required?

Each year, thousands of preventable deaths and hospitalizations result from complications of influenza and pneumococcal disease, mostly in elderly persons, despite the availability of vaccines. Obtaining signed consent prior to administering the vaccines represents an obstacle to achieving the Healthy People 2010 goals for vaccinating individuals against influenza and pneumococcal disease. Signed consent is neither legally mandated nor a guarantee that the patient (or proxy) has given informed consent. Nonetheless, many health care providers and institutions currently require signed consent before administering these vaccines. Rather, health care providers should use the Vaccine Information Sheets developed by the Centers for Disease Control and Prevention to inform patients about the risks and benefits associated with these vaccines. Requiring signed consent before administering these low-risk, high-benefit vaccines is inconsistent with the current practice of not requiring signed consent before prescribing other common treatments, eg, antibiotic treatment, whose risk levels are the same or higher.

Centers for Disease Control and Prevention, U.S.↗

Consent (assent) for research with pediatric patients.

OBJECTIVES: To discuss the unique terms and conditions relative to the assent of children and the consent of their parents for research participation, to describe the capabilities of children as they influence understanding of and willingness to participate in research, and to discuss issues related to research participation. DATA SOURCES: Research articles, review articles, clinical experience, and government policies. CONCLUSIONS: The participation of children in research is complex. Developmental limitations, the imbalance of power between children and adults, and, in some cases, their compromised health status can influence the willingness of children to participate in clinical research. IMPLICATIONS FOR NURSING PRACTICE: Health care providers and researchers must be aware of the need of children to have full disclosure and clear descriptions about research in age-appropriate language. Obtaining a child's agreement to participate in research should be carefully planned and implemented.

Age Factors↗

Reasons for entry into and understanding of HIV/AIDS clinical trials: a preliminary study.

Thirty-two men who participated in a trial of Zidovudine (> 500 CD4 cells/10(6) L) were surveyed regarding their reasons for participation in clinical trials. The major source of influence to enter the trial was the clinic doctor, and importance for self in participation was rated as the least important reason. Medical science and medical researchers were seen as the major beneficiaries. Being seen to do something about one's illness was also seen as being important and probability of delaying AIDS was rated lowest. Chance of occurrence of risks of treatment were rated as slightly below 50%. Results of Flesch and Fry tests of informed consent documents suggested that they were written in the style of a scientific article, required the readability level of a university graduate and that recall was imperfect. Those who saw more benefits in their trial participation appeared to be most knowledgeable. These data suggest that participation in this clinical trial was based on altruistic, rather than personal reasons and that participants had realistic perceptions of outcomes.

Acquired Immunodeficiency Syndrome↗