PubMed · 7431597
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L J Miller. 1980-12-05. Informed consent: III.. https://pubmed.ncbi.nlm.nih.gov/7431597/
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OBJECTIVE: Illustration of the difficulties in approaching critically ill patients for informed consent for inclusion into a randomized controlled trial and the impact of a waiver of consent from the patient's next of kin in the conduction of such studies. DESIGN: Descriptive survey of the inclusion rates into the Ger-Inf-05 study before and after a waiver of consent from the patient's next of kin. SETTING: Nineteen intensive care units in France. PATIENTS: Septic shock patients (n=300) included in a placebo-controlled randomized double-blind study on the efficacy and safety of a 7-day treatment with 50 mg hydrocortisone every 6 h intravenously and 50 microg fludrocortisone every 24 h orally. INTERVENTION: Introduction, 10 months after the beginning of the study, of a waiver of consent from the patient's next of kin if it was not present at the time of the patient's inclusion. MEASUREMENTS AND RESULTS: The mean inclusion rate was four patients per month before the introduction of the waiver of consent and increased to 10 patients per month after the study amendment including the waiver of consent. Informed consent was obtained from the patient himself or herself in 10 patients (3%) and from next of kin in 70 patients (23%). For the 220 other patients (74%), the investigators could not contact the responsible relative within the inclusion period. CONCLUSIONS: Recruitment rate in the Ger-Inf-05 study was clearly improved after the waiver of consent from the patient's next of kin. This probably contributed to the successful completion of the study.
Consumer health information is available in more than 30 languages. Using family members as interpreters raises issues of quality and ethics. Administrative forms the first phase; education will follow.
Dentistry began to incorporate informed consent and risk management into its practice after 1950. Today, an obligation to ensure that the patient has accepted a given treatment and understands all its implications are part of a dentist"s prime responsibilities. The purpose of this article is to inform dentists who are asking for consent that they can use a tool to make this task easier--the personalized consent form.