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PubMed1983

Informed consent: what does it mean?

The editorial in the September 1982 issue of this journal and many articles before and since have addressed the problem of informed consent. Is it possible? Is it a useful concept? Is there anything new to be said about it? In this article the basic rationale of the rule (patient autonomy) is explained and the extent of the rule explored. Various exceptions have been offered by the law and an attempt is made to catalogue the chief of these. A number of specially vulnerable groups are then identified, the most important, and vexed, being children. How can informed consent be secured in the case of young patients? Finally, a few problems are mentioned in an attempt to get this subject back to reality. The appeal to the principle primum non nocere may be medical paternalism in disguise. Informed consent is the competing principle that reminds us of the primacy of human autonomy. A pointer is given to the future: even the use of sound recordings to explain medical procedures and to activate informed consent so that it may become a reality and not just a lawyer's myth, should be considered.

Australia↗
PubMed2005

How informed is online informed consent?

We examined participants' reading and recall of informed consent documents presented via paper or computer. Within each presentation medium, we presented the document as a continuous or paginated document to simulate common computer and paper presentation formats. Participants took slightly longer to read paginated and computer informed consent documents and recalled slightly more information from the paginated documents. We concluded that obtaining informed consent online is not substantially different than obtaining it via paper presentation. We also provide suggestions for improving informed consent--in both face-to-face and online experiments.

Analysis of Variance↗
PubMed2004

A guide to informed consent for clinician-investigators.

Informed consent in clinical research is a matter of both ethics and federal regulation. A research subject must enter a study voluntarily, be informed about risks and benefits, and understand the difference between experiment and treatment.

Conflict of Interest↗
PubMed1981

Proving consent.

Explore the source record for details and available documents.

Australia↗
PubMed2004

Telemedicine and informed consent.

Though pursuing robotic technology offers a solution to geographically or economically isolated patients, it also causes new problems with regard to the safeguarding of patients' rights, including those relating to informed consent. Questions that need to be answered concern the content of the informed consent requirement; the form of the consent; whose responsibility is it to gain the consent, etc. In this paper we will discuss all these topics and take a closer look at international aspects, since telemedicine can also be performed across state boundaries.

European Union↗
PubMed2005

[Questionnaire survey about an anesthesia information sheet].

BACKGROUND: The anesthesia information sheet used in our hospital describes the anesthetic management and complications in a simple style. Patients scheduled for operations receive it from their doctor with some explanation about anesthesia. The written informed consent on the sheet is obtained from the patients. METHODS: One hundred and one patients undergoing elective operations were interviewed after receiving explanations during the anesthesiologist's preoperative rounds. RESULTS: From this survey, 85% of the patients read it before the anesthesiologist's preoperative rounds and 75% of them understood the contents. After the anesthesiologist's explanation, 94% of the patients who had read it understood enough. About a third of the patients who had read the information sheet had anxiety about anesthesia. After the anesthesiologist's explanation, the percentage of patients who had anxiety decreased to 8%. 98% of the patients who read the information sheet answered that it should be read before the anesthesiologist's preoperative rounds. CONCLUSIONS: In view of this survey we concluded that reading the information sheet before the anesthesiologist's preoperative rounds is useful to increase the patients understanding of anesthesia.

Anesthesia↗
PubMed2004

Research participant information sheets are difficult to read.

Written information for potential research participants should be easy to read to enable comprehension and facilitate informed choices. We conducted an analysis of the parent information sheets for 74 research studies involving children. Readability was assessed using the Flesch Reading Ease (FRE) score. The mean FRE was 53.54 (reading age of 15.88 years) and FRE did not differ based on study characteristics. These findings suggest that the reading level of research participant information sheets is above recommended levels. Researchers should routinely compute the reading ease of study information sheets and make greater efforts to improve readability of written documents for potential participants.

Child↗