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The subjective incremental cost of informed consent and documentation in hospital care: a multicentre questionnaire survey in Japan.

OBJECTIVE
To reveal the amount of time and financial cost required to obtain informed consent and to preserve documentation.


METHODS
The questionnaire was delivered to all staff in six acute care public hospitals in Japan. We examined health care staff perceptions of the time they spent obtaining informed consent and documenting information. All data were collected in 2006 and estimates in the past week in 2006 were compared to estimates of time spent in a week in 1999. We also calculated the economic costs of incremental amounts of time spent in these procedures.


RESULTS
In 2006, health care staff took about 3.89 hours [95% Confidence Interval (CI) 3.71-4.07] per week to obtain informed consent and 6.64 hours (95% CI 6.40-6.88) per week to write documentation on average. Between 1999 and 2006, the average amount of time for conducting informed consent was increased to 0.67 (P < 0.001) hours per person-week, and the average amount of time for documentation was increased to 0.70 (P < 0.001) hours per person-week. The annual economic cost of activities for informed consent and documentation in a 100-bed hospital increased from 117 755 to 449 402 US dollars.


CONCLUSIONS
We found a considerable increase in time spent on informed consent and documentation, and associated cost over a 7-year time period. Although greater attention to the informed consent process should be paid to ensure the notions of patient autonomy and self-determination, the increased resources devoted to these practices must be considered in light of current cost containment policies.