Objectives—To assess perceptions of the informed consent process in patients undergoing urgent abdominal surgery.Design—A prospective observational study was carried out using structured questionnaire-based interviews. Patients who had undergone urgent abdominal surgery were interviewed in the postoperative period to ascertain their perceptions of the informed consent process. Replies were compared to responses obtained from a control group undergoing elective surgery, to identify factors common to the surgical process and those specific to urgent surgery. Patients' perceptions of received information were also compared (...) to the information perceived to have been provided by the consent obtainers. Setting—Gastrointestinal surgical service of a university teaching hospital.Patients—Seventy-four consecutive patients undergoing urgent abdominal surgery and 80 control patients undergoing elective surgery. Main measurements—Principal outcome measures were patients' perceptions of factors interfering with the ability to give informed consent, assessment of the quality of informed consent and the degree of discussion of the expected outcomes. Results—Forty-nine of the seventy-four (66%) patients undergoing urgent surgery perceived that pain did not affect their ability to give informed consent. Twenty-seven reported an adverse effect of analgesia on the ability to give informed consent. Only 22% of patients undergoing urgent surgery perceived that there had been any discussion of potential side effects and complications of surgery. Conclusion–The majority of patients in this series with acute intra-abdominal surgical conditions perceive that they retain the ability to give informed consent for surgery. There is a need for improved discussion of therapeutic options and likely outcomes. (shrink)

The Japanese Ministry of Health and Welfare has implemented a policy of paying physicians to explain the nature of the patient's medical condition and the treatment plan. We describe the precepts of this policy and examine ethical dimensions of this development. We question whether this policy will be sufficient to ensure patients will have the opportunity to become informed participants in medical decision making. The policy also raises a broader philosophical question as to whether informed consent is a fundamental ethical (...) requirement of all doctor-patient encounters or an option that can be exercised by physicians for financial gain. The impact of this policy in Japan merits continued observation from abroad. (shrink)

Background and objectives: There are few insights from sub-Saharan Africa on research participants’ experiences of the informed consent process, particularly in the context of randomised controlled trials, where issues of randomisation and the use of placebos may be confusing concepts for participants. This study investigated the knowledge and perceptions of the informed consent process among individuals participating in influenza vaccine trials in two disadvantaged communities in South Africa.Method: Four to 12 months after completion of the trials, participants were contacted to (...) return to participate in the informed consent study. The semistructured questionnaire administered to assess recall of trial procedures and the informed consent process covered key issues including: purpose of the study; awareness that the study was not part of routine treatment; voluntary nature of participation and freedom to withdraw; randomisation; placebos; and remuneration.Results: A total of 334 participants completed the questionnaire. Only 21% were able to recall that they were allocated randomly to the different treatment arms. Only 19% of those involved in the placebo controlled study had interpreted the concept of placebo as an inactive medication.Conclusion: Although a good general recall of trial concepts was demonstrated, only a small proportion of the participants correctly interpreted and recalled the concepts of randomisation and placebos. Informed consent in this and similarly disadvantaged communities may often be inadequate and new ways to improve understanding of the research process should be explored. (shrink)