Patients' perceived purpose of clinical informed consent: Mill's individual autonomy model is preferred

Background: Although informed consent is an integral part of clinical practice, its current doctrine remains mostly a matter of law and mainstream ethics rather than empirical research. There are scarce empirical data on patients' perceived purpose of informed consent, which may include administrative routine/courtesy gesture, simple honest permission, informed permission, patient-clinician shared decision-making, and enabling patient's self decision-making. Different purposes require different processes. Methods: We surveyed 488 adults who were planning to undergo or had recently undergone written informed consent-requiring procedures. Perceptions of informed consent purpose (from norm and current practice perspectives) were explored by asking respondents to rank (1 = most reflective) 10 randomly-presented statements: meaningless routine, courtesy gesture litigation protection, take away compensation rights, inform patient', make sure patient understand, document patient's decision, discover patient's preferences, have shared decision, and help patient decide. Results: Respondents' mean (SD) age was 38.3 (12.5); 50.4% were males, 56.8% had >= college education, and 37.3% had undergone a procedure. From the norm perspective, the least reflective statement was meaningless routine (ranked 1-3 by 2.6% of respondents) and the most reflective statements were help patient decide, make sure patient understand, and inform patient (ranked 1-3 by 65%, 60%, and 48% of respondents with median [25%, 75%] ranking scores of 2 [1,5], 3 [2,4], and 4 [2,5], respectively). Compared to their counterparts, males and pre-procedure respondents ranked help patient decide better, whereas females and post-procedure respondents ranked inform patient better (p = 0.007 to p < 0.001). Age was associated with better ranking of help patient decide and make sure patient understand statements (p < 0.001 and p = 0.002, respectively), which were ranked 1-3 by only 46% and 42% of respondents from the current practice perspective (median ranking score 4 [2,6], p < 0.001 vs. norm perspective for both). Conclusions: 1) the informed consent process is important to patients, however, patients vary in their views of its purpose with the dominant view being enabling patients' self decision-making, 2) males, pre-procedure, and older patients more favor a self decision-making purpose, whereas females and post-procedure patients more favor an information disclosure purpose, and 3) more self decision-making and more effective information disclosure than is currently practiced are desired. An informed consent process consistent with Mill's individual autonomy model may be suitable for most patients.