The consent process: Enabling or disabling patients’ active participation?

Abstract

Standards expected by doctors’ regulatory bodies in respect of the process of consent to treatment have arguably sought to restructure the nature of the doctor–patient relationship from one of the paternalism to that of shared decision-making. Yet, few studies have explored empirically, from patients’ perspectives, the extent to which the process of consent to treatment enables or disables patients’ participation in medical decision-making. Our article examines patients’ attitudes towards the consent process, exploring how and why these attitudes influence patients’ active participation in decision-making and considering possible consequent medico-legal issues. Data were collected longitudinally using semi-structured interviews and field observations involving 35 patients and 19 of their caregivers, in an English hospital between February and November 2014. These indicate that generally patients defer to the doctor in respect of treatment decision-making. Although most patients and their caregivers wanted detailed information and discussion, they did not necessarily expect that this would be provided. Furthermore, patients perceived that signing the consent form was an obligatory routine principally to protect doctors from legal action should something go wrong. Our study suggests that patients’ predominantly paternalistic perceptions of the consent process can not only undermine attempts by doctors to involve them in decision-making but, as patients are now considered in law as informed actors, their perceptions of the consent form as not being in their interests could be a self-fulfilling prophecy if signing is undertaken without due consideration to the content.

Hope and despair: a qualitative exploration of the experiences and impact of trial processes in a rehabilitation trial

“…These narratives suggest that an individual’s very desire/desperation to participate in a trial may render them vulnerable to suggestion, which in turn disrupts the equipoise deemed essential for ethical consent-gaining and hence for effective randomisation [10]. Such imbalances in decision-making parallel those seen in treatment decision-making in general healthcare [30, 31] and other clinical trials [16, 17], and create an ethical challenge for trial managers and recruitment personnel worthy of further enquiry.…”

Physicians’ communication patterns for motivating rectal cancer patients to biomarker research: Empirical insights and ethical issues

“…For patients this orally conveyed information is central which they relate to in retrospect, despite comprehensive written material given to them. 7,13 Therefore, physician-researchers should be aware of the kind of communication patterns they use and of the implications for patients. By becoming aware of the used communication patterns for motivating patients to research participation, those patterns can be identified which are ethically acceptable and could then be deliberately implemented in this research context.…”

“…In our case, the consent procedure for the biomarker study constituted a constantly repeating act, which means that patients perceive it as a form of paternalistic and bureaucratic routine rather than a session catering to their benefit. 13 Physicians but also ethics committees still seem to incorrectly assume that patients will acquire information by means of written material. Previous research has found that most patients do not fully read the informed consent information material because they are content with signing the consent form after being provided with verbal information by the physician.…”

“…Some socio-empirical ethical studies have argued that both the ethical concept and the current, often legalistic, practice of informed consent should be adapted to the complexity of the clinical research environment. [12][13][14][15][16][17][18][19] Furthermore, qualitative studies and quantitative surveys indicate that many patients wish for more patient-centred decision making or shared decision making (SDM) supporting their self-determination and wish for more detailed information. [20][21][22][23][24][25][26][27][28][29] Communication processes are highly relevant to research recruitment.…”

What patients really got and what they wanted in surgical informed consent: a cross-sectional survey in China

“…Informed consent (IC) is imperative and necessary prior to lots of patients' medical treatments, Despite its critical importance to the provision of safe, high-quality, patient-centered health care, practical problems remain in the IC process [ 1,7,8]. Prior research has demonstrated that patients' comprehension and recollection of the key elements of IC are often poor [9][10][11][12][13].…”