La quête du consentement éclairé en médecine comme construction sociale [The application of informed consent in medicine as social construction].

The aim of this article is to propose an anthropological point of view about informed consent in medicine. This quest for legitimacy should be read as a relational and social construction. In the heart of clinical complexity we find on one side various techniques employed by the medical community to validate research and to obtain the consent of patients. On the other side patients offer plural and subjective answers due to the doctor patient hierarchical and long relationship. Between constraints and freedoms, informed consent brings to light social relation.

Informed consent: Biobank donors should have a say.

Comment on: Saha K, Hurlbut JB. Research ethics: treat donors as partners in biobank research. Nature. 2011;478(7369):312-3. doi: 10.1038/478312a. PMID: 22012372.

Need for informed consent in substance use studies--harm of bias?

OBJECTIVE: The aim of this study was to examine the differences between those who gave informed consent to a study on substance use and those who did not, and to analyze whether differences changed with varying nonconsent rates. METHOD: Cross-sectional questionnaire data on demographics, alcohol, smoking, and cannabis use were obtained for 6,099 French- and 5,720 German-speaking 20-year-old Swiss men. Enrollment took place over 11 months for the Cohort Study on Substance Use Risk Factors (C-SURF). Consenters and nonconsenters were asked to complete a short questionnaire. Data for nearly the entire population were available because 94% responded. Weekly differences in consent rates were analyzed. Regressions examined the associations of substance use with consent giving and consent rates and the interaction between the two. RESULTS: Nonconsenters had higher substance use patterns, although they were more often alcohol abstainers; differences were small and not always significant and did not decrease as consent rates increased. CONCLUSIONS: Substance use currently is a minor sensitive topic among young men, resulting in small differences between nonconsenters and consenters. As consent rates increase, additional individuals are similar to those observed at lower consent rates. Estimates of analytical studies looking at associations of substance use with other variables will not differ at reasonable consent rates of 50%-80%. Descriptive prevalence studies may be biased, but only at very low rates of consent.

Longitudinal study of informed consent in innovative therapy research: experience and provisional recommendations from a multicenter trial of intracerebral grafting.

BACKGROUND: There is an urgent need to assess and improve the consent process in clinical trials of innovative therapies for neurodegenerative disorders. METHODS: We performed a longitudinal study of the consent of Huntington's disease patients during the Multicenter Fetal Cell Intracerebral Grafting Trial in Huntington's Disease (MIG-HD) in France and Belgium. Patients and their proxies completed a consent questionnaire at inclusion, before signing the consent form and after one year of follow-up, before randomization and transplantation. The questionnaire explored understanding of the protocol, satisfaction with the information delivered, reasons for participating in the trial and expectations regarding the transplant. Forty-six Huntington's disease patients and 27 proxies completed the questionnaire at inclusion, and 27 Huntington's disease patients and 16 proxies one year later. RESULTS: The comprehension score was high and similar for Huntington's disease patients and proxies at inclusion (72.6% vs 77.8%; P > 0.1) but only decreased in HD patients after one year. The information satisfaction score was high (73.5% vs 66.5%; P > 0.1) and correlated with understanding in both patients and proxies. The motivation and expectation profiles were similar in patients and proxies and remained unchanged after one year. CONCLUSIONS: Cognitively impaired patients with Huntington's disease were capable of consenting to participation in this trial. This consent procedure has presumably strengthened their understanding and should be proposed before signing the consent form in future gene or cell therapy trials for neurodegenerative disorders. Because of the potential cognitive decline, proxies should be designated as provisional surrogate decision-makers, even in competent patients.

Health professionals ethical and legal liability on patient’s inadequate clarification in order to obtain free and informed consent

It is required that patients are provided information about therapeutic possibilities, showing the risks, benefits, prognosis and costs of each possible and indicated alternative. This is an ethical and legal resolution. However, health professionals possess the clinical/technical/scientific knowledge and determine what information will be (or not) provided. The patient in question decides to undergo a treatment, providing his/her free and informed consent on the basis of the data presented. Unfortunately, some professionals may not provide all the information necessary for making an informed decision or, after obtaining the consent of the patient, may provide him information that causes the patient to give up on the treatment initially accepted. Such information, if relevant, and not a supervening fact, should have been provided initially. However, the information may not be entirely true, and bring the patient, for instance, to decide based on inadequately presented risks. The craniofacial rehabilitation of the temporomandibular joint (TMJ) by means of TMJ prosthesis, is indicated in many situations. Often, patients in need of such prostheses have aesthetic and functional problems and the rehabilitation expectations run high. This work presents a case and discusses ethical and legal issues, including the liability of partial and inadequate information to a patient.