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.

Property enforcement as organized consent

This article develops and tests a theory of the institutions that makeproperty rights viable, ensuring their enforcement, mobilizing thecollateral value of assets and promoting growth. In contrast tocontractual rights, property rights are enforced in rem, being affectedonly with the consent of the right holder. This ensures enforcement butis costly when multiple, potentially colliding rights are held in thesame asset. Different institutions reduce the cost of gathering consentsto overcome this trade-off of enforcement benefits for consent costs:recording of deeds with title insurance, registration of rights and evena regimen of purely private transactions. All three provide functionallysimilar services, but their relative performance varies with the numberof transactions, the risk of political opportunism and regulatoryconsistency. The analysis also shows the rationality of allowingcompetition in the preparation and support of private contractswhile requiring territorial monopoly in recording and registrationactivities, this to ensure independence and protect third parties.

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.

Assessment of the capacity to consent to treatment in patients admitted to acute medical wards.

BACKGROUND: Assessment of capacity to consent to treatment is an important legal and ethical issue in daily medical practice. In this study we carefully evaluated the capacity to consent to treatment in patients admitted to an acute medical ward using an assessment by members of the medical team, the specific Silberfeld's score, the MMSE and an assessment by a senior psychiatrist. METHODS: Over a 3 month period, 195 consecutive patients of an internal medicine ward in a university hospital were included and their capacity to consent was evaluated within 72 hours of admission. RESULTS: Among the 195 patients, 38 were incapable of consenting to treatment (unconscious patients or severe cognitive impairment) and 14 were considered as incapable of consenting by the psychiatrist (prevalence of incapacity to consent of 26.7%). Agreement between the psychiatrist's evaluation and the Silberfeld questionnaire was poor (sensitivity 35.7%, specificity 91.6%). Experienced clinicians showed a higher agreement (sensitivity 57.1%, specificity 96.5%). A decision shared by residents, chief residents and nurses was the best predictor for agreement with the psychiatric assessment (sensitivity 78.6%, specificity 94.3%). CONCLUSION: Prevalence of incapacity to consent to treatment in patients admitted to an acute internal medicine ward is high. While the standardized Silberfeld questionnaire and the MMSE are not appropriate for the evaluation of the capacity to consent in this setting, an assessment by the multidisciplinary medical team concurs with the evaluation by a senior psychiatrist.

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.

Military crisis management in the next decade (2020-2030) : inducing consent or relying on compliance?

The most outstanding conceptual challenge of modern crisis management is the principle of consent. It is not a problem only at the operational level - it challenges the entire decision-making structures of crisis management operations. In post-cold war times and especially in the 21st century, there has been a transition from peacekeeping with limited size and scope towards large and complex peace operations. This shift has presented peace operations with a dilemma. How to balance between maintaining consent for peace operations, whilst being able to use military force to coerce those attempting to wreck peace processes? To address such a dilemma, this research aims to promote understanding, on what can be achieved by military crisis management operations (peace support operations) in the next decade. The research concentrates on the focal research question: Should military components induce consent or rely on the compliance of conflicting parties in crisis management operations of the next decade (2020 – 2030)? The focus is on military – political strategic level considerations, and especially on the time before political decisions to commit to a crisis management operation. This study does not focus on which actor or organisation should intervene. The framework of this thesis derives from the so called ‘peacebuilding space’, the scope of peace operations and spoiler theory. Feasibility of both peace enforcement and peacekeeping in countering future risk conditions are analysed in this framework. This future-orientated qualitative research uses the Delphi-method with a panel of national and international experts. Citation analysis supports identification of relevant reference material, which consists of contemporary literature, the Delphi-questionnaires and interviews. The research process followed three main stages. In the first stage, plausible future scenarios and risk conditions were identified with the Delphi-panel. In the second stage, operating environments for peace support operations were described and consequent hypotheses formulated. In the third stage, these hypotheses were tested on the Delphi-panel. The Delphi-panel is sufficiently wide and diverse to produce plausible yet different insights. The research design utilised specifically military crisis management and peace operations theories. This produced various and relevant normative considerations. Therefore, one may argue that this research; which is based on accepted contemporary theory, hypotheses derived thereof and utilising an expert panel, contributes to the realm of peace support operations. This research finds that some degree of peace enforcement will be feasible and necessary in at least the following risk conditions: failed governance; potential spillover of ethnic, religious, ideological conflict; vulnerability of strategic chokepoints and infrastructures in ungoverned spaces; as well as in territorial and extra-territorial border disputes. In addition, some form of peace enforcement is probably necessary in risk conditions pertaining to: extremism of marginalised groups; potential disputes over previously uninhabited and resource-rich territories; and interstate rivalry. Furthermore, this research finds that peacekeeping measures will be feasible and necessary in at least risk conditions pertaining to: potential spillover of ethnic, religious, ideological conflict; uncontrolled migration; consequences from environmental catastrophes or changes; territorial and extra-territorial border disputes; and potential disputes over previously uninhabited and resource-rich territories. These findings are all subject to both generic and case specific preconditions that must exist for a peace support operation. Some deductions could be derived from the research findings. Although some risk conditions may appear illogical, understanding the underlying logic of a conflict is fundamental to understanding transition in crisis management. Practitioners of crisis management should possess cognizance of such transition. They must understand how transition should occur from threat to safety, from conflict to stability – and so forth. Understanding transition is imperative for managing the dynamic evolution of preconditions, which begins at the outset of a peace support operation. Furthermore, it is pertinent that spoilers are defined from a peace process point of view. If spoilers are defined otherwise, it changes the nature of an operation towards war, where the logic is breaking the will of an enemy - and surrender. In peace support operations, the logic is different: actions towards spoilers are intended to cause transition towards consent - not defeat. Notwithstanding future developments, history continues to provide strategic education. However, the distinction is that the risk conditions occur in novel futures. Hence, lessons learned from the past should be fitted to the case at hand. This research shows compelling evidence that swaying between intervention optimism and pessimism is not substantiated. Both peace enforcement and peacekeeping are sine qua non for successful military crisis management in the next decade.

The Colour of Electronic Consent

This paper is a translation of the first part of an article published in Cahiers de propriété intellectuelle (2003).