Protecting Vulnerable Research Subjects in Critical Care Trials: Enhancing the Informed Consent Process and Recommendations for Safeguards

Although critically ill patients represent a vulnerable group of individuals, guidelines in research ethics assert that ethically acceptable research may proceed with such vulnerable subjects if additional safeguards are in place to minimize the risk of harm and exploitation. Such safeguards include the proper obtainment of informed consent that avoids the presence of the therapeutic misconception and the assessment of decisional capacity in critically ill patients recruited for research. Also discussed in this review are additional safeguards for such vulnerable subjects, as well as the issues involved with proxy consent. Heightened awareness to principles of ethics and provision of additional safeguards to enhance protections of vulnerable subjects would help to maintain the public trust in the research endeavor

Insight in bipolar disorder: a comparison between mania, depression and euthymia using the Insight Scale for Affective Disorders

Objective: To evaluate whether having general insight into bipolar disorder and its symptoms is affected by the mood state of the patient, using the Insight Scale for Affective Disorders, a hetero-application scale for people with mood disorders.Methods: Ninety-five patients with bipolar disorder were evaluated and divided into different groups according to the mood state presented during assessment (i.e., euthymia, mania and depression). Sociodemographic and clinical data (Hamilton Depression Scale, Young Mania Rating Scale, and Clinical Global Impressions Scale) were recorded. Insight was evaluated using the Insight Scale for Affective Disorders.Results: Patients with bipolar disorder in mania show less insight about their condition than patients in depression or euthymia, and less insight about their symptoms than patients with depression, with the exception of awareness of weight change.Conclusions: Loss of insight during mania may have important implications for treatment compliance and adherence and needs to be taken into account in the clinical management of people with bipolar disorder

The pathophysiology of essential tremor and Parkinson's tremor

Item does not contain fulltextWe review recent evidence about the pathophysiology of essential tremor and tremor in Parkinson’s disease. We believe that a network perspective is necessary to understand this common neurological symptom, and that knowledge of cerebral network dysfunction in tremor disorders will help to develop new therapies. Both essential tremor and Parkinson’s tremor are associated with increased activity in the cerebellothalamocortical circuit. However, different pathophysiological mechanisms lead to tremulous activity within this circuit. In Parkinson’s disease, evidence suggests that dopaminergic dysfunction of the pallidum triggers increased activity in the cerebellothalamocortical circuit. In essential tremor, GABAergic dysfunction of the cerebellar dentate nucleus and brain stem, possibly caused by neurodegeneration in these regions, may lead to tremulous activity within the cerebellothalamocortical circuit. In both disorders, network parameters such as the strength and directionality of interregional coupling are crucially altered. Exciting new research uses these network parameters to develop network-based therapies, such as closed-loop deep brain stimulation and transcranial magnetic or direct current stimulation.10 p