Informed consent and the use of placebo in poland: Ethical and legal aspects

The concept of informed consent was one of the most fruitful ideas that deeply changed the relationships between physicians and their patients from paternalism to respect for the personal autonomy of subjects needing professional medical care. The great progress in medicine, also involving the pharmaceutical industry, has created an increasing need to perform different clinical and experimental trials. The evolution of clinical research in the last decades has influenced strongly the design of these studies. One of the most important changes in this field has been the use of placebo groups in double-blind controlled studies. The controversies have involved not only the use of placebo when standard or proven treatment was available, but also some specific problems concerning the procedure of obtaining informed consent in such trials. This paper briefly presents the evolution of informed consent in Poland as well as different ethical and legal problems concerning informed consent and the use of placebo controls in clinical trials. An earlier version of this paper was presented at an international conference, “Placebo: Its Action and Place in Health Research Today,” held in Warsaw, Poland on 12–13 April, 2003.     

Temporal kinetics of prefrontal modulation of the extrastriate cortex during visual attention

Single-unit, event-related potential (ERP), and neuroimaging studies have implicated the prefrontal cortex (PFC) in top-down control of attention and working memory. We conducted an experiment in patients with unilateral PFC damage (n=8) to assess the temporal kinetics of PFC-extrastriate interactions during visual attention. Subjects alternated attention between the left and the right hemifields in successive runs while they detected target stimuli embedded in streams of repetitive task-irrelevant stimuli (standards). The design enabled us to examine tonic (spatial selection) and phasic (feature selection) PFC-extrastriate interactions. PFC damage impaired performance in the visual field contralateral to lesions, as manifested by both larger reaction times and error rates. Assessment of the extrastriate P1 ERP revealed that the PFC exerts a tonic (spatial selection) excitatory input to the ipsilateral extrastriate cortex as early as 100 msec post stimulus delivery. The PFC exerts a second phasic (feature selection) excitatory extrastriate modulation from 180 to 300 msec, as evidenced by reductions in selection negativity after damage. Finally, reductions of the N2 ERP to target stimuli supports the notion that the PFC exerts a third phasic (target selection) signal necessary for successful template matching during postselection analysis of target features. The results provide electrophysiological evidence of three distinct tonic and phasic PFC inputs to the extrastriate cortex in the initial few hundred milliseconds of stimulus processing. Damage to this network appears to underlie the pervasive deficits in attention observed in patients with prefrontal lesions.     

Iberian rock lizards (Lacerta monticola) assess short-term changes in predation risk level when deciding refuge use

Prey might assess that risk level estimated in the first encounter with a predator was fixed in subsequent responses, whereas prey using flexible behavior would track short-term changes in risk. The authors examined, in the field, refuge use of Iberian rock lizards (Lacerta monticola) after simulated predator attacks and tested (a) how risk was assessed when multiple sources of risk were present simultaneously, (b) how short-term changes in risk level of successive attacks affected refuge use, and (c) whether the interval between attacks was important, insofar as attacks were considered to be coming from the same or different predators. Results suggest that lizards have a flexible estimate of risk that is based on multiple sources and flexibly dependent on previous estimates.     

Development of a Spanish version of the Participation Motivation Inventory for young competitive swimmers

The present study examined the validity of a Spanish version of the Participation Motivation Inventory, modified for swimming by Gould, Feltz, and Weiss in 1985, and investigated whether young swimmers differing in sex and age vary in their objectives for participation. Swimmers (204 boys and 224 girls, ranging in age from 8 to 22 years) were administered the inventory. Factor analysis with varimax rotation identified seven factors fairly consistent with previous research. Differences were found across age and sex. Females placed greater emphasis than males on Friendship and Fun and indicated lower importance rating to Status. Younger children (8-10 years) rated Fun/Friendship, Competition/Skills, Significant Others, and Status significantly higher in importance than did the other age groups.     

Dogs (Canis familiaris) learn from their owners via observation in a manipulation task

Eighty-seven pet dogs (Canis familiaris) were involved in an experiment in which they had to solve a task to obtain a ball. After witnessing a full demonstration by their owner (10 times pushing the handle of the box, which released a ball), most dogs preferred to touch the handle sooner and more frequently in comparison with other parts of the box, and they used the handle to get the ball. In contrast, dogs in 3 control groups developed their own respective methods. The lack of emergence of the ball and playing after the demonstration did not affect the learning performance strongly. This suggests that in dogs the outcome of a demonstration plays only a restricted role in the manifestation of social learning.     

Gender differences in cardiovascular and hypothalamic-pituitary-adrenal axis responses to psychological stress in healthy older adult men and women

Gender differences in the neuroendocrine and cardiovascular response to psychological stress may contribute to the gender differences in the prevalence of diseases associated with hypothalamic-pituitary-adrenal (HPA) axis reactivity such as cardiovascular disease (CVD), diabetes and hypertension. We measured plasma ACTH, cortisol, heart rate (HR), and blood pressure (BP) responses in 8 men and 8 women (55-75 years) exposed to the Matt Stress Reactivity Protocol (MSRP), a psychological challenge. The MSRP elicited significant increases in HR, systolic-, and diastolic BP, ACTH and cortisol (all p<0.01). Men had significantly greater cortisol and diastolic BP responses compared to women (p<0.05). Additionally, a positive correlation between the ACTH and cortisol responses was only found in the males (r=0.71, p<0.05). There were no group differences in HR, systolic BP, or ACTH responses. We conclude, that among older adults, men respond to psychological stress with greater increases in cortisol, compared to women. This greater activation of the HPA axis could translate into an elevated risk for CVD, diabetes and hypertension and may be related to the higher prevalence of these diseases in males. Gender differences in brain structures and/or cognitive processes may be responsible for these sexually dimorphic stress responses.     

The early origins of goal attribution in infancy

We contrast two positions concerning the initial domain of actions that infants interpret as goal-directed. The 'narrow scope' view holds that goal-attribution in 6- and 9-month-olds is restricted to highly familiar actions (such as grasping). The cue-based approach of the infant's 'teleological stance', however, predicts that if the cues of equifinal variation of action and a salient action effect are present, young infants can attribute goals to a 'wide scope' of entities including unfamiliar human actions and actions of novel objects lacking human features. It is argued that previous failures to show goal-attribution to unfamiliar actions were due to the absence of these cues. We report a modified replication of Woodward (1999) showing that when a salient action-effect is presented, even young infants can attribute a goal to an unfamiliar manual action. This study together with other recent experiments reviewed support the 'wide scope' approach indicating that if the cues of goal-directedness are present even 6-month-olds attribute goals to unfamiliar actions.     

Social psychology of mental health: the social structure and personality perspective

Previous research has revealed a persistent association between social structure and mental health. However, most researchers have focused only on the psychological and psychosocial aspects of that relationship. The present paper indicates the need to include the social and structural bases of distress in our theoretical models. Starting from a general social and psychological model, our research considered the role of several social, environmental, and structural variables (social position, social stressors, and social integration), psychological factors (self-esteem), and psychosocial variables (perceived social support). The theoretical model was tested working with a group of Spanish participants (N = 401) that covered a range of social positions. The results obtained using structural equation modeling support our model, showing the relevant role played by psychosocial, psychological and social, and structural factors. Implications for theory and intervention are discussed.     

Acquired ‘theory of mind'' impairments following stroke

The ability to attribute thoughts and feelings to self and others (‘theory of mind') has been hypothesised to have an innate neural basis and a dedicated cognitive mechanism. Evidence in favour of this proposal has come from autism; a brain-based developmental disorder which appears to be characterised by impaired theory of mind, despite sometimes good general reasoning skills/IQ. To date no case of specific acquired theory of mind impairment has been reported. The present study examined theory of mind in adults who had suffered right hemisphere stroke, a group known to show pragmatic and social difficulties. In one study using story materials and two using cartoons, patients' understanding of materials requiring attribution of mental states (e.g. ignorance, false belief) was significantly worse than their understanding of non-mental control materials. Data from healthy elderly subjects, and a small group of left hemisphere patients (who received the tasks in modified form), suggest that this impairment on mental state tasks is not a function of task difficulty. The findings support the notion of a dedicated cognitive system for theory of mind, and suggest a role for the healthy right hemisphere in the attribution of mental states.     

The recognition potential: An ERP index of lexical access

Recognition potential (RP) is a brain electrical response that appears when a subject views recognizable images of words. However, it has yet to be determined whether the processes reflected by RP are related to orthographic or to semantic analysis. This study aimed to resolve this question by studying the RP evoked by orthographically correct stimuli that were devoid of meaning. Results showed RP not only to this type of stimuli, but also to others achieving lower levels in the reading process. Strikingly, however, the RP amplitude significantly differed in parallel with the levels of the reading processes attained by the stimuli, the amplitude of the RP progressively increasing as the level approached the semantic one, which showed the highest amplitude. These results not only confirm the replicability of RP, but also its promise of potential usefulness in the study and assessment of language perception.