Emergency Research without Consent under Polish Law

Although Directive 2001/20/EC of the European Parliament and of Council of 4 April 2001 on the approximation of the laws regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use does not contain an exception for emergency situations, and requires the informed consent of a legal representative in all cases where research is conducted on legally competent individuals who are unable to give informed consent, in Poland, emergency research can be conducted without consent. Polish regulations on emergency research can hardly be treated as a result of intentional legislative policy. Our provisions arise from multiple and sophisticated interpretations of different regulations that govern medical experiments on human subjects and clinical trials. These interpretations can be summarized as follows: (1) There are two categories of medical experiments: therapeutic and non-therapeutic experiments. Emergency research without consent may be conducted in the category of therapeutic experiment only (therapeutic experiment consists of the introduction by the physician of new or only partially proven diagnostic, therapeutic or preventive methods in order to achieve direct benefit to the health of the patients, and it can be carried out when hitherto applied methods were ineffective or their effectiveness was insufficient). (2). Emergency research may be conducted without consent if there is a situation of great urgency in which the research subject's life is in danger and there is no possibility of obtaining immediate consent from the research subject him or herself, or from his or her legal representative or guardianship court, and the research subject has not refused to give consent for the participation in an emergency therapeutic experiment. The legal representative or guardianship court shall be provided with all the relevant information concerning subject's participation in an experiment as soon as possible. All projects of emergency research with intent to be done without the research subject's consent must be approved by an independent bioethics committee. Because these five requirements seem to provide insufficient protection for a subject's autonomy and rights it is necessary to add to them two other conditions: (1) the emergency research could not be conducted using other research participants capable of giving informed consent; and (2) informed consent for continued participation in the emergency research shall be obtained from either the participant him or herself or the legally authorized representative as soon as possible (requirement of obtaining deferred consent). A consolidated single Act that will govern all aspects of medical experiments on human subjects, including emergency research, should be prepared and enacted as soon as possible.     

动、名词损伤的脑功能性定位

动词与名词之间的差异近年来已引起认知心理学家、心理语言学家和神经语言学家的广泛兴趣。本文从神经语言学角度出发,以Levelt的语言产生模型为框架,对词语加工哪一水平上的损伤会导致动词和名词分离的研究进行了综述和评价。     

Informed Consent Procedure for Clinical Trials in Emergency Settings: The Polish Perspective

Setting reasonable and fair limits of emergency research acceptability in ethical norms and legal regulations must still adhere to the premise of well-being of the research subject over the interests of science and society. Informed consent of emergency patients to be enrolled in clinical trials is a particularly difficult issue due to impaired competencies of patients’ to give consent, short diagnostic and therapeutic windows, as well as the requirement to provide detailed information to participants. Whereas the Declaration of Helsinki, Good Clinical Practice guideline, Additional Protocol to the European Bioethical Convention concerning Biomedical Research, as well as appropriate regulations adopted by the Food and Drugs Administration (USA) allow waivers from participants’ consent or deferred consent for emergency research, the regulations of most European Community countries following the Clinical Trial Directive (2001/20/EC) do not give space for a deferred consent or a waiver from consent for adult patients (unless surrogate consent is made use of). This is even more confusing in case of Poland, where conflicting regulations on a waiver from a participant’s consent in emergency research exist and the regulations on surrogate consent of temporarily incompetent adults are too restrictive and authorise only the guardianship courts to consent, which is not or hardly feasible in practice. European Community regulations need to be amended to allow for implementation of the deferred consent or waivers from consent for emergency research in order to enable ethical research of emergency conditions that should become a large part of important public health priorities.     

Four Keys to Success (Theory, Implementation, Evaluation, and Resource/System Support): High Hopes and Challenges in Participation

In this article, I attempt to merge two themes. First, there is often a large gap between high hopes about impacts of policies or programs and the demonstrated results. I describe four keys/threats to success in any social problem area: theory, implementation, evaluation, and resource/system support. Second, I present theory and research from over 30 years of work on participation, conducted by my colleagues and myself that can illuminate and be illuminated by theory, implementation, evaluation, and resource/system support. I offer ideas for solutions that increase the probability of success. I conclude with the need to have high hopes tempered by theory and research to develop realistically ambitious solutions to social problems.     

Recherche sur données : aspects juridiques et éthiques à travers l’expérience de l’hôpital Foch

Health data is the object of covetousness by many actors, of course by the healthcare industry, in particular the drug and medical device industry, by hospitals and research institutes, but also by all types of merchant companies which would like to derive substantial benefits from it. Faced with this phenomenon, the European Commission, within the framework of the replacement of the European Directive on health data of 1995, by the General Data Protection Regulation of 2016 (GDPR) has strengthened the protection of health data which is particularly sensitive data for everyone and, consequently, carrying out studies on health data. Researches that does not involve human beings, improperly called “Data studies”, are closely regulated by the GDPR and, for France, by the Data Protection Act, which has been amended accordingly. This article describes the steps to be taken for the implementation of data studies and what are the rights of participants/patients in the context of these researchs. Ethical vigilance would require that such research be reviewed by an ad hoc committee.     

The Challenges of HIV/AIDS Counselling in Nigerian Secondary Schools: A Case Study of Kwara State

The study investigated the challenges of HIV/AIDS counselling in Nigerian secondary schools as expressed by school counsellors in Kwara state, Nigeria. The respondents comprised 132 purposively selected counsellors in Kwara state public secondary schools (Male=85; Female=47). Data were collected with the use of a survey instrument and the data were quantitatively analyzed. The study identified the challenges hindering effective implementation of HIV/AIDS counselling in Nigerian secondary schools as ignorance, non-existence of governmental policy on HIV/AIDS counselling in schools and negative attitudes of school administrators, students and teachers to HIV/AIDS. Geographical location and job status had significant influence on the respondents' views of the challenges facing HIV/AIDS counselling in Nigerian secondary schools. The Counselling Association of Nigeria (CASSON) should enlighten Nigerians on the importance of HIV/AIDS counselling in schools.     

Aspiration/reservation-based decision support—a step beyond goal programming

Real-life decision problems are usually so complex that they cannot be modelled with a single objective function, thus creating a need for clear and efficient techniques for handling multiple criteria to support the decision process. A widely used technique and one commonly taught in general OR/MS courses is goal programming, which is clear and appealing. On the other hand, goal programming is strongly criticized by multiple-criteria optimization specialists for its non-compliance with the efficiency (Pareto-optimality) principle. In this paper we show how the implementation techniques of goal programming can be used to model the reference point method and its extension, aspiration/reservation-based decision support. Thereby we show a congruence between these approaches and suggest how the GP model with relaxation of some traditional assumptions can be extended to an efficient decision support technique meeting the efficiency principle and other standards of multiobjective optimization theory.     

Decreasing overt discrimination increases covert discrimination: Adverse effects of equal opportunities policies

Building on the moral licensing literature, this paper examines whether highlighting the successful implementation of an equal opportunities policy in a company leads to covert forms of discrimination in hiring decisions (i.e., expressing a preference for a white candidate over an equally qualified black/Moroccan candidate in an ambiguous context). Furthermore, moral self‐image is indirectly tested as a possible underlying mechanism. Two scenario studies first revealed that covert discrimination is more likely after highlighting a successful implementation of an equal opportunities policy in the company (study 1) and that elevated levels of moral self‐image are related to covert discrimination (study 2). Subsequently, a field study revealed that the presence of successful equal opportunities policies positively related to employees’ moral self‐image (study 3).     

A Qualitative Systematic Review of Youth Participatory Action Research Implementation in U.S. High Schools

This qualitative systematic review examined the context-specific factors that influence the implementation of youth participatory action research (YPAR) projects in high schools within the United States. Thematic synthesis was conducted to identify and analyze the YPAR implementation factors that were present in 38 peer-reviewed studies. Results indicate the following two analytic themes concerning YPAR implementation in high schools: (a) pedagogical strategies and (b) stakeholder dynamics and needs. The themes provide support for existing ecological frameworks of implementation factors and demonstrate that adult researchers’ project-specific decisions are nested within educational power structures. This paper will discuss the implications of these YPAR implementation themes in executing YPAR projects in high schools.     

HIV/AIDS in scottish prisons: Attitudes of staff and prisoners

Abstract

Prison is commonly regarded as a high risk environment for the transmission of HIV/AIDS. Five hundred and fifty-nine prisoners and 591 prison staff sampled from 8 Scottish prisons completed questionnaires concerning attitudes towards various issues of HIVIAIDS. A majority of prisoners and prison staff expressed liberal attitudes with respect to HIV/AIDS. For both staff and prisoners, the most liberal responses were to items dealing with personal and social contact with people with HIVIAIDS. A majority of prisoners and prison staff expressed conservative attitudes in relation to screening of individuals for HIV. With regard to differences between prisoners and prison staff, prisoners were more supportive than prison staff of the provision of free condoms to homosexuals and free condoms and syringes to intravenous drug users, and the provision of free medical care to both groups in the case of AIDS. Among the prisoner sample, intravenous drug users, in comparison to non-users, were found to be more positive in their attitudes toward HIVIAIDS on a wide range of issues. The implications of the study for health psychology are discussed with regard to prisoner and prison staff educational needs and prisoner management.     

Working Memory Deficits in Boys with Attention-deficit/Hyperactivity Disorder (ADHD): The Contribution of Central Executive and Subsystem Processes

The current study investigated contradictory findings from recent experimental and meta-analytic studies concerning working memory deficits in ADHD. Working memory refers to the cognitive ability to temporarily store and mentally manipulate limited amounts of information for use in guiding behavior. Phonological (verbal) and visuospatial (nonverbal) working memory were assessed across four memory load conditions in 23 boys (12 ADHD, 11 typically developing) using tasks based on Baddeley's (Working memory, thought, and action, Oxford University Press, New York, 2007) working memory model. The model posits separate phonological and visuospatial storage and rehearsal components that are controlled by a single attentional controller (CE: central executive). A latent variable approach was used to partial task performance related to three variables of interest: phonological buffer/rehearsal loop, visuospatial buffer/rehearsal loop, and the CE attentional controller. ADHD-related working memory deficits were apparent across all three cognitive systems--with the largest magnitude of deficits apparent in the CE--even after controlling for reading speed, nonverbal visual encoding, age, IQ, and SES.     

Do Actions Speak Louder Than Words? A Comparison of Three Organizational Practices for Reducing Racial/Ethnic Harassment and Discrimination

We assessed the effectiveness of three commonly suggested organizational practices for reducing racial/ethnic harassment and discrimination (REHD): training; resources for reporting REHD; and implementation actions taken by leadership to reduce REHD. In a sample of 39,475 U.S. military personnel, we conducted dominance analyses to examine the relative contributions of these practices to REHD. Implementation contributed more to the prediction of REHD than did training or resources. Moreover, implementation moderated the effect of resources and training. This suggests that active leadership effort to address REHD can be 1 of the most effective means of reducing such behavior.     

Asking “why” helps action control by goals but not plans

The present research investigated whether asking “why” concerning the pursuit of one goal can affect the subsequent pursuit of a previously chosen goal. Asking “why” should activate cognitive procedures involving deliberation over the pros and cons of a goal (why-mindset). This mode of thinking should spill over to subsequently pursued goals, with different consequences for goal striving guided by goal intentions and for goal striving guided by implementation intentions (if-then plans). As goal intentions guide behavior by effortful top-down action control processes motivated by the expected value of the desired outcomes, being in a why-mindset should induce defensive postdecisional deliberation and thereby promote goal pursuit. In contrast, implementation intentions guide behavior by automatic bottom-up action control processes triggered by the specified situational cues; in this case, being in a why-mindset should eliminate the effects implementation intentions have on goal pursuit. Performance on a handgrip self-control task (Study 1) as well as on a dual-task (simultaneous go/no-go task and tracking tasks; Study 2) supported these predictions: why-mindsets reinforced goal intention effects and impaired implementation intention effects on handgrip and dual-task performance. Implications for effective goal striving are discussed.     

Multidimensional Family Therapy HIV/STD Risk-Reduction Intervention: An Integrative Family-Based Model for Drug-Involved Juvenile Offenders

Drug and juvenile justice involved youths show remarkably high rates of human immunodeficiency virus (HIV)/sexually transmitted disease (STD) risk behaviors. However, existing interventions aimed at reducing adolescent HIV risk behavior have rarely targeted these vulnerable young adolescents, and many approaches focus on individual-level change without attention to family or contextual influences. We describe a new, family-based HIV/STD prevention model that embeds HIV/STD focused multifamily groups within an adolescent drug abuse and delinquency evidence-based treatment, Multidimensional Family Therapy (MDFT). The approach has been evaluated in a multisite randomized clinical trial with juvenile justice involved youths in the National Institute on Drug Abuse Criminal Justice Drug Abuse Treatment Studies ( http://www.cjdats.org ). Preliminary baseline to 6-month outcomes are promising. We describe research on family risk and protective factors for adolescent problem behaviors, and offer a rationale for family-based approaches to reduce HIV/STD risk in this population. We describe the development and implementation of the Multidimensional Family Therapy HIV/STD risk-reduction intervention (MDFT-HIV/STD) in terms of using multifamily groups and their integration in standard MDFT and also offers a clinical vignette. The potential significance of this empirically based intervention development work is high; MDFT-HIV/STD is the first model to address largely unmet HIV/STD prevention and sexual health needs of substance abusing juvenile offenders within the context of a family-oriented evidence-based intervention.     

Impact of esteem-related feedback on mood, self-efficacy, and attribution of success: Self-enhancement/self-protection

It is suggested that positive ego-enhancing and negative ego-diminishing feedback conditions concerning social perceptiveness can give rise to altered affective states concerning self-esteem that generalize to other areas of cognitive functioning in such a way that this feedback accompanies a systematic self-serving attributional bias of cognitive/intellectual performance. The results of 40 participants in an ego-enhancing and 45 in an ego-diminishing feedback condition indicate more attribution of problem-solving success by the first group to effort and to ease of the task; participants who received ego-diminishing feedback attributed their initial problem-solving success less to ease of the task. Other more direct evidence of self-protective strategies on the part of those in the ego-diminishing feedback condition includes lower success expecta y on retest and reduced volunteering for additional challenge. The results are interpreted as evidence of the impact of generalized esteem-related affect on future success expectancy, on risk-taking, and on the attribution of success when future replication is a boundary condition.     

Operational Psychology Post-9/11: A Decade of Evolution

Operational psychology continues to expand at a rapid rate. Over the course of the last decade, it has emerged from relative obscurity and developed into an exciting, and somewhat controversial, professional subdiscipline within psychology. As the community of operational psychologists has increased and matured, it has reached a tipping point, creating the need for practice guidelines, training programs, and a greater emphasis on operationally relevant empirical research. The starting point for these developments is an integrative definition of operational psychology. In this article, we revisit previous definitions, relevant research literature, and recent developments in this specialty. We propose a definition that emphasizes consultation to an operational decision maker concerning issues of national security and defense.     

Countertransference disclosure and the asymmetry/mutuality dilemma

No single issue illustrates more clearly the interpersonal therapist's struggle between asymmetry and mutuality than countertransference disclosure. On a theoretical plane, all versions of interpersonal psychoanalysis share a comfortable tolerance for a central dynamic tension between the mutual influence of the participants and the asymmetry inherent in a relationship that emphasizes understanding the motivations of only one participant. This same marriage of concepts has, however, been a source of considerable confusion within the area of technique. The practitioner is charged with the technical implementation of the theory and must define the line between asymmetry and mutuality in everyday interactions with patients. Difficulty tolerating the ambiguity caused by the tension between asymmetry and mutuality results in the understandable urge to seek a definitive and unwavering position on countertransference disclosure.

Dimensions of the therapist's struggle include complex decisions concerning the primary unit of study (patient or relationship), the sequence of exploring new and old object transference experience, the use of disclosure with or without concurrent understanding, an assessment of the patient's capacities to tolerate disclosure, and, lastly, the initiation and frequency of disclosure interventions. An integrative perspective on the tension between mutuality and asymmetry allows the dialectical relationship between these principles to reach a constantly evolving equilibrium unique to each patient based on the moment of clinical interaction.     

Split-half and parallel reliabilities of the Purdue Pharmacist Directive Guidance Scale

Using R and SPSS, various forms of split-half and parallel reliabilities were calculated. Robust split-half and parallel reliability coefficients for the Purdue Pharmacist Directive Guidance Scale are presented with coefficients greater than .84.     

A Mid-Career Perspective on the Opportunity-Structure/Occupational-Choice Debate

Research into mid-career change lends support to K. Roberts' thesis on the significance of the opportunity structure for initial entry to work and during the early working years. Whether objective or 'socially constructed', it was perceived as a determinant by men who were ensuring that their children should not be constrained as they had been. The study also offers evidence of the subsequent strengthening and implementation of the self-concept and of a consequent change in the significance of the opportunity structure. The conclusions, highlighted in a case-history, tend to support all parties to the opportunity-structure/occupational-choice debate so far. They suggest that in today's turbulent environment there is an urgent need for careers information, guidance and counselling throughout working life.