Univ., Diss.-2003--Hamburg, 2002.

Indiana University-Purdue University Indianapolis (IUPUI) / Children's and adolescents' capacity to provide valid informed consent is one of the key ethical concerns in pediatric research, and the focus of this project. The original contribution to knowledge is the advancement of both conceptual and empirical bioethical approaches to research with vulnerable populations. First, a review of adolescent vulnerability is presented to highlight the complex interplay between capacity and other forms of vulnerability. This review is offered as an interdisciplinary analysis to better understand why the study of vulnerable populations is critical to the ethical advancement of clinical research. Results from this analysis suggest the need for enhanced screening techniques as well as the utilization of specialized staff to identify and reduce the impact of different forms of vulnerability. The primary tasks of the empirical portion of the dissertation were to: (1) Adapt a validated adult competency assessment tool for clinical research, the MacArthur Competency Assessment Tool for Clinical Research, to assess the capacity of children and adolescents to consent to clinical research; (2) Identify predictors that impact children and adolescents’ capacity to provide consent to clinical research; and (3) assess differences and similarities in capacity between healthy and chronically ill children and adolescents. Overall results suggest adolescent capacity to consent to research was similar to adults, and most strongly associated with their family's socioeconomic status as well as their level of health literacy. These findings contrast starkly with the age-based criterion for providing consent currently utilized in assent and consent determinations. These findings also provide insights into ways to ethically involve youth in complex biomedical research.

This dissertation focuses on the issue of health care provision without the consent of a patient within the system of intensive care provision. Situations when its possible to hospitalize a patient without his or her consent are defined in § 38 ZZS (Health Services and Terms and Conditions of Health Service Provision Act as amended). In the intensive care unit we are very often faced with patients that need to be urgently treated without their consent. Also very frequently a treatment is provided to patients that are under the influence of addictive substances therefore are dangerous to themselves and to others. Health of these patients is damaged and even their lives are at risk. A treatment without a patient's consent is debatable from the ethical point of view. A conflict occurs between the fundamental ethical principles (benefit principle and principle of autonomy) because it is not entirely clear which one of the two principles should be prioritize during the treatment. Work and moral obligation of every medical personnel is to provide a medical treatment in accordance with the law and ethical principles. A theoretical part of the paper is dedicated to the legal and ethical sides of the examined issue. The empirical part of the paper is dedicated to the research. A qualitative analysis of...

L’approche statique de la notion d’acquéreur, retenue par le Code civil, a été remise en cause par la professionnalisation des vendeurs, suite au renouvellement des méthodes de vente et à la complexification des biens. Au stade de la formation du contrat de vente, l’équilibre postulé par le droit commun s’est progressivement affaibli pour donner naissance à des rapports déséquilibrés entre l’acquéreur et le vendeur. Pour remédier à cette situation, les normes contemporaines, d’inspiration consumériste, ont adopté une approche dynamique de la notion en établissant différentes catégories d’acquéreurs, en vue de leur permettre d’exprimer un consentement réfléchi et éclairé. Les enjeux, théoriques et pratiques, d’une étude confrontant l’acquéreur aux règles de la formation du contrat de vente ont pour objet de déterminer si l’évolution législative a permis de rétablir l’équilibre. L’immixtion du droit de la consommation dans le droit de la vente met en œuvre un dispositif protecteur du consentement de l’acquéreur. Ainsi, les normes consuméristes restaurent-elles l’équilibre pour tous les rapports ? Les règles protectrices du consentement, n’étant pas exclusivement attachée à la qualité de l’acquéreur, autorisent-elles le retour à l’équilibre ou au contraire, donnent-elles naissance à de nouvelles situations déséquilibrées ? La réponse à cette interrogation nécessite d’analyser les dispositions organisant le contrat de vente mais, également, celles relatives au contrat de prêt. Le financement de l’acquisition est, généralement, lié à la conclusion de la vente. / The static approach of the idea of buyer, chosen by the Civil Code, has been challenged by the professionalization of the buyer, following the renewal of sales techniques and the fact that the goods are becoming more complex. On the level of the making of the sales contract, the balance implied by the common-law has gradually weakened to generate unbalanced relationships between the buyer and the seller. To solve this, the contemporary standards based on consumerism have adopted a dynamic approach of the notion by distinguishing different categories of buyers, in order to give them the opportunity to express a well-thought and informed consent. The major issues, both theoretical and practical, of a study which confronts the buyer to the rules of the making of a sales contract, are to determine if the legal evolution allowed to reestablish the balance. The interference of the consumption right in the sales right generates a protective system of the buyer's consent. Can the consumerist standards restore the balance at all levels? Do the protective rules of consent, not being exclusively attached to the quality/ nature of the buyer, allow a way back to the original balance or on the contrary, do they give birth to new unbalanced situations? The answer to this question requires to analyze the rules which organize the sales contract and those connected to the rental contract too. The acquisition financing is currently connected to the sealing of the sale. The diversity of these rules requires to deal with them under the light of the protection of the buyer's consent, in order to allow him to give a well-thought and informed consent.

BACKGROUND: Centres in Phases I and III of the International Study of Asthma and Allergies in Childhood (ISAAC) programme used the method of consent (passive or active) required by local ethics committees. METHODS: Retrospectively, relationships between achieved response rates and method of consent for 13-14 and 6-7-year-olds (adolescents and children, respectively), were examined between phases and between English and non-English language centres. RESULTS: Information was obtained for 113 of 115 centres for adolescents and 72/72 centres for children. Both age groups: most centres using passive consent achieved high response rates (>80% adolescents and >70% children). English language centres using active consent showed a larger decrease in response rate. Adolescents: seven centres changed from passive consent in Phase I to active consent in Phase III (median decrease of 13%), with five centres showing lower response rates (as low as 34%). Children: no centre changed consent method between phases. Centres using active consent had lower median response rates (lowest response rate 45%). CONCLUSION: The requirement for active consent for population school-based questionnaire studies can impact negatively on response rates, particularly English language centres, thus adversely affecting the validity of the data. Ethics committees need to consider this issue carefully. / Revisión por pares

Zugl.: Mannheim, University, Diss., 2006.

The entire dissertation/thesis text is included in the research.pdf file; the official abstract appears in the short.pdf file (which also appears in the research.pdf); a non-technical general description, or public abstract, appears in the public.pdf file. Title from PDF of title page (University of Missouri--Columbia, viewed on April 1, 2010). Vita. Thesis advisor: Lawrence H. Ganong. "May 2008" Includes bibliographical references

abstract: Sexual violence is a problem on college campuses across that United States. In the past few years, federal and state legislation has been drafted in order to address campus sexual violence. A main feature of this legislation addresses an important communicative construct related to students’ sexual behavior: sexual consent. Colleges and universities are adopting an affirmative-standard of consent, which emphasizes that consent for sexual activity be communicated verbally or via unambiguous actions, mutual, voluntary, enthusiastic, and ongoing throughout the sexual encounter. Literature has explored how college students communicate and interpret sexual consent, but antecedents to sexual consent behaviors, particularly affirmative consent, are largely unknown. The current investigation seeks to longitudinally explore the antecedents to college students’ affirmative sexual consent behaviors (i.e., nonverbal, initiating, verbal). Using the Theory of Planned Behavior (TPB) as a theoretical framework, hypotheses predicted that at Time 1 (T1) attitudes, norms, and perceived behavioral control would positively and significantly predict students’ (T1) intentions to communicate affirmative consent to their partner. Then, it was predicted that at Time 2 (T2)—thirty days later—intentions to communicate consent from T1 would positively and significantly predict college students’ communication of affirmative consent to their partner during their most recent sexual encounter. The final matched (i.e., completed T1 and T2 surveys) sample included two hundred twenty-five (N = 225) college students who had engaged in sexual activity during the 30 days between survey distributions. Results from the path analyses support the theoretically driven hypotheses for all three affirmative consent behaviors, and demonstrate that subjective norms and perceived control are important and strong determinants of students’ communication of affirmative sexual consent. Furthermore, multi-group invariance tested the potential moderating effects of three individual, two dyadic, and two environmental/contextual variables on the strength of path coefficients between TPB constructs for all three sexual consent behaviors. Only individual and environmental/contextual variables significantly moderated relationships within the TPB for the three models. Results are discussed with regard to theoretical implications as well as practical implications for university health educators and other health professionals. Additionally, limitations and future directions are noted. / Dissertation/Thesis / Doctoral Dissertation Communication 2016

La protection pénale du consommateur est un enjeu essentiel, à plus forte raison, à la suite des dernières réformes législatives intervenues en la matière. La protection du consentement du consommateur représente l'essence même de l'intervention du droit pénal dans la sphère consumériste. La question fondamentale qu'il convient de se poser est donc celle de savoir si ce droit pénal sanctionne les comportements délictueux dont peut faire preuve le professionnel de manière accessoire au droit civil ou bien, plus intéressant, s'il revêt une autonomie dans la protection du consentement du consommateur, sans être un simple droit sanctionnant et dissuasif. / The consumer’s penal protection is an essential stake, even more so following the last legislative reforms that occurred in the matter. The consumer’s consent’s protection represents the very essence of criminal law’s intervention in the consumerist sphere. The fundamental question that must be asked is whether criminal law punishes the criminal behaviour that a professional might show as an additional legislation which is dependent on civil law or, more interestingly, if criminal law is in fact autonomous in the consumer’s consent’s protection without being nothing more than a repressive and dissuasive legislation.

Introduction and background Recruitment to cancer clinical trials needs to be improved, as does patient understanding about clinical trials, to enable patients to make an informed choice about whether or not to take part. The main reason that clinically eligible patients do not take part in clinical trials is because they refuse; poor understanding of the research has been associated with patient refusal. Audiovisual patient information (AVPI) has been shown to improve knowledge/understanding in various areas of practice but there is limited information about its effect in the cancer clinical trial setting, particularly in relation to recruitment rates. Understanding the research is necessary for informed consent, and it was hypothesised that if patient understanding about clinical trials was increased with AVPI, then this could result in a reduction in the number of patients refusing clinical trials, and therefore provide an ethical approach to improving recruitment. This study aimed to test the impact of an audiovisual patient information intervention on recruitment to randomised cancer clinical trials (refusal rates), patient understanding of the information given, and levels of anxiety. Reasons for patients’ decisions about trial participation were also assessed. Method An AVPI intervention was developed that aimed to address the common misconceptions associated with randomisation and clinical equipoise, as well as improve patient understanding generally of randomised cancer trials, and of other core clinical trial informational requirements, such as voluntariness. Patients were randomised to receive either AVPI in addition to the standard trial-specific written information, or the written information alone. A new questionnaire was developed to assess patient understanding (also referred to as knowledge) in the randomised trial setting and, following testing with patients and research nurses, this was shown to be reliable and valid. Patients completed self-report questionnaires to assess their understanding (new knowledge questionnaire) and anxiety (Spielberger State-Trait Anxiety Inventory), at baseline and after they had made their decision about clinical trial entry, when their perceptions of the intervention, as well as factors contributing to their decision were also determined (this tool incorporated Jenkins and Fallowfield’s (2005) questionnaire which assessed reasons for accepting and declining randomised cancer trials). Results A total of 173 patients with breast cancer (65%), colorectal cancer (32%) and lung cancer (3%) were entered into the main study. The median age was 60 (range 37-92 years). There was no difference in clinical trial recruitment rates between the two groups: 72.1% in the AVPI group and 75.9% in the standard information group. The estimated odds ratio for refusal (intervention/no intervention) was 1.19 (95% ci 0.55-2.58, p=0.661). Knowledge scores increased more in the intervention group compared to the standard group (U= 2029, p=0.0072). The change in anxiety score between the arms was also statistically significant (p=0.011) with anxiety improving in the intervention arm more than in the no-intervention arm. The estimated difference in the median anxiety change score between the groups is –4.6 (95% ci –7.0 to –2.0). Clinical trial entry was not influenced by tumour type, stage of cancer, age, educational qualifications or previous research experience, however, there was a modest association with deprivation status (p=0.046) where more affluent patients were the least likely to consent to a trial. Educational qualifications and stage of cancer were independently associated with knowledge: patients who were better educated had higher levels of knowledge about randomised trials, and patients who had limited stage of cancer had higher baseline knowledge than patients with advanced cancer. Acceptability of the intervention was high with 93% of those who watched it finding it useful, and 42% stating that it made them want to take part in the clinical trial. Personal benefit and altruism were key motivating factors for clinical trial participation, with reasons for refusal being less clear. Discussion and conclusions Although the potential for AVPI to increase clinical trial recruitment rates was highlighted in the literature, in this study, AVPI was not shown to have any effect on refusal rates to randomised cancer trials. However, by improving patient understanding prior to decision making, AVPI was shown to be a useful addition to the consent process for randomised cancer trials. AVPI addresses the fundamental ethical challenges of informed consent by improving patient understanding, and supports the ethical framework integral to Faden and Beauchamp’s (1986) theory of informed consent. The new knowledge questionnaire was shown to be a sensitive and effective instrument for measuring understanding of randomised clinical trials in the cancer setting, although it would benefit from further testing. The AVPI appears to reduce anxiety at the decision making time point and has been shown to be an acceptable medium for patients. This study confirms existing findings from studies assessing factors affecting decision making, with personal benefit and altruism being key motivating factors, and reasons for refusal being less clear. The need for further qualitative work in this area is highlighted to gain a deeper understanding of what is important to patients, in terms of why they refuse clinical trial participation. Implications for practice and further research Several implications for practice have been identified, including using AVPI as part of the standard information package for patients considering randomised cancer trials, and focussing on patient and staff education in this area. The knowledge questionnaire could be introduced to routine practice as a tool to determine patient understanding prior to decision making, allowing clinicians the opportunity to correct any misconceptions prior to consent. Further research focussing on AVPI specific to individual trials would be helpful, to determine if a more customised approach would be of benefit in terms of clinical trial recruitment. The importance of studying other aspects of the consent process such as the interaction between the clinician and the patient, in addition to more detailed exploration of the factors affecting patients’ decisions were highlighted.