Written parental consent in school-based HIV/AIDS prevention research. (41/200)

OBJECTIVES: We examined the process of obtaining "active," written parental consent for a school-based HIV/AIDS prevention project in a South African high school by investigating (1) parental consent form return rates, (2) parents' recall and knowledge of the research, and (3) the extent to which this consent procedure represented parents' wishes about their child's involvement in the research. METHODS: This cross-sectional descriptive study comprised interviews with parents of children in grades eight and nine in a poor, periurban settlement in Cape Town. RESULTS: Within 2 weeks, 94% of 258 parents responded to a letter requesting written consent and of those, 93% consented, but subsequent interviews showed that 65% remembered seeing the consent form. At the end of the interview, 99% consented to their child's participation. CONCLUSIONS: These findings challenge many of the assumptions underlying active written parental consent. However, they should not be used to deny adolescents at high risk of HIV infection the opportunity to participate in prevention trials. Rather, researchers together with the communities in which the research is undertaken need to decide on appropriate informed consent strategies.  (+info)

The implications of the David Glass case for future clinical practice in the UK. (42/200)

A recent decision of the European Court of Human Rights (ECtHR) raises issues of considerable importance to medical practitioners and paediatricians in particular. The case concerns the parental right to withhold consent to medical intervention that doctors believe to be necessary in a child's best interests. The dramatic facts of this case (in which a boy's family felt they had to fight for his life) has significant repercussions for clinical practice. This is discussed in the light of previous and recent cases that have involved babies, infants and children. The worrying trend to use the Courts to resolve these difficult clinical cases is discussed.  (+info)

Comparisons of adolescent and parent willingness to participate in minimal and above-minimal risk pediatric asthma research protocols. (43/200)

PURPOSE: Through the processes of permission and assent, parents and adolescents have a shared involvement in decision-making about adolescent research participation. Yet little empirical data exists examining the prevalence and contexts in which adolescents and parents disagree on research participation decisions. The purpose of this study was to compare parent and adolescent willingness to participate in minimal and above-minimal risk pediatric asthma research protocols. METHOD: Thirty-six adolescents diagnosed with asthma and a parent of each, independently rated their willingness to participate in nine pediatric asthma research protocol vignettes. The selected protocols were chosen by an expert panel as representative of typical minimal and above-minimal risk pediatric asthma studies. RESULTS: Parents and adolescents were significantly less likely to enroll in above-minimal risk studies. However, this was qualified by a finding that adolescents were significantly more willing than parents to enroll in above-minimal risk research. Across all nine studies, parents and adolescents held concordant views on participation decisions 60% of the time, on average. Perception of potential study benefit was the most frequent reason provided for participation decisions by both parents and adolescents. CONCLUSION: Parents and their adolescents report substantial discordance in their views about participating in asthma research across a variety of protocols. These differences of opinion highlight the need to carefully consider the process by which families are offered the option of adolescent research participation. Investigators may want to adopt recruitment procedures that involve adolescents in initial discussions, especially for above-minimal risk studies.  (+info)

The role of the courts in clinical decision making. (44/200)

With advances in medical technology more can be offered with respect to treatment, for example, in neonates born prematurely. This raises the public's expectations of what medical professionals can offer and puts healthcare professionals under pressure to continue treatment, which may ultimately be futile. The courts may be asked to intervene in those cases where there is disagreement between parents and healthcare professionals. This may occur where doctors refuse to instigate or continue futile treatments or where treatment is not felt to be in the best interests of the patient. Cases may also be referred to the courts where doctors feel treatment options do exist but those with parental responsibility refuse to consent. Disagreement may also occur between parents. The best interests of the child are paramount and their welfare should always be the primary consideration. However, the court's opinion will be increasingly sought as parents' expectations increase and doctors fear litigation if they act against the parents' wishes. This paper reviews the role of the courts, using a number of high profile cases as examples. While the courts generally support the views of the healthcare professional, this cannot be guaranteed.  (+info)

The psychological profile of parents who volunteer their children for clinical research: a controlled study. (45/200)

Three standard psychometric tests were administered to parents who volunteered their children for a randomised, double-blind placebo-controlled trial of a new asthma drug and to a control group of parents whose children were eligible for the trial but had declined the invitation. The trial took place at a children's hospital in Australia. The subjects comprised 68 parents who had volunteered their children and 42 who had not, a participation rate of 94 per cent and 70 per cent, respectively. The responses of these parents to the Gordon Survey of Interpersonal Values Questionnaire, the Coopersmith Self-Esteem Inventory and the Cattell Sixteen Personality Factor Questionnaire were analysed by computer. There was a marked difference between the psychological profiles of the two groups of parents. Volunteering parents put more value on benevolence while non-volunteering parents were more concerned with power and prestige. The self-esteem of volunteering parents was much lower than that of non-volunteering parents. Finally, volunteering parents were more introverted, exhibited greater anxiety and low supergo, while non-volunteering parents appeared to have greater social confidence and emotional stability. Since an individual's values, self-esteem and personality may be important antecedents of behaviour, these findings suggest that parents who volunteer their children for clinical research are not only socially disadvantaged and emotionally vulnerable, but may also be psychologically predisposed to volunteering. Furthermore, these findings provide evidence for the existence of a psychosocial 'filter' effect of the informed consent procedure, which may be discouraging the better educated, more privileged and psychologically resilient members of society from participation as research subjects.  (+info)

Parental consent in paediatric clinical research. (46/200)

AIMS: To assess parental understanding and memorisation of the information given when seeking for consent to their child's participation to clinical research, and to identify the factors of significant influence on parents' decision making process. METHODS: Sixty eight parents who had been approached for enrolling their child in a clinical oncology or HIV study were asked to complete an interview. Their understanding was measured by a score which included items required to obtain a valid consent according to French legislation. RESULTS: Items that were best understood by parents were the aims of the study (75%), the risks (70%), the potential benefits to their child (83%), the potential benefits to other children (70%), the right to withdraw (73%), and voluntariness (84%). Items that were least understood were the procedures (44%), the possibility of alternative treatments (53%), and the duration of participation (39%). Less than 10% of the parents had understood all these points. Ten parents (15%) did not remember that they had signed up for a research protocol. Thirty three parents (48%) reported no difficulty in making their decision. Twenty four parents (38%) declared that they made their decision together with the investigator; 26 (41%) let the physician decide. Fifty four parents (78%) felt that the level of information given was satisfactory. CONCLUSION: There was an apparent discrepancy between parents' evaluation of the adequacy of the information delivered and evaluation of their understanding and memorisation. The majority of parents preferred that the physician take as much responsibility as possible in the decision making process.  (+info)

Parental consent for newborn screening in southern Taiwan. (47/200)

OBJECTS: With the advent of genetic technologies, many genetic/metabolic disorders can be detected asymptomatically but might be untreatable, and the benefits and risks of screening for them are not fully known. The purpose of this study is to explore current practice with regard to the parental consent process in newborn screening (NBS). DESIGN: Staff in 23 obstetric clinics/hospitals that conduct NBS in one city of southern Taiwan were interviewed. Using content analysis, 15 interview transcripts, eight completed questionnaires, and other relevant documents from the 23 clinics/hospitals were analysed to reveal the framework of the parental consent process in NBS in southern Taiwan. MAIN MEASURES: Three categories-informed consent, informed dissent, and no informed/consent-were developed to analyse the parental consent process in NBS. RESULTS: The parental consent procedures in NBS and the quality of the information provided before obtaining consent vary widely. Because the traditional NBS was incorporated into routine paediatric practices in most clinics/hospitals, the most frequently encountered consent model is "informed dissent" (60.9%) and "no informed/consent" (30.4%); while an "informed consent" model (45.5%) is the frequent model for screening rare metabolic/genetic disorders. CONCLUSIONS: Specific guidelines to regulate the parental consent process for NBS are essential. Further studies should investigate parental responses to NBS, taking these as the basis on which to establish an informed consent model in Taiwan.  (+info)

Jehovah's Witnesses in the emergency department: what are their rights? (48/200)

The Jehovah's Witnesses Society is best known to outsiders for its refusal of blood products, even when such a refusal may result in death. Since the introduction of the blood ban in 1945, Jehovah's Witness (JW) parents have fought for their rights to refuse blood on behalf of their children, based on religious beliefs and their right to raise children as they see fit. Adolescent JWs have also sought to refuse blood products based on their beliefs, regardless of the views of their parents. Adult JWs have fought to protect their autonomy when making both contemporaneous and advance treatment refusal. The refusal of blood products by JWs raises ethical and legal dilemmas that are not easily answered. Do an individual's rights (namely bodily control, right to privacy, right to decide about life/death issues, right to religious freedom) outweigh society's rights (namely the preservation of life, the prevention of suicide, the protection of innocent third parties, and the maintenance of the ethical integrity of the medical profession)? Does the right to choose outweigh the value of human life? For doctors, conflict occurs between the desire to respect patient autonomy and the need to provide good medical care. The Watchtower Society (the JW governing body) imposes a strict code of moral standards among its members, and it is unlikely that individual JWs are making truly autonomous decisions about blood transfusions. While young children and adolescents are protected by the courts and conscious adults are afforded autonomy, dilemmas still arise in the emergency situation. This article examines the rights of young children, adolescents, and adults, focusing in the latter half on adults in the emergency situation.  (+info)