Physicians' understanding of consent requirements for phase I clinical trials in cognitively impaired or highly vulnerable populations

We investigated physicians' attitudes about entering patients who cannot give informed consent or who are of a vulnerable population into clinical trials. A survey instrument asked a nationwide sample of practicing physicians about whether ten hypothetical patients could be enrolled in a phase I clinical trials. The impact of demographic variables on the number of scenarios viewed as completely or somewhat acceptable was analyzed via student's T tests or analysis of variance (ANOVA) as applicable. All significant (p<0.01) variables were entered into a multiple logistic regression model. Eighty-four percent of respondents indicated that at least one case scenario was acceptable. A majority of those who conduct clinical trials (62%), who had training in the ethics of clinical research (78%), and who sit on institutional review boards (IRBs) (83%) approved of at least one case scenario. Physicians approved of the entry of some patients who cannot give informed consent or who are of a vulnerable population into clinical trials. More effective education on the guidelines involving clinical research should be available to practicing physicians, residents, and medical students. There should also be assurance that physicians who conduct clinical trials or who sit on IRBs have the requisite knowledge about the ethics of clinical research.     

American women and the lingering implications of coverture

Because coverture restrictions prevented most married American women from the colonial period through a good part of the 19th century from acting as their own agents at law or to have independent property rights, attempts were made to modify this legal disability. Married Women Property Acts partially remedied some of these legal disabilities, but others lingered well into the 20th century because, unlike most contracts, the marriage contract in the United States still remains unwritten and so, its terms are not defined. Even with the advent of contractual marriages in the 1970s and 1980s, coverture overtones continue to exist. While some state courts have accepted these contractual arrangements, others have not and their enforcement remains problematic “because the law still prescribes sex-differentiated marital roles and male domination.”     

Birth control socialization: How to avoid discussing the subject

Observational data from parents-adolescent son or daughter triads' discussions concerning birth control reveal the strategies used by both generations to avoid the transmission of information. Questionnaire data from all members of the triads provide additional confirming evidence that neither parents nor adolescents engage easily in birth control socialization.     

The role of attachments in female adolescent development

Traditional theories of normal adolescent development have incorrectly underscored the importance of the individuation as the psychological goal. This paper will discuss how adolescent girls use their relationships to clarify their identity and differentiate themselves from their families of origin. Girls use friends, as journals, to achieve self differentiation in the context of their relationships. The clinical implications of this newer model, with its emphasis on attachments rather than on separation, will be considered, and group therapy recommended as the treatment of choice for adolescent girls.She is also in private practice in individual and group therapy.     

Representing the Mental World in Children's Social Behavior: Playing Hide-and-Seek and Keeping a Secret

This study examined the relationship between children's developing theory of mind and their ability to engage in two social behaviors which have, as their cognitive underpinning, the representation that what one knows may not be accessible to others. Children of 3, 4, and 5 years, in a quasi‐naturalistic setting, played hide‐and‐seek and also were required to keep a secret about a surprise. The ability to play hide‐and‐seek was significantly related to children's ability to refrain from disclosing the secret, and there was a significant relationship between these behaviors and children's social cognition, as measured by theory of mind tasks. The relationship between these social behaviors and tasks measuring executive function was not significant once age was taken into account. With regard to the development of these social behaviors, few 3‐year‐olds, but most 4‐year‐olds, and almost all 5‐year‐olds could successfully play hide‐and‐seek and keep a secret. This study demonstrates the importance of the conceptual understanding of mental states in the young child's social world.     

Preparation for residential treatment: An anticipatory mourning process

This paper discusses the intense emotional bonding between parent and adolescent as it interferes with the adolescent and family's ability to tolerate the physical separation inherent in long-term residential treatment. It describes the mourning process through which both adolescent and parent experience and partially relinquish their attachment to one another in anticipation of the separation. The process is completed when both parent and child accept the need for placement and are ready to accept the possibility of new relationships in the residential treatment setting.