What's so important about conducting research involving third parties?

Controversy has arisen over the long-standing practice of collecting family health and behavioral history information in the course of conducting biomedical research. Identifiable individuals (third parties) on whom investigators collect private data through primary research subjects (probands) also are considered research subjects. At issue is whether informed consent is required from third parties prior to obtaining information about them from probands. A recent federal regulatory ruling dictates that investigators must either obtain informed consent from all third parties or their research must qualify for a waiver of consent. Because of the ruling, a traditional family medical history questionnaire, typical of those routinely used in genetic epidemiologic studies of familial risk, failed to meet the criteria for the waiver. The implications of this ruling are far-reaching. They could influence the quality of research in the United States on the causes of most human diseases. To enable continuing medical and bioethical education on the topic, in March 2001, Virginia Commonwealth University hosted a 2-day open conference, "Third Party Rights and Risks: A Forum on Informed Consent from Persons Affected by the Study of Human Subjects." International leaders from the fields of biomedical ethics and law convened with federal regulatory officials, Institutional Review Board members, academic and industry scientists, and patient-family rights advocates to discuss and debate this critical topic. Conference presenters submitted papers to clarify the issues, promote continued debate, and assist in the formulation of policy recommendations regarding third-party rights and risks.

Adolescent religiousness and its influence on substance use: preliminary findings from the Mid-Atlantic School Age Twin Study.

Research has consistently shown that religiousness is associated with lower levels of alcohol and drug use, but little is known about the nature of adolescent religiousness or the mechanisms through which it influences problem behavior in this age group. This paper presents preliminary results from the Mid-Atlantic School Age Twin Study, a prospective, population-based study of 6-18-year-old twins and their mothers. Factor analysis of a scale developed to characterize adolescent religiousness, the Religious Attitudes and Practices Inventory (RAPI), revealed three factors: theism, religious/spiritual practices, and peer religiousness. Twin correlations and univariate behavior-genetic models for these factors and a measure of belief that drug use is sinful reveal in 357 twin pairs that common environmental factors significantly influence these traits, but a minor influence of genetic factors could not be discounted. Correlations between the multiple factors of adolescent religiousness and substance use, comorbid problem behavior, mood disorders, and selected risk factors for substance involvement are also presented. Structural equation modeling illustrates that specific religious beliefs about the sinfulness of drugs and level of peer religiousness mediate the relationship between theistic beliefs and religious/spiritual practices on substance use. Limitations and future analyses are discussed.

Tobacco, alcohol and drug use in eight- to sixteen-year-old twins: the Virginia Twin Study of Adolescent Behavioral Development.

OBJECTIVE: This study reports prevalences of lifetime and current alcohol, tobacco and drug use in adolescents; examines associations between substance use and a number of putative risk factors; and estimates the contribution of genetic, shared and unique environmental influences on substance use. METHOD: Substance use data were collected using the Child and Adolescent Psychiatric Assessment on a population sample of 1,412 male and female monozygotic and dizygotic twin pairs, aged 8 through 16, from the Virginia Twin Study of Adolescent Behavioral Development. RESULTS: Heritabilities were estimated to be 84% and 82% for liability to lifetime and current tobacco use, respectively. For alcohol use the role of genes and environment varied according to the context of reporting. Liability to lifetime alcohol use was estimated to be under environmental control, with 71% of the variation shared by members of a twin pair and 29% unique to individual twins. Lifetime alcohol use without the permission of a parent or guardian and current use of alcohol were predominantly explained by genetic factors (h2 = 72% and 74%). The role of genetic factors increased and that of unique environmental factors decreased with increasing severity of alcohol use. Lifetime use of any drug showed a heritability of 45%, with the shared environment accounting for 47% of the variation. Shared environmental factors explained most of the variation in marijuana use. CONCLUSIONS: Genetic factors explained a significant proportion of the variation in the use of tobacco, alcohol and other drugs. Shared environmental factors contributed significantly to lifetime alcohol use and other drug use.

The influence of genetic factors and life stress on depression among adolescent girls.

BACKGROUND: The possible causes of greater depression among adolescent girls were investigated by examining variation in the influence of genetic and environmental risk factors among 182 prepubertal female, 237 prepubertal male, 314 pubertal female, and 171 pubertal male twin pairs from the Virginia Twin Study of Adolescent Behavioral Development. OBJECTIVES: To compare the trajectory of depressive symptoms among boys and girls from childhood to adolescence; to analyze the role of genetic, shared, and unique environmental factors in depression among prepubertal and pubertal male and female twins; and to investigate a possible link between liability to depression and one salient index of the child's environment: past-year life events. METHODS: Child-reported depression was assessed using the Child and Adolescent Psychiatric Interview and ratings of past-year life events and pubertal status obtained by maternal questionnaire and interview, respectively. RESULTS: The impact of life events on depression was particularly evident in the adolescent girls. The results from model fitting indicate increased heritability for depression in this group, and its long-term consistency was mediated primarily by latent genetic factors. Model fitting also showed that at least part of the liability to depression and to life events can be linked to a common set of genes in the adolescent girls, and there is a notable developmental increase in the genetic variance for life events. CONCLUSIONS: The greater heritability for depression in pubertal girls, its genetic mediation over time, and the increase in genetic variance for life events may be one possible explanation for the emergence of increased depression among pubertal girls and its persistence through adolescence.

Understanding biological and social influences on religious affiliation, attitudes, and behaviors: a behavior genetic perspective.

Although the transmission of religiousness has been assumed to be purely cultural, behavior genetic studies have demonstrated that genetic factors play a role in the individual differences in some religious traits. This article reviews the extant behavior genetic literature and presents new analyses from the "Virginia 30,000" on the causes of variation in religious affiliation, attitudes, and practices, and relates these to personality as construed by Eysenck. Results indicate that religious affiliation is primarily a culturally transmitted phenomenon, whereas religious attitudes and practices are moderately influenced by genetic factors. Further, Eysenck's personality traits do not mediate genetic influences on religiousness, but significant negative genetic correlations are found between church attendance and liberal sexual attitudes. Implications and possibilities for future studies are discussed.

[The use of brief questionnaire in the diagnosis of attention deficit. Study group of the Manizales University Foundation]. / Uso de un cuestionario breve para el diagnóstico de deficiencia atencional. Grupo de Investigación de la Fundación Universidad de Manizales.

INTRODUCTION: American Psychiatric Association has defined the DSM-IV ADD diagnostic criteria and symptoms, however, there is not a quantitative instrument to evaluate them in Spanish speaker population. OBJECTIVE: To evaluate the utility of a ADD checklist in a Colombian schooling population. PATIENTS AND METHODS: A randomized and stratified by sex, age and socioeconomic level, 4 to 17-year old, sample of 540 schooling subjects was selected from Manizales City, Colombia. An ADD checklist was applied to the parents of these subjects. RESULTS: The reliability of the different dimensions of the questionnaire (18 total items, 9 items for inattention, 9 for hyperactivity-impulsivity, and 6 for hyperactivity) were strong in both sex and in all age groups (Cronbach's alpha coefficient 0.71-0.92). Only the impulsivity dimension formed by three variables showed fairly weak reliability (0.42-0.79 Cronbach's alpha). Some factorial analysis found two dimensions. In the male sample first dimension (inattention) explain around the 45% of the variance, and the second dimension (hyperactivity-impulsivity) explain around the 12 to 15% of the variance in the different age groups. In the female sample the first dimension was hyperactivity-impulsivity and the second dimension was inattention. A categorical (yes or not) scored questionnaire found a ADD estimated prevalence of 16.1, distributed in type I (combined) 3.3%, in type II (inattentive) 4.3%, and type III (hyperactive-impulsive) 8.5%. Male prevalence was 19.8% and female 12.4%. CONCLUSIONS: ADD checklist Spanish version showed a strong reliability. A bidimensional stable structured was found. A clinical related ADD prevalence was presented, it was much higher than the prevalence of the developed countries.

Substance abuse and associated psychosocial problems among Argentina adolescents: sex heterogeneity and familial transmission.

OBJECTIVE: The goal of this investigation was to clarify the effects of sex and familial transmission in the psychosocial concomitants of substance abuse problems among adolescents. METHOD: Male (n = 956) and female (n = 303) adolescents in school, and male adolescents in a drug treatment program (n = 51) in Buenos Aires Province, Argentina were administered a translated version of the Drug Use Screening Inventory. Use of substances, familial substance abuse and associations between psychosocial problem domains and substance abuse problems were examined. RESULTS: Sex heterogeneity was broadly observed in terms of both substance abuse and psychosocial problems. Female adolescents in the school-based sample were found to generally report higher levels of psychosocial problems and greater use of minor tranquillizers than school boys or boys in treatment for substance abuse. Conduct deviancy was associated with substance abuse problems only in males, while health problems were associated only in females. However, among all youth, substance abuse problems were found to be associated with older age, greater social competency, problems in school performance, and involvement with deviant peers. Familial substance abuse was associated with substance abuse problems among all adolescents, however, the pattern of associations with other psychosocial problems differed between males and females. CONCLUSIONS: Sex heterogeneity was found in the associations between psychosocial problems, adolescent substance abuse, and familial substance abuse. Furthermore, the results are consistent with a syndrome of problem behaviors.

Familial and nonfamilial factors in the prediction of disruptive behaviors in boys at risk for substance abuse.

This study aims to identify (1) a core disruptive behavior disorder (DBD) postulated to presage a substance use disorder, and (2) the relative importance of parental DBD phenotypes, and familial and nonfamilial environmental factors in the determination of DBD in male children. DBD symptom counts and measures of familial and nonfamilial environmentals were collected from intact families ascertained through the presence (SA+) or absence (SA-) of substance dependence in fathers. Multivariate analyses revealed that both behavioral symptoms and environmental measures were significant discriminators of the families. In SA+ families, the child's score DBD was best predicted by magnitudes of parental dyssocial behaviors and by familial environmental factors. However, in SA- families only familial environmental factors were significant predictors of the child's DBD. These findings suggest that in addition to independent actions of familial transmissible and nonfamilial factors, strong genotype-environment interactions may determine DBD in children and that may contribute to the liability for a substance use disorder.

Saccharin intake predicts ethanol intake in genetically heterogeneous rats as well as different rat strains.

Saccharin and ethanol intakes were measured in seven strains of rats known to differ in their preferences for ethanol: The Fawn-Hooded (FH), alcohol-preferring (P) and Maudsley Reactive rats have been reported to drink ethanol voluntarily, whereas the alcohol-nonpreferring, Maudsley Nonreactive and Flinders Line (FSL and FRL) rats do not. Saccharin and ethanol intakes were highly correlated (r = +0.61) over all strains, with the FH rats drinking the most of both solutions. Correlation coefficients between pairs of drinking versus nondrinking rat strains were even higher. In a second experiment, genetically heterogeneous F2 progeny from cross-breeding the ethanol-preferring FH rats with the ethanol-nonpreferring Flinders Resistant Line (FRL) rats were studied. The results indicated a high positive correlation between saccharin and ethanol intakes (+0.65). These findings suggest that the association between saccharin and ethanol intakes previously reported in rat strains with different preferences for ethanol may have a similar genetic basis.

Computerized mental health risk appraisal for college students: user acceptability and correlation with standard pencil-and-paper questionnaires.

Due to an interaction of age, birth cohort, genetics, and the lifestyle factors inherent in the "college experience," some college students are at increased risk for mental health problems such as alcohol, tobacco, and other drug abuse; depression; stress and anxiety; and eating disorders. A program to promote self-monitoring of students' health behaviors could prove beneficial to their future well-being and potentially reduce overall medical costs for this group. Computerized mental health risk appraisals, if valid, reliable, and acceptable to students and administrators, could facilitate implementation and minimize the costs of such a program. This pilot study was designed to determine whether a confidential computer-based risk appraisal is a valid and acceptable measure of current mental health status in a university student sample. Two basic questions were addressed. First, do computerized questionnaires yield results similar to their pencil-and-paper counterparts? Second, how do students rate and compare the two formats?

Consumption of dependence-producing substances in Colombia.

A survey examining the use of six dependence-producing substances (alcohol, tobacco, tranquilizers, marijuana, coca paste or "basuca," and cocaine) was conducted in Colombia in 1987. The survey population consisted of 2,800 urban residents in four cities (Barranquilla, Bogotá, Cali, and Medellín) between the ages of 12 and 64. The results indicated that substantially more men than women were using all the substances involved except tranquilizers, that high proportions of study subjects used alcohol and tobacco, that 8.1% of the study subjects could be considered alcoholics, and that another 7.3% were at risk of becoming alcoholics. User prevalences of the three illegal substances (marijuana, basuca, and cocaine) were much lower, and the prevalence of marijuana users exceeded that of the other two drugs combined. However, 1% of the male study subjects reported using basuca within the past year. The high prevalence of basuca use has important public health implications, because the drug typically does great harm to its users within a short period of time.

[Consumption of dependency-producing substances in Colombia]. / Consumo de sustancias que producen dependencia en Colombia.

In 1987 a study was made of the consumption of dependency-producing substances in the urban population of Colombia. For this purpose the prevalence survey method was applied to a representative sample of 2,800 individuals between the ages of 12 and 64. The descriptive analysis was supplemented by the exploration of causal associations and measurement of the strength of such associations by means of the prevalence ratio coupled with calculation of the degree of statistical significance. The study included three substances whose consumption is socially accepted--alcohol, tobacco, and tranquilizers--and another three considered to be illicit--basuco (coca-paste), cocaine, and marijuana. Alcohol and tobacco were the two drugs most used by both sexes (560 and 297 per 1,000 subjects studied, respectively). Tranquilizers, the only one of the drugs in the study that was used more by women, ranked third (60 per 1,000). Reported in much smaller proportions were marijuana (11 per 1,000), basuco (6 per 1,000), and cocaine (3 per 1,000). It may be noted that the consumption of basuco has recently reached a level double that of cocaine. Analysis of the use and abuse of these substances by age, marital status, socioeconomic situation, and other variables indicates that the prevalence of consumption is higher in the medium age groups, that unmarried persons are at excess risk compared with those who are married, that men from the upper classes tend to use cocaine and marijuana, and that both sexes in the lower classes use basuco as the drug of preference. Differences in suicide rates between users and nonusers were statistically significant in the population aged 15 to 54, and it was determined that the substances of greatest risk, generally for women, were basuco and marijuana.