Rationale for the use of passive consent in smoking prevention research: Politics, policy, and pragmatics

doi:10.1016/0091-7435(89)90074-1

Preventive Medicine

Volume 18, Issue 2, March 1989, Pages 267-279

https://doi.org/10.1016/0091-7435(89)90074-1 Get rights and content

Abstract

The empirical evaluation of school-based smoking prevention programs requires a broad sampling of subjects who are exposed to treatment or control conditions. The low base rate of ongoing smoking among young adolescents, the slow increase in smoking rates, and concerns about the representativeness of samples make it imperative that assessment of smoking and drug use include almost all students. Positive consent procedures outlined by regulations for the protection of human subjects (Department of Health and Human Services. Code of Federal Regulations, Part 46: Protection of Human Subjects. #45 CFR 46, 1983) require parental permission for minors to participate in a research project. However, those subjects who are at highest risk to smoke are least likely to have parental consent for such a project. Low participation rates and subject selection bias are serious threats to the external validity of studies that use a positive consent procedure. With passive consent, parents respond only if they wish to withhold consent; a nonresponse is interpreted as approval of their child's participation. The subject retains the right to consent or decline participation. Four criteria must be met to waive the requirement of positive parental consent. The passive consent procedure, as used in smoking prevention research, meets those criteria. Data are presented that support the use of this procedure. Research is recommended to examine how consent procedures can affect the results of prevention studies.

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Data were collected in the 2010–2011 school year. Schools that participated in the project surveyed the entire student body; Consistent with practices established in previous research (Severson & Biglan, 1989), passive consent procedures were used to obtain parental consent. Approval to conduct this research was obtained from the Institutional Review Board at a northeastern university.
Using data from 3305 students mistreated by peers two to three times per month or more often, we examined predictors of targets' telling adults at home and school about what happened. Grade, being in special education, having lower socioeconomic status, and physical and forms of social mistreatment were predictors of telling an adult at school. Grade, being in special education, race/ethnicity, experiencing some forms of social mistreatment and specific foci of mistreatment were related to telling an adult at home. We also report how helpful targets found 14 specific adult responses to be (things got better, things stayed the same, things got worse). The helpful responses from teachers most often leading to reports that things got better including showing concern and care for the targeted child.
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2011, Journal of Adolescent Health
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Questionnaires took approximately 45 minutes to complete; teachers were present to provide assistance with reading and technology. Consistent with practices established in previous research [18], passive consent procedures were used to obtain parental consent. Approval to conduct this research was obtained from the Institutional Review Board at a Northeastern University.
To develop effective prevention and intervention efforts that optimize adolescent health, factors must be identified that affect health outcomes. The purpose of this study was to examine the association between somatic symptomatology and experiences with relational victimization (RV).
We prospectively tested the unique role of relational peer victimization in predicting adolescents' somatic complaints (SC), while accounting for their previous physical symptoms and peer victimization experiences (i.e., relational and physical victimization), as well as concurrent experiences with physical victimization (PV). Questionnaires were administered to 1,595 students (52% females) from eight schools in one school district (grades, 5–8) in the Midwestern part of the United States during the fall and spring sessions of the academic school year. Self-reported measures included demographic characteristics, victimization experiences, and assessment of SC.
RV was a unique predictor of increased somatic symptoms, even after controlling for adolescents' sex, grade level, initial SC, previous victimization experiences, and concurrent experiences with PV. Notably, RV was a stronger predictor of somatic symptoms than was PV.
Our findings underscore the need for a comprehensive approach when addressing adolescents' physical health symptoms. Adolescents may benefit from clinicians looking beyond the obvious and using gentle probing to uncover how unique experiences with RV may be associated with overall health.
Parental consent in adolescent substance abuse treatment outcome studies
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It is impossible to know, however, whether the adolescents excluded for failure to return consents were drug users. Studies have shown that the manner in which parental consent is collected impacts both participation rates and demographic characteristics of samples, but findings are mixed with regard to whether different consenting procedures result in lower reports of drug use and other risk behaviors (Anderman et al., 1995; Eaton et al., 2004; Esbensen, Miller, Taylor, He, & Freng, 1999; Frissell et al., 2004; Henry, Smith, & Hopkins, 2002; Jason et al., 2001; Kearney, Hopkins, Mauss, & Weisheit, 1983; Severson & Biglan, 1989; Severson & Ary, 1983; White, Hill, & Effendi, 2004). For example, passive consenting procedures often yield adolescent participation rates around 90%, whereas studies requiring active parental consent usually have participation rates ranging from 30% to 60% (Frissell et al., 2004).
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The schools varied in size from 245 to 1436 students (with a mean of approximately 700). While the response rates varied by schools (37% to 65%), they were well within the range of 30% to 67% typically observed in drug-related school surveys requiring active parental consent (Esbensen et al., 1996; Jessor, Van Den Bos, Vanderryn, & Costa, 1995; Severson & Biglan, 1989). Despite three attempts to inform parents about the study, only about 60% of the parents from the target sample returned a signed consent form.
The task persistence construct has previously been measured primarily behaviorally (e.g., with a mirror-tracing task, or breath holding), and only in adults. It has been shown to differentiate between adult smokers and non-smokers and to predict smoking cessation in adult smokers trying to quit. This theory-based analysis is the first to examine task persistence in adolescent smokers and to examine a two-item, internally consistent, self-report measure of task persistence. Results indicate that task persistence is greater among adolescent non-smokers as compared to adolescent current smokers, and those planning to quit smoking as compared to those with no plans to quit. Contrary to hypotheses, task persistence was not found to be related to prior successful attempts to quit smoking. Our results suggest that a brief, self-report measure of task persistence may be a methodologically sound, practical clinical tool for this population.
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Because of ethical considerations it is often not possible to keep identified computerized health records of young people without obtaining guardian's consent (Moolchan and Mermelstein, 2002). Although rules may vary between countries, consent procedures are often long, complex and may lead to a substantial dropout from the study base, with consequent loss of efficiency (Severson and Biglan, 1989). However, if record linking would still be possible without the use of personal identifiers, the guardian's consent would in many cases not be mandatory.
To study the feasibility of an anonymous coding procedure linking longitudinal information in a multi-center trial of substance abuse prevention among adolescents.
A school-based survey with re-test procedure was conducted among 485 students (mean age 13.8 years) from three countries at four study centers in order to study accuracy and repeatability of a self-generated anonymous code.
Errors affected 18% of codes and 3% of all digits required for the code generation, with highest figures for two of the seven generation items. Sixty-one percent of the codes generated at the test were repeated identically at the re-test. Seventy-six percent of the codes could be linked excluding the 2 digits with the highest error rate in code generation, while 92% were linked using the best combination of the remaining seven or six digits. There was substantial variation between the centers in the results.
Self-generation of anonymous codes is a feasible, but not a very efficient procedure to link longitudinal data among adolescents. Easy derivation and iterative matching procedures are crucial for achieving high efficiency of this type of anonymous linkage.
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Rationale for the use of passive consent in smoking prevention research: Politics, policy, and pragmatics

Abstract

J. Amer. Acad. Child Psychiatry

Addict. Behav.

Prev. Med.

Children and consent to participate in research

Sample bias resulting from a requirement for written parental consent

Public Opinion Quart.

The Volunteer Subject

Three Theories of Informed Consent: Philosophical Foundations and Policy Considerations

Ethical and legal considerations in high risk studies of schizophrenia

Schizophrenia Bull.