The contributions of adolescent and parent perspectives to ethical planning of survey research on youth drug use and suicide behaviors are highlighted through an empirical examination of 322 7th-12th graders' and 160 parents' opinions on questions related to 4 ethical dimensions of survey research practice: evaluating research risks and benefits, establishing guardian permission requirements, developing confidentiality and disclosure policies, and using cash incentives for recruitment. Generational and ethnic variation in response to questionnaire items developed from discussions within adolescent and parent (...) focus groups are described. The article concludes with a discussion of the potential contributions and challenges of adolescent and parent perspectives for planning scientifically valid and ethically responsible youth risk survey research. (shrink)

Interventions to decrease acquisition and transmission of sexually transmitted diseases among African American women using text messages versus small-group delivery modalities pose distinct research risks and benefits. Determining the relative risk–benefit ratio of studies using these different modalities has relied on the expertise of investigators and their institutional review boards. In this study, African American women participated in focus groups and surveys to elicit and compare risks and benefits inherent in these two intervention delivery modalities, focusing on issues such as (...) convenience, privacy, and stigma of participation. Some risk/benefit variables were implicated in willingness to participate the two intervention modalities. (shrink)

This study explored perceived benefits and risks of participation in HIV research among 33 female sex workers in Tecún Umán, Guatemala. Stigma associated with sex work and HIV was a critical barrier to research participation. Key benefits of participation included access to HIV/sti prevention and testing, as well as positive and trusting relationships between sex workers and research teams. Control exerted by managers had mixed influences on perceived research risks and benefits. Results underscore the critical need for HIV investigators to (...) develop population-tailored procedures to reduce stigma; engage managers; and reinforce trusting, reciprocal relationships between sex work communities and researchers. (shrink)

Although there is clearly a need for evidenced‐based behavioral or biomedical prevention or treatment programs for suicide, substance abuse, and sexual health targeted to members of the LGBT population under the age of eighteen, few such programs exist, due in substantial part to limited research knowledge. Ambiguities in regulations that govern human subjects protections and the related inconsistencies in institutional review board (IRB) interpretations of regulatory language are the key reason for the lack of rigorous clinical trial evidence to support (...) treatment choices and prevention approaches to reducing health disparities for this population. Given the socially sensitive nature of suicide, substance abuse, and HIV and STI research in general and LGBT research specifically, in the absence of empirical data to guide their decisions, IRBs must often rely on subjective judgments of minimal risk, which can lead to overestimation of the magnitude and probability of psychological, social, and informational harms that might arise from LGBT youth participation in clinical trials. In addition, more than other youth, LGBT adolescents whose families are unaware of their sexual orientation or gender identity or whose families have victimized them on account of it may be reluctant to participate in studies that require guardian permission. This, in turn, intensifies problems of recruitment and unbiased sampling. However, many IRBs are reluctant to apply federal regulations permitting waiver of guardian permission under conditions in which such permission is clearly not “feasible” or “reasonable” to require. Consequently, many investigators have excluded LGBT individuals under eighteen years of age in health intervention research proposals because of anticipated or actual difficulties obtaining IRB approval. This situation is in conflict with current ethical discourse focusing on the right of youths to participate in trials that will protect them from receiving developmentally untested, inappropriate, and unsafe treatments. In this article, we describe these barriers and recommendations for providing LGBT youth safe and fair access to health research. (shrink)

This article describes challenges of conducting an HIV prevention program involving 40 male and female participants ages 12–18 in Hammanskraal, South Africa, aimed at increasing awareness and knowledge of laws protecting children’s sexual health rights and access to services through a culturally based “study circle” format. Challenges highlighted by the project included Institutional Review Board approval of youth consent procedures, cooperation and coordination with local policymakers, the need to modify presentation materials to youths’ comprehension levels, availability of youth-based sexual health (...) service providers, and cultural ambiguity over parental involvement in youth health care decisions and laws pertaining to sexual relationships among minors. (shrink)

As children and adolescents receive increased research attention, ethical issues related to obtaining informed consent for pediatric intervention research have come into greater focus. In this article, we conceptualize parent permission and child assent within a goodness-of-fit framework that encourages investigators to create consent procedures “fitted” to the research context, the child's cognitive and emotional maturity, and the family system. Drawing on relevant literature and a hypothetical case example, we highlight four factors investigators may consider when constructing consent procedures that (...) best reflect participants' rights, concerns, and well-being: (a) the child's current assent capacity and the likely impact of study information on the child's mental and physical development, (b) parents' understanding of their child's treatment needs and distinctions between treatment and clinical trials research, (c) the family's history of shared decision making, and (d) the child's strivings for autonomy within the context of their parents' duty to make decisions in the child's best interest. (shrink)

This study sought to assess barriers and enhance readiness to consent to home and Planned Parenthood HIV testing among 60 out-patients from a mental health and substance abuse clinic in rural Appalachia. Testing barriers included not knowing where to get tested, lack of confidentiality, and loss of partners if one tested sero-positive. The intervention yielded lowered HIV stigma, increase in HIV knowledge, and agreement to take the HIV home test. These results are encouraging because they suggest that a brief educational (...) intervention is a critical pathway to the success of the National Institutes on Drug Abuse’s Seek, Test, Treat, and Retain initiative in poor rural counties. (shrink)

Drawing on a conception of scientists and community members as partners in the construction of ethically responsible research practices, this article urges investigators to seek the perspectives of teenagers and parents in evaluating the personal and political costs and benefits of research on adolescent risk behaviors. Content analysis of focus group discussions involving over 100 parents and teenagers from diverse ethnic and socioeconomic backgrounds revealed community opinions regarding the scientific merit, social value, racial bias, and participant and group harms and (...) benefits associated with surveys, informant reports, intervention studies, blood sampling, and genetic research on youth problems. Participant comments highlight new directions for socially responsible research. (shrink)

Young men who have sex with men younger than 18 years are often excluded from HIV prevention research in Thailand due to cultural attitudes toward youth sexuality, social stigma, and difficulties obtaining guardian permission. Culturally sensitive focus group discussions conducted with parents and YMSM in Bangkok, Thailand, identified barriers and facilitators related to minors’ participation in HIV prevention research. Although gender and class differences emerged, mothers and fathers were generally accepting of research to reduce HIV risk but not in favor (...) of waiver. Youth’s positive attitude toward parental permission was tempered by concerns about harms posed by disclosing same-sex attraction through permission forms. (shrink)

This study examined female sex workers’ evaluation of ethically relevant experiences of participating in an HPV4 vaccine clinical trial conducted in Lima, Peru. The Sunflower Study provided all participants with HPV testing, treatment for those testing positive, and access to the vaccine for all testing negative. Themes that emerged from content analysis of interviews with 16 former participants included the importance of respectful treatment and access to healthcare not otherwise available and concerns about privacy protections, the potential for HIV stigma, (...) and poststudy abandonment. (shrink)