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)

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 presents data from the Growing up with Media study related to the implementation of a risk reduction protocol that resulted in three groups of youth: low-risk youth (no flags), youth flagged because of violence involvement and not clinically referred; and flagged youth who were referred to a team clinician due to additional risk considerations. Data are from 3,979 US youth 14–15 years of age recruited through social media between October 2018-August 2019. Four in ten youth were flagged for (...) review. Findings suggest that this methodology of identifying and reviewing cases appears to be working as intended: Not only did referred youth have more flags than non-referred youth, but post-hoc analyses suggested that these youth also had higher rates of psychosocial problems (e.g., non-victimization adversity, substance use, and depressed mood). The implementation of a risk reduction protocol such as the one described in this article adds a layer of human subject protection beyond the more standard list of websites and hotlines provided to all participants in most studies. This protocol leads the way for future studies to recreate a similar process to address concerning responses collected from survey research. (shrink)

The HIV/aids pandemic has brought global attention to the ethical challenges of conducting research involving socially vulnerable participants. Such challenges require not only ethical deliberation but also an empirical evidentiary basis for research ethics policies and practices. This need has been addressed through the Fordham University HIV and Drug Abuse Prevention Research Ethics Institute, a National Institute on Drug Abuse–funded program that trains and funds early career scientists in conducting research on HIV/drug abuse research ethics. This article describes the ethical (...) framework guiding Institute training and introduces readers to six empirical articles in this special issue that illuminate and help foster the responsible conduct of research. (shrink)

To inform ethical procedures for human subjects research using mobile health, we examined perceived risks and benefits of study participation among emerging adults with drug use who completed text message assessments of substance use and sexual behaviors. Most participants reported comfort with participation and some reported perceived benefits, such as improved relationships. Perceived risks were infrequently reported, including negative emotions and legal or financial concerns. In conclusion, participants from a vulnerable population reported few perceived harms of participation in longitudinal mHealth (...) assessments of sensitive behaviors. Researchers should continue characterizing participants’ perspectives on ethical aspects of mHealth 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)