In an earlier Dissecting Bioethics contribution, Debra J. H. Mathews, Joseph J. Fins, and Eric Racine challenge standard ways of thinking about the therapeutic misconception in the context of consent for research participation. They propose that instead of demanding “rational congruence” between how researchers and participants conceive of a given protocol, we should accept a less stringent standard of “reasonable coherence.” While Mathews, Fins, and Racine (MFR) provide some important insights, their proposal needs refinement. There is room for a wide (...) but not unlimited range of participant hopes and motivations. However, their model of reasonable coherence is too weak a standard for whether participants have adequate understanding of the scientific goals of a protocol. By the time participants are recruited for medical research, the goals of the protocol, having been set and agreed to through accepted scientific processes, are no longer open for alternate interpretations. This paper discusses this and other objections to MFR’s proposal. It then suggests that a concept of “deal breakers” might be useful in this context. (shrink)

CABLES is both an acronym and metaphor for conceptualizing research participation risk by considering 6 distinct domains in which risks of harm to research participants may exist: cognitive, affective, biological, legal, economic, and social/cultural. These domains are described and illustrated, along with suggestions for minimizing or eliminating the potential hazards to human participants in biomedical and behavioral science research. Adoption of a thoughtful ethical analysis addressing all 6 CABLES strands in designing research provides a strong protective step toward safeguarding and (...) promoting the well-being of study participants. (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)

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)

This commentary draws on the thoughtful contemplation and innovative procedures described in the special section articles as well as current professional codes and federal regulations to highlight ethical practices and paradoxes of deception research involving children. The discussion is organized around 4 key decision points for the conduct of responsible deception research involving children: (a) evaluating the scientific validity and social value of deception research within the context of alternative methodologies, (b) avoiding and minimizing experimental risk, (c) the use of (...) child assent procedures as questionable ethical safeguards, and (d) debriefing as both remedy and risk. (shrink)

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)

This paper provides an introduction to ethical issues arising in children's research that takes place in school-settings. It addresses three main areas of ethical concern: the informed consent process, confidentiality, and harm and benefit. Informed consent in school settings is characterized by the involvement of multiple stakeholders, including not just researchers, parents and individual children but also school principals, teachers and the children's peer group. The added complexity of the setting has implications for the management of the informed consent process, (...) including the decision at what point and in which manner each stakeholder group needs to be involved in the process. The presence and divergent roles of these multiple stakeholders in the school setting also have implications for addressing issues of confidentiality, especially due to the group setting in which participants take part in the research and role expectations within school settings. Harm and benefit in school-based research are of a non-physical nature; relevant areas of concern relate primarily to the potential for psychological and social harm, realistic presentation of likely benefits from research and the issue of rewards for research participation. (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)

Schizophrenia affects more than 1% of the world's population, causing great personal suffering and socioeconomic burden. These costs associated with schizophrenia necessitate inquiry into the causes and treatment of the illness but generate ethical challenges related to the specific nature and deficits of the illness itself. In this article, we present a systematic analysis of narrative data from 63 people living with the illness of schizophrenia collected through semistructured interviews about their attitudes, beliefs, and experiences related to psychiatric research. In (...) the comments of these individuals, half of whom had had prior personal experience in research protocols, we identified factors influencing openness toward research involvement as well as deterrents that appear to lessen interest in participation. Clear response pattern differences emerged between those with prior research experience and those without such experience. In the discussion, we explore these key findings and outline the implications for safeguards in mental illness research. (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)

This chapter addresses ethical issues for informed consent when recruiting autistic participants for research. The process of informed consent for participation in research involves some abilities, such as dialogue and understanding the intentions of the researchers, that can be especially challenging when autistic individuals are being asked to participate. This chapter reviews these abilities, and suggests ways to provide meaningful support to promote autonomy and help researchers meet their responsibilities. Beyond these more general challenges, it explores Hans Jonas’s suggestion that (...) true informed consent for research requires that participants identify with the goals of the researchers. Given the plurality of perspectives on how to respond to autism, Jonas’s ideas point to additional ethical concerns that can arise when autistic people are recruited for research on autism. (shrink)