Physician duties in the conduct of human subject research

In this article, I examine a skeptical argument against the possibility of ethically justifying risky human subject research (rHSR). That argument asserts that such research is unethical because it holds the possibility of wronging subjects who are harmed and whose consent to participate was less than fully voluntary. I conclude that the skeptical argument is not in the end sufficient to undermine the ethical foundation of rHSR because it fails to take account of the special positive duty researchers owe their clients and future patients. Although the skeptical argument is defeated, it exacts certain novel concessions from the pro‐research position. Of particular importance are the admissions (a) that researchers presumptively owe a fiduciary duty to research subjects, (b) that because the most important risks of rHSR are unknown and unquantifiable that duty must be explicitly waived by all subjects before they participate in any protocol, and (c) that such waivers must be made by individuals who satisfy objective criteria of competence for giving fully voluntary consent. The implementation of procedures responsive to these concerns might have a dampening effect on the conduct of research. However, the article concludes with a consideration of the likely benefits to researchers and society of a more cautious ethical regime.     

Ethical Beliefs of Social Work Researchers

Abstract

The purpose of this study is to examine the beliefs of social work researchers about ethical practices. Surveys were mailed to a random sample of 240 members of the Society for Social Work and Research (SSWR) to elicit their views about ethical practices in social work research. Responses from 160 members (67% response rate) yielded information regarding the appropriateness of dual relationships, authorship practices, informed consent procedures, and other conduct in social work research. Age, gender, educational level, years of social work research experience, and current teaching of social work research were related to respondents' ethical views about practices with students and sexual relationships with research subjects. The need for additional resources on ethics in social work research is highlighted.     

Ethical Challenges in International HIV Prevention Research

Members of an HIV-prevention research network were asked to describe ethical challenges faced in their work. Major themes included acceptable standards of care for participants, defining research of relevance to host countries, reducing risks related to stigma, designing research that meets local needs without contributing to an inadequate status quo, and ensuring informed consent for complex research with potentially vulnerable participants. The challenges are interrelated and highlight the need for innovative, practical strategies to be incorporated into the planning, design, and conduct of HIV prevention trials. Research in applied ethics to support decision-making about HIV prevention research is needed, along with ethics training, mechanisms to support community-wide benefit from research, and expanded dialog on the ethics surrounding HIV prevention and public health research.     

Queer Youth Space: A Protective Factor for Sexual Minority Youth

Physical, psychological, and social vulnerabilities of sexual minority youth are well documented. Yet factors that protect this population from these risks remain relatively unknown. Previous researchers suggest that (1) a sense of safety, meaningful relationships with others, and positive identity development are protective and (2) social support programs focusing on sexual minority youth (Queer Youth Space) have a positive impact. In this article, Queer Youth Space is explored as a program that may promote protective factors and mediate risks. Theories of attachment, self psychology, and social identity are applied to conceptualize Queer Youth Space and its protective roles. Implications for social work practice and research are discussed.     

Physician duties in the conduct of human subject research

In this article, I examine a skeptical argument against the possibility of ethically justifying risky human subject research (rHSR). That argument asserts that such research is unethical because it holds the possibility of wronging subjects who are harmed and whose consent to participate was less than fully voluntary. I conclude that the skeptical argument is not in the end sufficient to undermine the ethical foundation of rHSR because it fails to take account of the special positive duty researchers owe their clients and future patients. Although the skeptical argument is defeated, it exacts certain novel concessions from the pro-research position. Of particular importance are the admissions (a) that researchers presumptively owe a fiduciary duty to research subjects, (b) that because the most important risks of rHSR are unknown and unquantifiable that duty must be explicitly waived by all subjects before they participate in any protocol, and (c) that such waivers must be made by individuals who satisfy objective criteria of competence for giving fully voluntary consent. The implementation of procedures responsive to these concerns might have a dampening effect on the conduct of research. However, the article concludes with a consideration of the likely benefits to researchers and society of a more cautious ethical regime.     

Promoting Self-Efficacy and Self-Esteem for Multiethnic Sexual Minority Youth: An Evidence-Informed Intervention

ABSTRACT

Sexual minority youth face multiple challenges, yet research regarding evidence-informed practice strategies for this population is limited. This study describes the pilot efforts of Strengths First, the first strengths-based intervention created specifically to promote self-esteem and self-efficacy among multiethnic sexual minority youth. A pretest–posttest design was used to gather preliminary data from program participants (n = 162) about the potential effectiveness of the program during a 2-year period that ranged from the inception of the program in June 2008 to September 2010. Significant increases in self-esteem and self-efficacy were found. Implications for social service research and practice are discussed.     

Gender‐Sensitive Research in a Chinese Community

The aim of this article is to foster an awareness of the need for gender‐sensitive research in the context of the methodological and ethical challenges posed by such research. We trace the development of gender sensitivity and masculinity in social work practice and research and connect this to an overview of the issues posed by research on sensitive topics. Reflecting on a research project involving Chinese male sexual abuse survivors, we draw conclusions illustrating and proposing a range of methodological practices and ethical safeguards. We underscore the importance of gender‐sensitivity in performing research on sensitive topics with men in a Chinese community.     

A Leadership Training Group for at Risk Fifth & Seventh Graders: Results from A Brief Strength-Based Group Program

ABSTRACT

An increasing number of youth are exhibiting social, emotional, and behavioral problems that hinder their ability to function at grade level. Subsequently, school mental health services have not been able to address the need for services particularly among students who are minority and poor. A mixed methodology study was conducted to determine the treatment outcomes from a brief strength-based leadership training group for primarily students who are African American and poor. Pre–post scores on three scales and focus group data revealed significant positive changes in regard to internal areas of functioning and social skills, anger management skills, and school attitude. Gender and age significantly impacted outcomes.     

Youth Experiences Survey (YES): Exploring the Scope and Complexity of Sex Trafficking in a Sample of Youth Experiencing Homelessness

ABSTRACT

In the United States, sex trafficking victims have been identified at ages across the lifespan but young persons (under age 25) have been found to have unique vulnerabilities. At-risk youth, such as those who run away from home or those experiencing homelessness, are also at an increased risk of sexual exploitation. To better understand the scope and complexity of sex trafficking among these at-risk youth, a convenience sample of 131 homeless youth aged 12 to 25 years old experiencing homelessness recruited from Kentuckiana youth service providers completed an enhanced version of the Youth Experiences Survey (YES). Univariate and bivariate analyses were conducted. Results indicated that 41.2% of the homeless youth were victims of sex trafficking. The sex trafficked youth were more likely to report previous self-harm behaviors, suicide attempts, and substance use. This study not only provides support for improved service delivery, but also provides essential statistics that should inform internal policy and procedures for youth serving agencies in Kentucky and Indiana. Findings highlight a need for trauma-informed interventions designed to treat not only females but also males and LGBTQ youth. Additionally, service providers should consider partnering with victim providers and clinicians to offer therapeutic groups, individual therapy, and supportive services that increase prevention, education, and wraparound care for clients. In regards to future research, findings point towards a need to better understand the role that trauma and adverse childhood experiences may play in making young people vulnerable to sex trafficking, and encourage the need for testing prevention and early intervention practices among vulnerable youth.     

Accessing a hard to reach population: reflections on research with young carers in Ireland

In keeping with developments in children's rights, research is increasingly including the views of children. Accessing a hard to reach population of children can, however, raise significant ethical and methodological challenges for researchers. Negotiating access through gatekeepers, securing parental consent and limits on confidentiality are central issues in the recruitment process of children. This paper is based on a qualitative study of young carers in the Irish population. It outlines the methodological approaches employed to access a representative sample of young carers and the measures taken to fulfil ethical obligations. In the recruitment phase of the study, researchers attempted to strike a balance between two sometimes competing requirements, the need to protect children from harm and to respect children's competence. This paper reflects on the success and limitations of the approaches adopted towards achieving this balance, exploring the use of gatekeepers as a method to identify and recruit a hidden population, and revisiting the measures taken to comply with the ethical requirements of parental consent and limits on confidentiality.     

An Ecological Systems Comparison Between Homeless Sexual Minority Youths and Homeless Heterosexual Youths

ABSTRACT

This study examined risk and protective outcomes by comparing homeless sexual minority youths to heterosexual homeless youths regarding family, peer behaviors, school, mental health, stigma, discrimination, substance use, and sexual risk behaviors. Structured interviews (N = 147) were conducted with individuals aged 16 to 24 years old in Toronto. Bivariate analyses indicated statistically significant differences between homeless sexual minorities (n = 66) and their heterosexual counterparts (n = 81) regarding all variables: family, peer behaviors, stigma, discrimination, mental health, substance use, and sexual risk behaviors, with the exception of school belonging. Implications for future research are suggested.     

Sexual Health Services for Homeless Youth: A Qualitative Analysis of their Experiences

The sexual health problems experienced by homeless youth bring into question their use of available sexual health services. Using a qualitative typological analysis, this study aims to identify sexual health services utilization profiles for homeless youth, and to understand the role of the homeless experience on the utilization of sexual health services. Individual interviews were conducted with 33 homeless youth (17 men, 16 women) between 18 and 25?years of age. Typological analysis identified four profiles: (1) a targeted use of sexual health services to determine one’s serological status following a relational change during the homeless experience; (2) a limited use of sexual health services to manage sexual emergencies that arise during the homeless experience; (3) a regular use of sexual health services to avoid the risks associated with the homeless experience; (4) a frequent use of sexual health services to obtain support when engaging in prostitution during the homeless experience. This study shows that the precarious and unstable conditions within the homeless experience incite youth to utilize sexual health services in different ways. These findings point to the importance of rethinking sexual health services to better adapt them to the different utilization profiles of homeless youth.     

Student School Engagement Among Sexual Minority Students: Understanding the Contributors to Predicting Academic Outcomes

ABSTRACT

Hierarchical multiple regression is used to examine whether student school engagement predicts grade point average (GPA) and fear-based truancy among 315 sexual minority youth aged 13 to 24 years. Results indicate that student school engagement is a significant predictor of GPA, and this relationship is strongest in the presence of a gay–straight alliance. Having an adult ally at school is associated with a decrease in fear-based truancy, while student school engagement predicts a decrease in fear-based truancy only for youth who have higher levels of subjective fear at school. Implications for future research and for practice among school-based helping professionals are discussed.     

Informed Consent and Investigational New Drug Abuses in the U.S. Military

Objective: The focal point of this investigation was to research the ethical issues surrounding the military's requests for informed consent waivers when using investigational drugs, and the recent debate surrounding the anthrax vaccine as an investigational new drug (IND). Design: The military's management of the informed consent process was examined using documents obtained through the Freedom of Information Act, Institutional Review Board (IRB) minutes, consent forms, legal pleadings, and protocols for specific investigational drugs. Results: In December 1990, prior to Operation Desert Storm, the Federal Drug Administration (FDA) granted the Department of Defense (DoD) an unprecedented waiver to the federally mandated informed-consent requirement for the use of investigational drugs. However, the waiver approval was conditional, and the FDA insisted on several safeguards. Partially in response to the subsequent Gulf War Syndrome debate, the FDA recently evaluated the military's use of investigational drugs during the Gulf War. The FDA cited the military for significant deviations from the originally approved protocols. Most notably, the military was found to be abusing the IRB process by convening a second IRB when the first IRB concluded that waiving informed consent was unethical. In addition, there was a gross lack of documentation and no monitoring of adverse reactions. The DoD's plan to use the current anthrax vaccine on all 2.4 million troops against inhalation anthrax has kindled an additional investigational drug controversy. The safety and efficacy of the use of the anthrax vaccine as a prophylactic against inhalation anthrax have been questioned by both military and medical organizations. There have never been any published studies of human efficacy or long-term effects for the anthrax vaccine. In addition, the military is not using the vaccine for its intended purpose, and it is also not adhering to prescribed dosing schedules. There is clear evidence to support the claim that, in fact, the military's use of the anthrax vaccine should be considered experimental. Conclusions: I argue that in medical situations, the military is obligated to treat its troops as autonomous persons entitled to basic rights and protections. The DoD is currently using an approved drug, the anthrax vaccine, for an unapproved purpose and in an unapproved manner. In doing so, the DoD is not only violating the FDA's regulations against such practices, it is also violating an executive order which only allows the president to authorize the use of INDs on service members without their consent.     

Ethical challenges in international HIV prevention research

Members of an HIV-prevention research network were asked to describe ethical challenges faced in their work. Major themes included acceptable standards of care for participants, defining research of relevance to host countries, reducing risks related to stigma, designing research that meets local needs without contributing to an inadequate status quo, and ensuring informed consent for complex research with potentially vulnerable participants. The challenges are interrelated and highlight the need for innovative, practical strategies to be incorporated into the planning, design, and conduct of HIV prevention trials. Research in applied ethics to support decision-making about HIV prevention research is needed, along with ethics training, mechanisms to support community-wide benefit from research, and expanded dialog on ethics surrounding HIV prevention and public health research.     

Transitions of Youth in Mental Health Residential Care to Less Restrictive Settings: The Role of Strengths and Gender

ABSTRACT

Changes in youth's behavioral/psychosocial functioning has been found to play an important role in the transitions from mental health residential care to less restrictive settings, and this functioning differs significantly by gender. However, there has been little attention paid to the roles played by psychosocial strength and gender in transitions out of residential care. The current study examined gender differences in the role of strengths in transitions to less restrictive settings using data on 675 youth's admission and discharge records collected from Illinois Residential Treatment Outcome System during 2005–2007 (Mean age = 15 years, SD = 2.0; 57.5% = boys). The results of multivariate logistic regression model indicated that positive recreational activities and lack of chronic illness were related to a higher likelihood of transitions to less restrictive settings among girls, while appropriate sexual development, psychological strengths, and strong spiritual/religious strengths were related to the transitions among boys. This study demonstrates the potential importance of youth strengths in the provision of mental health services and suggests a need to develop models of outcomes that take gender into account. Additional research based on multiple informants including youth self-report is needed to understand the role of gender in transitions out of residential care.     

A systematic review of studies on ethnic minority youth development in Hong Kong: an application of the ecological framework

Abstract

Ethnic minority young people play a significant role in the socio-economic growth of an ageing society with a decreasing fertility rate. The successful social integration of individuals with diverse cultural backgrounds within a society is a core value of the social work profession. This study examines the understanding of ethnic minority youth development in Hong Kong using a systematic review methodology. Risk prevention and positive promotion factors were identified using Bronfenbrenner’s ecological framework. Articles were searched through multiple databases in English, and 36 academic articles were reviewed. These studies mainly examined the risks of academic failure of these students in Hong Kong while few focused on the positive directions of multidimensional youth development. Future social work research and practice should examine positive youth development for ethnic minorities which can inform social work practice in Hong Kong and within other East Asian traditionally ethnically homogeneous societies undergoing significant changes in ethnic diversity.     

Ethics of research design

Discussions of ethical issues in research involving human subjects most usually provoke concerns about valid informed consent procedures. However, considering the recognized limitations of informed consent, arguably the way a study is designed is a more consequential concern for subject well‐being. This paper summarizes ethical issues in the design of clinical research, with reference to historic and current guidelines. Special attention is given to randomized clinical trials (RCTs) and psychiatric research.     

Research on environmental health interventions: ethical problems and solutions

This article reviews a variety of ethical issues one must consider when conducting research on environmental health interventions on human subjects. The paper uses the Kennedy Krieger Institute lead abatement study as well as a hypothetical asthma study to discuss questions concerning benefits and risks, risk minimization, safety monitoring, the duty to warn, the duty to report, the use of control groups, informed consent, equitable subject selection, privacy, conflicts of interest, and community consultation. Research on environmental health interventions can make an important contribution to our understanding of human health and disease prevention, provided it is conducted in a manner that meets prevailing scientific, ethical, and legal standards for research on human subjects.     

EXCLUDING PARTICULAR INFORMATION FROM CONSENT FORMS

Although the informed consent process is crucial to protecting human research subjects, there are cases when particular information within the consent form may present risks to those subjects. In this paper, we examine a case in which including the sponsor’s name on the consent form may allow the form to serve as a surrogate for subjects’ HIV status.

There is no literature addressing the ethical acceptability of excluding particular information from consent forms, and there exists little regulatory guidance on this issue. We argue that excluding information from the consent form is, in fact, obligatory when that information is disclosed orally during the consent process but its presence on the form poses risks to the subjects the consent process is designed to protect. Further, we argue that the regulations ought to be amended to reflect this obligation.