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.     

HIV/AIDS treatments

Although fewer people are being diagnosed with AIDS in the U.S. and deaths continue to decline, the number of adults age 50 and older who are living with HIV/AIDS is larger than ever. It is likely that older people will continue to comprise an increasingly larger proportion of individuals diagnosed with HIV/AIDS, reflecting both the ineffective prevention efforts targeting older adults and the highly effective antiretroviral therapies that allow many people to live for significantly longer periods of time. These recent trends have created two distinct populations of older persons with HIV/AIDS: those who were infected later in life and those infected earlier and now aging with HIV disease. Aging with HIV/AIDS presents unique psychosocial challenges that may be exacerbated by the aging process. HIV-related stigma, social support and coping issues and evidence-based psychosocial interventions for older adults with HIV/AIDS are reviewed in this paper and suggestions for future research are discussed.     

Addressing procedural challenges of ethical review system: Towards a better ethical quality of clinical trials review in Malaysia

The review of clinical trials with human participants in Malaysia is governed by a decentralized control system. The clinical trial protocols are reviewed by 13 registered research ethics committees (RECs) in Malaysia. A governmental body, the National Pharmaceutical Control Bureau, is responsible for the inspection and oversight of these registered RECs to ensure that they comply with the regulatory requirements. However, this study highlights that each REC in Malaysia has a different standard operating procedure and ethical review process. Other procedural challenges identified include inadequate membership, poor mechanism for research monitoring after ethical approval, and insufficient resources. Establishments of a national standard of REC and a central ethics committee are suggested to ensure procedural compliance in the oversight of clinical trials in Malaysia. While there is a growing concern that procedural compliance may not have a direct impact on the protection of human subjects, our key point is that an ethical review system compliant with the national standards could serve as a strong framework to support and enhance the ethical quality of decision-making and judgement. We believe that being aware of how influential procedural compliance can be would help committees improve the ethical quality of their research review.     

AIDS Exceptionalism: On the Social Psychology of HIV Prevention Research

The current analysis considers the  human immunodeficiency virus (HIV)  prevention research record in the social sciences. We do so with special reference to what has been termed "AIDS Exceptionalism"—departures from standard public health practice and prevention research priorities in favor of alternative approaches to prevention that, it has been argued, emphasize individual rights at the expense of public health protection. In considering this issue, we review the historical context of the HIV epidemic; empirically demonstrate a pattern of prevention research characterized by systematic neglect of prevention interventions for HIV-infected persons; and articulate a rationale for "Prevention for Positives," supportive prevention efforts tailored to the needs of HIV+ individuals. We then propose a social psychological conceptualization of processes that appear to have influenced developments in HIV prevention research and directed its focus to particular target populations. Our concluding section considers whether there are social and research policy lessons to be learned from the record of HIV prevention research that might improve our ability to address effectively, equitably, and in timely fashion future epidemics that play out, as HIV does, at the junction of biology and behavior.     

Supporting HIV/AIDS affected families and children: the case of four Chinese counties

This article focuses on the impact that HIV/AIDS has on children in China and the social support provided to these children. The research finds that the consequences of HIV/AIDS are serious: the entire environment in which children develop is adversely affected by the disease. These negative socio-economic effects are due not only to HIV/AIDS, but also to the social discrimination and exclusion experienced by affected communities and families. Local governments and societies have started to provide support to HIV/AIDS-affected children and work to reduce the social exclusion they suffer. However, many challenges and problems still lie ahead.     

The HOPE Family Project: A Family-Based Group Intervention to Reduce the Impact of Homelessness on HIV/STI and Drug Risk Behaviors

The HOPE Family Project (HIV Prevention for Parents and Early Adolescents) is an eight- session, family-based group intervention modeled on three evidence-based curricula targeting HIV/AIDS and alcohol and drug abuse prevention. The design and implementation of the HOPE Family Project was carried out by an established community collaborative board. The project aims to educate and provide tailored support to families and their youth (ages 11–14), residing in homeless shelters, regarding HIV and alcohol abuse prevention. The group model proved successful in offering an informal social support network for families living in homeless shelters and improving family functioning and youth mental health outcomes.     

‘You Get More Respect,’ Reasons for Sex Among African American High School Youth: A Qualitative Study

ABSTRACT

African American adolescents continue to be disproportionately impacted by HIV, sexually transmitted infections (STIs), and unanticipated pregnancies. In-depth, face-to-face interviews among a convenience sample of 32 African American adolescents (16 male and 16 female) were used to explore the reasons why some adolescents decided to engage in sex while others chose to delay sexual debut. Data were analyzed using a thematic analysis. Among the overall sample, psychological motivations, external pressure, physical pleasure seeking, and relationship-related motivations were the major themes cited for engaging in sex by participants and their friends. External support, motivation to avoid negative consequences, not feeling ready or lacking interest in sex, and having negative views about sex were among the major reasons for delaying sex. Several of the emergent themes showed gender differences. Suggestions for future research include the need for sexual education, and STI/HIV prevention programs that are gender sensitive and flexible enough to accommodate multiple factors related to sexual debut.     

Spinning a Stem Cell Ethics Web

The goal of this study was to provide an ethics education resource for trainees and researchers in the Canadian Stem Cell Network that would address the multiple ethical challenges in stem cell research including accountability in and for research across its multiple dimensions. The website was built using a bottom-up type approach based on an ethics needs assessment in combination with a top-down expert-driven component. There have been 3,615 visitors to the website since it was launched in July, 2011. The ongoing rate of returning visitors (20%) indicates that the website is becoming a valuable tool used multiple times.     

Enriching our understanding of vulnerability through the experiences and perspectives of individuals living with mental illness

ABSTRACT

Vulnerability is a central concept in research ethics and typically serves to identify individuals or groups whose participation in research prompts specific concerns or warrants special consideration. While theoretical discussions on vulnerability have contributed valuable insights to discussions of mental health research and care, they have not been enriched thus far by stakeholder perspectives. This oversight has important consequences for the ways in which we frame vulnerability. It misses the far-reaching insights and experiential knowledge of mental health research participants whose experiences this ethics concept ultimately seeks to capture. In view of this gap, our study combines a pragmatist ethics framework and interpretive phenomenological analysis of qualitative interviews to explore user perspectives on the notion of vulnerability through the lived experiences of mental health research participants and patient-advocates. Importantly, these perspectives offer essential clues to address the difficulties of operationalizing concerns for vulnerability in concrete and practical ways. They help refine our understanding of this key ethics concept.     

Blood Money: Bayer’s Inventory of HIV-Contaminated Blood Products and Third World Hemophiliacs

This article presents an overlooked case of research misconduct and violations of basic principles of medical and business ethics. When Bayer’s Cutter Laboratories realized that their blood products, Factor VIII and IX or antihemophiliac factor (AHF), were contaminated with human immunodeficiency virus (HIV), the financial investment in the product was considered too high to destroy the inventory. Cutter misrepresented the results of its own research and sold the contaminated AHF to overseas markets in Asia and Latin America without the precaution of heat treating the product recommended for eliminating the risk. As a consequence, hemophiliacs who infused the HIV-contaminated Factor VIII and IX tested positive for HIV and developed AIDS.     

Methodological Challenges of Studying Asian Gangs in Canada

This paper discusses the methodological challenges encountered in a research study on Asian gangs in Canada with reference to (a) defining Asian gangs; (b) seeking external funding; (c) securing support from ethnic communities; (d) getting approval for ethical research with human subjects; (e) recruiting research participants; (f) ensuring safety of the researcher; and (g) protecting the identity of research participants. The issues discussed would be relevant to those who are interested to examine the same phenomenon in countries with large Asian populations in Western counties (e.g., the United States and the United Kingdom) and in the Asia-Pacific Region such as Australia, Singapore, and Malaysia.     

Reflexive Research Ethics in Fetal Tissue Xenotransplantation Research

For biomedical research in which the only involvement of the human subject is the provision of tissue or organ samples, a blanket consent, i.e., consent to use the tissue for anything researchers wish to do, is considered by many to be adequate for legal and Institutional Review Board (IRB) requirements. Alternatively, a detailed informed consent provides patients or study participants with more thorough information about the research topic. We document here the beliefs and opinions of the research staff on informed consent and the discussion-based reflexive research ethics process that we employed in our fetal tissue xenotransplantion research on the impact of environmental exposures on fetal development. Reflexive research ethics entails the continued adjustment of research practice according to relational and reflexive understandings of what might be beneficent or harmful. Such reflexivity is not solely an individual endeavor, but rather a collective relationship between all actors in the research process.     

Person-oriented research ethics: integrating relational and everyday ethics in research

Research ethics is often understood by researchers primarily through the regulatory framework reflected in the research ethics review process. This regulatory understanding does not encompass the range of ethical considerations in research, notably those associated with the relational and everyday aspects of human subject research. In order to support researchers in their effort to adopt a broader lens, this article presents a “person-oriented research ethics” approach. Five practical guideposts of person-oriented research ethics are identified, as follows: (1) respect for holistic personhood; (2) acknowledgement of lived world; (3) individualization; (4) focus on researcher-participant relationships; and (5) empowerment in decision-making. These guideposts are defined and illustrated with respect to different aspects of the research process (e.g., research design, recruitment, data collection). The person-oriented research ethics approach provides a toolkit to individual researchers, research groups, and research institutions in both biomedical and social science research wishing to expand their commitment to ethics in research.     

More Nuanced Universal Services for New Parents: Avoiding Assumptions of Homogeneity

Abstract

Universal services focus on prevention and providing the support to parents that will help them meet the challenges of parenthood and deal with problems before they become entrenched. Many countries now have good universal services available for new families, and significant advances have been made in recent years to recognize the importance of the early years in the optimal development of the child. This article is based on a qualitative study of transition to parenthood. The study explored the experience of 25 first-time mothers in socioeconomically diverse circumstances in New Zealand. Eleven partners of these women also participated. Mothers were interviewed three times, first in late pregnancy, then 3 and 12?months after giving birth. Partners were interviewed once, mid-way through the baby’s first year. The article focuses on how participants experienced service support. It illustrates some of the diverse needs of new parents, and explains ways in which prevention services might become more responsive to parents’ expressed needs. The authors offer a case for stronger interplay between universal services and informal systems of support, and the development of a new generation of universal services that act as enablers of natural support hubs for new families within their own communities.     

Conspiracy beliefs about HIV/AIDS and birth control among African Americans: implications for the prevention of HIV, other STIs, and unintended pregnancy

In this article, we examine the potential role that conspiracy beliefs regarding HIV/AIDS (e.g., "HIV is a manmade virus") and birth control (e.g., "The government is trying to limit the Black population by encouraging the use of condoms") play in the prevention of HIV, other STIs, and unintended pregnancies among African Americans in the United States. First, we review prior research indicating that substantial percentages of African Americans endorse conspiracy beliefs about HIV/AIDS and birth control. Next, we present a theoretical framework that suggests how conspiracy beliefs influence sexual behavior and attitudes. We then offer several recommendations for future research. Finally, we discuss the policy and programmatic implications of conspiracy beliefs for the prevention of HIV, other STIs, and unintended pregnancy .     

Research ethics review for the use of anonymized samples and data: A systematic review of normative documents

While the anonymization of biological samples and data may help protect participant privacy, there is still debate over whether this alone is a sufficient safeguard to ensure the ethical conduct of research. The purpose of this systematic review is to examine whether the review of an ethics committee is necessary in the context of anonymized research, and what the considerations in said ethics review would be. The review of normative documents issued by both national and international level organizations reveals a growing concern over the ability of anonymization procedures to prevent against reidentification. This is particularly true in the context of genomic research where genetic material’s uniquely identifying nature along with advances in technology have complicated previous standards of identifiability. Even where individual identities may not be identifiable, there is the risk of group harm that may not be protected by anonymization alone. We conclude that the majority of normative documents support that the review of an ethics committee is necessary to address the concerns associated with the use of anonymized samples and data for research.     

Emphasizing the experiences of researchers after RCR instructions: Introduction to Responsible Conduct of Research (RCR) in Malaysia

The purpose of this study is to highlight the experiences of individuals who participate in the Responsible Conduct of Research (RCR) training program held at various universities in Malaysia. In response to a mailing request sent to 40 individuals who had undertaken a RCR training program, 15 participants agreed to be interviewed. The results of the study showed that the three main reasons for participating in the training were as follows: anticipation for knowledge gained; personal experience with research misconduct; and establishing a new network of researchers. In terms of the positive effects gained from undertaking the training, the participants highlighted an increased awareness of the issues and problems related to research misconduct; the need to promote integrity in research conduct; a change in the way they conduct their research; and a change in the way they confront and address misconduct. The findings of this study should be valuable for policy makers and those involved in the management of research programs and ethics, as it demonstrated the importance of RCR training in equipping researchers with the necessary knowledge to conduct research responsibly, and to avoid research misconduct.     

An 8-Year Telephone Support Group for Home-Bound People with Multiple Sclerosis: Adapting Therapeutic Methods to Overcome Isolation and Immobility

This article explores the dynamics of a long-term telephone support group, over eight years, for individuals with multiple sclerosis (MS). MS is a progressive neurological disease that frequently affects mobility and engenders isolation. All of the participants in this group are physically disabled by their disease. The mobility challenges of this population led to the idea of using conference call technology as a treatment modality. Incorporating theory from neurobiology research, this article chronicles the implementation of the group and offers observations about the interplay between individual self-esteem, group participation, and the use of technology in mental health treatment.     

Preventing Substance Abuse Among American Indian and Alaska Native Youth

Research on the prevention of substance abuse among American Indian and Alaska Native youth offers challenges and demands careful methods. This paper describes such challenges in terms of philosophical, political, and cultural issues surmundiig substance abuse prevention research with American Indian and Alaska Native people. The authors suggest how social work researchers can address these issues through strategies of community 'collaboration, goal sening, and cultural sensitivity. The paper discusses the limits, implications, and future applications of the described strategies for research on the prevention of alcohol and drug abuse among American Indian and Alaska Native youth.     

Negotiating Partnerships in Research on Poverty With Community-Based Agencies

This article argues that researchers must negotiate true partnerships with poor women, maintain mutual support systems, and build mutual respect, if they are to have success in challenging poverty through research. The experience of establishing partnerships with community-based agencies is discussed and the rationale for including poor women in partnerships is considered in terms of the benefits and the challenges for researchers. Among the critical issues are problems of difference, including ethnicity, social class, and gender and relationships between researchers and participants. These issues are highlighted using two examples. A negative outcome from noncollaboration is represented by the case of an after-school program in an inner-city school. The failure to establish collaboration leads to disappointing results. A successful case is described by the cooperative efforts between researchers and poor women in a program for substance abuse. Several strategies and recommendations are offered in conclusion.