We explore ethical issues faced by investigators as they conduct research as part of a peer-delivered HIV/AIDS risk reduction program for injection drug users (IDUs). Staff and participant experiences in peer-delivered interventions among IDUs have come under scrutiny by ethics researchers because of their potential to inadvertently and negatively impact participant rehabilitation due to continued engagement with drug-using networks during the course of outreach. This study explores whether enhanced communication of participant concerns and experiences with clinic and research staff helps to reduce inadvertent malfeasance in peer-delivered drug treatment interventions. Results contribute to the development of patient support infrastructure in peer-delivered risk reduction programs involving IDUs.
HIV prevention; peer-delivered prevention; prevention in clinics; ethics; program support; participant experience
Social networking sites and online advertising organizations provide HIV/AIDS researchers access to target populations, often reaching difficult-to-reach populations. However, this benefit to researchers raises many issues for the protections of prospective research participants. Traditional recruitment procedures have involved straightforward transactions between the researchers and prospective participants; online recruitment is a more complex and indirect form of communication involving many parties engaged in the collecting, aggregating, and storing of research participant data. Thus, increased access to online data has challenged the adequacy of current and established procedures for participants’ protections, such as informed consent and privacy/confidentiality. Internet-based HIV/AIDS research recruitment and its ethical challenges are described, and research participant safeguards and best practices are outlined.
ethics; Internet research; online recruitment; social media; privacy; informed consent
There has been debate about sponsor-investigator ethical responsibilities to address participants’ medical needs in trials in resource-constrained contexts. Certain ethical guidelines make detailed recommendations. This study explored whether ethical guideline recommendations for care in HIV vaccine trials were being met, and whether stakeholders were facing difficulties addressed by guidelines. It sampled key stakeholders involved in two trials across five sites in South Africa, and reviewed relevant documentation. It concluded that sites were largely meeting guideline recommendations for addressing needs, with some exceeding these. Recommendations for writing protocols were only partially achieved. Recommendations for engaging participating community were mostly met, except for “moral negotiation” recommendations. Suggestions are made to strengthen practices, and to improve guidelines so they address empirical concerns.
HIV vaccine trials; ethics; ancillary care; ART; protocol-development; community engagement
Orphans are a subpopulation with a unique set of additional vulnerabilities. Increasing focus on children’s rights, pediatric global health, and pediatric research makes it imperative to recognize and address unique vulnerabilities of orphaned children. This paper describes the unique vulnerabilities of the orphaned pediatric population and offers a structured set of factors that require consideration when including orphans in biomedical research. Pediatric orphans are particularly vulnerable due to decreased economic resources, psychosocial instability, increased risk of abuse, and delayed/decreased access to healthcare. These vulnerabilities are significant. By carefully considering each issue in a population in a culturally specific and study-specific manner, researchers can make valuable contributions to the overall health and well-being of this uniquely vulnerable population.
orphan; vulnerability; research; HIV; Kenya
The US National Institutes of health, Fogarty International Center (NIH-FIC) has, for the past 13 years, been a leading funder of international research ethics education for resource-limited settings. Nearly half of the NIH-FIC funding in this area has gone to training programs that train individuals from sub-Saharan Africa. Identifying the impact of training investments, as well as the potential predictors of post-training success, can support curricular decision-making, help establish funding priorities, and recognize the ultimate outcomes of trainees and training programs. Comprehensive evaluation frameworks and targeted evaluation tools for bioethics training programs generally, and for international research ethics programs in particular, are largely absent from published literature. This paper shares an original conceptual framework, data collection tool, and detailed methods for evaluating the inputs, processes, outputs, and outcomes of research ethics training programs serving individuals in resource-limited settings. This paper is part of a collection of papers analyzing the Fogarty International Center’s International Research Ethics Education and Curriculum Development program.
research ethics; bioethics; capacity development; training; program evaluation; Africa
The last fifteen years have witnessed a significant increase in investment in research ethics capacity development throughout the world. We examine nine research ethics training programs that are focused on Sub-Saharan Africa and supported by the US National Institutes of Health. We collected data from grants awards’ documents and annual reports supplemented by questionnaires completed by the training program directors. Together, these programs provided long-term training in research ethics to 275 African professionals, strengthened research ethics committees in 19 countries in Sub-Saharan Africa, and created research ethics curricula at many institutions and bioethics centers within Africa. Trainees’ leadership resulted in new national systems and policies on research ethics, human tissue storage and export, and methods of monitoring compliance with research ethics guidelines. Training programs adapted to challenges that arose due to varied trainees’ background knowledge in ethics, duration of time available for training, spoken and written English language skills, administrative obstacles, and the need to sustain post-training research ethics activities. Our report showcases the development of awareness of research ethics and building/strengthening of basic research ethics infrastructure in Sub-Saharan Africa. Nevertheless, the increasing amount and complexity of health research being conducted in Sub-Saharan Africa suggests the need for continued investment in research ethics capacity development in this region. This paper is part of a collection of papers analyzing the Fogarty International Center’s International Research Ethics Education and Curriculum Development program.
bioethics; capacity building; research ethics; Sub-Saharan Africa
The post-Communist countries of Central and Eastern Europe and Central Asia are at various stages of development with respect to their capacity to protect human research participants. We examined the impact of two Fogarty-funded programs in this region, the Union Graduate College–Vilnius University Advanced Certificate Program and the Case Western Reserve University Master’s Degree Program, by surveying these programs’ graduates and by examining alumni activities. Alumni have served in leadership roles on research ethics committees, developed and taught new courses in research ethics, and contributed to scholarship. However, political, social, and economic challenges impede the ability of graduates to maximize their effectiveness. Additional curricular attention is needed in research methodology, policy development and implementation, and the interplay between research ethics and human rights.
research ethics; capacity building; training
We present an analytical frame-work for use by fellows of the Fogarty International Center–sponsored Advanced Certificate Program in Research Ethics for Central and Eastern Europe to identify gaps in the public policies establishing research ethics review systems that impede them from doing their job of protecting human research subjects. The framework, illustrated by examples from post-Communist countries, employs a logic model based on the public policy and public management literature. This paper is part of a collection of papers analyzing the Fogarty International Center’s International Research Ethics Education and Curriculum program.
research ethics; public policy; capacity building; training
This qualitative study explored the ethical issues of female sex workers’ (FSWs) participation in HIV prevention research. Twenty female bar/spa workers and 10 venue managers in the Philippines underwent individual semi-structured interviews; three community advisory board meetings informed the study design and interpretation of findings. Results: Informed consent was constrained by perceived government coercion and skepticism that research results would translate into community benefits. Disclosure was constrained by distrust in confidentiality and perceived intrusiveness of survey questions. FSWs and managers were frustrated by the government's inability to stop police from using condoms as evidence of prostitution. Findings suggest HIV interventions move beyond didactic prevention workshops to include FSWs in intervention design and implementation, and to reduce social and structural constraints on participation.
female sex workers; research ethics; disclosure; consent; social; structural; interventions; HIV; substance use
Female sex workers (FSW) from Andhra Pradesh, India who had participated in HIV research were interviewed to examine participant perspectives on research ethics. Content analysis indicated that aspects of the consent process, staff gender and demeanor, study environment, survey content, time requirements for study participation, and perceived FSW community support for research were key factors influencing whether FSW perceived their confidentiality and privacy had been maintained, and whether they felt the study was conducted respectfully. Findings suggest that partnership with community-based organizations and investigation of participant’s experiences in HIV prevention research can provide critical information to best inform research ethics protocols, a particular priority among research studies with highly stigmatized populations, such as FSW.
Female sex workers; research ethics; HIV prevention
Vulnerability of participants in research and the provision of special protections for vulnerable research participants are key concepts in research ethics. Despite international consensus requiring special protections for vulnerable research participants, both the concept of vulnerability and the nature and adequacy of strategies to reduce vulnerability remain vague and, consequently, are subject to varying interpretations. We report on observations of the challenges faced in understanding this key concept by 20 Russian and Romanian trainees participating in a one-year M.A. training program in research ethics from 2000 through 2011. We describe how trainees’ understanding of and appreciation for the need for special protections of vulnerable research participants was nurtured. This paper is part of a collection of papers analyzing the Fogarty International Center's International Research Ethics Education and Curriculum Development program.
bioethics; vulnerability; research ethics
Mentoring is an important component of training in the basic and clinical sciences due to the increasing complexities associated with establishing a career.
Data relating to 466 long term trainees in research ethics training programs were obtained from the Fogarty International Center's database. Data were supplemented with survey data (n=17) and telephone interviews (n=10) of the 21 principal investigators whose programs offered long-term training. The programs most successful with mentoring involved (1) the provision of an orientation to the trainees at the commencement of training; (2) a highly structured process of mentoring that required regular meetings and task achievement timelines; (3) intensive, frequent contact with the PI; and (4) support with personal issues that were troublesome to trainees.
This paper is part of a collection of papers analyzing the Fogarty International Center's International Research Ethics Education & Curriculum Development program.
bioethics; mentoring; research ethics
Study of ethical, legal, and social implications (ELSI) of human microbiome research has been integral to the Human Microbiome Project (HMP). This study explores core ELSI issues that arose during the first phase of the HMP from the perspective of individuals involved in the research. We conducted semi-structured in-depth interviews with investigators and NIH employees (“investigators”) involved in the HMP, and with individuals recruited to participate in the HMP Healthy Cohort Study at Baylor College of Medicine (“recruits”). We report findings related to three major ELSI issues: informed consent, data sharing, and return of results. Our findings demonstrate that investigators and recruits were similarly sensitive to these issues yet generally comfortable with study design in light of current knowledge about the microbiome.
ethics; policy; research; human micro-biome; data sharing; informed consent; return of results; qualitative research
we describe the research ethics capacity needs of the countries from the Middle East region. Against this background, we relate the experience of an international training program focused on providing long-term training in research ethics to individuals from low- and middle-income countries in the Middle East area. We describe our pedagogical approach to training, program changes to address challenges faced, and accomplishments of trainees. Many former trainees developed research ethics curricula in their home institutions, established or enhanced their institutions’ research ethics committees, provided leadership to national research ethics systems, and conducted research in research ethics. Based on our analysis, we make recommendations for how trainees can further address current regional research ethics needs in the Middle East and conduct future research. This paper is part of a collection of papers analyzing the Fogarty International Center’s International Research Ethics Education and Curriculum Development program.
research ethics; Middle East; education
Several training programs sponsored by the NIH/Fogarty International Center’s International Research Ethics Education and Curriculum Development Program offer online graduate-level courses in research ethics to participants in low- and middle-income countries. This paper describes the evaluation of four of these online courses and recommendations for improvements to achieve the highest-quality design and delivery. We used an evaluation matrix consisting of 95 criteria based on recommended best practices in eLearning. Our results showed that these courses are developing or meeting nearly 73% of the criteria, while they are not meeting approximately 21% of the criteria. Together, one or more of the courses are developing or meeting 89 of the 95 criteria. These results suggest that the necessary skills and expertise exist in these programs to bring all of the eLearning courses close to 100% proficiency by sharing a common set of best practices. This paper is part of a collection of articles analyzing the Fogarty International Center’s International Research Ethics Education and Curriculum Development Program.
online courses; education; low- and middle-income countries; research ethics; best practices
Current Human Subject Research training modules fail to capture ethically relevant cultural aspects of research involving American Indian and Alaska Native (AI/AN) community members. Applying a Community Engaged Research (CEnR) approach, we adapted the Collaborative IRB Training Initiative training module “assessing risk and benefits.” In a two-arm randomized controlled trial, followed by debriefing interviews, we evaluated module acceptability and understandability (test scores) among 40 reservation-based community members. Participants who took the adapted module, compared to those who took the standard module, reported higher scores on relevance of the material overall satisfaction, module quiz scores, and a trend toward higher self-efficacy. Implications of the efficacy of this approach for enhancing ethics training and community participation in research within AI/AN and other cultural populations within and outside the United States are discussed.
American Indian and Alaska Native (AI/AN); Community Engaged Research (CEnR); culturally responsive human subjects training
Some survey research has documented distress in respondents with pre-existing emotional vulnerabilities, suggesting the possibility of harm. In this study, respondents were interviewed about a personally distressing event; mood, stress, and emotional reactions were assessed. Two days later, respondents participated in interventions to either enhance or alleviate the effects of the initial interview. Results indicated that distressing interviews increased stress and negative mood, although no adverse events occurred. Between the interviews, moods returned to baseline. Respondents who again discussed a distressing event reported moods more negative than those who discussed a neutral or a positive event. This study provides evidence that, among nonvulnerable survey respondents, interviews on distressing topics can result in negative moods and stress, but they do not harm respondents.
survey; risk; ethics
As genomic researchers are urged to openly share generated sequence data with other researchers, it is important to examine the utility of informed consent documents and processes, particularly as these relate to participants’ engagement with and recall of the information presented to them, their objective or subjective understanding of the key elements of genomic research (e.g., data sharing), as well as how these factors influence or mediate the decisions they make. We conducted a randomized trial of three experimental informed consent documents (ICDs) with participants (n = 229) being recruited to genomic research studies; each document afforded varying control over breadth of release of genetic information. Recall and understanding, their impact on data sharing decisions, and comfort in decision making were assessed in a follow-up structured interview. Over 25% did not remember signing an ICD to participate in a genomic study, and the majority (54%) could not correctly identify with whom they had agreed to share their genomic data. However, participants felt that they understood enough to make an informed decision, and lack of recall did not impact final data sharing decisions or satisfaction with participation. These findings raise questions about the types of information participants need in order to provide valid informed consent, and whether subjective understanding and comfort with decision making are sufficient to satisfy the ethical principle of respect for persons.
data sharing; genome research; informed consent; understanding; participant perspectives
Critical illness clinical trials that entail genomic data collection pose unique challenges. In this qualitative study, we found that surrogate decision makers (SDMs) for critically ill individuals, such as those who would be approached for study participation, appeared to have a limited grasp of genomic principles. We argue that low levels of genomic literacy should neither preclude nor be in conflict with the conduct of ethically rigorous clinical trials.
genomic research; critical illness; intensive care unit
When community partners have direct interaction with human research participants, it is important to consider potential threats to participant protections and research integrity. Few studies have directly compared the views of academic and community partners. This pilot focus group study explores the views of academic partners (APs) and community partners (CPs) regarding challenges to the protection of research participants and research integrity in community-engaged research (CEnR). Data are analyzed to understand how APs and CPs define and think about ethical problems and how meaning and analysis may differ between the two groups. Findings have implications for the development of research ethics training materials for academic-community research partnerships and IRBs; best practices for CEnR; and future research on ethical issues in CEnR.
community engagement; human subjects protections; research integrity; community partner views
Whether and How IRBs Assess social risks remains unclear, with little empirical investigation. I contacted leaders of 60 IRBs, and interviewed IRB leaders from 34 (response rate = 55%) and additionally, 12 members and administrators. IRBs struggle to assess and balance social risks and benefits, and vary in whether, how, and how much to do so, and how to balance these against individual risks/benefits. Risks to a group affect individuals within it. Hence, social risks can include indirect individual risks, raising ambiguities. Dilemmas emerge: e.g., how much responsibility researchers and IRBs have for addressing broader health inequities. These data, the first to examine how IRBs make decisions about social risks, reveal how IRBs face critical challenges, dilemmas, and ambiguities.
ANPRM; justice; stigma; autonomy; vulnerability; autonomy; research ethics; equipoise
Involving vulnerable pediatric populations in international research requires culturally appropriate ethical protections. We sought to use mabaraza, traditional East African community assemblies, to understand how a community in western Kenya viewed participation of children in health research and informed consent and assent processes. Results from 108 participants revealed generally positive attitudes towards involving vulnerable children in research, largely because they assumed children would directly benefit. Consent from parents or guardians was understood as necessary for participation while gaining child assent was not. They felt other caregivers, community leaders, and even community assemblies could participate in the consent process. Community members believed research involving orphans and street children could benefit these vulnerable populations, but would require special processes for consent.
community-based research; pediatrics; sub-Saharan Africa; ethics; informed consent; Kenya
IRBs have been criticized for long and complicated consent forms, but how IRBs make decisions about these issues hasn’t been examined. I contacted leaders of 60 IRBs, and interviewed IRB leaders from 34 (response rate = 55%), and 13 members and administrators. IRBs confront challenges and dilemmas regarding these documents: what and how much these forms should include (e.g., how “perfect” forms should be). While IRBs generally seek to decrease the length and complexity, institutions and industry funders often want these forms to be legal documents. IRBs may also “nitpick” these documents without realizing the costs. This study, the first to explore how IRBs view and make decisions about consent forms, suggests underlying tensions, ambiguities, and subjectivities that have important implications for future policy, practice, education, and research.
research ethics committees; conflicts of interest (COIs); therapeutic misconception; comprehension; misunderstanding; research integrity; decision making