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
Community-based participatory research (CBPR) introduces new
ethical challenges for HIV prevention studies in low-resource international
settings. We describe a CBPR study in rural Kenya to develop and pilot a
family-based HIV prevention and mental health promotion intervention. Academic
partners (APs) worked with a community advisory committee (CAC) during formative
research, intervention development, and a pilot trial. Ethical challenges
emerged related to: negotiating power imbalances between APs and the CAC; CAC
members’ shifting roles as part of the CAC and wider community; and
anticipated challenges in decision making about sustainability. Factors
contributing to ethical dilemmas included low access to education, scarcity of
financial resources, and the shortage of HIV-related services despite high
HIV prevention; community-based participatory research; ethical challenges; adolescents; children; families; mental health; Kenya
The recent increase in research in the Middle East has been associated with the establishment of research ethics committees (RECs). Our aim was to obtain perspectives of RECs regarding the challenges that impede their effective functioning. We conducted in-depth interviews using a semi-structured interview guide. We transcribed and analyzed the interviews to uncover major themes and subthemes. We identified the following themes: membership composition; training needs of members; availability of human and capital resources; role of the national government; concerns with the informed consent process; government scrutiny of research; investigator-related issues; and concerns with transfer of biological samples to other countries. Our interview study revealed several barriers that need to be considered by appropriate stakeholders to enhance adequate functioning of RECs.
ethics; Egypt; research ethics committees; research; informed consent; biological samples; qualitative research
The National Institutes of Health (NIH) training grant requirement to provide training in the responsible conduct of research (RCR) is now more than 20 years old. Implicit in the requirement is that this training will have an impact not only on what trainees know, but on what they know how to do. There is, however, a range of responses about what skills are seen to be necessary for the ethical practice of science. As part of a larger, earlier study examining RCR instructors’ overall goals in teaching RCR, we asked 50 RCR instructors from 37 different institutions what their goals were for teaching skills in their RCR courses. The responses about what constituted necessary skills were wide ranging, from a focus on teaching the skill of ethical decision making to the perceived importance of ensuring that trainees understand the importance of the community in some research relationships. This diversity in responses about what skills should be taught in RCR courses is not especially surprising, given the variation in instructors, formats, instruction, goals, and outcome measures for RCR courses, but it does reinforce the necessity of giving more thought to what goals are to be achieved. This is true not only of skills to be learned, but of any other objectives one might have for research ethics teaching and learning.
responsible conduct of research; skills; RCR; education; teaching; research context; ethics
We describe ethical issues that emerged during a one-year CBPR study of HIV and human papillomavirus (HPV) vulnerabilities and prevention in two Pacific Islander (PI) communities, and the collaborative solutions to these challenges reached by academic and community partners. In our project case study analysis, we found that ethical tensions were linked mainly to issues of mutual trust and credibility in PI communities; cultural taboos associated with the nexus of religiosity and traditional PI culture; fears of privacy breaches in small, interconnected PI communities; and competing priorities of scientific rigor versus direct community services. Mutual capacity building and linking CBPR practice to PI social protocols are required for effective solutions and progress toward social justice outcomes.
HIV; human papillomavirus (HPV); Pacific Islanders; Chamorro; Tongan; research ethics; community-based participatory research; social justice
Epidemics of both HIV/AIDS and alcohol abuse in sub-Saharan Africa have spurred the conduct of local behavioral therapy trials for these problems, but the ethical issues involved in these trials have not been fully examined. In this paper, we discuss ethical issues that emerged during the conduct of a behavioral intervention adaptation and trial using cognitive-behavioral therapy to reduce alcohol use among HIV-infected outpatients in Eldoret, Kenya. The study was performed within our multinational collaboration, the USAID-Academic Model Providing Access to Healthcare Partnership. We discuss relevant ethical considerations and how we addressed them.
HIV; AIDS; alcohol abuse; cognitive behavioral therapy; ethical issues; sub-Saharan Africa
Strengthening the informed consent process is one avenue for improving recruitment of minorities into research. This study examines that process from two different perspectives, that of researchers and that of African American and Latino community members. Through the use of two separate surveys, we compared strategies used by researchers with the preferences and attitudes of community members during the informed consent process. Our data suggest that researchers can improve the informed consent process by incorporating methods preferred by the community members along with methods shown in the literature for increasing comprehension. With this approach, the informed consent process may increase both participants’ comprehension of the material and overall satisfaction, fostering greater trust in research and openness to future research opportunities.
informed consent; minorities; improving informed consent
Concerns about research wrongdoing in biomedical research are growing in developing countries, where research ethics training and research regulatory systems are just emerging. In a first-time study in Africa, medical/dental researchers (N = 132) in two states in Nigeria were interviewed on a wide range of research wrongdoings and potential predictors. Using multivariate logistic regression, significant predictors of research wrongdoing were identified. Some 22.0% admitted to at least one of fabrication, falsification, and plagiarism, the predictors of which were knowledge gaps in research ethics and pressure to publish enough papers for promotion. Acknowledging inadequate knowledge of research ethics was a predictor of admitting a wrongdoing. Systems that support ethical research, including skilled training and funding, are recommended.
research misconduct; research wrongdoing; Nigeria
It is unclear how genomic incidental finding (GIF) prospects should be addressed in informed consent processes. An exploratory study on this topic was conducted with 34 purposively sampled Chairs of institutional review boards (IRBs) at centers conducting genome-wide association studies. Most Chairs (96%) reported no knowledge of local IRB requirements regarding GIFs and informed consent. Chairs suggested consent processes should address the prospect of, and study disclosure policy on, GIFs; GIF management and follow-up; potential clinical significance of GIFs; potential risks of GIF disclosure; an opportunity for participants to opt out of GIF disclosure; and duration of the researcher's duty to disclose GIFs. Chairs were concerned about participant disclosure preferences changing over time; inherent limitations in determining the scope and accuracy of claims about GIFs; and making consent processes longer and more complex. IRB Chair and other stakeholder perspectives can help advance informed consent efforts to accommodate GIF prospects.
informed consent; genomic incidental findings; institutional review board
How IRBs relate to federal agencies, and the implications of these relationships, have received little, if any, systematic study. I interviewed 46 IRB chairs, directors, administrators, and members, contacting the leadership of 60 U.S. IRBs (every fourth one in the list of the top 240 institutions by NIH funding), interviewing IRB leaders from 34 (response rate=55%). IRBs describe complex direct and indirect relationships with federal agencies that affect IRBs through audits, guidance documents, and other communications, and can generate problems and challenges. Researchers often blame IRBs for frustrations, but IRBs often serve as the “local face” of federal regulations and agencies and are “stuck in the middle.” These data have critical implications for policy, practice, and research.
research ethics; health care system; organizational system; sociology; policymaking; regulations
Guidance requires that consent processes for research be appropriately tailored to their cultural context. This paper discusses the use of rapid assessments to identify cultural and ethical issues arising when explaining research in studies in The Gambia and Ethiopia. The assessments provided insights into appropriate ways of providing information to minimize the risk of stigmatizing vulnerable research populations; research participants’ views about the most important information to provide about research and their understandings of research; and perceived constraints upon reaching voluntary decisions about participation. These insights demonstrate that rapid assessments are a relatively quick and inexpensive intervention that can provide valuable information to assist in the tailoring of information provision and consent processes to research context while maintaining and enhancing participants’ fundamental protections.
consent; research ethics; empirical research; Africa; The Gambia; Ethiopia