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
THIS STUDY REPORTS ON QUALITATIVE research conducted in the UK with people with Parkinson’s Disease and their relatives on the subject of “sham surgery.” It explores attitudes toward sham surgery and reasoning about hypothetical participation in a sham-controlled trial. Results showed that attitudes toward sham surgery may not necessarily predict trial participation behavior. A small majority of interviewees deemed sham surgery ethically acceptable with certain provisos, but hypothetical participation was driven primarily by disease severity and a lack of standard treatment options, with a preference for receiving the real surgery over sham. Ethical implications for patient equipoise and the autonomy of patients’ research participation decisions are discussed.
sham surgery; Parkinson’s Disease; research ethics; placebo; control groups; autonomy
The goal of this study was to describe the contributions of community members (unaffiliated members) who serve on institutional review boards (IRBs) at large medical research centers and to compare their contributions to those of other IRB members. We observed and audiotaped 17 panel meetings attended by community members and interviewed 15 community members, as well as 152 other members and staff. The authors coded transcripts of the panel meetings and reviewed the interviews of the community members. Community members played a lesser role as designated reviewers than other members. They were infrequently primary reviewers and expressed hesitation about the role. As secondary or tertiary reviewers, they were less active participants than other members in those roles. Community members were more likely to focus on issues related to confidentiality when reviewing an application than other reviewers. When they were not designated reviewers, however, they played a markedly greater role and their discussion focused more on consent disclosures than other reviewers. They did not appear to represent the community so much as to provide a nonscientific view of the protocol and the consent form.
IRB; community member; bioethics; research ethics
Community engagement is increasingly becoming an integral part of research. “Community-engaged research” (CEnR) introduces new stakeholders as well as unique challenges to the protection of participants and the integrity of the research process. We—a group of representatives of CTSA-funded institutions and others who share expertise in research ethics and CEnR—have identified gaps in the literature regarding (1) ethical issues unique to CEnR; (2) the particular instructional needs of academic investigators, community research partners, and IRB members; and (3) best practices for teaching research ethics. This paper presents what we know, as well as what we still need to learn, in order to develop quality research ethics educational materials tailored to the full range of stakeholder groups in CEnR.
community-based participatory research; community-engaged research; research ethics education
Current practice relies on surrogates to enroll incapacitated adults in research. Yet, it is unclear to what extent this practice protects adults who have lost the ability to consent for themselves. To address this question, we conducted two literature searches to identify articles which report empirical data on three issues central to protecting adults who have lost the ability to consent: (1) adults’ willingness to participate in research should they lose the ability to consent; (2) adults’ willingness to allow a surrogate to make research decisions for them; and (3) the extent to which surrogates’ enrollment decisions are consistent with their charges’ preferences and values. These searches identified 21 articles, representing 20 distinct datasets. The data indicate that many adults are willing to participate in research should they lose the ability to consent, and many are willing to allow their family members to make research decisions for them if they become incapacitated. The data also raise concern that surrogates may be making research enrollment decisions that, in some cases, are inconsistent with their charges’ preferences and values. These findings suggest that modifications to current practice should be considered to better protect adults who have lost the ability to consent. One option would be to require, in addition to surrogate permission and subject assent, sufficient evidence that enrollment is consistent with the individual’s preferences and values.
capacity; consent; research
During informed consent conferences (ICCs) for Phase I trials, oncologists must present complex information while addressing concerns. Research on communication that evolves during ICCs remains largely unexplored. We examined communication during ICCs for pediatric Phase I cancer trials using a stratified random sample from six pediatric cancer centers. A grounded theory approach identified key communication steps and factors influencing the negotiation of decisions for trial participation. Analysis suggests that during ICCs, families, patients, and clinicians exercise choice and control by negotiating micro-decisions in two broad domains: drug logic and logistics, and administration/scheduling. Micro-decisions unfold in a four-step communication process: (1) introduction of an issue; (2) response; (3) negotiation of the issue; and (4) resolution and decision. Negotiation over smaller micro-decisions is prominent in ICCs and merits further study.
informed consent; informed consent conversations; pediatric oncology Phase I trials; decision-making
We explored how often journal articles reporting HIV research sponsored by a developed country, but conducted in a developing country, mention research ethics committee (REC) approval from both countries, and what factors are involved. Of all such 2007 articles on Medline conducted in one of four developing countries (N = 154), only 52% mentioned such dual approval. Mention of dual vs. single approval was more likely among articles with ≥ 50% sponsor country authors, and the United States as the sponsor country. Also, dual approval was more likely among articles that mentioned informed consent and funding, had ≥ 50% sponsor country authors, were biomedical (vs. psychosocial), and appeared in journals adopting International Committee Medical Journal Editors (ICMJE) guidelines. Dual approval was thus obtained in only half of the articles and was associated with ethical and logistic issues, indicating the need for clearer and more universally accepted guidelines.
developing world; HIV/AIDS; policy; medical journals; research integrity; risks; benefits
As genetic research is increasingly conducted in children, it is important to understand how parents make decisions about enrolling their children and what they think about receiving their children’s genetic research results. We conducted semi-structured phone interviews with 23 parents of children enrolled in genetic studies of autism or diabetes. Qualitative thematic analysis focused on two important components of genetic research and genotype-driven recruitment: participation in genetic research and return of results. Our findings suggest that parents’ preferences and perspectives may be specific to their child’s disease and the needs of the family as a whole. Assessing the expectations of target research populations will be beneficial for developing best practices for pediatric genetic research, return of results, and genotype-driven recruitment.
informed consent; recruitment; risk; benefit; genotype-driven; autism; diabetes; ethics
Genetic research can produce information that is beyond the aims of the research study yet may be of clinical or personal interest to study participants. We conducted semi-structured interviews with 44 researchers who were asked to describe how they would respond to a hypothetical vignette regarding the disclosure of findings with unanticipated clinical significance to research study participants. Interviews were transcribed and analyzed using content and thematic analyses. Researchers’ decision-making processes about whether to disclose incidental findings were governed by potentially conflicting duties in three primary domains: information quality, adherence to rules, and participant welfare. There are several actions researchers can take to prepare for incidental findings, including: adding specific language in informed consent documents to state clearly how investigators will handle disclosure; exploring how prepared participants might be during the consent process to make decisions about how they would like to be approached in the event of incidental findings; developing procedures for appropriately communicating individual results and providing follow-up support based on participant preferences; and, in genetic research, having an awareness of the range of traits expressed by the genes under study.
incidental findings; genetic studies; decision-making processes; communication of results; disclosure; qualitative research; vignette study
Better understanding of how research participants with a known condition ascribe meaning to individual genetic results is important to help researchers and institutional review boards evaluate the potential benefits and harms of disclosing results in the context of genotype-driven research recruitment. Based on 29 in-depth interviews with epilepsy patients participating in a genetic study, we found that this population of research subjects anticipated that genetic research results would provide answers to a range of questions about the research process and their condition. Their multi-layered interpretations underscore the need for clear communication about the nature and limitations of results if individual or aggregate genetic results are returned in the process of recruitment for additional research.
research recruitment; research participants; disclosure of research results; genetic research; research participants; genetic results