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How scholars and IRBs perceive and apply the Belmont principles in crowd work‐based research was an open and largely neglected question. As crowd work becomes increasingly popular for scholars to implement research and collect data, such negligence, signaling a lack of attention to the ethical issues in crowd work‐based research more broadly, seemed alarming. To fill this gap, we conducted a qualitative study with 32 scholars and IRB directors/analysts in the United States to inquire into their perceptions and applications of the Belmont principles in crowd work‐based research. We found two dilemmas in applying the Belmont principles in crowd work‐based research, namely the dilemma between the dehumanization and expected autonomy of crowd workers, and the dilemma between the monetary incentive/reputationall risks and the conventional notion of research benefits/risks. We also compared the scholars' and IRBs' ethical perspectives and proposed our research implications for future work. [ABSTRACT FROM AUTHOR]

High-income country (HIC) trainees are participating in research in low- and middle-income countries (LMIC) in increasing numbers, yet the ethical challenges they face have not been well described. We conducted a mixed methods study of U.S. graduate and undergraduate students who conducted research in LMIC, including an online survey and semi-structured interviews. Among 123 online survey respondents, 31% reported ethical challenges and nearly two-thirds of respondents did not feel well prepared to deal with ethical challenges. Qualitative analysis of the 17 semi-structure interviews and narrative survey responses revealed many themes of 'ethics in practice': challenges in setting research priorities, navigating relationships with host country partners, scope of research practice, and human subject protections. Respondents reported that pre-departure trainings were not reflective of ethical frameworks or research contexts in LMIC, and few described seeking host mentor help in addressing ethical challenges. These results suggest a need for improvements in training, oversight and mentorship of trainee researchers, and to further engage both HIC and LMIC institutions, educators and researchers in addressing ethical issues. [ABSTRACT FROM AUTHOR]

OBJECTIVES: To investigate the ethical challenges experienced by oncology clinical trials nurses (OCTNs) during the management of CTs and to examine how they resolve those conflicts. SAMPLE & SETTING: 12 licensed RNs who had been practicing as full- or part-time OCTNs for a minimum of two years at various academic medical centers in the United States. METHODS & VARIABLES: Classical grounded theory (CGT), an inductive methodology used to explore a social process in which little is known and to develop a theory grounded in the data, was used, in addition to CGT data analysis strategies. RESULTS: CGT data analysis revealed the OCTNs' main concern (implementing an undefined job) and the way in which the OCTNs resolve this concern through the process of figuring it out. Figuring it out consists of learning as they go, utilizing their assets, standing their ground, and managing hope. IMPLICATIONS FOR NURSING: Although some nursing research provides examples of ethical challenges OCTNs might encounter in practice, there is little information regarding how nurses manage those encounters. A theoretical understanding of the OCTNs' experiences managing ethical challenges fills a gap in the nursing literature and provides a framework for how OCTNs manage and respond to challenges in professional practice. [ABSTRACT FROM AUTHOR]

In qualitative interviews with a diverse group of experts, the vast majority believed unregulated researchers should seek out independent oversight. Reasons included the need for objectivity, protecting app users from research risks, and consistency in standards for the ethical conduct of research. Concerns included burdening minimal risk research and limitations in current systems of oversight. Literature and analysis supports the use of IRBs even when not required by regulations, and the need for evidence-based improvements in IRB processes. [ABSTRACT FROM AUTHOR]

Libraries remain one of the last places on campus where the purging of usage data is encouraged and "tracking" is a dirty word. While some libraries have demonstrated the usefulness of analytics, opponents bring up issues of privacy and debate the feasibility of student-generated library data for planning and assessment. Using a study conducted at the University Library, California State University, Long Beach, the authors of this article identified practical knowledge of data research that academic librarians will benefit from understanding. Readers will learn about the role campus culture plays in data gathering, be exposed to the complexities of learning analytics and Institutional Review Board (IRB) clearance, and read how the authors weighed the ethical use of big data analysis for assessing students. [ABSTRACT FROM AUTHOR]

Background: An ethical, informed consent process requires that potential participants understand the study, their rights, and the risks and benefits. Yet, despite strategies to improve communication, many participants still lack understanding of potential risks and benefits. Investigating attitudes and practices of research nurses can identify ways to improve the informed consent process. Research question: What are the attitudes, practices, and preparedness of nurses involved in the informed consent process regarding communication of risks and benefits? Research design: A survey was developed and administered online to a national purposive sample of 107 research nurses with experience obtaining informed consent for clinical trials. Survey responses stratified by selected work-related characteristics were analyzed. Ethical considerations: Participants were instructed they need not answer each question and could stop at any time. They consented by clicking "accept" on the email which linked to the survey. The study was approved by the Northeastern University Institutional Review Board, Boston, Massachusetts (NU-IRB Protocol #: 13-06-17). Findings: Most research nurses (87%) used a teach-back method to assess participant comprehension, while 72% relied on their intuition. About one-third did not feel prepared to communicate related statistics. About 20% did not feel prepared to tailor information, and half did not feel competent using supplemental materials to enhance risks and benefits comprehension. Only 70% had received training in the informed consent process which included in-person training (84%), case studies (69%), online courses (57%), feedback during practice sessions (54%), and simulation, such as role playing (49%) and viewing videos (45%). Perceived preparedness was significantly associated with greater informed consent experience and training. Conclusion: Research nurses may have inadequate training to encourage, support, and reinforce communication of risks and benefits during the informed consent process. Relevant purposeful education and training should help to improve and standardize the ethical informed consent process. [ABSTRACT FROM AUTHOR]

Precision medicine research is rapidly taking a lead role in the pursuit of new ways to improve health and prevent disease, but also presents new challenges for protecting human subjects. The extent to which the current "web" of legal protections, including technical data security measures, as well as measures to restrict access or prevent misuse of research data, will protect participants in this context remains largely unknown. Understanding the strength, usefulness, and limitations of this constellation of laws, regulations, and procedures is critical to ensuring not only that participants are protected, but also that their participation decisions are accurately informed. To address these gaps, we conducted in-depth interviews with a diverse group of 60 thought-leaders to explore their perspectives on the protections associated with precision medicine research. [ABSTRACT FROM AUTHOR]

Research participants are entitled to many rights that may easily come into conflict. The most important ones are that researchers respect their autonomy as persons and act on the principles of beneficence, nonmaleficence, and justice. Since 2014, research subjects from numerous states in the United States of America also have a legal “right to try” that allows them, under certain circumstances, to receive experimental (i.e., preliminarily tested) interventions, including medical devices, before official approval from the United States Food and Drug Administration. In the context of experimental interventions, such as deep brain stimulation (DBS) for Alzheimer’s disease, this article argues that research participants ought never to have a legal “right to try” without a corresponding “right to be sure.” The latter refers to external epistemic justification construed in terms of reliance on reliable evidence. This article demonstrates that the mere complexity of intervention ensembles, as in the case of DBS for Alzheimer’s disease which serves as a paradigm example, illustrate how unanswered and/or unasked open questions give rise to a “combinatorial explosion” of uncertainties that require epistemic responses that no single research team alone is likely able to provide. From this assessment, several epistemic asymmetrical relations between researchers and participants are developed. By elucidating these epistemic asymmetries, this article unravels the reasons why open science, transparent exhaustive data reporting, preregistration, and continued constant critical appraisal via pre- and postpublication peer review are not scientific virtues of moral excellence but rather ordinary obligations of the scientific work routine required to increase reliability and strength of evidence. [ABSTRACT FROM AUTHOR]

Critical suicidology (White, Marsh, Kral, & Morris, 2016) offers a critique of positivism as the mainstream rhetoric of scientific research. In this article, the authors add a critique to the moral detachment of scientific inquiry (Wilkinson & Kleinman, 2016) in suicidology. They provide a discussion at the intersection of theory and research when considering moral care of all stakeholders in the implementation of suicide research toward the development of more humanitarian policies and program alternatives. The authors reflect upon their experience of conducting an Interpretative Phenomenological Analysis (Finlay, 2011) on suicide in the U.S. military. [ABSTRACT FROM AUTHOR]

Background Bullying is a critical public health problem and a screening tool for use in healthcare is needed. Focus groups are a common tool for generating qualitative data when developing an instrument and evidence suggests that technology-enhanced focus groups can be effective in simultaneously engaging participants from diverse settings. Aim To examine the use of technology-enhanced focus groups in generating an item pool to develop a youth-bullying screening tool. Discussion The authors explore methodological and ethical issues related to conducting technology-enhanced focus groups, drawing on their experience in developing a youth-bullying measure. They conducted qualitative focus groups with professionals from the front lines of bullying response and intervention. They describe the experience of conducting technology-enhanced focus group sessions, focusing on the methodological and ethical issues that researchers engaging in similar work may encounter. Challenges associated with this methodology include establishing rapport among participants, privacy concerns and limited non-verbal communication. Conclusion The use of technology-enhanced focus groups can be valuable in obtaining rich data from a wide variety of disciplines and contexts. Organising these focus groups was inexpensive and preferred by the study's participants. Implications for practice Researchers should consider using technology-enhanced focus groups to generate data to develop health-related measurement tools. [ABSTRACT FROM AUTHOR]

The different countries that death and dying researchers reside within often shape not only research agendas but also research methodologies. The United Kingdom and the United States are two examples of countries that share a common language and intellectual history but their discourses on death have been very different. These differences are partly explained through cultural practices, and also government funding of research, definitions of death and end-of-life planning education. In this article, we argue that early death scholarship in the United States impacted death research and outcomes in both the US and the UK, but that recent scholarship in both countries has caused the two countries to diverge in two major areas: (1) the methodological approaches to death studies and (2) the educational training of medical and hospice personnel in direct contact with the dying. We argue that in order for death studies to fully benefit from trans-Atlantic dialogue on death, both countries need to move towards a more integrated trans-disciplinary model. [ABSTRACT FROM PUBLISHER]

Commonalities are presented from the experiences of U.S. nurse researchers who conducted studies in India, Jordan, Aotearoa/New Zealand, and Trinidad and Tobago. While planning research, it is important to engage collaborators who are members of the culture to be studied to understand what are culturally appropriate aims and methods. It is also vital to observe cultural etiquette, especially while gaining entrée and collecting data. Issues related to data collection include timing it around local holidays and events, and adapting individualist methods for obtaining consent and data to be more respectful for those in a collectivist culture. Care must be taken to give back, to sharing findings, and insure sustainability for future research in the host culture. Based on these and other reflections, recommendations are offered to support investigators planning research in a culture that is not their own. [ABSTRACT FROM AUTHOR]

Institutional review board (IRB) delays may hinder the successful completion of federally funded research in the U.S. military. When this happens, time-sensitive, mission-relevant questions go unanswered. Research participants face unnecessary burdens and risks if delays squeeze recruitment timelines, resulting in inadequate sample sizes for definitive analyses. More broadly, military members are exposed to untested or undertested interventions, implemented by well-intentioned leaders who bypass the research process altogether. To illustrate, we offer two case examples. We posit that IRB delays often appear in the service of managing institutional risk, rather than protecting research participants. Regulators may see more risk associated with moving quickly than risk related to delay, choosing to err on the side of bureaucracy. The authors of this article, all of whom are military-funded researchers, government stakeholders, and/or human subject protection experts, offer feasible recommendations to improve the IRB system and, ultimately, research within military, veteran, and civilian populations. [ABSTRACT FROM AUTHOR]

Background: Prior research has identified unrealistic optimism as a bias that might impair informed consent among patient-subjects in early-phase oncology trials. However, optimism is not a unitary construct; it also can be defined as a general disposition, or what is called dispositional optimism. The authors assessed whether dispositional optimism would be related to high expectations for personal therapeutic benefit reported by patient-subjects in these trials but not to the therapeutic misconception. The authors also assessed how dispositional optimism related to unrealistic optimism.Methods: Patient-subjects completed questionnaires designed to measure expectations for therapeutic benefit, dispositional optimism, unrealistic optimism, and the therapeutic misconception.Results: Dispositional optimism was found to be significantly associated with higher expectations for personal therapeutic benefit (Spearman rank correlation coefficient [r], 0.333; P<.0001), but was not associated with the therapeutic misconception (Spearman r, -0.075; P = .329). Dispositional optimism was found to be weakly associated with unrealistic optimism (Spearman r, 0.215; P = .005). On multivariate analysis, both dispositional optimism (P = .02) and unrealistic optimism (P<.0001) were found to be independently associated with high expectations for personal therapeutic benefit. Unrealistic optimism (P = .0001), but not dispositional optimism, was found to be independently associated with the therapeutic misconception.Conclusions: High expectations for therapeutic benefit among patient-subjects in early-phase oncology trials should not be assumed to result from misunderstanding of specific information regarding the trials. The data from the current study indicate that these expectations are associated with either a dispositionally positive outlook on life or biased expectations concerning specific aspects of trial participation. Not all manifestations of optimism are the same, and different types of optimism likely have different consequences for informed consent in early-phase oncology research. [ABSTRACT FROM AUTHOR]

Considered here are matters relating to the responsible conduct of research in economics and science in the United States for the last forty years. In science there was a “late 20th century wave” of scientific misconduct and then a “millennial wave”. For economics in the former era, episodes of honest error and replication failure occurred. Recently plagiarism and data manipulation have been reported. Overall few economists seem to fabricate data, but falsification of data, replication failure, and plagiarism occur. Furthermore, replication failure is the one thing that scientific misconduct and honest error have in common. In economics and compared to the sciences, there have been no misconduct hearings, no economist has been charged with a crime, nor has anyone served time in prison for scientific misconduct. Science and economics seem to be sufficiently self-corrective so that systemic science failure does not utterly thwart scientific progress in the long run. [ABSTRACT FROM AUTHOR]

Purpose: The purposes of this study were to assess the exposure that medical students (MSs) have to radiation oncology (RO) during the course of their medical school career, as evidenced by 2 time points in current medical training (ie, first vs fourth year; MS1s and MS4s, respectively) and to assess the knowledge of MS1s, MS4s, and primary care physicians (PCPs) about the appropriateness of RT in cancer management in comparison with RO attendings.Methods: We developed and beta tested an electronic survey divided into 3 parts: RO job descriptions, appropriateness of RT, and toxicities of RT. The surveys were distributed to 7 medical schools in the United States. A concordance of >90% (either yes or no) among RO attendings in an answer was necessary to determine the correct answer and to compare with other subgroups using a χ(2) test (P<.05 was significant).Results: The overall response rate for ROs, MS1s, MS4s, and PCPs was 26%; n (22 + 315 + 404 + 43)/3004. RT misconceptions decreased with increasing level of training. More than 1 of 10 MSs did not believe that RT alone could cure cancer. Emergent oncologic conditions for RT (eg, spinal cord compression, superior vena cava syndrome) could not be identified by >1 of 5 respondents. Multiple nontoxicities of RT (eg, emitting low-level radiation from the treatment site) were incorrectly identified as toxicities by >1 of 5 respondents. MS4s/PCPs with an RO rotation in medical school had improved scores in all prompts.Conclusions: Although MS knowledge of general RT principles improves from the first to the fourth year, a large knowledge gap still exists between MSs, current PCPs, and ROs. Some basic misconceptions of RT persist among a minority of MSs and PCPs. We recommend implementing formal education in RO fundamentals during the core curriculum of medical school. [ABSTRACT FROM AUTHOR]

The authors propose four key strategies for developing and maintaining research capacity in child welfare agencies, using the example of supportive housing-agency partnerships. Drawing on the authors' experience as evaluators on two federally funded supportive housing and child welfare demonstration projects, we contextualize these strategies with examples from process and outcome evaluations of the demonstrations. [ABSTRACT FROM AUTHOR]

Relying on a critical pedagogy framework and youth participatory action research (YPAR) and visual sociology methods, the authors of this article – teachers, teacher educators, and community activists – have worked with photo elicitation methods and young adults in the USA and Haiti to document youths' impressions of the purposes of, supports for, and impediments to school. Participants have shot more than 12,000 images and written about 1800 of these, which the authors have analysed to discover approximately 30 findings related to school leadership, literacy instruction, and secondary curricula and pedagogies. These methods have raised a number of professional, personal, and research ethics issues, particularly as the project has shifted to include international participants. The nature of authorship and the risks involved with young people sharing their ‘difficult stories’ are just two considerations that have consistently arisen. Recently, the authors have recognized connections between visual methods, YPAR methods, international development, and the ethical issues considered by these fields. The authors suggest that visual research projects in the US and international contexts – where the social contract of schooling is at best damaged – might be understood as ‘development’ activities. The authors illustrate how such methods might be informed by a development perspective and the ‘agreements’ that development ethicists consider. [ABSTRACT FROM PUBLISHER]

Background:In 2003, Havasupai Tribe members in Arizona discovered that their DNA samples, collected for genetic studies on type II diabetes, had been used for studies on schizophrenia, migration, and inbreeding without their approval. The resulting lawsuit brought by the Havasupai reached a settlement in April 2010 in which tribe members received monetary compensation and the return of DNA samples. In this study, we examine the perceptions of institutional review board (IRB) chairpersons and human genetic researchers about the case and its impact on the practice of research.Methods:Twenty-minute semistructured interviews were conducted with 26 institutional review board (IRB) chairs and researchers at six top National Institutes of Health (NIH)-funded institutions. Participants were questioned about their knowledge and perceived impact of the Havasupai case and their perceptions of informed consent in genetic research studies.Results:We found that most study participants did not perceive that the Havasupai case had a large impact. However, we identified key concerns and opinions of the case, in particular, increased awareness of culturally sensitive issues with informed consent and secondary uses of samples.Conclusions:The results provide a deeper understanding of how informed consent issues are understood by IRB members and human genetic researchers and the implications for research ethics education. [ABSTRACT FROM AUTHOR]

The research and publication practices by which scientists produce biomedical knowledge about race and ethnicity remain largely unexamined, and most of the existing research looks at the knowledge production process at a single point in time. In light of this, we specifically focus on the questions of whether and in what ways researchers' discussions of race and ethnicity change over the course of the research process by comparing grant proposals to published articles. Using content analysis, we investigated the use of race and ethnicity in 72 grants funded by the National Cancer Institute of the National Institutes of Health between 1990 and 1999 and 144 matched articles published between 1996 and 2010, tracing the production of biomedical knowledge from study design to published findings. This is also the first study to look at whether the NIH Inclusion Mandate, which went into effect in June of 1994, changed the way investigators research and write about racial and ethnic differences. In following this knowledge production process, we explore how scientists "deliver" on their research proposal goals. In addition, we provide insight into whether and how state policies directed at guiding research practices can shape output. [ABSTRACT FROM AUTHOR]

The STD experiments in Guatemala from 1946-1948 have earned a place of infamy in the history of medical ethics. But if the Guatemala STD experiments were so "ethically impossible; how did the U.S. government approve their funding? Although much of the literature has targeted the failings of Dr. John Cutler, we focus on the institutional context and research ethos that shaped the outcome of the research. After the end of WWII, Dr. Cassius Van Slyke reconstructed the federal research contracts process into a grant program. The inaugural NIH study section recommended approval of the Guatemala STD experiments at its first meeting. The funding and oversight process of the Guatemala research was marked with serious conflicts of interest and a lack of oversight, and it was this structure, as opposed to merely a maleficent individual, that allowed the Guatemala STD experiments to proceed. We conclude that while current research regulations are designed to prevent the abuses perpetrated on the subjects of the Guatemala STD experiments, it takes a comprehensive understanding of research ethics through professional education to achieve the longstanding ideal of the responsible investigator, and ensure ethical research under any regulatory scheme. [ABSTRACT FROM AUTHOR]

Background:Research has generally examined institutional review boards (IRBs) in isolation, but critical questions arise of how these entities fit into the larger institutional contexts in which they operate and what the implications may be.Methods:Semistructured interviews were conducted with leaders of IRBs from among the top 240 institutions receiving funding from the National Institutes of Health.Results:Interviewees felt that institutions may affect IRBs through both broad, indirect features (e.g., size, type of research, and culture of the institution), and more direct, IRB-related factors (e.g., amount of leadership and resource support for the IRB). Interviewees thought that institutional support of IRBs ranged from financial to nonfinancial, and direct to indirect, and that these institutional factors can mold amounts of IRB staff and education, audits, education of principal investigators (PIs), and tensions IRBs had to address. Respondents felt that these factors can in turn potentially affect IRB reviews of protocols and interactions with PIs. Within the complex systems of an institution, IRBs felt that PIs’ experiences and complaints about the IRB to institutional leaders may also shape how the institution related to the IRB.Conclusions:These data are the first to show how IRBs perceive themselves as working within the contexts of dynamic local institutional relationships and systems that pose challenges and tensions that can potentially affect critical aspects of IRB functioning. The findings have implications for practice, future research, and policy. [ABSTRACT FROM PUBLISHER]

Context: In connection with health care reform, the U.S. Department of Health and Human Services commissioned a 'mystery shopper,' or simulated patient study, to measure access to primary care. But the study was shelved because of public controversy over 'government spying' on doctors. Opponents of the study also raised ethical concerns about the use of deception with human subjects without soliciting their informed consent. Methods: We undertook an ethical analysis of the use of simulated patient techniques in health services research, with a particular focus on research measuring access to care. Using a case study, we explored relevant methodological considerations and ethical principles relating to deceptive research without informed consent, as well as U.S. federal regulations permitting exceptions to consent. Findings: Several relevant considerations both favor and oppose soliciting consent for simulated patient studies. Making research participation conditional on informed consent protects the autonomy of research subjects and shields them from unreasonable exposure to research risks. However, scientific validity is also an important ethical principle of human subjects research, as the net risks to subjects must be justified by the value to society of the knowledge to be gained. The use of simulated patients to monitor access is a naturalistic and scientifically sound experimental design that can answer important policy-relevant questions, with minimal risks to human subjects. As interaction between researchers and subjects increases, however, so does the need for consent. Conclusions: As long as adequate protections of confidentiality of research data are in place, minimally intrusive simulated patient research that gathers policy-relevant data on the health system without the consent of individuals working in that system can be ethically justified when the risks and burdens to research subjects are minimal and the research has the potential to generate socially valuable knowledge. [ABSTRACT FROM AUTHOR]

Genomic biobanks present ethical challenges that are qualitatively unique and quantitatively unprecedented. Many critics have questioned whether the current system of informed consent can be meaningfully applied to genomic biobanking. Proposals for reform have come from many directions, but have tended to involve incremental change in current informed consent practice. This paper reports on our efforts to seek new ideas and approaches from those whom informed consent is designed to protect: research subjects. Our model emerged from semi-structured interviews with healthy volunteers who had been recruited to join either of two biobanks (some joined, some did not), and whom we encouraged to explain their concerns and how they understood the relationship between specimen contributors and biobanks. These subjects spoke about their DNA and the information it contains in ways that were strikingly evocative of the legal concept of the trade secret. They then described the terms and conditions under which they might let others study their DNA, and there was a compelling analogy to the commonplace practice of trade secret licensing. We propose a novel biobanking model based on this trade secret concept, and argue that it would be a practical, legal, and ethical improvement on the status quo. [ABSTRACT FROM AUTHOR]

Background: Ethical concerns were identified as a potential barrier to advancing palliative and end-of-life science at the 2004 National Institutes of Health State of the Science Meeting. However, data are lacking about the nature of ethical concerns and strategies for balancing the need to advance science with human subjects protections. Methods: A qualitative case-study design was used to follow 43 end-of-life studies from proposal development through the review process and implementation. Investigators participated in semi-structured telephone interviews and provided document data regarding their experiences with grant and IRB reviews. Using constant comparative analysis within and across cases, the investigators identified commonly encountered and unique concerns and strategies for managing these concerns. Findings: Investigator strategies fell into two broad categories: 1) Recruitment and consent strategies related to subject identification and enrollment; and 2) Protocol-related strategies related to the process of data collection. These strategies shared the overarching meta-themes of compassion, as evidenced by a heightened sensitivity to the needs of the population, coupled with vigilance, as evidenced by close attention to the possible effects of study participation on the participants' well-being, clinical care, and the needs of research staff. Conclusions: Ethical concerns have led to the development of compassionate and vigilant strategies designed to balance the potential for risk of harm with the need to advance the science of palliative and end-of-life care. These strategies can be used by investigators to address ethical concerns and minimize barriers to the development of palliative and end-of-life care science. [ABSTRACT FROM AUTHOR]

In 2010, randomized controlled trials (RCTs) of two different biomedical strategies to prevent HIV infection had positive findings. However, despite ongoing very high levels of HIV infection in some countries and population groups, it has been made clear by regulatory authorities that the evidence remains insufficient to support either product being made available outside of research contexts in the developing world for at least two years. In addition, prevention trials in endemic areas will continue to test new interventions against placebo. But the judgments of evidentiary standards are never value-neutral. Using the recent trials and their contexts as case studies, we examine the basis for these decisions, which will potentially delay access to scientific innovation to the people who are most urgently in need of it. [ABSTRACT FROM AUTHOR]

Background: Informed consent is required in most clinical research with humans. While federal regulations state consent information should be understandable to participants, concerns have been raised that consent forms are overly long and complex.Design: Consent forms from 2006 HIV network trials sponsored by the National Institutes of Health (NIH), Division of AIDS (DAIDS), were analyzed for complexity and length. Comparisons were made between US and international sites, template and site forms, adult and pediatric trials, and trial type. How randomization and placebos were explained was examined as these are frequently misunderstood.Results: One hundred twenty-four consent forms (21 template and 103 site forms) were reviewed. Median readability was 9.2 grade level, although confidentiality sections were 12.35 median grade level. International sites' forms had lower readability than US forms (p = 0.025), template forms had lower readability than site forms (p = 0.046), and adult forms were less complex than pediatric (parent) forms (p < 0.0001). Median length of all forms was 22.4 pages; the 85 forms from adult studies had a median length of 27.4 pages. Sections describing randomization were a median length of 53 words.Conclusions: Consent forms are extremely long, exceeding recommendations for how much information readily can be processed. Networks should consider providing shorter consent templates, consistent with federal recommendations, given that sites' forms are based on these models. Further research should examine whether forms emphasizing key information (rather than providing details about all aspects of the research) improve understanding of research. [ABSTRACT FROM AUTHOR]

Objectives. We assessed attitudes and opinions of members of newborn blood screening (NBS) advisory committees regarding the storage and secondary research use of residual specimens from NBS. Methods. We conducted focus groups in 2008 and 2009 with NBS advisory committees (4 focus groups; n = 39 participants) in the Mountain States region (i.e., AZ, CO, MT, NM, NV, TX, UT, and WY). Results. Participants identified several challenges to implementing policies for storage of and research on residual newborn blood specimens. Themes that emerged from the data were public health relevancy; improvement of parental knowledge; impact of enhanced parental involvement; concerns over ownership, privacy, and confidentiality; identification of secondary research uses; and role of advisory committees. Conclusions. Participants indicated that secondary uses of residual specimens entailed opportunities for improvements in NBS programs but also carried significant risks for their programs. Addressing concerns from stakeholders will be necessary for state-level adoption of national recommendations. [ABSTRACT FROM AUTHOR]

Flame retardant chemicals, used in many furniture and electronic products to slow combustion, are an example of science and policy problems related to chemical usage. Drawing on a literature review and interviews with stakeholders, we argue that early warnings of the health hazards some flame retardants pose were not heeded as their use expanded to different products. Continued use of flame retardants coincides with their increased presence in people and adverse human health effects. We recommend policy changes applicable to oversight of chemicals in general: examining classes of chemicals rather than individual ones, assessing alternative methods and materials, product labeling, and stronger regulation. [ABSTRACT FROM AUTHOR]

The article discusses a study which analyzed the validity and reliability of the Research Attitudes Questionnaire (RAQ) as a tool for measuring how people perceive biomedical research. The RAQ is referred to as a significant scale or predictor of the attitudes of the public and willingness to participate in research. The study determined the internal consistency and dimensionality of the scale through the use of a large Internet-based sample from the U.S.

Background: The Framingham Heart Study (henceforth Framingham) is among the gold standards for epidemiological research. Being a prospective cohort study of 5,000+ men and women, it provided early findings about the causes of coronary heart disease (CHD), following a cohort over the course of 24 years. After US government funding ended, the tobacco industry funded Council for Tobacco Research (CTR) provided continued funding for analyses related to smoking.Objective: This study sought to understand the tobacco industry's motivation and activities in funding Framingham.Study Design and Setting: We analyzed previously undisclosed tobacco industry documents, conducting iterative searches of the Legacy Tobacco Documents Library (http://legacy.library.ucsf.edu/), and assembled a historical case study.Results: CTR funded Framingham to obtain full access to Framingham data. CTR planned for long-time industry consultant Carl Seltzer to reanalyze them to suggest that tobacco-related morbidity and mortality primarily resulted from "constitutional" factors, such as age or ethnicity. Once data were obtained, CTR terminated funding for the Framingham principal investigator, who disagreed with Seltzer. Seltzer's critical analyses of subsequently published work by the Framingham team created confusion about the association between CHD and cigarette smoking.Conclusion: Researchers accepting tobacco industry funding risk losing control of data, analysis, and publication. [ABSTRACT FROM AUTHOR]

The article focuses on the call of the National Council of Teachers of Mathematics (NCTM) Research Committee to address issues on connection and coherence practice as the key to improve mathematics education. It states that the Research Agenda Conference example shows the connection complexities between research and practice by answerable questions or will be valuable to answer. It mentions that cycle of innovation would be useful to map the potential effect of research on practice of which tool is developed for analysis of research priorities, phases, and balance at the U.S. National Science Foundation while a logic model may be useful in connecting research and practice by the use program evaluation focused on interventions that are beyond the direct control of researchers.

Abstract: Bioethicists have warned against the dangers of mixing research with treatment. They are concerned that research priorities may take precedence over individual patient needs and that research subjects tend to misunderstand the purpose of research or overestimate the direct medical benefits of participating in studies. Yet, other work has questioned whether clinical research can always be separated from therapeutic benefit for participants. Using in-depth interviews with participants in two phase III randomized U.S. clinical trials for methamphetamine dependency, we examine the treatment options available to participants, their experiences with participating in the trials, and potential problems of trial participation. We find that while participants have experience with four alternative treatment modalities – quitting alone, support groups, in-patient treatment facilities, and consulting primary care physicians – the randomized clinical trials compare favorably to alternatives because they provide access to evidence-based behavioral treatments, specialized medical professionals, non-judgmental staff, and the possibility of receiving an experimental drug. We conclude that while randomized clinical trials are imperfect substitutes for clinical care, they constitute a fragile and sporadic therapeutic niche in a country with fundamental problems in access to health care, a mixed punitive-therapeutic drug addiction policy, and a profit-driven pharmaceutical development and approval process. [Copyright &y& Elsevier]

The article cites a survey of U.S. Research Ethics Board (REB) administrators regarding the required inclusion of women, minorities, and children by the U.S. National Institutes of Health (NIH). It presents a background of the inclusion guidelines for NIH-sponsored researches. It examines the methodology in deriving the information for the REB's reactions on the inclusion guideline. Furthermore, it also states that 63% of the respondents have researches sponsored by the federal government.

The article highlights several commentaries in response to the articles presented at the "American Ethnologists Forum" in the U.S. Some commentaries formulates the distinctive features of participant-observation fieldwork by considering unfunded research at home. It analyzes the conjuncture of research style and the existing U.S. system for regulating research ethics. There are comments that marked the ineffectively of the U.S. systems regarding the support it provides for ethnographic practice.

Context: Sequencing of the human genome provides an immense resource for studies correlating DNA variation and epidemiology. However, appropriately powered genetic epidemiology studies often require recruitment from multiple sites.Objectives: To document the burden imposed by review of multicenter studies and to determine the variability among local institutional review boards (IRBs) in the approval of a multicenter genetic epidemiology study.Design: A PubMed search was performed to determine the frequency of citations of multicenter studies by 5-year intervals from 1974 through 2002. A 7-question survey was sent to all participating study centers to obtain information on frequency of IRB meetings, dates for submission and approval, use/nonuse of a specific consent form, type of review performed, types of consent forms required, preparation time, and number of changes requested by the IRB at each center. Centers also provided a copy of all consent forms they generated and IRB correspondence regarding the study.Setting and Participants: Thirty-one of 42 cystic fibrosis care centers in this single US multicenter genetic epidemiology study of cystic fibrosis replied, yielding a 74% response rate.Main Outcome Measures: Frequency of published research studies and consistency among IRBs.Results: The number of all published single-center studies has increased 1.3-fold since 1985, while the number of published epidemiology and genetic epidemiology multicenter studies increased by 8- and 9-fold, respectively, during this same period. Evaluation of the risk of the same genetic epidemiology study by 31 IRBs ranged from minimal to high, resulting in 7 expedited reviews (23%) and 24 full reviews (77%). The number of consents required by the IRBs ranged from 1 to 4; 15 IRBs (48%) required 2 or more consents, while 10 (32%) did not require assent for children. The most common concern (52%) of IRBs pertained to the genetic aspects of the study.Conclusions: Review of a protocol for a multicenter genetic epidemiology study by local IRBs was highly variable. Lack of uniformity in the review process creates uneven human subjects protection and incurs considerable inefficiency. The need for reform, such as the proposed centralized review, is underscored by the ever increasing rate of genetic discoveries facilitated by the Human Genome Project and the unprecedented opportunity to assess the relevance of genetic variation to public health. [ABSTRACT FROM AUTHOR]

A medical statistician's routine professional activities are likely to have important ethical consequences. This is due in part to the fact that good medical practice and scientifically valid medical research both require as precursors high quality statistical design and data analysis. In this paper I discuss various ethical issues that I have encountered while working as a biostatistician at M.D. Anderson Cancer Center. I describe particular experiences and the ethical issues involved. Topics include medical decision making, benefit-harm trade-offs, safety monitoring, adaptive randomization, informed consent, and publication bias. [ABSTRACT FROM AUTHOR]

The recent controversy at Virginia Commonwealth University involving research ethics raises important and complex issues in survey and pedigree research. The primary questions are whether family members of survey respondents themselves become subjects of the project and if they are subjects whether informed consent must be obtained for investigators to retain private information on these individuals. This article provides an analysis of the ethical issues and regulatory standards involved in this debate for consideration by investigators and institutional review boards. The analysis suggests that strong protections for the rights and welfare of subjects and their family members can be incorporated into survey and pedigree research protocols without hindering projects with extensive consent requirements. [ABSTRACT FROM AUTHOR]

Context: The professional integrity of scientists is important to society as a whole and particularly to disciplines such as medicine that depend heavily on scientific advances for their progress.Objective: To characterize the professional norms of active scientists and compare them with those of individuals with institutional responsibility for the conduct of research.Design: A mailed survey consisting of 12 scenarios in 4 domains of research ethics. Respondents were asked whether an act was unethical and, if so, the degree to which they considered it unethical and to select responses and punishments for the act.Participants: A total of 924 National Science Foundation research grantees in 1993 or 1994 in molecular or cellular biology and 140 representatives from the researchers' institutions to the US Department of Health and Human Services Office of Research Integrity.Main Outcome Measures: Percentage of respondents considering an act unethical and the mean malfeasance rating on a scale of 1 to 10.Results: A total of 606 research grantees and 91 institutional representatives responded to the survey (response rate of 69% of those who could be contacted). Respondents reported a hierarchy of unethical research behaviors. The mean malfeasance rating was unrelated to the characteristics of the investigator performing the hypothetical act or to its consequences. Fabrication, falsification, and plagiarism received malfeasance ratings higher than 8.6, and virtually all thought they were unethical. Deliberately misleading statements about a paper or failure to give proper attribution received ratings between 7 and 8. Sloppiness, oversights, conflicts of interest, and failure to share were less serious still, receiving malfeasance ratings between 5 and 6. Institutional representatives proposed more and different interventions and punishments than the scientists.Conclusions: Surveyed scientists and institutional representatives had strong and similar norms of professional behavior, but differed in their approaches to an unethical act. INSET: Scenario. [ABSTRACT FROM AUTHOR]

The authors reflect on the article "The Diverse Ethics of Translational Research," by Neema Sofaer and Nir Eyal. In the article the authors offer their opinions on several arguments and assertions that are contained in Sofaer and Eyal's article and on the bioethics that are associated with post-approval research in translational science.

A letter to the editor is presented in response to the article "The Diverse Ethics of Translational Research," by N. Sofaer and N. Eyal.

A letter to the editor is presented in response to an article which was written by David Hunter and James Wilson.

An introduction is presented in which the authors discuss the supplemental issue of the journal which examines the replication typology and guidelines for adolescent pregnancy prevention programs in America, as well as the U.S. Department of Health and Human Services' Office of Adolescent Health.

In this article the author discusses aspects of the U.S. PolyHeme clinical trial in which unconscious trauma patients received blood substitutes. The author notes a policy by the U.S. Food and Drug Administration (FDA) in which an experimental product can be given to patients without prior informed consent if a study meets FDA requirements for emergency research. An overview of the safety and ethical concerns of the policy are presented.

In this article the author reflects on the 20th anniversary of the National Institutes of Health (NIH) Revitalization Act of 1993 and on a provision of the law that directed the NIH to establish guidelines for the inclusion of women and members of minority groups in clinical research. In the article the author offers his opinions on the ethical issues associated with research and minorities and on the challenges that are associated with conducting ethically responsible research with minorities.