Jeremy Sugarman

Ethics and Best Practice Guidelines for Training Experiences in Global Health

Academic global health programs are growing rapidly in scale and number. Students of many disciplines increasingly desire global health content in their curricula. Global health curricula often include field experiences that involve crossing international and socio-cultural borders. Although global health training experiences offer potential benefits to trainees and to sending institutions, these experiences are sometimes problematic and raise ethical challenges. The Working Group on Ethics Guidelines for Global Health Training (WEIGHT) developed a set of guidelines for institutions, trainees, and sponsors of field-based global health training on ethics and best practices in this setting. Because only limited data have been collected within the context of existing global health training, the guidelines were informed by the published literature and the experience of WEIGHT members. The Working Group on Ethics Guidelines for Global Health Training encourages efforts to develop and implement a means of assessing the potential benefits and harms of global health training programs.

Research Ethics Recommendations for Whole-Genome Research: Consensus Statement

Interest in whole-genome research has grown substantially over the past few months. This article explores the challenging ethics issues associated with this work.

The limitations of "vulnerability" as a protection for human research participants.

Vulnerability is one of the least examined concepts in research ethics. Vulnerability was linked in the Belmont Report to questions of justice in the selection of subjects. Regulations and policy documents regarding the ethical conduct of research have focused on vulnerability in terms of limitations of the capacity to provide informed consent. Other interpretations of vulnerability have emphasized unequal power relationships between politically and economically disadvantaged groups and investigators or sponsors. So many groups are now considered to be vulnerable in the context of research, particularly international research, that the concept has lost force. In addition, classifying groups as vulnerable not only stereotypes them, but also may not reliably protect many individuals from harm. Certain individuals require ongoing protections of the kind already established in law and regulation, but attention must also be focused on characteristics of the research protocol and environment that present ethical challenges.

Trust The Fragile Foundation of Contemporary Biomedical Research

It is widely assumed that informing prospective subjects about the risks and possible benefits of research not only protects their rights as autonomous decisionmakers, but also empowers them to protect their own interests. Yet interviews with patient-subjects conducted under the auspices of the Advisory Committee on Human Radiation Experiments suggest this is not always the case. Patient-subjects often trust their physician to guide them through decisions on research participation. Clinicians, investigators, and IRBs must assure that such trust is not misplaced.

New ISSCR Guidelines Underscore Major Principles for Responsible Translational Stem Cell Research

The International Society for Stem Cell Research (ISSCR) task force that developed new Guidelines for the Clinical Translation of Stem Cells discusses core principles that should guide the responsible transition of basic stem cell research into appropriate clinical applications.

Getting Meaningful Informed Consent from Older Adults: A Structured Literature Review of Empirical Research

OBJECTIVES: To perform a structured literature review of the published empirical research on informed consent with older adults in order to make recommendations to improve the informed consent process and to highlight areas needing further examination.

Ethical goals of community consultation in research

In response to the traditional emphasis on the rights, interests, and well-being of individual research subjects, there has been growing attention focused on the importance of involving communities in research development and approval. Community consultation is a particularly common method of involving communities. However, the fundamental ethical goals of community consultation have not been delineated, which makes it difficult for investigators, sponsors, and institutional review boards to design and evaluate consultation efforts. Community consultation must be tailored to the communities in which it is conducted, but the purposes of consultation-the ethical goals it is designed to achieve-should be universal. We propose 4 ethical goals that give investigators, sponsors, institutional review boards, and communities a framework for evaluating community consultation processes.

Do Patients Treated With Dignity Report Higher Satisfaction, Adherence, and Receipt of Preventive Care?

PURPOSE Although involving patients in their own health care is known to be associated with improved outcomes, this study was conducted to determine whether respecting persons more broadly, such as treating them with dignity, has additional positive effects. METHODS Using data from the Commonwealth Fund 2001 Health Care Quality Survey of 6,722 adults living in the United States, we performed survey-weighted logistic regression analysis to evaluate independent associations between 2 measures of respect (involvement in decisions and treatment with dignity) and patient outcomes (satisfaction, adherence, and receipt of optimal preventive care). Then we calculated adjusted probabilities of these outcomes and performed stratified analyses to examine results across racial/ethnic groups. RESULTS After adjustment for respondents’ demographic characteristics, the probability of reporting a high level of satisfaction was higher for those treated with dignity vs not treated with dignity (0.70 vs 0.38, P <.001) and for those involved in, versus not involved in, decisions (0.70 vs 0.39, P <.001). These associations were consistent across all racial/ethnic groups. Being involved in decisions was significantly associated with adherence for whites, whereas being treated with dignity was significantly associated with adherence for racial/ethnic minorities. The probability of receiving optimal preventive care was marginally greater for those treated with dignity (0.68 vs 0.63, P = .054), but did not differ with respect to involvement in decisions (0.67 vs 0.67, P = .95). CONCLUSIONS Being treated with dignity and being involved in decisions are independently associated with positive outcomes. Although involving patients in decisions is an important part of respecting patient autonomy, it is also important to respect patients more broadly by treating them with dignity.

Ethical Considerations for Short-term Experiences by Trainees in Global Health

Academic Global Health Programs are Burgeon-ing.1 According to a recent review of the Web sites of 129 accredited MD-granting US medical schools2 and their parent universities, almost half (60; 47%) have established initiatives, institutes, centers, or offices for global health. These programs announce goals that include reducing disparities in global health through a combination of research, education, and service. In part responding to student demand and enthusiasm,3 many programs provide short-term training and service experiences in resource-limited settings. Nevertheless, there are important ethical considerations inherent to sending individuals from resource-replete settings for training and service experiences in resource-limited settings. However, unlike clinical research conducted across international borders, which has attracted considerable attention in the lay and scholarly literature,4,5 much less attention has been given to ethical issues associated with education and service initiatives of global health programs.6–8 We describe some of these issues so they can be addressed explicitly by those engaged in global health education and service initiatives to facilitate the goals of providing medical students, residents, and other trainees in disciplines related to global health the opportunity for international experience while minimizing unintended adverse consequences.

Variability among institutional review boards' decisions within the context of a multicenter trial

BackgroundInstitutional review boards (IRBs) are given discretion to interpret and apply the federal regulations governing the protection of human subjects in research. ObjectiveTo determine the extent of the variability among different IRBs on their approved research practices and informed consent forms within the context of a multicenter trial that used a common protocol. DesignDescriptive analysis of survey information and informed consent forms. Setting and Participants Sixteen IRBs from the institutions participating in a multicenter trial comparing lower vs. traditional tidal volume ventilation in patients with acute lung injury. MeasurementsAnalysis of survey information on IRBs’ approved research practices. Analysis of informed consent forms for the presence and the adequacy of description of each basic element of informed consent specified in the federal regulations. Reading levels of informed consent forms. Main ResultsSurveys and IRB-approved consent forms were obtained from all of the contacted IRBs (n = 16). Variability was observed among several of the research practices; one IRB waived the requirement for informed consent, five IRBs permitted telephone consent, and three IRBs allowed prisoners to be enrolled. Three consent forms contained all of the basic elements of informed consent outlined in the federal regulations, and 13 forms had varying numbers of these elements absent (six forms without one element, four without two, one without three, and two without four). Reading levels of the consent forms ranged from grades 8.2 to 13.4 (mean ± sd was 11.6 ± 1.2 grade level). ConclusionsWithin a multicenter trial, IRBs reviewing a common protocol varied in several of their approved research practices and in the extent to which the basic elements of informed consent were included in their consent forms.