American Academy of Pediatrics (AAP) and American College of Medical Genetics (ACMG) recently provided two recommendations about predictive genetic testing of children. The Clinical Sequencing Exploratory Research Consortium's Pediatrics Working Group compared these recommendations, focusing on operational and ethical issues specific to decision making for children. Content analysis of the statements addresses two issues: (1) how these recommendations characterize and analyze locus of decision making, as well as the risks and benefits of testing, and (2) whether the guidelines (...) conflict or come to different but compatible conclusions because they consider different testing scenarios. These statements differ in ethically significant ways. AAP/ACMG analyzes risks and benefits using best interests of the child and recommends that, absent ameliorative interventions available during childhood, clinicians should generally decline to order testing. Parents authorize focused tests. ACMG analyzes risks and benefits using the interests of the child and other family members and recommends that sequencing results be examined for additional variants that can lead to ameliorative interventions, regardless of age, which laboratories should report to clinicians who should contextualize the results. Parents must accept additional analysis. The ethical arguments in these statements appear to be in tension with each other. (shrink)

Research question and aimClinical Ethics Committees (CECs) aim to support healthcare professionals (HPs) and healthcare organizations to deal with the ethical issues of clinical practice. In 2020,...

It is well established that demographic representation in clinical research is important for understanding the safety and effectiveness of novel therapeutics and vaccines in diverse patient populations. In recent years, the National Institutes of Health and Food and Drug Administration have issued guidelines and recommendations for the inclusion of women, older adults, and racial and ethnic minorities in research. However, these guidelines fail to provide an adequate explanation of why racial and ethnic representation in clinical (...) class='Hi'>research is important. This article aims to both provide the missing arguments for why adequate representation of racial and ethnic minorities in clinical research is essential and to articulate a number of recommendations for improving diversity going forward.Appropriate racial and ethnic representation and fair inclusion help (1) increase the generalisability of clinical trial results, (2) equitably distribute any benefits of clinical research and (3) enable trust in the research enterprise. (shrink)

The Belmont Report was written by a US Commission charged by the US Congress to advise on research supported by the US government. Its focus was understandably domestic. In the 40 years since its publication, clinical research has become increasingly international. Many clinical trials have sites in multiple countries, and many of the host countries are relatively impoverished. Such research raises some distinctive ethical issues. This paper outlines some of the key ethical challenges that have (...) been raised by clinical research conducted in low- and middle-income countries (LMICs) and sponsored by high-income country (HIC) institutions. It then considers whether the Belmont Report has the resources to address these problems and argues that it does not. The article closes by noting some parallels between this international research and domestic US research, which suggest that the US might benefit from the discussions abroad. (shrink)

In this book, Dr. Robert J. Levine reviews federal regulations, ethical analysis, and case studies in an attempt to answer these questions.

Concerns about exploiting the poor or economically disadvantaged in clinical research are widespread in the bioethics community. For some, any research that involves economically disadvantaged individuals is de facto ethically problematic. The economically disadvantaged are thought of as “venerable” to exploitation, impaired decision making, or both, thus requiring either special protections or complete exclusion from research. A closer examination of the worries about vulnerabilities among the economically disadvantaged reveals that some of these worries are empirically or (...) logically untenable, while others can be better resolved by improved study designs than by blanket exclusion of poorer individuals from research participation. The scientific objective to generate generalisable results and the ethical objective to fairly distribute both the risks and benefits of research oblige researchers not to unnecessarily bar economically disadvantaged subjects from clinical research participation. (shrink)

This book discusses 'how' to respectfully and responsibly include pregnant women in clinical research. In sharp contrast, the existing literature predominantly focuses on the reasons 'why' the inclusion of pregnant women in clinical research is necessary - viz., to develop effective treatments for women during pregnancy, to promote fetal safety, to reduce harm to women and fetuses from suboptimal care, and to allow access to the benefits of research participation. This book supports the shift to (...) a new default position, whereby pregnant women are included in clinical research unless researchers argue convincingly for their exclusion. This shift raises many as yet unexplored ethical and policy questions about existing barriers to the equitable inclusion of pregnant women in research. This book is original in three key ways. First, it presents an unparalleled depth of analysis of the ethics of research with pregnant women, bringing together many of the key authors in this field as well as experts in research ethics and in vulnerability who have not previously applied their work to pregnant women. Second, it includes innovative theoretical work in ethics and disease specific case studies that highlight the current complexity and future challenges of research involving pregnant women. Third, the book brings together authors who argue both for and against including more pregnant women in formal clinical trials. (shrink)

Starting research -- Enrolling research participants -- Protecting research participants -- Conducting research with vulnerable populations -- Balancing clinical research and clinical care -- Navigating interpersonal difficulties -- Ending research.

Since its introduction in 1987, Benjamin Freedman’s principle of clinical equipoise has enjoyed widespread uptake in bioethics discourse. Recent years, however, have witnessed a growing consensus that the principle is fundamentally flawed. One of the most vocal critics has undoubtedly been Franklin Miller. In a 2008 paper, Steven Joffe and Miller build on this critical work, offering a new conception of clinical research ethics based on science, taking what they call a “scientific orientation” toward the ethics of (...) clinical research. Though there is much to recommend Joffe and Miller’s scientifically oriented conception of clinical research ethics, I believe that both the critical and constructive projects suffer from the same basic mistake: inattention to context. The internal norms of science cannot be fully specified, let alone satisfied, independently of contextual (external) factors that only come into view when we are attentive to the particular context of that form of inquiry. (shrink)

This article addresses two areas of continuing controversy about consent in clinical research: the question of when consent to low risk research is necessary, and the question of when consent to research is valid. The article identifies a number of considerations relevant to determining whether consent is necessary, chief of which is whether the study would involve subjects in ways that would (otherwise) infringe their rights. When consent is necessary, there is a further question of under (...) what conditions consent is valid or successful in waiving a right. The most influential account of validity conditions is non-moralized, in the sense that the conditions make no essential reference to whether the researcher soliciting consent has obtained it in a way that wrongs the subject. The article examines the implications of this account, and compares it with recent accounts that moralize some of the validity conditions. -/- . (shrink)

At least since the seminal work of the (US) National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in the 1970s, a fundamental distinction between research and practice has underwritten both conceptual work in research ethics and regulations governing research involving human subjects. Notwithstanding its undoubted historical importance, I believe the distinction is problematic because it misrepresents clinical inquiry. In this essay, I aim to clarify the character of clinical inquiry (...) by identifying crucial contextual constraints on justification constitutive of clinical science. This analysis shows that, from an epistemological point of view, clinical research and clinical practice are not sharply distinct but intimately intertwined. This result is important in its own right—an enriched understanding of the epistemology of clinical research is valuable in and of itself. But this result is also important because it has profound implications for the ethics of human subjects research. (shrink)

Background: Only data of published study results are available to the scientific community for further use such as informing future research and synthesis of available evidence. If study results are reported selectively, reporting bias and distortion of summarised estimates of effect or harm of treatments can occur. The publication and citation of results of clinical research conducted in Germany was studied.Methods: The protocols of clinical research projects submitted to the research ethics committee of the (...) University of Freiburg in 2000 were analysed. Published full articles in several databases were searched and investigators contacted. Data on study and publication characteristics were extracted from protocols and corresponding publications.Results: 299 study protocols were included. The most frequent study design was randomised controlled trial , followed by uncontrolled studies , laboratory studies and non-randomised studies . 182 were multicentre studies including 97 international collaborations. 152 of 299 had commercial funding and 46 non-commercial funding. 109 of the 225 completed protocols corresponded to at least one full publication ; the publication rate was 48%. 168 of 210 identified publications were cited in articles indexed in the ISI Web of Science. The median was 11 citations per publication .Conclusions: Results of German clinical research projects conducted are largely underreported. Barriers to successful publication need to be identified and appropriate measures taken. Close monitoring of projects until publication and adequate support provided to investigators may help remedy the prevailing underreporting of research. (shrink)

ABSTRACT An ethical analysis of Jordan's Clinical Research Law, which became effective in 2001, was performed. Accordingly, this paper discusses the major components, key strengths and weaknesses of this law. As an initial effort, the Law addresses important aspects of research ethics and, hence, should serve as an example for other Arab Countries in the Middle East. Unique aspects of the Law include the requirement that those conducting any study have insurance that can compensate for research (...) injuries and a system of fines and punishments for noncompliance with the Law. There are, however, some key items missing in the Jordanian Law. For example, the Law does not mention the requirement of a favourable assessment of risks and benefits, the fair selection of subjects, or articles regarding the protection of the rights and welfare of children and other vulnerable subjects participating in research. The paper concludes with the suggestion that new amendments should be considered for future revisions of the Clinical Research Law in Jordan. (shrink)

(2002). Clinical Research Should Not Be Permitted to Escape the Ethical Orbit of Clinical Care. The American Journal of Bioethics: Vol. 2, No. 2, pp. 27-28.

This article investigates whether or not theories of justice from political philosophy, first, support the position that health research should contribute to justice in global health, and second, provide guidance about what is owed by international clinical research (ICR) actors to parties in low- and middle-income countries. Four theories—John Rawls's theory of justice, the rights-based cosmopolitan theories of Thomas Pogge and Henry Shue, and Jennifer Ruger's health capability paradigm—are evaluated. The article shows that three of the four (...) theories require the conduct of health research for justice in global health. The theories help identify the ends of justice to which ICR is to contribute, but they cannot tell us how to organize ICR to promote these ends. Aside from Ruger's health capability paradigm, the theories also lack an allocative principle for assigning specific duties to specific actors. This creates difficulties for establishing obligations for certain types of ICR actors. (shrink)

We argue that charging people to participate in research is likely to undermine the fundamental ethical bases of clinical research, especially the principles of social value, scientific validity, and fair subject selection.

Clinical research must be understood to be the foundation of scientific medicine of the clinical type. But the essence of scientific clinical medicine remains a matter of profound confusion, even in clinical academia, and so does the essence of clinical research. The confusion now revolves, principally, around ‘clinical epidemiology’. We address clinical research in the meaning of quintessentially ‘applied’ clinical research, which we take to be the foundation of (...) the scientific knowledge base of clinical medicine, of gnosis (dia‐, etio‐, pro‐) in it. More specifically, we address the essence, priorities, and status quo of this research – and argue that the requisite theory of this is not a matter of ‘clinical epidemiology’ but of theory of clinical research endogenous to clinical (rather than epidemiological) academia. (shrink)

This paper comments on Polish legal guarantees for diseased persons with reference to the hazards that accompany experimental treatment. While acknowledging that participation in a clinical research program provides patients with additional opportunities for advanced treatment, the paper also points out that systems for monitoring patients participating in experimental treatment require improvement.

The nature of the relationship between clinical investigator and research participant continues to be contested. The related discussions have largely focused on the doctor-researcher dichotomy thought to permeate the work of a clinical investigator with research participants, whom in turn occupy two corresponding roles: patient and subject. This paper contributes to current debates on the topic by providing a voice to research participants, whose perspectives have been largely invisible. It draws on 42 in-depth interviews conducted (...) in Ghana and South Africa with respondents at different stages of involvement in clinical research, ranging from no experience in clinical research to enrollment in several clinical trials. The perspectives of all respondents were largely congruent and rooted in the common view that clinical research contributed to the improvement of local health. They went beyond the researcher/participant versus doctor/patient dichotomy, long established in research ethics, and preferred to view participants and investigators as partners working together to find ways to address local health needs. The conceptualization of investigator-participant relations as a partnership reinforced expectations of care, transparency and accountability, which were viewed as necessary expressions of mutuality and respect within equal collaborations. It is important to engage with these views in order to avoid antagonizing societal expectations and to build up long-term public trust, crucial for the continuous operation of clinical research. (shrink)

Gaining ethical clearance to conduct a study is an important aspect of all research involving humans but can be time-consuming and daunting for novice researchers. This article stems from a larger ethnographic study that examined research capacity building in Irish nursing and midwifery. Data were collected over a 28-month time frame from a purposive sample of 16 nurse or midwife research fellows who were funded to undertake full-time PhDs. Gaining ethical clearance for their studies was reported as (...) an early ‘rite of passage’ in the category of ‘labouring the doctorate’. This article penetrates the complexities in Irish clinical research ethics by describing the practices these nurse and midwife researchers encountered and the experiences they had. The key issue of representation that occurred in the context of ‘medicalized’ research ethics is further explored including its meaning for nursing or midwifery research. (shrink)

Although informed consent is important in clinical research, questions persist regarding when it is necessary, what it requires, and how it should be obtained. The standard view in research ethics is that the function of informed consent is to respect individual autonomy. However, consent processes are multidimensional and serve other ethical functions as well. These functions deserve particular attention when barriers to consent exist. We argue that consent serves seven ethically important and conceptually distinct functions. The first (...) four functions pertain principally to individual participants: (1) providing transparency; (2) allowing control and authorization; (3) promoting concordance with participants' values; and (4) protecting and promoting welfare interests. Three other functions are systemic or policy focused: (5) promoting trust; (6) satisfying regulatory requirements; and (7) promoting integrity in research. Reframing consent around these functions can guide approaches to consent that are context sensitive and that maximize achievable goals. (shrink)

Problems with clinical research that create conflicts between doctors' therapeutic and research obligations may be fueled by a rigid view of science as determiner of truth, a heavy reliance on statistics, and certain features of randomized clinical trials. I suggest some creative, feminist approaches to such research and explore ways to provide choice for patients and to use values in directing both therapy and science - to enhance the effectiveness of each.

An ethical analysis of Jordan's Clinical Research Law, which became effective in 2001, was performed. Accordingly, this paper discusses the major components, key strengths and weaknesses of this law. As an initial effort, the Law addresses important aspects of research ethics and, hence, should serve as an example for other Arab Countries in the Middle East. Unique aspects of the Law include the requirement that those conducting any study have insurance that can compensate for research injuries (...) and a system of fines and punishments for noncompliance with the Law. There are, however, some key items missing in the Jordanian Law. For example, the Law does not mention the requirement of a favourable assessment of risks and benefits, the fair selection of subjects, or articles regarding the protection of the rights and welfare of children and other vulnerable subjects participating in research. The paper concludes with the suggestion that new amendments should be considered for future revisions of the Clinical Research Law in Jordan. (shrink)

Fraud is often coupled with misconduct and the two are certainly related; fraud by definition is misconduct, but not all misconduct is fraud. Fraud always contains intent whilst misconduct covers a wide range of activities, from carelessness, right through to deliberate deception. It is vitally important that fraud and misconduct, once suspected, are reported and fully investigated. But unless everyone involved in research at any level accepts the possibility that fraud exists, there will still be research fraud, and (...) patients will continue to be abused and put at risk. (shrink)

Comprehensive in scope and research, this book will be a crucial resource for researchers in the medical sciences, as well as teachers and students alike.

Nanomedicine promises unprecedented innovations for diagnosis and therapy as well as for predicting and preventing diseases. On the other hand it raises fears linked to new and unknown characteristics of nanoscale materials. Both, promises and fears, are closely linked to the realm of uncertainty. To a large extent it is currently not known which expectations could become reality and which suspected adverse events might come true. Medicine is quite familiar with decision-making under uncertainty. Rules and regulations for clinical (...) class='Hi'>research have been developed to reduce possible harm for research participants without abandoning necessary investigations. Here we examine whether clinical research trials of nanomedicine need new regulations and conclude that the established rules should suffice. (shrink)

Innovative practice occurs when a clinician provides something new, untested, or nonstandard to a patient in the course of clinical care, rather than as part of a research study. Commentators have noted that patients engaged in innovative practice are at significant risk of suffering harm, exploitation, or autonomy violations. By creating a pathway for harmful or nonbeneficial interventions to spread within medical practice without being subjected to rigorous scientific evaluation, innovative practice poses similar risks to the wider community (...) of patients and society as a whole. Given these concerns, how should we control and oversee innovative practice, and in particular, how should we coordinate innovative practice and clinical research? In this article, I argue that an ethical approach to overseeing innovative practice must encourage the early transition to rigorous clinical research without delaying or deferring the development of beneficial innovations or violating the autonomy rights of clinicians and their patients. (shrink)

Volume 20, Issue 2, February 2020, Page 38-41.

The revelation that data obtained for the US-based National Surgical Adjuvant Breast and Bowel Project (NSABP) from subjects enrolled at Hôpital Saint-Luc in Montreal was falsified has eroded public trust in research. Institutions can educate researchers and help prevent unethical research practices by establishing procedures to monitor research involving human subjects. Research monitoring encompasses four categories of activity: annual reviews of continuing research, monitoring of informed consent, monitoring of adherence to approved protocols and monitoring of (...) the integrity of data. The authors describe characteristics of research projects that may call for monitoring procedures in each category. The form taken by such monitoring depends on the nature of the protocol. Although appropriate research monitoring requires substantial investment of personnel and financial resources, it is required under guidelines regulating research involving human subjects in Canada. Research monitoring is a step forward in re-establishing public confidence in medical research. (shrink)

(2002). Clarifying the Ethics of Clinical Research: A Path toward Avoiding the Therapeutic Misconception. The American Journal of Bioethics: Vol. 2, No. 2, pp. 22-23.

In response to calls to expand the scope of research ethics to address justice in global health, recent scholarship has sought to clarify how external research actors from high-income countries might discharge their obligation to reduce health disparities between and within countries. An ethical framework—‘research for health justice’—was derived from a theory of justice (the health capability paradigm) and specifies how international clinical research might contribute to improved health and research capacity in host communities. (...) This paper examines whether and how external funders, sponsors, and researchers can fulfill their obligations under the framework. (shrink)

During a pandemic, where there is widespread human infection, various and varying measures are taken that are targeted at public health objectives. During the early stages of a pandemic, these objectives may focus on containing the disease and minimizing its spread, but they may switch to mitigation as the emergent infectious disease takes hold in a population. There has been considerable debate and elucidation of the ethical principles and framework for the various responses including the need to fast track (...) class='Hi'>research and vaccine development. However, the measures imposed during a pandemic would have unintended and untoward effect on ongoing clinical research. For example, precautionary measures, such as social distancing, may hamper ongoing clinical research, because recruitment and participation of patients and healthy volunteers is a potential source of virus spread. In this paper, we argue that a framework is needed to ensure the continuity of such research. Such a framework that considers the pertinent issues would need the ‘buy in’ of the key stakeholders (policy makers, funding agencies, institutional authorities, researchers and subjects) to ensure that the issues that are ethically relevant to pandemic planning would not be neglected or overlooked. (shrink)

La investigación clínica es la actividad encaminada a conocer el resultado de una intervención o un producto para el diagnóstico o la terapéutica en los seres humanos. El ensayo clínico es el principal exponente de la investigación clínica y toda evaluación experimental de una sustancia o medicamento en seres humanos. En Cuba, existe un desarrollo importante de la biotecnología y de los centros de investigación que necesitan de ensayos clínicos según estándares nacionales e internacionales. En el presente trabajo se exponen (...) aspectos relacionados con la evolución histórica de la Investigación Clínica, el Ensayo Clínico y su contexto en el país como un primer acercamiento al tema. Clinical research is just that activity to know the potential diagnostic or therapeutic nature of an intervention or a product in humans. The clinical trial is the leading exponent of clinical research and the whole experimental evaluation of a substance or drug in humans and has revolutionized medical practice around the mundo.Sus precursors date back to the XVII and XVIII centuries and evolved since this methodology until the randomized controlled clinical trial. From the fifties significant regulatory and ethical changes appear. In Cuba, there is a significant development of biotechnology and research institutions that require clinical trials to national and international standards. This paper aims to clarify aspects of the historical development of Clinical Research, Clinical Trial in Cuba and its context as a first approach to the subject. (shrink)

Introduction -- Facing up to paternalism in research ethics -- Preface to a theory of consent transactions in research : beyond valid consent -- Should we worry about money? -- Exploitation in clinical research -- The interaction principle.

The results of the first randomized controlled trial of a medical treatment were reported in 1947. The antibiotic streptomycin was demonstrated to be dramatically superior to bed rest alone in treating tuberculosis. Looking back on this trial in 1990, A. B. Hill, the distinguished medical statistician who played a prominent role in the use of randomization in this study, made a telling statement about the moral climate of clinical research at the time: "Of course, there were no ethical (...) problems in those days: we did not ask the patient’s permission or anybody’s permission. We did not tell them they were in a trial—we just did it" (1990, 78). From our perspective today it is obvious that it is not true that there .. (shrink)

Clinical research has become a burgeoning activity in recent years, largely stimulated by the pharmaceutical industry's interest in new drugs with high marketing profiles. Several other forces fuel this thrust: the increasing dependence of academic medical institutions on research funding from industry; the need for large, efficient multicenter trials to obtain reliable and statistically significant results in the shortest possible time for drug registration purposes; and access to research subjects in countries. The intense interest in HIV/AIDS (...) research and recent controversies about revisions to the Helsinki Declaration, which have been seen by some to be motivated by the desire to facilitate exploitative research in countries, have stimulated renewed interest in the ethics of clinical research. (shrink)

Jansen and Wall suggest a new way of defending hard paternalism in clinical research. They argue that non-therapeutic research exposing people to more than minimal risk should be banned on egalitarian grounds: in preventing poor decision-makers from making bad decisions, we will promote equality of welfare. We argue that their proposal is flawed for four reasons.First, the idea of poor decision-makers is much more problematic than Jansen and Wall allow. Second, pace Jansen and Wall, it may be (...) practicable for regulators to uncover the values that a potential research participant holds when agreeing to enter a research project, so their claim that we must ban such research projects for all if we are to ban them for poor decision-makers looks to be unmotivated. Third, there seem to be cases where the liberty to enter the sort of research project Jansen and Wall discuss is morally weighty, and arguably should outweigh concerns of egalitarian distribution. Fourth, banning certain types of research, which seem on the face of it to offer an unfavourable risk-benefit ratio, would have unwelcome consequences for all clinical research, which Jansen and Wall do not recognize. (shrink)

Background Protecting the privacy of research participants is widely recognized as one of the standard ethical requirements for clinical research. It is unknown, however, how research professionals regard concepts of privacy as well as the situations in the research setting that require privacy protections. The aim of this study was to explore the views of research professionals from Arab countries regarding concepts and scope of privacy that occur in clinical research. Methods We (...) adopted an exploratory qualitative approach by the use of focus group discussions. We recruited individuals involved in research from Egypt and Morocco. We analyzed focus group data via a constant comparison approach, which consisted of close reading of the transcribed interviews followed by coding and then determining themes and subthemes. Results Between August 2016 and July 2018, we conducted nine focus group discussions. Respondents discussed several privacy issues that occurred before the research began ; during research, and after the research. Respondents revealed their perspectives of patients towards privacy in the clinical and research settings and mentioned that patients are more likely to permit access to their privacy in the clinical setting compared with research setting due to the existence of benefits and trust in clinical care. Respondents also recommended training regarding data protections for individuals involved in research. Conclusions Our study shows that research professionals discussed a range of privacy issues that are present during the different stages of research. We recommend 1) development of standards regarding privacy protections during recruitment efforts; 2) additional training for individuals involved in research regarding best practices with data security in secondary research; 3) a quantitative study involving investigators and REC members to determine their knowledge, attitudes and practices regarding privacy issues that occur in research; and 4) a quantitative study involving patients to elicit their views regarding their privacy concerns in research. (shrink)

Chapter One: Introduction “The ethical basis of all [medical] research is that information gained from one patient's experience should, where feasible, ...

This paper aims to show that to reduce the level of exploitation present in (some) international clinical trials, research sponsors must aim to provide both an ex-ante expected gain in utility and a fair ex-post distribution of benefits for research subjects. I suggest the following principles of fair risk distribution in international research as the basis of a normative definition of fairness: (a) Persons should not be forced (by circumstance) to gamble in order to achieve or (...) protect basic goods; (b) In cases where one party is gambling with basic goods and the other party is not, the distribution of benefits and burdens must be arranged so that they are of greatest benefit to the worst off; (c) In relationships where one party is gambling for basic goods and the other party is not, the party gambling for basic goods must be assured of some guaranteed benefits in addition to the chance of gaining some potential benefits.These principles are applied to the case of HIV international research. I conclude that the research (as described) is mutually advantageous but still exploitative because the distribution of surplus benefits is unfair. It is unfair because research subjects are gambling with and for basic goods but they are not assured of a fair ex-post distribution of benefits. Principles (b) and (c) are not satisfied. Research participants are not accorded enough guaranteed benefits to outweigh the risks they undertake. (shrink)

Debates about justice in international clinical research problematically conflate two quite different forms of obligation. International research ethics guidelines were intended to describe how to conduct biomedical research in a just manner at the micro or clinical level (within the researcher-participant interaction) but have come to include requirements that are clearly intended to promote justice at the global level. Ethicists have also made a variety of claims regarding what international research should contribute to global (...) justice. This paper argues that the conflation of debates about justice at the micro and macro-levels has not only resulted in the placement of obligations upon the wrong actors but has also served to exclude relevant actors from the ethical picture. Suggestions for who should properly bear macro-level obligations of justice in international clinical research are offered. The paper further contends that, unlike researchers who violate informed consent requirements, no similar type of accountability exists for obligations of global justice, even for those obligation-bearers (incorrectly) identified by current ethics guidelines. (shrink)

There is a dilemma in modern medicine, and, as a general family practitioner, this dilemma has great impact on me as a professional with a responsibility to my patients, and on the treatments I prescribe. Every day we receive a lot of updated information about relevant issues in treatment of various conditions we encounter in our daily practice. There is a great deal of interesting, serious research; however, frequently results and conclusions are very different and at times, contradictory. It (...) is extremely difficult to evaluate updated research information, and to understand trends in current medicine. Our responsibility to our patients is to find a solution for this problem. (shrink)

As a 2006 Institute of Medicine report highlights, surprisingly little empirical attention has been paid to how prisoners arrive at decisions to participate in modern research. With our study, we aimed to fill this gap by identifying a more comprehensive range of factors as reported by prisoners themselves during semistructured interviews. Our participants described a diverse range of motives, both favoring and opposing their eventual decision to join. Many are well-recognized considerations among nonincarcerated clinical research participants, including (...) a desire for various forms of personal benefit, altruism, and concern about study risks and inconveniences. However, a number of influences seem unique to prisoners. Participants did not report that they were not coerced into enrolling, and they have even been under pressure not to enroll. However, many sought to enroll in order to obtain access to better health care, raising a concern about whether they were unfairly exploited. (shrink)