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 clinicalresearch conducted in Germany was studied.Methods: The protocols of clinicalresearch 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 clinicalresearch 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)
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 clinicalresearch, ranging from no experience in clinicalresearch to enrollment in several clinical trials. The perspectives of all respondents were largely congruent and rooted in the common view that clinicalresearch 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 clinicalresearch. (shrink)
We argue that charging people to participate in research is likely to undermine the fundamental ethical bases of clinicalresearch, especially the principles of social value, scientific validity, and fair subject selection.
Background Protecting the privacy of research participants is widely recognized as one of the standard ethical requirements for clinicalresearch. 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 clinicalresearch. 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)
Clinicalresearch 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 clinicalresearch. The confusion now revolves, principally, around ‘clinical epidemiology’. We address clinicalresearch in the meaning of quintessentially ‘applied’ clinicalresearch, 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 clinicalresearch endogenous to clinical (rather than epidemiological) academia. (shrink)
Concerns about exploiting the poor or economically disadvantaged in clinicalresearch 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 clinicalresearch participation. (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 clinicalresearch 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.
ABSTRACT An ethical analysis of Jordan's ClinicalResearch 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 ClinicalResearch Law in Jordan. (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, clinicalresearch 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 clinicalresearch 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)
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 clinicalresearch ethics based on science, taking what they call a “scientific orientation” toward the ethics of (...)clinicalresearch. Though there is much to recommend Joffe and Miller’s scientifically oriented conception of clinicalresearch 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 book discusses 'how' to respectfully and responsibly include pregnant women in clinicalresearch. In sharp contrast, the existing literature predominantly focuses on the reasons 'why' the inclusion of pregnant women in clinicalresearch 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 clinicalresearch 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)
Child assent is recommended in addition to parental consent when enrolling children in clinicalresearch; however, appreciation and relevance ascribed to these concepts vary in different contexts, and information on attitudes towards storage of biological samples for future research is limited, especially in developing countries. We assessed caregivers’ understanding and appreciation of consent and assent procedures, and their attitudes towards use of stored blood samples for future research prior to enrolling a child in clinical (...) class='Hi'>research. A total of 17 in-depth interviews were conducted with primary caregivers of children at enrolment or on the immediate follow-up date. All caregivers recalled significant amount information from the study information sheet and were able to appropriately link such information to the consent process. While all participants confirmed information received prior to blood sampling as adequate, a few noted that the purpose was not sufficiently well communicated. Caregivers felt children were cognitively vulnerable, and prone to decisions that were not necessarily in their best interest. Nearly all caregivers felt it was their right and responsibility to overrule objections from their ward’s regarding enrolment into specific study or receipt of a therapeutic procedure. There were no objections or concerns regarding use of stored biological samples for future research purposes. There is thus, a need to improve understanding of caregivers on the information provided during the informed consent process. Context-specific studies on the age of assent in specific populations are needed. (shrink)
Starting research -- Enrolling research participants -- Protecting research participants -- Conducting research with vulnerable populations -- Balancing clinicalresearch and clinical care -- Navigating interpersonal difficulties -- Ending research.
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 clinicalresearch trials of nanomedicine need new regulations and conclude that the established rules should suffice. (shrink)
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)
Problems with clinicalresearch 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.
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, clinicalresearch 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 clinicalresearch 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)
As a feminist bioethicist, I have frequently wondered why the exclusion of pregnant women has been the default position for most clinicalresearch and how social values have influenced this decision. Relatedly, I wonder what responsible research involving pregnant women would look like. As a theorist who conducts research on the concept of vulnerability, I have often wanted to know why there has been so little research into the harmful effects of the routine exclusion of (...) pregnant women, including questions such as: What do pregnant women actually think about participating in research? How should we treat pregnant women and their fetuses for the purposes of consent (are they two separable persons or one complex... (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. Clinicalresearch 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 clinicalresearch 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 ClinicalResearch, 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 clinicalresearch -- The interaction principle.
In emergency research, obtaining informed consent can be problematic. Research to develop and improve treatments for patients admitted to hospital with life-threatening and debilitating conditions is much needed yet the issue of research without consent (RWC) raises concerns about unethical practices and the loss of individual autonomy. Consistent with the policy and practice turn towards greater patient and public involvement in health care decisions, in the US, Canada and EU, guidelines and legislation implemented to protect patients and (...) facilitate acute research with adults who are unable to give consent have been developed with little involvement of the lay public. This paper reviews research examining public opinion regarding RWC for research in emergency situations, and whether the rules and regulations permitting research of this kind are in accordance with the views of those who ultimately may be the most affected. (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 clinicalresearch? In this article, I argue that an ethical approach to overseeing innovative practice must encourage the early transition to rigorous clinicalresearch without delaying or deferring the development of beneficial innovations or violating the autonomy rights of clinicians and their patients. (shrink)
Although informed consent is important in clinicalresearch, 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)
An ethical analysis of Jordan's ClinicalResearch 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 ClinicalResearch Law in Jordan. (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 clinicalresearch 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)
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 clinicalresearch 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)
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 clinicalresearch. For example, precautionary measures, such as social distancing, may hamper ongoing clinicalresearch, 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)
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 clinicalresearch 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)
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)
Jansen and Wall suggest a new way of defending hard paternalism in clinicalresearch. 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 clinicalresearch, which Jansen and Wall do not recognize. (shrink)
Shared views regarding the moral respect which is owed to children in family life are used as a guide in determining the moral permissibility of nontherapeutic clinicalresearch procedures involving children. The comparison suggests that it is not appropriate to seek assent from the preadolescent child. The analogy with interventions used in family life is similarly employed to specify the permissible limit of risk to which children may be exposed in nontherapeutic research procedures. The analysis indicates that (...) recent writers misconceive how certain moral principles, such as respect for personal autonomy, require us to act toward children. The results are also used to assess proposed federal regulations on research with children. (shrink)
Clinicalresearch 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 clinicalresearch. (shrink)
This article addresses two areas of continuing controversy about consent in clinicalresearch: 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)
Previous research conducted in 1999 highlighted ethical concerns behind challenge studies inducing psychosis with ketamine and made recommendations to enhance ethical standards. Recently, a plethora of clinical trials have evaluated the efficacy of ketamine to treat mood disorders, which lead to complex ethical issues. Pharmaceutical companies and researchers hope to profit by developing patentable variations on ketamine for treating depression. Media have labeled ketamine as a “miracle” antidepressant. Some clinics offer expensive off-label use of ketamine to treat mood (...) disorders. This article examines the ecological validity of ketamine trials, measures to protect patients, informed consent procedures, financial inducements to participants and conflict of interest of researchers, therapeutic misconception, concealment, and deception. Further recommendations are purposed to improve ethical standard of clinicalresearch involving ketamine. (shrink)
Debates about justice in international clinicalresearch 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 clinicalresearch 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)
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)