The rapidly changing field of genetics affects society through advances in health-care and through implications of genetic research. This study addresses the impacts of new genetic discoveries and technologies on different segments of today's society. The book begins with a chapter on genetic complexity, and subsequent chapters discuss moral and ethical questions arising from today's genetics from the perspectives of health care professionals, the media, the general public, special interest groups and commercial interests.

Cancer research is experiencing ‘paradigm instability’, since there are two rival theories of carcinogenesis which confront themselves, namely the somatic mutation theory and the tissue organization field theory. Despite this theoretical uncertainty, a huge quantity of data is available thanks to the improvement of genome sequencing techniques. Some authors think that the development of new statistical tools will be able to overcome the lack of a shared theoretical perspective on cancer by amalgamating as many data as possible. (...) We think instead that a deeper understanding of cancer can be achieved by means of more theoretical work, rather than by merely accumulating more data. To support our thesis, we introduce the analytic view of theory development, which rests on the concept of plausibility, and make clear in what sense plausibility and probability are distinct concepts. Then, the concept of plausibility is used to point out the ineliminable role played by the epistemic subject in the development of statistical tools and in the process of theory assessment. We then move to address a central issue in cancer research, namely the relevance of computational tools developed by bioinformaticists to detect driver mutations in the debate between the two main rival theories of carcinogenesis. Finally, we briefly extend our considerations on the role that plausibility plays in evidence amalgamation from cancer research to the more general issue of the divergences between frequentists and Bayesians in the philosophy of medicine and statistics. We argue that taking into account plausibility-based considerations can lead to clarify some epistemological shortcomings that afflict both these perspectives. (shrink)

America has poured about 200 billion dollars into cancer research since President Nixon declared war on cancer in 1971. How is the war going after three decades? Why do assessments vary as widely as “beating cancer” and “loosing the war on cancer?”.

In recent cancer research, strong and apparently conflicting epistemological stances have been advocated by different research teams in a mist of an ever-growing body of knowledge ignited by ever-more perplexing and non-conclusive experimental facts: in the past few years, an 'organicist' approach investigating cancer development at the tissue level has challenged the established and so-called 'reductionist' approach focusing on disentangling the genetic and molecular circuitry of carcinogenesis. This article reviews the ways in which 'organicism' and 'reductionism' (...) are used and opposed in this context, with an aim at clarifying the debate. Methodological, epistemological and ontological implications of both approaches are discussed. We argue that the 'organicist/reductionist' opposition in the present case of carcinogenesis is more a matter of diverging heuristics than a claim about theoretical or ontological (ir)reducibility. As a matter of fact, except for the downward causation claim, which we question, we argue that the organicist arguments are compatible with the reductionist approach. Moreover, we speculate that both approaches, which currently focus on specific entities i.e., genes versus tissues, will need to shift their conceptual frameworks to studying complex arrays of relationships potentially ranging over several levels of entities, as is the case with 'systems biology'. (shrink)

BackgroundThe annual number of retracted publications in the scientific literature is rapidly increasing. The objective of this study was to determine the frequency and reason for retraction of cancer publications and to determine how journals in the cancer field handle retracted articles.MethodsWe searched three online databases (MEDLINE, Embase, The Cochrane Library) from database inception until 2015 for retracted journal publications related to cancer research. For each article, the reason for retraction was categorized as plagiarism, duplicate publication, (...) fraud, error, authorship issues, or ethical issues. Accessibility of the retracted article was defined as intact, removed, or available but with a watermark over each page. Descriptive data was collected on each retracted article including number of citations, journal name and impact factor, study design, and time between publication and retraction. The publications were screened in duplicated and two reviewers extracted and categorized data.ResultsFollowing database search and article screening, we identified 571 retracted cancer publications. The majority (76.4%) of cancer retractions were issued in the most recent decade, with 16.6 and 6.7% of the retractions in the prior two decades respectively. Retractions were issued by journals with impact factors ranging from 0 (discontinued) to 55.8. The average impact factor was 5.4 (median 3.54, IQR 1.8–5.5). On average, a retracted article was cited 45 times (median 18, IQR 6–51), with a range of 0–742. Reasons for retraction include plagiarism (14.4%), fraud (28.4%), duplicate publication (18.2%), error (24.2%), authorship issues (3.9%), and ethical issues (2.1%). The reason for retraction was not stated in 9.8% of cases. Twenty-nine percent of retracted articles remain available online in their original form.ConclusionsRetractions in cancer research are increasing in frequency at a similar rate to all biomedical research retractions. Cancer retractions are largely due to academic misconduct. Consequences to cancer patients, the public at large, and the research community can be substantial and should be addressed with future research. Despite the implications of this important issue, some cancer journals currently fall short of the current guidelines for clearly stating the reason for retraction and identifying the publication as retracted. (shrink)

In the last decades, Systems Biology (including cancer research) has been driven by technology, statistical modelling and bioinformatics. In this paper we try to bring biological and philosophical thinking back. We thus aim at making diferent traditions of thought compatible: (a) causality in epidemiology and in philosophical theorizing—notably, the “sufcient-component-cause framework” and the “mark transmission” approach; (b) new acquisitions about disease pathogenesis, e.g. the “branched model” in cancer, and the role of biomarkers in this process; (c) the (...) burgeoning of omics research, with a large number of “signals” and of associations that need to be interpreted. In the paper we summarize frst the current views on carcinogenesis, and then explore the relevance of current philosophical interpretations of “cancer causes”. We try to ofer a unifying framework to incorporate biomarkers and omic data into causal models, referring to a position called “evidential pluralism”. According to this view, causal reasoning is based on both “evidence of diference-making” (e.g. associations) and on “evidence of underlying biological mechanisms”. We conceptualize the way scientists detect and trace signals in terms of information transmission, which is a generalization of the mark transmission theory developed by philosopher Wesley Salmon. Our approach is capable of helping us conceptualize how heterogeneous factors such as micro and macro-biological and psycho-social—are causally linked. This is important not only to understand cancer etiology, but also to design public health policies that target the right causal factors at the macro-level. (shrink)

Based on an original ethnographic study of a translational cancer research institute in the United States, we propose calibration as a process that makes interdisciplinary collaboration without consensus possible. Calibration refers to ongoing, day-to-day negotiation and alignment of personal identities, disciplinary commitments, and research group customs that occur during face-to-face group deliberations around everyday research concerns. Calibration provides a mechanism that explains how collaboration without consensus is possible. Crucially, it does not presuppose that interdisciplinary collaboration either (...) indicates or causes the blurring or softening of disciplinary boundaries. We argue that at the microsociological level it may be disciplinary robustness, rather than synthesis, that contributes to interdisciplinary innovation. (shrink)

In 2018 and 2019 Cancer Research UK launched a controversial advertising campaign to inform the British public of obesity being a preventable cause of cancer. On each occasion the advertisements used were emotive and provoked frustration among the British public which was widely vocalised on social media. As well serving to educate the public of this association, the advertisements also had the secondary effect of acting as health promotion through social marketing, a form of advertising designed to (...) influence behavioural changes. As CRUK delivered a public health message through its campaign, the advertisements should be held according to the ethical principles which underpin healthcare in the UK. This article evaluates whether the advertisements used by CRUK in 2018 and 2019 fulfilled the ethical principles of beneficence, autonomy, non-maleficence and justice. It is found that while providing an important message, the oversimplification of obesity as being the result of personal decisions ignored the complex aetiology and served to stigmatise the target demographic, potentially disengaging them from the message. Additionally, posting cancer as the consequence of obesity invokes feelings of fear due to its connotations of suffering and premature death. Based on available evidence, the use of fear in social marketing does not create sustained behavioural change. This essay recommends that CRUK discontinue its use of such strategies in its future social marketing endeavours. (shrink)

Cancer research has been at the forefront of biomedical activity in recent decades, and advances in molecular biology have provided a growing amount of information on the mechanisms involved in the etiopathogenesis of tumors. Nevertheless, despite these advances, the complexity of cancer is more evident, especially as different levels of phenomena are considered to explain the heterogeneity of the neoplastic process. A synthetic analysis of advances in cancer research illustrates these changes. In attempting to overcome (...) the limits of epistemological reductionism, there is a move from a view of a genetic basis for cancer to a more comprehensive perspective aiming to integrate a large amount of information and to understand the neoplastic phenomenon at higher levels of biological complexity through a new interpretative framework. (shrink)

Research on diseases such as cancer reveals that primary mechanisms, which have been the focus of study by the new mechanists in philosophy of science, are often subject to control by other mechanisms. Cancer cells employ the same primary mechanisms as healthy cells but control them differently. I use cancer research to highlight just how widespread control is in individual cells. To provide a framework for understanding control, I reconceptualize mechanisms as imposing constraints on flows (...) of free energy, with control mechanisms operating on flexible constraints in primary mechanisms. I argue that control mechanisms themselves often form complex, integrated networks. (shrink)

Many researchers consider cancer to have molecular causes, namely mutated genes that result in abnormal cell proliferation (e.g. Weinberg 1998). For others, the causes of cancer are to be found not at the molecular level but at the tissue level where carcinogenesis consists of disrupted tissue organization with downward causation effects on cells and cellular components (e.g. Sonnenschein and Soto 2008). In this contribution, I ponder how to make sense of such downward causation claims. Adopting a manipulationist account (...) of causation (Woodward 2003), I propose a formal definition of downward causation and discuss further requirements (in light of Baumgartner 2009). I then show that such an account cannot be mobilized in support of non-reductive physicalism (contrary to Raatikainen 2010). However, I also argue that such downward causation claims might point at particularly interesting dynamic properties of causal relationships that might prove salient in characterizing causal relationships (following Woodward 2010). (shrink)

Many researchers consider cancer to have molecular causes, namely mutated genes that result in abnormal cell proliferation (e.g. Weinberg 1998); yet for others, the causes of cancer are to be found not at the molecular level but at the tissue level and carcinogenesis would consist in a disrupted tissue organization with downward causation effects on cells and cellular components (e.g. Sonnenschein & Soto 2008). In this contribution, I ponder how to make sense of such downward causation claims. Adopting (...) a manipulationist account of causation (Woodward 2003), I propose a formal definition of downward causation, and discuss further requirements (in light of Baumgartner 2009). I then show that such an account cannot be mobilized in support of non-reductive physicalism (contrary to Raatikainen 2010). However, I also argue that such downward causation claims might point at particularly interesting dynamic properties of causal relationships that might prove salient in characterizing causal relationships (following Woodward 2010). (shrink)

The three claims put forward by Dr. Roger Poisson to rationalize his enrollment of ineligible subjects in clinical trials do not justify research fraud. None the less, certain lessons for the conduct of clinical research can be learned from the affair: experimental therapies should be made available to technically ineligible subjects when no effective therapy exists for their disease; further research must investigate the possible benefits of clinical-trial participation; broadly based, pragmatic trials must be regarded as the (...) ideal model; and each eligibility criterion in a clinical-trial protocol should be justified. (shrink)

In the last few decades, philosophy of science has increasingly focused on multilevel models and causal mechanistic explanations to account for complex biological phenomena. On the one hand, biological and biomedical works make extensive use of mechanistic concepts; on the other hand, philosophers have analyzed an increasing range of examples taken from different domains in the life sciences to test—support or criticize—the adequacy of mechanistic accounts. The article highlights some challenges in the elaboration of mechanistic explanations with a focus on (...) cancer research and neuropsychiatry. It jointly considers fields, which are usually dealt with separately, and keeps a close eye on scientific practice. The article has a twofold aim. First, it shows that identification of the explananda is a key issue when looking at dynamic processes and their implications in medical research and clinical practice. Second, it discusses the relevance of organizational accounts of mechanisms, and questions whether thorough self-sustaining mechanistic explanations can actually be provided when addressing cancer and psychiatric diseases. While acknowledging the merits of the wide ongoing debate on mechanistic models, the article challenges the mechanistic approach to explanation by discussing, in particular, explanatory and conceptual terms in the light of stances from medical cases. (shrink)

Cancers rely on multiple, heterogeneous processes at different scales, pertaining to many biomedical fields. Therefore, understanding cancer is necessarily an interdisciplinary task that requires placing specialised experimental and clinical research into a broader conceptual, theoretical, and methodological framework. Without such a framework, oncology will collect piecemeal results, with scant dialogue between the different scientific communities studying cancer. We argue that one important way forward in service of a more successful dialogue is through greater integration of applied sciences (...) (experimental and clinical) with conceptual and theoretical approaches, informed by philosophical methods. By way of illustration, we explore six central themes: (i) the role of mutations in cancer; (ii) the clonal evolution of cancer cells; (iii) the relationship between cancer and multicellularity; (iv) the tumour microenvironment; (v) the immune system; and (vi) stem cells. In each case, we examine open questions in the scientific literature through a philosophical methodology and show the benefit of such a synergy for the scientific and medical understanding of cancer. (shrink)

Joshua Crites and Eric Kodish focuses on unrealistic optimism as a significant factor in parental decisions when consenting for their child to participate in a phase I study.1 They define unrealistic optimism as ‘when people perceive their own personal outcomes as being more positive than those of other people in similar circumstances’. Faced with the dire circumstances of relapsed malignant disease with a fatal outcome, most parents are confronted with the dilemma of either accepting the inevitable death of their child (...) or clinging to straws of hope. When approached by an investigator who suggests that there is still something that can be done in the ‘fight against the disease’ there is an opportunity to retain a glimmer of hope. No matter how impartial and accurate …. (shrink)

Mainstream breast cancer social movements such as that of Susan G. Komen have called on all women to race or fight for the cure for breast cancer. They suggest that the fight can be won by buying and wearing pink ribbons, taking part in races and walks, donating money, and participating in research. For some patients with breast cancer, research participation may involve non-diagnostic tumor biopsies. While this clinical research is performed in the hope (...) of gaining new knowledge through the removal and study of breast cancer tissue, these procedures have been heavily criticized because they offer little potential benefit to the patient providing the tissue (Helft and Daugherty 2006; Kimmelman et al. 2012;... (shrink)

Fact/value holism has become commonplace in philosophy of science, especially in feminist literature. However, that facts are bearers of empirical content, while values are not, remains a firmly-held distinction. I support a more thorough-going holism: both facts and values can function as empirical claims, related in a seamless, semantic web. I address a counterexample from Kourany where facts and values seem importantly discontinuous, namely, the simultaneous support by the Nazis of scientifically sound cancer research and morally unsound political (...) policies. I conclude that even by the criteria available at the time, Nazi cancer research was empirically weak, and the weaknesses in their research are continuous with their moral failures in just the ways predicted by the holism I support. (shrink)

In the nearly 40 years since implementation of federal regulations governing the protection of human participants in research, the number of clinical studies has grown exponentially. These studies have become more complex, with multisite trials now common, and there is increasing use of archived biospecimens and related data, including genomics data. In addition, growing emphasis on targeted cancer therapies requires greater collaboration and sharing of research data to ensure that rare patient subsets are adequately represented. Electronic records (...) enable more extensive data collection and mining, but also raise concerns about the potential for inappropriate or unauthorized use of data, bringing patient protections into a new landscape. There are also long-standing concerns about the processes and forms used to obtain informed consent from patients participating in clinical studies. These changes and challenges raise new ethical and practical questions for the oversight of clinical studies, and for protecting patients and their health information in an efficient manner that does not compromise the progress of biomedical research. Contemporary Issues for Protecting Patients in Cancer Research is the summary of a workshop convened by the National Cancer Policy Forum of the Institute of Medicine in February 2014 to explore contemporary issues in human subjects protections as they pertain to cancer research, with the goal of identifying potential relevant policy actions. Clinical researchers, government officials, members of Institutional Review Boards, and patient advocates met to discuss clinical cancer research and oversight. This report examines current regulatory provisions that may not adequately protect patients or may be hindering research, and discusses potential strategies and actions to address those challenges. (shrink)

Metaphysical presuppositions are important for guiding scientific practices and research. The success of twentieth-century biology, for instance, is largely attributable to presupposing that complex biological processes are reducible to elementary components. However, some biologists have challenged the sufficiency of reductionism for investigating complex biological phenomena and have proposed alternative presuppositions like organicism. In this article, contemporary cancer research is used as a case study to explore the importance of metaphysical presuppositions for guiding research. The predominant paradigm (...) directing cancer research is the somatic mutation theory, in which mutated genes are presumed to be ultimately responsible for explaining carcinogenesis. This reductionistic approach to cancer has been criticised recently, and an organistic approach has been proposed. The article concludes with a discussion of the reciprocal interaction of metaphysical presuppositions and scientific practices for investigating cancer's complex nature. (shrink)

Despite the spectacular contributions to knowledge made by molecular biology during the last half century, cancer research has not delivered an agreed explanation of how malignant tumours originate. The models assiduously investigated in molecular terms largely reflect waves of fashion, and time has revealed their inadequacy: cancer is (1) not caused by the direct action of oncogenes, (2) not fully explained by the impairment of tumour suppressor genes, (3) not set in motion by mutations controlling the cell (...) cycle, (4) not governed by the dependence of malignant tumours on an adequate blood supply and (5) not triggered by a failure of programmed cell death. But there is now strong evidence that cancers may have their origin in mutations that block the execution of critical steps in the process of normal differentiation. Cancer, thus seen, is not initially a disease of cell multiplication, but a disease of differentiation. The evidence for this point of view should now be explored. BioEssays 27:833–838, 2005. © 2005 Wiley Periodicals, Inc. (shrink)

Rapid Ethical Assessment is an approach used to design context tailored consent process for voluntary participation of participants in research including human subjects. There is, however, limited evidence on the design of ethical assessment in studies targeting cancer patients in Ethiopia. REA was conducted to explore factors that influence the informed consent process among female cancer patients recruited for longitudinal research from Addis Ababa Population-based Cancer Registry. Qualitative study employing rapid ethnographic approach was conducted from (...) May–July, 2017, at the Tikur Anbessa Specialized Referral Hospital. In-depth and key informants’ interviews were conducted among purposively selected 16 participants. Regular de-briefings among the study team helped to identify emerging themes and ensure saturation. Interviews and debriefings were tape recorded in Amharic, and transcribed and translated to English. Coding of the transcripts was facilitated by use of NVivo software. Thematic analysis was employed to respond to the initial questions and interpret findings. Perceived barriers to voluntary study participation included lack of reporting back study results of previous studies, the decision making status of women, hopelessness or fatigue in the patients, shyness of the women, data collectors approach to the patient, and patient’s time constraints. Most of the patients preferred oral over written consent and face-to-face interview over telephone interview. Provision of detail information about the study, using short and understandable tool, competent, compassionate and respectful enumerators of the same gender were suggested to assure participation. Due to the perceived severity, the use of the term “cancer” was associated with fear and anxiety. Alternatively, uses of phrases like “breast or cervical illness/disease” were suggested during patient interviews. Voluntary participation is not straight forward but affected by different factors. Using competent, compassionate and respectful enumerators, short and precise questioning tools to limit the time of the interview could improve voluntary participation. Moreover, careful consideration of the patients and families concept of the disease such as wording and information has to be taken into account. This assessment helped in improving the consent process of the ongoing project on breast and cervical cancer patients. (shrink)

One of the most pressing ethical challenges facing phase I cancer research centres is the process of informed consent. Historically, most scholarship has been devoted to redressing therapeutic misconception, that is, the conflation of the nature and goals of research with those of therapy. While therapeutic misconception continues to be a major ethical concern, recent scholarship has begun to recognise that the informed consent process is more complex than merely a transfer of information and therefore cannot be (...) evaluated only according to how well an individual understands such information. Other components of decision-making operate independently of understanding and yet still may compromise the quality of informed consent. Notable among these components is unrealistic optimism, an event-specific belief that one has a better chance of receiving benefit than others similarly situated. In this article, we consider responses to interviews with parents who had recently completed an informed consent conference for enrolling their child in a phase I cancer clinical trial to examine how this influence manifests and how investigators might address it during informed consent. (shrink)

There is societal consensus that cancer clinical trial participation is unjust because some sociodemographic groups have been systematically underrepresented. Despite this, neither a definition nor an ethical explication for the justice norm of equity has been clearly articulated in this setting, leading to confusion over its application and goals. Herein we define equity as acknowledging sociodemographic circumstances and apportioning resource and opportunity allocation to eliminate disparities in outcomes, and we explore the issues and tensions this norm generates through practical (...) examples. We assess how equality-based enrollment structures in clinical cancer research have perpetuated historical disparities and what equity-based alternatives are necessary to achieve representativeness and an expansive conception of participatory justice in clinical cancer research. This framework addresses the breadth from normative to applied by defining the justice norm of equity and translating it into practical strategies for addressing participation disparities in clinical cancer research. (shrink)

On December 20, 2002, the Ohio Supreme Court issued an opinion in Dardinger v. Anthem Blue Cross & Blue Shield granting a landmark punitive damages award against the defendant-insurer for breach of contract and bad faith in its coverage of a cancer patient. The court directed that the punitive damages award of $30 million, should it be accepted by the plaintiff, be apportioned between the plaintiff and a cancer research fund to be established in the name of (...) the plaintiff's deceased wife, Esther Dardinger. In so doing, the court broke new ground in the scope and social purpose of punitive damages in health care litigation, as well as the courts’ role in distributing those damages.After being diagnosed with metastatic brain tumors in October 1996, Esther began intra-arterial chemotherapy treatments at the recommendation of her physician, Dr. Newton. IAC is a targeted form of chemotherapy in which an arterial catheter is threaded through a cranial artery near the tumor and into the brain. (shrink)

On December 20, 2002, the Ohio Supreme Court issued an opinion in Dardinger v. Anthem Blue Cross & Blue Shield granting a landmark punitive damages award against the defendant-insurer for breach of contract and bad faith in its coverage of a cancer patient. The court directed that the punitive damages award of $30 million, should it be accepted by the plaintiff, be apportioned between the plaintiff and a cancer research fund to be established in the name of (...) the plaintiff's deceased wife, Esther Dardinger. In so doing, the court broke new ground in the scope and social purpose of punitive damages in health care litigation, as well as the courts’ role in distributing those damages.After being diagnosed with metastatic brain tumors in October 1996, Esther began intra-arterial chemotherapy treatments at the recommendation of her physician, Dr. Newton. IAC is a targeted form of chemotherapy in which an arterial catheter is threaded through a cranial artery near the tumor and into the brain. (shrink)

There is growing interest in tissue procurement for cancer research through autopsy. Establishing an autopsy/tissue donation programme for breast cancer research within an academic medical centre i...

Background This article describes the issues encountered when designing a study to evaluate recruitment of minority ethnic groups into clinical cancer research in order to monitor adherence to the principles for good practice set out in the Department of Health, Research Governance Framework, England. Methods (i) A review of routine data sources to determine whether their usefulness as a source of data on prevalence of cancer in the population by ethnic category. (ii) A local case study (...) at one hospital trust to ascertain whether the ethnicity of cancer trial participants was representative of admitted cancer patients. Results (i) The lack of a comparator population makes it problematic to assess recruitment levels by ethnic group in clinical research. (ii) The odds of being in a trial were 30% lower for a member of a minority ethnic group compared to a white cancer patient after adjusting for disease, age and gender, OR 0.70 (0.53 to 0.94). These results differed for each ethnic group; Asian patients did not appear under-represented while Black and Chinese did so. However, there are important caveats to the findings based on the limited recording of ethnicity. Conclusions The lack of available data on the ethnicity of participants in clinical research and the prevalence of cancer in the population according to ethnicity makes it difficult to design a study to monitor representation of minority ethnic groups. This information is necessary to assess adherence to the Research Governance Framework principle that research evidence reflects the diversity of the population. (shrink)

The concepts of informed consent and surveillance of human research designed to protect human subjects is commendable. The regulations of the Institutional Review Board are having a major impact on clinical cancer research. There is greater administrative time needed of the investigator, the mechanisms of patient care have become cumbersome and some patients reject optional medical management that could be life saving. IRB regulations must be flexible to meet the needs of human subjects as well as those (...) of the clinical investigator. (shrink)

ArgumentIn August of 1977, Australian pathologist David W. Buntine delivered a presentation at the Annual Meeting of the Royal College of Pathologists of Australia in Melbourne, Victoria. In this presentation, he used the diagnostic category of “Eskimoma,” to describe a unique set of salivary gland tumors he had observed over the past five years within Winnipeg’s Health Sciences Center. Only found amongst Inuit patients, these tumors were said to have unique histological, clinical, and epidemiological features and were unlike any other (...) disease category that had ever been encountered before. To understand where this nosological category came from, and its long-term impact, this paper traces the historical trajectory of the “Eskimoma.” In addition to discussing the methods and infrastructures that were essential to making the idea of Inuit cancer “visible,” to the pathologist, the epidemiologist, and to society at large, this paper discusses how Inuit tissue samples obtained, stored, and analyzed in Winnipeg, Manitoba, came to be codified into a new, racially based disease category – one that has guided Canadian and international understandings of circumpolar cancer trends and shaped northern healthcare service delivery for the past sixty years. (shrink)

In his highly regarded history of the rise of clinical trials in America, HarryMarks describes how their widespread adoption resulted largely fromthe efforts of ‘therapeutic reformers’ who sought to replace the individualexpertise of clinicians with the ‘science of controlled experiment’. Thetransition described by Marks resembles in many respects the transition fromthe ‘truth-to-nature’ objectivity of individual experts to a ‘mechanical’ formof objectivity portrayed by Daston and Galison. In particular,Marks details the passage from a regime of trust in expertise and experts to (...) aregime based on the mechanical generation of data, the elimination ofhuman judgement and the adoption of a ‘view from nowhere’ where individual and group idiosyncrasies are systematically suppressedthrough recourse to quantitative methods.[...]. (shrink)

In his highly regarded history of the rise of clinical trials in America, HarryMarks describes how their widespread adoption resulted largely fromthe efforts of ‘therapeutic reformers’ who sought to replace the individualexpertise of clinicians with the ‘science of controlled experiment’. Thetransition described by Marks resembles in many respects the transition fromthe ‘truth-to-nature’ objectivity of individual experts to a ‘mechanical’ formof objectivity portrayed by Daston and Galison. In particular,Marks details the passage from a regime of trust in expertise and experts to (...) aregime based on the mechanical generation of data, the elimination ofhuman judgement and the adoption of a ‘view from nowhere’ where individual and group idiosyncrasies are systematically suppressedthrough recourse to quantitative methods.[...]. (shrink)

The use of human tissue for scientific research is a highly sensitive issue. A lack of confidence in patient recruitment is one reason for the failure of many studies to be funded and it is important therefore that recruitment procedures are as effective and sympathetic as possible. The authors recruited patients with uveal melanoma into a postmortem study investigating tumour latency in this cancer. Two approaches were used—firstly a direct approach when patients attended clinic and secondly an initial (...) approach by mail followed by telephone contact. In the first year of study the authors had a take up rate of 88.5%, significantly higher than the average rate of 40% quoted by the National Institute for Clinical Excellence . Key features are a sympathetic personal approach by experienced oncology nurses, the provision of clear information, and the inclusion of the next of kin in the recruitment procedure. (shrink)

The Institutional Review Board is a committee of the institution responsible for carrying out the institution's responsibilities for the protection of human research subjects. Since it is a local committee, most of the complaints about the IRB can be resolved locally provided it is borne in mind that the IRB is the champion not only of the human research subject but also of the investigator. National or regional cooperative research protocols present problems that are not insurmountable.