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Laboratory science fostered a novel paradigm which assured the veriﬁability and reproducibility of knowledge underpinning biological phenomena. It also brought about the emergence of exactness and precision into the clinical practice of medicine. However, a number of ethical issues arise in its theory and praxis generally and in its application in the sphere of medicine. This entry engages some of the associated moral quandaries in terms of the nature of laboratory science as well as how it is put to use in the healthcare context. It also examines some of the attendant global ethical dimensions.
Laboratory science engendered a novel paradigm which assured the veriﬁability and reproducibility of knowledge underpinning biological phenomena. It also brought about ensuring a sound scientiﬁc backbone for medicine as well as the emergence of exactness and precision into healthcare delivery. However, a number of ethical issues are embedded in laboratory science generally and in its praxis. This entry engages some of the pressing aspects of these issues within the context of healthcare broadly and some of the global ethical dynamics.
Laboratory science may convey at least four distinct ideas. First, it may refer to general laboratory epistemology such that the different sets of knowledge produced via laboratory methods in disciplines such as chemistry, biology, biotechnology, and so forth will fall in this category. Laboratory science may also refer to how speciﬁc laboratories generate epistemologies. The elaboration of epistemologies via animal models of experimental scientiﬁc enquiry, for instance, falls in this category as well as the ethnography of laboratory science contained in the works of scholars like Bruno Latour. In the healthcare context, laboratory science may refer to the use of laboratory epistemology to realize the telos of medicine, that is, patient and social ﬂourishing. It may also refer to the profession of certain healthcare professionals called medical/clinical laboratory scientists (MLSs).
Each of these conceptual renderings as well as the attendant praxis generates distinct ethical issues. As such, an investigation of the moral issues embedded in laboratory science demands an examination of the pressing dimensions of all four associated interpretations. This entry however only engages those issues encountered in the healthcare context. Lastly, it is important to point out that while the concept of laboratory science is often synonymous with laboratory medicine, laboratory medicine may refer to something completely distinct. Speciﬁcally, it may refer to a specialty in clinical medicine where clinical laboratory data are employed via pathologists (who form a professional nexus between other genres of physicians and the domain of the laboratory) for directed clinical management of selected patients.
The Evolution Of Laboratory Science In Healthcare
A proper understanding of the notion of laboratory science in the healthcare context is exigent to set a proper conceptual foreground for teasing out and examining the attendant ethical issues. In this vein, how the laboratory helped scientify the practice of clinical medicine and incorporated exactness and precision into the diagnostic process as well as how the use of the laboratory to foster improved patient outcome ultimately led to the emergence and establishment of MLSs as distinct healthcare professionals are germane. This section engages this perspective.
Laboratory Science And The Scientification Of Clinical Medicine
Scholars like Steven Sturdy (1992) have remarked that a striking feature in twentieth-century medical practice was the growing involvement of laboratory science in everyday clinical decision-making. That involvement was likewise the epistemological impetus which largely facilitated the emergence of scientiﬁc medicine. But before the advent of scientiﬁc medicine, physicians relied heavily on patient clinical history, signs, and symptoms as well as individual intuition to make diagnoses which thereafter informed the kinds of interventions. Principles of humoralism, heroicism, and therapeutic skepticism particularly reigned supreme in guiding pathological understanding of diseases as well as clinical interventions. Writing on this theme, John Harley Warner remarked that speculative systems of pathology and therapeutics represented the core of the regular physician’s special knowledge (Warner 1992). As such, the fabric of the epistemic and professional skills and the overall beneﬁts which patients derived from orthodox practitioners were meager and at best palliative. Speciﬁcally, standard therapeutic interventions such as bloodletting and the use of mercury and arsenic for inducing vomiting (with a view to balancing the mythical humors) generally fraught more harm than good to the patient populace (Sharpe and Faden 1998). With the beneﬁt of ethical hindsight, this seriously contravened the physicians’ Hippocratic ideal of doing no harm to their patient clients.
Despite its many drawbacks, this medical paradigm persisted. The discovery of the hypothetic reductionist method in the physical sciences and its increasing application through laboratory experimentation in the sphere of medical sciences however altered the prevailing status quo. Combination of speciﬁc packets of knowledge including anatomy, pharmacology, pathology, immunology, and physiology ultimately engendered a novel and discrete explanatory system which emphasized the nature of disease entities rather than the concatenation of environmental, social, and constitutional factors that were traditionally held to inﬂuence health (Sharpe and Faden 1998). With this paradigmatic change came the transition of clinical medicine, via its associated parts, into a scientiﬁc endeavor in terms of the capacity to properly elucidate the underlying processes responsible for symptoms and causes of diseases.
Laboratory Science And The Evolution Of Clinical Laboratory Scientists
An appraisal of physicians throughout the ﬁrst two-thirds of the nineteenth century showed that their medicine was already scientiﬁc (Warner 1992). However, that scientiﬁc sort of medicine was turned upon the correlation of systematic clinical observations with path anatomical ﬁndings made at autopsy, and its utility was in elucidating pathophysiology. Whereas the basic sciences could explicate therapeutic theory, suggest therapeutic possibilities and explain what was clinically observed, it could not direct practice. This lacuna was however bridged via the evolution of the medical laboratory. Although historians still have no satisfactory general account of how this transition came to be, three distinct kinds of developments offer useful insights: ﬁrstly, technical innovation and advances in scientiﬁc knowledge (Marks 1990); secondly, the input of applied scientists, pathologists, biologists, and chemists (Hatcher and Farr 1978); and, lastly, efforts from a group of clinical/medical laboratory assistants who forged ahead to develop more of their own body of knowledge as they have innovated and examined their techniques and given them sound scientiﬁc footing (Afolabi 2007). The revolution and value brought about by the laboratory was so important that Ellis Kellert in the early part of the twentieth century described the medical laboratory as the hothouse of medical progress, without which medical practice would revert back to that of the ﬁfteenth century (Kellert 1918). Today, the medical laboratory has been pivotal in erecting the scientiﬁc basis of modern medical practice and critical to the public esteem and success of modern medicine largely because of its clinically useful epistemic lens in relation to disease etiologies and intervention which may help direct clinical practice (Sharpe and Faden 1998). In this vein, Feinstein (1967) notes that the scientiﬁc aspects of modern clinical care are often focused more on the patient’s laboratory identiﬁcation and evaluation. Indeed, it is estimated that about 60–70 % of all healthcare decisions affecting diagnosis or treatment and subsequent therapeutic monitoring, hospital admission, length of hospital stay, and discharge often depend on laboratory data (Charlton and Miles 1998).
The distinctive facet which the medical laboratory foists into the clinical domain may be illustrated by recourse to the philosophical problem of induction. Within the pre-laboratory clinical practice, if a patient X elaborates a spectrum of symptoms a, d, f, and j and is diagnostically categorized as having a condition L, then another patient Y’s condition is considered same as X’s provided the same sort of symptoms are elaborated. By implication, a drug or any other intervention therapeutic for X would be assumed to be equally therapeutic for Y (Afolabi 2007). This line of reasoning constitutes the central idea of inductive reasoning, viz.:
If some A’s (selected in such and such a fashion) are B, therefore all A’s are B.
But the principle of induction is a logically inconsistent mode of thought. Applied to medicine, it is very problematic because a single clinical disease may ensue from infection from any of several pathogens. Inﬂuenza virus, for example, causes a wide variety of respiratory syndromes that cannot be distinguished clinically from those caused by streptococci, mycoplasmas, or more than a hundred other viruses. Obviously, effective patient management, hence patient survival in instances such as these, hangs on the clariﬁcatory knowledge that is derivable from the laboratory bench. As such, the evolution of the clinical laboratory attempts to eliminate and minimize the errors of induction inherent in the medical domain.
Having set the thematic boundaries of what constitutes the idea of laboratory science and elaborated how the notion and praxis evolved as well as how these function in the healthcare context, the conceptual coast seems clear to begin analyzing the attendant ethical issues. In this section, these issues will be examined through the lens of the epistemological nature of laboratory science and through its praxis in the healthcare context.
Ethical Issues Associated With The Epistemological Nature Of Laboratory Science
The moral issues that may be placed in this category include scientiﬁc reductionism, subjugation of clinical authority, arbitration of public health, and the legitimization of medicalization.
Reductionism involves the process through which complex and higher order entities are made amenable to simpliﬁed and malleable logical relationships. Reductionism clearly contributes to the epistemic basis upon which diseases can be understood and fought and enables the sphere of medicine overcome much of the challenges hitherto experienced by clinical giants like Galen, Hippocrates, and William Osler who could not treat any diseases successfully. However, reducing diseases solely to the lens of parameters present in biological ﬂuids or seen under the microscope misses and greatly oversimpliﬁes the complex interplay between the subjective and objective elements associated with the disease phenomenon. To be sure, the process of healing the whole person cannot be completely separated from the sphere of subjectivism. This is particularly important when considering inter-patient variations in relation to available knowledge and how such variations have to be carefully put to clinical use and tailored to individual contexts.
How laboratory science reduces human experiences into diagnostic decrees and serves as the epistemic arbiter in distinguishing the infected from the no infected often comes with attendant social, psychological, and existential tensions. For instance, by declaring a person seropositive to the HIV antigen, the laboratory wields an unimpeachable power that may singe the chord of family ties, toll the knell of imminent death, and inescapably bring an individual into the perpetual need to secure anti-retrovirals to stay alive (Afolabi 2007). In this regard, Sweeney (2001, p. 93) describes the experience of an elite woman diagnosed of cancer thus:
The diagnosis had irrevocably altered the woman’s status: she was now a sick person who would from that moment forward lose control of her destiny, surrendering it to medical people who, acting with the best of intentions, would forever consign her to a hierarchy in which she would be the subject.
If the state of being healthy is not always tied to the absence of disease, then reductionism falls short in explaining the psychosocial elements and causes of diseases.
Subjugation Of Authority
The change in the structure of the medical landscape partly as a result of the hitherto inadequacies of the healthcare system in properly engaging the disease phenomenon and partly as a result of scientiﬁc revolution constitutes a type of social ﬂux which is a normal part of any social and political life. With social change however comes alteration in norms and power shifts. Not surprisingly, the birth of the medical laboratory and its involvement in improving patient outcome which increasingly transferred and subjugated clinical authority to the diagnostic decrees of the laboratory threatened the physician with a vision of the laboratory rather than the bedside as the hub about which scientiﬁc medicine would revolve (Warner 1985). The perceived threat of the medical laboratory also sheds some insights into how the quantitative principles of test selection and interpretation have been reluctantly integrated into clinical practice.
In relation to laboratory science, subjugation occurs in two ways. Firstly, it may involve the idea that the professional working in the laboratory has the capacity to interpret their test results which as a consequence makes the clinician irrelevant. Although in individual and unusual cases the laboratory practitioner (depending on level of training and expertise) is often more skillful in interpreting his results than the physician, this does not offer a professional leeway to side-step the clinician. Neither does it grant the license to always directly engage the public in relation to diagnosing and treating diseases. Concerns such as these were echoed by Kolmer (1925) who describe it as an evil that can be cured solely by the right kind of education.
Secondly, subjugation occurs when pathologists as specialist clinicians hold the faulty view that expertise in clinical medicine always constitutes an equivalence of expertise in scientiﬁc laboratory procedures and epistemology and by implication a license to control the affairs of the laboratory (Afolabi 2007). Both of these scenarios are problematic and run against the ethos of professionalism. To be sure, subjugation in any form is unscientiﬁc and comes close to what Feynman (1999) describes as cargo cult science. Care has to be taken in terms of avoiding biases and prejudices to percolate into the sciences of medicine since science is hardly a personal property. Subjugation of authority has the undesirable effect of abrogating the pathway of transferring scientiﬁc knowledge to clinical practice as well as enabling the limits of clinical medicine to be solved via reproducible scientiﬁc knowledge. Sadly, the patient populace, the ultimate beneﬁciary of the healthcare system’s collective efforts, bears the brunt of subjugation. Subjugation therefore clearly shortchanges the goals of patient care.
Whereas every member of the science and clinical community ought to be given the liberty to express or exercise their knowledge and skills, the issue of subjugation has often led to interprofessional rivalry among clinicians, pathologists, and clinical/medical laboratory scientists. This development is partly reminiscent of the active, energetic, urgent, and committed opposition and attack to which laboratory science was subjected in its formative years in the strata of American health service (Warner 1992). Since healthcare as an integral aspect of the social matrix is shaped by social currents speciﬁc to the peculiar nature of the society, relevant public health policies arrived via a dialogical process involving all stakeholders remain the key to stemming this challenge.
Legitimization Of Medicalization
Medicalization entails a subtle process by means of which medicine comes to exercise practical and theoretical control over human life by converting human activities or experiences into domains amenable to medical expertise, dominion, and intervention. It may involve deviant behaviors such as alcoholism and underrating or natural life processes such as sexuality, aging, and death (Conrad 1992). If medicalization qua clinical medicine is problematic, then it is made much more so by the credence and legitimacy which laboratory science imparts to it. In other words, knowledge generated in research or diagnostic laboratories are increasingly employed to validate medicalized behaviors and activities. In this regard, levels of 5-hydroxyindoleacetic acid (5-HIAA) or highly raised levels of catecholamine’s may become the basis for categorizing individuals as criminal and suicidal or aggressive in behavior, respectively, thereby serving as a biological and moral yardstick for the exercise of legal and medical interventions. In the same vein, an isolated genetic association may serve as the basis for explaining away deviant sexual behavior, therefore providing an avenue for affected people to no longer “need” standard therapies.
The moral issue in relation to how laboratory science legitimizes medicalization often lies in the counterintuitive notions often presented to the human society for acceptance into the fabric of life. For instance, equating levels of 5-HIAA in the cerebrospinal ﬂuid with suicidal tendencies generally assumes that human behavior mirrors brain events in a one-to-one manner and speciﬁcally ignores questions about individual choice, free will, and intentions. This critique also gives some credence to the social constructivist notion of disease which holds that human interests and not biological malfunctions explain the judgments about disease designation due to their departure from a shared notion of human nature.
Arbitration Of Public Health
Public health embeds the science and art of preventing disease, prolonging life, and promoting health by employing organized efforts and informed choices of society, organizations, and public and private communities as well as individuals. Due to the varied personal, political, and social interests often involved, public health raises the ethical question of balancing individual or microcommunity needs against those of the larger society. In this regard, laboratory science serves as an arbiter of public health in the generation of biomedical data and the distribution of this via state and federal laboratories and international agencies and ensuring that these have current and consistent scientiﬁc information in order to be ready for outbreaks and other public health emergencies (Inhorn et al. 2010). In a way, the degree of public safety that any given society potentially has in the face of outbreaks such as Ebola, Marburg, pandemic inﬂuenza, cholera, and bioterrorism will be as good as the quality of the sciences that may readily be generated via its laboratories. Perhaps, this may partly explain how the recent Ebola outbreak could be readily curtailed and casualties kept to a minimum in a country like Nigeria, as opposed to other affected West African nations.
Counterintuitive Notion Of Disease
The intuitive notion of disease embeds the idea that sick persons feel or perceive some sense of biological dysregulation or physiological anomaly usually manifesting in the form of symptoms peculiar to particular disease types. However, laboratory science presents a different notion of disease. In the purview of the laboratory, someone could be sick without being aware of the ongoing pathological process. This phenomenon radically runs counter to the common-sense relationship between feeling well and being well. In the same vein, the laboratory advances a deﬁnition of disease that overcomes the limits inherent in the standard clinical detection of diseases (for instance, through history taking and auscultation). Speciﬁcally, laboratory epistemology can help establish the presence, absence, or extent of such subtle diseases by generating relevant information or knowledge through appropriate biochemical, serological, histochemical, or microbiological markers, with which the disease process may be quantitated and relevant clinical intervention determined (Afolabi 2007). One clear problematic implication of this is that no one is really healthy until a thorough laboratory checkup has been carried out on them, a scenario which again echoes the medicalization rhetoric. The issuance of a clean bill of health through laboratory investigations however does not always guarantee optimal health. This unsettling notion was recently echoed in the case of Pauline Cafferkey, the British nurse who developed Ebola relapse. In short, the case partly afﬁrms the limits of laboratory epistemology vis-a-vis always reﬂecting a one-to-one relationship with biological realities.
Ethical Issues Associated With The Praxis Of Laboratory Science
A number of moral quandaries come to the fore in relation to the practice of laboratory science. These include non-maleﬁcence, consent to diagnostic tests and privacy issues, patient self-referral to private diagnostic laboratories, ethics education of laboratory professionals, and dipstick technology testing.
This embeds the notion of doing no harm or, depending on speciﬁc contexts, keeping harm to the barest minimum. It derives from the general obligations that healthcare professionals have toward patients. In relation to the practice of laboratory science, it follows that the interaction of laboratory personnel with patients (for instance, in blood or body ﬂuid collection or in preparing patients for special procedures) will cause the patient no harm. Keeping to standard operating procedures will usually help realize this goal.
Consent To Diagnostic Tests And Privacy Issues
Consent involves agreeing to a given course of action after the presentation of the main associated pros and cons. While patients ideally need to always consent to sample collection for laboratory investigations, consent issues often arise in morally sensitive scenarios such as HIV, prenatal, paternity, and genetic testing. A related issue revolves around the privacy of the patient to undergo testing as well as to determine eligible parties to test results. Failure to obtain consent may foster legal claims of battery, while disclosing test results to unauthorized persons may also have penal consequences as well as lead to professional disciplinary measures.
Patient Self-Referral To Private Diagnostic Laboratories
Patient self-referral is one development which echoes the notion that the medical act is no longer produced by a compassionate doctor serving a needing patient. In tandem with the social change impulse which altered physicians as exclusive gatekeepers to healthcare, there are countries where patients may directly seek the services of MLSs. Patient self-referral to medical laboratories however elicits some ethical issues which revolve around whether or not the attending professional possesses the necessary skills as well as the locus ethicus in discharging such duties. To be sure, whereas patient self-referral to diagnostic laboratories may foster their medical good in several ways, it potentially presents the opportunity for non-clinicians to cross professional boundaries. Speciﬁcally, and especially in the absence of proper regulation or for ﬁnancial gains, some MLSs may be tempted to begin the unethical process of combining diagnostic responsibilities with therapeutic maneuvers.
Ethics Education of Laboratory Professionals
While clinical/medical laboratory scientists in different countries generally have a code of conduct which usually engages intra-professional ethics, ethics education in the broader sense is usually almost absent. Bruns and colleagues (2015) recently note that formal teaching of ethics is absent from many training programs in laboratory medicine. They further report that for the few trainings available, the focus ranged from research ethics to introductory principles of medical ethics. This shows the paucity of discourse on bench-based ethical issues as well as the exigency for developing the requisite ethics education relevant to engaging them.
Since dealing with ethical issues often requires a keen sense of ethical awareness, the knowledge of which does not come within a vacuum, there is clearly a need for teaching bioethics to laboratory scientists in the course of their training and afterward. Without this, MLSs may remain ill-trained to deal with and resolve the complex ethical issues during their practice years. Such educational process will however be seriously constrained by the absence of pedagogical materials. Indeed, it has been reported that there is difﬁculty in ﬁnding a single book focused speciﬁcally on ethics and laboratory medicine and that the coverage of ethical topics in general laboratory science textbooks are usually meager (Bruns et al. 2015). One major implication of this is that laboratory scientists have participated little in bioethical debates as these pertain to their profession-speciﬁc issues and in the broader healthcare context. It is therefore not surprising that while one may easily ﬁnd journals devoted to medical, nursing, and pharmacy ethics, none of such exists for laboratory science.
Interpretation Of Test Results
Interpretation of test results of patients constitutes another area of tension in the practice of laboratory science. While competence at clinically interpreting laboratory test results often depends on the nature of the professional concerned (generalist or resident physician, specialist clinical scientist, or pathologist) as well as the nature of the given test, what is often at stake here is the question of professional autonomy and authority. This moral tension is however historical and recurs often in the history of medicine literature.
In countries where professional teamwork operates, tensions about who interprets test results hardly arise because the referring physician will often be ethically motivated to seek help in scenarios where interpreting particular tests is beyond his professional competence. Team consultations between pathologists and MLSs likewise help minimize such tensions. However, in a healthcare system riddled with competition among professionals, inter-professional consultation is hardly the norm. In Nigeria, for instance, clinicians and pathologists often insist on interpreting all laboratory test results with an almost absolute disregard for the input of specialist clinical laboratory scientists. At the same time, MLSs often feel that since they carry out most of the tests, they are professionally equipped to interpret all. The humility to recognize the limits of profession-speciﬁc skills as well as the moral attitude to recognize and respect professional boundaries are clearly needed in this regard. Also important is recognizing that shifting professional boundaries imply a rather ﬂuid state like a sandbank in a tidal stream, and both boundary and the sandbank may undergo alterations as a result of the inevitable current of social change.
Dipstick Technology Testing
We now live in an era of do-it-yourself diagnostic kits where a small “stick” impregnated with reagents may give qualitative and semi quantitative clinical information of selected health indices. What is often needed is a small blood sample or other body ﬂuids such as urine and saliva to give readable results via colored reactions. This dipstick technology testing (DTT) however raises some moral concerns. Although generally suited for straightforward clinical scenarios, rural areas, as well as contexts of urgency (where some diagnostic data is required to steer the course of the clinical management of patients), DTT is ethically problematic due to the varying degrees of accuracy (which may be shaped by factors such as storage conditions, skill of handling personnel, place of manufacture, etc.), the potential for misuse in the hands of untrained persons, the potential to seemingly oversimplify and trivialize the complexities underlying diagnostic tasks of the medical laboratory, and the possibility that some patients may suffer varying forms of psychological harms as a consequence of misinterpreting test results in sensitive contexts (for instance, false positive pregnancy test).
Minimal Patient Interaction
MLSs generally have very limited direct interaction with the patient populace. This has consistently fueled some misconceptions about their identity. It is therefore no surprise that they are sometimes believed to be phlebotomists, technicians, technologists, or laboratory boys. It is interesting to note that in a fairly recent article that sought to engage the ethical issues in the laboratory, the authors referred to clinical laboratory scientists as laboratory physicians (Wijeratne and Benatar 2010).
Global Ethical Dimensions
There are global ethical dimensions to the practice of laboratory science. Two important ones relate to questions of global justice and diagnostic reference parameters. Global justice comes to the fore considering the disparity in healthcare resources which ultimately shapes the extent and efﬁciency of available laboratory science. At national levels, absence of laboratories equipped to rapidly test and isolate infectious pathogens, especially those responsible for epidemic outbreaks, clearly jeopardizes public health. Suboptimal laboratory science, for instance, where potential vaccine recipients are not screened for hem agglutination-inhibiting antibodies is partly responsible for selected cases of vaccine failure and the propagation of vaccine preventable diseases. The question of global justice arises due to the 10/90 gap and when ample mechanisms are not instituted to bridge such lacunas. For example, failure to garner global solidarity in relation to strengthening the capacities of laboratories in the Ebola-prone regions will contribute to making the populace remain vulnerable.
Another global ethical issue engendered by laboratory science concerns diagnostic reference parameters or reference values. Except for tropical or region-speciﬁc diseases, it is important to note that most of such values employed in issuing diagnostic decrees are values obtained from Euro-American populations. The effects of constitutional and environmental differences however show that such a trend embeds a dyscorrelation with biological realities such that certain class of patients (depending on particular diagnostic domains) may be undertreated or over treated. Related to this theme is the use of the Euro-American values as a global cutoff when patients not originally from such regions enter into their healthcare system.
Laboratory science constitutes a social and scientiﬁc change impulse that both helped to make medicine scientiﬁc and introduced some level of exactness and precision into the diagnostic process in a manner that could both shape clinical cognition and have clinically useful beneﬁts. A number of ethical concerns are however elicited via the nature and practice of laboratory science, each of which further raises distinct sets of issues. Questions of global justice and the use of a largely Euro-American-derived reference range are some of the issues that come to the fore in the context of global bioethics.
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