Medical/research Ethics

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Ethics governance, modernity and human beings' capacity to reflect and decide   a genealogy of medical research ethics in the UK and Singapore

Ethics governance, modernity and human beings' capacity to reflect and decide a genealogy of medical research ethics in the UK and Singapore

Such mentalities or styles o f governm ent were, according to these scholars, made up of particular grids o f intelligibility, series o f technologies and types o f authorities brought together in a complex strategic assemblage which Foucault termed a ‘dispositif or ‘apparatus’: a ‘resolutely heterogeneous grouping com posing discourses, institutions, architectural environm ents, policy decisions, laws, administrative measures, scientific statements, philosophic, moral and philanthropic propositions; in sum, the said and the not-said’ (cited in Rabinow and Rose 2003:10-11. Cf. also: D ean 1999; Rose 1999a; Miller and Rose 2008. Cf. Hacking 1992 on the related notion o f 'style o f reasoning'). By ‘grids o f intelligibility,’ these authors m eant ‘rational schemas’ (Foucault 1991a:80) which allow one to perceive, represent, analyse and evaluate a particular reality and which include: a particular language, idioms and argumentative style; key categories and concepts; typical explanations about how best to govern; ideals or moral principles; distinctive problems that can be addressed; and a specific understandings o f both the objects and subjects o f government, such as a particular figure o f the citizen. Unsurprisingly given the increasing role played by formalized kinds o f knowledge (savoirs) in the governm ent o f conduct (cf. G ordon 1991; Foucault 2004a), these ways o f thinking, representing and evaluating stem from expert bodies o f knowledge, such as theories o f management, medicine, criminology, economics, political science or, in the case o f ethics governance, a mixture o f law, moral philosophy and medical sociology. By ‘technologies,’ Foucault and others referred to ways o f intervening upon and changing the reality that the grids o f intelligibility allow to perceive and represent. They are mechanisms for the operationalisation and realisation o f thought; they include written instructions, ad hoc procedures for evaluating a problem, architectural complexes, m ethods’ manuals, timetables and systems o f supervision and control. Finally, by ‘types o f authorities’ these authors referred to the institutional forms and the kind o f expertise which are deemed competent and legitimate to enunciate, deploy and transform the grids o f intelligibility and technologies that compose particular forms o f rationalities and practices.
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What do international ethics guidelines say in terms of the scope of medical research ethics?

What do international ethics guidelines say in terms of the scope of medical research ethics?

Background: In research ethics, the most basic question would always be, “ which is an ethical issue, which is not? ” Interestingly, depending on which ethics guideline we consult, we may have various answers to this question. Though we already have several international ethics guidelines for biomedical research involving human participants, ironically, we do not have a harmonized document which tells us what these various guidelines say and shows us the areas of consensus (or lack thereof). In this manuscript, we attempted to do just that. Methods: We extracted the imperatives from five internationally-known ethics guidelines and took note where the imperatives came from. In doing so, we gathered data on how many guidelines support a specific imperative. Results: We found that there is no consensus on the majority of the imperatives and that in only 8.2 % of the imperatives were there at least moderate consensus (i.e., consensus of at least 3 of the 5 ethics guidelines). Of the 12 clusters (Basic Principles; Research Collaboration; Social Value; Scientific Validity; Participant Selection; Favorable Benefit/ Risk Ratio; Independent Review; Informed Consent; Respect for Participants; Publication and Registration; Regulatory Sanctions; and Justified Research on the Vulnerable Population), Informed Consent has the highest level of consensus and Research Collaboration and Regulatory Sanctions have the least.
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Current Perspectives on Research Ethics in Qualitative Research

Current Perspectives on Research Ethics in Qualitative Research

The question of ethics has been a mainstay of philosophical inquiry for millennia —e.g., when the ancient Greek wondered about phronesis, that is, the nature of wisdom in practical action that inherently affects others (RICŒUR, 1990). In research involving human subjects, the phenomenon is much more recent (ROTH, 2004a). In the historical development of the debate, medical research ethics played a prominent role. For example, the Nuremberg Code (1947) constituted a key milestone. It was formulated in response to the inhuman medical experimentation practices under the Nationalist-Socialist regime in Germany and included principles such as voluntary participation and informed consent. Since then debates and ethics codes have evolved in many fields and disciplines throughout the world. Yet, during the 1950s and 1960s it was still possible to expose human beings to extreme physical and mental stress—such as testing the chemical weapons Agent Orange and Agent Purple on the Canadian Forces Base Gagetown (New Brunswick) without 1. informing nearby communities, 2. the consent of the Canadian and U.S. military personnel
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Medical Ethics and the Nazi War Data

Medical Ethics and the Nazi War Data

While arguments from both sides may seem legitimate, I believe the use of the Nazi research is wrong based solely on the nature and requirements of morally superogatory deeds. As pointed out by Quinn, no one ever raises the question of whether the use of the data is in fact harming the victims (2000). If one takes into consideration the moral levels of duty, there may indeed be direct harm to them or their descendants.

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Medical Ethics: Context Is the Key Word

Medical Ethics: Context Is the Key Word

The relevance of this to medical practice and Medical Board matters brought before tribunals and courts is obvious. Contrived allegations made by the Medical Board are added to patient claims and/or change as investi- gations unfold. In a declared and transparent process designed to be in the public interest and to protect the pub- lic such obsequiousness and duplicity would not and ought to not be tolerated. Yet the Tribunal system thrives on contorting facts, unashamed dishonesty by literal interpretation taken out of context to create doubt, to exer- cise bias. Doctors on panels are often out of their depth in assessing complex cases and out of date with new ad- vances in knowledge and current practice and those cases outside of their areas of expertise when they were in practice. Experts called by the Medical Board to give evidence tend to subscribe to its dogma or are not given the full brief, only documents or witness statements which support the Medical Board’s position. One has to clarify what material has been given. Tribunal members have difficulty accepting wrong can be done by the Medical Board or be seen to be done even when glaring and obvious, which is the reason to demand independ- ent evaluation of decisions by an independent committee/jury and to award compensation in terms of both costs and damages to discourage the wholesale investigation of complaints without discretion by Medical Board in- vestigators and ensuing abuses.
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Medical Tourism: Ethics, Risks and Benefits

Medical Tourism: Ethics, Risks and Benefits

Medical tourism comes with two main risks that are broadly discussed in the context of in terms of psychol- ogy and physiology. Psychologically and emotionally, being away from the closest people such as family, spouse, and parents may lead to acquired stress to medical tourist. Such health risk related to travel is due to the mental burden and particularly during the healing period abroad. Besides that, physiological risk that may be developed during airline travel is the major concern that for the medical tourist before and after having medical treatment or services). Potential health conditions using long haul flight are more susceptible to travelers’ throm- bosis which also known as deep vein thrombosis (the swelling of deep vein due to the clotting of blood in those particular areas). 48 It is more likely to occur for
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ANCIENT MEDICAL ETHICS AND PRESENT SCENARIO .......

ANCIENT MEDICAL ETHICS AND PRESENT SCENARIO .......

tice was either non-existent or was only related to certain limited aspects, the trained physicians derived their authority as healer from the membership of their primitive associations and the reputation of their skills. In any case, the patient ap- proaching a doctor did need a reassurance that the doctor had certain social standing, and this standing was gained from the au- thority and self-regulation of their associa- tions. The code was useful to the physician to build his reputation in the society. Simi- larly, the ancient Indian medical system of Ayurveda had well defined code of medi- cal ethics, expounded in our ancient texts. These codes were purely voluntary codes, adopted within the specific social envi- ronment by the physicians to bring about self-regulation. And the same time, to as- sure the society that a physician governed by such a code would conduct himself in a manner which would be in the best interest of the patient and the society. Further, im- portantly, these codes were not part of any legal system of the state, and therefore the state had no responsibility to enforce it amongst the doctors. These elaborate codes for self-regulations were thus, mor- ally binding on doctors and the morality of doctors was considered extremely im- portant. This morality gave a social image and authority to doctors. The ethical code was a regulator of the patient care as well as the professionalism in medical care. Unfortunately for the medical technology, there are now several hurdles which the conscience of the medical practitioner should cross or circumvent, to maintain the so called professional dignity; what his judgment be in cases like euthanasia, iat- rogenic diseases, medico-legal responsibil- ities, pregnancy tests, legal responsibili- ties, artificial insemination, organ trans- plantation, vitro fertilization, embryo transfer technology, genetic engineering,
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Time for a unified approach to medical ethics

Time for a unified approach to medical ethics

A code of ethics is used by individuals to justify their actions within an environment. Medical professionals require a keen understanding of specific ethical codes due to the potential consequences of their actions. Over the past thirty years there has been an increase in the scope and depth of ethics instruction in the medical profession; however the teaching of these codes is still highly variable. This inconsistency in implementation is problematic both for the medical practitioner and for the patient; without standardized training, neither party can be assured of the practitioner's overall depth of knowledge. Within the field of ethics certain principles have reached a consensus of importance. Incorporation of these concepts in meaningful ways via a consistent curriculum would provide students with an appropriate skill set for navigating their ethical environment. Moreover, this curriculum should also be extended to residents and professionals who may have missed formal ethical training. This would provide a consistent framework of knowledge for practitioners, creating a basis for clear judgment of complex issues.
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The concept of vulnerability in medical ethics and philosophy

The concept of vulnerability in medical ethics and philosophy

Given the broad scope of the concept of vulnerability as described above and the potential ethical impact it may have on care in healthcare, it may come as a surprise that the concept does not play a major role in medical ethics today. Admittedly, there are classic approaches to medical ethics and philosophy of medicine that often implicitly describe the situation of patients seeking medical help as a situation of vulnerability [5]. One may argue that it is also part of the principles of beneficence and non-maleficence in the principles approach to med- ical ethics [6]. Nonetheless, if one focusses on explicit uses of the term, application of the concept of vulner- ability in medical ethics is mainly confined to research ethics. Here, following the ethical rationale that even if information and consent procedures are in place, some groups of research participants may need extra protec- tion, vulnerability is introduced as a supplement to in- formed consent. Certain groups of patients or healthy volunteers may be inclined to consent to participate in research due to factors that unduly influence their decision-making. Examples include persons at the lower end of strictly hierarchically ordered institutions (e.g. prisons, the army) who are asked to participate in research via this institution, and socially disadvantaged persons who may take part in research comprising high risk of harm because of monetary gratification, or in order to obtain otherwise inaccessible medical treat- ment. In the same vein, persons whose capacity to consent is impaired, inexistent, or not fully developed yet, such as the mentally impaired, advanced stage de- mentia patients, the comatose, and children, are termed “vulnerable” as well [7].
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Effectiveness of the Course of Medical Ethics for Undergraduate Medical Students

Effectiveness of the Course of Medical Ethics for Undergraduate Medical Students

Comparing the end of the course data between group A and B: Mean score of group B students at the end of the term (6.12 ± 1.3) was significantly more than the mean score of group A students (3.63 ± 1.7) (P=0.001). Students' knowledge about informed consent (P<0.001), decision making capacity (P<0.001), confidentiality (P<0.0001) and conflict of interest (P=0.001) was significantly higher in group B (Table 3), while knowledge of the two groups were not significantly different on other issues such as medical error, ethical theories, abortion and euthanasia.

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Principles of medical ethics: implications for the disclosure of medical errors

Principles of medical ethics: implications for the disclosure of medical errors

The provider-patient relationship is generally unequal in respect to decision-making power and medical knowledge. In the context of an error disclosure, the power relationship changes. Providers are at the mercy of the patient to forgive them and not to pursue legal action, humbling themselves onto the “level” of the patient. At the same time, patients are at the mercy of the provider to find out what happened in their medical care. In an attempt to meet the ethical imperative of justice, competent error disclosure needs to include communicative elements that optimize a fair distribution of these scarce resources. Providers can contribute to accomplishing this goal by offering their medical expertise to the patient. At the same time, patients need to recognize and respect the provider’s difficult situation and the fallibility of the medical profession as a whole. In the midst of finding out about an error in their medical care, patients will likely not experience this empathy for the provider on their own. Thus, competent provider communication is necessary to facilitate this ethical goal. Specifically, providers could be assertive by stating that their job is to cure, and that having to face a harmed patient is very difficult for them. They could apologize to the patient for having transgressed boundaries, and express that they would like to reinstate the patient’s privacy and trust. They should also solicit support from their institution to be able to offer financial assistance and provide fair compensation for injuries that the error may have caused to the patient.
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Ethics Rounds in a Children's Medical Center: Evaluation of a Hospital-Based Program for Continuing Education in Medical Ethics

Ethics Rounds in a Children's Medical Center: Evaluation of a Hospital-Based Program for Continuing Education in Medical Ethics

The informed, retrospective scrutiny of medical-ethical deci- sions serves a useful function in continuing profes- sional education and program evaluation at the Children’s Hospital Medi[r]

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Research on Medical Practices and the Ethics of Disclosure

Research on Medical Practices and the Ethics of Disclosure

In March 2013, the Office of Human Research Protection (OHRP) issued a finding against the University of Alabama and other institutions for failing to meet regulatory informed consent requirements, in particular regarding reasonably foreseeable risks during the conduct of the Surfactant, Positive Pressure, and Oxygenation Randomized Trial. 1 This study compared 2 different target oxygen saturation levels that were part of usual practice in extremely premature infants. As a result of public disagreement regarding whether the differences in outcomes should be considered a “ research risk, ” OHRP suspended the determination and held a public hearing in August 2013. 2
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Research ethics committees: agents of research policy?

Research ethics committees: agents of research policy?

The Finnish law requires that informed consent is obliga- tory in all drug trials, and the procedures are regulated in detail; in non-drug clinical trials, informed consent may be waived in exceptional circumstances. Informed con- sent is defined such that the people who are "the targets" of the trial will be included in the study only after the trial has been described to them honestly and in detail, and they have then voluntarily given their permission, free of any pressures. The consent "must be written, dated and signed", and in the case of incapable persons, this should be made by his or her legal representative. If the person cannot write, oral consent may be accepted in the pres- ence of at least one witness [16]. The Finnish Act (Sublaw 986/1999) gives a detailed list of the formal requirements of informed consent and additional details on how to ask for informed consent and which kinds of documents are needed are given by drug control authorities and the cen- tral ethics committee. One requirement is that a copy of the signed consent is to be given to the patient or other research participant, suggesting a contract arrangement. Informed consent on data acquisition and its use is much vaguer. In general, the legal and ethical issues of data use in health research are a muddle due to law changes over time, historic data sets, commercial interest, and special questions of genetic data or other biological samples. In multinational studies, the issue is complicated by the effects of varying data protection laws and their interpre- tation in different countries. Many researchers have decided to avoid the problems by asking for informed consent from the patient to also use his/her data outside the current research frame. This consent is likely to be uninformed, because an average patient does not know, for example, what information can be obtained from a blood sample or what data national registers contain, or what does anonymity of genetic samples imply. In clinical trials, informed consent for data storage or transfer often ends up being a quasi-action from an ethical point of view.
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A review of research ethics in internet-based research

A review of research ethics in internet-based research

Internet-based research methods can include: online surveys, web page content analysis, videoconferencing for online focus groups and/or interviews, analysis of ‘e-conversations’ through social networking sites, email, chat rooms, discussion boards and/or blogs. Over the last ten years, an upsurge in internet-based research (IBR) has led to increased interest in IBR and research ethics. Here we present some ethical guidelines for IBR while accepting that it would be unrealistic to expect that any single set of guidelines can cover all ethical situations concerning IBR. There is simply too much diversity across internet cultures, values and modes of operation for that to be the case. Perhaps the most useful solution to the complex challenges of IBR lies with a form of ‘negotiated ethics’, a situated approach grounded in the specifics of the online community, the methodology and the research question(s). This does not mean an ‘anything goes’ relativist approach, rather an open, pluralistic policy in relation to IBR ethical issues (Ess, 2009; AoIR, 2002).
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Ethics, conflict and animal research

Ethics, conflict and animal research

The previous section raises questions of context and complexity that are seldom addressed explicitly in the literature on animal research. Philosophers, obsessed with principles and ethical theories, often gloss over the details of how moral decisions are reached. It is much easier to say that a practice is wrong than to suggest ways in which it can be made better. At the most general theoretical levels, there is a tendency to think in terms of exclusive positions: complete abolitionism at one side, and freedom for science on the other. Debates between such extremes are generally sterile, however inspirational their ideals. Institutions, caught in the middle, have set up committees and adopted national standards in an attempt to find a way forward that respects some of the demands of science on the one hand and the case for animals on the other. What I have argued above is that this is not enough. The ethical scrutiny of scientific animal use inevitably raises questions that cannot be settled within the institutional context.
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PHL : MEDICAL ETHICS Fall 2003

PHL : MEDICAL ETHICS Fall 2003

[from Undergraduate Catalog ] Course Objectives: At the conclusion of the course, students who have mastered the course material should be better able (1) to formulate and evaluate [r]

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Curricular priorities for business ethics in medical practice and research: recommendations from Delphi consensus panels

Curricular priorities for business ethics in medical practice and research: recommendations from Delphi consensus panels

and conducting research without adequately disclosing industry sponsorship [7-10]. Preserving trust in the insti- tution of medicine will require interventions to protect medical professionalism in an increasingly complex busi- ness environment. Second, over the past 5 years, profes- sional associations [11,12], the Institute of Medicine [13], the Department of Health and Human Services [14], Congress [15], and the pharmaceutical industry [16], have issued new guidelines and requirements address- ing financial conflicts of interest in medical practice and research. It will be important to update the curric- ula of medical ethics and professionalism training pro- grams to incorporate information about these evolving standards and requirements. Third, the Accreditation Council for Graduate Medical Education (ACGME) lists both professionalism (which includes “an adherence to ethical principles”) and systems-based practice (which includes “an awareness of the larger context and system of health care”) as two of their 6 core competencies of patient care [17]. Moreover, medical students and resi- dents support initiatives in ethics and professionalism educational initiatives [18]. Nevertheless, while courses in medical ethics have been an established part of the medical curriculum for more than a decade [19,20], these courses have traditionally focused on matters of clinical ethics with limited regard for the impact finan- cial factors can have on clinical care. Finally, physicians struggle with questions of business ethics on a day-to- day basis as they decide whether to use newer more expensive treatments, respond to demands from hos- pital administrators and practice managers, collaborate with device representatives, or decide whether to en- roll a patient in a clinical trial [21,22].
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How To Write A Book On Medical Ethics

How To Write A Book On Medical Ethics

President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, Why "Update" Death. Charles M[r]

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ISLAMIC MEDICAL ETHICS: The IMANA Perspective

ISLAMIC MEDICAL ETHICS: The IMANA Perspective

================================== In 1963, Muslim students studying in American colleges and universities organized themselves into an association, the Muslim Students’ Association (MSA). Four years later, in 1967, American Muslim physicians did the same and formed the Islamic Medical Association of North America (IMANA). MSA transformed into the Islamic Society of North America (ISNA) and IMANA became a constituent body of ISNA. Since its inception in 1967, IMANA has dedicat- ed itself to serving Muslim physicians, Muslim allied health care professionals, Muslim patients and the community at large on issues related to Islamic Medicine nationally and worldwide. IMANA is also a member of the international Federation of Islamic Medical Associations (FIMA). Islamic Medicine is defined as the art and science of practice of medicine by Muslim physicians and other health care providers in the service of humanity under Islamic guidelines as ordained by the divine book al-Qur’an and taught by Prophet Muhammad, peace be upon him (PBUH). IMANA has headquarters in a Chicago suburb and regional chapters in many cities of USA. It is governed by a Board of Regents and an executive committee according to established by-laws. It has several operational committees including the medical ethics committee. For detailed information about IMANA, one can visit www.imana.org.
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