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Publication of scientific paper is critical for modern science evolution, and professional advancement. However, it comes with many responsibilities. An author must be aware of good publication practices. While refraining from scientific misconduct or research frauds, authors should adhere to Good Publication Practices (GPP). Publications which draw conclusions from manipulated or fabricated data could prove detrimental to society and health care research. Good science can blossom only when research is conducted and documented with complete honesty and ethics. Unfortunately, publish or perish attitude has led to unethical practices in scientific research and publications. There is need to identify, acknowledge, and generate awareness among junior researchers or postgraduate students to curb scientific misconduct and adopt GPP. This article discusses various unethical publication practices in research. Also, the role and responsibilities of authors have been discussed with the purpose of maintaining the credibility and objectivity of publication.

Background The red tape and delays around research ethics and governance approvals frequently frustrate researchers yet, as the lesser of two evils, are largely accepted as unavoidable. Here we quantify aspects of the research ethics and governance approvals for one interview- and questionnaire-based study conducted in England which used the National Health Service (NHS) procedures and the electronic Integrated Research Application System (IRAS). We demonstrate the enormous impact of existing approvals processes on costs of studies, including opportunity costs to focus on the substantive research, and suggest directions for radical system change. Main text We have recorded 491 exchanges with 89 individuals involved in research ethics and governance approvals, generating 193 pages of email text excluding attachments. These are conservative estimates (e.g. only records of the research associate were used). The exchanges were conducted outside IRAS, expected to be the platform where all necessary documents are provided and questions addressed. Importantly, the figures exclude the actual work of preparing the ethics documentation (such as the ethics application, information sheets and consent forms). We propose six areas of work to enable system change: 1. Support the development of a broad range of customised research ethics and governance templates to complement generic, typically clinical trials orientated, ones; 2. Develop more sophisticated and flexible frameworks for study classification; 3. Link with associated processes for assessment, feedback, monitoring and reporting, such as ones involving funders and patient and public involvement groups; 4. Invest in a new generation IT infrastructure; 5. Enhance system capacity through increasing online reviewer participation and training; and 6. Encourage researchers to quantify the approvals processes for their studies. Conclusion Ethics and governance approvals are burdensome for historical reasons and not because of the nature of the task. There are many opportunities to improve their efficiency and analytic depth in an age of innovation, increased connectivity and distributed working. If we continue to work under current systems, we are perpetuating, paradoxically, an unethical system of research approvals by virtue of its wastefulness and impoverished ethical debate.

Background We describe our experience from a multi-national application of a European Union-funded research-driven paediatric trial (DEEP-2, EudraCT 2012-000353-31; NCT01825512). This paper aims to evaluate the impact of the local and national rules on the trial authorisation process in European and non-European countries. National/local provisions and procedures, number of Ethics Committees and Competent Authorities to be addressed, documentation required, special provisions for the paediatric population, timelines for completing the authorisation process and queries received were collected; compliance with the European provisions were evaluated. Descriptive analysis, Wilcoxon Rank-Sum test and General Linear Model analysis were used to determine factors potentially influencing the timelines. The Cluster Analysis procedure was used to identify homogenous groups of cases. Result The authorisation process was completed in 7.7 to 53.8 months in European countries and in 17.1 to 27.1 months in non-European countries. The main factors influencing these timelines were the requests for changes/clarifications in European countries and the different national legislations in non-European countries. Conclusion This work confirms that the procedures and requirements for the clinical trial application of a paediatric trial are different. In the European Union, the timeframes for submission were generally harmonised but longer. In non-European countries, delays were caused by national dispositions but the entire authorisation process resulted faster with less requests from ECs/CAs. The upcoming application of Regulation (EU) 536/2014 is expected to harmonise practices in Europe and possibly outside. Networks on paediatric research acting at international level will be crucial in this effort.

International audience; Medical practice is ideally based on robust, relevant research. However, the lack of diseasemodifying treatments for Alzheimer's disease has motivated "innovative practice" to improve patients' well-being despite insufficient evidence for the regular use of such interventions in health systems treating millions of patients. Innovative or new non-validated practice poses at least three distinct ethical questions: first, about the responsible application of new non-validated practice to individual patients (clinical ethics); second, about the way in which data from new non-validated practice are communicated via the scientific and lay press (scientific communication ethics); and third, about the prospect of making new non-validated interventions widely available before more definitive testing (public health ethics). We argue that the authors of metabolic enhancement protocols for Alzheimer's disease have overstated the evidence in favor of these interventions within the scientific and lay press, failing to communicate weaknesses in their data and uncertainty about their conclusions. Such unmeasured language may create false hope, cause financial harm, undermine informed consent, and frustrate the production of generalizable knowledge necessary to face the societal problems posed by this devastating disease. We therefore offer more stringent guidelines for responsible innovation in the treatment of Alzheimer's disease.

Advances in biotechnology necessitate both an understanding of scientific principles and ethical implications to be clinically applicable in medicine. In this regard, therapeutic cloning offers significant potential in regenerative medicine by circumventing immunorejection, and in the cure of genetic disorders when used in conjunction with gene therapy. Therapeutic cloning in the context of cell replacement therapy holds a huge potential for de novo organogenesis and the permanent treatment of Parkinson's disease, Duchenne muscular dystrophy, and diabetes mellitus as shown by in vivo studies. Scientific roadblocks impeding advancement in therapeutic cloning are tumorigenicity, epigenetic reprogramming, mitochondrial heteroplasmy, interspecies pathogen transfer, low oocyte availability. Therapeutic cloning is also often tied to ethical considerations concerning the source, destruction and moral status of IVF embryos based on the argument of potential. Legislative and funding issues are also addressed. Future considerations would include a distinction between therapeutic and reproductive cloning in legislative formulations.

Background: The article studies specific ethical issues arising from the use of big data in Life Sciences and Healthcare. Methods: Main consensus documents, other studies, and particular cases are analyzed. Results: New concepts that emerged in five key areas for the bioethical debate on big data and health are identified&mdash, the accuracy and validity of data and algorithms, questions related to transparency and confidentiality in the use of data, aspects that raise the coding or pseudonymization and the anonymization of data, and also problems derived from the possible individual or group identification, the new ways of obtaining consent for the transfer of personal data, the relationship between big data and the responsibility of professional decision, and the commitment of the Institutions and Public Administrations. Conclusions: Good practices in the management of big data related to Life Sciences and Healthcare depend on respect for the rights of individuals, the improvement that these practices can introduce in assistance to individual patients, the promotion of society&rsquo, s health in general and the advancement of scientific knowledge.

Background Despite the high burden of new HIV infections in minor adolescents, they are often excluded from biomedical HIV prevention trials, largely owing to the ethical complexities of obtaining consent for enrollment. Researchers and ethics regulators have a duty to protect adolescents—as a special category of human subjects, they must have protection that extends beyond those afforded to all human subjects. Typically, additional protection includes parental consent for enrollment. However, parental consent can present a risk of harm for minor adolescents. Research involving minor adolescents indicate that they are unwilling to join biomedical trials for stigmatized health problems, such as HIV, when parental consent is required. This presents a significant barrier to progress in adolescent HIV prevention by creating delays in research and the translation of new scientific evidence generated in biomedical trials in adult populations. Objective This protocol aims to examine how parental involvement in the consent process affects the acceptability of hypothetical participation in biomedical HIV prevention trials from the perspectives of minor adolescents and parents of minor adolescents. Methods In this protocol, we use a quasi-experimental design that involves a simulated consent process for 2 different HIV prevention trials. The first trial is modeled after an open-label study of the use of tenofovir disoproxil fumarate and emtricitabine as preexposure prophylaxis for HIV. The second trial is modeled after a phase IIa trial of an injectable HIV integrase inhibitor. There are 2 groups in the study—minor adolescents aged 14 to 17 years, inclusive, and parents of minor adolescents in the same age range. The adolescent participants are randomized to 1 of 3 consent conditions with varying degrees of parental involvement. After undergoing a simulated consent process, they rate their willingness to participate (WTP) in each of the 2 trials if offered the opportunity. The primary outcome is WTP, given the consent condition. Parents undergo a similar process but are asked to rate the acceptability of each of the 3 consent conditions. The primary outcome is acceptability of the consent method for enrollment. The secondary outcomes include the following: capacity to consent among both participant groups, the prevalence of medical mistrust, and the effects of the study phase (eg, phase IIa vs the open-label study) and drug administration route (eg, oral vs injection) on WTP (adolescents) and acceptability (parents) of the consent method. Results Enrollment began in April 2018 and ended mid-September 2019. Data are being analyzed and dissemination is expected in April 2020. Conclusions The study will provide the needed empirical data about minor adolescents’ and parents’ perspectives on consent methods for minors. The evidence generated can be used to guide investigators and ethics regulators in the design of consent processes for biomedical HIV prevention trials. International Registered Report Identifier (IRRID) DERR1-10.2196/16509

This article examines the impact of biomedical ethics on the formation of a professional outlook of an ­anesthesiologist. The main provisions of bioethics are co­vered and how they influence the process of making clinical decisions, form the doctor-patient and doctor-doctor relationship, promote the permanent self-improvement of medical specialists., В данной статье рассмотрено влияние биомедицинской этики на формирование профессионального мировоззрения врача-анестезиолога. Освещены основные положения биоэтики и то, как они влияют на процесс принятия клинических решений, формируют отношения уровня «врач — врач», «врач — пациент», способствуют постоянному самосовершенствованию специалистов медицинского профиля., В даній статті розглянуто вплив біомедичної етики на формування професійного світогляду лікаря-анестезіолога. Висвітлено основні положення біоетики і те, як вони впливають на процес прийняття клінічних рішень, формують відносини рівня «лікар — пацієнт», «лікар — лікар», сприяють постійному самовдосконаленню спеціалістів медичного профілю.

Patients with progressive neurodegenerative diseases often pursue trial entry seeking to access cutting edge therapies. However, cutting edge therapies for neurodegenerative diseases tend to have higher adverse event rates and underperform placebo. This essay argues that patients seeking trial entry are probably better off, medically, by being assigned to the placebo arm. Because trials involve extra clinic visits and research procedures, patients may be still better off medically by skipping trial participation altogether. I close by arguing that the Neurology research community might better honor the contributions of research subjects by pressing sponsors to promptly publish the results of non-positive trials, minimizing the use of uneven randomization ratios that favor assignment to the investigational treatment, and by fostering systematic collection of data on the risk/benefit balance of trial participation.

Health care providers (HCP) and clinical scientists (CS) are generally most comfortable using evidence-based rational decision-making models. They become very frustrated when policymakers make decisions that, on the surface, seem irrational and unreasonable. However, such decisions usually make sense when analysed properly. The goal of this paper to provide a basic theoretical understanding of major policy models, to illustrate which models are most prevalent in publicly funded health care systems, and to propose a policy analysis framework to better understand the elements that drive policy decision-making. The proposed policy framework will also assist HCP and CS achieve greater success with their own proposals.

Euthanasia is a complex medical procedure. Even though end of life decisions are common situations in health practice, there is a lack of consensus about their terminology. In this manuscript, the main concepts about this issue are defined and delimited; including active and passive euthanasia and limitation of therapeutic effort. Then, a revision is made about the international experience on euthanasia, to then go through the Chile’s history in euthanasia and the population’s opinion. In Chile, euthanasia is an act that has been removed from the social dialogue and legislation. In order to have an open discussion in our population about the issue, the debate has to be opened to the citizens, accompanied by clear medical information about the procedure.

ContextAlthough patient and physician characteristics are thought to be predictive of discretionary interventions at the end of life (EoL), few studies have data on both parties.ObjectiveTo test the hypothesis that patient preferences and physician attitudes are both independently associated with discretionary interventions at the EoL.MethodsWe report secondary analyses of data collected prospectively from physicians (n=38) and patients with advanced cancer (n=265) in the Values and Options in Cancer Care study. Predictor variables were patient attitudes toward EoL care and physician-reported comfort with medical paternalism, assessed indirectly using a modified version of the Control Preference Scale. We explored whether the magnitude of the physician variable was influenced by the inclusion of particular patient treatment-preference variables (i.e., effect modification). Outcomes were a chemotherapy use score (≤14days before death [scored 2], 15-31days before death [scored 1], and >31days [scored 0]) and an emergency department visit/inpatient admission score (two or more admissions in the last 31days [scored 2], one admission [1], and 0 admissions [0]) in the last month of life.ResultsChemotherapy scores were nearly 0.25 points higher if patients expressed a preference for experimental treatments with unknown benefit at study entry (0.238 points, 95% CI= 0.047-0.429) or reported an unfavorable attitude toward palliative care (0.247 points, 95% CI= 0.047-0.450). A two-standard deviation difference in physician comfort with medical paternalism corresponded to standardized effects of 0.35 (95% CI= 0.03-0.66) for chemotherapy and 0.33 (95% CI= 0.04-0.61) for emergency department visits/inpatient admissions. There was no evidence of effect modification.ConclusionPatient treatment preferences and physician attitudes are independently associated with higher levels of treatment intensity before death. Greater research, clinical, and policy attention to patient treatment preferences and physician comfort with medical paternalism might lead to improvements in care of patients with advanced disease.

Certain jurisdictions in Canada legally require that physicians report unfit drivers. Physician attitudes and patterns of practice have yet to be evaluated in Canada for patients with brain tumours. We conducted a survey of 97 radiation oncologists, eliciting demographics, knowledge of reporting laws, and attitudes on reporting guidelines for unfit drivers. Eight scenarios with varying disability levels were presented to determine the likelihood of a patient being reported as unfit to drive. Statistical comparisons were made using the Fisher exact test. Of physicians approached, 99% responded, and 97 physicians participated. Most respondents (87%) felt that laws in their province governing the reporting of medically unfit drivers were unclear. Of the responding physicians, 23 (24%) were unable to correctly identify whether their province had mandatory reporting legislation. Physicians from provinces without mandatory reporting legislation were significantly less likely to consider reporting patients to provincial authorities (p = 0.001), and for all clinical scenarios, the likelihood of reporting significantly depended on the physician&rsquo, s provincial legal obligations. The presence of provincial legislation is of primary importance in determining whether physicians will report brain tumour patients to drivers&rsquo, licensing authorities. In Canada, clear guidelines have to be developed to help in the assessment of whether brain tumour patients should drive.

Ethical consideration is an inseparable part of policy-making in modern society. Biomedical ethics is an interdisciplinary study of ethical issues that result from advances in medical practices and research. Because these issues often arise at the bedside, society must provide solutions or judgments that are effective and applicable. Thus, the development and progress of biomedical ethics has been made possible via the cooperation of experts from diverse backgrounds. The biomedical ethics discourse should not be seen as a conflict between values but as a collective activity for problem-solving. To support this perspective on ethics discourse, a historical perspective on biomedical ethics in Korea was given emphasis on the participants and their perspectives. Major cases and the changes resulting therefrom were discussed with the agenda proposed. The Korean situation with respect to ethics development shows the interactions between groups participating in policy development and its collaborative nature.

The lifesaving processes of organ donation and transplantation in neonatology and pediatrics carry important ethical considerations. The medical community must balance the principles of autonomy, non-maleficence, beneficence, and justice to ensure the best interest of the potential donor and to provide equitable benefit to society. Accordingly, the US Organ Procurement and Transplantation Network (OPTN) has established procedures for the ethical allocation of organs depending on several donor-specific and recipient-specific factors. To maximize the availability of transplantable organs and opportunities for dying patients and families to donate, the US government has mandated that hospitals refer potential donors in a timely manner. Expedient investigation and diagnosis of brain death where applicable are also crucial, especially in neonates. Empowering trained individuals from organ procurement organizations to discuss organ donation with families has also increased rates of consent. Other efforts to increase organ supply include recovery from donors who die by circulatory criteria (DCDD) in addition to donation after brain death (DBD), and from neonates born with immediately lethal conditions such as anencephaly. Ethical considerations in DCDD compared to DBD include a potential conflict of interest between the dying patient and others who may benefit from the organs, and the precision of the declaration of death of the donor. Most clinicians and ethicists believe in the appropriateness of the Dead Donor Rule, which states that vital organs should only be recovered from people who have died. The medical community can maximize the interests of organ donors and recipients by observing the Dead Donor Rule and acknowledging the ethical considerations in organ donation.

The use of face transplants has become possible in Turkey and the world in recent years. Face transplants are not just an exchange of tissue between the donor and the recipient and are social and ethical issues concerning the health care institutions, health care team and the public. The interest and criticism of the health care professionals, institutions, public and media regarding the transplants have led to various ethical problems. This study aimed to perform an biomedical ethical evaluation of the newspaper articles on face transplant cases. The study used retrospective, descriptive, qualitative and quantitative data. The study scope included news from the three highest-selling newspapers published in Turkey with Internet archives that were accessible online. An evaluation form developed by the investigators after a literature review was used for evaluation of the articles. According to the study data, we found that the articles focused mostly on benefits such as the positive changes in the individual patient and the relatives, the decreased or eliminated psychological pain of the patient, the importance of organ transplants, and increased trust in the health care team. The most common violations in the articles were regarding protection of privacy and confidentiality by announcing the names of the donor and recipient, and sharing the treatment process. In conclusion, the necessary training must be provided to ensure health care staff, health care institutions and journalists possess the necessary ethical sensitivity and act according to professional ethical principles.

Euthanasia or assisted suicide&mdash, and sometimes both&mdash, have been legalized in a small number of countries and states. In all jurisdictions, laws and safeguards were put in place to prevent abuse and misuse of these practices. Prevention measures have included, among others, explicit consent by the person requesting euthanasia, mandatory reporting of all cases, administration only by physicians (with the exception of Switzerland), and consultation by a second physician.

Although many people welcome the recent move by the United States to give its Food and Drug Administration (fda) the authority to regulate the content of tobacco, some worry that such regulation constitutes unwarranted interference with the freedom of competent adult tobacco consumers. The concern for protecting the autonomy of individuals is valuable indeed, but given the highly addictive nature of tobacco products (and especially the nicotine in tobacco products), the continued use of tobacco by smokers cannot &mdash, without straining credulity&mdash, be said to be autonomous. This fact, combined with a proper construal of the fda&rsquo, s role and an appreciation of the substantial morbidity and mortality associated with tobacco use, makes a strong case for content regulation.

Our contribution discusses the possibilities and limits of using video games for apprehending and reflecting on the moral actions of their players. We briefly present the results of an extended study that introduces the conceptual idea of a Serious Moral Game (SMG). Then, we outline its possible application in the domain of bioethics for training medical professionals such that they can deal better with moral problems in medical practice. We briefly sketch major components of a SMG Bioethics. The contribution should demonstrate how such an instrument may improve psychological competences that are needed for dealing with various ethical questions within healthcare. The contribution is an intermediate step of a project that aims at actually creating a SMG for training in moral competences that are needed for putting bioethics in practice.

More than 90 people attended a March 25–27, 2004, conference on Ethics and Epidemics. This conference was sponsored by the Albany Medical College–Graduate College of Union University Masters in Bioethics Program, the University at Albany School of Public Health, the New York State Department of Health, and the Wadsworth Laboratories. Attendees came from Australia, Africa, Asia, Europe, Canada, and the United States. Among the 24 papers and panels, presentations were made by George Annas, professor and chair of Health Law at the Boston University School of Public Health; Ezekiel Emanuel, chair of the Department of Clinical Bioethics of the Magnuson Center of the National Institutes of Health; Thomas R. Freiden, commissioner, New York City Department of Health; Matthew Wynia, director of the Institute of Ethics of the American Medical Association; Kenyan bioethicist Angela Wassuna associate for International Affairs of the Hastings Center; and 19 other bioethicists and health professionals. Presentations ranged from case studies to health policy debates. Many reviewed the history of epidemics, emphasizing their global nature and the imperative of global strategies for epidemic control. Several papers examined recent epidemics and explored new strategies for dealing with epidemic control while respecting human rights. The consensus was that the old policeman model of public health needs updating. Discussion focused on how best to balance public safety, professional responsibility, personal liberty, and human rights, while effectively containing epidemics. Emanuel and Wynia reaffirmed the responsibility of physicians and first responders to put their health and lives at risk in combating epidemics. Yet, noting the vulnerability of first responders (in the Toronto severe acute respiratory syndrome [SARS] outbreak and elsewhere), they distinguished between bravery and foolhardiness, arguing that just as professionals have a responsibility to protect the public from disease, the public, in turn, has a responsibility to provide the training, equipment, and resources to minimize the need to take risks. Virtually all conferees observed that the public health infrastructure needs substantial rebuilding to cope effectively with epidemics. Annas, however, noted that in bioterrorist assaults the control of biologic agents is a public health problem to be dealt with by public health officials, not by the U.S. Department of Defense or the U.S. Department of Homeland Security. He further stated that policies on epidemic control that involve consistent, open, and truthful communication with the public—like those used in New York and Toronto during the recent SARS outbreak—create cooperative environments that minimize conflicts between freedom and safety and limit the effects of isolation and quarantine. However, Emanuel et al. asserted that the traditional enforcement authority of public health law was essential and needed as a fallback. The result of the debate was that 21st century methods need to be developed to control infectious disease epidemics that reconcile the need to protect public health and respect human rights. The conference program is available on http://www.bioethics.union.edu under "News." For further information contact bioethics@union.edu or 518-388-8045.

Background: The knowledge of medical ethics is essential for health care practitioners worldwide. The main objective of this study was to evaluate the knowledge of medical doctors in a tertiary care hospital in Nigeria in the area of medical ethics. Materials and Methods: A cross– sectional questionnaire‑based study involving 250 medical doctors of different levels was carried out. The questionnaire, apart from the bio‑data, also sought information on undergraduate and postgraduate training in medical ethics, knowledge about the principles of biomedical ethics and the ethical dilemmas encountered in daily medical practice. Results: One hundred and ninety (190) respondents returned the filled questionnaire representing a response rate of 76%. One hundred and fifty‑two respondents (80%) have had some sort of medical ethics education during their undergraduate level in the medical education. The median duration of formal training or exposure to medical ethics education was 3.00 hours (range: 0‑15). One hundred and twenty‑nine respondents have read at least once the code of medical ethics of the Medical and Dental Council of Nigeria while 127 (66.8%) have some general knowledge of the principles of biomedical ethics. The breakdown of the identified ethical dilemmas shows that discharge against medical advice was the most identified by the respondents (69.3%) followed by religious/cultural issues (56.6%) while confidentiality was recognized by 53.4%. Conclusion: The knowledge of medical ethics by Nigerian medical doctors is grossly inadequate. There is an urgent need for enhancement of the teaching of the discipline at both undergraduate and postgraduate levels in Nigeria.Keywords: Biomedical ethics, developing countries, ethical dilemma, medical education, physiciansNigerian Medical Journal | Vol. 53 | Issue 4 | October-December | 2012