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DOAJ Open Access 2025
Therapeutic Contract and Ethical Practice in Counselling and Psychotherapy

Sunjida Shahriah, Sunjida Islam, Khalid Arafat

Psychotherapists and counsellors confront several ethical dilemmas as they tend to provide effective services. There has been much debate among psychotherapists and counsellors alike around the utility of therapeutic contracts. Some view contracts as being restrictive to the therapeutic process and often hindering the work done in sessions. In contrast, many counsellors and psychotherapists use those agreements to revisit specific therapeutic topics and establish the guidelines necessary for this professional arrangement. No matter the opinion or preference of contracts, the development of written and/or verbal consent of specific topics in psychotherapy remains essential. This remains one of the formal features of the arrangement and starting relationship in current counselling and psychotherapy practice. This paper aims to discuss the necessity and ethical demand of therapeutic contract in counselling and psychotherapy practice.

Medical philosophy. Medical ethics, Ethics
DOAJ Open Access 2025
The Deontological Dimension of Consent in Public Health Governance

Hua CHEN

Digital health inequality not only stems from the lag of health concepts and cognition, but also lies in the deep embedding of technological logic in social relations, as well as the erosion of medical health by the mutual embedding of capital and technology. Attaching importance to the digital determinants of health is to regard health as a basic human right in the digital age. It is essential to adopt a more profound understanding that humans are the ultimate purpose of development, and that the supremacy of life should be the core value and underlying logic in the field of healthcare in the digital era. To achieve health justice in the digital age, it is crucial to focus on the relationship between digital technology and social systems, update the concept of health, and dismantle the domination of capital and technology over individuals. This entails realizing human-centered health services and advocating for health data development based on the principle of mutual aid, while constructing a digital health community.

Medical philosophy. Medical ethics
DOAJ Open Access 2025
El Observatorio de la Red Iberoamericana de Bioética (ORIBI), bases para su operación

Antonio Cabrera Cabrera, Alejandro Sánchez Guerrero, David Cerdio Domínguez et al.

El texto presenta una visión detallada sobre la importancia y operación del Observatorio de la Red Iberoamericana de Bioética (ORIBI), argumentando la relevancia de la bioética en la contemporaneidad. La bioética, definida como la ética aplicada a la vida, ha expandido su influencia más allá de la medicina para abarcar áreas como el medio ambiente, derechos humanos y lucha contra la pobreza, destacando el enfoque interdisciplinario esencial para abordar dilemas éticos complejos. El ORIBI, desarrollado por el Centro Anáhuac de Desarrollo Estratégico en Bioética (CADEBI), busca consolidar algunos esfuerzos dispersos en Iberoamérica, fomentando la colaboración regional en investigación, formación y gestión de la bioética. Se destaca la necesidad de trabajo colaborativo entre observatorios existentes, aprovechando recursos y conocimientos para promover el bienestar social. El ORIBI planea su acción en torno al monitoreo continuo, análisis de actividades y red de vinculación, apoyándose en herramientas como el Atlas Iberoamericano de Bioética y una serie de indicadores de seguimiento. Este enfoque estratégico y flexible permite adaptar la operación del observatorio a desafíos emergentes.

Science, Medical philosophy. Medical ethics
DOAJ Open Access 2024
Questionable research practices of medical and dental faculty in Pakistan – a confession

Ayesha Fahim, Aysha Sadaf, Fahim Haider Jafari et al.

Abstract Purpose Intellectual honesty and integrity are the cornerstones of conducting any form of research. Over the last few years, scholars have shown great concerns over questionable research practices (QRPs) in academia. This study aims to investigate the questionable research practices amongst faculty members of medical and dental colleges in Pakistan. Method A descriptive multi-institutional online survey was conducted from June-August 2022. Based on previous studies assessing research misconduct, 43 questionable research practices in four domains: Data collection & storage, Data analysis, Study reporting and Collaboration & authorship were identified and investigated. Descriptive (Frequencies, Percentages, Mean, SD) and Inferential (chi square) statistics were calculated. Results A total of 654 faculty members responded. Every respondent reported committing at least one QRP in their career. The most common QRPs included deliberately failing to mention funding, publishing program evaluation data not meant for research purposes or approved by an ethical body, inappropriately storing identifiable information and non-disclosure of any conflicts. There was significant association of age, gender and academic rank with QRPs in ‘Data collection and storage’ and ‘Data Analysis’ domains. Conclusion Medical and dental faculty members participating in this study are involved in a range of questionable research practices (QRPs) in Pakistan. Their confession might have contributed to the faculty developing self-awareness and reinforcing academic integrity. There is a need for reviewing policies and practices to improve research culture. Future research should explore the factors resulting in such practices.

Medical philosophy. Medical ethics
DOAJ Open Access 2024
Human dignity: a contract or an abstract?

Seyed Abdolsaleh Jafari, Behin Aramnia, Hanie Tavasoli et al.

Although human dignity has been the focus of many researchers, fundamental debates about its existence have often been ignored. Different views on human dignity and its existence can lead to divergent interpretations of human rights. In this study, we attempted to find an answer to the question of the nature of human dignity by examining and collecting the opinions of experts and analyzing and criticizing them. Our analysis showed that since dignity is linked to human existence and understanding, it has a subjective nature. Subjective existences have different types, including contractual and abstract. Contractual existence finds its way to objective entities through human thought, and it is changeable. An abstract existence, on the other hand, is created by perception of an objective entity in a constant way among human beings. Human dignity is consistent with the contractual type, because simply seeing a human does not bring to mind the existence of dignity and human rights. Once we accept the contractual nature of dignity, we must determine who bestowed this dignity on man. Through investigations, we came to the conclusion that God is the only one that can grant such privilege, and the existence of dignity for humans is a proof of God's existence.

History of medicine. Medical expeditions, Medical philosophy. Medical ethics
DOAJ Open Access 2022
Percepção de adolescentes com lesão medular sobre autonomia

Isabel Cristina Correia, Eliane Maria Fleury Seidl

Resumo Considerando que, a partir do referencial dos direitos humanos do paciente, aspectos bioéticos da autonomia relacional são importantes na construção da autonomia como projeto de vida, analisou-se a percepção do processo de autonomia em adolescentes com lesão medular participantes de um programa de reabilitação. Trata-se de estudo transversal quali-quantitativo que utilizou entrevista para coletar dados e o software Iramuteq para analisá-los. Participaram 14 adolescentes, 50% do sexo masculino, 29% moradores do Distrito Federal, 71% com paraplegia. Na análise dos dados qualitativos, identificaram-se cinco classes: programa de reabilitação (20,9%); autonomia (21,8%); relações familiares (16,7%); sentimentos e vivências (23,9%); e rotina (16,7%). A mãe foi apontada como principal cuidadora (64%) e a autonomia muitas vezes foi relacionada ao conceito de independência. Outras formas de relacionamentos corroboraram o modelo da autonomia relacional, sendo identificados desafios intrínsecos e extrínsecos à condição dos participantes analisadas na perspectiva dos direitos humanos do paciente.

Medical philosophy. Medical ethics
DOAJ Open Access 2021
In love with machines: The bioethical debate about sexual automation

Elen Cristina Carvalho Nascimento, Eugenio da Silva, Rodrigo Siqueira-Batista

A few companies around the world are now developing and selling sex robots. Questions such as “how will relationships with robots’ impact human relations in the future” emerge when technologies are used to meet the social and emotional needs of individuals. Considering that technology and design have embedded values and biases, this article surveys the use of sex robots from a bioethical perspective. Relationships with robots and computational systems, like Artificial Intelligence, are a possibility for many people around the world. We present questions raised by the voices in favor of robot sex, and against it.  Beyond a binary polarization, the bioethical perspective recalls the Foucaultian concepts of biopolitics and biopower to situate the problems with the mechanization of intimate relationships. We argue that sex robots offer the opportunity to review old patterns regarding gender, inequality, and health.

Jurisprudence. Philosophy and theory of law, Medical philosophy. Medical ethics
DOAJ Open Access 2021
Cross-cultural validation of the IRB Researcher Assessment Tool: Chinese Version

Xing Liu, Ying Wu, Min Yang et al.

Abstract Background Using an effective method for evaluating Institutional Review Board (IRB) performance is essential for ensuring an IRB’s effectiveness, efficiency, and compliance with applicable human research standards and organizational policies. Currently, no empirical research has yet been published in China evaluating IRB performance measures by the use of a standardized tool. This study was therefore conducted to develop a Chinese version of the IRB Researcher Assessment Tool (IRB-RAT), assess the psychometric properties of the Chinese version (IRB-RAT-CV), and validate the tool for use in China. Methods In this cultural adaptation, cross-sectional validation study, the IRB-RAT-CV was developed through a back-translation process and then distributed to 587 IRB staff members and researchers in medical institutions and schools in Hunan Province that review biomedical and social-behavioral research. Data from the 470 valid questionnaires collected from participants was used to evaluate the reliability, content validity, and construct validity of the IRB-RAT-CV. Results Participants’ ratings of their ideal and actual IRB as measured by the IRB-RAT-CV achieved Cronbach's alpha 0.989 and 0.992, Spearman-Brown coefficient 0.964 and 0.968, and item-total correlation values ranging from 0.631 to 0.886 and 0.743 to 0.910, respectively. Conclusion The IRB-RAT-CV is a linguistically and culturally applicable tool for assessing the quality of IRBs in China.

Medical philosophy. Medical ethics
DOAJ Open Access 2021
The Edge of Perinatal Viability: Understanding the Dutch Position

L. De Proost, L. De Proost, L. De Proost et al.

The current Dutch guideline on care at the edge of perinatal viability advises to consider initiation of active care to infants born from 24 weeks of gestational age on. This, only after extensive counseling of and shared decision-making with the parents of the yet unborn infant. Compared to most other European guidelines on this matter, the Dutch guideline may be thought to stand out for its relatively high age threshold of initiating active care, its gray zone spanning weeks 24 and 25 in which active management is determined by parental discretion, and a slight reluctance to provide active care in case of extreme prematurity. In this article, we explore the Dutch position more thoroughly. First, we briefly look at the previous and current Dutch guidelines. Second, we position them within the Dutch socio-cultural context. We focus on the Dutch prioritization of individual freedom, the abortion law and the perinatal threshold of viability, and a culturally embedded aversion of suffering. Lastly, we explore two possible adaptations of the Dutch guideline; i.e., to only lower the age threshold to consider the initiation of active care, or to change the type of guideline.

DOAJ Open Access 2020
Julgamento ético no Rio Grande do Norte entre 2000 e 2015

Armando Otávio Vilar de Araújo, Danielle Dutra Araújo, Alice Helena de Araújo Silva Nogueira et al.

Resumo Com os crescentes processos contra médicos, seja na esfera cível, administrativa ou criminal, a judicialização da medicina tem se tornado cada vez mais comum. Portanto, é fundamental que o profissional de medicina conheça a realidade atual e se prepare para enfrentá-la. Partindo desse princípio, este estudo investigou os arquivos do Conselho Regional de Medicina do Estado do Rio Grande do Norte a fim de levantar as denúncias recebidas, sindicâncias, processos instaurados e julgados e penas disciplinares aplicadas entre 2000 e 2015. Após análise dos dados, observou-se maior índice de médicos homens denunciados e número reduzido de penas aplicadas. A pesquisa conclui que é necessário investir na prevenção do erro mediante educação médica continuada e de qualidade, a fim de conservar boa relação entre profissional e paciente.

Medical philosophy. Medical ethics
DOAJ Open Access 2018
Setting standards for empirical bioethics research: a response to Carter and Cribb

Michael Dunn, Jonathan Ives, Bert Molewijk et al.

Abstract This paper responds to the commentaries from Stacy Carter and Alan Cribb. We pick up on two main themes in our response. First, we reflect on how the process of setting standards for empirical bioethics research entails drawing boundaries around what research counts as empirical bioethics research, and we discuss whether the standards agreed in the consensus process draw these boundaries correctly. Second, we expand on the discussion in the original paper of the role and significance of the concept of ‘integrating’ empirical methods and ethical argument as a standard for research practice within empirical bioethics.

Medical philosophy. Medical ethics
DOAJ Open Access 2014
Estrategias para inhibir y prevenir el fraude en la investigación científica

Omar França Tarragó

En este artículo se expone la preocupación creciente de la comunidad científica en relación con las malas conductas en investigación científica; así mismo, se caracterizan someramente los principales tipos de fraude investigativo y se proponen algunas medidas de prevención y de control de las inconductas científicas que podrían ser implementadas por los países, las universidades e institutos de investigación.

Medical philosophy. Medical ethics, Ethics
DOAJ Open Access 2014
Tyler Perry’s "The Haves and the Have Nots"

Obiora Anekwe

Tyler Perry has become an American entertainment icon. His golden touch as an actor, writer, producer, and director has reached arenas in stage, television, and film. Perry continues to bring forth ethical and moral messages in the visual arts that are often overlooked or underestimated. It is no different with his first soap opera, The Haves and the Have Nots, broadcast on the OWN Channel. The racially diverse cast of characters portrays the lives of the rich (the Cryer and Harrington families) and the poor and destitute (the Young family) in the southern city of Savannah, Georgia. But beyond the surface of class difference, these families share common bioethical themes and challenges such as cancer, substance abuse, homosexuality, suicide, prostitution, poverty, rape, perpetual crime, abortion, mental illness, and life support. One of the more salient themes of the show is the issue of life support and health care disparities based on class. Katheryn Cryer (the Haves) befriends and confides in Hanna, her maid (the Have Nots), during her treatment of cancer. Katheryn and Hanna share a bond as parents, but most significantly, as two cancer survivors.  After Hanna aids Katheryn in her recovery efforts, Katheryn promotes Hanna as the head maid in the Cryer household. Hanna has a son, Benny, who lives with her and diligently operates a tow truck company. While working late one night, Benny is accidentally struck by a car driven by Katheryn Cryer’s son, Wyatt, who was under the influence of heroin. Wyatt not only harms Benny, but subsequently kills a girl in the accident. As a result of this horrific turn of events, Benny is in a coma with very little hope of recovery. His mother, Hanna, constantly prays for her only son’s recovery; while Wyatt, a young man of privilege, is being protected by his family’s wealth and power. To make matters worse, Benny’s father, Tony, who was not involved in his son’s life as a young man, legally seeks to remove his son off life support in order to acquire a much-needed kidney. This tale’s tragedy is found in the victim of the accident, Benny. He cannot receive the treatment he deserves in a community hospital because he does not have health care insurance. The lack of access to medical resources is limited by Benny’s status as a young person without medical capital. Tyler Perry creatively brought the issue of health care disparities to the forefront without preaching to the choir. His writing is so well crafted that you, as a viewer, are confronted with this issue without much notice. Perry’s narrative from The Haves and the Have Nots highlights how the passing of the Affordable Care Act begins to bring justice and equality to health care. Opposition to the Act by those who seldom have read it in its entirety and oftentimes possess comprehensive health care insurance themselves simply brings to light subversive and undermining discriminatory practices against the poor and most vulnerable. As Tyler Perry’s television series demonstrates, the lack of comprehensive health insurance oftentimes results in the death of the poor. In this scenario, the poor and vulnerable are not the only victims. Their families and even the larger society are harmed because of a lack of compassion for the helpless. Rather than promoting further divide over disagreements about certain sections of the Affordable Care Act, we, as a nation, should seek to make health care a nationalistic fundamental right that benefits all society. Although the health care system in America seems fragile and even broken to some, it can be healed and repaired through a concerted effort of bipartisan political leadership and citizen support. Tyler Perry’s television series reminds us that we have what it takes to bridge the divide between the Haves and the Have Nots if we are willing to work together for a common and necessary good.

Medical philosophy. Medical ethics, Ethics
DOAJ Open Access 2014
Ebola Patients and the Ethics of Unilateral Do-Not-Resuscitate Orders

Kevin Van Geem

The bioethicist Joseph Fins, M.D. recently called for unilateral do-not-resuscitate (DNR) orders for all patients suffering from Ebola virus infection. [1] If Dr. Fins’ suggestion is adopted it will mark the first time unilateral DNR orders will be made based solely on infection status, and not on individual prognosis. His thoughtful argument is based in the principle of non-maleficence and the concept of futility. Despite this Dr. Fins fails to adequately address the popular misconceptions of DNR orders as “giving up” and letting patients die. [2,3,4] As a result, Dr. Fins’ well-reasoned call for unilateral DNR orders may inflict unintended harms to patients suffering from Ebola hemorrhagic fever. The course of action that strikes an appropriate balance between ethical action and practicality should be a clear, in-depth conversation with patients and their loved ones about the limitations of Ebola critical care in the event of cardiopulmonary arrest, the initiation of preventative intubation or extracorporeal membrane oxygenation (ECMO) before a patient arrests, and the provision of limited cardiopulmonary resuscitation in the event of arrest. While Dr. Fins argues for unilateral DNR orders for all Ebola patients from an ethical standpoint, a DNR may be justified based solely on healthcare workers’ inability to provide cardiopulmonary resuscitation (CPR) for Ebola patients. CPR requires a team of physicians, nurses, and a respiratory therapist. In the event of a “code blue” (i.e., patient’s cardiopulmonary arrest), any physicians, nurses, and respiratory therapists not involved in the patient’s routine care, but necessary for CPR would need to put on their required personal protective equipment (PPE) before helping the patient. Depending on the protocol, 10 to 28 steps are required to properly put on PPE. [5,6,7,8] In an emergency (e.g., cardiopulmonary arrest), these steps will either take too long for healthcare providers to successfully attend to the patient, or the healthcare providers may accidently skip, or err on any given step, exposing them to risk of infection. The most likely scenario would be a combination of the two where the patient receives unsuccessful CPR–due to a delay in receiving resuscitative efforts–and one or more healthcare workers are needlessly exposed to the Ebola virus. The only way to overcome this barrier to providing CPR would be to have a 24/7 on call CPR staff already suited in PPE; this would effectively render them unable to attend to any other patients shifting the healthcare worker to Ebola patient ratio to around a dozen to one. Practical concerns aside, a unilateral DNR for Ebola patients can be ethically justified–just as Dr. Fins argues–on grounds of non-maleficence. [1] Ebola virus infections cause massive internal bleeding, which means that at least some patients experiencing cardiopulmonary arrest will most likely be in extremis due to exsanguination (i.e., bleeding out). The chest compressions involved in CPR would most likely worsen the patient’s blood loss, in effect hastening death. Furthermore, CPR for such a patient will most likely be futile, due to their disease process and compounded by the time it takes for healthcare workers to properly don their PPE. Patients who arrest in hospitals have a 6.5-15% chance of survival. [9] These data do not take underlying disease process into account, which has a great effect on survival rates. [10] As was previously outlined, the time between arrest and CPR will be greatly protracted in the Ebola patient due to the lengthy process of donning PPE, which will make any resuscitative efforts much less effective then if they were started immediately. Despite these practical and ethical justifications for the unilateral DNR for Ebola patients, Dr. Fins fails to acknowledge that many people, physicians included, do not have an accurate understanding of DNR orders. [4,9,11,12] A popular misconception of the DNR order treats it synonymously with “giving up.” However the more accurate understanding of a DNR–and how Dr. Fins views it in relation to Ebola patients–is described by the American Medical Association (AMA) as an order preventing the initiation of CPR, exclusive of an other treatment. [10] A review of CPR on television found that resuscitative efforts in popular media rarely fail. [9] This feeds an unrealistic public perception of DNR orders as a withdrawal of care. Asking the public to understand a DNR order based on the futility of CPR is extraordinarily difficult if most people expect CPR to revive a majority of patients suffering cardiopulmonary arrest. The potential for misunderstanding a unilateral DNR order is great, and could potentially undermine many patient-physician relationships, regardless of disease. Although considerations of public perception are important, a widespread misconception of DNR orders among the lay public is much less problematic than misconceptions within hospital staff. Some studies have indicated that the AMA’s definition of DNR orders is not fully understood or implemented by healthcare providers. [11,12] The implications of these findings indicate that the mere appearance of a DNR in a patient’s chart affects the non-CPR treatments they will receive, potentially resulting in less than optimal care. If a unilateral DNR is enacted for all Ebola patients, any physicians without a proper understanding of DNR orders may treat Ebola patients less aggressively than they would patients requesting full resuscitative efforts. While this potential exists already, the individualized nature of ordering a DNR requires a discussion between physicians and patients regarding the patients’ end-of-life goals of care, including but not limited to CPR and a DNR orders. However a unilateral DNR order removes the impetus for such a discussion to occur. In effect the unilateral DNR could cause, at least theoretically, the death of patients suffering from Ebola infection who might otherwise have otherwise recovered, solely because of physician misunderstanding. This is ethically unacceptable. Rather than call for the highly controversial unilateral DNR as Dr. Fins has done, a more nuanced approach would be equally effective at maintaining healthcare worker safety and would be less ethically problematic. Upon admission, the attending physician should have a conversation with the patient, and their loved ones, as to the realities of providing CPR to patients with Ebola hemorrhagic fever. They should explore the patient’s goals of care, and whether or not the patient wants CPR or a DNR order. In the event that a patient requests “everything be done” (i.e., perform aggressive CPR), the physician and the ICU team should explore “pre-emptive” CPR-like options (i.e., aggressive, non-futile life-sustaining medical treatments like intubation or ECMO) prior to an arrest, as well as less aggressive, yet still effective, CPR efforts (i.e., withholding chest compressions, only the attending physician and the nurses perform CPR, epinephrine injections, monitor electrolytes) after an arrest. Most importantly, healthcare providers must ensure that their patients don’t feel abandoned, or feel like their physicians will give up on them because they are unfortunate enough to have contracted the Ebola hemorrhagic fever. Photo by Jonathan Borba on Unsplash References: [1] Fins Joseph. “Responding to Ebola: Questions about Resuscitation.” The Hastings Center: Bioethics Forum. Last modified October 10, 2014. http://www.thehastingscenter.org/bioethicsforum [2] Bishop Jeffrey, Brothers Kyle, Perry Joshua, Ahmad Ayesha. “Reviving the Conversation Around CPR/DNR.” The American Journal of Bioethics 10 No. 1 (2010): 61-67. [3] Burns Jeffrey, Edwards Jeffrey, Johnson Judith, Cassem Ned, Truog Robert. “Do-not-resuscitate order after 25 years.” Critical Care Medicine 31 No. 5 (2003):1543-1550. [4] Clark Jonna, Dudzinski Denise. “The False Dichotomy: Do ‘Everything’ or Give Up.” The American Journal of Bioethics 11 No. 11 (2011): 26-27. [5] Centers for Disease Control and Prevention. “Guidance on Personal Protective Equipment To Be Used by Healthcare Workers During Management of Patients with Ebola Virus Disease in U.S. Hospitals, Including Procedures for Putting On (Donning) and Removing (Doffing).” Centers for Disease Control and Prevention Web site. Last modified October 20, 2014. http://www.cdc.gov/vhf/ebola/hcp/procedures-for-ppe.html [6] Sterk Esther, ed. “Filovirus Haemorrhagic Fever Guideline, 2008.” Medicines Sans Frontieres 2008. [7] University of Nebraska Medical Center. “Donning Biological PPE – Ebola Patients.” University of Nebraska Medical Center. Accessed November 7, 2004. http://app1.unmc.edu/nursing/heroes/ppe_posters_vhf.cfm [8] World Health Organization. “Steps to put on personal protective equipment (PPE).” World Health Organization. Last modified August 2014. http://www.who.int/csr/resources/publications/ebola/filovirus_infection_control/en/ [9] Diem Susan, Lantos John, Tulsky James. “Cardiopulmonary resuscitation on Television.” The New England Journal of Medicine 334 No. 24 (1996): 1578-1582. [10] Council on Ethical and Judicial Affairs American Medical Association. “Guidelines for the appropriate use of do-not-resuscitate orders.” Journal of the American Medical Association 265 No.14 (1991): 1868–1871. [11] Beach Mary Catherine, Morrison R. Sean. “The Effect of Do-Not-Resuscitate Orders on Physician Decision-Making.” Journal of the American Geriatrics Society 50 No.12 (2002): 2057-2061. [12] Cohen Rubin I, Lisker Gita N, Eichorn Ann, Multz Alan S, Silver Alan. “The impact of do-not-resuscitate order on triage decisions to a medical intensive care unit.” Journal of Critical Care 24 No.2 (2009): 311-315.

Medical philosophy. Medical ethics, Ethics
DOAJ Open Access 2010
Ethics, economics and the regulation and adoption of new medical devices: case studies in pelvic floor surgery

Ross Sue, Weijer Charles, Gafni Amiram et al.

<p>Abstract</p> <p>Background</p> <p>Concern has been growing in the academic literature and popular media about the licensing, introduction and adoption of surgical devices before full effectiveness and safety evidence is available to inform clinical practice. Our research will seek empirical survey evidence about the roles, responsibilities, and information and policy needs of the key stakeholders in the introduction into clinical practice of new surgical devices for pelvic floor surgery, in terms of the underlying ethical principals involved in the economic decision-making process, using the example of pelvic floor procedures.</p> <p>Methods/Design</p> <p>Our study involves three linked case studies using, as examples, selected pelvic floor surgery devices representing Health Canada device safety risk classes: low, medium and high risk. Data collection will focus on stakeholder roles and responsibilities, information and policy needs, and perceptions of those of other key stakeholders, in seeking and using evidence about new surgical devices when licensing and adopting them into practice. For each class of device, interviews will be used to seek the opinions of stakeholders. The following stakeholders and ethical and economic principles provide the theoretical framework for the study:</p> <p indent="1"><b>Stakeholders </b>- federal regulatory body, device manufacturers, clinicians, patients, health care institutions, provincial health departments, and professional societies. Clinical settings in two centres (in different provinces) will be included.</p> <p indent="1"><b>Ethics </b>- beneficence, non-maleficence, autonomy, justice.</p> <p indent="1"><b>Economics </b>- scarcity of resources, choices, opportunity costs.</p> <p>For each class of device, responses will be analysed to compare and contrast between stakeholders. Applied ethics and economic theory, analysis and critical interpretation will be used to further illuminate the case study material.</p> <p>Discussion</p> <p>The significance of our research in this new area of ethics will lie in providing recommendations for regulatory bodies, device manufacturers, clinicians, health care institutions, policy makers and professional societies, to ensure surgical patients receive sufficient information before providing consent for pelvic floor surgery. In addition, we shall provide a wealth of information for future study in other areas of surgery and clinical management, and provide suggestions for changes to health policy.</p>

Medical philosophy. Medical ethics

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