Researchers in primary care share the general ethical obligations of all researchers. However, these obligations may raise different issues in the unique context of primary care. Current professional ethical guidance for primary care research is complex and fragmentary. The newly introduced research governance framework does not specifically address primary care research, and recent changes in legal requirements have significant implications for research. In this paper, ethical issues arising from research in primary care are considered, current standards and resources are described, and strategies for supporting ethical practice are discussed. Four ethical issues are discussed: consent and competence; confidentiality; power relations; and procedural issues. In the final part of the paper, broad strategies to support ethical practice in primary care research are recommended. These include education and resources, greater clarity of relevant standards, financial support, a greater role for primary care networks, and greater public debate.
Organ donation after cardiac or circulatory death (DCD) has been introduced to increase the supply of transplantable organs. In this paper, we argue that the recovery of viable organs useful for transplantation in DCD is not compatible with the dead donor rule and we explain the consequential ethical and legal ramifications. We also outline serious deficiencies in the current consent process for DCD with respect to disclosure of necessary elements for voluntary informed decision making and respect for the donor's autonomy. We compare two alternative proposals for increasing organ donation consent in society: presumed consent and mandated choice. We conclude that proceeding with the recovery of transplantable organs from decedents requires a paradigm change in the ethics of organ donation. The paradigm change to ensure the legitimacy of DCD practice must include: (1) societal agreement on abandonment of the dead donor rule, (2) legislative revisions reflecting abandonment of the dead donor rule, and (3) requirement of mandated choice to facilitate individual participation in organ donation and to ensure that decisions to participate are made in compliance with the societal values of respect for autonomy and self-determination.
In Turkey, there was no legal regulation of research on human beings until 1993. In that year "the amendment relating to drug researches" was issued. The main objectives of the regulation are to establish a central ethics committee and local ethics committees, and to provide administrative control.There are no compulsory clinical ethics lectures in the medical curriculum, so it is also proposed that research ethics committees (RECs) play a central educational role by helping physicians to be aware of moral problems and by contributing to the training of research teams.
Key Words: Medical ethics education • ethics committees in Turkey • good clinical practice • informed consent • respiratory distress syndrome
Physicians-in-training today are learning in an ethical environment that is unprecedented in its complexity. There is a call for new approaches in preparing medical students and residents for the ethical and professional issues they will encounter. The perspectives of physicians-in-training at different levels regarding the level of curricular attention needed for emerging bioethics concepts, practical informed consent considerations, and the care of special populations are unknown.
The authors performed a hypothesis-driven, confidential survey study to assess perceived needs and preferences among medical students and residents related to medical ethics education at the University of New Mexico School of Medicine.
A total of 336 physicians-in-training volunteered (62% response rate). Overall, strong interest was expressed for increased curricular attention to the domains of bioethics principles, informed consent, and care of special populations. Women students expressed greater interest generally. For certain domains, clinical students expressed relatively less curricular need and psychiatry and primary care residents expressed relatively greater curricular need. Two of the four hypotheses were supported, a third received partial support, and a fourth was not supported by the findings.
To be valuable and effective, new ethics curricular approaches must be responsive to the current complex ethical environment and attentive to the preferences of medical students and residents of both genders, at different stages of training, with different patient care responsibilities. This hypothesis-driven study provides guidance for the inclusion of novel and important ethics domains in training curricula across medical school and diverse residency programs.
The right to refuse medical intervention is well established, but it remains unclear how best to respect and exercise this right in life support. Contemporary ethical guidelines for critical care give ambiguous advice, largely because they focus on the moral equivalence of withdrawing and withholding care without confronting the very real differences regarding who is aware and informed of intervention options and how patient values are communicated and enacted. In withholding care, doctors typically withhold information about interventions judged too futile to offer. They thus retain greater decision‐making burden (and power) and face weaker obligations to secure consent from patients or proxies. In withdrawing care, there is a clearer imperative for the doctor to include patients (or proxies) in decisions, share information and secure consent, even when continued life support is deemed futile. How decisions to withhold and withdraw life support differ ethically in their implications for positive versus negative interpretations of patient autonomy, imperatives for consent, definitions of futility and the subjective evaluation of (and submission to) benefits and burdens of life support in critical care settings are explored. Professional reflection is required to respond to trends favouring a more positive interpretation of patient autonomy in the context of life support decisions in critical care. Both the bioethics and critical care communities should investigate the possibilities and limits of growing pressure for doctors to disclose their reasoning or seek patient consent when decisions to withhold life support are made.
Ethical dilemmas in family practice have increased in frequency and complexity as both the potential benefit and the potential harm of medical treatments have increased. All physicians must be aware of moral issues relating to medicine. Family physicians commonly face ethical problems concerning the patient with diminished autonomy; the right to refuse treatment; allocation of resources; informed consent; surrogate consent (for children, for the incompetent, and for those with diminished autonomy); and the appropriate level of aggressiveness in treatment.
bioethics; ethics; family practice; informed consent; patient-physician relations
Tailoring medical treatment to individual patients requires a strong foundation in research to provide the data necessary to understand the relationship between the disease, the patient, and the type of treatment advocated for. Non-therapeutic oncology clinical trials studying therapeutic resistance require the participation of patients, yet only a small percentage enroll. Treating physicians are often relied on to recruit patients, but they have a number of ethical obligations that might be perceived as barriers to recruiting. Concepts such as voluntariness of consent and conflicts of interest can have an impact on whether physicians will discuss clinical trials with their patients and how patients perceive the information. However, these ethical obligations should not be prohibitive to physician recruitment of patients – precautions can be taken to ensure that patients’ consent to research participation is fully voluntary and devoid of conflict, such as the use of other members of the research team than the treating physician to discuss the trial and obtain consent, and better communication between researchers, clinicians, and patients. These can ensure that research benefits are maximized for the good of patients and society.
ethics; recruitment; clinical trial; informed consent; conflict of interest
OBJECTIVE: To review the ethical and legal implications of the involvement of medical practitioners in workplace screening for drug misuse. CONCLUSIONS: Workplace screening for drugs of abuse raises many ethical issues. If screening is considered as being part of medical practice with the involvement of occupational health physicians, as suggested by the Faculty of Occupational Medicine, then the ethical requirements of a normal medical consultation are fully applicable. The employee's full and informed consent to the process must be obtained and the employee should have an unfettered right of access to all the relevant records and to the urine sample he/she has provided in the event that he/she wishes to challenge the opinion expressed by the physician. If the process is not part of medical practice then employees should have the same rights as they would have if required to provide intimate body samples in the course of a criminal investigation, given the potentially serious consequences of an erroneous positive finding for their livelihood.
A process evaluation was conducted to assess whether the newly developed Problem-Based Learning (PBL) curriculum designed to teach professionalism and ethics to biomedical graduate students was achieving its objectives. The curriculum was chosen to present realistic cases and issues in the practice of science, to promote skill development and to acculturate students to professional norms of science.
The perception to which the objectives for the curriculum and courses were being reached was assessed using 5-step Likert-scaled questions, open-ended questions and interviews of students and facilitators.
Process evaluation indicated that both facilitators and students perceived course objectives were being met. For example, active learning was preferred over lectures; both faculty and students percieved that the curriculum increased their understanding of norms, role obligations, and responsibilities of professional scientists; their ability to identify ethical situations was increased; skills in moral reasoning and effective group work were developed.
Information gathered was used to improve course implementation and instructional material. For example, a negative perception as an “ethics” course was addressed by redesigning case debriefing activities that reinforced learning objectives and important skills. Cases were refined to be more engaging and relevant for students, and facilitators were given more specific training and resources for each case. The PBL small group strategy can stimulate an environment more aware of ethical implications of science and increase socialization and open communication about professional behavior.
This paper examines two topics in Japanese medical ethics: non-disclosure of medical information by Japanese physicians, and the history of human rights abuses by Japanese physicians during World War II. These contrasting issues show how culture shapes our view of ethically appropriate behavior in medicine. An understanding of cultural context reveals that certain practices, such as withholding diagnostic information from patients, may represent ethical behavior in that context. In contrast, nonconsensual human experimentation designed to harm the patient is inherently unethical irrespective of cultural context. Attempts to define moral consensus in bioethics, and to distinguish between acceptable and unacceptable variation across different cultural contexts, remain central challenges in articulating international, culturally sensitive norms in medical ethics.
Preventive interventions may have few or unproven benefits, or they may even be harmful. Since three of the fundamental precepts of Western biomedical ethics are beneficence, non-maleficence and respect for individual autonomy, failure to obtain truly informed consent for many current preventive interventions may be unethical. However, there are many impediments to obtaining such consent. Physicians need to be aware of an immense amount of up-to-date, complex information. It may be difficult for patients to assimilate this information, and there is rarely time for physicians to become informed and to inform their patients. Clinical practice guidelines may be helpful, but not all are based on evidence, and recommendations are often conflicting. Medical institutions, as well as individual clinicians, can help solve these dilemmas. Authors and journal editors can make a commitment to report and publish well-referenced evidence-based guidelines. Organizations such as the Canadian Task Force on the Periodic Health Examination and the US Preventive Services Task Force can develop balanced, evidence-based patient-information material. Faculty at all levels of medical education can increase their emphasis on the ethics of prevention. Individual clinicians should avoid making clinical decisions on the basis of relative reductions of morbidity or mortality, should use evidence-based clinical practice guidelines rather than those based on authority whenever possible, should make use of patient-information material and, most important, should have a consistent policy of obtaining informed consent from patients before they participate in potentially harmful preventive programs.
Every healthcare organisation (HCO) enacts a multitude of policies, but there has been no discussion as to what procedural and substantive requirements a policy writing process should meet in order to achieve good outcomes and to possess sufficient authority for those who are asked to follow it.
Using, as an example, the controversy about patient's refusal of blood transfusions, I argue that a hospital wide policy is preferable to individual decision making, because it ensures autonomy, quality, fairness, and efficiency.
Policy writing for morally controversial medical practices needs additional justification compared to policies on standard medical practices and secures legitimate authority for HCO members by meeting five requirements: all parties directed by the policy are represented; the deliberative process encompasses all of the HCO's obligations; the rationales for the policy are made available; there is a mechanism for criticising, and for evaluating the policy.
Three recent Canadian legal cases have dealt with the proposed blood transfusion of adolescent members of Jehovah’s Witness (JW) families. In each case, the court permitted transfusions if medically necessary. Much critical analysis of the issue of forced treatment of decisionally competent adolescents focuses exclusively on competence and questions why mature minors may not decide for themselves. The authors argue that a focus on decision-making competence alone is too narrow. Before one may legally give or refuse consent to medical treatment, three conditions must be met: competence, adequate information and lack of coercion. In striving to find agreement on medical treatment, physicians, patients and JW family members seek and, in fact, often achieve mutual understanding and cooperation. Coercion by actual or threatened shunning and excommunication can occur, and these factors may affect adolescent decision-making. In this context, a court order authorizing medical treatment can, therefore, be seen as enhancing patient freedom. The authors suggest that, in addition to fulfilling existing statutory duties to report a child in need of protection, health care professionals caring for acute patients of JW families should actively look for evidence that the patient has accurate medical information and is acting without coercion. The authors also explore suggestions on how to deal with the unusual complexities of such cases.
Blood; Children; Emergency; Ethical issues; Jehovah’s Witness; Management
Clinical trials involving children previously considered unethical are now considered essential because of the inherent physiological differences between children and adults. An integral part of research ethics is the informed consent, which for children is obtained by proxy from a consenting parent or guardian. The informed consent process is governed by international ethical codes that are interpreted in accordance with local laws and procedures raising the importance of contextualizing their implementation.
In Zimbabwe the parental informed consent document for children participating in clinical research is modeled along western laws of ethics and requires that the parent or legally authorized representative provide consent on behalf of a minor. This article highlights the experiences and lessons learnt by Zimbabwean researchers in obtaining informed consent from guardians of orphaned children participating in a collaborative HIV clinical trial involving the Medical Research Council, United Kingdom and four centers, three of which are in Uganda. Researchers were faced with a situation where caregivers of orphaned children were not permitted to provide informed consent for trial participation. The situation contrasted with general clinical practice where consent for procedures on orphans is obtained from their caregivers who are not legal guardians.
The challenges faced in obtaining informed consent for orphans in this clinical trial underscores the need for the Zimbabwe ethics committee to develop an ethical and legal framework for pediatric research that is based on international guidelines while taking into account the cultural context. The Medical Research Council of Zimbabwe has since started the process that is expected to involve critical stakeholders namely the community including children, ethicists, the legal fraternity and researchers.
Photographs are commonly taken of children in medical and research contexts. With the increased availability of photographs through the internet, it is increasingly important to consider their potential for negative consequences and the nature of any consent obtained. In this research we explore the issues around photography in low-resource settings, in particular concentrating on the challenges in gaining informed consent.
Exploratory qualitative study using focus group discussions involving medical doctors and researchers who are currently working or have recently worked in low-resource settings with children.
Photographs are a valuable resource but photographers need to be mindful of how they are taken and used. Informed consent is needed when taking photographs but there were a number of problems in doing this, such as different concepts of consent, language and literacy barriers and the ability to understand the information. There was no consensus as to the form that the consent should take. Participants thought that while written consent was preferable, the mode of consent should depend on the situation.
Photographs are a valuable but potentially harmful resource, thus informed consent is required but its form may vary by context. We suggest applying a hierarchy of dissemination to gauge how detailed the informed consent should be. Care should be taken not to cause harm, with the rights of the child being the paramount consideration.
Photography; Ethics; Informed consent; Teleconference
Several situations of great ethical implications are encountered by physicians in daily urological practice. Informed consent for interventions, selection of patients for operative demonstrations and educational workshops, enrollment of patients in clinical trials, and the use of technology are some issues that call for stringent application of ethical principles in decision making. The issues of autonomy, privacy, rights, duties, and privileges that arise have to pass the tests prescribed by contemporary social mores and regulations. Some of the issues encountered, principles applicable, and covenants and documents that guide decision making are discussed.
Contemporary urology; ethics; principles
Medical research involving human subjects raises complex ethical, legal and social issues. Investigators sometimes find that their obligations with respect to a research project come into conflict with their obligations to individual patients. The ethical conduct of research rests on 3 guiding principles: respect for persons, beneficience, and justice. Respect for persons underlies the duty to obtain informed consent from study participants. Beneficence demands a favourable balance between the potential benefits and harms of participation. Justice requires that vulnerable people not be exploited and that eligible candidates who may benefit from participation not be excluded without good cause. Studies must be designed in a way that ensures the validity of findings and must address questions of sufficient importance to justify the risks of participation. In any clinical trial there must be genuine uncertainty as to which treatment arm offers the most benefit, and placebo controls should not be used if effective standard therapies exist. Researchers have a responsibility to inform themselves about the ethical, legal and policy standards that govern their activities. When difficulties arise, they should consult the existing literature and seek the advice of experts in research ethics.
The FME symposium on teaching medical ethics takes up the issue of competence and responsibility in matters concerning bioethics (1). Foreseeably, the medical participants argue that physicians are prepared, or can be easily prepared, to handle all relevant aspects of medical ethics. The contrary position is sustained by the philosophically trained participants, who believe that physicians do not, in fact cannot, sufficiently manage medico-ethical problems. This paper sees a role for both parties. Medical ethicists should properly be involved in medical education and in analytical and systematic study of medical ethics. They should not generally be involved in clinical medico-moral decision-making, which is properly the realm of patient and (ethically competent) doctor.
Practicing physicians are frequently faced with the question of whether or not to institute cardiopulmonary resuscitation in case of cardiac or respiratory arrest in a patient in hospital. Medical training has usually not included any systematic analysis of this issue from either an ethical or a legal standpoint. Many physicians may be unaware that ethical and legal principles, as well as professional guidelines, exist to guide such decision making. In practice, physicians make this decision without the benefit of training in ethical analysis. The problem is especially acute in teaching hospitals when young physicians unacquainted with formal ethics or the law must often make decisions emergently. Studies show some discrepancy between ethical and legal principles and the actual decision making by physicians. For this reason, we recommend an approach that will enable physicians to make and implement decisions not to resuscitate that are consistent with current ethical and legal standards.
This paper explores the ethical implications of introducing non-invasive prenatal diagnostic tests (NIPD tests) in prenatal screening for foetal abnormalities. NIPD tests are easy and safe and can be performed early in pregnancy. Precisely because of these features, it is feared that informed consent may become more difficult, that both testing and selective abortion will become ‘normalized', and that there will be a trend towards accepting testing for minor abnormalities and non-medical traits as well. In our view, however, the real moral challenge of NIPD testing consists in the possibility of linking up a technique with these features (easy, safe and early) with new genomic technologies that allow prenatal diagnostic testing for a much broader range of abnormalities than is the case in current procedures. An increase in uptake and more selective abortions need not in itself be taken to signal a thoughtless acceptance of these procedures. However, combining this with considerably enlarging the scope of NIPD testing will indeed make informed consent more difficult and challenge the notion of prenatal screening as serving reproductive autonomy. If broad NIPD testing includes later-onset diseases, the ‘right not to know' of the future child will become a new issue in the debate about prenatal screening. With regard to the controversial issue of selective abortion, it may make a morally relevant difference that after NIPD testing, abortion can be done early. A lower moral status may be attributed to the foetus at that moment, given the dominant opinion that the moral status of the foetus progressively increases with its development.
Many studies have been published about ethics committees and the clarifications requested about the submitted applications. In Finland, ethics committees require a separate statement on ethical aspects of the research in applications to the ethics committee. However, little is known about how researchers consider the ethical aspects of their own studies.
The data were collected from all the applications received by the official regional ethics committee in the Hospital District of Northern Savo during 2004–2009 (n = 688). These included a total of 56 studies involving research on tissue other than blood. The statements by the researchers about the ethics about their own research in these applications were analyzed by thematic content analysis under the following themes: recruitment, informed consent, risks and benefits, confidentiality and societal meaning.
The researchers tended to describe recruitment and informed consent process very briefly. Usually these descriptions simply stated who the recruiter was and that written consent would be required. There was little information provided on the recruitment situation and on how the study recruiters would be informed. Although most of the studies were clinical, the possibility was hardly ever discussed that patients could fail to distinguish between care and research.
The written guidelines, available on the webpages of the ethics committee, do not seem to be enough to help researchers achieve this goal. In addition to detailed guidelines for researchers, investigators need to be taught to appreciate the ethical aspects in their own studies.
Thematic content analysis; Ethical views of scientists; Application to ethics committee; Informed consent; Recruitment
The discussion of the ethical issues involved in patient-physician relations are traditionally based on the assumption that the parties involved are in direct contact and that their interaction occurs in the same spatio-temporal context. Problems such as confidentiality, paternalism, consent, responsibility etc. are discussed in light of the interpersonal interaction of the two parties. Medicine in the Internet and in other forms of digital medical applications, however, allow for a mode of interaction where the type of the contact between the patient and the physician is altered. The authors argue that the new types of physician-patient interaction create new ethical dilemmas.
The authors examine the traditional ethical issues in medicine and place them in their historical and methodological context. The immediacy factor in patient-physician relations is responsible for moral dilemmas which are non-existent in a "digital" environment. On the other hand, such an environment raises new issues and it creates new dilemmas. The concept of responsibility assumes a different moral weight in cases where the addressee of an action is distant in space and time. Requesting or granting consent is a different process in the Web than it is in an examination room of a hospital. Paternalistic behaviour on the part of a physician may well be viewed as committing the fallacy of authority by the patient when seeking medical information in the Internet.
In light of the above discussion, the authors claim that the major ethical issue arising out of the use of the Internet for medical purposes lies in the responsibility of both the physicians involved in the decision making process as well as the patients. The information made available on the Web by health care professionals is differently perceived by the various individuals accessing it. Further, the patient who engages in self-diagnosis on the basis of such information assumes a different type of responsibility from that when consulting a medical encyclopedia due to the interactive nature of the medium which attempts to minimise the assumption of "a universal type of patient" that underlies the whole enterprise.
It is therefore necessary to redefine the role of the patient and the physician in the Internet environment of health care services in order to determine the respective moral responsibility of both parties.
Medical Ethics; Responsibility; Patient-Physician Relation
The health information needs of developing countries increasingly include population-based estimates determined by biological and physiological measures. Collection of data on these biomarkers requires careful reassessment of ethical standards and procedures related to issues of safety, informed consent, reporting, and referral policies. This paper reviews the survey practices of health examination surveys that have been conducted in developed nations and discusses their application to similar types of surveys proposed for developing countries.
The paper contends that a unitary set of ethical principles should be followed for surveys around the world that precludes the danger of creating double standards (and implicitly lowers standards for work done in developing countries). Global ethical standards must, however, be interpreted in the context of the unique historical and cultural context of the country in which the work is being done. Factors that influence ethical considerations, such as the relationship between investigators in developed and developing countries are also discussed.
The paper provides a set of conclusions reached through this discussion and recommendations for the ethical use of biomarkers in populations-based surveys in developing countries.
population based health surveys; ethical standards; less developed countries
Now that the Clinton Administration has overturned the ban on federal funding for fetal tissue transplantation, old ethical issues renew their relevance and new ethical issues arise. Is fetal tissue transplantation necessary and beneficial? Are fetal rights violated by the use of fetal tissue in research? Is there a moral danger that the potential of fetal tissue donation will encourage elective abortions? Should pregnant women be allowed to designate specific fetal transplant recipients? What criteria should be used to select fetal tissue transplants? Whose consent should be required for the use of fetal tissue for transplantation? We review the current state of clinical research with fetal tissue transplantation, the legal history of fetal tissue research, the major arguments against the use of fetal tissue for transplantation, and the new postmoratorium ethical dilemmas. We include recommendations for guidelines to govern the medical treatment of fetal tissue in transplantation.
Deep brain stimulation (DBS) is currently used to treat neurological disorders like Parkinson's disease, essential tremor, and dystonia, and is explored as an experimental treatment for psychiatric disorders like major depression and obsessive compulsive disorder. This mini review discusses ethical issues in DBS treatment and research, as they have been discussed in the medical and ethical literature. With regard to DBS treatment, the most important issues are balancing risks and benefits and ensuring respect for the autonomous wish of the patient. This implies special attention to patient selection, psycho-social impact of treatment, effects on personal identity, and treatment of children. Moreover, it implies a careful informed consent process in which unrealistic expectations of patients and their families are addressed and in which special attention is given to competence. In the context of research, the fundamental ethical challenge is to promote high-quality scientific research in the interest of future patients, while at the same time safeguarding the rights and interests of vulnerable research subjects. Several guidelines have been proposed to ensure this. One of the preconditions to further development of responsible and transparent research practices is the establishment of a comprehensive registry.
medical ethics; bioethics; neuroethics; deep brain stimulation; neuromodulation; research ethics; psychosurgery; neuro-psychiatric disorders