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PubMedDate not supplied

Changing attitudes about end-of-life decision making of medical students during third-year clinical clerkships.

To better define the learning objectives of ethics curricula and evaluate changes in medical students' attitudes about end-of-life decision making, enrolled students (N = 96) of a pilot medical ethics program were surveyed at the beginning and end of their third-year clinical clerkship about their experiences and attitudes about end-of-life decision making. At the end of their clinical clerkship year, the majority of students had participated in end-of-life decisions, prioritized patient autonomy and quality-of-life issues, were concerned about legal liability, were polarized over issues such as physician-assisted suicide, and gained confidence in their ethical decision-making ability. To train future physicians such that clinical practice is consistent with ethical guidelines and legislation on end-of-life care, medical ethics curricula should focus on symptom relief, clarification of legal issues, and resolution of conflicts between personal beliefs and public opinion about such issues as physician-assisted suicide. Appropriate role-modeling and mentoring by residents and attending physicians should also be emphasized.

Adult↗
PubMed1990

Toxic tort litigation: medical and scientific principles in causation.

A definition and an explanation of the legal standard for imposition of legal liability in a toxic tort case are set forth. The focus is on how expert witnesses utilize the applicable medical and scientific data in order to provide opinion evidence of the causal relation between exposure to a toxic substance and disease in an individual case. The author concludes that policy considerations are present in both the legal standard and the basis for establishing a cause and effect relation.

Causality↗
PubMed2002

Transfusion medicine technology transfer: traps to avoid.

Technology transfer is the process of commercializing technology and taking it from the laboratory to the marketplace. At some stage in the technology transfer process, a due diligence will be undertaken. A due diligence is an enquiry into the technology and, in particular, its ownership. Research organizations including hospitals, universities, and blood banks need to own the intellectual property that they seek to commercialize. They own the intellectual property created by their staff in the course of employment. But volunteers, students, and collaborators, not being members of staff, will own the intellectual property that they create. This gives rise to due diligence and ownership defects, when intellectual property may in fact be owned by someone other than the research organization that seeks to commercialize it. Joint ownership can sometimes prevent commercialization. An assignment of intellectual property from a volunteer or student may sometimes be required. Such an assignment, if it inadequately deals with all relevant issues, may be void pursuant to laws throughout the world. A void deed of assignment may expose the research organization to legal liabilities. The categories of technology transfer traps to be explored are (1) ownership issues arising from the participation of students and volunteers in research, (2) ownership issues arising from collaborative research relationships, (3) ownership issues arising from the participation in research of visitors from another research organization, and (4) ownership issues arising from inventions made by employees. Each of these is considered in the context of the legal and regulatory framework in Australia, Canada, the United States of America, and the United Kingdom.

Australia↗
PubMedDate not supplied

[Judicial claims for medical malpractice].

BACKGROUND: Physicians' legal liability regarding malpractice has reached a previously unknown importance in Spain. This paper brings forward some statistical data on judicial claims presented by patients and their relatives. METHODS: The whole of resolutions of the First and Second Court of the Supreme Court were collected between 1870 and 1992. In Madrid, the number of lawsuits in proceedings were obtained from a sample of the Courts at the Plaza de Castilla in April 1990, and figures on legal complaints, accusations and demands were obtained through consultations at the Medical College. RESULTS: The great majority of verdicts, both in Civil and Penal Jurisprudence, correspond to the last 13 years. In Madrid, the average of penal cases in proceedings was 3.8 per Court, and an appreciable increase of claims can be noticed, with an annual rate of about 0.4 per 100 physicians. CONCLUSIONS: Appealing to Justice in order to accuse a practitioner for presumed malpractice is no longer an unusual event. Various reasons contribute in this respect. However, other reasons exist to consider the Spanish situation very far from the level in the United States of America.

Malpractice↗
PubMed2004

Communications with research participants and communities: foundations for best practices.

Communities and research participants increasingly feel that they have rights to be equal partners with researchers and to have access to the results of studies to which they have contributed. Concurrently, research sponsors have become aware of legal liabilities, societal repercussions, and credibility impacts of ignoring research communication responsibilities. However, issues related to research communications are rarely discussed at professional meetings or taught in academic programs. As a result, individual investigators may not be clear about their duties to communicate the results of their research. It is important to address this gap between expectations and abilities, because researchers' lack of communication fosters a climate of distrust in science and implies disinterest or disrespect for participants and communities. Ethical, legal, and professional frameworks and practices were reviewed to develop insights about principles, guidelines, and means that can be used to promote best practices. A review of general research guidance and specific requests for proposals revealed sponsors' communication priorities. While there are barriers to research communication, there is an increasing awareness among sponsors and investigators that effective and responsive communication is not a cheap or uniform add-on to a project or proposal. Communications must be tailored to the project considering all potential stakeholders, and resources need to be allocated specifically for communication activities within projects. Researchers, sponsors, professional societies and academia all have opportunities to improve principles, policies, frameworks, guidelines and strategies to foster "best practice" communication of research results.

Australia↗
PubMed1980

[Ethical and legal problems of medical responsibility in drug trials (author's transl)].

Trials of new drugs are not without risk. Standards have been laid down ensuring the objectivity and quality of the scientific studies of investigators involved in the clinical trial. Article 19 of the French Medical Code of Ethics and the recommendations on medical ethics formulated by the World Medical Association (Helsinki, 1964; and Tokyo, 1975) are designed to ensure that clinical trials on human subjects are of benefit to the subjects themselves, that the interests of the individual are placed before those of society, and, finally, that the trials are conducted with the informed consent of the subjects. In the case of injury sustained by a subject as a result of a clinical trial, the question arises as to the legal liability of the investigator. Possible grounds for malpractice include absence of licitness of the trial, lack of informed consent and negligence or irresponsibility in the conduct of the trial. In certain cases it is difficult to determine the licitness of a clinical trial; exceptions to the rule of informed consent may appear necessary; and it is sometimes difficult to ensure adequate control and evaluation of potential risks of a trial. Hence the need to submit such cases to an ethical committee, provided its members are so chosen as to guarantee the technical and legal competence of its pronouncements.

Clinical Trials as Topic↗
PubMed2006

Patient refusal of emergency cesarean delivery: a study of obstetricians' attitudes in Europe.

OBJECTIVE: To compare the attitudes of a large sample of obstetricians from eight European countries toward a competent woman's refusal to consent to an emergency cesarean delivery for acute fetal distress. METHODS: Obstetricians' attitudes in response to a hypothetical clinical case were surveyed through an anonymous, self-administered questionnaire. The sample included 1,530 obstetricians (response rate 77%) from 105 maternity units (response rate 70%) in eight countries: France, Germany, Italy, Luxembourg, Netherlands, Spain, Sweden and the United Kingdom. RESULTS: In every country, the majority of obstetricians would keep trying to persuade the woman, telling her that failure to perform cesarean delivery might result in the fetus surviving with disability, or even that her own life might be endangered. In Spain, France, Italy, and, to a lesser extent, Germany and Luxembourg, a consistent proportion of physicians would seek a court order to protect fetal welfare or avoid possible legal liability or both. In the United Kingdom, Sweden, and Netherlands, several respondents (59%, 41%, and 37%, respectively) would accept the woman's decision and assist vaginal delivery. Only a small minority (from 0 in the United Kingdom to 10% in France) would proceed with cesarean delivery without a court order. CONCLUSION: Case law arising from a few countries (United States, Canada, and the United Kingdom) and professional guidelines favoring women's autonomy have not solved the underlying ethical conflict, and in Europe acceptance of a woman's right to refuse cesarean delivery, at least in emergency situations, is not uniform. Differing attitudes between obstetricians from the eight countries may reflect diverse legal and ethical environments. LEVEL OF EVIDENCE: III.

Adult↗
PubMed2004

Policy versus practice: comparison of prescribing therapy and durable medical equipment in medical and educational settings.

OBJECTIVE: The American Academy of Pediatrics (AAP) has promoted pediatrician involvement in the care of children with special health care needs (CSHCN), including the prescription and/or supervision of therapies and durable medical equipment (DME) for children in both medical and educational settings, such as schools and early intervention programs. Through this survey, we attempted to quantify objectively how pediatricians direct and coordinate therapy and DME for CSHCN and how these efforts correlate with AAP recommendations. METHODS: A survey was mailed to a random sample of 500 physicians listed in the AAP directory, resulting in a final sample of 217 responding physicians who indicated that they provide services to CSHCN. Results of the survey were reported as proportions, means with standard deviations, or medians with interquartile range. Comparisons of proportions among certain subgroups of interest were made using Fisher exact tests. RESULTS: The most recent AAP policy revision addressing the role of physicians in prescribing therapy services for children with motor disabilities appeared in Pediatrics 1996. It listed 6 key items that should be part of a therapy prescription: diagnosis, precautions, type, frequency, anticipated goals (educators may prefer the term "objectives"), and duration. The policy addressed and emphasized the need for what may be additional objectives, namely regular communication between all parties involved, ongoing supervision and reevaluation of the program and problem, and awareness of other community resources for possible referrals. Except for providing a diagnosis, the majority of surveyed pediatricians do not regularly comply with AAP policy recommendations on prescribing therapies and DME in medical and educational settings. Physicians who were trained before 1980 tend to follow AAP recommendations more closely than later graduates. Decreasing involvement of private outpatient pediatricians in coordinating and supervising CSHCN's care was noted. Furthermore, the majority is willing to defer decisions about treatment and goals to nonphysician health care providers (NPHCPs) and, in some cases, even equipment vendors. More than two thirds of the respondents indicated that they would sign a prescription for therapy without their previous initiation if it had been initiated by a therapist. Likewise, most respondents said that they would sign a wheelchair prescription sent to them by a therapist. Few expressed confidence in determining the appropriateness of leg brace (orthosis) prescriptions and arm/hand brace prescriptions. The majority of survey participants said that they give open-ended length of time (no limits under 1 year) on prescriptions for therapy services as part of school-based programs. However, patients' conditions and their therapeutic or equipment needs may change during the school year. Because open-ended prescriptions do not require periodic renewal, they do not provide opportunities for periodic feedback that helps to ensure that the pediatrician is kept abreast of the patient's status and progress. The majority of respondents indicated that they would see a patient before signing either a therapy or DME prescription if they had not seen that patient in the past year. A little more than half of survey respondents said that they would participate initially in recommending which professional services or therapies should be performed as part of early intervention programs most of the time, but one third said that they participated less than half the time and approximately 14% said that they never participated. A majority would require being involved before authorizing therapy services as part of a school-based program, but a substantial minority would provide retroactive authorization for services that they did not initiate themselves. More than three quarters of respondents would prefer to let the therapist or educator set the goals. Only 58% of pediatricians reported receiving a detailed progress report once or twice a year, and approximately one fifth received no reports on patients in school-based programs. A literature review suggested that there are different perceptions among physicians and educationally based service providers regarding the physician's role in initiating and supervising educationally based services and equipment, which may influence the extent of physician involvement. AAP and other professional organizations, such as the American Medical Association and the American Academy of Physical Medicine and Rehabilitation, as well as federal guidelines and third-party payers emphasize the important role of physicians in initiating, determining the medical necessity, and ordering of services as well as in ongoing patient treatment. If therapists through their states' scope of practice guidelines have autonomy of practice or if the school self-funds educationally based services, then there may be no issues regarding physician authorization. However, if a physician's authorization is required for reimbursement, then the physician's professional, legal, and practice guidelines come into play. Physicians should be conscientious about fulfilling their responsibilities in serving as the medical home and supervising and monitoring medical services for their patients in both community and educational settings. Failure to properly fulfill the responsibilities inherent in signing a prescription may bring adverse consequences for the patient as well subject the physician to legal liability if adverse events occur. CONCLUSIONS: Ideally, there should be a seamless continuity and cooperation among the environments of medicine, home, community, and education rather than separate and perhaps conflicting domains. All health care professionals and other service providers involved should be acknowledged as collaborative team members. Except for provision of the diagnosis, the majority of surveyed pediatricians do not comply with AAP policy recommendations on prescribing community/medical-based and educationally based services for CSHCN. Furthermore, the majority are willing to defer these decisions to other NPHCP. This raises issues regarding overall continuity of care versus care of the child in a variety of environments, the concept of the medical home, and legal risk as a result of failure to follow federal and state practice guidelines. Also, there seem to be different cultural perceptions among physicians and educationally based service providers regarding the physician's role in educationally based services. These cultural differences should be explored further to promote a greater collegial cooperation and understanding. Decreasing involvement of private outpatient pediatricians in coordinating and supervising CSHCN care and a trend toward greater deference to NPHCP since 1979 were noted. If the numerous policies and guidelines previously promoted by AAP have not had a significant impact on pediatrician practices in these fields, then other, more effective alternatives should be explored.

Child↗
PubMed1982

IUCD liability.

In the UK the marketing and quality control of all intrauterine devices (IUCDs) is controlled by the Medicines Act (1968). Training is supervised by the Joint Committee of Contraception (JCC), and Trainers have to ensure that the trainee has acquired safe standards before the JCC certificate is granted. Patients must be adequately counselled and consent obtained. There is no unequivocal evidence of its mode of action in humans, which might limit its acceptability to certain individuals. There are a number of problem areas. How long should a copper-containing IUCD be retained when there is clinical evidence of continued effectiveness for more than the statutory 2 years? Perforation of the uterus and the resulting abnormal situation of an IUCD can be potentially dangerous. Sound technique minimizes its occurrence but if perforation occurs there must be defined and documented action. Because the IUCDs' primary intrauterine action is to prevent implantation, should pregnancy occur, there is an increased likelihood of ectopic gestation. Awareness of this, and appropriate early action, should prevent a disastrous outcome. There is clear evidence that ascent of organisms relates to the cervical thread. Perhaps tailless devices should be made available for women who are at risk of developing pelvic inflammatory disease? Other potential problem areas, where there might be legal liability involving practitioners, include the management of abnormal bleeding and difficult removals.

Female↗
PubMed1990

Recognizing personhood and the right to die with dignity.

Death cannot be viewed properly as either an event or a configuration. Indeed, multiple parts of the body can continue to live long after the disintegration of its central organization is recorded. Instead of collapsing at a moment in time, technological mechanisms are capable of sustaining the major bodily processes indefinitely--all designed to allow for the harvesting of needed organs for transplantation. State legislative efforts have been undertaken in America to define those specific circumstances when death occurs legally. Although always allowed to exercise reasonable discretion in their decision making, attending physicians will nonetheless be aided by these laws that only limit their legal liability but assure for the patient that his final choices will be honored consistent with basic principles of self-determination. The Law Reform Commission of Canada recommended in 1987 that criminal liability be rejected for the offenses of helping, advising, or inciting a person to commit suicide. This is an exceedingly wise and humane position to follow. Instead of being held captive to words such as "rational suicide" or "euthanasia", what is needed is an acceptance of more contemporary watchwords such as autonomy and self-determination. When at all possible, final choices about death should be made by the patient's family and their medical advisers--and not be subjected to judicial scrutiny.

Brain Death↗
PubMed2002

Hospital ethics committees in Israel: structure, function and heterogeneity in the setting of statutory ethics committees.

OBJECTIVES: Hospital ethics committees increasingly affect medical care worldwide, yet there has been little evaluation of these bodies. Israel has the distinction of having ethics committees legally required by a Patients' Rights Act. We studied the development of ethics committees in this legal environment. DESIGN: Cross-sectional national survey of general hospitals to identify all ethics committees and interview of ethics committee chairpersons. SETTING: Israel five years after the passage of the Patients' Rights Act. MAIN MEASUREMENTS: Patients' rights and informal ethics committee structure and function. RESULTS: One-third of general hospitals have an ethics committee, with committees concentrated in larger facilities. Hospitals without committees tended to lack any structure to handle ethics issues. Committees tend to be interdisciplinary and gender-mixed but ethnic mix was poor. Confidentiality is the rule, however, legal liability is a concern. One-third of patients' rights ethics committees never convened and most committees had considered fewer than ten consults. Access to the consultation process and the consultation process itself varied substantially across committees. Some patients' rights ethics committees attempted to solve cases, others only rendered decisions. Informal committees often refused to consider cases within Patients' Rights Act jurisdiction. CONCLUSIONS: Despite statutory requirement, many Israeli patients and clinicians do not have access to ethics committees. The scant volume of cases shows serious discrepancies between practice and Patients' Rights Act regulations, suggesting the need for education or revision of the law. Heterogeneity in committee function demonstrates need for substantial improvement.

Confidentiality↗
PubMed1996

What influences physician practice behavior? An interview study of physicians who received consultative geriatric assessment recommendations.

BACKGROUND: Comprehensive geriatric assessment (CGA) in outpatient settings has not been shown to be as effective in reducing mortality and improving health as in hospital settings; this difference has been attributed in part to a lack of direct control over recommendation implementation. OBJECTIVE: To identify inhibiting and facilitating factors in physicians' compliance with consultative CGA recommendations, so that the effectiveness of outpatient CGA might be improved. METHODS: A 49-item questionnaire was administered via the telephone to 87 eligible community primary care physicians in Los Angeles, Calif, whose patients had received consultative outpatient CGAs as part of a study of CGA (response rate, 96%). The questionnaire assessed physician compliance with CGA recommendations, reasons for implementing or not implementing the recommendations, and specific physician attitudes, perceptions, and characteristics. The focus of the interview was the CGA recommendation that was determined to be the "most important" by the evaluating geriatrician. Recommendations addressed geriatric syndromes, general medical problems, or psychiatric conditions. RESULTS: Of the 87 physician respondents, 62 (71%) implemented the most important recommendation. In multivariate analysis, 4 variables were predictive of physician compliance: (1) a patient's request that the recommendation be implemented (odds ratio [OR], 10.8; 95% confidence interval [CI], 1.9-61.3; P = .007); (2) perceived legal liability resulting from nonimplementation of the recommendation (OR, 10.8; 95% CI, 1.1-108.2; P = .04); (3) female physician gender (OR, 9.6; 95% CI, 1.4-67.9; P = .04); and (4) perceived cost-effectiveness of the recommendation (OR, 7.0; 95% CI, 1.6-30.5; P = .01). CONCLUSIONS: Patient behavior, which may be modifiable, was among the strongest determinants of physician compliance with recommended care. Specifically, when patients requested that a recommendation be implemented, physicians were highly likely to comply. Changing patient behavior within the physician-patient relationship as a way of effecting desired changes in physician health care practices merits further attention.

Ambulatory Care↗
PubMed2006

Reasons why few patients with acute stroke receive tissue plasminogen activator.

Despite the US Food and Drug Administration's approval in 1996, tissue plasminogen activator (tPA) therapy for acute ischemic stroke remains substantially underused. We reviewed 3 potential reasons for low rates of tPA use: poor patient education, physicians' perceived risk of legal liability from negative patient outcomes, and insufficient reimbursement. The recent addition of diagnosis-related grouping code 559 will provide higher payment for stroke patients treated with tPA, creating a natural experiment to examine our third reason.

Drug Utilization↗
PubMed2003

Patients' and physicians' attitudes regarding the disclosure of medical errors.

CONTEXT: Despite the best efforts of health care practitioners, medical errors are inevitable. Disclosure of errors to patients is desired by patients and recommended by ethicists and professional organizations, but little is known about how patients and physicians think medical errors should be discussed. OBJECTIVE: To determine patients' and physicians' attitudes about error disclosure. DESIGN, SETTING, AND PARTICIPANTS: Thirteen focus groups were organized, including 6 groups of adult patients, 4 groups of academic and community physicians, and 3 groups of both physicians and patients. A total of 52 patients and 46 physicians participated. MAIN OUTCOME MEASURES: Qualitative analysis of focus group transcripts to determine the attitudes of patients and physicians about medical error disclosure; whether physicians disclose the information patients desire; and patients' and physicians' emotional needs when an error occurs and whether these needs are met. RESULTS: Both patients and physicians had unmet needs following errors. Patients wanted disclosure of all harmful errors and sought information about what happened, why the error happened, how the error's consequences will be mitigated, and how recurrences will be prevented. Physicians agreed that harmful errors should be disclosed but "choose their words carefully" when telling patients about errors. Although physicians disclosed the adverse event, they often avoided stating that an error occurred, why the error happened, or how recurrences would be prevented. Patients also desired emotional support from physicians following errors, including an apology. However, physicians worried that an apology might create legal liability. Physicians were also upset when errors happen but were unsure where to seek emotional support. CONCLUSIONS: Physicians may not be providing the information or emotional support that patients seek following harmful medical errors. Physicians should strive to meet patients' desires for an apology and for information on the nature, cause, and prevention of errors. Institutions should also address the emotional needs of practitioners who are involved in medical errors.

Adult↗
PubMed2004

Attorney-directed screenings can be hazardous.

BACKGROUND: The history of occupational health screenings indicate that they are often necessary to protect the health and interests of workers. However, medical screenings for asbestos and other occupational diseases which are organized and funded by attorneys may result in serious adverse outcomes to those screened. METHODS: We report a case of death that appears to have been heavily influenced by an attorney-initiated and -directed screening program. RESULTS: While well-run medical screening programs are essential to disease detection in workers, attorney-run and corporate screenings can be fraught with ethical and practical problems. Screenings have been used by corporations to identify workers with occupational illness in order to terminate their employment and avoid legal liability. Screenings can also be used to motivate workers to stop smoking and implement workplace controls. However, these screenings must be conducted responsibly. CONCLUSIONS: Although this is only one case it illustrates the gravity and potential danger of attorney-directed screening programs.

Aged↗
PubMed1980

The legal implications of refusing to provide prenatal diagnosis in low-risk pregnancies or solely for sex selection.

As more people learn about prenatal diagnosis, medical personnel are increasingly being asked to perform these procedures in both low-risk pregnancies and for purposes of sex selection. Analysis of present legal rules illustrates that it is highly unlikely genetic counselors will be subjected to legal liability for refusing to provide prenatal diagnosis in these situations. This freedom from liability will probably continue into the foreseeable future, despite recent developments in the areas of informed consent and allocation of scarce medical resources that tend to limit the traditionally broad deference given to medical personnel.

Ethics, Medical↗
PubMed2003

Medical Geneticists' duty to warn at-risk relatives for genetic disease.

A patient who refuses to notify their relatives of potential at-risk status brings a genetics provider to face conflicting ethical principles and ill-defined legal precedent. Genetics professionals' views on the disclosure of patient information to at-risk relatives have remained largely unexamined. Prior analyses have been limited to identifying factors contributing to genetics providers' self-predicted responses in hypothetical scenarios. Our group was the first to examine the clinical experience of genetic counselors with this issue [Dugan et al., 2003]. We report here results from our follow-up survey of medical geneticists who are members of either the American Society of Human Genetics and/or American College of Medical Genetics in an effort to identify their experiences in warning at-risk relatives and the factors driving their decision-making processes. Over two-thirds of medical geneticists surveyed (69%, 143/206) believe they do bear responsibility to warn their patients' relatives when found to be at-risk for genetic disease. One-quarter (25%, 31/123) of medical geneticists who faced the dilemma of a patient refusing to notify their at-risk relatives seriously considered disclosure to those at-risk relatives without patient consent. Only four respondents proceeded to warn at-risk relatives of their status. Whereas genetic counselors cited emotional issues as playing a primary role in their decision not to warn, medical geneticists identified patient confidentiality, eventual case resolution by other means, and legal liability as the major factors leading to non-disclosure in 76% of actual scenarios. Responsibilities of medical geneticists, genetic counselors, and non-genetics healthcare professionals facing this issue will need to be more clearly defined to provide optimal medical care within the bounds of acceptable practice.

Confidentiality↗
PubMed2000

Legal and ethical issues involved when counseling minors in nonschool settings.

Many counselors in non-school settings will work with children at some time during their practice; therefore, it is essential that they understand the legal and ethical issues relevant to working with minors. Major court cases and legislation are presented, and 4 critical ethical issues--counselor competence, the client's rights to confidentiality and informed consent, and duties related to child abuse--are addressed. Suggestions for working ethically with minors in order to limit legal liability are presented.

Child↗