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The four principles: Can they be measured and do they predict
ethical decision making?
Background:
The four principles of Beauchamp and Childress - autonomy, non-maleficence, beneficence and justice - havebeen extremely influential in the field of medical ethics, and are fundamental for understanding the currentapproach to ethical assessment in health care. This study tests whether these principles can be quantitativelymeasured on an individual level, and then subsequently if they are used in the decision making process whenindividuals are faced with ethical dilemmas.
Methods:
The Analytic Hierarchy Process was used as a tool for the measurement of the principles. Four scenarios, whichinvolved conflicts between the medical ethical principles, were presented to participants and they madejudgments about the ethicality of the action in the scenario, and their intentions to act in the same manner if theywere in the situation.
Results:
Individual preferences for these medical ethical principles can be measured using the Analytic HierarchyProcess. This technique provides a useful tool in which to highlight individual medical ethical values. Onaverage individuals have a significant preference for non-maleficence over the other principles, however, andperhaps counter-intuitively, this preference does not seem to relate to applied ethical judgements in specificethical dilemmas.
Conclusions:
People state they value these medical ethical principles but they do not actually seem to use them directly in thedecision making process. The reasons for this are explained through the lack of a behavioural model to accountfor the relevant situational factors not captured by the principles. The limitations of the principles in predictingethical decision making are discussed.
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The decision-making process for the fate of frozen embryos by Japanese infertile women: a qualitative study
Background:
Previous studies have found that the decision-making process for stored unused frozenembryos involves much emotional burden influenced by socio-cultural factors. This studyaims to ascertain how Japanese patients make a decision on the fate of their frozen embryos:whether to continue storage discard or donate to research.
Methods:
Ten Japanese women who continued storage, 5 who discarded and 16 who donated toresearch were recruited from our infertility clinic. Tape-recorded interviews were transcribedand analyzed for emergent themes.
Results:
A model of patients' decision-making processes for the fate of frozen embryos wasdeveloped, with a common emergent theme, "coming to terms with infertility" resulting ineither acceptance or postponing acceptance of their infertility. The model consisted of 5steps: 1) the embryo-transfer moratorium was sustained, 2) the "Mottainai"-embryo andhaving another child were considered; 3) cost reasonability was taken into account; 4)partner's opinion was confirmed to finally decide whether to continue or discontinue storage.Those discontinuing, then contemplated 5): the effect of donation. Great emotional conflictwas expressed in the theme, steps 2, 4, and 5.
Conclusions:
Patients' 5 step decision-making process for the fate of frozen embryos was profoundlyaffected by various Japanese cultural values and moral standards. At the end of their decision,patients used culturally inherent values and standards to come to terms with their infertility.While there is much philosophical discussion on the moral status of the embryo worldwide,this study, with actual views of patients who own them, will make a significant contributionto empirical ethics from the practical viewpoint.
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Ethics, patient rights and staff attitudes in
Shanghai's psychiatric hospitals
Background:
Adherence to ethical principles in clinical research and practice is becoming topical issue inChina, where the prevalence of mental illness is rising, but treatment facilities remainunderdeveloped. This paper reports on a study aiming to understand the ethical knowledgeand attitudes of Chinese mental health professionals in relation to the process of diagnosisand treatment, informed consent, and privacy protection in clinical trials.
Methods:
A self-administered survey was completed by 1110 medical staff recruited from Shanghai's22 psychiatric hospitals. Simple random selection methods were used to identify targetindividuals from the computerized registry of staff.
Results:
The final sample for analysis consisted 1094 medical staff (including 523 doctors, 542nurses, 8 pharmacologists and 21 other staff). The majority reported that their medicalinstitutions had not established an Ethics Committee (87.8%) and agreed that EthicsCommittees should be set up in their institutions (72.9%). Approximately half (52%) had notreceived systematic education in ethics, and almost all (89.1%) of the staff thought it wasnecessary. Nearly all participants (90.0%) knew the Shanghai Mental Health Regulationswhich was the first local regulations relating to mental health in China, but only 11% and16.6% respectively knew of the Nuremberg Code and the Declaration of Helsinki. About half(51.8%) thought that the guardian should make the decision as to whether the patientparticipated in clinical trials or not.
Conclusions:
The study indicates that most psychiatric hospitals in Shanghai have no Medical EthicsCommittee. More than half the medical staff had not received systematic education andtraining in medical ethics and they have insufficient knowledge of the ethical issues related toclinical practice and trials. Training in ethics is recommended for medical staff during theirtraining and as ongoing professional development.
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Can physicians' judgments of futility be accepted by
patients? A comparative survey of Japanese
physicians and laypeople
Background:
Empirical surveys about medical futility are scarce relative to its theoretical assumptions. Weaimed to evaluate the difference of attitudes between laypeople and physicians towards theissue.
Methods:
A questionnaire survey was designed. Japanese laypeople (via Internet) and physicians withvarious specialties (via paper-and-pencil questionnaire) were asked about whether they wouldprovide potentially futile treatments for end-of-life patients in vignettes, important factors forjudging a certain treatment futile, and threshold of quantitative futility which reflects thenumerical probability that an act will produce the desired physiological effect. Also, thephysicians were asked about their practical frequency and important reasons for futiletreatments.
Results:
1134 laypeople and 401 (80%) physicians responded. In all vignettes, the laypeople weremore affirmative in providing treatments in question significantly. As the factors for judgingfutility, medical information and quality of life (QOL) of the patient were rather stressed bythe physicians. Treatment wish of the family of the patient and psychological impact onpatient side due to the treatment were rather stressed by laypeople. There were widevariations in the threshold of judging quantitative futility in both groups. 88.3% of thephysicians had practical experience of providing futile treatment. Important reasons for itwere communication problem with patient side and lack of systems regarding futility orforegoing such treatment.
Conclusion:
Laypeople are more supportive of providing potentially futile treatments than physicians. Thedifference is explained by the importance of medical information, the patient family'sinfluence to decision-making and QOL of the patient. The threshold of qualitative futility issuggested to be arbitrary.
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The risk-benefit task of research ethics committees:
An evaluation of current approaches and the need to
incorporate decision studies methods
Background:
Research ethics committees (RECs) are tasked to assess the risks and the benefits of a trial.Currently, two procedure-level approaches are predominant, the Net Risk Test and theComponent Analysis.DiscussionBy looking at decision studies, we see that both procedure-level approaches conflate thevarious risk-benefit tasks, i.e., risk-benefit assessment, risk-benefit evaluation, risk treatment,and decision making. This conflation makes the RECs' risk-benefit task confusing, if notimpossible. We further realize that RECs are not meant to do all the risk-benefit tasks;instead, RECs are meant to evaluate risks and benefits, appraise risk treatment suggestions,and make the final decision.
Conclusion:
As such, research ethics would benefit from looking beyond the procedure-level approachesand allowing disciplines like decision studies to be involved in the discourse on RECs' riskbenefittask.
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Empirical research in medical ethics: How conceptual accounts on normative-empirical collaboration may improve research practice
Background:
The methodology of medical ethics during the last few decades has shifted from a predominant use of normative-philosophical analyses to an increasing involvement of empirical methods. The articles which have been published in the course of this so-called 'empirical turn' can be divided into conceptual accounts of empirical-normative collaboration and studies which use socio-empirical methods to investigate ethically relevant issues in concrete social contexts.DiscussionA considered reference to normative research questions can be expected from good quality empirical research in medical ethics. However, a significant proportion of empirical studies currently published in medical ethics lacks such linkage between the empirical research and the normative analysis. In the first part of this paper, we will outline two typical shortcomings of empirical studies in medical ethics with regard to a link between normative questions and empirical data: (1) The complete lack of normative analysis, and (2) cryptonormativity and a missing account with regard to the relationship between 'is' and 'ought' statements. Subsequently, two selected concepts of empirical-normative collaboration will be presented and how these concepts may contribute to improve the linkage between normative and empirical aspects of empirical research in medical ethics will be demonstrated. Based on our analysis, as well as our own practical experience with empirical research in medical ethics, we conclude with a sketch of concrete suggestions for the conduct of empirical research in medical ethics.SummaryHigh quality empirical research in medical ethics is in need of a considered reference to normative analysis. In this paper, we demonstrate how conceptual approaches of empirical-normative collaboration can enhance empirical research in medical ethics with regard to the link between empirical research and normative analysis.
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The publication of ethically uncertain research: attitudes and practices of journal editors
Background:
Publication of ethically uncertain research occurs despite well-published guidelines set forth in documents such as the Declaration of Helsinki. Such guidelines exist to aide editorial staff in making decisions regarding ethical acceptability of manuscripts submitted for publication, yet examples of ethically suspect and uncertain publication exist. Our objective was to survey journal editors regarding practices and attitudes surrounding such dilemmas.
Methods:
The Editor-in-chief of each of the 103 English-language journals from the 2005 Abridged Index Medicus list publishing original research were asked to complete a survey sent to them by email between September-December 2007.
Results:
A response rate of 33% (n = 34) was obtained from the survey. 18% (n = 6) of respondents had published ethically uncertain or suspect research within the last 10 years. 85% (n = 29) of respondents stated they would always reject ethically uncertain articles submitted for publication on ethical grounds alone. 12% (n = 4) of respondents stated they would approach each submission on a case-by-case basis. 3% (n = 1) stated they would be likely to publish such research, but only with accompanying editorial. Only 38% (n = 13) give reviewers explicit instruction to reject submissions on ethical grounds if found wanting.
Conclusions:
Editorial compliance with the Declaration of Helsinki in rejecting research that is conducted unethically was difficult to ascertain because of a poor response rate despite multiple attempts using different modalities. Of those who did respond, the majority do reject ethically suspect research but few explicitly advise reviewers to do so. In this study editors did not take advantage of the opportunity to describe their support for the rejection of the publication of unethical research.
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Patterns of biomedical science production in a sub-Saharan research center
Background:
Research activities in sub-Saharan Africa may be limited to delegated tasks due to the strong control from Western collaborators, which could lead to scientific production of little value in terms of its impact on social and economic innovation in less developed areas. However, the current contexts of international biomedical research including the development of public-private partnerships and research institutions in Africa suggest that scientific activities are growing in sub-Saharan Africa. This study aims to describe the patterns of clinical research activities at a sub-Saharan biomedical research center.
Methods:
In-depth interviews were conducted with a core group of researchers at the Medical Research Unit of the Albert Schweitzer Hospital from June 2009 to February 2010 in Lambarene, Gabon. Scientific activities running at the MRU as well as the implementation of ethical and regulatory standards were covered by the interview sessions.
Results:
The framework of clinical research includes transnational studies and research initiated locally. In transnational collaborations, a sub-Saharan research institution may be limited to producing confirmatory and late-stage data with little impact on economic and social innovation. However, ethical and regulatory guidelines are being implemented taking into consideration the local contexts. Similarly, the scientific content of studies designed by researchers at the MRU, if local needs are taken into account, may potentially contribute to a scientific production with long-term value on social and economic innovation in sub-Saharan Africa.
Conclusion:
Further research questions and methods in social sciences should comprehensively address the construction of scientific content with the social, economic and cultural contexts surrounding research activities.
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Ethical problems in pediatrics: what does the setting of care and education show us?
Background:
Pediatrics ethics education should enhance medical students' skills to deal with ethical problems that may arise in the different settings of care. This study aimed to analyze the ethical problems experienced by physicians who have medical education and pediatric care responsibilities, and if those problems are associated to their workplace, medical specialty and area of clinical practice.
Methods:
A self-applied semi-structured questionnaire was answered by 88 physicians with teaching and pediatric care responsibilities. Content analysis was performed to analyze the qualitative data. Poisson regression was used to explore the association of the categories of ethical problems reported with workplace and professional specialty and activity.
Results:
210 ethical problems were reported, grouped into five areas: physician-patient relationship, end-of-life care, health professional conducts, socioeconomic issues and health policies, and pediatric teaching. Doctors who worked in hospitals as well as general and subspecialist pediatricians reported fewer ethical problems related to socioeconomic issues and health policies than those who worked in Basic Health Units and who were family doctors.
Conclusions:
Some ethical problems are specific to certain settings: those related to end-of-life care are more frequent in the hospital settings and those associated with socioeconomic issues and public health policies are more frequent in Basic Health Units. Other problems are present in all the setting of pediatric care and learning and include ethical problems related to physician-patient relationship, health professional conducts and the pediatric education process. These findings should be taken into consideration when planning the teaching of ethics in pediatrics.Trial registrationThis research article didn't reports the results of a controlled health care intervention. The study project was approved by the Institutional Ethical Review Committee (Report CEP-HIJG 032/2008).
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Promoting advance planning for health care and research among older adults: a randomized controlled trial
Background:
Family members are often required to act as substitute decision-makers when health care or research participation decisions must be made for an incapacitated relative. Yet most families are unable to accurately predict older adult preferences regarding future health care and willingness to engage in research studies. Discussion and documentation of preferences could improve proxies' abilities to decide for their loved ones. This trial assesses the efficacy of an advance planning intervention in improving the accuracy of substitute decision-making and increasing the frequency of documented preferences for health care and research. It also investigates the financial impact on the healthcare system of improving substitute decision-making.Methods/DesignDyads (n = 240) comprising an older adult and his/her self-selected proxy are randomly allocated to the experimental or control group, after stratification for type of designated proxy and self-report of prior documentation of healthcare preferences. At baseline, clinical and research vignettes are used to elicit older adult preferences and assess the ability of their proxy to predict those preferences. Responses are elicited under four health states, ranging from the subject's current health state to severe dementia. For each state, we estimated the public costs of the healthcare services that would typically be provided to a patient under these scenarios. Experimental dyads are visited at home, twice, by a specially trained facilitator who communicates the dyad-specific results of the concordance assessment, helps older adults convey their wishes to their proxies, and offers assistance in completing a guide entitled My Preferences that we designed specifically for that purpose. In between these meetings, experimental dyads attend a group information session about My Preferences. Control dyads attend three monthly workshops aimed at promoting healthy behaviors. Concordance assessments are repeated at the end of the intervention and 6 months later to assess improvement in predictive accuracy and cost savings, if any. Copies of completed guides are made at the time of these assessments.DiscussionThis study will determine whether the tested intervention guides proxies in making decisions that concur with those of older adults, motivates the latter to record their wishes in writing, and yields savings for the healthcare system.Trial RegistrationISRCTN89993391
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