Community engagement is increasingly promoted as a marker of good, ethical practice in the context of international collaborative research in low-income countries. There is, however, no widely agreed definition of community engagement or of approaches adopted. Justifications given for its use also vary. Community engagement is, for example, variously seen to be of value in: the development of more effective and appropriate consent processes; improved understanding of the aims and forms of research; higher recruitment rates; the identification of important ethical issues; the building of better relationships between the community and researchers; the obtaining of community permission to approach potential research participants; and, the provision of better health care. Despite these diverse and potentially competing claims made for the importance of community engagement, there is very little published evidence on effective models of engagement or their evaluation.
In this paper, drawing upon interviews with the members of a Community Advisory Board on the Thai-Myanmar border, we describe and critically reflect upon an approach to community engagement which was developed in the context of international collaborative research in the border region.
Results and conclusions
Drawing on our analysis, we identify a number of considerations relevant to the development of an approach to evaluating community engagement in this complex research setting. The paper also identifies a range of important ways in which the Community Advisory Board is in practice understood by its members (and perhaps by community members beyond this) to have morally significant roles and responsibilities beyond those usually associated with the successful and appropriate conduct of research.
Ethics; Evaluation; Community engagement; Community advisory boards; Developing countries; Thailand; Myanmar; Global health; International research
In this manuscript, we argue that within the context of phase IV, physician-researchers retain their fiduciary obligation to treat the patient-participants.
We first clarify why the perspective that research ethics ought to be differentiated from clinical ethics is not applicable in phase IV, and therefore, why therapeutic orientation is most convivial in this phase. Next, assuming that ethics guidelines may be representative of common morality, we show that ethics guidelines see physician-researchers primarily as physicians and only secondarily as researchers. We then elaborate on what a fiduciary obligation is and how some of the obligations are default duties. Lastly, we look at the fiduciary obligation of the physician-researcher in phase IV interventional trials.
The fiduciary obligation to treat is not as easily waived as in earlier trials. Assuming the entwinement of research and practice in phase IV, physician-researchers, in collaboration with other researchers, investigators, and research ethics committees, should ensure that in terms of study design, methodology, and research practice, the therapeutic value of the research to the patient-participants is not diminished.
Phase IV; Fiduciary obligation; Interventional trials; Physician-researchers
Since Japan adopted the concept of informed consent from the West, its inappropriate acquisition from patients in the Japanese clinical setting has continued, due in part to cultural aspects. Here, we discuss the current status of and contemporary issues surrounding informed consent in Japan, and how these are influenced by Japanese culture.
Current legal norms towards informed consent and information disclosure are obscure in Japan. For instance, physicians in Japan do not have a legal duty to inform patients of a cancer diagnosis. To gain a better understanding of these issues, we present five court decisions related to informed consent and information disclosure. We then discuss Japanese culture through reviews of published opinions and commentaries regarding how culture affects decision making and obtaining informed consent. We focus on two contemporary problems involving informed consent and relevant issues in clinical settings: the misuse of informed consent and persistence in obtaining consent. For the former issue, the phrase "informed consent" is often used to express an opportunity to disclose medical conditions and recommended treatment choices. The casual use of the expression "informed consent" likely reflects deep-rooted cultural influences. For the latter issue, physicians may try to obtain a signature by doing whatever it takes, lacking a deep understanding of important ethical principles, such as protecting human dignity, serving the patient’s best interest, and doing no harm in decision-making for patients.
There is clearly a misunderstanding of the concept of informed consent and a lack of complete understanding of ethical principles among Japanese healthcare professionals. Although similar in some respects to informed consent as it originated in the United States, our review makes it clear that informed consent in Japan has clear distinguishing features.
Japanese healthcare professionals should aim to understand the basic nature of informed consent, irrespective of their attitudes about individualism, liberalism, and patient self-determination. If they believe that the concept of informed consent is important and essential in Japanese clinical settings, efforts should be made to obtain informed consent in an appropriate manner.
Informed consent; Japanese culture; Ethical principles; Ethical issues; Misuse; Healthcare professionals
The increased use of human biological material for cell-based research and clinical interventions poses risks to the privacy of patients and donors, including the possibility of re-identification of individuals from anonymized cell lines and associated genetic data. These risks will increase as technologies and databases used for re-identification become affordable and more sophisticated. Policies that require ongoing linkage of cell lines to donors’ clinical information for research and regulatory purposes, and existing practices that limit research participants’ ability to control what is done with their genetic data, amplify the privacy concerns.
To date, the privacy issues associated with cell-based research and interventions have not received much attention in the academic and policymaking contexts. This paper, arising out of a multi-disciplinary workshop, aims to rectify this by outlining the issues, proposing novel governance strategies and policy recommendations, and identifying areas where further evidence is required to make sound policy decisions. The authors of this paper take the position that existing rules and norms can be reasonably extended to address privacy risks in this context without compromising emerging developments in the research environment, and that exceptions from such rules should be justified using a case-by-case approach. In developing new policies, the broader framework of regulations governing cell-based research and related areas must be taken into account, as well as the views of impacted groups, including scientists, research participants and the general public.
This paper outlines deliberations at a policy development workshop focusing on privacy challenges associated with cell-based research and interventions. The paper provides an overview of these challenges, followed by a discussion of key themes and recommendations that emerged from discussions at the workshop. The paper concludes that privacy risks associated with cell-based research and interventions should be addressed through evidence-based policy reforms that account for both well-established legal and ethical norms and current knowledge about actual or anticipated harms. The authors also call for research studies that identify and address gaps in understanding of privacy risks.
The Editors of BMC Medical Ethics would like to thank all our reviewers who have contributed to the journal in Volume 13 (2013).
The preventative paradigm of preconception care is receiving increasing attention, yet its boundaries remain vague in three respects: temporally; agentially; and instrumentally. Crucially, it remains unclear just who is to be considered a ‘potential parent’, how soon they should take up preconception responsibilities, and how weighty their responsibilities should be.
In this paper, we argue that a normal potential parent of reasonable prudence has a moral duty to adequately optimize the conditions under which she or his reproductive partner will conceive, though a proportionality calculus calls for toleration of several forms of preconception behaviour that are non-ideal from the perspective of reproductive risk. We distinguish between five categories of potential parents to which different duties of preconception care should be ascribed. This framework is advanced to assign preconception care responsibilities with more precision than is often done in the current debate on preconception care. We conclude by applying our theoretical framework to three types of preconception care interventions: consumption of folic acid; keeping one’s weight under control; and engaging in preconception genetic screening. Our analysis shows that the literature on preconception care often glosses over crucial distinctions between different types of potential parents and uses a notion of preconception beneficence that may be overly demanding. Nevertheless, preconception moral duties will often be weighty and reluctance to accept such duties on account of the burden they impose do not warrant preconception insouciance.
To avoid misplaced responsibility ascriptions in the growing field of preconception care, distinctions must be made between different types of potential parents to whom different degrees of preconception responsibility apply. We present such a preliminary framework and bring it to bear on the cases of folic acid consumption, obesity and genetic testing.
Preconception care; Beneficence; Folic acid; Obesity; Genetic testing
The use of biological samples in research raises a number of ethical issues in relation to consent, storage, export, benefit sharing and re-use of samples. Participant perspectives have been explored in North America and Europe, with only a few studies reported in Africa. The amount of research being conducted in Africa is growing exponentially with volumes of biological samples being exported from the African continent. In order to investigate the perspectives of African research participants, we conducted a study at research sites in the Western Cape and Gauteng, South Africa.
Data were collected using a semi-structured questionnaire that captured both quantitative and qualitative information at 6 research sites in South Africa. Interviews were conducted in English and Afrikaans. Data were analysed both quantitatively and qualitatively.
Our study indicates that while the majority of participants were supportive of providing samples for research, serious concerns were voiced about future use, benefit sharing and export of samples. While researchers view the provision of biosamples as a donation, participants believe that they still have ownership rights and are therefore in favour of benefit sharing. Almost half of the participants expressed a desire to be re-contacted for consent for future use of their samples. Interesting opinions were expressed with respect to export of samples.
Eliciting participant perspectives is an important part of community engagement in research involving biological sample collection, export, storage and future use. A tiered consent process appears to be more acceptable to participants in this study. Eliciting opinions of researchers and research ethics committee (REC) members would contribute multiple perspectives. Further research is required to interrogate the concept of ownership and the consent process in research involving biological samples.
Although informed consent is an integral part of clinical practice, its current doctrine remains mostly a matter of law and mainstream ethics rather than empirical research. There are scarce empirical data on patients’ perceived purpose of informed consent, which may include administrative routine/courtesy gesture, simple honest permission, informed permission, patient-clinician shared decision-making, and enabling patient’s self decision-making. Different purposes require different processes.
We surveyed 488 adults who were planning to undergo or had recently undergone written informed consent-requiring procedures. Perceptions of informed consent purpose (from norm and current practice perspectives) were explored by asking respondents to rank (1 = most reflective) 10 randomly-presented statements: “meaningless routine”, “courtesy gesture” “litigation protection”, “take away compensation rights”, “inform patient’, “make sure patient understand”, “document patient’s decision”, “discover patient’s preferences”, “have shared decision”, and “help patient decide”.
Respondents’ mean (SD) age was 38.3 (12.5); 50.4% were males, 56.8% had ≥ college education, and 37.3% had undergone a procedure. From the norm perspective, the least reflective statement was “meaningless routine” (ranked 1–3 by 2.6% of respondents) and the most reflective statements were “help patient decide”, “make sure patient understand”, and “inform patient” (ranked 1–3 by 65%, 60%, and 48% of respondents with median [25%,75%] ranking scores of 2 [1,5], 3 [2,4], and 4 [2,5], respectively). Compared to their counterparts, males and pre-procedure respondents ranked “help patient decide” better, whereas females and post-procedure respondents ranked “inform patient” better (p = 0.007 to p < 0.001). Age was associated with better ranking of “help patient decide” and “make sure patient understand” statements (p < 0.001 and p = 0.002, respectively), which were ranked 1–3 by only 46% and 42% of respondents from the current practice perspective (median ranking score 4 [2,6], p < 0.001 vs. norm perspective for both).
1) the informed consent process is important to patients, however, patients vary in their views of its purpose with the dominant view being enabling patients’ self decision-making, 2) males, pre-procedure, and older patients more favor a self decision-making purpose, whereas females and post-procedure patients more favor an information disclosure purpose, and 3) more self decision-making and more effective information disclosure than is currently practiced are desired. An informed consent process consistent with Mill’s individual autonomy model may be suitable for most patients.
Informed consent; Middle East; Norm perception; Current practice; Gender difference; Autonomy
The current doctrine of informed consent for clinical care has been developed in cultures characterized by low-context communication and monitoring-style coping. There are scarce empirical data on patients’ norm perception of information disclosure in other cultures.
We surveyed 470 adults who were planning to undergo or had recently undergone a written informed consent-requiring procedure in a tertiary healthcare hospital in Saudi Arabia. Perceptions of norm and current practice were explored using a 5-point Likert scale (1 = strongly agree with disclosure) and 30 information items in 7 domains: practitioners’ details, benefits, risks, complications’ management, available alternatives, procedure’s description, and post-procedure’s issues.
Respondents’ mean (SD) age was 38.4 (12.5); 50.2% were males, 57.2% had ≥ college education, and 37.9% had undergone a procedure. According to norm perception, strongly agree/agree responses ranged from 98.0% (major benefits) to 50.5% (assistant/trainee’s name). Overall, items related to benefits and post-procedure’s issues were ranked better (more agreeable) than items related to risks and available alternatives. Ranking scores were better in post-procedure respondents for 4 (13.3%) items (p < 0.001 to 0.001) and in males for 8 (26.7%) items (p = 0.008 to <0.001). Older age was associated with better ranking scores for 3 (10.0%) items and worse for one (p < 0.001 to 0.006). According to current practice perception, strongly agree/agree responses ranged from 93.3% (disclosure of procedure’s name) to 13.9% (lead practitioner’s training place), ranking scores were worse for all items compared to norm perception (p < 0.001), and post-procedure status, younger age, and lower educational level were associated with better ranking scores for 15 (50.0%), 12 (40.0%), and 4 (13.3%) items, respectively (p < 0.001 to 0.009).
1) even in an overall high-context communication culture, extensive and more information than is currently disclosed is perceived as norm, 2) the focus of the desired information is closer to benefits and post-procedure’s issues than risks and available alternatives, 3) male, post-procedure, and older patients are in favor of more information disclosure, 4) male, older, and more educated patients may be particularly dissatisfied with current information disclosure. The focus and extent of information disclosure for clinical informed consent may need to be adjusted if a “reasonable” patient’s standard is to be met.
Clinical informed consent; Middle East; Information disclosure; Norm perception; Current practice; Gender; Age; High-context communication; Blunting-style coping; Reasonable patient’s standard
The growing prevalence of health care ethics consultation (HCEC) services in the U.S. has been accompanied by an increase in calls for accountability and quality assurance, and for the debates surrounding why and how HCEC is evaluated. The objective of this study was to evaluate the effectiveness of HCEC as indicated by several novel outcome measurements in East Asian medical encounters.
Patients with medical uncertainty or conflict regarding value-laden issues, and requests made by the attending physicians or nurses for HCEC from December 1, 2009 to April 30, 2012 were randomly assigned to the usual care group (UC group) and the intervention group (HCEC group). The patients in the HCEC group received HCEC conducted by an individual ethics consultant. Data analysis was based on the intention-to-treat principle. Mann–Whitney test and Chi-squared test were used depending on the scale of measurement.
Thirty-three patients (53.23%) were randomly assigned to the HCEC group and 29 patients were randomly assigned to the UC group. Among the 33 patients in the HCEC group, two (6.06%) of them ultimately did not receive a HCEC service. Among the 29 patients in the UC group, four (13.79%) of them received a HCEC service. The survival rate at hospital discharge did not differ between the two groups. Patients in the HCEC group showed significant reductions in the entire ICU stay and entire hospital stay. HCEC significantly facilitated achieving the goal of medical care (p < .01). Furthermore, patients in the HCEC group had a shorter ICU stay and shorter hospital stay after the occurrence of medical uncertainty or conflict regarding value-laden issues than those in the UC group.
Our findings demonstrated that HCEC were associated with reduced consumption of medical resources as indicated by shorter entire ICU stay, entire hospital stay, and shorter ICU and hospital stay after the occurrence of the medical uncertainty or conflict regarding value-laden issues. This study also showed that HCEC facilitated achieving a consensus regarding the goal of medical care, which conforms to the goal of HCEC.
Health care ethics consultation; Effectiveness; Randomization; Intention-to-treat
Recently, individualized or personalized medicine (PM) has become a buzz word in the academic as well as public debate surrounding health care. However, PM lacks a clear definition and is open to interpretation. This conceptual vagueness complicates public discourse on chances, risks and limits of PM. Furthermore, stakeholders might use it to further their respective interests and preferences. For these reasons it is important to have a shared understanding of PM. In this paper, we present a sufficiently precise as well as adequate definition of PM with the potential of wide acceptance.
For this purpose, in a first step a systematic literature review was conducted to understand how PM is actually used in scientific practice. PubMed was searched using the keywords “individualized medicine”, “individualised medicine”, “personalized medicine” and “personalised medicine” connected by the Boolean operator OR. A data extraction tabloid was developed putting forward a means/ends-division. Full-texts of articles containing the search terms in title or abstract were screened for definitions. Definitions were extracted; according to the means/ends distinction their elements were assigned to the corresponding category. To reduce complexity of the resulting list, summary categories were developed inductively from the data using thematic analysis. In a second step, six well-known criteria for adequate definitions were applied to these categories to derive a so-called precising definition.
We identified 2457 articles containing the terms PM in title or abstract. Of those 683 contained a definition of PM and were thus included in our review. 1459 ends and 1025 means were found in the definitions. From these we derived the precising definition: PM seeks to improve stratification and timing of health care by utilizing biological information and biomarkers on the level of molecular disease pathways, genetics, proteomics as well as metabolomics.
Our definition includes the aspects that are specific for developments labeled as PM while, on the other hand, recognizing the limits of these developments. Furthermore, it is supported by the quantitative analysis of PM definitions in the literature, which suggests that it it is widely acceptable and thus has the potential to avoid the above mentioned issues.
Biomarkers; Conceptual vagueness; Definition; Individualized medicine; Stratification; Timing
The 3rd Pan-African Ethics Human Rights and Medical Law (3rd EHRML) conference was held in Johannesburg on July 7, 2013, as part of the Africa Health Congress. The conference brought together bioethicists, researchers and scholars from South Africa, Zimbabwe, Kenya and Nigeria working in the field of bioethics as well as students and healthcare workers interested in learning about ethical issues confronting the African continent. The conference which ran with a theme of "Bioethical and legal perspectives in biomedical research and medical practice in Africa with a focus on: Informed consent, HIV-AIDS & Tuberculosis, leadership & organizational ethics, patients and healthcare workers rights," was designed to expand the dialogue on African bioethics beyond the traditional focus on research ethics and the ethical dilemmas surrounding the conduct of biomedical research in developing countries. This introductory article highlights some of areas of focus at the conference including issues of leadership, organizational ethics and patients and healthcare workers rights in Africa. We analyze the importance of free speech, public debate of issues, argumentation and the need to introduce the teaching and learning of ethics to students in Africa in accordance with UNESCO guidelines. This article also focuses on other challenges confronting Africa today from an ethical standpoint, including the issues of poor leadership and organizational ethics which are main contributors to the problems prevalent in African countries, such as poverty, poor education and healthcare delivery systems, terrorism, social inequities, infrastructural deficits and other forms of 'structural violence' confronting vulnerable African communities. We believe that each of the eight articles included in this supplement, which have been rigorously peer-reviewed are a good example of current research on bioethics in Africa, and explore some new directions towards broadening the African bioethics agenda as we move forward to a new dawn for Africa in the 21st century.
Africa; argumentation; bioethics; leadership; organizational ethics; structural violence; viewpoint discrimination; vulnerable populations
This paper addresses the past, present and future aspects of African leadership and organizational ethics that have, are and will be key for any organization to sustain its systems and structures. Organizational ethics revolves around written and/or unwritten guidelines, ethical values, principles, rules and standards, that are drawn from the harmonious coexistence with the biosphere and it is how these elements are applied that dictates the style of leadership and the ethical thinking of the leaders. Africa has a wide range of complexities which are compounded by, inter alia, tribal divisiveness, selfish leadership, wealth inequality, and massive unemployment. Africans tend to draw their leadership and ethical practices and reflections from the events in the environment with which they have interacted for many years. However, in order to fully address and understand the African perspective in leadership and organizational ethics, a broad comprehension of the African diverse and complex landscape is needed through unravelling of the three dimensional existence of the people. African ethics, developed over time, unifies organizations and leadership since it is part of life and is practised, sub-consciously or unconsciously, by the people as they transform from one practice to the other, and during intergenerational transitions. Globalization, liberalization, technological changes and advancement, and market changes are rapidly transforming the environment in which organizations operate. In such a situation, an effective and true leader cannot be rigid but should be flexible, with the ability to use different leadership styles whenever the situation calls for it. Only those leaders with a three-dimensional perspective live inspiring lives, live with a cause and adopt organizational ethics and leadership styles that will stand the test of time. Despite Africa being the cradle of humankind, leadership and organizational ethics is still in its infancy and wanting, even with the new generation of young leaders. The future outlook of African organizational ethics and leadership is to be found in the intersection of changes in technology, life style, demographics and geopolitics with new trends emerging in global polity and economy.
Bioethics; ethical approaches; leadership styles; Internet; ethics drivers
Informed consent is a legal and ethical doctrine derived from the principle of respect for autonomy. Generally two rights derived from autonomy are accorded legal protection. The constitutional right to bodily integrity followed by the right to bodily well-being, protected by professional negligence rules. Therefore healthcare professionals treating patients' without valid consent may be guilty of infringing patients' rights. Many challenges are experienced by doctors obtaining informed consent in complex multicultural societies like South Africa. These include different cultural ethos, multilingualism, poverty, education, unfamiliarity with libertarian rights based autonomy, and power asymmetry between doctors and patients. All of which could impact on the ability of doctors to obtain legally valid informed consent.
The objective of this study was to evaluate whether the quality of informed consent obtained by doctors practicing in South Africa is consistent with international ethical standards and local regulations. Responses from 946 participants including doctors, nurses and patients was analyzed, using a semi-structured self-administered questionnaire and person triangulation in selected public hospitals in Durban, KwaZulu-Natal, South Africa.
The median age of 168 doctors participating was 30 years with 51% females, 28% interns, 16% medical officers, 26% registrars, 30% consultant/specialists. A broad range of clinical specialties were represented. Challenges to informed consent practice include language difficulties, lack of interpreters, workload, and time constraints. Doctors spent 5-10 minutes on consent, disclosed most information required to patients, however knowledge of essential local laws was inadequate. Informed consent aggregate scores (ICAS) showed that interns/registrars scored lower than consultants/specialists. ICAS scores were statistically significant by specialty (p = 0.005), with radiologists and anaesthetists scoring lowest, while internists, GPs and obstetricians/gynaecologists scored highest. Comparative ICAS scores showed that professional nurses scored significantly lower than doctors (p ≤ 0.001).
This study shows that though doctors had general knowledge of informed consent requirements, execution in practice was inadequate, with deficiency in knowledge of basic local laws and regulations. Remedying identified deficiencies may require a 'corps' of interpreters in local hospitals to assist doctors in dealing with language difficulties, and continuing education in medical law and ethics to improve informed consent practices and overall quality of healthcare service delivery.
Africa; Autonomy; Patients' rights; Informed consent; Doctors; Empirical ethics; Nurses; Laws; Regulations
Every year, research specimens are shipped from one institution to another as well as across national boundaries. A significant proportion of specimens move from poor to rich countries. Concerns are always raised on the future usage of the stored specimens shipped to research insitutions from developing countries. Creating awareness of the processes is required in all sectors involved in biomedical research. To maintain fairness and respect in sharing biomedical specimens and reserch products requires safeguarding by Ethics Review Committees in both provider and recepient institutions. Training in basic ethical principles in research is required to all sectors involved in biomedical research so as to level up the research playing field.
By agreeing to provide specimens, individuals and communities from whom samples are collected would have placed their trust and all ensuing up-keep of the specimens to the researchers. In most collaborative set-up, laid down material transfer agreements are negotiated and signed before the shipment of specimens. Researchers, research ethics committees (RECs) and institutions in the countries of origin are supposed to serve as overseers of the specimens. There is need to advocate for honesty in sample handling and sharing, and also need to oversee any written commitments by researchers, RECs and institutions at source as well as in recipient institution. Commitments from source RECs and Institutional Review Boards (IRBs) and in the receiving institution on overseeing the future usage of stored specimens are required; including the ultimate confirmation abiding by the agreement. Training in ethical issues pertaining to sample handling and biomedical research in general is essential at all levels of academic pursuit. While sharing of biological specimens and research data demands honesty and oversight by ethical regulatory agents from both institutions in developing country and recepient institutions in developed countries.
Archiving of biological specimens requires reconsideration for the future of biomedical findings and scientific break-throughs. Biomedical ethical regulations still need to established clear viable regulations that have vision for the future of science through shared and archived samples. This discussion covers and proposes essential points that need to be considered in view of future generations and scientific break-throughs. The discussion is based on the experience of working in resource-limited settings, the local regulatory laws and the need to refine research regulations governing sharing and storage of specimens for the future of science.
biological samples; sharing specimens; research collaboration; ethics; regulation of research; resource limited
Doctor and healthcare worker (HCW) strikes are a global phenomenon with the potential to negatively impact on the quality of healthcare services and the doctor-patient relationship. Strikes are a legitimate deadlock breaking mechanism employed when labour negotiations have reached an impasse during collective bargaining. Striking doctors usually have a moral dilemma between adherence to the Hippocratic tenets of the medical profession and fiduciary obligation to patients. In such circumstances the ethical principles of respect for autonomy, justice and beneficence all come into conflict, whereby doctors struggle with their role as ordinary employees who are rightfully entitled to a just wage for just work versus their moral obligations to patients and society.
It has been argued that to deny any group of workers, including "essential workers" the right to strike is akin to enslavement which is ethically and morally indefensible. While HCW strikes occur globally, the impact appears more severe in developing countries challenged by poorer socio-economic circumstances, embedded infrastructural deficiencies, and lack of viable alternative means of obtaining healthcare. These communities appear to satisfy the criteria for vulnerability and may be deserving of special ethical consideration when doctor and HCW strikes are contemplated.
The right to strike is considered a fundamental right whose derogation would be inimical to the proper functioning of employer/employee collective bargaining in democratic societies. Motivations for HCW strikes include the natural pressure to fulfil human needs and the paradigm shift in modern medical practice, from self-employment and benevolent paternalism, to managed healthcare and consumer rights. Minimizing the incidence and impact of HCW strikes will require an ethical approach from all stakeholders, and recognition that all parties have an equal moral obligation to serve the best interests of society. Employers should implement legitimate collective bargaining agreements in a timely manner and high-handed actions such as mass-firing of striking HCWs, or unjustifiable disciplinary action by regulators should be avoided. Minimum service level agreements should be implemented to mitigate the impact of HCW strikes on indigent populations. Striking employees including HCWs should also desist from making unrealistic wage demands which could bankrupt governments/employers or hamper provision of other equally important social services to the general population.
Doctors; Healthcare workers; Strikes; Employees; Employers; Health policy; Law; Ethics; Human Rights
Controversies still exists within the research fraternity on the form and level of incentives, compensation and reimbursement to study participants in resource-constrained settings. While most research activities contribute significantly to advancement of mankind, little has been considered in rewarding directly the research participants from resource-constrained areas.
A study was conducted in Zimbabwe to investigate views and expectations of various stakeholders on study participation incentives, compensation and reimbursement issues. Data was collected using various methods including a survey of about 1,008 parents/guardians of school children participating in various immunological cohort studies and parasitology surveys. Community advisory boards (CABs) at 9 of the sites were also consulted. Further, information was gathered during discussions held at a basic research ethics training workshop. The workshop had 45 participants that including 40 seasoned Zimbabwean researchers and 5 international research collaborators.
About 90% (907) of the study participants and guardians expected compensation of reasonable value, in view of the researchers' value and comparison to other sites regardless of economic status of the community. During discussion with researchers at a basic ethics training workshop, about 80% (32) believed that decisions on level of compensation should be determined by the local research ethics committees. While, the few international research collaborators were of the opinion that compensation should be in accordance with local guidelines, and incentives should be in line with funding. Both the CAB members and study participants expressed that there should be a clear distinction between study incentive and compensation accorded to individual and community expectations on benefits from studies. However, CABs expressed that their suggestions on incentives and compensation are often moderated by the regulatory authorities who cite fear of unknown concerns.
Overall, both personal and community benefits need to be considered colectively in future studies to be conducted in resource-constrained communities. There is projected fear that recruitment in future may be a challenge, now that almost every community, has somehow been reached and participated in some form of studies. A major concern on reimbursement, compensation or incentives should be internationally pegged regardless of different economic status of the individuals or communities where the study is to be conducted.
study participants; incentives; compensation; reimbursement; resource-constrained
Information and communication technologies are becoming an integral part of medical practice, research and administration and their use will grow as telemedicine and electronic medical record use become part of routine practice. Security in maintaining patient data is important and there is a statuary obligation to do so, but few health professionals have been trained on how to achieve this. There is no information on the use of computers and email by doctors and nurses in South Africa in the workplace and at home, and whether their current computer practices meets legal and ethical requirements. The aims of this study were to determine the use of computers by healthcare practitioners in the workplace and home; the use and approach to data storage, encryption and security of patient data and patient email; and the use of informed consent to transmit data by email.
A self-administered questionnaire was administered to 400 health care providers from the state and private health care sectors. The questionnaire covered computer use in the workplace and at home, sharing of computers, data encryption and storage, email use, encryption of emails and storage, and the use of informed consent for email communication.
193 doctors and 207 nurses in the private and public sectors completed the questionnaire. Forty (10%) of participants do not use a computer. A third of health professionals were the only users of computers at work or at home. One hundred and ninety-eight respondents (55%) did not know if the data on the computers were encrypted, 132 (36.7%) knew that the data were not encrypted and 30 (8.3%) individuals knew that the data on the computers they were using were encrypted. Few doctors, 58 (16%), received emails from patients, with doctors more likely to receive emails from patients than nurses (p = 0.0025). Thirty-one percent of individuals did not respond to the emails. Emails were saved by 40 (69%) recipients but only 5 (12.5%) doctors encrypted the messages, 19 (47.5%) individuals knowingly did not encrypt and 16 (40.0%) did not know if they encrypted the data. While 20% of health professionals have emailed patient data, but only 41.7% gained consent to do so.
Most health professionals as sampled in South Africa are not compliant with the National Health Act or the Electronic Communications Transactions Act of South Africa or guidelines from regulatory bodies when managing patient data on computers. Many appear ignorant or lack the ability to comply with simple data security procedures.
The issue of stigma is very important in the battle against HIV/AIDS in Africa since it may affect patient attendance at healthcare centres for obtaining antiretroviral (ARV) medications and regular medical check-ups. Stigmatization creates an unnecessary culture of secrecy and silence based on ignorance and fear of victimization. This study was designed to determine if there is external stigmatization of people living with HIV and AIDS (PLWHA) by health care workers (HCWs) at a tertiary hospital in KwaZulu-Natal (KZN) province, South Africa. The study investigated the impact of knowledge of HIV/AIDS by HCWs on treatment of patients, as well as the comfort level and attitude of HCWs when rendering care to PLWHA.
A descriptive cross sectional study was designed to collect data using an anonymous self-administered structured questionnaire from 334 HCWs. The study was conducted in clinical departments of a large multidisciplinary 922-bed tertiary care teaching hospital in Durban, KZN.
Overall HCWs had an above average knowledge about HIV/AIDS although some gaps in knowledge were identified. Tests of statistical significance showed that there was association between level of education and knowledge of HIV/AIDs (p ≤ 0.001); occupation and knowledge of HIV/AIDS (p ≤ 0.001); and gender and knowledge of HIV/AIDS (p = 0.004). Test for comfort level was only significant for gender, with males showing more comfort and empathy when dealing with PLWHA (p = 0.003). The study also revealed that patients were sometimes tested for HIV without informed consent before surgery, due to fear of being infected, and there was some gossiping about patients' HIV status by HCWs, thereby compromising patient confidentiality. The majority of HCWs showed a willingness to report incidents of stigmatization and discrimination to higher authorities, for better monitoring and control.
Although knowledge, attitude and comfort level of HCWs taking care of PLWHA was above average, enforcement of existing antidiscrimination laws and continuing education in medical ethics and healthcare law, would greatly improve the performance of HCWs taking care of PLWHAs. More psychological support and counselling should be provided to HCWs, to further reduce the impact of stigmatization and discrimination against PLWHA.
HIV/AIDS; Africa; Attitude; Comfort; Discrimination; Healthcare workers; PLWHA; Stigmatization
In clinical research scientific, legal as well as ethical aspects are important. It is well known that clinical investigators at university hospitals have to undertake their PhD-studies alongside their daily work and reconciling work and study can be challenging. The aim of this project was to create a web based course in clinical research bioethics (5 credits) and to examine whether the method is suitable for teaching bioethics. The course comprised of six modules: an initial examination (to assess knowledge in bioethics), information on research legislation, obtaining permissions from authorities, writing an essay on research ethics, preparing one’s own study protocol, and a final exam. All assignments were designed with an idea of supporting students to reflect on their learning with their own research.
57 PhD-students (medical, nursing and dental sciences) enrolled and 46 completed the course. Course evaluation was done using a questionnaire. The response rate was 78%. Data were analyzed using quantitative methods and qualitative content analysis.
The course was viewed as useful and technically easy to perform. Students were pleased with the guidance offered. Personal feedback from teachers about students’ own performance was seen advantageous and helped them to appreciate how these aspects could be applied their own studies. The course was also considered valuable for future research projects.
Ethical issues and legislation of clinical research can be understood more easily when students can reflect the principles upon their own research project. Web based teaching environment is a feasible learning method for clinical investigators.
Bioethics; Research ethics; Web learning; Legislation
In Japan, people are negative towards life-prolonging treatments. Laws that regulate withholding or discontinuing life-prolonging treatments and advance directives do not exist. Physicians, however, view discontinuing life-prolonging treatments negatively due to fears of police investigations. Although ministerial guidelines were announced regarding the decision process for end-of-life care in 2007, a consensus could not be reached on the definition of end-of-life and conditions for withholding treatment. We established a forum for extended discussions and consensus building on this topic.
We used the Neo-Socratic Dialogue (NSD) method which promotes philosophical discussion based on a case-study to address a question and formulate a consensus and answer in a group. The question chosen for the dialogue was: “What is a life-prolonging treatment?” A series of dialogues took place over a period of one and a half days. It was carried out by three groups in 2010 and 2011. Seven participants with diverse backgrounds were recruited per group. We analyzed the content of the discussion.
Based on three case studies concerning different opinions about treatment options for an older dementia patient, a patient demanding chemotherapy, and a severely ill neonate, conditions for futile life-prolonging treatment were elucidated through NSD. Such treatments are those carried out for the sole purpose of prolonging life and are detrimental to the patient, and should be decided based foremost on the patient’s lack of desire for treatment, the consensus of those involved, and through social acceptance. These arguments are essentially consistent with ones on medical futility in the United States. By expressing the objective of healthcare and the requirement of social acceptance, participants were also able to elucidate issues related to the awareness of those involved and the medical environment. Compared to the end-of-life guidelines in Japan, the objective of treatment, its effects, and benefits were more specifically discussed with the patient’s intentions as the foremost consideration, rather than being limited to the terminal stage.
This small study contributed to elucidating the conditions and current problems of futile life-prolonging treatment through NSD. They would suggest more substantial guidelines and improvements on the administration of the treatment.
Life-prolonging treatment; Futility; Socratic Dialogue; Philosophical group discussion
The 2006 Centers for Disease Control and Prevention (CDC) revised recommendations for HIV testing in clinical settings contained seven specific changes to how health care facilities should provide HIV testing. These seven elements have been both supported and challenged in the lay and medical literature. Our first paper in BMC Medical Ethics presented an analysis of the three HIV testing procedural changes included in the recommendations. In this paper, we address the four remaining elements that concern HIV screening policy changes: (1) nontargeted HIV screening, (2) making HIV screening similar to screening for other treatable conditions, (3) increasing HIV screening without assured additional funding for linkage to care, and (4) making patients bear the costs of increased HIV screening in health care settings.
We interviewed 25 members from the fields of US HIV advocacy, care, policy, and research about the ethical merits and demerits of the four changes to HIV screening policies. We performed a qualitative analysis of the participant responses in the interviews and summarized the major themes.
Participants commented that nontargeted HIV screening and making HIV screening similar to screening for other treatable medical conditions was ethical when it broadened the scope of people being tested for HIV. However, they believed it was unethical when it did not respect the exceptional nature of HIV and HIV testing. Some participants favored more testing regardless if there was assured additional funding for linkage to care or if patients might bear the costs of testing because they believed that merely alerting patients of their status was beneficial and would lead to positive consequences. Other participants found ethical flaws with testing without assured linkage to care and patients bearing the costs of testing, as this could discriminate against those who could not pay.
Our findings suggest that there are fundamental ethical disagreements that shape views on CDC’s recommended HIV testing policies. Differences remain on whether or not HIV remains an exceptional condition that requires it to be treated differently than other treatable conditions. Disagreement also exists on the responsibilities of health care providers and rights of patients in regards to screening in (1) the absence of assured linkage to care after an HIV diagnosis and (2) paying for the costs of HIV screening. Resolution of these disagreements is needed to serve the common goal of using testing to facilitate medical care for those who are HIV infected and for reducing HIV transmission.
This case report discusses an ethical communication dilemma in prehospital patient interaction, involving a patient who was about to board a plane at a busy airport. The article argues that the situation raised dilemmas about communication, patient autonomy and paternalism. Paramedics should be able to find good solutions to these dilemmas, but they have not received much attention in the literature on prehospital ambulance work.
The patient had chest pains that were consistent with serious heart disease, but she wanted to catch her plane and was unwilling to let paramedics assess her heart activity by means of an electrocardiogram (ECG). The paramedics had to decide, there and then, whether the patient’s refusal to submit to an ECG should be respected, or whether they should set the patient’s expressed wishes aside by exercising verbal power and persuasive communication techniques. The paramedics chose to do the latter. It later turned out that the patient was grateful that the paramedics had been very direct, almost brutal, in their communication. When the patient regained her autonomy, she saw clearly that taking time to obtain and monitor an ECG was the best option for her.
Looking forward in time might be a good professional strategy for deciding whether ethical paternalism in communication is justified. If there is good reason to believe that patients who later regain their autonomy will agree that paternalistic verbal actions were in their best interests, and if acting in accordance with patients’ preferences can have severe negative health consequences for them, then paramedics have good reason to believe that ethical paternalism is justified.
Defensive medicine is defined as a doctor’s deviation from standard practice to reduce or prevent complaints or criticism. The objectives of this study were to assess the prevalence of the practice of defensive medicine in the UK among hospital doctors and the factors affecting it.
A quantitative study was designed, with a detailed seventeen point questionnaire. Defensive medicine practice was assessed and tested against four factors age, gender, specialty and grade. Three hundred hospital doctors from three UK hospitals received the questionnaire.
Two hundred and four (68%) out of 300 hospital doctors responded to the survey. Seventy eight percent reported practicing one form or another of defensive medicine. Ordering unnecessary tests is the commonest form of defensive medicine reported by 59% of the respondents. This is followed by unnecessary referral to other specialties (55%). While only 9% of the sampled doctors would refuse to treat high risk patients, double this number would avoid high risks procedures all together (21%). A linear regression module has shown that only senior grade was associated with less practice of defensive medicine.
Defensive medical practice is common among the doctors who responded to the survey. Senior grade is associated with less practice of defensive medicine.
Although there is extensive information about why people participate in clinical trials, studies are largely based on quantitative evidence and typically focus on single conditions. Over the last decade investigations into why people volunteer for health research have become increasingly prominent across diverse research settings, offering variable based explanations of participation patterns driven primarily by recruitment concerns. Therapeutic misconception and altruism have emerged as predominant themes in this literature on motivations to participate in health research. This paper contributes to more recent qualitative approaches to understanding how and why people come to participate in various types of health research. We focus on the experience of participating and the meanings research participation has for people within the context of their lives and their health and illness biographies.
This is a qualitative exploratory study informed by grounded theory strategies. Thirty-nine participants recruited in British Columbia and Manitoba, Canada, who had taken part in a diverse range of health research studies participated in semi-structured interviews. Participants described their experiences of health research participation including motivations for volunteering. Interviews were recorded, transcribed, and analyzed using constant comparisons. Coding and data management was supported by Nvivo-7.
A predominant theme to emerge was 'participation in health research to access health services.’ Participants described research as ways of accessing: (1) Medications that offered (hope of) relief; (2) better care; (3) technologies for monitoring health or illness. Participants perceived standard medical care to be a “trial and error” process akin to research, which further blurred the boundaries between research and treatment.
Our findings have implications for recruitment, informed consent, and the dichotomizing of medical/health procedures as either research or treatment. Those with low health status may be more vulnerable to potential coercion, suggesting the need for a more cautious approach to obtaining consent. Our findings also indicate the need for boundary work in order to better differentiate treatment and research. It is important however to acknowledge a categorical ambiguity; it is not always the case that people are misinformed about the possible benefits of research procedures (i.e., therapeutic misconception); our participants were aware that the primary purpose of research is to gain new knowledge yet they also identified a range of actual health benefits arising from their participation.
Human subjects protection; Health research; Therapeutic misconception; Self-managing; Qualitative research; Accessing health services; Informed consent; Recruitment