Towards a competency assessment tool for nurses in ethics meetings.

BACKGROUND: Nurses require specific knowledge, skills and attitudes to participate competently in various forms of ethics meetings. The literature does not state the contents of the knowledge, skills and attitudes nurses need for ethics meetings. Without such a competency profile, it cannot be assessed in how far nurses actually possess these qualities for ethics meetings. OBJECTIVE: Corroborating an existing profile of the requisite knowledge, skills and attitudes in the form of a questionnaire contributes to the development of a tool to determine the competence nurses need for ethics meetings. QUESTION: In how far can this profile be confirmed by a quantitative follow-up in a random sample? DESIGN: A questionnaire was developed to determine in how far nurses with prior involvement in ethics meetings recognise the earlier competency profile as important and comprehensive. PARTICIPANTS: It was made available to subscribers of the digital newsletter of three widely read nursing journals in the Netherlands. Data collection and analysis took place in the spring of 2013. ETHICAL CONSIDERATIONS: Care was taken to state explicitly in the questionnaire that participation in the survey was completely voluntary and anonymous. FINDINGS: To a high degree, nurses with involvement in ethics meetings recognise the knowledge, skills and attitudes from the earlier interviews when presented as a survey. DISCUSSION: Although the sample was small, the respondents and the results reflect known characteristics of nurses serving on ethics meeting. CONCLUSION: This may be helpful to recruit and prepare nurses for professional ethics in nursing care, and to develop a tool to assess to what extent nurses actually possess competence for ethics meetings.

Financial compensation of oocyte donors: an Ethics Committee opinion.

Financial compensation of women donating oocytes for infertility therapy or for research is justified on ethical grounds and should acknowledge the time, inconvenience, and discomfort associated with screening, ovarian stimulation, and oocyte retrieval, and not vary according to the planned use of the oocytes, the number or quality of oocytes retrieved, the number or outcome of prior donation cycles, or the donor's ethnic or other personal characteristics. This document replaces the document of the same name, last published in 2007 (Fertil Steril 2007;88:305-9).

Liberalism, authority, and bioethics commissions.

Bioethicists working on national ethics commissions frequently think of themselves as advisors to the government, but distance themselves from any claims to actual authority. Governments however may find it beneficial to appear to defer to the authority of these commissions when designing laws and policies, and might appoint such commissions for exactly this reason. Where does the authority for setting laws and policies come from? This question is best answered from within a normative political philosophy. This paper explains the locus of moral authority as understood within one family of normative political theories--liberal political theories--and argues that most major "liberal" commentators have understood both the source and scope of ethics commissions' authority in a manner at odds with liberalism, rightly interpreted. The author argues that reexamining the implications of liberalism for bioethics commissions would mean changing what are considered valid criticisms of such commissions and also changing the content of national bioethics commission mandates. The author concludes that bioethicists who participate in such commissions ought to carefully examine their own views about the normative limits of governmental authority because such limits have important implications for the contribution that bioethicists can legitimately make to government commissions.

Donating embryos for human embryonic stem cell (hESC) research: a committee opinion.

hESC research is an ethically acceptable use of human embryos that are in excess of those needed to meet the fertility goals of patients. The ethical basis for this view and issues to be considered during the informed consent process for the donation of embryos are developed in this document. This report replaces the Committee's 2009 report, "Donating spare embryos for stem cell research" (Fertil Steril 2009;91:667-70).

Review of policies for injuries to research participants in India.

BACKGROUND: As there is little Indian data about severity, frequency and types of research related injuries, costs involved and policies regarding compensation, this study was conducted to review the present Indian scenario. METHODS: The study was carried out in three parts; a questionnaire-based survey, in-depth interviews, and a review of informed consent and insurance documents of projects submitted to three ethics committees. RESULTS: 47% of investigators were either unaware of, or had not understood, the legal requirements and depended on sponsors to manage these issues, whereas 74% of ethics committee members were aware of the requirements. Although 40% of investigators, 30% of ethics committee members and all sponsors had policies to manage compensation issues, these were mainly to provide immediate free medical care or reimbursement of expenses incurred for the acute management of an adverse event. Compensation for loss of time/wages, death, physical disability or long term incapacitation was not included. A review of informed consent and insurance documents showed that compensation issues were inadequately discussed, with only insurance certificates submitted to ethics committees. CONCLUSION: In India, there are no uniform policies and investigators are largely unaware of their responsibilities. Therefore, there is an urgent need to draft national guidelines regarding compensation for research injuries of research participants and highlight the responsibilities of each stakeholder. Potential research injuries should be categorised based on risk assessment, severity and seriousness of the injury. Further, it would be necessary to have arbitration committees to determine the extent of compensation. Training and awareness workshops for those involved in clinical research, including research participants, is also needed.

Clinical research in India: great expectations?

India is considered as a preferred site for conducting global clinical trials. Existence of a large treatment-naïve population, availability of English-speaking, skilled doctors, plenty of clinical material, and cost-savings are obvious advantages for carrying out clinical research in India. However, challenges exist at various levels. Lack of formal training in bioethics and research methodology, heavy burden of clinical duties and sub-optimal administrative support restrict investigators. Absence of oversight of functioning of ethics committees (ECs) and lack of mechanisms for ensuring quality of ethics review heighten societal concerns about safety of participants. Conducting research on issues not relevant to local needs and failure to ensure post-trial access further enhance society's cynicism. These issues need to be tackled through capacity building, training of investigators and EC members, strengthening of EC functioning and encouraging greater community participation.

Ethical dilemmas in palliative care in traditional developing societies, with special reference to the Indian setting.

BACKGROUND: There are intriguing and challenging ethical dilemmas in the practice of palliative care in a traditional developing society. OBJECTIVE: To review the different ethical issues involved in cancer and palliative care in developing countries, with special reference to India. METHODS: Published literature on pain relief and palliative care in the developing countries was reviewed to identify ethical issues and dilemmas related to these, and ways in which ethical principles could be observed in delivery of palliative care in such countries are discussed. RESULTS: The literature review revealed a number of ethical dilemmas and challenges that professionals, cancer patients and their families encountered during palliative care. It was noted that patients' preferences and decisions are influenced by family members. Dilemmas leave the professionals and families confused about how ethical their actions have been. Specific ethical issues were noted in relation to the availability and use of oral morphine for pain relief, spiritual care, lack of adequate palliative care services, and palliative care education. CONCLUSIONS: The four principles of ethics posed difficulties in understanding the complex ethical issues in a developing country with a traditional background. Ethical issues need to be handled delicately and sensitively in palliative care settings, within the framework of the traditions and culture of the society and financial constraints. The possible role of ethics committees in palliative care settings to help decision-making needs to be studied and discussed.

Ethics policies on euthanasia in nursing homes: a survey in Flanders, Belgium.

In many European countries there is a public debate about the acceptability and regulation of euthanasia. In 2002, Belgium became the second country after the Netherlands to enact a law on euthanasia. Although euthanasia rarely occurs, the complexity of the clinical-ethical decision making surrounding euthanasia requests and the need for adequate support reported by caregivers, means that healthcare institutions increasingly need to consider how to responsibly handle euthanasia requests. The development of written ethics policies on euthanasia may be important to guarantee and maintain the quality of care for patients requesting euthanasia. The aim of this study was to determine the prevalence, development, position, and communication of written ethics policies on euthanasia in Flemish nursing homes. Data were obtained through a cross-sectional mail survey of general directors of all Catholic nursing homes in Flanders, Belgium. Of the 737 nursing homes invited to participate, 612 (83%) completed the questionnaire. Of these, only 15% had a written ethics policy on euthanasia. Presence of an ethics committee and membership of an umbrella organization were independent predictors of whether a nursing home had such a written ethics policy. The Act on Euthanasia and euthanasia guidelines advanced by professional organizations were the most frequent reasons (76% and 56%, respectively) and reference sources (92% and 64%, respectively) for developing ethics policies on euthanasia. Development of ethics policies occurred within a multidisciplinary context. In general, Flemish nursing homes applied the Act on Euthanasia restrictively by introducing palliative procedures in addition to legal due care criteria. The policy was communicated to the consulting general practitioner and nurses in 74% and 89% of nursing homes, respectively. Although the overall prevalence of ethics policies on euthanasia was low in Flemish nursing homes, institution administrators displayed growing awareness of bearing responsibility for stimulating dialogue and reflection about how to deal with euthanasia requests within their institution.

Clinical audit and reform of the UK research ethics review system.

There is an international consensus that medical research involving humans should only be undertaken in accordance with ethical principles. Paradoxically though, there is no consensus over the kinds of activities that constitute research and should be subject to review. In the UK and elsewhere, research requiring review is distinguished from clinical audit. Unfortunately the two activities are not always easy to differentiate from one another. Moreover, as the volume of audit increases and becomes more formal in response to the demand for evidence-based practice in medicine, the overlap between research and audit grows more acute. Arguably, similar ethical standards and systems for ensuring that those standards are met should be applied regardless of whether or not a project is classified as research or audit. At a time when the research ethics review system in the UK is undergoing significant reform it is important that the opportunity is not missed to address the longstanding research-audit problem. We discuss suggestions for further reform that addresses this issue.

Medical ethics surveillance in the Armed Forces.

Modern defense services depend on a policy of the vigorous promotion of research to ensure that they retain an advantage in any future operational context. Research involving personnel within the armed forces, however, has certain constraints with respect to contemporary, best-practice medical ethics. Service members are one example of a class of "captive subjects" who require special protection in the context of medical research. (Prisoners, students, children, and the intellectually disabled are other such examples.) The majority of national defense forces now have ethical watchdog groups--institutional ethics committees--that oversee research involving service members. Such groups monitor the special considerations and constraints under which subjects in uniform can volunteer for biological research. These committees audit particularly the ethical themes of confidentiality, equality, and justice. Themes inherent in medical research in the military include the standard Beauchamp-Childress paradigm of autonomy, beneficence, nonmaleficence, and justice, to which are added the traditional military values of loyalty, respect, courtesy, and chivalry. Contemporary thinking is that the general principle of affording service members the opportunity to volunteer for research should be maintained within the constraints of compromised training time, national security, and operational necessity. Most biological research (and its outcome) does not in practice compromise confidentiality or military security. This paper presents an audit of the functioning of one national military medical ethics committee, the Australian Defence Medical Ethics Committee, and presents a discussion of its philosophies and influence within the broader military context. The Australian Defence Medical Ethics Committee believes that most research should, as an a priori condition of approval, be intended for open publication in peer-reviewed journals.

The new system of review by multicentre research ethics committees: prospective study.

OBJECTIVE: To assess the function of the new system of review by multicentre research ethics committees and to highlight areas where improvement is still needed. DESIGN: Prospectively collected data from a multicentre study was examined with respect to the ethics review process. Administrative, financial, and time elements of the review process were audited. SETTING: A single multicentre research ethics committee and 125 local ethics committees from six regions of England. MAIN OUTCOME MEASURES: Time to reply, time to approval, and number of non-local changes to the application requested. RESULTS: Only 40% of local ethics committees considered our study in the manner specified in the 1998 directive. Less than a third of committees replied within the 21 day period stipulated, although committees acting by executive subcommittee replied more quickly than those not acting by executive subcommittee. There was a tendency for executive subcommittees to approve studies in a shorter time. Local ethics committees asked for a large number of non-local changes to the application. The financial cost of applying to multiple ethics committees remains high, mainly because multiple copies of research applications are being requested. CONCLUSIONS: The new system of approval by multicentre research ethics committee for multicentre studies was introduced to reduce administrative costs, speed up the process of reviews by multiple research ethics committees, and standardise the conclusions of the local research ethics committees. Since its introduction an improvement has been seen, but the system is not yet universally functioning as intended. Ethics review still remains a hindrance to the financial resources and commencement of national studies. We strongly support the structure of review by multicentre research ethics committees but suggest that the system has yet to achieve its aims.

Conflict of interests, vested interests and health research.

This paper examines conflict of interest as it may arise in the activities of research advisory committees and ethical review committees. It distinguishes between vested interests and true conflict of interest. It also examines the ways in which stakeholdings differ from vested interests and conflicting interests differ from conflicts of interest. It explores the overlapping terrain of corruption and conflict of interest. The paper further examines the ways in which scientists, communities and the subjects of medical research all have legitimate stakeholdings in medical research. Each group thus has differently vested interests in the outcomes of the research. The vested interests of medical scientists are particularly complex because scientists have moral commitments to the welfare of patients that may compete with professional and personal interests in the outcome of research performed on those patients as research subjects. The more these interests diverge, the more opportunity will arise for conflict of interest. These observations have implications for the constitution of research advisory and ethical review committees, and the ways in which their discussions are conducted. Some practical help with protocols of discussion can be gained from philosophical and management writings.

Comites hospitalarios de etica

La sola existencia de comites hospitalarios de etica no garantiza en absoluto la presencia real de la etica en la institucion, ya que en muchos casos, lamentablemente, lo que se busca es dar tan solo un barniz de etica a las practicas establecidas. Pero si por el contrario, se toman los recaudos necesarios, asumiendo el riesgo que implica una revision profunda de los supuestos de la practica medica institucionalizada, estos comites pueden constituirse en un importante espacio de ejercicio democratico que nos permita avanzar hacia la creacion de un nuevo modelo de relacion, no solo entre el medico y el paciente, sino tambien entre la practica medica y el resto de las practicas sociales que constituyen nuestra realidad