WASP (write a scientific paper): The ethical stages of publishing a research paper.

BACKGROUND: Authors have to be aware of the ethical stages in writing a scientific paper in order to be cognizant of what is required of them as researchers. The research ethics committee concerns itself with patient protection and therefore looks closely not only at the protocol, but also at the informed consent process and data protection issues. Conversely the publishers has ethical issues of their own relating to their reputation in publishing ethically sound and justified studies. MATERIALS/METHODS: The article describes the ethics required of the research by looking at documents and directives which describe the ethical duties of the research, the functions of Research Ethics Committee and Publishing Ethics. RESULTS: The Researcher should be familiar with the informed consent process and data protection for research and the requirements of the research ethics committee. The informed consent process involves discussion of the research, the risks, the requirements from the patient/ participant and issues related with data protection. The second stage is that of the research ethics committee. This committee reviews the proposal and protocol of the research and any updates after the research approval. RECs are much concerned with the informed consent process and what is to be said to patients/participants. Any precautions or arrangement for vulnerable groups should be identified. RECs move according to research ethics guidelines and are objective in their response. The final stage is the ethics of publication. The editor of a journal must ensure that ethics review has been made and ascertain as much as possible any conflicting or competing interests on the part of the researcher/s. The issue of identity of reviewers of the paper is also discussed. CONCLUSION: The ethics of publication involves various ethical stages, each having their own responsibility towards patients and the scientific community.

WASP (Write a Scientific Paper): Ethics approval for a research study (1).

Past experience in science has thought us the importance of ethics in research. Research is important to the advancement of medicine and therefore good clinical practice in research maintains public trust which otherwise is not only lost but may cause science to seem negative. The rights of participants in the research trial are discussed. This includes knowledge and information about the research itself, the obligations of the researchers and the rights of participants during the research. The EU Directive on Good Clinical Practice in research trials is reviewed, including the twelve principles of the directive. The function and composition of Research Ethics Committees is discussed in the context of protecting patients and participants, asserting quality and monitoring of the research, qualifications of the scientists and liability.

WASP (Write a Scientific Paper): Informed consent in research.

The autonomy of patients participating in research means that a proper informed consent process must take place. This means that information must be given according to a reasonable person standard implying what legally and ethical a reasonable person participating in the research would want to know. The research must assure that the patient has understood all the information given and that a voluntary choice has been made. This means that no form of coercion must take place and that information must not be manipulated in such a way as to influence the participant. No undue pressure or persuasion must either occur. Particular attention must be paid to vulnerable groups and participants must be competent and have the capacity to consent. Where necessary the use of a proxy to act on behalf of a patient who does not have legal capacity must be used and the best interests of the patient must be asserted. In research consent must always include a signed consent form which again is duly explained and authorized by the research ethics committee.

WASP (Write a Scientific Paper): Ethics approval for a research study (2).

Research Ethics Committees are composed of a minimum of five members which include a lay person, a member from a different institution and at least another three members which should be versed in ethics. Legal and expert advisors can be sought by the committee. The REC will require a detailed protocol from the researcher including the curriculum of the principal investigator and all other researchers under him/her. The protocol should include all details of the research to be undertaken including a detailed description, the reasons for the research, literature pertaining to the research, a clear description of the target population, the actual consent form including what information is to be given to the participants, a declaration where necessary that things prohibited by the law (such as use of embryonic stem cells if this is the case in the country [2] will not be researchers, and a declaration that the relevant directives and rules and procedures which the REC falls under will be followed. The REC will also require a description of any risks and what actions are to be undertaken to eliminate hazards. The researchers must adhere only to the protocol given and any changes, minor or major, must be reported to the REC and approved.

WASP (Write a Scientific Paper): Recruitment for research.

The recruitment of patients must occur in accordance with approved standards. Speaking to a patient during a routine clinical consultation and offering to participate in a research, even if consented to, can only be an introduction to the recruitment process. The potential participant must then be referred to a competent person who explains the reasons for the research, why the patient is a good candidate, what the requirements from the participant will be, such as any additional visits and blood samples to be taken, how long the research will last, any compensation and what type of research is to be undertaken, such as a double blind-controlled trial and what it means. Participants must be given due time to reflect, discuss with friends or relatives, and have a contact person and number to be free to ask any questions. Their rights during the research have to be explicitly described and the extent to which the data is anonymised and protected must be explained realistically. Compensation moreover must be fair and not too enticing that it will cloud the judgement of the participant to volunteer. As the name implies the participant must remain a volunteer.

WASP (Write a Scientific Paper): Special cases of selective non-treatment and/or DNR.

Fetuses at low gestational age limit of viability, neonates with life threatening or life limiting congenital anomalies and deteriorating acutely ill newborn babies in intensive care, pose taxing ethical questions on whether to forego or stop treatment and allow them to die naturally. Although there is essentially no ethical difference between end of life decision between neonates and other children and adults, in the former, the fact that we are dealing with a new life, may pose greater problems to staff and parents. Good communication skills and involvement of all the team and the parents should start from the beginning to see which treatment can be foregone or stopped in the best interests of the child. This article deals with the importance of clinical ethics to avoid legal and moral showdowns and discusses accepted moral practice in this difficult area.

WASP (Write a Scientific Paper): The right to privacy.

The data protection directive of the EU was set up to allow the freedom of movement of people between member states. This has the consequence of allowing the freedom of transfer of data between member states in research. The paper discusses three cases discussed during the project to see whether RECs can refuse research based on concern for data protection in some member states. Since the directive is not, as commonly thought, intended to protect the rights and freedoms of individuals - something which is the function of the Data Protection Acts of individual states, Member States do not have a right to prohibit research based on data laws. One must express concerns directly to Brussels. Conversely it is debated whether some research considered unlawful in one particular member state can be refused by this same state.

An Innovative Model of a Home-Like Environment for People in Vegetative and Minimally Conscious States.

BACKGROUND AND PURPOSE: Many forms of assisted living have been proposed for people who have a loss of autonomy in activities of daily living. Despite the increasing prevalence of vegetative and minimally conscious states, no dedicated residential accommodation has been implemented for patients with chronic disorders of consciousness (DOCs). METHODS: This is a descriptive study addressing an innovative model of in-house assistance, named Casa Iride, which has recently been implemented in the attempt to ensure health, safety, and well-being for people with DOCs and their families. RESULTS: Our findings show that Casa Iride enables severely disabled individuals to live with dignity within a customized domestic environment. At the same time, it provides support for caregivers from both a practical and a psychological point of view. CONCLUSIONS: The results so far indicate a virtuous cycle that brings health, social, psychological, ethical, and economic advantages: the individuals receive all the assistance needed; the families share a place with other people with similar challenges, become more aware of their situation, and learn to cope with it and to maintain their productivity at work; and the care flow of patients through intensive care units and intensive rehabilitation wards is not delayed by a lack of post discharge services.

Towards an ethical theory in disaster situations.

Health Care professionals working in disaster situations have to face urgent choices which diverge from their normal deontological ethos and are more utilitarian. Such is the triage system used to choose whom to treat. Instead of entering a crisis these professionals should be thought that ethics is not harmonizable to all situations and that there are situations in which saving as many lives as possible mean sacrificing others. This calls for defining a perimeter zone in which such choices occur, and a time frame (a space-time niche) in which it ought to be considered ethical and legitimate to use such value laden choices.

Ethical aspects of vegetative and minimally conscious states.

The growing diffusion of life support procedures, including cardiopulmonary resuscitation (CPR) and advanced cardiac life support (ACLS), allows physicians to keep a person alive almost indefinitely when the person's heart has stopped beating autonomously or spontaneous breathing is precluded. However, in some cases patients are brought back to life but remain in a vegetative state (VS) or in a minimally conscious state (MCS). This prompts reflections on the 'pros and cons' of life support procedures and on the recommended conduct to be adopted for the general management of patients who survive in a VS or MCS. Important issues to be debated include the choice of therapeutic management which guarantees for the patient the maximum possible physical and mental well-being; the distinction between 'worthwhile' and 'disproportionate' treatments; the patient's right to make decisions concerning his or her own health status; the possibility to make 'advance directives' when still healthy or when a life-threatening illness has been diagnosed; the role of relatives and caregivers in the choice of the best treatment for unconscious patients and the identification of ethically and scientifically valid criteria for the inclusion of unconscious patients in studies investigating experimental therapies.

Developments in IVF legislation in a Catholic country.

Some time ago an article was published in this journal relating the difficulties of legislating for InVitro Fertilization in a Catholic country and the issues and side issues which had to be faced. Since then one has approached closer to having a law which regulates this technology. However several issues continue to challenge the country. The main concern, other than IVF not being a natural method of having children is the status of the embryo. The normative values of the country in fact induces politicians to discuss an 'embryology act' rather than a 'reproductive medicine' act. At the eleventh hour Bishops continue to launch concerns which raises queries on how the debate moved forward over the past two decades. This paper tackles these issues and other more recent concerns and suggestions and takes a look at how such processes can be improved through a more rigorous understanding and logistic of dialogue, as certainly such debates should have implications for bioethics in general. Although the Church's document Donum Vitae's instructions for politicians where legislation for this technology has to occur has been vindicated, I seems that whilst many disputes have been resolved, the main conflict--that of the value of the conjugal act--has not.

Are clarifications on feeding and hydration in PVS needed by Catholic authorities?

Ever since the possibility of keeping a person on advanced life support the Catholic Church has been concerned with the rights of the individual to a dignified death and the right to refuse treatment. This right has traditionally and in documents of the Church been extended to the family in the absence of specified wishes of the patient. Again, since the controversies on patients in a persistent vegetative state (PVS) have come to public knowledge, especially with the case of Terry Schiavo, and more recently, in Italy, the case of Eluana Englaro, people have been confused about the issue of what constitutes extraordinary treatment. This article focuses on the history of advanced life support and extraordinary treatment, with special reference to PVS and attempts to conclude that given the information already available decision to withdraw such care, even if in principle it may be considered ordinary, can be pursued within the same teachings and should therefore not pose problems to medical personnel once a proper legal and ethical procedure is followed. Failure to acknowledge such history and facts is indeed admitting a failure of bioethics as a futile subject.

Is there a Mediterranean bioethics?

Is there a special Mediterranean approach to Bioethics and if so what are the roots of this approach? And why not a Bosphorus, or a 'lake Michigan' bioethics? The answer to such a question depends on the focus one takes on defining 'Mediterranean'? On the one hand one can refer to the Mediterranean region which includes the surrounding coasts, having Europe on its northern coast line, northern Africa on its southern coast line (and these will include the north and South West coasts), and in the Eastern region countries which border with Middle-Eastern countries. This approach is the approach currently being taken by European Parliamentarians when they speak about the Mediterranean, namely including countries like France, Italy and Libya. On the other hand there is the look upon the Mediterranean as 'Southern Europe'; this is a more 'traditional' way on how westerners view the Mediterranean. This common approach is often recognized when, for example, we speak of 'Mediterranean diet', or, 'Mediterranean Temperament'. It would include Eastern countries like Greece and Cyprus. This article focuses on these two approaches to Mediterranean ethics after discussing issues pertaining to the region which are important to define in this context. It then analyses the need for having a Mediterranean approach to bioethical issues.

Clinical intervention in aging: ethicolegal issues in assessing risk and benefit.

The ethical dimension of treating the elderly, including risk-benefit analysis, focuses mainly on quality of life and end-of-life issues. These include arguments on advance directives and the concept of extraordinary treatments. This paper looks more closely at the philosophical approach to aging in order to address questions on the direction of research and issues such as longevity and social construction of the aging process. It is the way society moves to understand the value-laden choices on aging that directs the goals of treatment and research. Whilst these vary culturally, one has to reckon with a postmodern view of aging which may, in turn, reflect on the course of action of future care and research in aging. The paper canvasses how, in reality, four principles act as guidelines for moral discourse, and discusses how changing values in society decide this course of action.

Problems faced with legislating for IVF technology in a Roman Catholic country.

Malta traditionally enjoys a Roman Catholic Society, with the official religion of the country being cited in the second article of the constitution. Recently the government proposed to legislate to regulate human reproductive technology, in particular In Vitro Fertilization, which has been practiced for over two decades without controlling legislation. A Parliamentary Committee for social affairs was set up to study the situation inviting most stakeholders. The arguments gravitated mostly on issues of the status of the embryo and the media played a considerable role. At the end of the discussion the Archbishop made a statement which pointed out that IVF involves destruction of embryos and the process stopped. This article examines what caused the deterioration of the process and points favourably towards a way forward within the context of a Catholic Country.

Applying theological developments to bioethical issues such as genetic screening.

Catholic movements within the centre of Roman Catholic doctrine recently have discussed Trinitarian theology as applied to sciences, arts, economics, health and other social areas. We explore the possibilities Trinitarian theology offers to bioethical debate, concentrating particularly on genetic screening and testing. It is important therefore to analyse the philosophical implications of this approach onto the bioethical world, where much disagreement occurs on fundamental issues. It is Catholic basic teaching to recognize and see God's hand in plurality, not merely as a cliche and then doing what we feel is right, but to recognize how to live in a pluralistic world. We recognize, in agreement with these theologians, that in order for a Trinitarian mode of understanding to be used by those doing bioethical debate, there is a need to depart from fundamentalism.

Pragmatic approaches to genetic screening.

Pragmatic approaches to genetic testing are discussed and appraised. Whilst there are various schools of pragmatism, the Deweyan approach seems to be the most appreciated in bioethics as it allows a historical approach indebted to Hegel. This in turn allows the pragmatist to specify and balance principles in various contexts. There are problems with where to draw a line between what is referred to here as the micro- and macro-level of doing bioethics, unless one is simply to be classified as a principlist. Whilst most discussions on genetics occur at a macro level, most specifying must be done also at a micro level - the clinical encounter. Whilst pragmatism encourages us to understand better social and scientific factors and puts into perspective statements like 'playing God', doubts are raised about the 'consensus' process and how one can put aside fundamental values such as the moral status of the embryo on which there is general disagreement. If those doing pragmatism do not endorse these values, there seems to be little ground for process and compromise with those who do. It seems therefore that pragmatism cannot ignore values, even those which are not endorsed by everyone.