"The Bush administration and Congress are in concert on the goal of developing a fleet of unmanned aircraft that can reduce both defense costs and aircrew losses in combat by taking on at least the most dangerous combat missions. Unmanned combat aerial vehicles (UCAVs) will be neither inexpensive enough to be readily expendable nor-- at least in early development-- capable of performing every combat mission alongside or in lieu of manned sorties. Yet the tremendous potential of such systems is widely (...) recognized, and allies as well as potential adversaries are moving quickly to mount their own research and development programs. The United States is committed to fielding UCAV capabilities by 2010, principally for the missions of suppression of enemy air defense and deep strike, which are among the highest risk tasks for the Air Force and naval aviation."--Overview. (shrink)

Guideline 20 of the updated International Ethics Guidelines for Health‐related Research Involving Humans (2016) by the Council for International Organizations of Medical Sciences (CIOMS) provides guidance on research in disasters and disease outbreaks against the background of the need to generate knowledge quickly, overcome practical impediments to implementing such research, and the need to maintain public trust. The guideline recommends that research ethics committees could pre‐screen study protocols to expedite ethical reviews in a (...) situation of crisis, that pre‐arrangements be made regarding data sharing and biomedical sample sharing, and that sponsors and research ethics committees seek to minimize risk to researchers conducting research during a disaster. This paper critiques these recommendations against the background of the findings of a survey of public health officials and chairs of research ethics committees in the Caribbean during 2016, which sought to determine the best template for the expeditious ethical review of research proposals in emergency and epidemic situations in the Caribbean, and whose findings can serve as a model for other low‐ and middle‐income countries. (shrink)

This book is a comprehensive and unique text and reference in medical ethics. By far the most inclusive set of primary documents and articles in the field ever published, it contains over 100 selections. Virtually all pieces appear in their entirety, and a significant number would be difficult to obtain elsewhere. The volume draws upon the literature of history, medicine, philosophical and religious ethics, economics, and sociology. A wide range of topics and issues are covered, such as (...) law and medicine, truth-telling by the physician, research, population policy, genetics, abortion, dying, and individual rights in medical care. The selections span the centuries, beginning with material from the works of Hippocrates, continuing through Thomas Percival, John Stuart Mill, and Claude Bernard, down to modern commentators like Henry K. Beecher, Walsh McDermott, David L. Bazelon, Paul Freund, H. L. A. Hart, John Rawls, Paul Ramsey, Richard McCormick, Rashi Fein, and Bernard Barber. The text has eight major divisions, beginning with sections on the ethical dimensions of the physician-patient relationship in history; the moral bases of medical ethics; and regulation, compulsion, and protection of the consumer in clinical medicine and public health. Each of these sections includes key essays that appear for the first time. All of the book's major divisions contain primary documents: codes such as the Hippocratic Oath, Medieval Law for the Regulation of Medicine, and the first as well as the most recent code of the American Medical Association; court decisions, including those on Karen Quinlan and on abortion in the United States and West Germany; government documents such as the statement of the National Commission on the Protection of Human Subjects, the Tuskegee Syphilis Report, the British Parliamentary debate on euthanasia, and the Council of Europe on rights of the sick and dying; and various published guidelines such as the Harvard Medical School brain death criteria, the American Hospital Association on patient's rights, and Pope Pius XII on the prolongation of life. Cases that illustrate moral dilemmas are provided for discussion purposes. Each section is preceded by a succinct editor's introduction. The documents and essays are of practical value for practitioners and students in medicine, law, ethics, and counselling, and for individual patients and groups concerned with medical care. Through encompassing divergent viewpoints, the essays and primary documents were selected to encourage humane practices and deepen understanding of the multiple traditions that shaped and do shape the development of medicine. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Convention for Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Biomedicine: Convention on Human Rights and BiomedicineCouncil of EuropePreambleThe Member States of the Council of Europe, the other States and the European Community signatories hereto,Bearing in mind the Universal Declaration of Human Rights proclaimed by the General Assembly of the United Nations on 10 December 1948;Bearing in mind (...) the Convention for the Protection of Human Rights and Fundamental Freedoms of 4 November 1950;Bearing in mind the European Social Charter of 18 October 1961;Bearing in mind the International Covenant on Civil and Political Rights and the International Covenant on Economic, Social and Cultural Rights of 16 December 1966;Bearing in mind the Convention for the Protection of Individuals with Regard to Automatic Processing of Personal Data of 28 January 1981;Bearing also in mind the Convention on the Rights of the Child of 20 November 1989;Considering that the aim of the Council of Europe is the achievement of a greater unity between its members and that one of the methods by which that aim is to be pursued is the maintenance and further realisation of human rights and fundamental freedoms;Conscious of the accelerating developments in biology and medicine;Convinced of the need to respect the human being both as an individual and as a member of the human species and recognising the importance of ensuring the dignity of the human being; [End Page 277]Conscious that the misuse of biology and medicine may lead to acts endangering human dignity;Affirming that progress in biology and medicine should be used for the benefit of present and future generations;Stressing the need for international co-operation so that all humanity may enjoy the benefits of biology and medicine;Recognising the importance of promoting a public debate on the questions posed by the application of biology and medicine and the responses to be given thereto;Wishing to remind all members of society of their rights and responsibilities;Taking account of the work of the Parliamentary Assembly in this field, including Recommendation 1160 (1991) on the preparation of a Convention on bioethics;Resolving to take such measures as are necessary to safeguard human dignity and the fundamental rights and freedoms of the individual with regard to the application of biology and medicine;Have agreed as follows:Chapter IGeneral provisionsArticle 1. (Purpose and object)Parties to this Convention shall protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to the application of biology and medicine.Each Party shall take in its internal law the necessary measures to give effect to the provisions of this Convention.Article 2. (Primacy of the human being)The interests and welfare of the human being shall prevail over the sole interest of society or science.Article 3. (Equitable access to health care)Parties, taking into account health needs and available resources, shall take appropriate measures with a view to providing, within their jurisdiction, equitable access to health care of appropriate quality. [End Page 278]Article 4. (Professional standards)Any intervention in the health field, including research, must be carried out in accordance with relevant professional obligations and standards.Chapter IIConsentArticle 5. (General rule)An intervention in the health field may only be carried out after the person concerned has given free and informed consent to it.This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks.The person concerned may freely withdraw consent at any time.Article 6. (Protection of persons not able to consent)1. Subject to Articles 17 and 20 below, an intervention may only be carried out on a person who does not have the capacity to consent, for his or her direct benefit.2. Where, according to law, a minor does not have the capacity to consent to an intervention, the intervention may only be carried out with the authorisation of his or her representative or an authority or a person or... (shrink)

In this article we examine ethical aspects of the involvement of children in clinical research, specifically those who are incapable of giving informed consent to participate. The topic is, of course, not a new one in medical ethics but there are some tensions in current guidelines that, in our view, need to be made explicit and which need to be responded to by the relevant official bodies. In particular, we focus on tensions between the World Medical Association (...) Declaration of Helsinki, and the guidance offered by the British Medical Association, the Royal College of Paediatrics and Child Health , and the Council for International Organizations of Medical Sciences. We conclude with a call for these organisations to make their guidance explicit in relation to the World Medical Association Declaration. (shrink)

There has been a growing concern over establishing norms that ensure the ethically acceptable and scientifically sound conduct of clinical trials. Among the leading norms internationally are the World Medical Association's Declaration of Helsinki, guidelines by the Council for International Organizations of Medical Sciences, the International Conference on Harmonization's standards for industry, and the CONSORT group's reporting norms, in addition to the influential U.S. Federal Common Rule, Food and Drug Administration's body of regulations, and (...) information sheets by the Department of Health and Human Services. There are also many norms published at more local levels by official agencies and professional groups.Any account of international standards should cover both scientific and ethical norms at once – the two are conceptually intertwined. Recent sources recognize that “[s]cientifically unsound research on human subjects is unethical in that it exposes research subjects to risks without possible benefit.”. (shrink)

Records the papers and commentaries, with an edited discussion, presented at an international consultation convened by the Council for International Organizations of Medical Sciences (CIOMS) to guide revision of the CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. The Guidelines, first issued in 1982 and then revised in 1993, are being updated and expanded to address a number of new and especially challenging ethical issues. These include issues raised by international collaborative (...) trials of drugs in developing countries, especially expensive drugs, and the use of placebo controls in randomized clinical trials. Others arise from the complexity of research in human genetics, including stem-cell research, and in reproductive biology. Throughout, particular attention is given to the difficult questions that arose during the heated debate over trials in developing countries, of short-duration zidovudine (AZT) therapy to reduce perinatal transmission of HIV. The International Ethical Guidelines for Biomedical Research Involving Human Subjects set out a code of research ethics that is widely used by ethical review committees and other bodies responsible for reviewing and overseeing the ethical design of studies and conduct of research. The revision of the Guidelines is being coordinated by CIOMS, in collaboration with WHO. The consultation centered on seven specially commissioned papers, authored by international experts that explore some of the more difficult issues in depth. Each is followed by an invited commentary, often expressing opposing views, and a summary of the issues or conclusions that emerged during the subsequent debate. The first paper, on justice in international research, deals with the question of whether proposals for research to be conducted in a developing country should make provision for future access of the population involved to the interventions under investigation. Also considered are questions that arise when research uses populations in developing countries to investigate interventions that will be of exclusive benefit to the industrialized world. Case studies of recent drug trials and their research protocols are discussed to illustrate circumstances in which use of populations in developing countries is justified or constitutes exploitation. Ethical challenges of the randomized controlled trial are considered in the second paper, which includes a discussion on the equitable distribution of benefits and risks, the use of placebo for controls, and the obligation to ensure that the participation of controls does not compromise their medical care or endanger their health. A paper on informed consent in international health research considers how cultural factors influence communication and language in the informed-consent process and respect for privacy and confidentiality in the research. Subsequent papers address issues in genetics research and reproductive biology, including the moral status of fetuses and the use of embryos in research, and examine the contribution which international human rights instruments can make in the application of the general principles of ethics to research involving human subjects. The final paper gives an overview of capacity building and the role of communities in international biomedical research. (shrink)

Background Research ethics guidelines are essential for conducting medical research. Recently, numerous attempts have been made to establish national clinical research documents in the countries of the Middle East. This article analyzes these documents. Methods Thirteen Arab countries in the Middle East were explored for available national codes, regulations, and guidelines concerning research ethics, and 10 documents from eight countries were found. We studied these documents, considering the ethical principles stated in the Declaration of Helsinki, the (...) class='Hi'>Council for International Organizations of Medical Sciences (CIOMS) guidelines, and the International Conference of Harmonization - Guidelines for Good Clinical Practice (ICH-GCP). Our paper comprises a complete list of protections, such as confidentiality, informed consent, ethics committees, and others. Results This study found different levels and kinds of research ethics regulations and guidelines in the countries examined. Two groups can be distinguished: the countries in the first group have one or more research ethics regulations or guidelines, while the countries in the second group have not yet established any. Most of the documents showed various degrees of deficiencies in regard to ethical protection. The majority of the documents that were examined refer to one or more international documents on biomedical research ethics. Conclusions Recently, a lot of efforts have been made in many countries in the Middle East. However, compared with international documents, most of the research ethics documents in use in this region demonstrate numerous deficiencies. As it relates to these documents, extensive differences could be observed in regard to development, structure, content, and reference to international guidelines. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 13.1 (2003) 53-64 [Access article in PDF] Incentives for Providing Organs Patricia Milmoe McCarrick and Martina Darragh After a contentious debate at its 2002 annual meeting, the American Medical Association's House of Delegates voted to endorse the opinion of its Council on Ethical and Judicial Affairs that the impact of financial incentives on organ donation should be studied (Josefson 2002). The (...) shortage of organs for transplantation has been an ongoing problem for more than 20 years. In June1981, Representative Philip Crane (R-IL) introduced legislation in the U.S. House of Representatives proposing a $25,000 income tax deduction and a $25,000 estate tax exclusion for donating an organ (Tax Incentives 1981). Still the National Organ Transplant Act enacted in October 1984 prohibited the offering of any "valuable consideration" in return for organs (United States 1984).The developments of a legal market for tissues in the United States and a black market for organs around the world have raised the question of whether donation without compensation is the only ethically viable option. Some critics of the current system claim reliance on donation actually promotes a black market in organs (Kaserman and Barnett 2002, p. 38; Palmer 1999, p. 36). In addition, a new set of compensation issues has arisen as living kidney donor transplantations begin to rival those performed with cadaveric organs (United States 2001).As a result, current suggestions for incentives go far beyond the traditional death benefit payment to include such ideas as medals of honor for donors, reimbursement for funeral expenses, exchange programs for organ donation, and special medical insurance for living organ donors. Numerous bills introduced into the 107th Congress have proposed such incentives (Delmonico et al. 2002.) In October 2002, the U.S. Department of Health and Human Services awarded $5.2 million in grants to study both clinical and behavioral interventions for increasing organ donations that do not involve incentives. The inspiration for some of the funded proposals comes from the successes of Spain's social services and the United Kingdom's clinical administration of organ procurement programs (Robeznieks 2002). [End Page 53]With a nod to evidence-based medicine, the underlying concern expressed in much of the current literature is that no idea for increasing the supply of organs should be discounted before it is studied. This bibliography provides a short introduction to the range of opinions expressed on the issue of incentives for providing organs.al-Mousawi, M.; Samhan, M.; al-Mezairee I.; Razzak, M.A.; and Khawari, F. Cadaver Organ Procurement in Kuwait. Transplantation Proceedings 31 (8): 3375-76, 1999.The authors describe a protocol that significantly increased cadaveric organ donation and credit it with fostering the expansion of an organ sharing program among the Arab Gulf states. Developed by Kuwaiti neurologists and anesthetists after a continuing education course on transplantation, the protocol places a special emphasis on the role of local transplant coordinators who facilitate the investigation of brain death cases by neurologists.Arnold, Robert; Bartlett, Steven; Bernat, James; et al. [Ethics Committee of the American Society of Transplant Surgeons] Financial Incentives for Cadaver Organ Donation: an Ethical Reappraisal. Transplantation 73 (8): 1361-67, 27 April 2002.To prepare for proposed studies of financial incentives for organ donation, the American Society of Transplant Surgeons convened a panel to develop a methodology for evaluating the ethics of such research. Comprised of organ procurement organization executives, physicians, surgeons, and ethicists, the panel generated a list of nine criteria for use in judging any incentives proposal. While opposed to direct payment or tax incentives for organ donation, a majority of the members support funeral expense reimbursement or charitable contributions as incentives that would not violate or undermine the ideal of altruism.Cameron, J. Stewart, and Hoffenberg, Raymond. The Ethics of Organ Transplantation Reconsidered: Paid Organ Donation and the Use of Executed Prisoners as Donors. Kidney International 55 (2): 724-32, February 1999.After reviewing arguments for and against payment for organ procurement, the authors apply these arguments to the specific case of obtaining organs from executed... (shrink)

This baseline study was conducted to find out the knowledge, attitudes and practices of medical ethics among the undergraduate medical interns who did not have structured ethics curriculum in their course. A descriptive, cross-sectional study was carried out using a self-administered structured questionnaire among the medical undergraduate interns of Maharajgunj Medical Campus, the pioneer medical college of Nepal which enrols 60 students in a year. A total of 46 interns participated in the study. (...) The most common source of knowledge on ethics was lectures/seminars (35.7%) followed by experience at work (24.5%), training (21.4%) and own reading (17.3%). The main contents of Hippocratic Oath were known to 98.8% while 60.9% knew the main contents of Nepal Medical Council (NMC) code of ethics. Great majority (91.3%) regard ethics as very important in medical profession. “Doctors know the best irrespective of patients’ opinion” was disagreed by only 39.1% indicating the paternalistic attitude. However, 78.3% were in favour of adhering to the patient’s wish. None of the participant agreed to abandon confidentiality. Only about one-fourth (26.1%) claim to encounter ethical dilemma every day while the highest number (43.5%) had once in a month. To deal with the situation of ethical dilemma, majority approached to immediate supervisor followed by head of the department and colleagues. Eighty-seven percent of participating interns were involved in research activities involving human subjects. Only one of the participants had encountered the ethical issue on end-of-life and it was do-not-resuscitate consent in a terminally ill patient. On implementation of the curriculum on medical ethics focus should be - principles of biomedical ethics, sensitive ethical dilemmas like end-of-life care and practical experiences with participation in deliberations of the ethics committee. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:A Brief History of Medical Ethics Code in PolandJacek A. Piątkiewicz (bio)On March 15, 1934 a Parliamentary Act authorized the General Medical Chambers, a body incorporating all Polish physicians, to establish general rules of medical ethics. These rules governed medical conduct in Poland until 1950, when the Communist government dissolved the General Medical Chambers.From 1950 to 1989 the only medical organization (...) in Poland tolerated by the Communist government was the Polish Medical Association, which included about 30% of the country's physicians. In 1967 this group produced the "Collection of Ethico-deontological principles of the Polish Physician" which constituted a kind of code of medical ethics. This collection was a compromise between objective ethical principles and the demands of the Communist regime. For example, Principle 1 of the Collection stated that the physician "had to observe the ethico-deontological principles obligatory in socialist society."During round-table talks in early 1989 with representatives of the Communist government, the Solidarity movement argued for the revival of autonomous medical organizations like the Medical Chambers. On May 17, 1989 an Act of Parliament re-established the group. The Act (article 33, part 1) also stipulated that the National Congress of Physicians, the legislative body of Medical Chambers, establish rules of medical ethics. The Act (article 15, part 1) also states that all practicing Polish physicians are obliged to observe these rules.When the revived Chambers began its work in January 1990, its governing body—the General Medical Council—created a Commission to prepare a draft of a medical ethics code. After a year and a half of work, the Commission completed its draft, which received preliminary acceptance by the General Medical Council. [End Page 361]On December 13-14, 1991 the Extraordinary Second National Congress of Physicians was held in Bielsko-Biala (South Poland) and one of the main items on the agenda was the Code. Every article of the Code was discussed exhaustively throughout the second day of the meeting, and close to midnight the Code, including the Physician' Oath, was approved by an overwhelming majority (449 for, 75 against, 58 abstaining).Some of the liveliest discussion centered on Article 37, which relates to abortion. The delegates realized that the Code was inconsistent with a 1956 Act on abortion then under discussion in the Parliament which was not as restrictive as the Code. They decided to defer implementation of the Code for five months, until May 3, 1992. As described in the following text by Robert Baker, Article 37 has now been appealed and a decision resolving the discrepancy would have to come from Poland's Constitutional Tribunal or its Parliament. [End Page 362]Jacek A. Piątkiewicz Jacek A. Piątkiewicz, M.D., Ph.D., is Chairman of the Legislative Commission of the General Medical Council of Poland in Warsaw.Copyright © 1993 The Johns Hopkins University Press... (shrink)

In November 2016, the Council for International Organizations of Medical Sciences published its revised International Ethical Guidelines for Health-related Research Involving Humans. In relation to earlier versions, the scope of the new guidelines has been expanded to include public-health research. While successful to some extent, the document does not take into sufficient account the differences between public-health research and other types of health research. It is silent on some issues of importance to public-health research, such (...) as its definition, health inequities and novel research methodologies. Its treatment of some other issues, including the need for researchethics committee approval, consent, community involvement and dissemination of research results, are deficient in some respects. The guidelines that are particularly applicable to and useful for public-health research deal with social value, the health needs of communities and populations, community engagement, disasters and disease outbreaks, cluster randomised trials and data sharing. Much further development of the foundations and applications of public-health research ethics is needed to inform future revisions of the guidelines and of other international and national research-ethics documents. (shrink)

Today, the earth is an interconnected globe humming with electronic transmissions-a chattering planet nestled in the provident silence of space. The ethical question is whether this is contributing to authentic human development and helping individuals and peoples to be true to their transcendent destiny. The new media are powerful tools for education, cultural enrichment, commercial activity, political participation, intercultural dialogue and understanding. They also can serve the cause of religion. Yet the new information technology needs to be informed and guided (...) by solidarity in the service of the common good bridging the digital divide within and among nations. The value-laden message of Western secular culture to people and traditional societies in many cases ill-prepared to evaluate it leads to widespread crisis, for example, in regard to marriage and family life. This technology can be a means for solving human problems, promoting the integral development of persons, creating a world governed by justice, peace, and love. It also can help men and women in their age-old search for self-understanding. Like today's world itself, the world of media, including the Internet, has been brought by Christ, inchoately yet truly, within the boundaries of the kingdom of God and placed in service to the word of salvation. (shrink)

In 2006, the Indian Council of Medical Research (ICMR) published its ‘Ethical guidelines for Biomedical Research on human participants’. The intention was to translate international ethical standards into locally and culturally appropriate norms and values to help biomedical researchers in India to conduct ethical research and thereby safeguard the interest of human subjects. Unfortunately, it is apparent that the guideline is not fit for purpose. In addition to problems with the structure and clarity of the guidelines, there (...) are several serious omissions and contradictions in the recommendations. In this paper, we take a close look at the two key chapters and highlight some of the striking flaws in this important document. We conclude that ethics committees and national authorities should not lose sight of international ethical standards while incorporating local reality and cultural and social values, as focusing too much on the local context could compromise the safety of human subjects in biomedical research, particularly in India. (shrink)

Several influential ethical guidelines and frameworks endorse the view that research with human participants is ethically acceptable only when it has “social value,” meaning that it generates knowledge which can be used to benefit society. For example, the Nuremberg Code requires that medical experiments on human beings “yield fruitful results for the good of society, unprocurable by other methods or means of study”. The Council for International Organizations of Medical Sciences guidelines hold that “health-related research (...) with humans... must have social value” or the “prospect of generating the knowledge and the means necessary to protect and promote people’s health” (CIOMS... (shrink)

In exploring the concept of vulnerability, we do not begin with a blank slate. In research involving human subjects, ethics guidelines typically provide a rough definition of the concept. For example, the commentary on Guideline 13 in the International Ethical Guidelines for Biomedical Research Involving Human Subjects, issued by the Council for International Organizations of Medical Sciences (CIOMS), says that "vulnerable persons are those who are relatively (or absolutely) incapable of protecting their own interests. (...) More formally, they may have insufficient power, intelligence, education, resources, strength, or other needed attributes to protect their own interests" (CIOMS 2002). Because the CIOMS guidelines .. (shrink)

One of the key ethical requirements for biomedical research is that it have an acceptable risk-benefit profile (Emanuel, Wendler, and Grady 2000). The International Conference of Harmonization guidelines mandate that clinical trials should be initiated and continued only if “the anticipated benefits justify the risks” (1996). Guidelines from the Council for International Organizations of Medical Sciences state that biomedical research is acceptable only if the “potential benefits and risks are reasonably balanced” (2002). U.S. federal regulations (...) require that the “risks to subjects” be “reasonable in relation to anticipated benefits, if any, to subjects and the importance of the knowledge” to be gained from the .. (shrink)

Different ethical principles conflict in research conducted in emergency research. Clinical care and its development should be based on research. Patients in critical clinical condition are in the greatest need of better medicines. The critical condition of the patient and the absence of a patient representative at the critical time period make it difficult and sometimes impossible to request an informed consent before the beginning of the trial. In an emergency, care decisions must be made in a short period of (...) time, and the more time is wasted, the more the risk of death or severe tissue damage and incapacity increases. Consent requests take time, and so the time period before treatment might put the patient’s life in jeopardy. Not requesting consent before a trial is also contradictory. A person should not be forced to participate in a trial against his or her will. Due to the dark history of medical research previously, international declarations and conventions have set up ethical principles for medical research. They emphasize the autonomy of the research participant—or his or her legal representative—to give a free and informed consent prior to the initiation of research. In the case of a critical emergency, the unconscious state of the patient, the emotional stress of family members or the lack of time to start life-sustaining measures may often restrict the possibilities of communicating with the patient or his/her representative. Therefore, written informed consent is difficult to achieve, and its voluntariness in emergency situations is, at best, open to question. The mortality of patients is high without clinical interventions in emergency research. Random selection of patients is difficult and requires extra work from personnel in the emergency rooms. Recruitment, information and asking for consent may also take time, postpone the initiation of treatment and increase the risk of death and irreversible tissue and organ damage, and therefore be risky for the patient. It is therefore essential that the health care professionals recruiting suitable research participants are well motivated and well trained. Medical research in an emergency setting should always be regarded as an exceptional situation requiring special provisions. Only such research should be done as cannot be done in other conditions. An independent body must approve the research protocol and the ways in which the consent of the participant or proxy are to be sought. In addition, the trial must be expected to result in direct and significant benefit for the research participants. If research without prior consent is not approved, the development of emergency care is threatened. On the other hand, if prior consent is not required, a person could be recruited into a clinical trial against his or her will. Doing good and avoiding harm, and respecting the autonomy of the patient are in conflict in the context of emergency medical research. To develop better medicines for patients experiencing acute medical emergencies, research into such conditions should be allowed. Research participants should have the possibility to participate or refuse to participate in research that may benefit them and other patients. The risk of irreversible damage occurring as the consequence of time delays for seeking consent is unacceptable. A prior wish about participation in clinical trials should be respected, if known. The conditions under which medical research in emergencies can be considered acceptable can be determined and agreed upon nationally and internationally. (shrink)

Monrad JT. Ethical considerations for epidemic vaccine trials. J Med Ethics 2020;46:465–9. doi:10.1136/medethics-2020-106235 This ….

We consider the implications for the ethical evaluation of research programs of two fundamental changes in the revised research ethical guideline of the Council for International Organizations of Medical Sciences. The first is the extension of scope that follows from exchanging “biomedical” for “health‐related” research, and the second is the new evaluative basis of “social value,” which implies new ethical requirements of research. We use the example of antibiotic resistance interventions to explore the need to consider (...) the instances of what we term the pragmatic risks of such interventions to evaluate the social value of certain kinds of health‐related research. These (pragmatic) risks severely threaten the social value of interventions in every area where human and social responses significantly impact on their effectiveness. Thus, the social value of health‐related research needed to demonstrate its effectiveness depends on the extent and successful management of such risks. Research designed to take into account the management of pragmatic risks also gives rise to similar types of risks, and the potential for social value in light of those risks needs to be considered in ethical reviews based on the new guidelines. We argue that, to handle this new expanded task, the international system of research ethical review addressed by the guidelines needs institutional development. (shrink)

We thank our commentators for their thoughtful responses to our paper 1 covering among other issues the relationships of ethics law and professional codes, the tensions between ethical universalism and cultural relativism and the phenomenon of moral judgement required when ethical norms conflict, including the norms of patient care versus obligations to others both now and in the future. Although the comments deserve more extensive discussion, in what follows we respond briefly to specific aspects of each commentary and remind (...) readers that professional codes of ethics are necessarily brief and that the International Code of Medical Ethics (ICoME) explicitly refers to the World Medical Association’s (WMA) mutually concordant and far more extensive ‘body of policies’. 2 Should ethics shape law or vice versa? Sarela raises a fundamental and, as stated in the commentary, unresolved debate: ‘should ethics shape law or is it the converse’? 3... (shrink)

SETTING: Medical ethics education has become common, and the integrated ethics curriculum has been recommended in Western countries. It should be questioned whether there is one, universal method of teaching ethics applicable worldwide to medical schools, especially those in non-Western developing countries. OBJECTIVE: To characterise the medical ethics curricula at Asian medical schools. DESIGN: Mailed survey of 206 medical schools in China, Hong Kong, Taiwan, Korea, Mongolia, Philippines, Thailand, Malaysia, Singapore, Indonesia, (...) Sri Lanka, Australia and New Zealand. PARTICIPANTS: A total of 100 medical schools responded, a response rate of 49%, ranging from 23%-100% by country. MAIN OUTCOME MEASURES: The degree of integration of the ethics programme into the formal medical curriculum was measured by lecture time; whether compulsory or elective; whether separate courses or unit of other courses; number of courses; schedule; total length, and diversity of teachers' specialties. RESULTS: A total of 89 medical schools (89%) reported offering some courses in which ethical topics were taught. Separate medical ethics courses were mostly offered in all countries, and the structure of vertical integration was divided into four patterns. Most deans reported that physicians' obligations and patients' rights were the most important topics for their students. However, the evaluation was diverse for more concrete topics. CONCLUSION: Offering formal medical ethics education is a widespread feature of medical curricula throughout the study area. However, the kinds of programmes, especially with regard to integration into clinical teaching, were greatly diverse. (shrink)

Summary Principles Timely support for patients and people close to them, and effective, sensitive communication are essential. Decisions must be based on the individual patient's circumstances and reviewed regularly. Sensitive advance discussion should always be encouraged, but not forced. Information about CPR and the chances of a successful outcome needs to be realistic. Practical matters Information about CPR policies should be displayed for patients and staff. Leaflets should be available for patients and people close to them explaining about CPR, how (...) decisions are made and their involvement in decisions. Decisions about attempting CPR must be communicated effectively to relevant health professionals. In emergencies If no advance decision has been made or is known, CPR should be attempted unless: the patient has refused CPR; the patient is clearly in the terminal phase of illness; or the burdens of the treatment outweigh the benefits. Advance decision making Competent patients should be involved in discussions about attempting CPR unless they indicate that they do not want to be. Where patients lack competence to participate, people close to them can be helpful in reflecting their views. Legal issues Patients' rights under the Human Rights Act must be taken into account in decision making. Neither patients nor relatives can demand treatment which the health care team judges to be inappropriate, but all efforts will be made to accommodate wishes and preferences. In England, Wales and Northern Ireland relatives and people close to the patient are not entitled in law to take health care decisions for the patient. In Scotland, adults may appoint a health care proxy to give consent to medical treatment. Health professionals need to be aware of the law in relation to decision making for children and young people.IntroductionWhy policies are neededCardiopulmonary resuscitation can be attempted on any person whose cardiac or respiratory functions cease. Failure of these functions is part of dying and thus …. (shrink)

We write in response to the original article by Rennie and Rudland published in the April 2003 edition of this journal.1 Current and former Dundee Medical School students are concerned at the media misinterpretation of the study and the consequences that this branding of “dishonesty” will have on Dundee Medical School’s reputation and also on individuals embarking on their ….

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 14.4 (2004) 411-425 [Access article in PDF] Vulnerability, Vulnerable Populations, and Policy Mary C. Ruof "Special justification is required for inviting vulnerable individuals to serve as research subjects and, if they are selected, the means of protecting their rights and welfare must be strictly applied."Guideline 13: Research Involving Vulnerable Persons International Ethical Guidelines for Biomedical Research Involving Human Subjects Council for (...) International Organizations of Medical Sciences (CIOMS) and World Health Organization (WHO) Geneva, Switzerland, 2002 Within medical research and healthcare certain groups are afforded special protections and services because of their designation as vulnerable. The vulnerable require special justification to participate in human subject research in order to eliminate potential human rights abuses. The Nuremberg Code of 1947 was written in response to the extreme human subject abuses that occurred under the Nazi regime, and, although the intent of the 1947 Code was to protect human rights, rigid voluntary consent requirements deprived some individuals of the right to participate in clinical trials. Recent human research guidelines, such as the CIOMS/WHO guidelines referenced above and the guidelines referenced in Section V of this Scope Note, attempt to balance both protection from abuse in research and access to new, experimental treatments for the vulnerable.Although various protective guidelines stipulate special protections for vulnerable populations, the concept of vulnerability and consequently the criteria designating vulnerable populations remain vague. Precisely who are the vulnerable? The word "vulnerability" stems from the Latin vulnerare, "to wound." (Oxford Encyclopedic English Dictionary 1995). In clinical research, the term [End Page 411] vulnerable generally is applied to individuals who are unable to give informed consent or who are susceptible to coercion. The Common Rule (45 CFR 46, Subpart A) includes as vulnerable research subjects: children, prisoners, pregnant women, and persons who are handicapped, mentally disabled, economically disadvantaged, or educationally disadvantaged. Although the Common Rule specifies certain vulnerable categories, the guidelines were not intended to be exclusive, leaving open the interpretation of vulnerability.In medical research and health policy, vulnerability is an abstract concept that has concrete effects both for those labeled vulnerable and for those not. Clinical researchers, healthcare workers, ethical reviewers, and policymakers must be able to identify vulnerable subjects to establish how healthcare resources will be allocated and who will qualify for special protections and socialized benefits. Attempts to quantify vulnerability in clear, measurable ways have met little if any consensus. As Alexander Morawa (II, 2003, p. 150) states, "There is no single approach to definition of vulnerability. In fact, there is no purposeful categorisation at all."Difficulties in defining vulnerability have prompted discourse surrounding its utility as a qualifying factor in the allocation of health resources and its appropriateness as a guiding principle in bioethics. Some of the authors cited in this Scope Note argue against the labeling and categorization of vulnerable individuals and populations. "Labeling individuals as 'vulnerable' risks viewing vulnerable individuals as 'others' worthy of pity, a view rarely appreciated" (III, Danis and Patrick 2002, p. 320). The categories of vulnerable groups listed under the Common Rule have been the source of controversy, "for example, many find the suggestion that pregnant women are vulnerable to be quite sexist" (IV, DeBruin 2001, p. 7). Instead of creating categories of vulnerable populations, would it not be better to derive an account of just treatment from a just social policy at large that encompasses human vulnerabilities (II, Brock 2002, p. 283).For some of the authors listed here, the concept of vulnerability is essential to bioethics. Robert Goodin (I, 1985, p. 107) writes that the vulnerability of other human beings is the source of our special responsibilities to them. In contrast to the four American principles of biomedical ethics—autonomy, nonmaleficence, beneficence, and justice—the four principles of European bioethics and biolaw include vulnerability along with autonomy, dignity, and integrity. According to, Jacob Dahl Rendtorff and Peter Kemp (I, 2000, p. 274) "the principle of vulnerability is ontologically prior to the other [European] principles, it expresses better than all of the other ethical principles... the finitude of the human condition."Some of the... (shrink)

Health‐related data uses and data sharing have been in the spotlight for a while. Since the beginning of the big data era, massive data mining and its inherent possibilities have only increased the debate about what the limits are. Data governance is a relevant aspect addressed in ethics guidelines. In this context, the European project BRIDGE Health (BRidging Information and Data Generation for Evidence‐based Health policy and research) strove to achieve a comprehensive, integrated and sustainable EU health‐information system. One (...) of the aims of the project was to evaluate the requirements to construct a data‐linkage infrastructure for the secure management of health information. In a blueprint provided for this infrastructure, the topics ethics and the intimately related governance occupied a whole section, where the recent ethics guidelines by the Council for International Organizations of Medical Sciences (CIOMS) and the World Medical Association (WMA) were referenced. We explore what has changed in the latest versions of the ethics documents adopted by CIOMS and WMA regarding the management of health data and human tissues, the appropriateness of their application in new forms of research and infrastructures as the proposed in the BRIDGE Health project, and whether society should be so concerned about this topic, in the digital era of social exchange. (shrink)

Background. Responsible clinical research drives the advancement of healthcare. Despite tremendous improvements in the globalresearch and development environment since the 1950s, low- and middle-income countries (LMICs) are often left behind. There are several reasons for this. Firstly, operational, social, ethical and regulatory challenges in LMICs make it difficult for researchers to conduct clinical studies in those settings in line with international requirements. Secondly, many people living in low-resource settings distrust research because some past studies have not benefited the participants (...) or the communities involved.Objectives. To present the consensus recommendations by a Council for International Organizations of Medical Sciences (CIOMS) Working Group on how to advance good-quality, ethical clinical research in resource-limited settings.Methods. CIOMS convened a Working Group of senior scientists from drug regulatory authorities, the pharmaceutical industry, publicprivate partnerships for product development, and academia.Results. This article summarises the Working Group’s report.Conclusion. The report recommendations can foster the creation of a more enabling ecosystem for clinical research and promotecollaboration between policymakers, regulators, researchers and funders. (shrink)

The Fifth International Congress of Logic, Methodology and Philosophy of Science was held at the University of Western Ontario, London, Canada, 27 August to 2 September 1975. The Congress was held under the auspices of the International Union of History and Philosophy of Science, Division of Logic, Methodology and Philosophy of Science, and was sponsored by the National Research Council of Canada and the University of Western Ontario. As those associated closely with the work of the Division (...) over the years know well, the work undertaken by its members varies greatly and spans a number of fields not always obviously related. In addition, the volume of work done by first rate scholars and scientists in the various fields of the Division has risen enormously. For these and related reasons it seemed to the editors chosen by the Divisional officers that the usual format of publishing the proceedings of the Congress be abandoned in favour of a somewhat more flexible, and hopefully acceptable, method of pre sentation. Accordingly, the work of the invited participants to the Congress has been divided into four volumes appearing in the University of Western Ontario Series in Philosophy of Science. The volumes are entitled, Logic, Foundations of Mathematics and Computability Theory, Foun dational Problems in the Special Sciences, Basic Problems in Methodol ogy and Linguistics, and Historical and Philosophical Dimensions of Logic, Methodology and Philosophy of Science. (shrink)

The objective of this study was to review the design and delivery of medical ethics education within medical programs across Australia and New Zealand, how current teaching has been informed by the proposed core curriculum published in 2001 by the ATEAM and how it could look moving forward. We conducted a mixed methods study using an online questionnaire consisting of 51 items. This included both binary and open-ended questions to categorise and explore similarities and differences in (...) class='Hi'>medical ethics curricula in medical programs accredited by the Australian Medical Council across ANZ. Participants were asked about curriculum design format, duration, goals, assessments, content areas of their own ME curriculum. Convenors from 18 universities responded. The main commonality was that ME curricula were integrated both longitudinally and laterally with other content. There was also commonality in content areas addressed. The goals, format, educators, and assessments of the ME curricula were highly variable. Most respondents described a curriculum which prioritised knowledge and skill development related to ME. Although the core goals of including knowledge, skills, and attitudinal development in ME curricula are still present, there is no uniformity in terms of format, delivery, or assessment across medical programs in ANZ. This is an area for collaborative development. (shrink)

Developing countries face numerous barriers to conducting effective and efficient ethics reviews of international collaborative research. In addition to potentially overlooking important scientific and ethical considerations, inadequate or insufficiently trained ethics committees may insist on unwarranted changes to protocols that can impair a study's scientific or ethical validity. Moreover, poorly functioning review systems can impose substantial delays on the commencement of research, which needlessly undermine the development of new interventions for urgent medical needs. In response to (...) these concerns, the Drugs for Neglected Diseases Initiative, an independent nonprofit organization founded by a coalition of public sector and international organizations, developed a mechanism to facilitate more effective and efficient host country ethics review for a study of the use of fexinidazole for the treatment of late stage African Trypanosomiasis. The project involved the implementation of a novel ‘pre-review’ process of ethical oversight, conducted by an ad hoc committee of ethics committee representatives from African and European countries, in collaboration with internationally recognized scientific experts. This article examines the process and outcomes of this collaborative process. (shrink)

The Institute of Medicine (IOM) Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research published its report in 2006. It was charged with developing an ethical framework for the conduct of research with prisoners and identifying the safeguards and conditions necessary to ensure that research with prisoners is conducted ethically. The recommendations contained in the IOM report differ from current European regulations in several ways, some being more restrictive and some less so. For (...) example, the IOM report suggests limiting the percentage of prisoners that should be involved in a biomedical study to 50%, a limit that does not exist in Europe. However, the report does not specifically advise against research without a direct benefit to an individual prisoner: the European regulations are more restrictive than the IOM committee recommendations in this respect. The definition of minimal risk varies, as well as the proposed role of the minimal risk requirement and of the principle of subsidiarity (research that can only be done effectively in prisons). The IOM report proposes a number of thoughtful suggestions, which it would be beneficial to implement everywhere, such as registers of research on prisoners. The European regulations offer pragmatic solutions to several thorny issues. In summary, the IOM committee report represents an admirable effort to tackle the present inconsistencies and deficiencies of federal regulations in the US on research on prisoners (45 CFR 46 Subpart C). Nonetheless, before acting on the recommendations, US regulators might consider revisiting international guidelines such as those published by the Council for International Organizations of Medical Science (CIOMS) and the Declaration of Helsinki. (shrink)

The Research Excellence Framework of the Higher Education Funding Council for England is taking place in 2013, its three key elements being outputs, impact, and “quality of the research environment”. Impact will be assessed using case studies that “may include any social, economic or cultural impact or benefit beyond academia that has taken place during the assessment period.”1 Medical ethics in the UK still does not have its own cognate assessment panel—for example, bioethics or applied ethics—unlike (...) in, for example, Australia. Several researchers in medical ethics have reported to the Institute of Medical Ethics that during the internal preliminary stage of the Research Excellence Framework several medical schools have decided to include only research that entails empirical data gathering. Thus, conceptual papers and ethical analysis will be excluded. The arbitrary exclusion of reasoned discussion of medical ethics issues as a proper subject for medical research unless it is based on empirical data gathering is conceptually mistaken. “Empirical ethics” is, of course, a legitimate component of medical ethics research, but to act as though it is the only legitimate component suggests, at best, a partial understanding of the nature of ethics in general and medical ethics in particular. It also mistakenly places medicine firmly on only one side of the science/humanities “two cultures” divide instead of in its rightful place bridging the divide. Given the emphasis by the General Medical Council on medical ethics in properly preparing “tomorrow’s doctors,” we urge medical schools to find a way of using the upcoming Research Excellence Framework to highlight the expertise residing in their ethicist colleagues. We are confident that appropriate assessment will reveal work of high quality that can be shown to have social and cultural impact and benefit beyond academia, as required by the framework. (shrink)

ABSTRACT The Institute of Medicine (IOM) Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research published its report in 2006. It was charged with developing an ethical framework for the conduct of research with prisoners and identifying the safeguards and conditions necessary to ensure that research with prisoners is conducted ethically. The recommendations contained in the IOM report differ from current European regulations in several ways, some being more restrictive and some less so. (...) For example, the IOM report suggests limiting the percentage of prisoners that should be involved in a biomedical study to 50%, a limit that does not exist in Europe. However, the report does not specifically advise against research without a direct benefit to an individual prisoner: the European regulations are more restrictive than the IOM committee recommendations in this respect. The definition of minimal risk varies, as well as the proposed role of the minimal risk requirement and of the principle of subsidiarity (research that can only be done effectively in prisons). The IOM report proposes a number of thoughtful suggestions, which it would be beneficial to implement everywhere, such as registers of research on prisoners. The European regulations offer pragmatic solutions to several thorny issues. In summary, the IOM committee report represents an admirable effort to tackle the present inconsistencies and deficiencies of federal regulations in the US on research on prisoners (45 CFR 46 Subpart C). Nonetheless, before acting on the recommendations, US regulators might consider revisiting international guidelines such as those published by the Council for International Organizations of Medical Science (CIOMS) and the Declaration of Helsinki. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Religious Perspectives on Bioethics, Part ILaura Jane Bishop (bio) and Mary Carrington Coutts (bio)This is Part One of a two part Scope Note on Religious Perspectives on Bioethics. Part Two will be published in the December 1994 issue of this Journal. This Scope Note has been organized in alphabetical order by the name of the religious tradition.Contents for Parts 1 and 2Part 1Part 2I.GeneralI.Native AmericanII.African Religious TraditionsReligious TraditionsIII.Bahá'í FaithII.Protestantism—willIV.Buddhism (...) and Confucianisminclude a general sectionV.Eastern Orthodoxyand sections focused onVI.Hinduismspecific denominations.VII.IslamIII.Roman CatholicismVIII.JainismIX.JudaismIntroductionThe many religions of the world bring diverse, and occasionally divergent, attitudes to bioethical issues. These beliefs may guide patients and health care professionals as they seek or provide health care. In an attempt to facilitate understanding of and access to information about these beliefs in our pluralistic and global society, this Scope Note identifies literature by the world's major religious groups on topics relating to bioethics.Topics covered by this Scope Note include general attitudes to health and [End Page 155] health care, the physician-patient relationship, treatment refusal, abortion, contraception, sterilization, reproductive technologies, genetics, mental health, human experimentation, organ transplantation and donation, death, euthanasia, suicide, and prolongation of life. Material was not available on all of these topics for each religion.The literature gathered here represents only a small portion of the available writing on religion and medicine, and is limited to that which comments explicitly on bioethical issues. Some faiths have a rich tradition of writing in bioethics; for others the literature is more limited. Variation in coverage is not intended to indicate the relative importance of a faith, but reflects accessibility and space constraints. Individuals interested in obtaining additional information are encouraged to contact the National Reference Center for Bioethics Literature.Specific citations about a region or country were chosen because of the predominance of a religious tradition within the population. In all cases, variation in spelling represents author usage. This Scope Note treats only the literature published in English, and every attempt has been made to identify English language sources for these faiths.It is important to remember that doctrinal and theological differences exist even within the same denomination and that views of individual patients, family members, and health care providers should be sought.Dictionaries and EncyclopediasMelton, J. Gordon, ed. Encyclopedia of American Religions. Fourth edition. Detroit: Gale Research, 1993. 1217 p. Basic information about the history, sacred texts, membership, educational facilities, publications, and North American addresses are provided for 1,730 churches, denominations, sects, and cults. Bibliographies for many faiths supplement this extensive resource.Reich, Warren T., ed. Encyclopedia of Bioethics. New York: Free Press, Macmillan, 1978. 4 volumes. Articles on all the major religions as they relate to bioethics are included in this highly-regarded encyclopedia. In addition, many of the topical essays feature a section on the views of various faiths on the topic under discussion. For the best use of the Encyclopedia, see the subject index in volume 4. (Note: a revised, second edition is due to be published by Macmillan in late 1994.)GeneralAmerican Psychiatric Association. Committee on Religion and Psychiatry. Guidelines Regarding Possible Conflict Between Psychiatrists' Religious Commitment and Psychiatric Practice. American Journal of Psychiatry 147 (4): 542, April 1990. The American Psychiatric Association recommends that psychiatrists respect their patients' religious beliefs and that they not impose their own [End Page 156] beliefs on their patients.Bankowski, Z., and Bryant, J. H. Health Policy, Ethics and Human Values: Proceedings of the XVIIth CIOMS Round Table Conference, Athens Greece. Geneva: Council for International Organizations of Medical Sciences, 1985. 336 p. Many sections of this volume address issues where religion impacts health policymaking. Africa, the Middle East, Europe, Latin America, and Asia are highlighted for the varied ways in which their religions and cultures are integrated into the provision of health care.Batchelor, Edward, ed. Abortion: The Moral Issues. New York: Pilgrim Press, 1982. 246 p. Batchelor compiles a collection of essays by experts on religious ethics as they relate to abortion. Includes... (shrink)

A recent joint study by the Council of Europe and the United Nations focused on the criminality surrounding organ donations. Published in October 2009, it points out the various violations of the international prohibition on the trafficking of organs. This paper will first analyze this study and then contextualize it in the current discourse about organ donation in the Philippines. Finally, the issue of organ donation will be put in the wider discourse of justice in organ transplantation.Organ donation (...) and trafficking are much debated issues in medical ethics. This paper will discuss this problematic in three specific dimensions. After an explanation of the general lines of the debate on organ transplantation , it will analyze the recently published joint report of the Council of Europe and the United Nation on the trafficking of organs . The discussion afterwards will be situated in the concrete cultural, ethical and legal framework of the Philippines as a test case for the validity and applicability of the reports recommendation . Lastly, it will conclude with some ethical considerations on the horizon of an elaborate concept of justice. (shrink)

In October 2005, UNESCO (the United Nations Educational, Scientific and Cultural Organization) adopted the Universal Declaration on Bioethics and Human Rights. This was the culmination of nearly 2 years of deliberations and negotiations. As a non-binding instrument, the declaration must be incorporated by UNESCO’s member states into their national laws, regulations or policies in order to take effect. Based on documentary evidence and data from interviews, this paper compares the declaration’s universal principles with national bioethics guidelines and practice in Kenya (...) and South Africa. It concentrates on areas of particular relevance to developing countries, such as protection of vulnerable persons and social responsibility. The comparison demonstrates the need for universal principles to be contextualised before they can be applied in a meaningful sense at national level. The paper also assesses the ‘added value’ of the declaration in terms of biomedical research ethics, given that there are already well-established international instruments on bioethics, namely the World Medical Association Declaration of Helsinki and the CIOMS (Council for International Organizations of Medical Sciences) guidelines on biomedical research. It may be that the added value lies as much in the follow-up capacity building activities being initiated by UNESCO as in the document itself. (shrink)

Many pediatric research regulations, including those of the United States, the Council for International Organizations of Medical Science, and South Africa, offer similar rules for review board approval of higher hazard studies holding out no therapeutic or direct benefit to children with disorders or conditions. Authorization requires gaining parental permissions and the children’s assent, if that is possible, and showing that these studies are intended to gain vitally important and generalizable information about children’s conditions; it also (...) requires limiting the risks of harm to no more than a “minor increase over minimal risk” and showing the study is commensurable with the children’s experiences. For convenience, these investigations will be called “no benefit, higher hazard” studies.Despite the existence of these policies for decades, studies show that review boards’ judgments vary about what “no benefit, higher hazard” studies should be approved. (shrink)

Many pediatric research regulations, including those of the United States, the Council for International Organizations of Medical Science, and South Africa, offer similar rules for review board approval of higher hazard studies holding out no therapeutic or direct benefit to children with disorders or conditions. Authorization requires gaining parental permissions and the children’s assent, if that is possible, and showing that these studies are intended to gain vitally important and generalizable information about children’s conditions; it also (...) requires limiting the risks of harm to no more than a “minor increase over minimal risk” and showing the study is commensurable with the children’s experiences. For convenience, these investigations will be called “no benefit, higher hazard” studies.Despite the existence of these policies for decades, studies show that review boards’ judgments vary about what “no benefit, higher hazard” studies should be approved. (shrink)

I propose in this essay to briefly describe some of the main current stakeholders who issue guidance on the ethics of human subjects research. This will be preceded by a very brief historical introduction.Prior to World War II, as far as I have been able to ascertain, there were no international efforts to regulate human experimentation. National activities were few and far between. One exception was a Directive on Human Experimentation issued in December 1900 by the then Prussian (...) Minister of Religious, Educational and Medical Mairs. This was followed by a Circular on innovative therapy and scientific experimentation promulgated by the then Reich Minister of the Interior in February 1931. Just over five years later, in April 1936, the Bureau of the Medico-Scientific Council of the People’s Commissariat for Health of the Russian Socialist Federated Soviet Republic, the main constituent Republic of the then Union of Soviet Socialist Republics, issued an Advisory Resolution on the procedures for testing new medicinal substances and methods which may present a hazard for the health and life of patients. (shrink)

Whenever the legitimacy of a new or ethically contentious medical intervention is considered, a range of influences will determine whether the treatment becomes accepted as lawful medical treatment. The development and introduction of abortion, organ donation, gender reassignment, and non-therapeutic cosmetic surgery have, for example, all raised ethical, legal, and clinical issues. This book examines the various factors that legitimatise a medical procedure. Bringing together a range of internationally and nationally recognised academics from law, philosophy, medicine, health, (...) economics, and sociology, the book explores the notion of a treatment, practice, or procedure being proper medical treatment, and considers the range of diverse factors which might influence the acceptance of a particular procedure as appropriate in the medical context. Contributors address such issues as clinical judgement and professional autonomy, the role of public interest, and the influence of resource allocation in decision-making. In doing so, the book explores how the law, the medical profession, and the public interact in determining whether a new or ethically contentious procedure should be regarded as legitimate. This book will be of interest and use to researchers and students of bioethics, medical law, criminal law, and the sociology of medicine. (shrink)

The discovery and invention of new medical applications may be considered blessings to humankind. However, some applications which might be the only remedy for certain diseases may contain ingredients or involve methods that are not in harmony with certain cultural and religious perspectives. These situations have raised important questions in medical ethics; are these applications completely prohibited according to these perspectives, and is there any room for mitigation? This paper explores the concept of darurah and its deliberation (...) in the formulation of fatwas on medicine issued by the National Fatwa Council of Malaysia. Darurah has explicitly been taken into consideration in the formulation of 14 out of 45 fatwas on medicine thus far, including one of the latest fatwas regarding uterine donation and transplantation. These fatwas are not only limited to the issues regarding the use of unlawful things as remedies. They include issues pertaining to organ transplantation, management of the corpse and treatment of brain dead patients. While deliberation of darurah in medicine may vary from issue to issue, darurah applies in a dire situation in which there are no lawful means to prevent harm that may be inflicted upon human life. Nevertheless, other aspects must also be taken into the deliberation. For example, consent must be obtained from the donor or his next of kin to conduct a cadaveric organ transplantation. (shrink)