The Nuremberg Code drafted at the end of the Doctor’s trial in Nuremberg 1947 has been hailed as a landmark document in medical and research ethics. Close examination of this code reveals that it was based on the Guidelines for Human Experimentation of 1931. The resemblance between these documents is uncanny. It is unfortunate that the authors of the Nuremberg Code passed it off as their original work. There is evidence that the defendants at the trial did request that their actions be judged on the basis of the 1931 Guidelines, in force in Germany. The prosecutors, however, ignored the request and tried the defendants for crimes against humanity, and the judges included the Nuremberg Code as a part of the judgment. Six of ten principles in Nuremberg Code are derived from the 1931 Guidelines, and two of four newly inserted principles are open to misinterpretation. There is little doubt that the Code was prepared after studying the Guidelines, but no reference was made to the Guidelines, for reasons that are not known. Using the Guidelines as a base document without giving due credit is plagiarism; as per our understanding of ethics today, this would be considered unethical. The Nuremberg Code has fallen by the wayside; since unlike the Declaration of Helsinki, it is not regularly reviewed and updated. The regular updating of some ethics codes is evidence of the evolving nature of human ethics.
Ethics; guidelines; human subjects; Nuremberg; research
Though the Nuremberg medical trial was a United States military tribunal, British forensic pathologists supplied extensive evidence for the trial. The BMJ had a correspondent at the trial, and he endorsed a utilitarian legitimation of clinical experiments, justifying the medical research carried out under Nazism as of long term scientific benefit despite the human costs. The British supported an international medical commission to evaluate the ethics and scientific quality of German research. Medical opinions differed over whether German medical atrocities should be given publicity or treated in confidence. The BMJ's correspondent warned against medical researchers being taken over by a totalitarian state, and these arguments were used to oppose the NHS and any state control over medical research.
In the lessons of medical-scientific methodologies of the medical faculty at the Sapienza University of Rome, basic notions on the ethical and deontologic aspects characterizing the history of the medical profession are provided, including the formulation and application of bioethical principles to clinics and biomedical research. Within such framework, an educational project has been initiated on the historical origin of the current normative and juridic dispositions in the regulation of experimental biomedical research and the relationship between health operators and patients, with particular attention to the procedure, the meaning the value either professional or deontologic, of ethics and the legality of the informed consensus. Emphasis is put on medical and experimental abuses that occurred in Germany during the nazi regime.
history of bioethics; dentistry in the nazi Germany
Fifty years after the Nuremberg medical trial there remain many unanswered questions about the role of the German medical profession during the Third Reich. Other than the question of human experimentation, important ethical challenges arising from medicine in Nazi Germany which have continuing relevance were not addressed at Nuremberg. The underlying moral question is that of the exercise of professional power and its impact on vulnerable people seeking medical care. Sensitisation to the obligations of professional power may be achieved by an annual commemoration and lament to the memory of the victims of medical abuse which would serve as a recurring reminder of the physician's vulnerability and fallibility.
The requirement that animals be used in research and testing in order to protect humans was formalized in the Nuremberg Code and subsequent national and international laws, codes, and declarations.
We review the history of these requirements and contrast what was known via science about animal models then with what is known now. We further analyze the predictive value of animal models when used as test subjects for human response to drugs and disease. We explore the use of animals for models in toxicity testing as an example of the problem with using animal models.
We conclude that the requirements for animal testing found in the Nuremberg Code were based on scientifically outdated principles, compromised by people with a vested interest in animal experimentation, serve no useful function, increase the cost of drug development, and prevent otherwise safe and efficacious drugs and therapies from being implemented.
Animal; Biological complexity; Ethics; Evolution; Law; Nuremberg code; Species variation
The activities of German doctors during the Nazi regime are well known and documented. They include efforts at eugenic sterilization and euthanasia, gruesome medical experimentation, and contributions to genocide. The German medical profession embraced the Nazi ideology of racial superiority. Nazi doctors enthusiastically perverted traditional medical mores of viewing each patient as a full individual towards a misguided sense of protecting the racial well-being of the nation from the perceived threat of certain groups of people. Similarly, some 20th-century American physicians engaged in activities prompted by a misguided sense of patients' worth as individuals. This essay will examine the ethical problems of Nazi medicine and ethical missteps in the United States in the context of challenges for contemporary physicians, particularly the way in which we refer to our patients.
Clinical trials involving children previously considered unethical are now considered essential because of the inherent physiological differences between children and adults. An integral part of research ethics is the informed consent, which for children is obtained by proxy from a consenting parent or guardian. The informed consent process is governed by international ethical codes that are interpreted in accordance with local laws and procedures raising the importance of contextualizing their implementation.
In Zimbabwe the parental informed consent document for children participating in clinical research is modeled along western laws of ethics and requires that the parent or legally authorized representative provide consent on behalf of a minor. This article highlights the experiences and lessons learnt by Zimbabwean researchers in obtaining informed consent from guardians of orphaned children participating in a collaborative HIV clinical trial involving the Medical Research Council, United Kingdom and four centers, three of which are in Uganda. Researchers were faced with a situation where caregivers of orphaned children were not permitted to provide informed consent for trial participation. The situation contrasted with general clinical practice where consent for procedures on orphans is obtained from their caregivers who are not legal guardians.
The challenges faced in obtaining informed consent for orphans in this clinical trial underscores the need for the Zimbabwe ethics committee to develop an ethical and legal framework for pediatric research that is based on international guidelines while taking into account the cultural context. The Medical Research Council of Zimbabwe has since started the process that is expected to involve critical stakeholders namely the community including children, ethicists, the legal fraternity and researchers.
Randomized controlled trials (RCTs) are becoming increasingly common in environmental health research. Like all studies involving human subjects, environmental health RCTs raise many different ethical issues, ranging from obtaining informed consent, to minimizing risks, to protecting privacy and confidentiality. One of the most important issues raised by these studies is whether it is ethical to withhold effective environmental health interventions from research subjects in order to satisfy scientific objectives. Although environmental health investigators usually do not have professional obligations to provide medical care to research subjects, they have ethical obligations to avoid exploiting them. Withholding interventions from research subjects can be ethical, provided that it does not lead to exploitation of individuals or groups. To avoid exploiting individuals or groups, investigators should ensure that research subjects and study populations receive a fair share of the benefits of research.
Cluster randomized trials (CRTs) pose ethical challenges for investigators and ethics committees. This study describes the views and experiences of CRT researchers with respect to: (1) ethical challenges in CRTs; (2) the ethics review process for CRTs; and (3) the need for comprehensive ethics guidelines for CRTs.
Descriptive qualitative analysis of interviews conducted with a purposive sample of 20 experienced CRT researchers.
Informants expressed concern over the potential for bias that may result from requirements to obtain informed consent from research participants in CRTs. Informants suggested that the need for informed consent ought to be related to the type of intervention under study in a CRT. Informants rarely expressed concern regarding risks to research participants in CRTs, other than risks to privacy. Important issues identified in the research ethics literature, including fair subject selection and other justice issues, were not mentioned by informants. The ethics review process has had positive and negative impacts on CRT conduct. Informants stated that variability in ethics review between jurisdictions, and increasingly stringent ethics review in recent years, have hampered their ability to conduct CRTs. Many informants said that comprehensive ethics guidelines for CRTs would be helpful to researchers and research ethics committees.
Informants identified key ethical challenges in the conduct of CRTs, specifically relating to identifying subjects, seeking informed consent, and the use of gatekeepers. These data have since been used to identify topics for in-depth ethical analysis and to guide the development of comprehensive ethics guidelines for CRTs.
Cluster randomized trials; Research ethics; Informed consent; Clinical trials; Bioethics; Knowledge translation; Quality improvement; Implementation research
The importance of pediatric research especially in the ethically proven trials resulted in considerable legislative attempts in association with compiling ethical guidelines. Because of children's vulnerability conducting pediatric research raises different ethical issues; the two most important of which are informed consent and risk-benefit assessment. Differences in religious and socio-cultural context limit implication of ethical standards.
At the aim of finding a solution we critically reviewed guidelines, and literatures as well as Islamic points in addition to comparing different viewpoints in application of ethical standards in pediatric research.
The literature review showed that pediatric research guidelines and authors’ viewpoints have the same basic ethical core, but there are some variations; depend on cultural, religious, and social differences. Furthermore, these standards have some limitations in defining informed consent according to child's age and capacity upon application.
In this regard Islamic approach and definition about growth development and puberty sheds light and clarifies a clearer and more rational address to the issue.
Children; Pediatric Research; Ethics; Islamic Law
Improved quality of care is a policy objective of health care systems around the world. Implementation research is the scientific study of methods to promote the systematic uptake of clinical research findings into routine clinical practice, and hence to reduce inappropriate care. It includes the study of influences on healthcare professionals' behaviour and methods to enable them to use research findings more effectively. Cluster randomized trials represent the optimal design for evaluating the effectiveness of implementation strategies. Various codes of medical ethics, such as the Nuremberg Code and the Declaration of Helsinki inform medical research, but their relevance to cluster randomised trials in implementation research is unclear. This paper discusses the applicability of various ethical codes to obtaining consent in cluster trials in implementation research.
The appropriate application of biomedical codes to implementation research is not obvious. Discussion of the nature and practice of informed consent in implementation research cluster trials must consider the levels at which consent can be sought, and for what purpose it can be sought. The level at which an intervention is delivered can render the idea of patient level consent meaningless. Careful consideration of the ownership of information, and rights of access to and exploitation of data is required. For health care professionals and organizations, there is a balance between clinical freedom and responsibility to participate in research.
While ethical justification for clinical trials relies heavily on individual consent, for implementation research aspects of distributive justice, economics, and political philosophy underlie the debate. Societies may need to trade off decisions on the choice between individualized consent and valid implementation research. We suggest that social sciences codes could usefully inform the consideration of implementation research by members of Research Ethics Committees.
The conduct of biomedical research involving the participation of human beings implicates a variety of ethical concerns pertaining to such values as dignity, bodily integrity, autonomy, and privacy. These ethical concerns have been translated into a complex regulatory apparatus in the USA, containing specific legal provisions concerning such matters as participant safety, informed consent, and confidentiality. A topic of particular interest for pathologists is the handling of human tissue specimens that may be used for present, or stored for future, research purposes. This article examines the ethical and legal ramifications of obtaining and storing tissue samples for research purposes, with special attention to the issues of informed consent and confidentiality.
ethics; law; research; tissue
Medical research involving human subjects raises complex ethical, legal and social issues. Investigators sometimes find that their obligations with respect to a research project come into conflict with their obligations to individual patients. The ethical conduct of research rests on 3 guiding principles: respect for persons, beneficience, and justice. Respect for persons underlies the duty to obtain informed consent from study participants. Beneficence demands a favourable balance between the potential benefits and harms of participation. Justice requires that vulnerable people not be exploited and that eligible candidates who may benefit from participation not be excluded without good cause. Studies must be designed in a way that ensures the validity of findings and must address questions of sufficient importance to justify the risks of participation. In any clinical trial there must be genuine uncertainty as to which treatment arm offers the most benefit, and placebo controls should not be used if effective standard therapies exist. Researchers have a responsibility to inform themselves about the ethical, legal and policy standards that govern their activities. When difficulties arise, they should consult the existing literature and seek the advice of experts in research ethics.
Millions of people undergo displacement in the world. Internally displaced people (IDP) are especially vulnerable as they are not protected by special legislation in contrast to other migrants. Research conducted among IDPs must be correspondingly sensitive in dealing with ethical issues that may arise. Muslim IDPs in Puttalam district in the North-Western province of Sri Lanka were initially displaced from Northern Sri Lanka due to the conflict in 1991. In the backdrop of a study exploring the prevalence of common mental disorders among the IDPs, researchers encountered various ethical challenges. These included inter-related issues of autonomy, non-maleficence, beneficence, confidentiality and informed consent, and how these were tailored in a culture-specific way to a population that has increased vulnerability. This paper analyses how these ethical issues were perceived, detected and managed by the researchers, and the role of ethics review committees in mental health research concerning IDPs. The relevance of guidelines and methodologies in the context of an atypical study population and the benefit versus risk potential of research for IDPs are also discussed. The limitations that were encountered while dealing with ethical challenges during the study are discussed. The concept of post-research ethical conduct audit is suggested to be considered as a potential step to minimize the exploitation of vulnerable populations such as IDPs in mental health research.
Sri Lanka; Bioethics; Ethical challenges; Internally displaced people; Mental health research; Post-research ethics audit; Practical ethics; Developing world
Many ethical concerns revolve around the four basic principles of research: merit and integrity, respect for human beings, weighting of risk–benefit and justice. These principles form the basis for any discussion concerning human research ethics and are applicable to all areas of research including acupuncture and Chinese herbal medicine. World Health Organisation document, Guidelines for Clinical Research on Acupuncture, states that ‘consideration should be given to the different value systems that are involved in human rights such as social, cultural and historical issues’ and that ‘further studies should be conducted in relation to ethical issues involved in clinical research on acupuncture’. In addition to outlining the four basic principles, this paper will also examine the effect of Asian culture on Western human research ethics and how this may impact upon issues such as informed consent and weighting of risk–benefit.
acupuncture; Chinese medicine; culture; ethics; human research
The International Committee of Medical Journal Editors expects authors to report if their studies were carried out in accordance with the International Ethical Guidelines and Declaration of Helsinki; and inform readers regarding the same.
To determine the proportion of International Indexed Dental Journals reporting on ethical clearance for human and animal research, obtaining of informed consent and / or assent, and the conduction of research in accordance with the Declaration of Helsinki and International Medical Research, 2006.
Settings and Design:
A cross-sectional survey of ‘instructions for authors,’ for analysis of editorial policy on ethical processes, was done.
Materials and Methods:
One hundred and twenty-six dental journals (which included 50 general and 76 specialties) were reviewed for reporting, with regard to the Ethical Committee Approval for human and animal researches, obtaining of informed consent / assent from the research participants, and research in accordance with the Declaration of Helsinki as well as International Medical Research 2006 were analyzed.
Statistical Analysis Used:
Descriptive statistics was used and results were expressed in percentages.
Of the 126 dental journals, 57 (45.23%) reported having obtained approval from the Ethics Committee, 33 (26.19%) were instructed about the Animal Ethics Committee approval, and 38 (30.15%) insisted on obtaining and reporting informed consent / assent. 41 (32.53%) journals expected authors to mention the research being conducted according to Declaration of Helsinki and and 3 (2.38%) journals required researches to be conducted in accordance with International Medical Research, 2006.
A significant proportion of international indexed dental journals did not provide instructions to authors to report on the ethical approval, informed consent and / assent, and research conduction according to the Declaration of Helsinki as well as the International Medical Research, 2006.
Authors; ethics; publication; research
Tailoring medical treatment to individual patients requires a strong foundation in research to provide the data necessary to understand the relationship between the disease, the patient, and the type of treatment advocated for. Non-therapeutic oncology clinical trials studying therapeutic resistance require the participation of patients, yet only a small percentage enroll. Treating physicians are often relied on to recruit patients, but they have a number of ethical obligations that might be perceived as barriers to recruiting. Concepts such as voluntariness of consent and conflicts of interest can have an impact on whether physicians will discuss clinical trials with their patients and how patients perceive the information. However, these ethical obligations should not be prohibitive to physician recruitment of patients – precautions can be taken to ensure that patients’ consent to research participation is fully voluntary and devoid of conflict, such as the use of other members of the research team than the treating physician to discuss the trial and obtain consent, and better communication between researchers, clinicians, and patients. These can ensure that research benefits are maximized for the good of patients and society.
ethics; recruitment; clinical trial; informed consent; conflict of interest
Photographs are commonly taken of children in medical and research contexts. With the increased availability of photographs through the internet, it is increasingly important to consider their potential for negative consequences and the nature of any consent obtained. In this research we explore the issues around photography in low-resource settings, in particular concentrating on the challenges in gaining informed consent.
Exploratory qualitative study using focus group discussions involving medical doctors and researchers who are currently working or have recently worked in low-resource settings with children.
Photographs are a valuable resource but photographers need to be mindful of how they are taken and used. Informed consent is needed when taking photographs but there were a number of problems in doing this, such as different concepts of consent, language and literacy barriers and the ability to understand the information. There was no consensus as to the form that the consent should take. Participants thought that while written consent was preferable, the mode of consent should depend on the situation.
Photographs are a valuable but potentially harmful resource, thus informed consent is required but its form may vary by context. We suggest applying a hierarchy of dissemination to gauge how detailed the informed consent should be. Care should be taken not to cause harm, with the rights of the child being the paramount consideration.
Photography; Ethics; Informed consent; Teleconference
The conduct of experimental studies in humans is governed by a body of principles whose main precepts have evolved over the past few decades. Three of these provide the foundations for judging the ethical adequacy of such an experiment. One addresses the question of who receives the benefits of the research and who bears its burdens (justice). A second requires that the research maximize the potential benefits to the subjects and minimize the risk of harm (beneficence). The third, the source of guidelines for informed consent, requires that subjects enter into the research voluntarily and with adequate information (respect for persons). Unlike research conducted to evaluate drugs, however, environmental exposures to potentially toxic chemicals do not survey those exposed for their consent, nor do they provide an appropriate calculus for measuring risks and benefits, which typically involve two different populations. Especially for exposure to developmental neurotoxicants, where the risk-benefit incompatibility can be so striking, another element may need to be incorporated into risk characterization: a process of ethics assessment. A scheme for doing so can be derived from the procedures of fuzzy logic, which allow rules to be formulated that are applicable to ethical principles. Such an approach incorporates some of the tenets of the precautionary principle.
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.
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 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.
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.
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.
The growing number of individuals affected by dementia will intensify the ethical issues that emerge in clinical practice and research, issues early in disease relate to genetic testing, use of medications in mildly affected persons, and diagnostic disclosure. Research issues relate to appropriate informed consent processes, conflict of interests, and research design issues, such as the use of placebos and the use of biological tissues, in the later stages of disease concern about appropriate therapeutic goals and end-of-life care is appropriate.
ethics; dementia; Alzheimer's disease; clinical practice; research; informed consent; end-of-life care; genetic testing; use of placebo
As attention to, and motivation for, EMS-related research continues to grow, particularly exception from informed consent (EFIC) research, it is important to understand the thoughts, beliefs, and experiences of EMS providers who are actively engaged in the research.
We explored the attitudes, beliefs, and experiences of EMS providers regarding their involvement in prehospital emergency research, particularly EFIC research.
Using a qualitative design, 24 participants were interviewed including Nationally Registered Paramedics and Virginia certified Emergency Medical Technicians employed at Richmond Ambulance Authority, the participating EMS agency. At the time of our interviews, the EMS agency was involved in an exception from informed consent trial. Transcribed interview data were coded and analyzed for themes. Findings were presented back to the EMS agency for validation.
Overall, there appeared to be support for prehospital emergency research. Participants viewed research as necessary for the advancement of the field of EMS. Improvement in patient care was identified as one of the most important benefits. A number of ethical considerations were identified: individual risk versus public good and consent. EMS providers in our study were open to working with EMS researchers throughout the community consultation and public disclosure process.
EMS providers in our study value research and are willing to participate in studies. Support for research was balanced with concerns and challenges regarding the role of providers in the research process.
In a Liberal Democracy, Policy Decisions regarding ethical controversies, including those in research ethics, should incorporate the opinions of its citizens. Eliciting informed and well-considered ethical opinions can be challenging. The issues may not be widely familiar and they may involve complex scientific, legal, historical, and ethical dimensions. Traditional surveys risk eliciting superficial and uninformed opinions that may be of dubious quality for policy formation. We argue that the theory and practice of deliberative democracy (DD) is especially useful in overcoming such inadequacies. We explain DD theory and practice, discuss the rationale for using DD methods in research ethics, and illustrate in depth the use of a DD method for a long-standing research ethics controversy involving research based on surrogate consent. The potential pitfalls of DD and the means of minimizing them as well as future research directions are also discussed.
deliberative democracy; public opinion; surveys; bioethical issues; dementia; surrogate consent
Adolescents globally are at high risk for HIV acquisition and are the targets of HIV prevention interventions such as HIV vaccines. In order to understand stakeholders’ attitudes towards the ethical issues of adolescent involvement in HIV vaccine trials, we conducted focus group discussions with key members of a semi-urban, informal Cape Town community with high HIV prevalence in which HIV vaccine trials are taking place. Themes were identified from focus group transcripts by four researchers, and included necessity of guardian consent, age of independent consent, and confidentiality of in-trial medical results. In general, ethical adolescent HIV vaccine trials will be feasible in this community.
Adolescents; HIV vaccine trials; community; ethics
Although a main principle of medical ethics and law since the 1970s, standards of informed consent are regarded with great scepticism by many clinicans.
By reviewing the reactions to and adoption of this principle of medical ethics in neurosurgery, the characteristic conflicts that emerge between theory and everyday clinical experience are emphasised and a modified conception of informed consent is proposed.
The adoption and debate of informed consent in neurosurgery took place in two steps. Firstly, respect for patient autonomy was included into the ethical codes of the professional organisations. Secondly, the legal demands of the principle were questioned by clinicians. Informed consent is mainly interpreted in terms of freedom from interference and absolute autonomy. It lacks a constructive notion of physician–patient interaction in its effort to promote the best interest of the patient, which, however, potentially emerges from a reconsideration of the principle of beneficence.
To avoid insufficient legal interpretations, informed consent should be understood in terms of autonomy and beneficence. A continuous interaction between the patient and the given physician is considered as an essential prerequisite for the realisation of the standards of informed consent.