Since 1964, the Declaration of Helsinki has been accepted internationally as the cornerstone for research ethics. As such it has been incorporated into a number of guidance documents for research undertaken on human subjects. In 1999, the American Medical Association put forward a proposal for wide-ranging revision of the document, which would significantly weaken the rights of research subjects and lower the standards for research on human subjects. This article discusses the probable effects of the most significant proposals (...) for change and argues against them. It also urges nurses, especially those involved in research, to become involved in the international consultation currently being undertaken by the World Medical Association. (shrink)

The Helsinki Declaration is the ‘gold standard’ — a directive, not a law, on how to conduct controlled studies in humans in conformity with ethical principles. In spite of many discussions about their unsuitability some articles have remained unchanged in the most recent (sixth) revision of the Declaration. The demand to use “the best treatment” excludes use of placebo in the control group and presents an obstacle to the scientific evaluation of a number of drugs and treatments (...) in general. The use of placebo is justified whenever its use does not cause irreversible damage or considerable suffering to the well informed patient. It must be, is, and will be used in the controlled clinical trials of treatments of a great number of diseases especially those which have a tendency to spontaneous improvement, even healing, or have a pronounced psychological component. (shrink)

Research involving children or other incompetent subjects who are deemed unable to provide informed consent is complex, particularly in the case of research that does not directly benefit the research subjects themselves. The Helsinki Declaration, the World Medical Association's landmark document for research ethics, therefore states that incompetent research subjects must not be included in such research unless it entails only minimal risk and minimal burden. In this paper, we argue that now that research in these groups is (...) expected to expand, this undifferentiated minimal risk and burden requirement does not suffice any more. In the upcoming revision of the Declaration, the paragraph at stake should be refined in such a way that it is not unnecessarily restrictive or more permissive than can be ethically justified. Our first recommendation is to stimulate research ethics committees to identify more accurately those risks and burdens that the research subjects must undergo solely for research purposes by distinguishing between two types of study procedures instead of between two types of studies. Our second recommendation is to allow for exceptions to the minimal risk and burden requirement in cases of exceptionally valuable studies that involve subjects who can give their assent to participate in the study and that involve at most a minor increase over minimal risk and/or burden. (shrink)

The Helsinki Declaration is the ‘gold standard’ — a directive, not a law, on how to conduct controlled studies in humans in conformity with ethical principles. In spite of many discussions about their unsuitability some articles have remained unchanged in the most recent (sixth) revision of the Declaration. The demand to use “the best treatment” excludes use of placebo in the control group and presents an obstacle to the scientific evaluation of a number of drugs and treatments (...) in general. The use of placebo is justified whenever its use does not cause irreversible damage or considerable suffering to the well informed patient. It must be, is, and will be used in the controlled clinical trials of treatments of a great number of diseases especially those which have a tendency to spontaneous improvement, even healing, or have a pronounced psychological component. (shrink)

The Helsinki Declaration is the universally accepted standard for ethical behavior in research involving human subjects. The Declaration calls for research studies to compare new therapies to the best current therapies. Despite this standard, multiple studies of pain relief interventions in newborns have recruited placebo controls instead of active controls using the best current therapy. These studies are evaluated using the standards required by the Helsinki Declaration, and the reasons for the ethical shortcomings of these (...) studies are explored. (shrink)

The Helsinki Declaration, first published in 1964, is the universally accepted standard for ethical behavior in research involving human subjects. The Declaration was formulated in response to the abuses of human subjects by the scientists in Nazi Germany and to update the Nuremberg Code. Amended in 1975, 1983, 1989, 1996, and 2000, the Declaration provides the foundation for the United States federal regulations for research involving human subjects.To conform to standards developed in the Declaration, a (...) researcher must fulfill the following: respect the autonomy of the individual; promote and safeguard the individual’s health; provide informed consent without coercion; take special measures with vulnerable populations; compare new therapies to the best current therapies; have a thorough scientific knowledge of the subject; assess risk versus benefit of the intervention; perform studies that will ultimately benefit the population involved in the research; accurately report their findings; and fully disclose ethical concerns in their research protocols. (shrink)

Recent technological developments have considerably transformed the supply, storage, and transportation processes of cadavers, creating new and previously unforeseen ethical challenges regarding cadaver usage. In this study, we analyzed two aspects of the cadaver processing system—cadaver supply and its use in research. Thereafter, we highlighted the major ethical concerns underlying these stages and correlated our search results with the ethical principles outlined in the Declaration of Helsinki (DoH), or Helsinki Declaration. To ensure the reliability and continuity (...) of medical progress, human—especially cadaver—research depends on the ethical priorities as outlined in the DoH: respect for autonomy, privacy/confidentiality, risks/burdens/benefits, and the protection of vulnerable groups. According to our ethics analysis, which also corresponds with the ethics guidelines of the Consensus Panel on Research with the Recently Dead, the most ignored values were respect for autonomy and privacy/confidentiality issues. Based on these ethical concerns, we provide recommendations to address these challenges in anatomy research. (shrink)

The ignorance of Helsinki declaration is continuing in Japan for approximately 20 years. More than 400 children including preschoolers with developmental conditions including temper tantrums, hyperactivity, and/or autistic characteristics have been already operated. The cranioplasty for isolated mild trigonocephaly had been empirically introduced by a physician to re-establish the brain spatial environment, and a government-granted and multi-centered clinical observation study is now in operation without scientific verification of the procedure’s validity. The characteristic of the skull shape are too (...) mild and sometimes too subtle to be recognized by the parents and health checkup doctors. A physician may tentatively and extraordinarily use an unproven procedure in exceptional circumstances where proven and effective interventions do not exist. However, the intervention must as soon as possible be subjected to scientific scrutiny according to ethical principles in order to stop the utilization in case of misprediction. (shrink)

The World Medical Association has announced that a new revision process of the Declaration of Helsinki has been started. This article will identify the criticisms that have been made in the bioethics literature, particularly since the last revision. In addition, criticisms are discussed that were made in the literature even before the last revision and have not fallen silent. The plausibility of the recommendation for a change in the Declaration of Helsinki is examined.

This commentary was submitted to the World Medical Association on behalf of the International Network on Feminist Approaches to Bioethics. Our submission included a description of feminist research ethics, suggestions for specific revisions to the Declaration, and elements found in other international research ethics codes that are important from a feminist perspective. Our goals were to encourage the WMA to craft a declaration that: conceptualizes issues of vulnerability in richer and more nuanced ways, resists the influence of profit (...) motives, and extends the scope of responsibility for ethical research more broadly. (shrink)

This paper reflects on some amendments to the Declaration of Helsinki in 2008. It focuses on former paragraphs 5 (now 6) and 19 (now 17). Paragraph 5 suggested that the wellbeing of research participants should take precedence over the interests of science and society. Paragraph 6 now proposes that it should take precedence over all other interests. Paragraph 19, and the new paragraph 17, suggest that research involving the members of a disadvantaged population is only justified if the (...) clinical trial is likely to benefit them. In both cases, the recommendation is that the interests of the research subjects should prevail over the interests of third parties. This paper assesses the plausibility of these statements, and in order to do so, considers debates on the moral duty to participate in biomedical research. It is argued that, even if seen in the context of the Declaration as a whole, the statements contained in these paragraphs risk offering a misleading portrait of science and risk eroding some of the ethical principles that should form the basis of a satisfactory shared life, such as altruism and responsibility for our fellows. (shrink)

The World Medical Association's Declaration of Helsinki is one of the most important and influential international research ethics documents. Launched in 1964, when ethical guidance for research was scarce, the Declaration comprised eleven basic principles and provisions on clinical research. The document has since evolved to a complex set of principles, norms, and directions for action of varying degrees of specificity, ranging from specific rules to broad aspirational statements. It has been revised six times in an effort (...) to maintain its influence. While all revisions were the result of vigorous debate, the 2000 revision and two subsequent notes of clarification spurred particular controversy surrounding the use of placebo in clinical research and the standard of care and post-trial obligations in research in developing countries. Several institutions opted to cite earlier versions of the Declaration, and the U.S. Food and Drug Administration recently removed all reference to the Declaration in its approval requirements for drugs and biological products that are studied outside the United States. (shrink)

The World Medical Association's ‘Declaration of Helsinki’ on Medical Research on Human Subjects is undergoing its sixth revision in its 44 years. The aim of this paper is to put the Declaration into an historical context, define and identify the core ethical principles, and illustrate how these are applied within the Declaration.

Since 1964, through 7 revisions, the World Medical Association’s Declaration of Helsinki has stood as an important statement regarding the ethical principles guiding medical research with human participants. It is consulted by ethics review committees, funders, researchers, and research participants. It has been incorporated into national legislation and is routinely invoked to ascertain the ethical appropriateness of clinical trials. There is much to praise about the revision process and the latest revision, which coincides with the declaration’s 50th (...) anniversary. Nevertheless, the proposed declaration contains persistent flaws... (shrink)

Some of the recent criticisms published during and after the last revision process of the Declaration of Helsinki are directed at its basic legitimacy. In this article we want to have a closer look at the two criticisms we consider to be the most fundamental. The first criticism questions the legitimate authorship of the World Medical Association to publish a document such as the Declaration. The second fundamental criticism we want to examine argues that the last revision (...) process failed to meet the standards for fair, democratic procedures. Although both criticisms deny the formal legitimacy of the Declaration in the most fundamental way, they have never been addressed in detail in a single article. We refute most of the related arguments. However, acknowledging some of the points made, improvements for future revision processes and versions of the Declaration of Helsinki are outlined. (shrink)

In this paper we argue that the consensus around normative standards for the ethics of research in clinical trials, strongly influenced by the Declaration of Helsinki, is perceived from various quarters as too conservative and potentially restrictive of research that is seen as urgent and necessary. We examine this problem from the perspective of various challengers who argue for alternative approaches to what ought or ought not to be permitted. Key themes within this analysis will examine these claims (...) and argue they have implications for the interests of the research subject, research governance and regulation. Using our work with TREAT-NMD, the neuromuscular clinical trials network, we posit that there is a place for advancing the discourse of moral rights and moral duties in the context of research, especially from the perspective of patients and their families, and for including the politics of patient activism and empowerment. At the same time we remain vigilant to the danger that the therapeutic misconception and other serious vulnerabilities for the patient population in clinical trials, are at risk of being overlooked. (shrink)

The World Medical Association’s revised Declaration of Helsinki endorses the view that all trial participants in every country are entitled to the worldwide best standard of care. In this paper the authors show that this requirement has been rejected by every national and international committee that has examined this issue. They argue that the consensus view now holds that it is ethically permissible, in some circumstances, to provide research participants less than the worldwide best care. Finally, the authors (...) show that there is also consensus regarding the broad conditions under which this is acceptable. (shrink)

The general aim of this article is to give a critical interpretation of post-trial obligations towards individual research participants in the Declaration of Helsinki 2013. Transitioning research participants to the appropriate health care when a research study ends is a global problem. The publication of a new version of the Declaration of Helsinki is a great opportunity to discuss it. In my view, the Declaration of Helsinki 2013 identifies at least two clearly different types (...) of post-trial obligations, specifically, access to care after research and access to information after research. The agents entitled to receive post-trial access are the individual participants in research studies. The Declaration identifies the sponsors, researchers and host country governments as the main agents responsible for complying with the post-trial obligations mentioned above. To justify this interpretation of post-trial obligations, I first introduce a classification of post-trial obligations and illustrate its application with examples from post-trial ethics literature. I then make a brief reconstruction of the formulations of post-trial obligations of the Declaration of Helsinki from 2000 to 2008 to correlate the changes with some of the most salient ethical arguments. Finally I advance a critical interpretation of the latest formulation of post-trial obligations. I defend the view that paragraph 34 of ‘Post-trial provisions’ is an improved formulation by comparison with earlier versions, especially for identifying responsible agents and abandoning ambiguous ‘fair benefit’ language. However, I criticize the disappearance of ‘access to other appropriate care’ present in the Declaration since 2004 and the narrow scope given to obligations of access to information after research. (shrink)

In October 2013, the Declaration of Helsinki was revised a seventh time in its 50 year history. While it is the most widely accepted set of ethical principles for the protection of patients participating in medical research, the Declaration of Helsinki has also been subject of constant controversy. In particular, its paragraph on the use of placebo controls in clinical trials divides the research community into active-control and placebo orthodox proponents, both continuously demanding revisions of the (...) Declaration of Helsinki in favour of their position. The goal of the present project is to compare the mainly theoretical controversy with regulatory implementation. We distributed a questionnaire to national drug regulatory authorities from different countries to collect information on the authorities’ respective approaches to interpretation and implementation of the Declarations’ placebo paragraph in the conduct of medical research. Our findings suggest that the majority of drug regulatory authorities have established a practice of a middle ground, allowing placebo controls in some instances. Various interpretations of “serious harm” and “methodological reasons” are proposed as well as safeguards to avoid abuse of the option to use placebo-controls. Leaving the placebo paragraph open to various interpretation is a result of the Declaration of Helsinki’s character as a guidance document. With the current version controversy will continue. The Declaration should be continued to be strengthened to enforce the appreciation of conducting medical research with the highest ethical standard. (shrink)

In this paper, we argue that the professional engineering institutions ought to develop a Declaration of Climate Action. Climate change is a serious global problem, and the majority of greenhouse gas emissions come from industries that are enabled by engineers and represented by the engineering professional institutions. If the professional institutions take seriously the claim that a profession should be self-regulating, with codes of ethics that go beyond mere obedience to the law, and if they take their own ethical (...) codes seriously, recognising their responsibility to the public and to future generations, the professional institutions ought to develop a declaration for engineers, addressing climate change. Our argument here is largely inspired by the history of the Declaration of Helsinki. The Declaration of Helsinki was created by the medical profession for the profession, and it held physicians to a higher standard of ethical conduct than was found in the legal framework of individual countries. Although it was not originally a legal document, the influence of the Declaration can be seen in the fact that it is now enshrined in law in a number of different countries. Thus, we argue that the engineering profession could, and should, play a significant role in the abatement of climate change by making changes within the profession. If the engineering profession sets strict standards for professional engineers, with sanctions for those who refuse to comply, this could have a significant impact in relation to our efforts to develop a coordinated response to climate change. (shrink)

The World Medical Association's Declaration of Helsinki offers guidelines to doctors engaged in biomedical research with human subjects. The fundamental distinction of the Declaration is between clinical research combined with professional care and non-clinical scientific research. If hospital patients are the experimental subjects, then the former research must be carried out by the patient's own doctor, whereas the latter research must not be; it must be carried out by other doctors. The relevance of the distinction between the (...) patient's own doctor and other doctors is challenged and an alternative conception of the patient-doctor relationship is drawn, together with an alternative justification, based on the work of Hans Jonas, of the use of patients in research. Finally, the political nature of the patient-doctor relationship is mentioned, and it is claimed that the alternative conception of this relationship developed in the paper is more in line with the ethical principles of the Hippocratic tradition. (shrink)

Background: The Declaration of Helsinki, the World Medical Association’s statement of ethical guidelines regarding medical research, is published in the three official languages of the WMA: English, French and Spanish.Methods: A detailed comparison of the three official language versions was carried out to determine ways in which they differed and ways in which the wording of the three versions might illuminate the interpretation of the document.Results: There were many minor linguistic differences between the three versions. However, in paragraphs (...) 1, 6, 29, 30 and in the note of clarification to paragraph 29, there were differences that could be considered potentially significant in their ethical relevance.Interpretation: Given the global status of the Declaration of Helsinki and the fact that it is translated from its official versions into many other languages for application to the ethical conduct of research, the differences identified are of concern. It would be best if such differences could be eliminated but, at the very least, a commentary to explain any differences that are unavoidable on the basis of language or culture should accompany the Declaration of Helsinki. This evidence further strengthens the case for international surveillance of medical research ethics as has been proposed by the WMA. (shrink)

This paper explores ethical considerations for active studies of circumcision, i.e., the amputation of the foreskin, in the form of a case study of three major trials performed in African countries in the early 2000s. The paper outlines the function of the foreskin and method and history of its amputation as well as its current use in attempting to combat the global AIDS crisis. These trials are then interrogated in accordance with the Declaration of Helsinki. In particular, the (...) irreversible nature of amputation is given great consideration. The case studies are found to have serious failures in terms of the modern iteration of the Declaration of Helsinki. This paper calls for extreme scrutiny in accordance with international norms relating to the ethical treatment of human subjects in a research context of studies of circumcision if and when they are proposed again. (shrink)

Since its introduction in 1964, the World Medical Association’s Declaration of Helsinki—Ethical Principles for Medical Research Involving Human Subjects has enshrined the importance of safeguarding the well-being of human subjects in clinical research. The Declaration has undergone seven revisions, often in response to requests for clarification. I want to argue that the Declaration is in need of another revision in light of recent discoveries in placebo research.

This article briefly reviews the discussion over changes to the Declaration of Helsinki. It suggests that the final product the World Medical Association has adopted as its guiding research ethics document is superior to the version it has replaced, but falls short of what would be ethically desirable.

: Following a long process of revision, a new version of the Declaration of Helsinki was approved by the World Medical Association in 2000. Two provisions of the Declaration address ongoing international controversies regarding research sponsored by industrialized countries and conducted in developing countries. Despite the issuance of the final version of the Declaration, opponents remain locked in debate. Moreover, the Declaration remained silent on other prominent controversies concerning international research. An analysis of these current (...) controversies reveals reasons why they are not likely to be readily resolved, despite apparent agreement by opponents on overarching ethical principles. (shrink)

To examine the ethical issues involved in governmental decisions with potential health risks, we review the history of the decision to raise the interurban speed limit in Israel in light of its impact on road death and injury. In 1993, the Israeli Ministry of Transportation initiated an “experiment” to raise the interurban speed limit from 90 to 100 kph. The “experiment” did not include a protocol and did not specify cut-off points for early termination in the case of adverse results. (...) After the raise in the speed limit, the death toll on interurban roads rose as a result of a sudden increase in speeds and case fatality rates. The committee's decision is a case study in unfettered human experimentation and public health risks when the setting is non-medical and lacks a defined ethical framework. The case study states the case for extending Helsinki type safeguards to experimentation in non-medical settings. (shrink)

The Declaration of Helsinki is recognised worldwide as a cornerstone of research ethics. Working in the wake of the Nazi doctors’ trials at Nuremberg, drafters of the Declaration set out to codify the obligations of physician-researchers to research participants. Its significance cannot be overstated. Indeed, it is cited in most major guidelines on research involving humans and in the regulations of over a dozen countries.Although it has undergone five revisions,1 and most recently incorporated language aimed at addressing (...) concerns over research carried out in resource-poor countries,2–5 the Declaration could go much farther in addressing the profoundly altered landscape of research with humans. Research involving humans is now a global enterprise and often involves participants from resource-poor countries. Rather than being carried out at single institutions by veteran researchers, many studies are now conducted at many locations—including sites that are not academic medical centres—by new and relatively inexperienced investigators. A growing number of projects involve novel agents, based on innovative work in genomics and proteomics. Increasingly, research is sponsored by the for-profit sector. National governments and professional organisations around the globe provide laws, regulations and standards for the conduct of research involving humans. Considerable scholarship also critiques and guides this endeavour.In light of the current effort of the World Medical Association to revise the Declaration, we offer ideas on how to re-conceive the concept of “vulnerability” and its links with the principle of justice and, in turn, redirect the attention of researchers towards those who might be so designated.In the research context, “vulnerability” is associated with an inability partly or totally to protect one’s own interests. Typically, conceptions of vulnerability centre upon characteristics associated with particular groups that …. (shrink)

The Declaration of Helsinki is recognised worldwide as a cornerstone of research ethics. Working in the wake of the Nazi doctors’ trials at Nuremberg, drafters of the Declaration set out to codify the obligations of physician-researchers to research participants. Its significance cannot be overstated. Indeed, it is cited in most major guidelines on research involving humans and in the regulations of over a dozen countries.Although it has undergone five revisions,1 and most recently incorporated language aimed at addressing (...) concerns over research carried out in resource-poor countries,2–5 the Declaration could go much farther in addressing the profoundly altered landscape of research with humans. Research involving humans is now a global enterprise and often involves participants from resource-poor countries. Rather than being carried out at single institutions by veteran researchers, many studies are now conducted at many locations—including sites that are not academic medical centres—by new and relatively inexperienced investigators. A growing number of projects involve novel agents, based on innovative work in genomics and proteomics. Increasingly, research is sponsored by the for-profit sector. National governments and professional organisations around the globe provide laws, regulations and standards for the conduct of research involving humans. Considerable scholarship also critiques and guides this endeavour.In light of the current effort of the World Medical Association to revise the Declaration, we offer ideas on how to re-conceive the concept of “vulnerability” and its links with the principle of justice and, in turn, redirect the attention of researchers towards those who might be so designated.In the research context, “vulnerability” is associated with an inability partly or totally to protect one’s own interests. Typically, conceptions of vulnerability centre upon characteristics associated with particular groups that …. (shrink)

El objetivo del presente trabajo es analizar la nueva formulación del principio de acceso posinvestigación en la más reciente (2008) revisión de la Declaración de Helsinki. Se identifican los artículos relevantes de la Declaración y se presentan dos interpretaciones posibles del principio de acceso posinvestigación: una interpretación robusta y otra permisiva, inspiradas cada una por modelos de justicia distintos. Luego, se hace una evaluación crítica de dichas interpretaciones y se intenta avanzar argumentos en contra de la interpretación permisiva. [The (...) objective of this study is to critically analyze the new formulation of the principle of post-trial access in the most recent (2008) revision of the Helsinki Declaration. The relevant articles of the declaration are identified and two possible interpretations of the principle of post-trial access are set out; one robust and one permissive, inspired by different models of distributive justice. A critical evaluation of both interpretations is presented and arguments against the permissive one advanced.]. (shrink)