Helsinki declaration

Abstract: This article updates the ethical standards and methods for the conduct of high-quality animal and human biological rhythm research, which should be especially useful for new investigators of the rhythms of life. The editors of Chronobiology International adhere to and endorse the Code of Conduct and Best Practice Guidelines of the Committee On Publication Ethics (COPE), which encourages communication of such updates at regular intervals in the journal. The journal accepts papers representing original work, no part of which was previously submitted for publication elsewhere, except as brief abstracts, as well as in-depth reviews. The majority of research papers published in Chronobiology International entails animal and human investigations. The editors and readers of the journal expect authors of submitted manuscripts to have made an important contribution to the research of biological rhythms and related phenomena using ethical methods/procedures and unbiased, accurate, and honest reporting of findings. Authors of scientific papers are required to declare all potential conflicts of interest. The journal and its editors endorse compliance of investigators to the Guide for the Care and Use of Laboratory Animals of the Institute for Laboratory Animal Research of the National Research Council, relating to the conduct of ethical research on laboratory and other animals, and the principles of the Declaration of Helsinki of the World Medical Association, relating to the conduct of ethical research on human beings. The peer review of manuscripts by Chronobiology International thus includes judgment as to whether or not the protocols and methods conform to ethical standards. Authors are expected to show mastery of the basic methods and procedures of biological rhythm research and proper statistical assessment of data, including the appropriate application of time series data analyses, as briefly reviewed in this article. The journal editors strive to consistently achieve high standards for the research of original and review papers reported in Chronobiology International, and current examples of expectations are presented herein.

Abstract: Bibliography DOI https://doi.org/10.1055/a-1015-3123 Published online: 15.10.2019 Int J Sports Med 2019; 40: 813–817 © Georg Thieme Verlag KG Stuttgart · New York ISSN 0172-4622 Correspondence D. J. Harriss Research Institute for Sport and Exercise Sciences Liverpool John Moores University Tom Reilly Building Byrom Street Campus Webster Street L3 3AF Liverpool United Kingdom Tel.: + 44/15/19 04 62 36, Fax: + 44/15/12 07 32 24 d.harriss@ljmu.ac.uk

Abstract: The Declaration of Helsinki is a respected institution and one of the most influential documents in research ethics,1w1-w7 having withstood five revisions and two clarifications since its conception in 1964. Its guardian, the World Medical Association, recently invited submissions for further revision.2 The history of the declaration has been well documented.3 4 5 The Nuremberg Code (1947) was one of the first statements of the ethical principles involved in human experimentation.w8 However, because of its association with Nazi war crimes it had relatively little effect on practice.w9 The Declaration of Helsinki dealt with clinical research more directly, but was portrayed as a weakening of the stringent protections of Nuremberg. Nevertheless, for a quarter of a century only minor changes were made and it became engrained in the international culture of research ethics. In 1996, the declaration added a reference to placebos in response to concerns about trials in perinatal HIV transmission in developing countries. Critics pointed out that continuing to use placebos when efficacy had been demonstrated implied a different ethical standard for developing countries than for developed ones. Having entered into the specifics of trial design the declaration was drawn into a debate on whether ethical principles are universal or are relative to the context in which they are applied6 and also into related principles of research in developing countries. The World Medical Association was then pressured to make more radical reforms. An American proposal, seen by some as a further attempt to weaken the declaration, resulted in a vigorous debate, but despite lack of consensus and strong feelings by some that it should not be changed,7 a major revision was approved in 2000. This did little to improve acceptance. Concerns were also expressed that the cumulative changes represented a shift towards protecting the efficiency of research at the expense of the protection of human subjects. A division between developed and developing countries also emerged with claims of American ethical imperialism,6 8w10 although new emphasis on social justice and a duty to benefit communities as well as individuals received praise. Complaints about clarity resulted in the addition of footnotes in 2002 and 2004, but this also failed to achieve global endorsement. The situation was further complicated by the appearance of other guidelines, including those from the Council for International Organizations of Medical Sciences,w11 the Nuffield Council,w12 and Unesco (United Nations Educational, Scientific, and Cultural Organisation),w13 which were seen to be potentially conflicting. It was even suggested that the declaration was out of touch and irrelevant.9 The debate on the future of the declaration raises several fundamental questions about the essential purpose of the declaration, its structure (basic principles or procedural rules), its status (static or dynamic), the extent to which it can influence understanding and practice, and the nature and limits of universality in ethics. The nature of the declaration has progressively changed from simply restating Nuremberg as an ethical code to being increasingly prescriptive.10 The more procedurally based it has become the more divergent opinion has become, with calls for reversion to the simplicity and conciseness of a Nuremberg-like document. Other guidelines by contrast provide detailed commentaries, and the declaration may fail by being neither code nor commentary. The arguments surrounding the declaration point to a failure to clearly separate related but distinct concepts—standard of care, ethical standards, ethical principles, and the operationalisation of principles. Whether “ethical standards” are considered universal will depend on what exactly is meant by this term. They have been criticised as representing the North American context in which they were formulated.11 The more that basic principles are elaborated, the more room there is for interpretation and dissent. Among core ethical principles, respect for the individual's autonomy and their community have traditionally been considered the most important. The principle of autonomy has recently undergone much rethinking. Autonomy should not be thought of as always completely free of external influence, but to be relational, constrained by factors such as health, social relationships, sex, and power inequality.w14 The debate has occurred within too narrow a formal framework, without sufficient attention to the inherent inequalities and vulnerability that characterise the relationship between subjects and researchers. It requires reframing by stating that respect for the individual needs to encompass both their individuality and the cultural and relationship factors that shape their decision making. The World Medical Association needs to respond to criticisms that a lack of transparency in its revision process does not reflect the spirit of openness and disclosure in articles 11, 16, and 27 of the declaration. Similar considerations of transparency should apply to all aspects of the conduct and results of research itself, as described in the Ottawa Statement (ottawagroup.ohri.ca/index.html). The declaration has only limited direct legal authority1 but has gained considerable moral authority. As such it is more symbolic than instrumental. Symbolic function is evident by people's attitude towards it, and the frequency with which they use it to justify their opinions. Its instrumental role derives from direct reference in legal statutes, and indirectly through influence on legislators and courts.1 It is difficult to estimate how effective the declaration is. Claims that it is violated daily raise questions as to how effective it can be in the absence of monitoring or enforcement. However, a complete understanding of the role of the declaration requires us to recognise that it represents an external imposed morality, not the researcher's own internal morality,w15 which limits its ability to influence practice. Ethical research is a collective responsibility. Unless researchers incorporate the ethical principles outlined by codes such as Helsinki into their own and the collective morality12 they will remain simply words. The Declaration of Helsinki is a brave venture and “the property of all humanity,”4 which has the potential to continue to promote high ethical standards and protect the vulnerable, but only if we embrace it. The declaration's strength lies in its core principles, which are a moral compass transcending procedural rules and revisions.

Abstract: The World Medical Association's Declaration of Helsinki was first adopted in 1964. In its 40-year lifetime the Declaration has been revised five times and has risen to a position of prominence as a guiding statement of ethical principles for doctors involved in medical research. The most recent revision, however, has resulted in considerable controversy, particularly in the area of the ethical requirements surrounding placebo-controlled trials and the question of responsibilities to research participants at the end of a study. This review considers the past versions of the Declaration of Helsinki and asks the question: How exactly has the text of the Declaration changed throughout its lifetime? Regarding the present form of the Declaration of Helsinki we ask: What are the major changes in the most recent revision and what are the controversies surrounding them? Finally, building on the detailed review of the past and present versions of the Declaration of Helsinki, we give consideration to some of the possible future trajectories for the Declaration in the light of its history and standing in the world of the ethics of medical research.