Requirements for ethics approvals

In June of this year, the Journal’s guidelines to authors on ethics approval were modified. The principal modification arose from recognition that data can be obtained from routine monitoring of athletes and others as a condition of their employment.This editorial provides some background for the change. The need for ethics approval of studies in which humans are participants can be traced to the Nuremburg Military Tribunals that were held from 1945 to 1949. These Tribunals prosecuted and convicted perpetrators of crimes against humanity that had occurred during the Second World War. At the time of the trials, there were no defined principles for ethical conduct in research studies. As a result, psychiatrist and neurologist Dr. Leo Alexander was appointed chief medical advisor to Telford Taylor, the United States Chief of Counsel for War Crimes, to provide guidance. Alexander proposed six points that defined legitimate medical research. The Tribunals adopted these and added four more. These ten points became known as the Nuremberg Code. The Code formed the basis of the United Nations Universal Declaration of Human Rights, which was announced in 1948. In 1964 in Helsinki, the World Medical Association formally adopted the United Nations Declaration as the model for the conduct of research in which humans are participants. The Declaration of Helsinki and its subsequent modifications define the principles that should underpin all research on humans. Anxieties remained, however, and Beecher (1966) and Pappworth (1967) highlighted continued abuses. This led to the introduction of independent scrutiny of proposals in advance of the commencement of studies that now governs practice. The Journal fully supports the principles and practices of ethics approval and requires that published manuscripts include explicit statements that such approval has been granted by a recognized institutional committee or review board. Normally, such a statement is included in the Methods section of manuscripts. Where data are in the public domain, a similar explicit statement to that effect must be made, and where analyses arise from media broadcasts, a statement about appropriate permissions to use such broadcasts should be made. In the context of sport science support, there might be exceptional circumstances where retrospective analyses of data could provide valuable information on matters such as the identification of talented athletes, growth and development of such athletes, and evaluation of training and other interventions. In professional sport, these data can arise as a condition of employment in which athletes and players are routinely measured at various stages of their competitiveand off-seasons. It is probable that these data are not obtained as part of a formal research project and hence have not been subject to scrutiny by a properly constituted ethics committee. Moreover, in occupational settings, principles of informed consent might not be fully upheld. Exercise and other forms of functionalcapability testing is a requirement of employees such as players in professional soccer and rugby clubs and members of the armed and uniformed services. Although ethics-approved studies are the Journal’s clear preference, studies that arise from sport-science and similar support or occupationally based work will be considered for publication. In such cases, a clear statement about the source of data and the reasons for the absence of prior approval by an appropriate body, such as their requirement as a condition of employment, must be made explicitly. This change is facilitatory for a restricted area of work, and should not be interpreted as an easing of normal requirements for ethics approval. All studies must still conform to the highest standards that these approvals represent. It is the responsibility of editors and researchers to acknowledge and abide by the precedents that dictate practice.