Declaration of Principles

From a Declaration of Principles jointly adopted by a Committee of the American Bar Association and a Committee of Publishers... 

The Declaration of Principles stated by the World Suimnit on the Information Society (WSIS, 2003) indicated the necessity to share information and knowledge. It thereby places emphasis on the particular importance of Information and... 

International Committee of the Red Cross (1969) Declaration of principles for international humanitarian relief to the civihan population in disaster situations. Int Rev Red Cross 104 632-633... 

Assembly Resolution 2526 (XXV) on the Declaration of Principles of International Law and incompatible with the purposes and principles of the Charter. 

Sndan Nnba 31 Jnly 1996 Declaration of Principles for the Resolntion of the Nnba Monntains Problem between the Government of Sndan and the Nnba Monntains United SPLM/A, Nairobi 19 Jannary 2002 Agreement on the Cessation of Hostilities... 

Richard Dennis Debobes, Declaration of Principles of Interim Self-government Arrangements , 35 Survival, (1993-1994). 

ELO (2006) Tripartite declaration of principles concerning multinational enterprises and social policy. International Labour Office, Geneva, http //www.ilo.org/public/english/employment/ multi/download/declaration(2006).pdf. Accessed 4 June 2014 ISO Standard 26000 (2010) Guidance on social responsibihty. ISO (International Organization for Standardization), Geneva... 

Rosenstock R (1971) The declaration of principles of intematimial law concerning fiitaidly relations a survey. Am J Int Law 65 713-735... 

To ensure that that the rights, safety and well-being of trial subjects are protected, in accordance with ethical principles that were developed by the World Medical Organisation and set out in the Declaration of Helsinki. 

Clinical trials shall be conducted in accordance with the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects... 

Outcomes from the trial must be communicated to the subjects promptly and in an unbiased way. In addition to the ethical guidelines by the NIH, the World Medical Association has formalized a document called the Declaration of Helsinki—Ethical Principles for Medical Research Involving Human Subjects to describe the constraints on research involving human beings. Those countries that have signed this declaration are bound by the ethical principles. An extract of this document is given in Exhibit 6.3. 

Ethical Principles for Medical Research Involving Human Subjects The World Medical Association has developed the Declaration of Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. Medical research involving human subjects includes research on identifiable human material or identifiable data. 

Bioethics is a discipline that deals with the moral issues of biological research and its application in medicine. The United Nations Educational, Scientific and Cultural Organization (UNESCO) in its 2005 Universal Declaration on Bioethics and Human Rights addresses ethical issues related to medicine, life sciences, and associated technologies as applied to human beings. The aim of the declaration is to provide a universal framework of principles and procedures... 

Over the years, scientific research with human subjects has provided valuable information to help characterize and control risks to public health, but its use has also raised particular ethical concerns for the welfare of the human participants in such research as well as scientific issues related to the role of such research in assessing risks. Society has responded to these concerns by defining general standards for conducting human research. As an example, studies carried out for the authorization of a medical product, have to be conducted in line with the World Medical Association s Declaration of Helsinki, which describes the general ethical principles for medical research involving human subjects (World Medical Association 2004). The Helsinki Declaration was first issued by the World Medical Association in 1964 and has been revised several times since then. 

The principles of medical research are based on the Declaration of Helsinki. The general assemblies of the World Medical Association (WMA) have, since 1964, made recommendations for guiding physicians in clinical research involving human subjects. Although not legally binding, the Declaration forms the foundation of all other significant international documents on the ethical conduct of biomedical research. 

In October 2000, the latest revision of the Declaration of Helsinki was approved by the WMA (see Appendix 1). The new version is very different from previous versions, with more detail on how clinical trials should be conducted. It requires that study subjects should have access to the best treatment identified by the study once the study has been completed. It also recommends that local participants in a study should be able to benefit from the study results, whether they are positive or negative. These principles were approved to avoid the exploitation of economically poor countries. In addition, the Declaration requires greater transparency regarding economic incentives involved in clinical research. 

Ethical issues and randomisation There are ethical issues with randomisation. There are two t)rpes of ethics which are associated with human, medical research - individual and collective ethics. Individual ethics recognises the primacy of the individual and is aimed at doing what is best for the subjects in the current trial. In contrast, collective ethics is aimed at doing what is best for all future patients who will benefit from the results of the current trial. Clearly, there is a tension between these two principles that is recognised in the declaration of Helsinki, which comes down on the side of the individual ... 

A very useful review of the history and development of the Declaration of Helsinki in the last four decades from its evolution from the principles enunciated in the Nuremberg Code of 1947 to the current version has been published in the British Journal of Clinical Pharmacology and is recommended reading, it includes the texts of the various versions of the Declaration. 

It is on this basis that WHO has lead the establishment of the International Medical Product Anti-Counterfeiting Taskforce, IMPACT (www.who.int/ impact). IMPACT aims at gathering and mobilizing all key stakeholders at the international, regional and national level in order to effectively combat counterfeit medicines within the guiding principles enshrined in the Declaration of Rome (Box 7). 

World Medical Association (2000) Declaration of Helsinki Ethical principles for medical research involving human subjects , adopted in 1964, last amended 2000, www.wma.net/e/ policy/b3.htm, accessed January 2007... 

---