World Medical Association, Declaration Helsinki

Exhibit 6.3 World Medical Association Declaration of Helsinki... 

World Medical Association Declaration of Helsinki, Ethical Principals of Medical Research Involving Human Subjects, accepted on June 1963, latest amendment 2002. Available at www.wma.net/e/policy/b3.htm. 

World Medical Association Declaration of Helsinki (2000 Update) http //ohsr.od.nih.gov/guidelines/helsinki.html... 

APPENDIX 2—MAJOR COMPONENTS OF THE WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI ... 

World Medical Association, Declaration of Helsinki, Ethical Principles for Medical research... 

Schmidt, U.,andA. Frewer, The Declaration of Helsinki as a Landmark for Research Ethics—Protecting Human Participants in Modern Medicine , in The World Medical Association Declaration of Helsinki, 1 64-2014. oYears of Evolution of Medical Research Ethics, edited by U.Wiesing, R.W. Parsa-Parsi, and O. Kloiber (Cologne, Deutscher Arzteverlag, 2014b), pp. 56—7. 

World Medical Association Declaration of Helsinki, www.wma.net/en/30publications/ 10policies/b3/ (accessed July 12, 2014). 

World Medical Association. Declaration of Helsinki, amended Sept. 1989 in Hong Kong. 01210 Femay-Voltaire, France The World Medical Association, Inc., 1989. 

Assuming that standard codes of conduct, for example, the Nuremburg Code (1947) and the World Medical Association s Declaration of Helsinki, are followed by researchers, the element of consent will already have been satisfied. In fact, as far as the element of consent to the intrusion into privacy goes, the medical community s doctrine of informed consent is a very strict application of the element of consent. We may note that the specific informed consent of an individual human subject of research may not be adequate to the decisions surrounding data mining. 

First, the most recent (October, 2000) revision of the Declaration of Helsinki (World Medical Association, 2000) calls for discontinuing the use of placebo controlled trials in patients. While this is not currently binding on U.S. trials (FDA has specifically said that they will not mirror this as a requirement), and is intended to protect the health of participating patient subjects by precluding having some denied existing efficacious treatments (which would be the effect in most—but not all—cases), it will also likely cause the numbers of subjects required in a trial to increase. This will further stretch the economic aspects of limitations on the power of trials to assess potential drug safety in what will be the intended patient population. Trials are already very expensive each additional subject enrolled costs 15,000 or more in a Phase 11 or 111 trial. 

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. 

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. 

In the evaluation of human health risks, sound human data, whenever available, are preferred to animal data. Animal and in vitro studies provide support and are used mainly to supply evidence missing from human studies. It is mandatory that research on human subjects is conducted in full accord with ethical principles, including the provisions of the Helsinki Declaration (World Medical Association 2000). 

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. 

World Medical Association (WMA). Declaration of Helsinki, 52nd WMA General Assembly, Edinburgh, Scotland. Available at http //www.wma. net/e/pohcy/17-c e.html. Assessed 26June 2001. 

World Medical Association. 52nd Assembly, Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects. Edinburgh World Medical Association, Inc., 2000. 

The clinical trial guidelines published by the TGA specify that all clinical trials must be conducted in accordance with the Declaration of Helsinki, October 1996. The World Medical Association updated the Declaration of Helsinki in October 2000 but these changes were not adopted in Australia due to concerns in relation to the interpretation of two new clauses. 

Declaration of Helsinki. World Medical Association 2004 [cited 2008 Feb 25]. Available from URL http // www.wma.net/e/policy/b3. htm... 

For more than 50 years, scientists, physicians, bioethi-cists, and the media have focused on a variety of issues in research with human subjects, or clinical research. In 1948, in response to the atrocities perpetrated by Nazi experimentation, the Nuremberg Code was developed to set forth guidelines for the acceptable conduct of scientific research. In 1964 the World Medical Association adopted the Declaration of Helsinki, which specifically guides physicians in biomedical research. These documents specify basic moral guidelines ultimately founded on concerns for autonomy, beneficence, and justice. The guidelines require the following ... 

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