Helsinki, Declaration

Investigations must be conducted in accordance with the ethical principles contained in the Helsinki Declaration. 

Japan has adopted the ICH GCP guidelines for clinical trials since 1997. It upholds the Helsinki Declaration to ensure the rights, welfare, and privacy of subjects are protected in clinical trials. Japan accepts foreign clinical trials, but bridiging trials may need to be performed to take into consideration effects of ethnic factors. 

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 Helsinki Declaration covers all the important ethical considerations, such as the involvement of a qualified physician in any clinical... 

The Helsinki Declaration covers all the important ethical considerations, such as the involvement of a qualified physician in any clinical trial, putting the well-being of the study subject before science and society, the use of scientific principles in the design of the study, the need for informed consent and a review by an ethics review committee in fact, all areas covered by the ICH GCP. 

Non-inferiority trials are becoming more and more common as time goes on. This in part is due to the constraints imposed by the revised Helsinki Declaration (2004) and the increasing concern in some circles regarding the ethics of placebo use. These trials however require very careful design and conduct and we will discuss this whole area in a subsequent chapter. 

Helsinki Declaration (2004) Ethical Principles for Medical Research Involving Human Subjects WMA General Assembly, Tokyo 2004... 

Helsinki Declaration Declaration of Helsinki recommendations guiding doctors in clinical research. Fed. Reg. 40(69), 16056, 1975. 

World Medical Association Helsinki Declaration, available at www.wma.net/e/. 

ASEF as a well-established link between the regions could play a significant role, e.g. by developing a communication strategy for Asian regions and therefore putting into practice the Helsinki declaration on the future of ASEM ... 

ASEM (2006). Helsinki Declaration on the Future of ASEM, Helsinki, 10-11 September 2006... 

All participants in a clinical trial must respect ethical and professional principles and guidelines such as the Helsinki Declaration and the International Conference on Harmonisation (ICH) guidelines for GCP. 

The modem clinical trial (see section at end of Glossary) is an example of medical research. The two watershed events for the required ethics and structured ethical directives were the Nuremberg Code in response to Nazi experiments and the Helsinki Declaration on Human Rights (1964). These well-publicized events laid out the basic ethical principles for medical researchers to follow. Yet these principles were violated in several other reference cases and these in turn gave rise to the modem US regulations. 

Subjects and Loading of Oils. Six male volunteers (Table 2) were given orally the emulsified experimental oils (30 g lipid/m of body surface area) in the early morning after fasting for at least 12 h. The double-blind, crossover study was conducted in accordance with the principles of the Helsinki Declaration. All subjects gave their informed consent before starting this experiment. In the first examination, 3 of the men... 

In this study, 713 children attended the sampled classrooms. The children legal guardians received an envelope with information regarding the project as well as a written consent form, in accordance with the Helsinki declaration. The UFP exposure dose rates were calculated for all 488 (aged 8 to 10 years old) that were authorized to participate in the study (66.8%). Children s UFP exposure dose rates was calculated using the age and body weight-specific formula presented as Equation 1, which has been validated in previously published studies (Ginsberg et al., 2005, Kalaiarasan et al., 2009, Castro et al., 2011, Fonseca et al., 2014). 

We tested CRP levels in serum samples of 62 healthy individuals, 263 patients with liver disease, and 230 diabetic patients. Fifty diabetic patients had type 2 diabetes and were not under insulin treatment. All patients were examined in the Surugadai Nihon University Hospital, Tokyo, between April 2005 and March 2007. The study was approved in advance by the Ethics Committee of the hospital, and was conducted in accordance with the Helsinki Declaration. AH study pwticipants provided written informed consent prior to participation in this study. 

Ten healthy, adult volunteers (7 females and 3 males) participated in this study with normal vision. Their ages were between 19 and 43 years old. The study protocol had been approved by the local ethics committee and the Helsinki Declaration covering the use of human subjects was observed at all times. All subjects provided their written, informed consent in advance. 

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