Ethical aspect

After all the answers from the interviews had been uploaded, an expert analysed each supply chain for each of the seven defined criteria for quality and safety microbial toxins and abiotic contaminants potential pathogens natural plant toxicants freshness and taste nutrient content and food additives fraud social and ethical aspects. For example, an expert on freshness and taste would check each major step in a supply chain for tomatoes to determine if it fulfilled the definition of a CCP (HACCP, Principle 2) in relation to freshness and taste for this commodity. If the step was considered to be a CCP, the answers in the questionnaire that related to relevant substeps at this step would be reviewed, to assess the control procedures that were in use for this CCP. The expert would then fill in the text field, structuring the input to consist of the following points ... 

The government had required that the sponsors should have their own in-house study review board to review the ethical aspects of clinical trial protocols. Such a requirement was based on the former Japanese GCP, which stipulates that the company should organise an internal formal body or mechanism that reviews and authorises its planned studies before submitting to either study centres or the MHW for clinical trial plan notification. 

The IRB is responsible for judging all studies to be conducted at the centre concerned by reviewing protocols, the informed consent sheet, the investigator s brochure and other materials relating to the conduct of clinical trials. The IRB is also responsible for monitoring whether the clinical trials are conducted in compliance with both GCP and IRB s requirements, if any. When the study period of a clinical trial exceeds 1 year the IRB should review the study every year. As the new GCP allows the study sponsor to pay a reasonable amount of money to the study subjects, the IRB is expected to review whether the amount and method of payment is reasonable and does not infringe upon the ethical aspects of the study. Also, the advertisement of a trial for patient recruitment is allowed, but the IRB s approval to implement this at the study centre is required. 

The mission of clinical research is to provide scientifically appropriate and accurate information about new treatments in patients, keeping the safety of the patient as absolute priority referring to the law of Hippocrates Nil nocere (Not to harm). An additional ethical aspect of clinical research is the demand of high scientific standards. Therefore ... at the start of the trial, there must be a state of clinical equipoise regarding the merits of the regimens to be tested, and the trial must be designed in such a way as to make it reasonable to expect that, if it is successfully conducted, clinical equipoise will be disturbed (Freedman, 1987). 

Organic plant breeding and seed production ecological and ethical aspects... 

New therapies offer new chances, but also carry new risks. The risks include unknown efficacy and unknown side effects, whereas the chances include higher efficacy, lower side effects or easier applicability. The patient should be informed in detail about possible benefits, problems and open questions of different alternative therapies, and should be involved in the decision. Even such steps increase compliance and thereby success. An acceptable ethical aspect for the consideration of a therapy may be the mean state or severity of a disease, which is necessary to convince a patient of the need for such a therapy. This level might be lower for noninvasive immunotherapies than for invasive immunotherapies, and an earlier initiation of any kind of immunotherapy seems to lead to greater success. This hypothesis has yet to be proved by clinical investigations in allergy. 

As Schulte and Sweeney (1995) state, scientists like to think of gathering and interpreting data as being independent from the social and political context...But where controversies surround the issue of health risks, as they do in the case of biomonitoring data, the communication and ethical aspects cannot be divorced from the use of the data. 

Clinical Barriers and Attention to Social, Legal, and Ethical Aspects... 

Each study component has an ethical aspect. The ethical aspects of a clinical trial cannot be separated from the scientific objectives. Segregation of ethical issues from the full range of study design components demonstrates a flaw in understanding the fundamental nature of research involving human subjects. Compartmentalization of ethical issues is inconsistent with a well-run trial. Ethical and scientific considerations are intertwined (p. 4). 

Ethical considerations are of the utmost importance in clinical research, and the ethical aspects of new drug development will be highlighted throughout this book. (See also Salek and Edgar, 2002.)... 

Various regulatory agencies around the world are working to increase the number of clinical trials involving children. The FDA s Office of Pediatric Therapeutics focuses on both clinical and ethical aspects of clinical research in pediatric populations and works to increase the scientific understanding of the medical needs of children. 

The principles and practices concerning the clinical conduct with particular emphasis on ethical aspects are stated in guidelines. These principles have their origins in The Declaration of Helsinki . 

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