Clinical Research is a “Medical Research”subject to Human Beings.
Medical Research covers broader area from Biological Science Research and Basic Medicine Research to Therapeutic Trial.
Clinical Research is conducted in purposing to the prevention of disease, diagnostic, improvement of the medical treatment, clarification of pathogenesis of disease and the improvement of patient quality of life.
According to “The Ethical Guidelines for Clinical Research”, by The Ministry of Health, Labor and Welfare, Medical Research directed to Humans is targeting Humans (including sample and information of human) to:
Through above mentioned 1 thru 4
Stipulated as the activity targeting to acquire effective knowledge. Targeting to Humans is a clinical Research, but whether or not the sample and information which can identify the individuality is depending on “The Ethical Guidelines for Clinical Research”, by The Ministry of Health, Labor and Welfare.
Clinical Research is target to long-term developed diseases, or an unusual disease. Diagnosis of diseases or decision of the treatment principle, and various inspection for the follow-up are conducted at daily diagnosis. At the inspection, it is common to pick up several kinds of samples (blood, urine, coughed-up sputum, pleural effusion, ascites fluid, irrigation solution, spiral fluid, physiological tissue, extraction/ablation tissue, and so on). These samples are very important for “Human-targeted medical research”.
It is therefore, targeting for contributing to the progress on Medical Care, we preserve residual samples or things resulting from these samples. We are unable to go forward unless we have majority people understandings and support for “Human-targeted medical research”, which analyze the relation between samples and diagnosis information.
Regarding the sample (including residual sample) pick-up and/or collection and usage of diagnosis information, we must have every individuals’ written consent, and severe protection for character and individual information, furthermore Tokushukai Ethical Review Board evaluates severely and strictly how to use these samples at research activity. Samples only become available for the research activity after Ethical Review Board approved the usage. In addition, even after the agreement, it is able to retract the consent whenever necessary.
The relations of Clinical Research, Clinical Test and Clinical Trial are shown as below.
Clinical Test means that, within the Clinical Research, to evaluate the outcome with intervention on medical treatment and/or guidance.
Clinical Trial means that, within the Clinical Research, the activity targeting to collect objective data, in order to make new drug or medical equipment usable at ordinary medical care after getting the authorization by national government.
|Medical Research||Huma-targeted medical research|
|Clinical Test||Within Clinical Research, the activity targeted in evaluating the safety and effectiveness of Pharmaceutical, Cure method, diagnose method and prevention method.|
|Clinical Trial||Within Clinical Research, the activity to get an authorization from national government for new drug or production and distribution of medical equipment.|