The clinical trial studies conducted in the Shizuoka Cancer Center are strictly deliberated by its ethical review board to obtain approval in advance.
The board deliberates clinical trial studies conducted in the Shizuoka Cancer Center. The board consists of our medical staff such as doctors and nurses, our non-medical staff and other outside members, independent of us, to maintain the fairness of the board.
The Shizuoka Cancer Center has two ethical review boards, namely the “Ethical Review Board for Clinical Studies” and the “Ethical Review Board for Business Clinical Trial Studies”.
Both boards deliberate clinical trial studies, but the “Ethical Review Board for Business Clinical Trial Studies” deliberates new clinical trial studies to be carried out in April 2010 onward. The “Ethical Review Board for Clinical Trial Studies” deliberates changes to old clinical trial studies approved by the end of March 2010. Roster of the Ethical Review Board for Clinical StudiesRoster of the Ethical Review Board for Business Clinical Trial StudiesThe person responsible for the clinical trial study submits a plan document (protocol), which describes how the study will be conducted, and the letter of consent, which is used to explain about the clinical trial study to patients in order to obtain their approval, to the president of the Shizuoka Cancer Center. The president will then request that the ethical review board deliberate the proposed clinical trial study.The ethical review board will check the presented data to see whether the proposed clinical trial study is acceptable scientifically and ethically and report the results of their deliberations to the president. The president will then decide whether or not the proposed study is acceptable based on the deliberation results, but cannot approve the implementation of a study, which has been rejected by the ethical review board.
In some cases, the president may reject a study, which was approved by the ethical review board, if the president judges that the study cannot be approved.
For patients participating in a clinical trial study, the responsible doctor, nurse, pharmacist or clinical research coordinator (CRC) will explain the details.
We will explain about the purpose of the clinical trial study, method, cost for participation in the study and risks such as side effects in detail before patients decide whether or not to participate.
Needless to say, patients can decide freely whether or not to participate in the study, etc.
In addition, they can cancel their participation even after agreeing to participate in the study.
When a patient participates in a clinical trial study, etc., in some cases, we may report his or her sex, birth date and medical record number to an outside data center.
However, important information such as his or her name, address and telephone number, which can be used to identify an individual, will never be revealed to any outsider unless approved by the patient.
