IRBIRB Institutional Review Board Establishment of Institutional Review

This organization was established on 2003 for of research and development of institutional review board enlightenment activities, related to state of the art medicine to contribute to the development of medical care.

On April 2006, according to amendment of GCD, it became able for IRB established by medical NPO to examine clinical trials other than IRB established by a leader of medical institutions. This is to improve the quality of clinical trials.

Therefore, since our organization established and ran IRB in March 2007 as a concrete plan to support clinical trials, we have made steady progress.

In clinical trials, to protect examinee fairness and specialty of examination are required. We organized an Institutional Review Board which is composed with experienced medical professionals from various fields as well as sensible general people to contribute to the development of new medical care by examining fairly and promptly.

Since amendment of GCD in April 2006, not only IRB established by leaders of medical institute but also groups such as medical NPO obtained a right to examine clinical trials. This attempt is to improve the quality of clinical trials. Therefore, our organization established and managed IRB to support clinical tests and its progress is outstanding.

Characteristics of JAPSAM IRB

  • Institutional Review Board is composed with skilled and experienced medical professionals from various fields. If there is not anyone from certain medical field we are examining in our members, we appoint an observer who is a medical professional from the field to seek for advice if necessary.
  • We hold a meeting once a month and hold a special meeting if necessary.
  • We report result of examination promptly.

Advisory Board

  • It is composed with outstanding members from medical field.
  • It supports management of our IRB.

Contents of our Review

  • Advisory Board examination before clinical trials: institution, doctor to carry a clinical test, protocol, agreement explanation etc.
  • Advisory Board examination during clinical trials: safety information, examination of revision and continuation of protocol.
  • Quick examination: slight changes in protocol etc.

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