[Instruction on Clinical Samples and Ethical Guidelines -How We Should Handle These Matters, Measurements, and Problems in Kyoto Prefectural University Hospital-]

Since 2013, the institutional review board (IRB) of Kyoto Prefectural University of Medicine has adopted an on-line application system for medical research protocols to shorten the term of examination. In the same year, research misconduct regarding valsartan (Diovan®) was disclosed, which prompted our institute to reorganize research ethics especially through the Center for Quality Assurance in Research and Development. Concerning the questions asked by Prof. Tohyama, the answers from the IRB of our institute were as fol- lows: 1) the evaluation of new instruments or reagents should be approved by the IRB if it may be exhibited at an academic meeting or published in a scientific journal, 2) non-invasive non-interventional data collection without prior approval would become a target of verbal warnings by the IRB, and 3) residual samples after laboratory examination could be available for research use if the protocol is explained to the patients with an opt-out guarantee. For research use of residual samples after laboratory examination, we have been able to issue a letter of consent for laboratory examination since 2008. However, unfortunately, this letter does not seem to be convenient for the majority of clinicians in our hospital. A more useful and reasonable method seems neces- sary to assist clinical research using residual samples based on Ethical Guidelines for Medical and Health Research Involving Human Subjects, which was newly published in 2015. [Review].