Need for Clinical Trial Registry and Institutional Review Board Approval in Human Subjects Research

Declaration (revised edition of 2004) and in principle undergo scrutiny of an independent IRB which reviews ethical issues of the human experiment. But, in clinical studies, the approval of the IRB and patient’s consent must be received and stated on paper.” We must change our guidelines according to the revised act by changing ‘clinical studies’ to “human subjects research.” Some researchers may think that the need for a clinical trial registry and IRB approval in human subjects research are obstacles in the research process; however, adhering to such guidelines will bring us closer to our goal of becoming a leading journal in the international medical community.