The study of ethical issues of clinical trials on medical devices

2016 Fiscal Year Final Research Report

• Project/Area Number: 25871233
• Research Category: Grant-in-Aid for Young Scientists (B)
• Allocation Type: Multi-year Fund
• Research Field: Medical engineering assessment; Medical sociology
• Research Institution: The University of Tokyo (2015-2016); National Cardiovascular Center Research Institute (2013-2014)
• Principal Investigator: Haruka Nakada 東京大学, 医科学研究所, 特任研究員 (10592248)
• Project Period (FY): 2013-04-01 – 2017-03-31
• Keywords: 補助人工心臓 / 臨床試験 / 研究倫理

Outline of Final Research Achievements

We found that the investigators should make adequate considerations for the participants in clinical trials of implanted medical devices as follows: support after the trial periods or withdrawal from the trial, providing the information of daily life with implanted devices. In addition to these considerations, we should deal with the participants’ information during the trials periods carefully in the media reporting. We need to balance the protection of the participants’ privacy rights and transparency of the trials.

Free Research Field

研究倫理