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M Sugimoto, S Masutani, M Seki, H Kajino, K Fujieda, H Senzaki. High serum levels of procollagen type III N-terminal amino peptide in patients with congenital heart disease Heart 2009;95:2023–28 Published Online First: 6 August 2009 doi:10.1136/hrt.2009.170241

The author Hideaki Senzaki was the chief investigator and was responsible for the mis-statement: “the procedures were approved by the Committee on Clinical Investigation of Saitama Medical University” which was mentioned in each of these publications. The statement was inaccurate because he did not obtain approval for the procedures from the ethics review committee of the hospital. The procedures were approved for clinical use and all patients provided informed consent, but a Clinical Investigation Committee had not reviewed this specifically, and the studies themselves involved retrospective analysis of previously obtained data.

The author apologises but would also like to add these points:

1.There were no ethical guidelines for clinical research issued by the Japanese Government until July 2003. In fact, the institutional review board (IRB) for clinical research was established in the author's hospital in 2004. Referring to IRB before performing and/or publishing clinical studies of a retrospective nature was not a routine process in Japan in those days.

2. As mentioned, the studies described in the above publications relate to analysis of data collected from routine medical care and catheterization, which had been initiated before 2003. In other words, the study protocol was retrospective in nature.

3. In each study, a signed informed consent form was obtained from each patient or parents/guardians.

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