Compensation for venipuncture complications at medical studies whose invasive examination is venipuncture only

Abstract

In the Ethical Guidelines for Medical and Health Research Involving Human Subjects, usual venipuncture dealt as a minor invasiveness can be performed by the expedited review, and medical studies whose invasive examination is venipuncture only are not required to purchase a compensation insurance. Further, in clinical study insurances, complications of venipuncture are exempted from payment as a complication of medical practice. In clinical studies performed by other than clinical sectors, it is difficult for them to pay the medical care expenditure for complications of venipuncture, and use medical malpractice insurances which was subscribed by the hospital. Venipuncture is only invasion in blood donation, and the relief system for sufferers from blood donation complication has been established, and it can pay medical care and transportation expenditure for the complications, and compensation for permanent disablement. In medical studies whose invasive examination is venipuncture only, they should pay medical care and transportation expenditure, and compensation for permanent disablement. To pay those, the clinical study insurance including those payments should set for medical studies whose invasive examination is venipuncture only. Moreover, ethical committees should deliberate, in case of venipuncture complications, how to pay medical care and transportation expenditure for the complications, and compensation for permanent disablement.