Regulatory issues - informed consent for a device investigation.

Regulatory issues - informed consent for a device investigation.

For any patient about to undergo surgery, consent must be given; otherwise, the surgeon would be committing an assault. When a subject is to participate in a medical device investigation which is basically an experiment, a great deal more information is needed to assure that consent is really inform...

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Chi tiết về thư mục
Xuất bản năm:IEEE Engineering in medicine and biology magazine 23, 3 (2004).
Tác giả chính: Munzner, R.
Định dạng: Bài viết
Ngôn ngữ:English
Những chủ đề:
United States.
Drug investigations.
Human research committees.
Informed consent.
Institutional review board.
Medical device investigation.
Patient surgery.
Regulatory issues.
Risk assessment.
Surgeon.