Day Werts - Comment

Re: The proposed amendment to patient informed consent It seems to me that unless any of the 18 personal identifiers are included in the data contained on the clinical trial registry, the data submitted are no longer "human" and therefore this addition to the consent is unnecessary and superfluous. Moreover, it adds to the already stiltifying nonsense that you keep adding to consents. I'm a professional in the cancer business and am responsible for managing clinical trials. I can barely understand a 20page consent now. How 'bout considering the patient who is anxious and frightened of their diagnosis and treatment. Does anyone really believe they understand the consent? How 'bout seeing what you can do to reduce the size of these documents rather than adding to them.