Author: Christine Grady
Position: Research Scientist
Institution: National Institutes of Health
E-mail: cgrady@nih.gov
Submitted Date: December 17, 2007
Published Date: December 18, 2007
This comment was originally posted as a “Reader Response” on the publication date indicated above. All Reader Responses are now available as comments.

Our starting point was concern that individuals who don't understand that "the defining purpose of clinical research is to produce generalizable knowledge" instead think they are receiving clinical care. We did not envision the individual(s) who somehow knew they were in research, but weren't paying attention or somehow don't care what the defining purpose is. However, as Dr. Wendler points out, the definition might be strengthened by recognizing that failure to understand the purpose of research is problematic when someone therefore is left thinking they are involved in clinical care - and in that way their 'consent' to *research* is at least possibly suspect.