Monday, August 26, 2013

Treatment or Research? The Government Decides

Two neurosurgeons at the University of California - Davis (UCD) have resigned over an investigation into their activities at the university. The two neurosurgeons reportedly injected bacteria into the brains of patients in hopes that the bacteria would induce an immune reaction that would fight cancer. UCD launched an investigation and found that that the surgeons were conducting research without the proper ethical protocols. The surgeons argue that they were providing treatment, not conducting research.
Read more about the case at the website:
http://chronicle.com/blogs/ticker/2-neurosurgeons-who-were-accused-of-misconduct-at-uc-davis-resign/65193

The Office for Human Research Protections (OHRP) under the U.S. Department of Health and Human Safety (http://www.hhs.gov/) provides a definition of human subject research on their website.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.102
The definition indicates that activities might be considered research even if the activities are not "conducted or supported under a program which is considered research for other purposes."

The moral of the story -- caveat scolaris (scholar beware).

No comments:

Post a Comment