Researchers who use people in medical and scientific experiments should set up careful reviews of their work that are independent of any potential for profit, the U.S. government said on Wednesday.
New guidance from the Health and Human Services Department said every experiment involving people should be reviewed for potential financial conflicts of interest.
HHS has been examining the use of human research volunteers since the death in 1999 of Jesse Gelsinger, 18, during a gene therapy experiment. His doctors stood to profit from the gene therapy approach had it been shown to work.
The issue has become increasingly important as more and more academic scientists, who once toiled for usually low salaries, set up companies to exploit their research. Many universities also now have departments devoted to figuring out how to make money from research.
While no one has shown that anyone has recklessly treated a patient during experiments of potentially profitable therapies, doctors and health regulators say it is important to avoid even the appearance of doing so.
“All who take part in research deserve the strongest possible protection,” HHS Secretary Tommy Thompson said in a statement. “Openness and honesty help promote ethical research and can only strengthen the research process.”
The guidance is aimed mostly at the institutional review boards that already review experiments on human volunteers at universities and other institutions.
Responsibility for research activities should be separated from the institution’s financial interests, the new guidance says. Universities should also set up conflict of interest committees to make sure monetary concerns do not affect decisions to go ahead with experiments.
HHS published the guidelines on the Internet at http://ohrp.osophs.dhhs.gov/humansubjects/finreltn/finalguid.pdf
Revision date: July 4, 2011
Last revised: by Sebastian Scheller, MD, ScD