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New Conflict-of-Interest Guidelines Issued
By Lauren E. Losely
In May, the U.S. Department of Health and Human Services issued final guidelines on the financial involvement of researchers in human subject research. Noting that when researchers have a financial interest in their findings, their research results and the welfare of their human subjects can be compromised, the guidelines seek to limit the financial interest of researchers in the outcomes of their studies.
Human research conducted or supported by the health and human services department must be reviewed and approved by an institutional review board (IRB). As of 2000, roughly 4,000 IRBs were operating in the United States, primarily at universities, hospitals, and private research facilities. The new guidelines on IRBs seek to safeguard the rights and welfare of human subjects and to ensure that researchers who review research have no conflicts of interest. The guidelines do not specify a dollar threshold at which a conflict would occur. Instead, they suggest that each institution at which research is conducted draw up a list of financial relationships that might cause conflicts of interest, decide at what level such relationships should be barred, and perhaps form committees to examine conflicts of interest or to establish policies governing them.
The new guidelines, titled Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human-Subject Protection, replace a draft issued in 2001.
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