IRB Advisor – May 1, 2004
May 1, 2004
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Developing and assessing institutional conflict of interest policy can be tricky
When the National Institutes of Health (NIH) recently became the target of intense public criticism and scrutiny over potential conflicts of interest (COI) among NIH directors and staff and clinical trials, it became apparent to the research world that this is an issue that could be a problem for any institution. The best prevention strategy is to be proactive by having policies, procedures, and possibly a special committee that reviews COIs, experts say. -
NIH changes COI policy in response to scrutiny
IRBs and institutions might take away two important thoughts from the NIHs recent experience: First, it doesnt take more than the appearance of a conflict to harm ones reputation. Secondly, some of the measures NIH has taken in response might guide institutions in their own conflict of interest (COI) policy-making. -
Lawsuit challenges use of blood samples
The Havasupai Indian tribe of northwestern Arizona, and some of its individual members, have filed two federal lawsuits seeking a total of $75 million in damages against Arizona State University (ASU), the Arizona Board of Regents, and three university researchers, claiming that blood samples taken from tribe members as part of a diabetes study were destroyed, lost, or used in studies of schizophrenia, inbreeding, and population migration without the donors consent. -
Spotlight on Compliance, Experimental devices need FDA approval
A report in the March 25 Philadelphia Inquirer regarding the use of experimental treatment on an infant in connection with a heart repair highlights a series of issues related to both the use of devices not approved by the FDA and, in turn, their use on minors, including infants. -
Research on prisoners requires OHRP approval
The regulations regarding the use of prisoners in research have not changed since 1978, but the research communitys awareness and perception of these have changed. As a result its a good idea for IRBs to update policies regarding such research. -
Common compliance problems: IRB issues
Add up the number of citations of noncompliance related to IRB issues that the Office of Human Research Protections (OHRP) at the Department of Health and Human Services in Rockville, MD, handed out between October 1998 and June 2002 and the numbers are pretty staggering. Of the 1,120 citations given to 155 institutions, 1,014 of them say something about IRB noncompliance and deficiencies. -
News Brief
Bernard Schwetz to head OHRP.