IRB Advisor – July 1, 2004
July 1, 2004
View Issues
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IRBs may be less effective if policies fail to address psychological dynamics
IRBs are no different from other boards in how their psychological structure could lead to personality clashes and conflicts. However, unlike many organizations, when IRBs ignore such conflicts, the outcome might be a less-effective human subjects protection program or regulatory problems. -
Special Report: Regulations and Rules-Are We Heading in the Right Direction?
Improving consent form should be top priority: Think outside the box and go beyond regulations -
What can be done about the unwieldy consent form?
The consent form is the IRBs document, but the sponsor may say, If youre not willing to include this language, this disclaimer, then we wont open the trial at your institution, Joffe explains. Then the IRB can think of creative ways to put it in there without distracting from the message they want to convey in the consent form. -
Expedited reviews call for same due diligence
IRB members and others in the research community sometimes have misconceptions about the use of the expedited review process, including the idea that an expedited review is different from a review by the full IRB. -
Spotlight on Compliance: Who pays when trial subjects are injured?
A basic tenet of research involving human subjects is those who agree to be participate must give their informed consent after being informed about the known and unknown risks inherent in their participation. One category of risk is the possibility of injury. -
House subcommittee probes consulting fees
Drug and biotech companies that have paid government scientists for consulting services soon will receive a request from a House subcommittee to voluntarily release financial details of such agreements.