IRB Advisor articles from October 2008

IRB Advisor archives from October 2008

Court treatment order raises serious ethical questions about research.
October 1, 2008... Court treatment order raises serious ethical questions about research Treatment INDs should be balanced decision When a judge recently ordered a pharmaceutical company to provide an investigational drug to a teenage boy who had not met...

Did company go too far in subject recruitment?
October 1, 2008... Did company go too far in subject recruitment? Overnight stays blur boundaries, experts say Subject recruitment is one of the more ethically troubling issues raised by the recent case in which a judge ordered that a teenager receive an...

Follow the money: IRB office boosts collections.
October 1, 2008... Follow the money: IRB office boosts collections Taking ownership has dramatic impact IRB fees that are not billed or collected may cost an IRB office the staffing and resources it needs to maintain efficiency and quality in reviewing...

Avoid mission creep, blurred boundaries for IRB.
October 1, 2008... Avoid mission creep, blurred boundaries for IRB Worry less about liability An IRB expert makes the case that an IRB can improve its quality by working smartly with data safety monitoring boards (DSMBs), rather than sliding into their...

Tribal IRBs shape research in native populations.
October 1, 2008... Tribal IRBs shape research in native populations IRBs can point out potential harm to communities Across the country, Native American communities have begun setting up their own research processes -- in some cases, their own separate...

IRBs should consider effect on community.
October 1, 2008... IRBs should consider effect on community Regulations 'a floor, not a ceiling' While tribal and community IRBs can bring a unique perspective to the study of a specific population, all IRBs should consider community concerns in their...

Human subjects violations cited in report on AR facility.
October 1, 2008... Human subjects violations cited in report on AR facility Investigators: IRB failed to follow-up problems A Veterans Health Administration hospital in Arkansas is currently being monitored by the VA after an investigation found human...

Work with PBRNs to tailor HSP training.
October 1, 2008... Work with PBRNs to tailor HSP training One-size-fits-all training can be burdensome Because practice-based research networks (PBRNs) conduct research across a web of physicians' offices, making sure the necessary staff are trained in...

CNE/CME objectives/questions.
October 1, 2008... CNE/CME Objectives The CNE/CME objectives for IRB Advisor are to help physicians and nurses be able to: *establish clinical trial programs using accepted ethical principles for human subject protection; *apply the mandated...