IRB Advisor articles from December 2008

IRB Advisor archives from December 2008

Taking stock of financial disclosures: Most want to know, won't drop out.
December 1, 2008... Taking stock of financial disclosures: Most want to know, won't drop out More express negative views of stock interests held by PIs Knowing that an investigator has a financial interest in a clinical trial doesn't substantially affect...

Separating public health from research a challenge.
December 1, 2008... Separating public health from research a challenge IRBs must walk a blurred line The activities of state public health departments -- including disease tracking, cancer registries and death statistics -- can be a rich source of data...

Tool measures capacity of Alzheimer's patients to give consent for research.(Clinical report)
December 1, 2008... Tool measures capacity of Alzheimer's patients to give consent for research Survey results tracked opinions from experts A recent study of an instrument for assessing decisional capacity in patients with Alzheimer's disease shows that...

Strategies for handling poorly-written protocols.
December 1, 2008... Strategies for handling poorly-written protocols A jumble of jargon, tech terms, acronyms Put any group of IRB administrators into the same room and soon you'll hear a discussion about how they have to deal with so many poorly-written...

Advisor pilot program an immediate success.
December 1, 2008... Advisor pilot program an immediate success Reduction in returned protocols The new IRB Advisor pilot program at Rutgers, The State University of New Jersey in New Brunswick, NJ, resulted in a reduction in protocol submissions that had...

IRB improves consent forms with help from analysts.
December 1, 2008... IRB improves consent forms with help from analysts Avoiding the 'MEGO' syndrome It's just about a given that informed consent documents making their way to the IRB for approval will need to be revised for comprehension and readability....

Quality assurance in trials protects human subjects.
December 1, 2008... Quality assurance in trials protects human subjects Ensures they receive treatment specified in protocol Quality assurance programs for clinical trials do more than improve the data coming out of studies and the validity of the results....

Amend protocols to participants' needs.
December 1, 2008... Amend protocols to participants' needs Add flexibility to inclusion/exclusion criteria Clinical trial professionals and investigators should reconsider the inclusion/exclusion criteria and other factors to meet the needs of their study...

CE/CME objectives/questions.
December 1, 2008... CE/CME Objectives The CE/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...