Taking stock of financial disclosures: Most want to know, won't drop out

Knowing that an investigator has a financial interest in a clinical trial doesn't substantially affect people's willingness to participate, according to a study that surveyed 470 people about their reaction to informed consent documents that detailed such interests.

Separating public health from research a challenge

The activities of state public health departments including disease tracking, cancer registries and death statistics can be a rich source of data for research.

Tool measures capacity of Alzheimer's patients to give consent for research

A recent study of an instrument for assessing decisional capacity in patients with Alzheimer's disease shows that it's a reliable tool for determining whether those patients are competent to give their own consent for research.

Strategies for handling poorly-written protocols

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 protocols.

Advisor pilot program an immediate success

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 to be returned to investigators, according to the IRB director.

IRB improves consent forms with help from analysts

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. Investigators and sponsors tend to include long sentences and paragraphs and technical jargon that leads the MEGO syndrome "my eyes glaze over," says Stewart A. Laidlaw, PhD, an associate vice president for compliance at the Los Angeles Biomedical Research Institute at the Harbor-UCLA Medical Center (LA BioMed) in Torrance, CA.

Quality assurance in trials protects human subjects

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

Clinical trial professionals and investigators should reconsider the inclusion/exclusion criteria and other factors to meet the needs of their study participants, an expert suggests.

December 1, 2008