IRB Advisor – March 1, 2013
March 1, 2013
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Do IRB members read protocol review folders before meetings?
In days not so long ago, when all IRB members received heavy stacks of paper packets containing protocol submissions before each meeting, research institutions and regulatory compliance officials never questioned whether they would read the work before meetings. It was assumed they would be well-prepared for discussions. -
Here are steps to improve IRB member compliance
Research institutions with concerns about an IRBs preparation for reviews and regulatory compliance could learn a few lessons on how to assess their performance and improve any problems from the experience of the IRB at WellSpan Health in York, PA. -
Data integrity should be top priority
As research institutions become more thoroughly electronic in their IRB and clinical trial systems, they should not lose sight of the importance of securing all transmitted data, an expert says. -
Therapeutic misconception not well understood
What IRBs and the research ethics community commonly believe is evidence of therapeutic misconception among research participants often is the result of misinterpretation by the experts, a researcher says. -
IRB takes data storage to the cloud
IRBs run on data and paper and lots of it. Some organizations may find themselves running out of space to store the reams of paper that are needed to catalog the scores of research and submission data. This has led some IRBs to look for alternative methods of data storage. But an IRB cant live without paper or can it? -
GlaxoSmithKline to begin publishing trial data
Drugmaker GlaxoSmithKline (GSK) has announced its intentions to start publishing clinical study reports (CSRs) and clinical trial results in an effort for increased transparency, making it the first major drug company to do so. -
FDA lays path for early Alzheimer’s trials
The Food and Drug Administrations Center for Drug Evaluation and Research (FDA CDER) has issued a draft guidance to make it easier for development and testing of Alzheimers treatments in patients at an early stage of the disease. -
Study identifies barriers to use of central IRBs
A study conducted by the Clinical Trials Transformation Initiative (CTTI) identified some of the barriers IRBs may face when choosing a central IRB for multicenter studies.