When attempting to activate a clinical trial, one of the biggest concerns an institution faces is turnaround time. At Cedars-Sinai Medical Center in Los Angeles, activation of a new clinical trial could sometimes take 118 days, including IRB review, study team response time, and non-IRB required reviews such as contract negotiations. But for some protocols, including early-stage oncology or therapeutic studies, the institution looked for other ways to bring those new therapies to patients as efficiently and safely as possible.
As often happens in research, new rules, policies, and guidelines often follow media reports of research integrity and ethical breaches.
IRBs might help board members improve their protocol review process through the use of a tool that guides them through questions to ask about each study.
Technology now is driving the way informed consent documents are formatted and presented, according to an expert.
Experts offer strategies for international research
Universities and colleges that once thought international research was beyond their reach increasingly are looking for and finding ways to conduct research overseas, some experts say.
IRB managers sometimes are daunted by the prospect of streamlining their program.