-
IRBs should ask themselves: Are we gatekeepers? Or are we collaborators, navigators, and concierges?
-
For about 30 years, the Indiana University School of Medicine in Indianapolis has had a research partnership with Moi University's Teaching and Referral Hospital in Eldoret, Kenya, including an exchange program for medical students. As the clinical collaboration grew, IU researchers partnered with researchers at Moi to conduct studies in Kenya and other parts of Africa.
-
Not every clinical trial report sees the light of day. Some are abandoned when trial sponsors no longer actively seek publication, or when a study is misreported and no efforts are made to correct it.
-
Research institutions nationwide continue to look for ways to improve quality while eliminating redundancy, regulatory creep, and inefficiencies. The key to success is flexibility and considering changes in any type of process that is not working as efficiently as possible, experts say.
-
Informed consent discussions and recommendations are important and time-consuming. IRBs continually seek ways to improve the informed consent process while also finding better and more efficient ways of handling them. One way to streamline the IC process could be to make certain IRBs are not inundated with IC forms unnecessarily.
-
Research programs and IRBs across the nation increasingly are focusing on streamlining their human subjects research programs. One change that has grown over the past decade involves "unchecking the box" on the Federalwide Assurance (FWA).
-
The Food and Drug Administrations Center for Drug Evaluation and Research (FDA CDER) has issued a draft guidance to make it easier for development and testing of Alzheimers treatments in patients at an early stage of the disease.
-
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.
-
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.
-
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?
