-
Clinical researchers may be looking to expand their program horizons as some areas of research continue to grow.
-
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).
-
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 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.
-
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.
-
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.
-
The Food and Drug Administrations Center for Drug Evaluation and Research (FDA CDER) has issued a draft guidance to make it easier for development and testing of Alzheimers treatments in patients at an early stage of the disease.
-
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.
-
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.
-
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.
