Dissatisfied with the electronic IRB research management solution in use since 2007, OhioHealth Research & Innovation Institute set out to find a new solution that would meet its needs for compliance, efficiency, customer service, and cost. OhioHealth’s decision to implement IRBNet presented several clear advantages: rapid start up, seamless integration, and elimination of IRB IT […]
The IRB at Inova Health System of Falls Church, VA, began working with a central IRB 15 years ago. Since then, the IRB developed a well-organized process for its partnerships with independent IRBs. This article reviews some best practice strategies for developing an optimal relationship with a central IRB of record.
Studies show that most clinical trial participants want to know what was learned from their involvement. A growing number of sponsors are implementing plans to deliver plain language summaries to trial participants. Read this white paper, co-authored by the Center for Information and Study of Clinical Research Participation (CISCRP) to learn about the current best practices […]
In May 2018 the U.S. Food and Drug Administration (FDA) and the U.S. Office for Human Research Protections (OHRP) issued final guidance titled Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs. The 21st Century Cures Act requires the Secretary of the Department of Health and Human Services (HHS) to harmonize differences between […]