Insights

OhioHealth Case Study

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 […]

IRBs can make the most of central IRB partnerships

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.

Returning Study Results to Research Participants

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 […]

Written Procedures for IRBs: What Does the New Final Guidance from FDA and OHRP Mean to You?

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 […]

To What Extent Do Risks Need to Be Minimized?

Practical Ethicist column from the Journal of Empirical Research in Human Research Ethics.

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