Stakeholder Reflections on Implementing the National Institutes of Health's Policy on Single Institutional Review Boards.

The National Institutes of Health (NIH) requires use of a single institutional review board (sIRB) for multisite, nonexempt, NIH-funded research with human participants. The Clinical Trials Transformation Initiative (CTTI) conducted in-depth interviews with 34 stakeholders at two universities and in research administration leadership positions at multiple institutions about their experiences implementing the sIRB model, focusing on the NIH policy's goals soon after the policy was enacted. While some stakeholders suggested that using an sIRB has streamlined and reduced inefficiencies associated with the local IRB model, more stakeholders indicated that the sIRB model has not simplified the ethics review process and instead created new inefficiencies due to unclear roles and responsibilities for staff and institutions; a lack of systems and processes for implementing the sIRB model, including communication systems; and increased workloads.

Steps toward a System of IRB Precedent: Piloting Approaches to Summarizing IRB Decisions for Future Use.

Institutional review boards (IRBs) have been criticized for inconsistency and lack of transparency in decision-making, problems that undermine both trust in their ability to protect human research participants and respect for their decisions among researchers. The absence of robust documentation of their decisions and the inability or unwillingness to share those decisions together represent a missed opportunity for IRBs to learn from one another and advance debates about challenging ethical issues. The concept of IRB precedent, modeled upon the system of legal precedent, has been proposed as a potential solution to these problems.

Institutional Review Board Assessment-Balancing Efficiency and Quality.

Satisfactory measurements of the quality of institutional review board (IRB) reviews and services continue to be elusive. For evaluative purposes, the review process can be separated into two parts: the administrative functions that support the review board and the review board's decisions. Administrative performance and board decision-making lend themselves to very different measures of quality.

Late complications following treatment for severe aplastic anemia (SAA) with high-dose cyclophosphamide (Cy): follow-up of a randomized trial.

High-dose cyclophosphamide (Cy) has been promoted as curative therapy for severe aplastic anemia (SAA). However, our randomized trial comparing antithymocyte globulin (ATG) and Cy was terminated early because of excess morbidity/early mortality in the Cy arm. We now report analysis of secondary endpoints at a median of 38 months.