The SMART IRB platform: A national resource for IRB review for multisite studies.

Single institutional review board (IRB) review of multisite research increased in frequency over a decade ago with a proliferation of master IRB reliance agreements supporting statewide and regional consortia and disease- and population-specific networks. Although successful, the increasing number of agreements presented significant challenges and illuminated potential benefits of a single, nationwide agreement. Anticipated changes in federal regulations highlighted the need to systematize and simplify IRB reliance. To address these challenges, the NIH National Center for Advancing Translational Sciences funded a project to establish a national IRB reliance network that would support national adoption of single IRB (sIRB) review. The Streamlined, Multisite, Accelerated Resources for Trials (SMART) IRB Platform launched in July 2016 to facilitate dissemination, adoption, and implementation of a collaboratively developed master IRB reliance agreement and supportive tools and resources. More than 580 institutions have joined SMART IRB's Master Common Reciprocal Institutional Review Board Authorization Agreement and begun using the SMART IRB platform to support sIRB arrangements. Here, we describe the tenets of the agreement and operational benefits and challenges of its use. SMART IRB's early success affirms the utility of collaborative, flexible, and centralized approaches to supporting sIRB review while highlighting the need for further national harmonization.

Correlating phenotype and genotype in autism spectrum disorder research.

Genotype-phenotype association studies often require investigators to collaborate across institutions and research disciplines. However, the relevant data are often inaccessible, heterogeneous, and difficult to correlate. Our query aggregator allows an investigator to compose a query, broadcast it to Autism Consortium databases and aggregate the query results in near-real-time. This collaborative infrastructure enables integrative investigations across disciplines, institutions and modalities, and may drive new hypotheses for the genetic basis of disease.

Communications and Web services: What do CDC users desire in partner relationship management and does CDC's PHIN Directory meet the need?

The National Center on Birth Defects and Developmental Disabilities (NCBDDD) at the Centers for Disease Control and Prevention (CDC) sought to establish a database to proactively manage their partner relationships with external organizations. A user needs analysis was conducted, and CDC's Public Health Information Network Directory (PHINDIR) was evaluated as a possible solution. PHINDIR could sufficiently maintain contact information but did not address customer relationships; however, its flexible architecture allows add-on applications via web services. Thus, NCBDDD's needs could be met via PHINDIR.