Providing Public Engagement Training to Build Connections Between the Community and Research Ethics Professionals: A Pilot Project.

There is growing interest for research ethics professionals to engage with members of the public, yet they often lack the training needed to engage effectively. The STEM Ambassador Program provides a promising framework for training research ethics professionals to form authentic community connections and carry out effective engagement activities based on shared interests and values. The experiences of ten research administrators who participated in a pilot of the STEM Ambassador training for research ethics professionals are presented.

Using single IRB consultations to meet the educational needs of investigative teams.

Single IRB (SIRB) consultation resources were established by the Utah Trial Innovation Center to assist and educate investigative teams prior to the submission of funding applications for multisite, cooperative research. Qualitative analysis of the written consultation materials and meeting minutes revealed the most common areas of education needed by investigative teams, including (a) the differences and relationships between the IRB and a Human Research Protection Program (HRPP); (b) the main phases of the SIRB process; and (c) the use of technology platforms for documentation of SIRB review processes. For investigative teams who are inexperienced with using a SIRB, such consultation in the pre-award period is likely to fill in knowledge gaps and improve the study start-up process.

Key lessons and strategies for implementing single IRB review in the Trial Innovation Network.

The Trial Innovation Network has established an infrastructure for single IRB review in response to federal policies. The Network's single IRB (sIRBs) have successfully supported over 70 multisite studies via more than 800 reliance arrangements. This has generated several lessons learned that can benefit the national clinical research enterprise, as we work to improve the conduct of clinical trials.

An Approach to Reviewing Local Context for Exception from Informed Consent Trials Using a Single IRB.

In the context of emergency research, researchers can ask the institutional review board (IRB) to waive the regulatory requirement that individuals provide informed consent when enrolling in research studies. A requirement of the waiver of informed consent is that the reviewing IRB must review and approve a community consultation and public disclosure plan. It is critical that an IRB serving as the single IRB (sIRB) for multisite research be thoroughly versed in the local context concerns for each participating site to determine whether the site's community is being adequately consulted about the research in which individuals will be enrolled under an exception to the informed consent requirement.

Implementing a Central IRB Model in a Multicenter Research Network.

Implementing the National Institutes of Health's (NIH's) new single institutional review board (IRB) policy has caused a paradigm shift in IRB review across the country. IRBs and human research protection programs are looking more closely at their processes for ceding review and developing procedures to handle local review when relying on a single IRB. This article describes an NIH-funded network that proactively instituted a central IRB (CIRB) in 2012, anticipating the NIH future mandate.