On May 2, 2016, the National Center for Advancing Translational Science (NCATS) hosted a workshop for CTSA institutions to discuss the impending Federal requirement for a single institutional review board (IRB) reliance approach for multisite clinical studies sponsored by the National Institutes of Health (NIH) and recent progress towards developing a national level reliance review system amongst CTSA partners. The NIH proposal requiring single IRB use was previously outlined as an element of a larger "Notice of Proposed Rule Making" (NPRM) in September 2015 (https://www.federalregister.gov/articles/2015/09/08/2015-21756/federal-policy-for-the-protection-of-human-subjects ).

Of the 300 individuals who attended the conference, several of our CTSC leads participated in these discussions including: Philip A. Cola (Director of Regulatory Knowledge and Support Core (RKS) and local PI for the National Reliance Grant subcontracted to Case by Dartmouth and funded by NCATS), Kathy Lawry (Co-director of RKS and State of Ohio Regional electronic IRB HUB lead), Bridget Howard (Executive Director, CC IRB and Key Personnel on RKS), Megan Miller (Manager UH Clinical Research Unit and Key Personnel on Hub Capacity through Trial Innovation Network Application on subject recruitment) and James Chmiel (Co-Director of HUB Capacity and Co-Investigator on Trial Innovation Network application). The crux of the discussion surrounded the utilization of the SMART IRB Reliance platform and discussion of how NIH may determine what institution(s) will be able to serve as "IRBs of Record" .

CTSC partner institutions have participated in our own evolution of the reliant review processes over the course of the last 7 years, first locally as part of the CTSC Facilitated Review Network, regionally as part of the State for Ohio Reliance Review Network and then nationally under the NCATS supported grant "IRBRely" subcontracted with Dartmouth. As such, we do not anticipate locally developed processes and requirements for CTSC research institutions will change substantially. Local reliant review policies will be updated to include final NIH determination on whether a single site may serve as IRB of record nationally or they will allow several IRB of Records, one for each of the various regional "hubs" participating in an NIH sponsored trial. In addition, investigators will be educated on the use of the SMART IRB electronic system being developed at Dartmouth and Harvard. Currently, the CTSC handles reliant review requests amongst IRB administration staff, with minimal input from site PI, however NIH will now require the local PI of a participating NIH grant to submit requests personally within the national level electronic IRB reliant review system. Additional topics such as training requirements, appropriate billing and charge back mechanisms (direct and indirect costs) for using the platform and supporting local infrastructure, and implications for the new Trial Innovation Network hubs (soon to be announced by NCATS) were also discussed.

The final rule, which requires domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program, was published by NIH on June 21, 2016 (https://www.nih.gov/about-nih/who-we-are/nih-director/statements/single-irb-policy-streamline-reviews-multi-site-research ) and will go into effect for all competing grant applications submitted on or after May 17, 2017. Updates will be provided to local investigators in the near future with instructions as to how the new rule affects internal processes and procedures.

The Teen Pregnancy Prevention Program (TPP) looks at sexual health education programming through the use of fidelity checklists which are administered by program facilitators, objective observations made by staff, and data collected from students. Associate Director Erika Trapl, PhD and Research Associate Sarah Koopman-Gonzalez (pictured) are set to lead the program into its first year of implementation this fall.

Read more about the project in the PRCHN Newsletter.

The PRCHN is collaborating with the YMCA of Greater Cleveland, the Cleveland Urban Design Collaborative, and bike advocacy nonprofit Bike Cleveland to make Cleveland a more bicycle-friendly community as defined by the League of American Bicyclists (LAB). LAB uses bike ridership, safety, and education to to award communities with the status of a "Bike-Friendly Community", and currently Cleveland is rated at the bronze level. 

For more information go to: http://connectyourcommunity.org/updated-maps-shows-no-broadband-majorities-in-most-cleveland-and-detroit-neighborhoods/ 

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Monday, August 29, 2016; 4-7 pm; CWRU School of Medicine E321/323 

Education in the health professions is adopting instructional methods that require learners to engage with the material and apply knowledge to authentic problems using active instructional methods.  This workshop provides an orientation to Team-Based Learning (TBL) for health professions educators.   Participants will describe the theory, structure, and process of TBL, explain how TBL promotes problem solving and critical thinking skills and identify how it aligns with the goals of basic science courses.  Participants will describe the evidence of comparing TBL to other methods in terms of knowledge retention and application, and developing learners as practitioners. 

To register contact Diane Dowd at caml@case.edu. 

For more information view the School of Medicine homepage

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For more information visit the Damon Runyon webpage.

The American Association for Cancer Research (AACR) has announced that the following grant opportunities are currently being offered.

For more information visit the Meso Foundation webpage.

Medical Technology Enterprise Consortium (MTEC) has announced a solicitation focused on the clinical, prototyping, and manufacturing needs to develop a visual prosthesis that addresses capability gaps for vision restoration and rehabilitation. Specifically, this research opportunity will seek to develop an innovative solution for prototyping an appropriate brain-machine interface.

The Harrington Prize for Innovation in Medicine, presented by the American Society for Clinical Investigation and Harrington Discovery Institute at University Hospitals, honors a physician-scientist who has moved science forward with notable achievements in innovation, creativity and potential for clinical application.

This annual prize includes:

* An unrestricted $20,000 honorarium

* The Harrington Prize Lecture, delivered at the 2017 AAP/ASCI/APSA Joint Meeting

* Participation at the Harrington Discovery Institute annual symposium

* A personal essay, published in the Journal of Clinical Investigation

Nominations are being accepted through August 29, 2016.

For more information visit the Harrington Project webpage.

For more information visit the NIH webpage.

The ORISE Research Participation Programs at FDA accept applications from students, recent graduates, and faculty researchers year round.

Check out Pure Experts, a directory of researcher expertise that enables collaboration among researchers! For more information on Pure, see the Pure Brochure.

Also be sure to contact our Research Concierge Service for all CTSC and research-related queries.